e10vk
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2005 |
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OR |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period
from to |
Commission file number: 000-50447
Pharmion Corporation
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization) |
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84-1521333
(I.R.S. Employer
Identification No.) |
2525 28th Street, Suite 200,
Boulder, Colorado
(Address of principal executive offices) |
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80301
(Zip Code) |
720-564-9100
(Registrants telephone number, including area code)
None
(Former name, former address and former fiscal year, if
changed since last report)
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Title of Each Class
Common Stock, $.001 par value per share
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act.
Yes o No þ
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Exchange Act.
Yes o No þ
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of
Regulation S-K is
not contained herein, and will not be contained, to the best of
registrants knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this
Form 10-K or any
amendment to this
Form 10-K. o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer. See definition of accelerated filer and large
accelerated filer in
Rule 12b-2 of the
Exchange
Act. Large accelerated filer o Accelerated
filer þ Non-accelerated
filer o
Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2 of the
Exchange
Act). Yes o No þ
As of June 30, 2005, the aggregate market value of the
registrants voting and non-voting common equity held by
non-affiliates of the registrant was $628,659,909 based on the
closing sale price of our common stock as reported on the
National Association of Securities Dealers Automated Quotation
System National Market System.
Indicate the number of shares outstanding of each of the
registrants classes of common stock, as of the latest
practicable date.
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Class |
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Outstanding at March 14, 2006 |
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Common Stock, $.001 par value per share
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31,921,740 shares |
DOCUMENTS INCORPORATED BY REFERENCE
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Document |
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Parts Into Which Incorporated |
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Proxy Statement for the Annual Meeting of Stockholders to be
held June 8, 2006 (Proxy Statement) |
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Part III |
TABLE OF CONTENTS
PART I
Unless the context requires otherwise, references in this
report to Pharmion, the Company,
we, us, and our refer to
Pharmion Corporation.
All statements, trend analysis and other information contained
in this Form 10-K
and the information incorporated by reference which are not
historical in nature are forward-looking statements within the
meaning of the Private-Securities Litigation Reform Act of 1995.
These forward-looking statements include, without limitation,
discussion relative to markets for our products and trends in
revenue, gross margins and anticipated expense levels, as well
as other statements including words such as
anticipate, believe, plan,
estimate, expect and intend
and other similar expressions. All statements regarding our
expected financial position and operating results, business
strategy, financing plans, forecast trends relating to our
industry are forward-looking statements. These forward-looking
statements are subject to business and economic risks and
uncertainties, and our actual results of operations may differ
materially from those contained in the forward-looking
statements. Although we may elect to update forward-looking
statements in the future, we specifically disclaim any
obligation to do so, even if our estimates change, and readers
should not rely on those forward-looking statements as
representing our views as of any date subsequent to the date of
this annual report.
Overview
We are a global pharmaceutical company focused on acquiring,
developing and commercializing innovative products for the
treatment of hematology and oncology patients. We have
established our own regulatory, development and sales and
marketing organizations covering the U.S., Europe and Australia.
We have also developed a distributor network to cover the
hematology and oncology markets in 22 additional countries
throughout Europe, the Middle East and Asia. To date, we have
acquired the rights to six products. With our combination of
regulatory, development and commercial capabilities, we intend
to continue to build a balanced portfolio of approved and
pipeline products targeting the hematology and oncology markets.
We had total net sales of $221.2 million in 2005,
$130.2 million in 2004 and $25.5 million in 2003.
Our current product portfolio consists of the following six
products:
Vidaza®
(azacitidine for injectable suspension) We obtained
worldwide commercialization rights to Vidaza from
Pharmacia & Upjohn Company, now part of Pfizer, Inc.,
in June 2001. In 2004, we received full approval from the
U.S. Food and Drug Administration, or FDA, for the
treatment for Myelodysplastic Syndromes, or MDS. Vidaza is the
first approved treatment for MDS, and the first of a new class
of drugs known as demethylating agents to be approved. We
launched Vidaza for commercial sale in the U.S. in July
2004 and we are seeking approval to market Vidaza in Europe. We
currently have an ongoing Phase III clinical trial in MDS
patients examining the effect of Vidaza on the survival of 354
high risk MDS patients as compared to treatment with best
supportive care with or without a chemotherapy agent. Initial
data from this study is expected to be available in late 2006 or
early 2007. Pending the outcome of the trial, we intend to use
initial data generated in the study as the basis of a submission
of a Marketing Authorization Application (MAA) to the
European Agency for the Evaluation of Medicinal Products
(EMEA) in 2007. In 2005, net sales of Vidaza were
$125.6 million, which represented approximately 57% of our
total net sales for 2005, compared to $47.1 million in 2004
(6 months only), or approximately 36% of total net sales
for 2004.
Thalidomide Pharmion
50mgtm
(thalidomide) We obtained commercialization rights
to thalidomide from Celgene Corporation for all countries
outside of North America and certain Asian markets. Thalidomide
has become a standard of care for the treatment of relapsed and
refractory multiple myeloma, a cancer of the plasma cells in the
bone marrow and there is a growing body of data that
demonstrates its benefit as a first-line treatment of this
disease. We began selling thalidomide in Europe on a
compassionate use or named patient basis under a risk management
program in the third quarter of 2003 while we seek full
regulatory approval for this drug in Europe and several
additional countries. Thalidomide Pharmion 50mg has been
approved as a treatment for relapsed and refractory multiple
myeloma in Australia, New Zealand, Turkey and Israel.
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Although thalidomide has become a standard of care for the
treatment of relapsed and refractory multiple myeloma, these
regulatory approvals represent the first, and to date, only,
regulatory approvals for this indication. Pending further data
review, we expect that results from the pivotal Phase III
clinical trial in multiple myeloma trial that we announced in
January 2006 will form the basis of an MAA submission to the
EMEA for thalidomide in the first-line treatment of multiple
myeloma by early 2007. In 2005, net sales of thalidomide were
$79.4 million, which represented approximately 36% of our
total net sales for 2005, compared to $65.3 million in
2004, or approximately 50% of total net sales for 2004, and
$15.6 million in 2003, or approximately 61% of total net
sales for 2003.
Satraplatin In December 2005, we obtained
commercialization rights to satraplatin from GPC Biotech AG for
Europe, Turkey, the Middle East, Australia and New Zealand.
Satraplatin is the only oral platinum-based compound in advanced
clinical development. Satraplatin has shown promising safety and
efficacy as demonstrated by improvement in progression-free
survival in a randomized study of first-line treatment of
patients with hormone-refractory prostate cancer (HRPC) and
is currently the subject of a Phase III registrational
trial as second-line chemotherapy treatment for patients with
HRPC. If the results of this pivotal Phase III trial are
positive, we expect data from the trial to form the basis of a
MAA in Europe that we expect to submit to the EMEA in early
2007. We are exploring, in collaboration with GPC Biotech, the
efficacy of satraplatin for other indications.
MGCD0103 In January 2006, we obtained
commercialization rights from MethylGene Inc. for
MethylGenes histone deacetylase (HDAC) inhibitors in
North America, Europe, Middle East and certain other markets,
including MGCD0103, MethylGenes lead HDAC inhibitor, as
well as MethylGenes pipeline of second-generation HDAC
inhibitor compounds for oncology indications. As a single agent
therapy, MGCD0103 has completed one Phase I clinical trial
with daily dosing in solid tumors and a second Phase I
clinical trial is underway in solid tumors. Two Phase I
clinical trials are ongoing in hematological cancers. A
Phase I/ II combination trial with our DNA methylation
inhibitor Vidaza was initiated in November 2005 and enrollment
is under way at major cancer centers in the United States.
Additional combination Phase I/ II and monotherapy
Phase II trials are expected to begin in 2006.
Our licensing agreement with MethylGene for their oncology HDAC
inhibitor program represents our growing commitment to the
development of drugs for the epigenetic control of cancer. Both
Vidaza, a demethylating agent and MGCD0103, an HDAC inhibitor,
demonstrate specific effects on the regulation of gene
expression. DNA methylation and histone deacetylation are two of
more studied epigenetic regulators of gene expression. Vidaza
has been shown to reverse the effects of DNA hypermethylation
with subsequent gene re-expression and, likewise, MGCD0103 has
been shown, in pre-clinical tests, to reverse the effects of
inappropriate deacetylation resulting in gene expression
reactivation. In contrast with cytotoxic cancer therapies that
kill both normal and cancer cells, epigenetic cancer therapies
may enable the reactivation of silenced genes and, thereby,
re-establish the cancer cells natural mechanisms to
control abnormal growth.
Innohep (tinzaparin) Innohep is a low
molecular weight heparin approved in the U.S. for the
treatment of deep vein thrombosis, or DVT, which occurs when a
blood clot develops in the deep veins of the legs. We obtained
the U.S. rights to this product from LEO Pharma A/ S, which
markets Innohep in Europe and several additional countries. We
re-launched Innohep as a treatment for DVT in cancer patients in
the fourth quarter of 2002, and used this drug to establish our
U.S. sales and marketing organization.
Refludan (lepirudin) Refludan is an
anti-thrombin agent approved in the U.S., Europe and several
additional countries for the treatment of heparin-induced
thrombocytopenia, or HIT, an allergic, adverse immune response
to heparin, resulting in an absence of sufficient cell platelets
to enable blood clotting. We obtained rights to this product in
all countries outside of the U.S. and Canada from Schering AG.
We began selling Refludan in Europe and Australia in the third
quarter of 2002, and used this drug to establish our European
and Australian sales and marketing organizations. We have no
ongoing clinical development program for this drug.
We were incorporated in Delaware in August 1999 and commenced
operations in January 2000. Our principal executive offices are
located at 2525 28th Street, Boulder, Colorado 80301, and
our telephone number is (720) 564-9100. Our website is
located at www.pharmion.com. The reference to our website does
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not constitute incorporation by reference of the information
contained on our website into this annual report on
Form 10-K.
Our periodic and current reports, and all amendments to those
reports, are available free of charge, on our website at
www.pharmion.com, as soon as reasonably practicable after we
have electronically filed them with, or furnished them to, the
Securities and Exchange Commission.
Our Strategy
We believe that there are significant opportunities available
for a multinational pharmaceutical company with a focus on the
hematology and oncology markets. Our strategy for taking
advantage of these opportunities includes the following key
elements:
Focusing on the hematology and oncology markets. We focus
on the hematology and oncology markets for several reasons. The
hematology and oncology markets are characterized by a number of
disorders with high rates of recurrence and a limited response
from current therapies or treatments, many of which include
severe side effects. New hematology and oncology product
candidates addressing unmet medical needs or providing a
superior safety profile are frequently the subject of expedited
regulatory reviews and, if effective, can experience rapid
adoption rates. While the overall global hematology and oncology
markets are substantial, many drugs directed at hematology and
oncology patients treat relatively small patient populations or
subsets of patients with a specific cancer type. There is a
large number of emerging biotechnology companies doing research
in hematology and oncology, many of which do not have the global
commercial and regulatory capabilities that we have. We believe
we can be a regional or global partner for these companies,
particularly for compounds that target smaller patient
populations. Also, because large, multinational pharmaceutical
companies are increasingly seeking products with very large
revenue potential, they often do not devote resources to develop
drugs they discover with the potential to treat these patient
populations, presenting us the opportunity to acquire, develop
and market these drugs. There are approximately 11,000
hematologists and oncologists practicing in each of the U.S. and
Europe. In addition, a small number of opinion leaders
significantly influence the types of drugs prescribed by this
group of physicians. We believe that we can effectively reach
the hematology and oncology markets with a relatively small
sales organization focused on these physicians and opinion
leaders.
Expanding and leveraging our global sales and marketing
capabilities. We believe that our U.S., European and
Australian sales and marketing organizations, combined with our
distributor network in other countries, distinguish us from
other pharmaceutical companies of our size. In each of these
markets, we have developed a highly-trained sales force that
targets the hematology and oncology communities in conjunction
with medical science liaisons focused on advocate development,
educational forums, clinical development strategies and clinical
data publications. By managing the global sales and marketing of
our products on our own and with our partners, we believe we can
provide uniform marketing programs and consistent product
positioning and labeling. In addition, we seek consistent
pricing across these markets to maximize the commercial
potential of our products.
Leveraging our global regulatory expertise. We have
assembled a team of highly experienced regulatory professionals
with multinational expertise in obtaining regulatory approvals
for new drugs and maintaining compliance with the regulations
governing the sales, marketing and distribution of
pharmaceutical products. While some early stage biotechnology
and pharmaceutical companies have developed regulatory
capabilities in the country in which they are located, we have
built an organization with multinational regulatory expertise.
We believe our regulatory experience enables us to devise time
and cost-efficient strategies to obtain regulatory approvals for
new drugs, and to choose the regulatory pathway that allows us
to get a product to market as quickly as possible. We can use
our resources efficiently to generate a regulatory submission
that can be used in multiple jurisdictions. Our global
regulatory expertise is an essential element of effectively
evaluating and developing late-stage product candidates. We
believe that this provides us with a competitive advantage in
attracting biotechnology and pharmaceutical companies with
products in development that they want to out-license.
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Acquiring attractive development stage products. We
intend to continue to acquire or in-license rights to
development-stage products to more fully exploit our regulatory,
sales and marketing capabilities and build our product pipeline.
To date, we have licensed rights to six products, including
three currently approved products, two late-stage development
products, including thalidomide which is approved in certain
jurisdictions outside the E.U., and one product in earlier stage
development. We believe this product mix gives us significant
near and intermediate term growth opportunities. Pending data
from three Phase III clinical trials studies for three
different products, we plan to submit three MAAs to the
EMEA in the next 12 to 15 months. Further, we believe
certain of our products have the potential to work
synergistically with each other. For example, Vidaza and
MGCD0103 represent therapies that target two of the more studied
epigenetic regulators of gene expression.
Our Products
Our product portfolio is focused on addressing unmet needs in
the hematology and oncology markets. We believe these markets
present us with significant commercial opportunities. The
primary products in our current portfolio include the following
compounds.
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Disease/Indication |
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Phase of Development |
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Licensor |
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Licensed Territory |
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Vidaza®
(azacitidine for injectable suspension)
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Myelodysplastic Syndromes (MDS), Hematological malignancies, and
Solid tumors |
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Approved for MDS in the U.S., South Korea and Switzerland.
Ongoing MDS Phase III/IV survival study with initial data
expected late 2006 or early 2007.
Pending initial data from the Phase III/IV study, European
marketing submission expected to be filed in early 2007.
Oral formulation in development.
Several ongoing Phase I and II single agent and combination
studies in MDS, other hematological malignancies and solid
tumors. |
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Pfizer, Inc. |
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Global rights |
Thalidomide Pharmion
50mgtm
(thalidomide)
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Relapsed and refractory multiple myeloma, newly- diagnosed
multiple myeloma |
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Approved in Australia, New Zealand, Turkey and Israel.
Compassionate use and named patient sales ongoing in Europe.
Phase III study in relapsed and refractory multiple myeloma
currently enrolling patients. Data from Phase III
first-line myeloma study being compiled and reviewed. European
marketing submission expected to be filed by early 2007. |
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Celgene Corporation |
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All countries outside North America, Japan and China (except
Hong Kong) |
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Product |
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Disease/Indication |
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Phase of Development |
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Licensor |
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Licensed Territory |
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Satraplatin
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2nd Line Hormone Refractory Prostate Cancer (HRPC) |
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Phase III trial in HRPC fully enrolled. Data expected Q4
2006. Pending data, European submission expected Q1 2007
Several Phase I and II single agent and combination studies
ongoing in multiple cancers. |
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GPC Biotech AG |
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Europe, Turkey, Middle East and Australia and New Zealand |
MGCD0103
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Hematological Malignancies Solid Tumors |
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Several Phase I and Phase I/II single agent and
combination studies ongoing in hematological and solid tumors. |
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MethylGene Inc. |
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U.S., Canada, Europe, Middle East, Turkey, Australia, New
Zealand and Thailand |
In June 2001, we entered into an agreement with
Pharmacia & Upjohn Company, now part of Pfizer, Inc.,
to obtain the exclusive worldwide manufacturing, marketing and
distribution rights to azacitidine, which we market under the
trademark
Vidaza®.
In May 2004, we received full approval from the FDA to market
Vidaza in the U.S. for the treatment of all subtypes of
MDS. Vidaza was the first drug approved for the treatment of MDS
and is still the only drug approved for all subtypes of the
disease. It is also the first of a new class of drugs known as
demethylating agents to be approved. The subtypes of MDS are:
refractory anemia (RA), refractory anemia with ringed
sideroblasts (RARS) (if accompanied by neutropenia or
thrombocytopenia or requiring transfusions), refractory anemia
with excess blasts (RAEB), refractory anemia with excess blasts
in transformation (RAEB-T) and chronic myelomonocytic leukemia
(CMML).
We launched Vidaza for commercial sale in the U.S. in July
2004. We have assembled a field-based commercial organization in
the U.S. of approximately 100 employees, including sales
representatives, medical science liaisons, payor relation
specialists, nurse educators, national account managers, and
field-based management. In addition, we have developed medical
education programs geared to hematologists and oncologists, as
well as presentations at key industry conferences in support of
Vidaza. Vidaza has been granted orphan product designation by
the FDA that entitles the drug to market exclusivity for MDS in
the U.S. through May 2011. In 2005, net sales of Vidaza
were $125.6 million, compared to $47.1 million in 2004
(6 months only).
In September 2004 the EMEA accepted for review our Marketing
Authorization Application, or MAA, for Vidaza for the treatment
of MDS. In November 2005, we announced that the European
regulatory authorities will require additional data in order to
gain marketing approval for Vidaza in Europe and that we had
withdrawn our marketing application. We intend to use data from
the ongoing Vidaza survival trial discussed below to submit a
new marketing authorization application. We began named patient
and compassionate use sales of Vidaza in the fourth quarter of
2005 in the E.U. pending a marketing authorization for Vidaza in
the EU. The EMEA granted Vidaza Orphan Product Designation,
which, if an MAA for Vidaza is approved, and the criteria for
orphan drug designation continue to be met, entitles the drug to
ten years of market exclusivity from the date of the MAAs
approval for the MDS indication in the EU. During this period
the EMEA would be prohibited, except in very limited
circumstances, from approving another formulation of Vidaza for
the treatment of MDS.
Azacitidine, a pyrimidine nucleoside analog, was originally
developed by Upjohn Corporation as a cytotoxic agent, which is
an agent that indiscriminately kills actively multiplying cells.
Azacitidine was studied at high doses as a treatment for various
malignancies, including acute myelogenous leukemia, or AML. A
New Drug Application, or NDA, was submitted by Upjohn in 1982
for the treatment of AML, but was
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deemed not approvable by the FDA. Researchers at the National
Cancer Institute, or NCI, The Mount Sinai Medical Center and
other institutions continued to study azacitidine and determined
that it could be used effectively at much lower doses than
originally studied by Upjohn, thereby reducing the side effects
experienced in the earlier clinical studies. The results of
subsequent clinical studies suggest that azacitidine is an
effective treatment for MDS.
The recognition that azacitidine could be effective at lower
doses was based on the discovery that azacitidine acts not only
as a cytotoxic agent, but also through an additional mechanism
of action. Azacitidine is a member of a class of drugs in
development known as hypomethylating or
demethylating agents. Methylation of DNA is a major
mechanism regulating gene expression.
Researchers have determined that an increase in specific
methylation of DNA results in blockage of the activity of genes
that regulate cell division and differentiation, known as
suppressor genes. With suppressor genes blocked,
cell division becomes unregulated, causing cancer. In studies,
researchers have demonstrated that azacitidine can reverse the
methylation of DNA, leading to re-expression of suppressor genes
and a resulting differentiation and maturation of the cancer
cells back to normal.
MDS occurs when blood cells remain in an immature, or
blast, stage within the bone marrow and never
develop into mature cells capable of performing their necessary
functions. More than 80% of MDS cases occur in persons aged
60-80. According to the American Cancer Society, or ACS, the
exact number of cases of MDS in the U.S. is unknown, as
there is no registry tracking this information; however, most
estimates are between 10,000 and 30,000 new cases each
year. According to the ACS, these numbers appear to be
increasing each year. Currently, we estimate there are
approximately 40,000 MDS patients throughout the
U.S. with similar incidence and prevalence rates in the
E.U. According to the ACS, survival rates range from six months
to six years for the different types of MDS. MDS can result in
death from bleeding and infection in the majority of patients,
while transformation to AML occurs in up to 40% of patients.
Following transformation to AML, these patients have an
exceptionally poor prognosis. MDS may occur without any
identifiable cause, may be related to chemotherapy or radiation
therapy being administered to treat other diseases, or may
result from exposure to petrochemicals, benzene or rubber. Prior
to the availability of Vidaza, patients generally received best
supportive care, which typically consisted of a combination of
transfusions, antibiotics and growth factors, such as
erythropoietin and granulocyte colony stimulating factor. In
addition, best supportive care treatment options included
low-dose chemotherapies, if clinicians felt that their patients
could tolerate the side effects and, for patients under
60 years of age, bone marrow transplants.
Vidazas recommended starting dose is 75 mg/ m2
delivered subcutaneously, daily for seven consecutive days,
every four weeks. It is recommended that patients be treated for
a minimum of four cycles; however, complete or partial response
may require more than four cycles. Treatment may be continued as
long as the patient continues to benefit. Patients should be
monitored for hematologic response and renal toxicities, and
dosage delay or reduction may be necessary.
We have ongoing a comparative Phase III/ IV clinical trial
that is further examining the effect of Vidaza as a treatment of
MDS based on survival and other secondary end points. The aim of
this randomized, open label study is to compare the effect of
Vidaza plus best supportive care against conventional care
regimens plus best supportive care on survival in high-risk MDS
patients. There are three comparative conventional care
treatments in the comparator arm of the study: best supportive
care only; low dose cytarabine plus best supportive care; and
standard chemotherapy plus best supportive care. This design
takes into account the actual conventional care used
to treat MDS patients in each country targeted for trial
participation. The study will recruit 354 patients and will
be one of the largest studies to date in this disease. We expect
to complete enrollment of this study in mid-2006 and we intend
to conduct an initial analysis of data from this study as early
as late 2006. Pending a positive outcome of this initial data,
we expect to submit an MAA for Vidaza as a treatment of high
risk MDS to European regulatory authorities in early 2007.
The primary objective of this Phase III/ IV study is to
measure survival benefit in these MDS patients. This study will
also assess several other relevant endpoints, such as time to
transformation to AML, time to relapse after complete remission
or partial remission, disease progression, hematological status
(peripheral
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blood counts, need for platelet and red blood cell transfusions
and hematological response), episodes of infections requiring
intravenous antibiotics and safety parameters.
We have also initiated a study that is investigating the use of
Vidaza with alternative dosing schedules. The alternative dosing
study consists of three arms of forty patients each. The first
arm examines 75 mg/ m2 of Vidaza in a schedule of five days
on, two days off, two days on; the second arm examines
50 mg/ m2 of Vidaza in a schedule of five days on, two days
off, five days on; and the third arm examines 75mg/ m2 of Vidaza
in a schedule of five days on. The study is also designed to
provide important data on the long-term maintenance use of
Vidaza.
In addition, we are exploring Vidazas potential to be
effective in treating other cancers associated with
hypermethylation. A large number of ongoing Phase II
studies examining the use of Vidaza as a single agent or in
combination with other cancer therapies have been initiated by
us and independent clinical investigators. Cancers targeted by
these studies include AML and other hematological cancers as
well as certain solid tumors. Initial data from many of these
studies is expected in 2006, the outcome of which will drive the
next phase of our clinical development efforts.
Finally, we are also working to improve the Vidazas
formulation. These efforts are focused on improving
administration and manufacturing efficiencies, and, as a result
of these activities, potentially enhancing our intellectual
property. We have also initiated exploratory work to identify
the feasibility of developing an oral formulation of Vidaza
which, if successfully developed, may represent a more
convenient dosing schedule for patients.
In November 2001, we obtained exclusive marketing and
distribution rights to Celgene Corporations formulation of
thalidomide,
Thalomid®,
in all countries outside of North America, Japan, China, Taiwan
and Korea. Under the agreements with Celgene, we also obtained
an exclusive license in our territory to utilize Celgenes
current and future thalidomide-related patents, including its
patented System for Thalidomide Education and Prescribing
Safety, or
S.T.E.P.S.tm
program, and its current and future thalidomide-related
dossiers, including clinical and pharmaceutical formulation data.
In December 2004, we amended our license and supply agreements
with Celgene and its subsidiary Celgene U.K. Manufacturing
(CUK). Under the modified agreements we made a one-time payment
of $77 million in return for a substantial reduction in our
product supply price and royalty obligations to Celgene and CUK.
In addition, for an additional one-time payment to Celgene of
$3 million, we added Hong Kong, Korea and Taiwan to our
sales territories and eliminated a right held by Celgene to
terminate our license to market the product if regulatory
approval of thalidomide in Europe had not occurred by November
2006.
In the second quarter of 2003, we began selling thalidomide on a
compassionate use and named patient basis in Europe while we
actively seek marketing authorizations for this drug in Europe
and several additional countries. Thalidomide Pharmion 50mg has
been approved as a treatment for relapsed and refractory
multiple myeloma and erythema nodosum leprosum (ENL) in
Australia, New Zealand, Turkey and Israel. These approvals are
the only regulatory approvals of thalidomide for multiple
myeloma in the world. Despite the lack of any formal regulatory
approval for thalidomide in Europe, thalidomide has become a
widely used therapy for the treatment of multiple myeloma and
certain other forms of cancer. In 2005, our net sales of
thalidomide were $79.4 million compared to
$65.3 million in 2004.
Pharmion Risk Management Program In
connection with the commencement of compassionate use sales, we
implemented the Pharmion Risk Management Program (PRMP) in
2003. Given thalidomides history and risk, the development
of the PRMP was a critical element to our planned
commercialization of thalidomide and enrollment is obligatory
for all patients receiving the drug. Shortly after our
acquisition of the thalidomide rights from Celgene in 2001, we
began to develop the PRMP consistent with Celgenes
7
S.T.E.P.S. This process included the development of software and
educational materials in over 20 languages for use by
physicians, pharmacists and patients throughout Europe and our
other markets.
The PRMP is an integral component of our commercialization of,
and pursuit of marketing approvals for, thalidomide throughout
Europe and our other markets. The PRMP requires adherence to
strict guidelines both prior to and during the course of
thalidomide therapy, including comprehensive physician,
pharmacist and patient registration and education, emphasizing,
among other things, the need for adequate contraception in
patients taking thalidomide and pregnancy tests for female
patients of child-bearing potential. Under the PRMP, automatic
prescription refills are prohibited, and prescriptions may not
exceed four weeks dosing. The PRMP also permits authorization of
each prescription only upon confirmation of compliance with the
PRMP guidelines.
History of Thalidomide Thalidomide was
developed in the late 1950s as an oral, non-barbiturate sedative
and was prescribed throughout Europe for use as a sleep aid and
for the treatment of morning sickness in pregnancy. Shortly
thereafter, use of thalidomide was found to be associated with
severe birth defects and it was virtually withdrawn from the
worldwide market, without ever receiving approval in the
U.S. In 1964, thalidomide was discovered to be effective in
the treatment of ENL, which is an inflammatory complication of
leprosy. As a result, thalidomide has remained in use as a
treatment for ENL. In the 1990s, it was further discovered to
act as an anti-angiogenic agent, which is an agent that prevents
the formation of new blood vessels. Since many types of tumors
are associated with the formation of new blood vessels,
physicians began to explore thalidomides use as a
treatment to prevent the growth of tumor-associated blood
vessels on the theory that this would result in starvation of
the tumor.
In 1998, Celgenes Thalomid was approved in the
U.S. for the treatment of acute cutaneous manifestations of
moderate to severe ENL and as maintenance therapy for prevention
and suppression of cutaneous manifestation recurrences. Thalomid
was the first drug approved by the FDA under a special
restricted distribution for safety regulation. In
connection with FDA approval, given the known propensity of
thalidomide for causing birth defects, Celgene developed its
patented S.T.E.P.S. program, which is a comprehensive compliance
and risk management program designed to support the safe and
appropriate use of Thalomid by ensuring that women of
child-bearing potential do not come into contact with Thalomid.
While the treatment of ENL is the only currently approved
indication for thalidomide in the U.S., the drug is used
primarily in the treatment of multiple myeloma and other forms
of cancer.
Multiple myeloma is the second most common hematological cancer
after non-Hodgkins lymphoma. It is a cancer of the plasma
cells in the bone marrow, which is characterized by lytic bone
lesions or the production of elevated levels of M-protein, an
abnormal monoclonal antibody, in the blood or urine of patients.
The symptoms of multiple myeloma include painful bone
deterioration, bone marrow failure (anemia, leukopenia and
thrombocytopenia), plasma cell leukemia, infections, kidney
damage or failure and hyperviscosity of the blood. Although the
median age of onset of multiple myeloma is 65 to 70 years
of age, according to the Multiple Myeloma Research Foundation,
recent statistics indicate both increasing incidence and earlier
age of onset. The incidence of multiple myeloma in most western
industrialized countries is approximately four in every 100,000
persons. We estimate that there are approximately 65,000
multiple myeloma patients in the E.U., with approximately 21,000
new cases annually, and 4,000 to 5,000 multiple myeloma patients
in Australia, with approximately 800 new cases annually. While
current treatment regimens provide some therapeutic benefit,
multiple myeloma patients continue to have high rates of relapse
and suffer high mortality rates.
Thalidomide is currently being evaluated as a potential therapy
for all stages of multiple myeloma. Several leading
investigators at cancer research centers have published data on
the response rate, the median effective dose and the average
duration of response for multiple myeloma patients treated with
thalidomide in clinical trials.
Regulatory Status In 2002, we submitted
marketing authorization applications to the EMEA and the
Therapeutic Goods Administration, or the TGA, in Australia and
to regulatory authorities in New Zealand,
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South Africa, Saudi Arabia, Turkey, Israel, Thailand and the
Philippines seeking approval for thalidomide as a treatment for
relapsed and refractory multiple myeloma and for erythema
nodosum leprosum, or ENL. Thalidomide Pharmion 50mg has been
approved in Australia, New Zealand, Turkey and Israel for these
indications. Although thalidomide has become a standard of care
for the treatment of relapsed/ refractory multiple myeloma,
these regulatory approvals represent the first, and to date
only, regulatory approvals for this indication. In May 2004, we
withdrew our multiple myeloma applications with the EMEA, but
intend to resubmit our application with additional clinical data
from ongoing studies in first line (that is,
previously untreated) treatment or relapsed/ refractory multiple
myeloma patients. This action was based on the EMEAs
stated view that additional clinical data would be required
before it can reach an opinion on whether or not Thalidomide
Pharmion 50mg should be approved as a treatment for multiple
myeloma.
We expect the additional data needed to resubmit an MAA to the
EMEA will come from a pivotal Phase III study in the
first-line treatment of multiple myeloma patients sponsored by
Celgene. In January 2006, Celgene announced that based upon an
analysis of its multi-centered, randomized, placebo-controlled
Phase III clinical trial (MM-003) studying the combination
of thalidomide plus dexamethasone versus dexamethasone alone as
induction therapy for previously untreated multiple myeloma
patients, the Independent Data Monitoring Committee, or IDMC,
determined that the trial had met the pre-specified p<0.0015
value for stopping the trial. The IDMC determined that patients
in the trial demonstrated a time to disease
progression the primary endpoint of this
Phase III trial of 75.7 weeks versus
27.9 weeks (p=0.000065), and progression-free survival of
55.7 weeks versus 24.3 weeks (p=0.0003) in patients
receiving thalidomide plus dexamethasone compared to patients
receiving dexamethasone alone. A total of 270 patients were
randomized to receive thalidomide plus dexamethasone, or placebo
plus dexamethasone, in this multi-centered clinical trial.
Pending further review and analysis, we intend to submit this
data to the EMEA in support of an indication for Thalidomide
Pharmion 50mg as a treatment for newly diagnosed multiple
myeloma in early 2007.
In addition, we have initiated a Phase III study examining
thalidomide as a treatment for relapsed/ refractory multiple
myeloma. This four-arm, 470 patient trial compares three
different doses of thalidomide to a standard high dose
dexamethasone therapy, with a primary endpoint of time to
disease progression. This trial design was based on a scientific
advice procedure with the EMEA completed in 2005. We anticipate
this trial will be completed by the end of 2007, and if
successful, data from this trial would form the basis of a
marketing authorization application for relapsed/ refractory
multiple myeloma that we intend to submit in 2008.
We will continue to sell thalidomide on a named patient or
compassionate use basis in Europe while we pursue a marketing
authorization for the drug. We were granted orphan drug
designation for thalidomide in Europe by the EMEA for the
multiple myeloma indication, which, if the marketing
authorization application is approved and the criteria for
orphan drug designation continue to be met, would provide a ten
year period of exclusivity from the date of the marketing
authorization applications approval. During this period
the EMEA would be prohibited, except in very limited
circumstances, from approving another formulation of thalidomide
for treatment of relapsed and refractory multiple myeloma. We
were also granted orphan drug designation for thalidomide in
Australia, as well as data exclusivity, which provides similar
protection for a five-year period from the date of approval.
In December 2005, we entered into a co-development and license
agreement with GPC Biotech AG for the right to market, sell and
distribute satraplatin in Europe, Turkey, the Middle East,
Australia and New Zealand. Satraplatin, an investigational drug,
is a member of the platinum family of compounds. Over the past
two decades, platinum-based drugs have become a critical part of
modern chemotherapy treatments and are used to treat a wide
variety of cancers. Unlike the platinum drugs currently on the
market, all of which require intravenous administration,
satraplatin is an orally bioavailable compound and is given as
capsules that
9
patients can take at home. An oral platinum drug could offer key
advantages, including ease of administration and patient
convenience, in a variety of applications.
Satraplatin in Hormone Refractory Prostate Cancer
(HRPC) Satraplatin has shown promising safety
and efficacy as demonstrated by significant improvement in
progression-free survival (PFS) in a randomized study of
first-line treatment of patients with HRPC and is currently the
subject of a Phase III registrational trial as second-line
chemotherapy treatment for patients with HRPC. The
Phase III registrational clinical trial called
SPARC (satraplatin and prednisone against refractory
cancer) was initiated in the fall of 2003 to
evaluate satraplatin plus prednisone as a second-line
chemotherapy treatment for HRPC. The SPARC trial is a global,
double-blinded, randomized, placebo-controlled trial. The
endpoints of the trial are PFS, as well as overall survival and
time to pain progression. In December 2005, the target
enrollment of 912 patients was reached in the SPARC trial,
making this one of the fastest-accruing Phase III trials
for a chemotherapy treatment ever conducted in prostate cancer.
The SPARC trial is modeled on an earlier randomized, multicenter
study conducted by the European Organization for Research and
Treatment of Cancer (EORTC) that evaluated satraplatin plus
prednisone as first-line chemotherapy for HRPC. Fifty patients
were randomized to evaluate the use of satraplatin plus
prednisone versus prednisone alone for use as a first-line
chemotherapy treatment in HRPC. The study showed that treatment
with satraplatin significantly lengthened PFS in patients that
received satraplatin as compared with patients in the control
arm. The median PFS was 5.2 months for satraplatin compared
to 2.5 months for the control arm. Additionally, at six
months, 41% of patients treated in the satraplatin arm were
progression-free compared to 22% of patients in the control arm.
A greater than 50% decline in prostate-specific antigen was
experienced by 33% of patients in the satraplatin arm versus 9%
of patients in the control arm. The median overall survival time
was 15 months for patients treated in the satraplatin arm
versus 12 months for patients in the control arm, although
this result did not satisfy the criteria for statistical
significance. To date, satraplatin is the only platinum compound
that has demonstrated efficacy in a randomized trial in HRPC.
Based on the completion of a scientific advice procedure with
the EMEA, we intend to use final PFS data from the SPARC trial
plus available overall survival data as the basis for the
submission of an MAA for satraplatin for the treatment of
second-line HRPC to the EMEA. The final analysis of PFS data
from the SPARC trial is expected to be completed in the second
half of 2006 and, pending positive outcome of the trial, we
expect to file the MAA in Europe in early 2007.
Prostate cancer is the most common cancer among men in the U.S.
and Europe. An estimated 232,000 men in the U.S. were
diagnosed with the disease during 2005. With more than 30,000
deaths estimated in 2005 in the U.S., prostate cancer is second
only to lung cancer as a leading cause of cancer-related death
in men. The number of patients with this disease is expected to
increase with the aging of the population. Early-stage,
localized prostate cancer is usually treated with surgery and/or
radiation therapy. Patients who relapse with advanced disease
are then treated with hormone therapy. Although most patients
initially respond well to hormone therapy, the cancer cells
eventually become hormone resistant or
refractory and the disease again progresses.
Important advancements have been made in recent years in
treating HRPC. In particular, for the first time, trials with
Taxotere®
(docetaxel) showed that chemotherapy can prolong the
survival of patients with HRPC. Taxotere was approved in both
the U.S. and Europe in 2004 as a chemotherapy treatment for
HRPC. However, at this stage of the disease, there is no cure.
All patients will eventually progress and, once they do, average
survival is approximately one year. Thus, there is a growing
unmet medical need for new, effective treatments for patients in
whom initial chemotherapy has failed.
Satraplatin in Other Tumors Satraplatin has
been studied in a wide range of tumors, and Phase II
clinical trials have been completed in HRPC, ovarian cancer and
small cell lung cancer. In other trials, satraplatin appeared to
augment the antitumor effects of radiation therapy, a clinical
application in which satraplatins oral bioavailability
could be particularly advantageous. A Phase I/ II clinical
trial evaluating this combination in patients with non-small
lung cancer has been initiated. Several other Phase I and
Phase II clinical trials evaluating satraplatin in
combination with other therapies and in various cancers are
underway or
10
planned, including studies with Taxol in non-small cell lung
cancer, with Taxotere in solid tumors, and as mono therapy in
breast cancer.
We are also planning to initiate a study evaluating Vidaza in
combination with satraplatin in solid tumors. We believe that
preclinical and early clinical data indicates that Vidaza may
resensitize platinum resistant cells to platinum compounds and
we plan to initiate clinical trials exploring the potential for
this combination.
In January 2006, we entered into a license and collaboration
agreement with MethylGene Inc. for the research, development and
commercialization of MethylGenes histone deacetylase
(HDAC) inhibitors for the treatment of cancer in North
America, Europe, the Middle East, Turkey, Australia, New Zealand
and Thailand, including MGCD0103, MethylGenes lead HDAC
inhibitor, as well as MethylGenes pipeline of second
generation HDAC inhibitor compounds for oncology indications.
MGCD0103 is an oral, isotype-selective, small molecule inhibitor
of histone deacetylase. HDAC is a family of eleven enzymes, or
isoforms, that act as a master regulator of many diseases
including cancer. One key differentiating feature of
MethylGenes HDAC inhibitors is that they are selective for
specific isoforms while many other HDAC inhibitors currently in
clinical development are broad-spectrum inhibitors,
meaning that they target most or all of the HDAC isoforms. We
believe targeted and selective inhibition of cancer-related HDAC
isoforms may lead to more effective and less toxic cancer
therapies in contrast to non-specific or broad-spectrum
inhibition of HDAC isoforms.
MGCD0103 has completed one Phase I trial as a single agent
in solid tumors as a daily oral dose, with a second trial
ongoing in solid tumors as an intermittent three times per week,
oral dose. In addition, MGCD0103 is in two Phase I trials
in hematological cancers as a three times and two times per week
oral dose. MGCD0103 entered its first Phase I/ II
combination trial with Vidaza in high-risk MDS and AML patients.
We plan to enroll up to 50 patients in this trial. An
additional Phase I/ II combination trial is expected to be
initiated, with one or two Phase II monotherapy trials.
Current clinical trials are being conducted at leading cancer
centers in the United States and Canada.
About Histone Deacetylation Histones are
protein complexes around which DNA is wrapped. Histones play an
important role in gene regulation since histone arrangement has
an impact on the accessibility of DNA for transcription.
Histones and DNA together are called chromatin. Histone
acetylation exposes DNA so that gene expression can occur.
Conversely, histone deacetylation leads to dense packing of
chromatin and gene silencing. These processes are regulated in
enzyme families called histone acetylases and histone
deacetylases. In many cancerous tissues, through the activity of
DNA methylation and histone deacetylation, tumor suppressor
genes are silenced and not expressed. As a result, cell division
becomes unregulated, causing cancer. Using HDAC inhibitors, such
as MGCD0103, the effect of HDACs may be blocked and tumor
suppressor genes re-expressed to inhibit cancer progression.
MethylGenes research and observations suggest that only a
subset of the known HDAC isoforms may be involved in cancer
progression.
DNA Methylation and Histone Deacetylation
Epigenetic Regulators of Gene Expression DNA
methylation and histone deacetylation are two of the more
studied epigenetic regulators of gene expression. Epigenetics
refers to changes in the regulation of gene expression.
Epigenetic changes can silence gene expression and, unlike DNA
mutations, may be reversed by targeting the enzymes involved in
these changes. Researchers have observed the silencing of key
cell cycle control genes and tumor suppressor genes through
these two mechanisms of epigenetic regulation in hematological
malignancies and in solid tumors. Vidaza has been shown to
reverse the effects of DNA hypermethylation with subsequent gene
re-expression and, likewise, MGCD0103 has been shown, in
pre-clinical tests, to reverse the effects of inappropriate
deacetylation resulting in gene expression reactivation. In
contrast with cytotoxic cancer therapies that kill both normal
and cancer cells, epigenetic cancer therapies may enable the
reactivation of silenced genes and, thereby, re-establish the
cancer cells natural mechanisms to control abnormal growth.
Recent scientific evidence suggests that HDAC and DNA
methyltransferase inhibitors as single agents may be new
approaches for cancer therapy. In addition, the combination of
HDAC and DNA methyltransfer-
11
ase inhibitors may act synergistically to reverse gene silencing
and induce apoptosis (programmed cell death) in various cancers.
Through our collaboration with MethylGene, we will explore the
potential of combining MethylGenes HDAC inhibitors with
Vidaza as a cancer treatment and evaluate the use of
MethylGenes HDAC inhibitors in combination with other
chemotherapeutic agents.
Sales, Marketing and Distribution
We have established sales and marketing organizations in the
U.S., Europe and Australia. In the U.S., our field based
organization consists of approximately 100 professionals,
including clinical account specialists, medical science
liaisons, payor relations specialists, national accounts
managers, nurse educators, and field based management. Each
member of our field based staff has significant experience in
pharmaceutical and oncology products sales and marketing. They
target hematologists and oncologists who prescribe high volumes
of cancer therapies. The concentration of high volume
prescribers allows us to promote Vidaza and Innohep with a
relatively small, dedicated sales and marketing organization.
The field based organization is also supported by a medical
education team that focuses on the development, presentation and
distribution of scientific and clinical information regarding
our products and the diseases they treat.
In Europe, we employ a general manager in each of the U.K.,
France, Germany, Spain and Italy, and a general manager for the
Nordic countries. These general managers are responsible for all
commercial activities in each of their home countries, and may
also have responsibility for commercial activities in smaller
nearby countries. Each of our subsidiaries employs, in addition
to the general manager, a trained physician, regulatory
specialists if required by local law, sales representatives,
PRMP experts and administrative support staff. In general, we
only employ nationals in each of our local subsidiaries. All
marketing activities are centrally directed from our U.K. office
to ensure consistency across regional markets. In addition,
clinical development, regulatory affairs and information
technology functions are centrally managed from our U.K. office.
In this manner, we seek to develop globally consistent programs
but ensure that they are implemented according to local
practices. Our Australian sales and marketing organizational
structure is consistent with our European structure. Information
regarding geographic areas is included in the notes to our
consolidated financial statements included elsewhere in this
report.
In addition to our own sales organizations, we have access to
the hematology and oncology markets in 22 additional countries
through relationships with our distributors. Pursuant to the
agreements governing our relationships with our distributors, we
are prohibited from selling or marketing our products on our own
behalf in a country covered by one of these agreements until the
applicable agreement expires.
The chart below identifies the countries which are served
directly by our sales organizations and those which we access
using our third-party distribution network.
Direct Sales Countries
|
|
|
|
|
Australia
Belgium
Denmark
Finland
France |
|
Germany
Ireland
Italy
Luxembourg
Netherlands
Norway |
|
Portugal
Spain
Sweden
U.K.
U.S. |
12
Distribution Countries
|
|
|
|
|
Austria
Egypt
Greece
Hong Kong
Israel
Jordan
Kuwait |
|
Lebanon
Malaysia
Malta
New Zealand
Oman
Philippines
Saudi Arabia
Singapore |
|
South Africa
South Korea
Switzerland
Taiwan
Thailand
Turkey
United Arab Emirates |
By working closely with key opinion leaders, physicians and
association leaders, our sales and marketing professionals are
able to create science-based marketing materials of interest to
our customers. In addition, our product acquisition strategy has
been designed to maximize the success of our sales and marketing
efforts by focusing on the acquisition of products and product
candidates that make a clinical difference to patients in
markets responsive to key opinion leaders. We intend to seek new
countries in which to promote our products and we will continue
the expansion of our sales and marketing organization as product
growth or product acquisitions.
In the U.S., we sell to pharmaceutical wholesalers, who in turn
distribute product to physicians, retail pharmacies, hospitals,
and other institutional customers. In Europe and Australia, we
sell directly to retail and hospital pharmacies. Sales into
countries where we have partnered with third party distributors
are made directly to our partners. Our largest three wholesale
customers in the U.S., U.S. Oncology Supply, Cardinal Health and
McKesson Corporation generated 17%, 15% and 14%, respectively,
of our total consolidated net sales for the year ended
December 31, 2005.
Regulatory and Medical Affairs
Our regulatory affairs group is comprised of professionals with
experience from both large pharmaceutical companies and
biotechnology companies. The difference between an attractive
drug candidate and one which is not economically viable for
development often hinges on our assessment of the time and
expense required to get the drug approved and sold in a
particular jurisdiction. Determining the optimal regulatory
pathway for commercialization is an integral part of our product
candidate selection. We believe that our combination of
country-specific regulatory expertise and our focus on the
hematology and oncology markets provide a significant advantage
as we seek to acquire additional product candidates through
in-license or, if necessary and appropriate, through company
acquisition, and move our future product pipeline candidates
forward through the approval process.
Principal Collaborations and License Agreements
Celgene and CUK Agreements: In 2001, we licensed rights
relating to the use of thalidomide from Celgene and separately
entered into an exclusive supply agreement for thalidomide with
CUK, a company located in the U.K. that was subsequently
acquired by Celgene in 2004. Under the agreements, as amended,
we obtained the right to market thalidomide in all countries
other than the United States, Canada, Mexico, Japan and all
provinces of China (except Hong Kong). More specifically, under
agreements with Celgene, as amended, we obtained the rights in
these territories to Celgenes formulation of thalidomide,
Thalomid, exclusive licenses or sublicenses for the intellectual
property owned or licensed by Celgene relating to thalidomide,
as well as all existing and future clinical data relating to
thalidomide developed by Celgene, and an exclusive license to
employ Celgenes patented and proprietary S.T.E.P.S.
program as our PRMP in connection with the distribution of
thalidomide in these territories. Under agreements with CUK, as
amended, CUK is our exclusive supplier of thalidomide
formulations that we sell in certain territories licensed to us
by Celgene. We pay (i) Celgene a royalty/license fee of 8%
on our net sales of thalidomide under the terms of the license
agreements, and (ii) CUK product supply payments equal to
15.5% of our net sales of thalidomide under the terms of the
product supply agreement. In connection with our ongoing
relationship with Celgene, and to further the clinical
development of thalidomide, particularly in multiple myeloma, we
have also agreed to fund certain amounts incurred by Celgene for
the conduct of thalidomide clinical trials. Through
13
December 31, 2005, we have funded $10.7 million of
these costs and have agreed to fund an additional
$5.3 million of Celgenes costs for these studies
incurred between January 1, 2006 and December 31,
2007, payable in quarterly installments through the end of 2007.
The agreements with Celgene and CUK each have a ten-year term
running from the date of receipt of our first regulatory
approval for thalidomide in the United Kingdom.
Pfizer Agreement: We licensed worldwide exclusive rights
to Vidaza from Pharmacia & Upjohn Company, now a part
of Pfizer, Inc., in June 2001. Under the terms of our agreement,
we are obligated to pay Pfizer a royalty of 8% to 20% on net
sales of Vidaza. The license from Pfizer has a term extending
for the longer of the last to expire of valid patent claims in
any given country or ten years from our first commercial sale of
the product in a particular country.
GPC Biotech Agreement In December 2005, we
entered into a co-development and license agreement for the
development and commercialization of satraplatin. Under the
terms of the agreement, we obtained exclusive commercialization
rights for satraplatin in Europe, Turkey, the Middle East,
Australia and New Zealand, while GPC Biotech retained rights to
the North American market and all other territories. We made an
up front payment of $37.1 million to GPC Biotech, including
an $21.2 million reimbursement for satraplatin clinical
development costs and $15.9 million for funding of ongoing
and certain future clinical development to be conducted jointly
by us and GPC Biotech. The companies will pursue a joint
development plan to evaluate development activities for
satraplatin in a variety of tumor types and will share global
development costs, for which we have made an additional
commitment of $22.2 million, in addition to the
$37.1 million in initial payments. We could also pay GPC
Biotech $30.5 million based on the achievement of certain
regulatory filing and approval milestones, and $15 million
for each subsequent EMEA approval for certain additional
indications up to a maximum of $75 million for such
approvals. GPC Biotech will also receive royalties on sales of
satraplatin in our territories at rates of 26% to 30% on annual
net sales up to $500 million, and 34% on annual net sales
over $500 million. Finally, we will pay GPC Biotech sales
milestones totaling up to $105 million, based on the
achievement of significant annual sales levels in our
territories.
We are required to use commercially reasonable efforts to
develop and commercialize satraplatin in our territory. Our
agreement with GPC Biotech expires on a country-by-country basis
upon the expiration of patents covering satraplatin or available
market exclusivity for satraplatin in a particular country or,
if later, the entry of a significant generic competitor in that
country. Upon expiration, we will retain a non-exclusive,
fully-paid, royalty-free license to continue the
commercialization of satraplatin in our territories. In
addition, either party may terminate the agreement prior to
expiration under certain circumstances, including a material
breach of the agreement by the other party.
MethylGene Agreement In January 2006, we
entered into an exclusive license and collaboration agreement
for the research, development and commercialization of
MethylGene Inc.s HDAC inhibitors, including MGCD0103, for
oncology indications in North America, Europe, the Middle East
and certain other markets. Under the terms of the agreement, we
made up front payments to MethylGene totaling $25 million,
including a $5 million equity investment in MethylGene
common shares. As of January 30, 2006, our capital
investment represented a 7.8% ownership in MethylGene.
Our milestone payments to MethylGene for MGCD0103 could reach
$145 million, based on the achievement of significant
development, regulatory and sales goals. Furthermore, we may be
required to pay up to $100 million for each additional HDAC
inhibitor, also based on the achievement of significant
development, regulatory and sales milestones. In addition, we
will make research support payments of up to $2 million to
support a team of eight MethylGene scientists for one year who
will be dedicated to identifying second-generation clinical HDAC
inhibitor candidates.
MethylGene will initially fund 40% of the preclinical and
clinical development for MGCD0103 (and any additional second
generation compounds) required to obtain marketing approval in
North America while we will fund 60% of such costs. MethylGene
will receive royalties on net sales in North America ranging
from 13% to 21% based upon the level of annual sales achieved in
North America and the length of time development costs are
funded by MethylGene. MethylGene will have an option, at its
sole discretion, as long
14
as it continues to fund development, to co-promote approved
products and, in lieu of receiving royalties, to share the
resulting net profits equally with Pharmion. If MethylGene
exercises its right, at its sole discretion, to discontinue
development funding, we will be responsible for 100% of
development costs incurred thereafter. In all other licensed
territories, which include Europe, the Middle East, Turkey,
Australia, New Zealand, South Africa and certain countries in
Southeast Asia, we are responsible for development and
commercialization costs and MethylGene will receive a royalty on
net sales in those markets at a rate of 10% to 13% based on
annual net sales.
Both parties to the agreement are required to use commercially
reasonable and diligent efforts to conduct the research,
development and commercialization responsibilities allocated to
each party under the agreement. Our agreement with MethylGene
expires upon the expiration of patents covering all HDAC
inhibitor candidates being developed by the parties or, if
earlier, all research, development and commercialization
activities under the agreement cease. In addition, either party
may terminate the agreement prior to expiration under certain
circumstances, including a material breach of the agreement by
the other party.
Manufacturing
We currently use, and expect to continue to be dependent upon,
contract manufacturers to manufacture each of our products.
Although we are in the process of qualifying a second source
manufacturer for the fill and finishing process for Vidaza, we
do not currently have operational alternative manufacturing
sources for any of our products. Our contract manufacturers and
distributors are subject to extensive governmental regulation.
Regulatory authorities in our markets require that drugs be
manufactured, packaged and labeled in conformity with current
Good Manufacturing Practices, or cGMPs. We have established a
quality control and quality assurance program, including a set
of standard operating procedures and specifications, designed to
ensure that our products are manufactured in accordance with
cGMPs, and other applicable domestic and foreign regulations.
Thalidomide: We obtain our two formulations of
thalidomide from two different suppliers. Thalidomide Pharmion
50mg is formulated, encapsulated and packaged for us by CUK, of
Great Britain in a facility that is in compliance with the
regulatory standards of each of the countries where we sell and
expect to sell the product. Under the terms of our agreement
with CUK we purchase from CUK all of our requirements of the
product. Pricing is subject to an annual audit and, if
appropriate, an adjustment based upon the fully allocated cost
of manufacture. This agreement terminates upon the tenth
anniversary of the date upon which we receive regulatory
approval for thalidomide in the U.K.
Thalidomide Laphal is formulated, encapsulated and packaged for
us by Laphal Industrie, an unaffiliated company, in a facility
that is in compliance with the regulatory standards of each of
the countries where we sell and expect to sell the product.
Pricing is subject to an annual adjustment based upon a formula
that accounts for increases in the cost of manufacture. In
addition, in the event that prior to the expiration of the
agreement we decide to discontinue ordering Thalidomide Laphal
from Laphal Industrie, we are obligated to provide twelve months
advance notice and pay
300,000
(approximately $354,000 as of December 31, 2005). If our
notice to discontinue ordering Thalidomide Laphal is not timely,
the fee may increase to as much as
500,000
(approximately $590,000 as of December 31, 2005). This
agreement terminates in March 2013.
Vidaza. Under the terms of our supply agreements, Ash
Stevens, Inc. provides us with supplies of azacitidine drug
substance, the active ingredient in Vidaza, and Ben Venue
Laboratories, Inc. formulates and fills the product into vials
and labels the finished product for us. Both Ash Stevens and Ben
Venue operate facilities that are in compliance with the
regulatory standards of each of the countries in which we sell
or expect to sell the product. Under the terms of our agreement
with Ash Stevens, we are obligated to purchase all of our
requirements for azacitidine from Ash Stevens and Ash Stevens is
required to manufacture azacitidine exclusively for us. This
agreement expires in 2011. Under the terms of our agreement with
Ben Venue Laboratories, Inc., we are required to purchase up to
65% of our annual requirements for finished Vidaza product from
Ben Venue. This agreement expires in 2010. Under each of these
agreements, the prices our suppliers charge us for products may
increase or decrease annually based upon the percentage change
in the Producer Price Index for pharmaceutical preparations. In
addition, we have entered into an agreement
15
with a back-up manufacturer for finished and labeled Vidaza
product, and we are also working with a number of partners in
our reformulation efforts.
Satraplatin. We have entered into a supply agreement with
GPC Biotech AG under which we have agreed to purchase all of our
requirements for satraplatin from GPC Biotech, and GPC Biotech
has agreed to manufacture and supply our requirements for the
product and to maintain certain inventories of satraplatin on
our behalf. The supply price for the product under this
agreement is set at 110% of GPC Biotechs fully allocated
cost of manufacturing the product. This agreement will terminate
upon the termination of our Co-Development and License Agreement
with GPC Biotech.
Raw Materials
Raw materials and supplies are normally available in quantities
adequate to meet the needs of our business.
Government Regulation
Regulation by governmental authorities in the U.S. and other
countries is a significant factor in the manufacture and
marketing of our products and in ongoing research and product
development activities. All of our products require regulatory
approval by governmental agencies prior to commercialization. In
particular, our products are subject to rigorous preclinical and
clinical testing and other approval requirements by the FDA and
similar regulatory authorities in other countries. Various
statutes and regulations also govern or influence the
manufacturing, safety, reporting, labeling, storage, record
keeping and marketing of our products. The lengthy process of
seeking these approvals, and the subsequent compliance with
applicable statutes and regulations, require the expenditure of
substantial resources. Any failure by us to obtain, or any delay
in obtaining, regulatory approvals could harm our business.
The regulatory requirements relating to the manufacturing,
testing and marketing of our products may change from time to
time. For example, at present, member states in the E.U. are in
the process of incorporating into their domestic laws the
provisions contained in the E.U. Directive on the implementation
of good clinical practice in the conduct of clinical trials. The
Directive imposes more onerous requirements in relation to
certain aspects of clinical trial conduct than are currently in
place in many member states. This may impact our ability to
conduct clinical trials and the ability of independent
investigators to conduct their own research with support from us.
The clinical development, manufacturing and marketing of our
products are subject to regulation by various authorities in the
U.S., the E.U. and other countries, including, in the U.S., the
FDA, and, in the E.U., the EMEA. The Federal Food, Drug, and
Cosmetic Act and the Public Health Service Act in the U.S. and
numerous directives, regulations, local laws and guidelines in
the E.U. govern the testing, manufacture, safety, efficacy,
labeling, storage, record keeping, approval, advertising and
promotion of our products. Product development and approval
within these regulatory frameworks takes a number of years and
involves the expenditure of substantial resources.
Regulatory approval will be required in all the major markets in
which we, or our licensors, seek to test our products in
development. At a minimum, such approval requires the evaluation
of data relating to the quality, safety and efficacy of a
product for its proposed use. The specific types of data
required and the regulations relating to this data will differ
depending on the territory, the drug involved, the proposed
indication and the stage of development.
In general, new chemical entities are tested in animals until
adequate proof of safety is established. Clinical trials for new
products are typically conducted in three sequential phases that
may overlap. In Phase I, the initial introduction of the
pharmaceutical into healthy human volunteers, the emphasis is on
testing for safety (adverse effects), dosage tolerance,
metabolism, distribution, excretion and clinical pharmacology.
Phase II involves studies in a limited patient population
to determine the initial efficacy of the pharmaceutical
16
for specific targeted indications, to determine dosage tolerance
and optimal dosage and to identify possible adverse side effects
and safety risks. Once a compound shows evidence of
effectiveness and is found to have an acceptable safety profile
in Phase II evaluations, Phase III trials are
undertaken to more fully evaluate clinical outcomes.
In the U.S., specific preclinical data and chemical data, as
described above, needs to be submitted to the FDA as part of an
Investigational New Drug application, or IND, which, unless the
FDA objects, will become effective 30 days following
receipt by the FDA. Phase I studies in human volunteers may
commence only after the application becomes effective. Prior
regulatory approval for human healthy volunteer studies is also
required in member states of the E.U. Currently, in each member
state of the E.U., following successful completion of
Phase I studies, data is submitted in summarized format to
the applicable regulatory authority in the member state in
respect of applications for the conduct of later Phase II
studies. The regulatory authorities in the E.U. typically have
between one and three months in which to raise any objections to
the proposed study, and they often have the right to extend this
review period at their discretion. In the U.S., following
completion of Phase I studies, further submissions to
regulatory authorities are necessary in relation to
Phase II and III studies to update the existing IND.
Authorities may require additional data before allowing the
studies to commence and could demand that the studies be
discontinued at any time if there are significant safety issues.
In addition to the regulatory review, a study involving human
subjects has to be approved by an independent body. The exact
composition and responsibilities of this body will differ from
country to country. In the U.S., for example, each study will be
conducted under the auspices of an independent Institutional
Review Board at the institution at which the study is conducted.
This board considers among other things, the design of the
study, ethical factors, the safety of the human subjects and the
possible liability risk for the institution. Equivalent rules
apply in each member state of the E.U. where one or more
independent ethics committees, which typically operate similarly
to an Institutional Review Board, will review the ethics of
conducting the proposed research. Other authorities around the
rest of the world have slightly differing requirements involving
both the execution of clinical trials and the import/export of
pharmaceutical products. It is our responsibility to ensure we
conduct our business in accordance with the regulations of each
relevant territory.
Information generated in this process is susceptible to varying
interpretations that could delay, limit or prevent regulatory
approval at any stage of the approval process. The failure to
demonstrate adequately the quality, safety and efficacy of a
therapeutic drug under development would delay or prevent
regulatory approval of the product. There can be no assurance
that if clinical trials are completed, either we or our
collaborative partners will submit applications for required
authorizations to manufacture and/or market potential products
(including a marketing authorization application, NDA or
abbreviated NDA) or that any such application will be reviewed
and approved by the appropriate regulatory authorities in a
timely manner, if at all.
In order to gain marketing approval we must submit a dossier to
the relevant authority for review, which is known in the U.S. as
an NDA and in the E.U. as an MAA. The format is usually specific
and laid out by each authority, although in general it will
include information on the quality of the chemistry,
manufacturing and pharmaceutical aspects of the product as well
as the non-clinical and clinical data. The FDA undertakes the
review for the U.S. In the E.U. there is, for many products, a
choice of two different authorization routes: centralized and
decentralized. Under the centralized route one marketing
authorization is granted for the entire E.U., while under the
decentralized route a series of national marketing
authorizations are granted. In the centralized system the
application will be reviewed by members of the Committee for
Medicinal Products for Human Use, or the CHMP, on behalf of the
EMEA. The EMEA will, based upon the review of the CHMP, provide
an opinion to the European Commission on the safety, quality and
efficacy of the product. The decision to grant or refuse an
authorization is made by the European Commission. In
circumstances where use of the centralized route is not
mandatory, we can choose to use the decentralized route, in
which case the application will be reviewed by one member
states regulatory agency. If the regulatory agency grants
the authorization, other member states regulatory
authorities are asked to mutually recognize the
authorization granted by the first member states
regulatory agency. Approval can take several months to several
years, or be denied. The approval process can be affected by a
number of factors. Additional studies or
17
clinical trials may be requested during the review and may delay
marketing approval and involve unbudgeted costs. The regulatory
authorities may conduct an inspection of relevant facilities,
and review manufacturing procedures, operating systems and
personnel qualifications. In addition to obtaining approval for
each product, in many cases each drug manufacturing facility
must be approved. Further inspections may occur over the life of
the product. An inspection of the clinical investigation sites
by a competent authority may be required as part of the
regulatory approval procedure. As a condition of marketing
approval, the regulatory agency may require post-marketing
surveillance to monitor for adverse effects, or other additional
studies as deemed appropriate. After approval for the initial
indication, further clinical studies are usually necessary to
gain approval for any additional indications. The terms of any
approval, including labeling content, may be more restrictive
than expected and could affect the marketability of a product.
In many markets outside of the U.S., regulations exist that
permit patients to gain access to unlicensed pharmaceuticals,
particularly for severely ill patients where other treatment
options are limited or non-existent. Generally, the supply of
pharmaceuticals under these circumstances is termed
compassionate use or named patient
supply. In the E.U., each member state has developed its own
system under an E.U. directive that permits the exemption from
traditional pharmaceutical regulation of medicinal
products supplied in response to a bona fide unsolicited order,
formulated in accordance with specifications of an authorized
health care professional and for use by his individual patients
on his direct personal responsibility. Essentially, two
systems operate among E.U. member states: approval can be given
for cohort supply, meaning more than one patient can
be supplied in accordance with an agreed treatment protocol; or,
alternatively, as is the case in the majority of E.U. member
states, supply is provided on an individual patient basis. Some
countries, such as France, have developed other systems, where
an ATU involves a thorough review and approval by the regulator
of a regulatory data package. In France, the company then
receives an approval to supply. All E.U. member states require
assurance of the quality of the product, which is usually
achieved by provision of good manufacturing practice, or GMP,
certification. In the majority of markets, the prescribing
physician is responsible for the use for the product and in some
countries the physician in conjunction with the pharmacist must
request approval from the regulator to use the unlicensed
pharmaceutical. Outside of the E.U., many countries have
developed named patient systems similar to those prevalent in
Europe.
The U.S., the E.U. and Australia may grant orphan drug
designation to drugs intended to treat a rare disease or
condition, which, in the U.S., is generally a disease or
condition that affects no more than 75 in 100,000 persons or
fewer than 200,000 individuals. In the E.U., orphan drug
designation can be granted if: the disease affects no more than
50 in 100,000 persons in the E.U. or the drug is intended for a
life-threatening, seriously debilitating or serious and chronic
condition; without incentive it is unlikely that the drug would
generate sufficient return to justify the necessary investment;
and no satisfactory method of treatment for the condition exists
or, if it does, the new drug will provide a significant benefit
to those affected by the condition. In Australia, orphan drug
designation can be granted to drugs intended to treat a disease
that affects no more than 11 in 100,000 persons or fewer than
2,000 individuals. If a product that has an orphan drug
designation subsequently receives the first regulatory approval
for the indication for which it has such designation, the
product is entitled to orphan exclusivity, meaning that the
applicable regulatory authority may not approve any other
applications to market the same drug for the same indication,
except in certain very limited circumstances, for a period of
seven years in the U.S., ten years in the E.U. and five years in
Australia. Orphan drug designation does not prevent competitors
from developing or marketing different drugs for an indication.
Orphan drug designation must be requested before submitting an
NDA or MAA. After orphan drug designation is granted, the
identity of the therapeutic agent and its potential orphan use
are publicly disclosed. Orphan drug designation does not convey
an advantage in, or shorten the duration of, the review and
approval process.
Holders of an approved NDA are required to report certain
adverse reactions and production problems, if any, to the FDA,
and to comply with certain requirements concerning advertising
and promotional labeling for their products. Also, quality
control and manufacturing procedures must continue to conform to
cGMP after approval, and the FDA periodically inspects
manufacturing facilities to assess compliance with cGMP.
Accordingly, manufacturers must continue to expend time, money,
and effort in the area of production and
18
quality control to maintain compliance with cGMP and other
aspects of regulatory compliance. We continue to rely upon
third-party manufacturers to produce our products. We cannot be
sure that those manufacturers will remain in compliance with
applicable regulations or that future FDA inspections will not
identify compliance issues at the facilities of our contract
manufacturers that may disrupt production or distribution, or
require substantial resources to correct.
For both currently marketed and future products, failure to
comply with applicable regulatory requirements after obtaining
regulatory approval can, among other things, result in the
suspension of regulatory approval, as well as possible civil and
criminal sanctions. Renewals in Europe may require additional
data, which may result in a license being withdrawn. In the U.S.
and the E.U., regulators have the authority to revoke, suspend
or withdraw approvals of previously approved products, to
prevent companies and individuals from participating in the
drug-approval process, to request recalls, to seize violative
products and to obtain injunctions to close manufacturing plants
not operating in conformity with regulatory requirements and to
stop shipments of violative products. In addition, changes in
regulation could harm our financial condition and results of
operation.
We are also subject to various federal and state laws pertaining
to health care fraud and abuse, including
anti-kickback laws and false claims laws. Anti-kickback laws
make it illegal for a prescription drug manufacturer to solicit,
offer, receive, or pay any remuneration in exchange for, or to
induce, the referral of business, including the purchase or
prescription of a particular drug. False claims laws prohibit
anyone from knowingly and willingly presenting, or causing to be
presented for payment to third party payers (including Medicare
and Medicaid) claims for reimbursed drugs or services that are
false or fraudulent, claims for items or services not provided
as claimed, or claims for medically unnecessary items or
services.
As a drug marketer, we participate in the Medicaid rebate
program established by the Omnibus Budget Reconciliation Act of
1990, and under amendments of that law that became effective in
1993. Participation in this program includes requirements such
as extending comparable discounts under the Public Health
Service, or PHS, pharmaceutical pricing program. Under the
Medicaid rebate program, we pay a rebate for each unit of our
product reimbursed by Medicaid. The amount of the rebate for
each product is set by law as a minimum 15.1% of the average
manufacturer price, or AMP, of that product, or if it is
greater, the difference between AMP and the best price available
from us to any customer. The rebate amount also includes an
inflation adjustment if AMP increases faster than inflation. The
PHS pricing program extends discounts comparable to the Medicaid
rebate to a variety of community health clinics and other
entities that receive health services grants from the PHS, as
well as hospitals that serve a disproportionate share of poor
Medicare and Medicaid beneficiaries. The rebate amount is
recomputed each quarter based on our current average
manufacturer price and best price for each of our products and
reported to the Centers for Medicare and Medicaid Services, or
CMS.
As a result of the Veterans Health Care Act of 1992, federal law
requires that product prices for purchases by the Veterans
Administration, the Department of Defense, Coast Guard, and the
PHS (including the Indian Health Service) be discounted by a
minimum of 24% off the AMP to non-federal customers, the
non-federal average manufacturer price, or non-FAMP. Our
computation and report of non-FAMP is used in establishing the
price, and the accuracy of the reported non-FAMP may be audited
by the government under applicable federal procurement laws.
In addition, the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 together with rulemaking by CMS,
changed the methodology for Medicare reimbursement of
pharmaceutical products administered in physician offices and
hospital outpatient facilities, including Vidaza and Innohep.
Under the new regulations, reimbursements are now the average
selling price, or ASP, of a product plus 6%, rather than a
specified discount from the average wholesale price, or AWP, as
was the case under prior regulations. The ASP-based
reimbursement regime has generally reduced the reimbursement
physicians receive under Medicare for most office-administered
injectable drugs, including Vidaza and Innohep.
19
Under the laws of the U.S., the member states of the E.U. and
other countries, we and the institutions where we sponsor
research are subject to certain obligations to ensure the
protection of personal information of human subjects
participating in our clinical trials. We have instituted
procedures that we believe will enable us to comply with these
requirements and the contractual requirements of our data
sources. The laws and regulations in this area are evolving and
further regulation, if adopted, could affect the timing and the
cost of future clinical development activities.
We are subject to the U.S. Foreign Corrupt Practices Act that
prohibits corporations and individuals from engaging in certain
activities to obtain or retain business or to influence a person
working in an official capacity. Under this act, it is illegal
to pay, offer to pay, or authorize the payment of anything of
value to any foreign government official, government staff
member, political party, or political candidate in an attempt to
obtain or retain business or to otherwise influence a person
working in an official capacity.
Before a pharmaceutical product may be marketed and sold in
certain foreign countries the proposed pricing for the product
must be approved. The requirements governing product pricing
vary widely from country to country and can be implemented
disparately at the national level.
The E.U. generally provides options for its member states to
control the prices of medicinal products for human use. A member
state may approve a specific price for the medicinal product or
it may instead adopt a system of direct or indirect controls on
the profitability of the company placing the medicinal product
on the market. For example, the regulation of prices of
pharmaceuticals in the U. K. is generally designed to provide
controls on the overall profits that pharmaceutical companies
may derive from their sales to the U.K. National Health Service.
The U.K. system is generally based on profitability targets or
limits for individual companies that are normally assessed as a
return on capital employed by the company in servicing the
National Health Service market, comparing capital employed and
profits.
In comparison, Italy generally establishes prices for
pharmaceuticals based on a price monitoring system. The
reference price is the European average price calculated on the
basis of the prices in four reference markets: France, Spain,
Germany and the U.K. Italy typically establishes the price of
medicines belonging to the same therapeutic class on the lowest
price for a medicine belonging to that category. Spain generally
establishes the selling price for new pharmaceuticals based on
the prime cost, plus a profit margin within a range established
each year by the Spanish Commission for Economic Affairs.
Promotional and advertising costs are limited.
There can be no assurance that any country that has price
controls or reimbursement limitations for pharmaceuticals will
allow favorable reimbursement and pricing arrangements for our
products. In addition, in the U.S. there have been, and we
expect that there will continue to be, a number of federal and
state proposals to implement governmental pricing control.
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Third Party Reimbursement |
In the U.S., E.U. and elsewhere, sales of therapeutic and other
pharmaceutical products are dependent in part on the
availability of reimbursement to the consumer from third party
payers, such as government and private insurance plans. Third
party payers are increasingly challenging the prices charged for
medical products and services. The E.U. generally provides
options for its member states to restrict the range of medicinal
products for which their national health insurance systems
provide reimbursement. Member states in the E.U. can opt to have
a positive or a negative list. A
positive list is a listing of all medicinal products covered
under the national health insurance system, whereas a negative
list designates which medicinal products are excluded from
coverage. In the E.U., the U.K. and Spain use a negative list
approach, while France uses a positive list approach. In some
countries, in addition to positive and negative lists, products
may be subject to a clinical and cost effectiveness review by a
health technology assessment body. A negative determination by
such a body in relation to one of our products could affect the
prescribing of the product. For example, in the U.K., the
National Institute for Clinical Excellence, or the NICE,
provides guidance to the National Health Service on whether a
particular drug is clinically effective and cost effective.
Although
20
presented as guidance, doctors are expected to take
the guidance into account when choosing a drug to prescribe. In
addition, health authorities may not make funding available for
drugs not given a positive recommendation by the NICE. There is
a risk that a negative determination by the NICE will mean fewer
prescriptions. Although the NICE will consider drugs with orphan
status, there is a degree of tension in the application by the
NICE of the standard cost assessment for orphan drugs, which are
often priced more highly to compensate for the limited market.
It is unclear whether the NICE will adopt a more relaxed
approach toward the assessment of orphan drugs. We cannot assure
you that any of our products will be considered cost effective
and that reimbursement to the consumer will be available or will
be sufficient to allow us to sell our products on a competitive
and profitable basis.
Our present and future business has been and will continue to be
subject to various other laws and regulations.
Patents and Proprietary Rights
Our success will depend in part on our ability to protect our
existing products and the products we acquire or license by
obtaining and maintaining a strong proprietary position both in
the U.S. and in other countries. To develop and maintain such a
position, we intend to continue relying upon a combination of
orphan drug status, trade secrets, know-how, continuing
technological innovations and licensing opportunities. In
addition, we intend to seek patent protection whenever available
for any products or product candidates, in particular in
conjunction with our formulation and manufacturing process
development activities, and related technology we acquire in the
future.
Composition of matter patent protection for Vidaza, thalidomide,
Refludan and Innohep has expired or was not pursued. We have
exclusive rights to two issued patents and several pending
European patent applications that relate to uses of thalidomide.
Patent protection for uses of thalidomide expires in February
2014. We own, or co-own with Ash Stevens, Inc., three patent
families and have exclusive rights to one additional patent
family relating to the production or formulation of Vidaza, of
which two patents have issued in the United States and we have
received notice of allowance from the U.S. Patent and Trademark
Office that a third patent will be issued. These patents will
expire in 2023. We have exclusive rights to a family of patents
and patent applications relating to the production of Refludan
with protection until November 2016.
We have recently licensed from GPC Biotech AG exclusive rights
to issued patents and related pending patent applications in the
E.U. and certain other international markets for satraplatin.
Issued patents covering compositions of matter and certain
methods of use of satraplatin expire in January 2009. In
addition, we have recently licensed from MethylGene exclusive
rights to patents issued in the United States and related
pending patent applications in the E.U. and certain other
international markets for MGCD0103. The basic patent covering
the composition of matter for MGCD0103 expires in September
2022. Under both of these licenses, our licensing partners are
responsible for prosecuting and maintaining these patents and
patent applications, and we are required to reimburse them for
expenses they incur in connection with the prosecution and
maintenance of the patents or patent applications in our
territories.
The patent positions of pharmaceutical firms like us are
generally uncertain and involve complex legal, scientific and
factual questions. In addition, the coverage claimed in a patent
application can be significantly reduced before the patent is
issued. Consequently, we do not know whether any of the products
or product candidates we acquire or license will result in the
issuance of patents or, if any patents are issued, whether they
will provide significant proprietary protection or will be
challenged, circumvented or invalidated. Because unissued patent
applications filed in the U.S. prior to November 29, 2000
and patent applications filed within the last 18 months are
maintained in secrecy, and since publication of discoveries in
the scientific or patent literature often lags behind actual
discoveries, we cannot be certain of the priority of inventions
covered by pending patent applications. Moreover, we may have to
participate in interference proceedings declared by the U.S.
Patent and Trademark Office or a foreign patent office to
determine priority of invention, or in opposition proceedings in
a foreign patent office, either of which could result in
substantial cost to us, even if the eventual outcome is
favorable to us. There can be no assurance that the patents, if
issued, would be held valid by a
21
court of competent jurisdiction. An adverse outcome could
subject us to significant liabilities to third parties, require
disputed rights to be licensed from third parties or require us
to cease using such technology.
In the absence of or to supplement patent protection for our
existing products and any products or product candidates we
should acquire in the future, we have sought and intend to
continue seeking orphan drug status whenever it is available. To
date, we have been granted orphan drug status in the U.S. for
Vidaza for the MDS indication, in the E.U. for Vidaza for the
MDS indication and for Thalidomide Pharmion 50mg for the
indications multiple myeloma and ENL and in Australia for Vidaza
for the MDS indication and for Thalidomide Pharmion 50mg for
multiple myeloma and ENL indications. If a product which has an
orphan drug designation subsequently receives the first
regulatory approval for the indication for which it has such
designation, the product is entitled to orphan exclusivity,
meaning that the applicable regulatory authority may not approve
any other applications to market the same drug for the same
indication, except in certain very limited circumstances, for a
period of seven years in the U.S. and ten years in the E.U.
Orphan drug designation does not prevent competitors from
developing or marketing different drugs for an indication. See
Government Regulation for a more detailed
description of orphan drug status.
Additionally, we will rely on Supplementary Protection
Certificates and data exclusivity available in the E.U. to
extend our period of market exclusivity for satraplatin in the
E.U beyond the expiration date of the basic satraplatin patent.
A Supplementary Protection Certificate, if granted, would extend
the protection provided by the existing satraplatin patent for
five years, that is, until January 2014. Data exclusivity in the
E.U. provides a period of up to ten years from the date a
product is granted marketing approval in the E.U., during which
the regulatory authorities are not permitted to cross-refer to
the data submitted by the original applicant for approval when
reviewing an application from a generic manufacturer of the same
approved product. Unlike orphan drug exclusivity, data
exclusivity does not prevent a generic manufacturer from filing
for regulatory approval of the same or similar drug, even in the
same indication for which that drug was previously approved in
the E.U., based upon data generated independently by that
manufacturer.
We also rely on trade secret protection for our confidential and
proprietary information. No assurance can be given that others
will not independently develop substantially equivalent
proprietary information and techniques or otherwise gain access
to our trade secrets or disclose such technology, or that we can
meaningfully protect our trade secrets. However, we believe that
the substantial costs and resources required to develop
technological innovations, such as the PRMP, will help us to
protect the competitive advantage of our products.
It is our policy to require our employees, consultants, outside
scientific collaborators, sponsored researchers and other
advisors to execute confidentiality agreements upon the
commencement of employment or consulting relationships with us.
These agreements provide that all confidential information
developed or made known to the individual during the course of
the individuals relationship with us is to be kept
confidential and not disclosed to third parties except in
specific circumstances. In the case of employees, the agreements
provide that all inventions conceived by the individual shall be
our exclusive property. There can be no assurance, however, that
these agreements will provide meaningful protection or adequate
remedies for our trade secrets in the event of unauthorized use
or disclosure of such information.
Competition
The development and commercialization of new drugs is
competitive and we will face competition from major
pharmaceutical companies, specialty pharmaceutical companies and
biotechnology companies worldwide. Our competitors may develop
or market products or other novel technologies that are more
effective, safer or less costly than any that have been or are
being developed by us, or may obtain regulatory approval for
their products more rapidly than we may obtain approval for ours.
The acquisition or licensing of pharmaceutical products is also
very competitive, and a number of more established companies,
which have acknowledged strategies to license or acquire
products, may have competitive advantages as may other emerging
companies taking similar or different approaches to product
acquisitions. In addition, a number of established
research-based pharmaceutical and biotechnology companies may
acquire products in late stages of development to augment their
internal product lines. These
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established companies may have a competitive advantage over us
due to their size, cash flows and institutional experience.
Many of our competitors will have substantially greater
financial, technical and human resources than we have.
Additional mergers and acquisitions in the pharmaceutical
industry may result in even more resources being concentrated in
our competitors. Competition may increase further as a result of
advances made in the commercial applicability of technologies
and greater availability of capital for investment in these
fields. Our success will be based in part on our ability to
build and actively manage a portfolio of drugs that addresses
unmet medical needs and create value in patient therapy.
Vidaza. We believe that the primary potential future
competition for Vidaza will be
Dacogentm
from Supergen Inc., with marketing rights held by MGI Pharma,
Inc., which like Vidaza, is a demethylating agent, and
Thalomid®
and Revlimid, each from Celgene. Dacogen is currently in
development and/or under review for regulatory approval by the
FDA and EMEA. Revlimid was approved in the U.S. for a subset of
low-risk MDS patients in December 2005. In addition to these
products, there are additional products in clinical development
for the treatment of MDS and the enrollment of patients in
clinical trials for these products may reduce the number of
patients that will receive Vidaza treatment. We also face
competition for Vidaza from traditional therapies for the
treatment of MDS, including the use of blood transfusions and
growth factors.
Thalidomide Pharmion 50mg. We believe that the primary
competitors for Thalidomide Pharmion 50mg are
Velcadetm
from Millennium Pharmaceuticals Inc., a proteasome inhibitor,
and potentially
Revlimid®
from Celgene, a small molecule compound that affects multiple
cellular pathways and is currently being evaluated for a wide
range of hematological cancers, including relapsed and
refractory multiple myeloma and MDS. In addition, in certain of
our markets, we face competition from other suppliers of generic
or unlicensed forms of thalidomide, including compounding of
thalidomide by pharmacists.
Satraplatin Competition for satraplatin may
include other drugs either marketed or being developed for
prostate cancer, as well as other platinum-based compounds and
other chemotherapy drugs for other cancers. In the prostate
cancer market, currently approved drugs include
Emcyt®
from Pfizer, Inc.,
Novantrone®
from (osi) pharmaceuticals, Inc. and Serono S.A.,
Quadramet®
from Schering AG and CYTOGEN Corporation,
Metastron®
from Amersham Health and Medi-Physics, Inc. and
Taxotere®
from Sanofi-Aventis S.A.. In addition to these drugs, there are
other agents in development for both advanced HRPC and earlier
stages of prostate cancer, which may compete with satraplatin.
Examples of such drugs are atrasentan from Abbott Laboratories,
calcitriol from Novacea Inc.,
Provenge®
from Dendreon Corporation, and ixabepilone from Bristol-Myers
Squibb Company. There are currently three marketed
platinum-based drugs in the United States and in Europe. These
are cisplatin, carboplatin and oxaliplatin. All three agents are
administered intravenously and are not indicated for the
treatment of prostate cancer. Another platinum-based drug, which
is not currently on the market, is NX 473 (from NeoRx
Corporation). NX 473 is administered intravenously and has
shown activity for HRPC in a Phase II clinical trial. We
are aware that other companies may be developing orally
bioavailable, platinum-based compounds. We are not aware,
however, of any other orally bioavailable, platinum-based
compounds that are approved or are in Phase III clinical
trials. Satraplatin could also be developed for the treatment of
other cancers, either as a single agent or in combination with
radiation therapy or other drugs. In these other clinical
settings, it will also face competition from a variety of other
anticancer drugs.
We are aware that other companies may be developing orally
bioavailable platinum-based compounds. We are not aware,
however, of any other orally bioavailable platinum-based
compounds that are approved or are in Phase III clinical
trials. Satraplatin could also be developed for the treatment of
other cancers, either as a single agent or in combination with
radiation therapy or other drugs. In these other clinical
settings, it will also face competition from a variety of other
anticancer drugs.
MGCD0103 We believe the development of HDAC
inhibitors to be very competitive. We are currently aware of 10
HDAC inhibitors currently in clinical development, with
approximately 18 additional compounds in preclinical
development. These compounds are being studied in a variety in
cancers, including both solid tumors and hematological
malignancies. Several of these compounds are in a more advanced
stage
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of development than MGCD0103. We believe the compound in the
most advanced stage of development to be Mercks vorinostat
(SAHA), which is the subject of several ongoing Phase II
and Phase III clinical trials.
Clinical, Development and Regulatory Expense
In the years ended December 31, 2005, 2004 and 2003, we
incurred clinical, development and regulatory expense of
$42.9 million, $28.4 million, and $24.6 million,
respectively.
Employees
As of March 9, 2006, we had 328 employees, consisting of
120 in regulatory affairs and clinical development, 153 in sales
and marketing and 55 in general and administrative. We believe
that our relations with our employees are good and we have no
history of work stoppages.
In February 2006, Judith A. Hemberger notified our Board of
Directors of her intention to resign her positions as Executive
Vice President, Chief Operating Officer and member of the Board
of Directors of the company, effective April 1, 2006.
In addition to other information included in this report, the
following factors should be considered in evaluating our
business and future prospects.
Risks Related to Our Business
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We have a history of net losses, and may not maintain
profitability in the future. |
Except for our most recent fiscal year, we have incurred annual
net losses since our inception. As of December 31, 2005, we
had an accumulated deficit of $135.8 million. Although we
achieved profitability for our 2005 fiscal year, we expect to
further increase our expenditures to:
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commercialize our marketed products; |
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support our development efforts associated with completing
clinical trials and seeking regulatory approvals of our
products, including development expenses associated with our
recently-acquired product candidates, satraplatin and MGCD0103; |
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satisfy our obligations to make milestone payments under the
existing license agreements for our product candidates; and |
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acquire additional product candidates or companies. |
Accordingly, we do not expect to maintain profitability during
our 2006 fiscal year and we are unsure as to when we will again
achieve profitability for any substantial period of time. If we
fail to achieve profitability within the time frame expected by
investors or securities analysts, the market price of our common
stock may decline.
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Our existing commercial business is largely dependent on
the success of Vidaza. |
Sales of Vidaza account for a significant portion of our total
product sales. For the fiscal year ended December 31, 2005,
Vidaza net sales represented 57% of our total net sales. Vidaza
sales have not increased significantly over the past several
calendar quarters. In addition, Vidaza will face increased
competition from
Revlimidtm,
which was recently approved for marketing by the FDA as a
treatment for a subset of low-risk MDS patients, and we may face
competition from new therapeutics for treating MDS under
development by our competitors that are currently being
considered for approval by the FDA. The commercial success of
Vidaza and future growth in Vidaza sales will depend, among
other things, upon:
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continued acceptance by regulators, physicians, patients and
other key decision-makers as a safe, superior therapeutic as
compared to currently existing or future treatments for MDS; |
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the success of our current survival clinical trial for Vidaza in
MDS; |
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our ability to achieve a marketing authorization for Vidaza in
Europe and in other countries; and |
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our ability to expand the indications for which we can market
Vidaza. |
As a consequence, we cannot make assurances that Vidaza will
gain increased market acceptance from members of the medical
community or that the acceptance of Vidaza we have observed thus
far will be maintained. Even if Vidaza does gain increased
market acceptance, we may not be able to maintain that market
acceptance over time if these new products are introduced and
are more favorably received than Vidaza or render Vidaza
obsolete.
Regulatory authorities in our markets subject approved products
and manufacturers of approved products to continual regulatory
review. Previously unknown problems, such as unacceptable
toxicities or side effects, may only be discovered after a
product has been approved and used in an increasing number of
patients. If this occurs, regulatory authorities may impose
labeling restrictions on the product that could affect its
commercial viability or could require withdrawal of the product
from the market. Accordingly, there is a risk that we will
discover such previously unknown problems associated with the
use of Vidaza in patients, which could limit sales growth or
cause sales of Vidaza to decline.
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We may not receive regulatory approvals for our product
candidates, including thalidomide, satraplatin or, outside of
the United States, for Vidaza, or approvals may be
delayed. |
Our ability to fully commercialize thalidomide and satraplatin
is subject to regulatory approval by governmental authorities in
Europe and our other markets, and our ability to commercialize
Vidaza outside the U.S. is subject to regulatory approval by
governmental authorities in Europe and elsewhere. The regulatory
review and approval process to obtain marketing approval, even
for a drug that is approved in other jurisdictions, takes many
years and requires the expenditure of substantial resources.
This process can vary substantially based on the type,
complexity, novelty and indication of the product candidate
involved. Changes in the regulatory approval policy during the
development period, changes in or the enactment of additional
statutes or regulations, or changes in regulatory review for
each submitted product application may cause delays in the
approval or rejection of an application. The regulatory
authorities have substantial discretion in the approval process
and may refuse to accept any application or may decide that data
is insufficient for approval and require additional
pre-clinical, clinical or other studies. In addition, varying
interpretations of the data obtained from pre-clinical and
clinical testing by regulatory authorities could delay, limit or
prevent regulatory approval of a product candidate.
In July 2005, we announced the completion of the scientific
advice procedure with the EMEA regarding the clinical data
needed to support a marketing authorization for thalidomide in
relapsed/ refractory multiple myeloma. Based on this scientific
advice, we initiated a four arm randomized study of 400-500
patients in this indication in February 2006. We expect to
complete the study in 2007. In January 2006, we announced that,
pending further data review and communication with the European
regulatory authorities, we expect that the results of a pivotal
Phase III multiple myeloma trial conducted by Celgene
Corporation will form the basis of a new MAA for thalidomide in
the treatment of first-line treatment of multiple myeloma in
Europe. Just before our announcement, Celgene announced that the
study met the pre-specified interim endpoint for efficacy and
would be stopped. We cannot assure you that the results of this
trial or our ongoing clinical trials for thalidomide will
support our applications for these regulatory approvals.
In November 2005, we withdrew our previously filed MAA with the
EMEA for Vidaza, based on the EMEAs stated view that
additional clinical data would be required before it can reach
an opinion on whether or not Vidaza should be approved as a
treatment of MDS. We have previously initiated a clinical study
of 354 high-risk MDS patients with overall survival as the
primary endpoint of the study, which we expect to complete in
2007. If the results of this study are positive, we intend to
submit a new MAA for Vidaza with the EMEA based on data from
this study.
In addition, we have recently acquired marketing rights to
satraplatin in Europe and certain other countries from GPC
Biotech AG. Satraplatin is the subject of an ongoing
Phase III clinical trial as a second-
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line chemotherapy treatment for patients with HRPC. Based on
data from this trial, we expect to file an MAA in Europe in 2007.
We cannot assure you that the results of these studies for
Vidaza or satraplatin will be positive or, even if either study
is positive, that the EMEA will accept the results of the
studies as the basis for a marketing approval.
The timing of our submissions, the outcome of reviews by the
applicable regulatory authorities in each relevant market, and
the initiation and completion of clinical trials are subject to
uncertainty, change and unforeseen delays. Moreover, favorable
results in later stage clinical trials do not ensure regulatory
approval to commercialize a product. Some companies that have
believed their products performed satisfactorily in clinical
trials have nonetheless failed to obtain regulatory approval of
their products. We will not be able to market thalidomide,
Vidaza or satraplatin in any country where the drug is not
approved, and if thalidomide, Vidaza or satraplatin is not
approved for sale in a market where we have acquired rights to
the product, we will only be able to sell it in such market, if
at all, on a compassionate use or named patient basis, which
will limit sales.
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Thalidomides history of causing birth defects may
prevent it from becoming commercially successful. |
At the time thalidomide first came on the market in the late
1950s and into the early 1960s, it was not known
that the drug could cause birth defects in babies born to women
who had taken the drug while pregnant. Although no proper census
was ever taken, it has been estimated that there were between
10,000 and 20,000 babies born with birth defects as a result of
thalidomide. The majority of these births were in the U.K. and
Germany, two of our largest target markets for sales of
thalidomide. As a result, thalidomides historical
reputation in our target markets may delay or prevent regulatory
approval in Europe or may present a substantial barrier to its
market acceptance. Thalidomides potential for causing
severe birth defects and its negative historical reputation may
limit the extent of its market acceptance among both doctors and
patients, despite the efficacy that it has been proven to have
in patients afflicted with a number of different diseases. In
addition, any report of a birth defect attributed to the current
use of thalidomide could result in a material decrease in our
sales of thalidomide, and may result in the forced withdrawal of
thalidomide from the market.
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If the third party manufacturers upon whom we rely fail to
produce our products in the volumes that we require on a timely
basis, or to comply with stringent regulations applicable to
pharmaceutical drug manufacturers, we may face delays in the
commercialization of, or be unable to meet demand for, our
products and may lose potential revenues. |
We do not manufacture any of our products and we do not plan to
develop any capacity to do so. We have contracted with
third-party manufacturers to manufacture each of our products.
The manufacture of pharmaceutical products requires significant
expertise and capital investment, including the development of
advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter
difficulties in production, especially in scaling up initial
production. These problems include difficulties with production
costs and yields, quality control and assurance and shortages of
qualified personnel, as well as compliance with strictly
enforced federal, state and foreign regulations. Our third-party
manufacturers may not perform as agreed or may terminate their
agreements with us.
Regulatory authorities in our markets require that drugs be
manufactured, packaged and labeled in conformity with cGMP
regulations and guidelines. In addition, before any product
batch produced by our manufacturers can be shipped, it must
conform to release specifications pre-approved by regulators for
the content of the pharmaceutical product. The manufacturing
process for Vidaza is very complex. There is a risk that our
manufacturers will not comply with all applicable regulatory
standards, and may not be able to manufacture Vidaza on a
commercial scale that conforms on a consistent basis to our
release specifications approved by the FDA.
To date, we have relied on sole sources for the manufacture of
our products and, although we are in the process of qualifying a
second-source manufacturer for the fill and finishing processes
for Vidaza, we do not have operational alternate manufacturing
facilities in place at this time. The number of third-party
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manufacturers with the expertise, required regulatory approvals
and facilities to manufacture bulk drug substance on a
commercial scale is extremely limited, and it would take a
significant amount of time to arrange for alternative
manufacturers. If we need to change to other commercial
manufacturers, the FDA and comparable foreign regulators must
approve these manufacturers facilities and processes prior
to our use, which would require new testing and compliance
inspections, and the new manufacturers would have to be educated
in or independently develop the processes necessary for the
production of our products.
Any of these factors could cause us to delay or suspend clinical
trials, regulatory submissions, required approvals or
commercialization of our products or product candidates, entail
higher costs and result in our being unable to effectively
commercialize our products. Furthermore, if our third-party
manufacturers fail to deliver the required commercial quantities
of bulk drug substance or finished product on a timely basis and
at commercially reasonable prices, and we are unable to promptly
find one or more replacement manufacturers capable of production
at a substantially equivalent cost, in substantially equivalent
volume and on a timely basis, we would likely be unable to meet
demand for our products and we would lose potential revenues.
Moreover, failure of our third party manufacturers to comply
with applicable regulations could result in sanctions being
imposed on us, including fines, injunctions, civil penalties,
suspension or withdrawal of approvals, license revocation,
seizures or recalls of product candidates or products, operating
restrictions and criminal prosecutions, any of which could
significantly and adversely affect supplies of Vidaza and our
other products.
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Fluctuations in our operating results could affect the
price of our common stock. |
Our operating results may vary significantly from period to
period due to many factors, including the amount and timing of
sales of our products, underlying demand and wholesaler buying
patters for Vidaza, the availability and timely delivery of a
sufficient supply of our products, the timing and amount of
operating expenses, particularly for development activities,
announcements regarding clinical trial results and product
introductions by us or our competitors, the availability and
timing of third-party reimbursement and the timing of regulatory
submissions and approvals. If our operating results do not match
the expectations of securities analysts and investors as a
result of these and other factors, the trading price of our
common stock will likely decrease.
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Our effective tax rate has, and likely will continue to,
vary significantly from period to period. Increases in our
effective tax rate would have a negative effect on our results
of operations. |
Our effective tax rate has varied significantly since our
inception. This is largely due to the fact that we are subject
to income taxes in a number of jurisdictions. The tax provision
for each country is based on pre-tax earnings or losses in each
specific country, and tax losses in one country cannot be used
to offset taxable income in other countries. As a result, our
consolidated effective tax rate has historically been far in
excess of U.S. statutory tax rates. We expect this trend will
continue for the foreseeable future
Since our inception, we have had minimal or no provision for
U.S. income taxes due to incurring losses in the U.S. or, in the
case of 2005, utilizing tax net operating loss carryforwards to
offset taxable income in the U.S. As of December 31, 2005
we had approximately $131 million in U.S. federal and
foreign tax loss carryforwards, including approximately
$35 million in U.S. loss carryforwards and $86 million
in Swiss tax loss carryforwards. U.S. net operating loss
carryforwards are subject to change of ownership
limitations under Sections 382 of the Internal Revenue Code
and may also be subject to various other limitations on the
amounts utilized. A change in ownership last occurred in 2001,
but that change had minimal impact on the availability of net
operating loss carryforwards as the majority of the losses were
incurred subsequent to the change in ownership. We anticipate
that a second change in ownership may occur in 2006. If so, the
amount of net operating loss carryforwards available in 2006 and
in subsequent years may be reduced significantly. If we maintain
profitability in the U.S., the reduction in the availability of
net operating loss carryforwards may result in an increase in
U.S. income tax expense and our overall effective tax rate. This
in turn would result in a reduction in our net income and net
income per share beginning with the quarter of implementation.
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If we breach any of the agreements under which we license
commercialization rights to products or technology from others,
we could lose license rights that are important to our
business. |
We license commercialization rights to products and technology
that are important to our business, and we expect to enter into
similar licenses in the future. For instance, we acquired rights
to certain intellectual property and technology for Vidaza,
thalidomide, satraplatin and MGCD0103 through exclusive
licensing arrangements with third parties. Under these licenses
we are subject to commercialization and development,
sublicensing, royalty, milestone payments, insurance and other
obligations. If we fail to comply with any of these
requirements, or otherwise breach these license agreements, the
licensor may have the right to terminate the license in whole or
to terminate the exclusive nature of the license. Loss of any of
these licenses or the exclusivity rights provided therein could
harm our financial condition and operating results.
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We face substantial competition, which may result in
others commercializing competing products before or more
successfully than we do. |
Our industry is highly competitive. Our success will depend on
our ability to acquire, develop and commercialize products and
our ability to establish and maintain markets for our products.
Potential competitors in North America, Europe and elsewhere
include major pharmaceutical companies, specialized
pharmaceutical companies and biotechnology firms, universities
and other research institutions. Many of our competitors have
substantially greater research and development capabilities and
experience, and greater manufacturing, marketing and financial
resources, than we do. Accordingly, our competitors may develop
or license products or other novel technologies that are more
effective, safer or less costly than our existing products or
products that are being developed by us, or may obtain
regulatory approval for products before we do. Clinical
development by others may render our products or product
candidates noncompetitive.
Other pharmaceutical companies may develop generic versions of
our products that are not subject to patent protection or
otherwise subject to orphan drug exclusivity or other
proprietary rights. In particular, because we have only limited
patent protection for thalidomide, we face substantial
competition from generic versions of thalidomide throughout
Europe and other territories in which we sell thalidomide
without orphan drug exclusivity. Governmental and other
pressures to reduce pharmaceutical costs may result in
physicians writing prescriptions for these generic products.
Increased competition from the sale of competing generic
pharmaceutical products could cause a material decrease in sales
of our products.
The primary competition and potential competition for our
products currently are:
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Vidaza:
Thalomid®
and
Revlimidtm,
each from Celgene, and
Dacogentm
from Supergen Inc., with marketing rights held by MGI Pharma,
Inc., which like Vidaza, is a demethylating agent; |
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Thalidomide:
Velcadetm
from Millennium Pharmaceuticals Inc., and
Revlimidtm
from Celgene Corporation, in addition to competing sales of
other versions of thalidomide described above; |
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Satraplatin:
Emcyt®
from Pfizer Inc.;
Novantrone®
from (osi) pharmaceuticals/ Serono, Inc.;
Quadramet®
from Schering AG/Cytogen Corporation;
Metastron®
from Amersham Health/ Medi-Physics, Inc.; and
Taxotere®
from Sanofi Aventis SA, as approved drugs. There are other
agents in development for prostate cancer, including pemetrexel
from Eli Lilly and Company; calcitriol from Novacea, Inc.;
Provenge®
from Dendreon Corporation; ixabepilone from Bristol-Myers Squibb
Co.; Avastin from Genentech Inc.;
Velcade®
from Millenium Pharmaceuticals Inc./ Johnson & Johnson
Pharmaceutical Research & Development LLC; and
Nexavar®
from Onyx Pharmaceuticals, Inc./ Bayer Pharmaceuticals
Corporation; |
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Innohep:
Lovenox®,
from Sanofi-Aventis;
Fragmin®,
from Pfizer Inc.; and Arixtra, from GlaxoSmithKline plc; and |
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Refludan: Argatroban, from GlaxoSmithKline. |
Dacogen is currently under review for regulatory approval by the
FDA and Revlimid was recently approved by the FDA as a treatment
for certain low risk MDS patients and is currently under review
for regulatory approval by the EMEA. In addition to these
products, there are additional products in clinical
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development for the treatment of MDS and the enrollment of
patients in clinical trials for these products may reduce the
number of patients that will receive Vidaza treatment. We also
face competition for Vidaza from traditional therapies for the
treatment of MDS, including the use of blood transfusions and
growth factors.
In addition, MGCD0103, a histone deacetylase (HDAC) inhibitor
recently licensed by us from MethylGene Inc., is in a very early
stage of development and we do not anticipate completing
clinical trials for several years. However, several other HDAC
inhibitors are in more advanced clinical trials, including SAHA
from Merck & Co., Inc., and may reach the market before
MGCD0103. If this occurs, the market potential for MGCD0103 may
be significantly reduced.
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The timing of customer purchases and the resulting product
shipments have a significant impact on the amount of product
sales that we recognize in a particular period. |
The majority of our sales of Vidaza in the United States are
made to independent pharmaceutical wholesalers, including
specialty oncology distributors, which, in turn, resell the
product to an end user customer (normally a clinic, hospital,
alternative healthcare facility or an independent pharmacy).
Inventory in the distribution channel consists of inventory held
by these wholesalers. Our product sales in a particular period
are impacted by increases or decreases in the distribution
channel inventory levels. We cannot significantly control or
influence the purchasing patterns or buying behavior of
independent wholesalers or end users. Although our wholesaler
customers typically buy product from us only as necessary to
satisfy projected end user demand, we cannot predict future
wholesalers buying practices. For example, wholesalers may
engage in speculative purchases of product in excess of the
current market demand in anticipation of future price increases.
Accordingly, purchases by any given customer, during any given
period, may be above or below actual patient demand of any of
our products during the same period, resulting in fluctuations
in product inventory in the distribution channel. If
distribution channel inventory levels substantially exceed end
user demand, we could experience reduced revenue from sales in
subsequent periods due to a reduction in end user demand.
Furthermore, our customer base is highly concentrated. Net sales
generated from our largest three wholesale customers in the U.S.
totaled approximately 45% of our total consolidated net sales
for the year ended December 31, 2005. If any of these
customers becomes insolvent or disputes payment of the amount it
owes us, it would adversely affect our results of operations and
financial condition.
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Our failure to successfully acquire, in-license, develop
and market additional product candidates or approved products
would impair our ability to grow and could affect the price of
our common stock. |
As part of our growth strategy, we intend to acquire,
in-license, develop and market additional products and product
candidates. Because we neither have, nor currently intend to
establish, internal research capabilities, we are dependent upon
pharmaceutical and biotechnology companies and other researchers
to sell or license products to us. The success of this strategy
depends upon our ability to identify, select and acquire the
right pharmaceutical product candidates and products.
Any product candidate we license or acquire may require
additional development efforts prior to commercial sale,
including extensive clinical testing and approval by the FDA and
applicable foreign regulatory authorities. All product
candidates are prone to the risks of failure inherent in
pharmaceutical product development, including the possibility
that the product candidate will not be shown to be sufficiently
safe and effective for approval by regulatory authorities. Even
where we are successful in gaining approval for product
candidates we acquire, we cannot assure you that those products
will be manufactured or produced economically, successfully
commercialized or widely accepted in the marketplace. In
addition, we will be required to integrate any acquired products
into our existing operations, including satraplatin and
MGCD0103, products that we have only recently acquired. Managing
the development of a new product entails numerous financial and
operational risks, including difficulties in attracting
qualified employees to develop the products.
Proposing, negotiating and implementing an economically viable
acquisition and licenses is a lengthy and complex process. Other
companies, including those with substantially greater financial,
marketing and sales resources, may compete with us for the
acquisition of product candidates and approved products. We may
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be able to acquire the rights to additional product candidates
and approved products on terms that we find acceptable, or at
all.
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We may not be able to obtain sufficient product liability
insurance on commercially reasonable terms or with adequate
coverage for thalidomide. |
Historically, the vast majority of product liability insurers
have been unwilling to write any product liability coverage for
thalidomide. Although we currently have product liability
coverage for thalidomide that we believe is appropriate, if our
sales of this product grow in the future, our current coverage
may be insufficient. We may be unable to obtain additional
coverage on commercially reasonable terms if required, or our
coverage may be inadequate to protect us in the event claims are
asserted against us. In addition, we might be unable to renew
our existing level of coverage if there were a report of a birth
defect attributable to the current use of thalidomide, whether
or not sold by us.
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Failure to achieve our sales targets or raise additional
funds in the future may require us to delay, reduce the scope
of, or eliminate one or more of our planned activities. |
We will need to generate greater sales to maintain profitability
on an annual basis. The product development, including clinical
trials, manufacturing development and regulatory approvals of
Vidaza, thalidomide, satraplatin and MGCD0103, and the
acquisition and development of additional product candidates by
us will require a commitment of substantial funds. Our future
capital requirements are dependent upon many factors and may be
significantly greater than we expect.
We believe, based on our current operating plan, including
anticipated sales of our products, that our cash, cash
equivalents and short-term investments will be sufficient to
fund our operations through at least the next twelve months. If
our existing resources are insufficient to satisfy our liquidity
requirements due to slower than anticipated sales of our
products or otherwise, or if we acquire additional products or
product candidates, we may need to sell additional equity or
debt securities. If we are unable to obtain this additional
financing, we may be required to delay, reduce the scope of, or
eliminate one or more of our planned development,
commercialization or expansion activities, which could harm our
financial condition and operating results.
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|
|
We may not be able to manage our business effectively if
we are unable to attract and retain key personnel. |
Our industry has experienced a high rate of turnover of
management personnel in recent years. We are highly dependent on
our senior management team, whose services are critical to the
successful implementation of our business strategies. Each of
our senior executives have entered into an employment agreement
with us for a term that runs until the agreement is otherwise
terminated by us or them. These employment agreements provide
that the executive cannot compete with us for a period of one
year after his or her employment with us is terminated. If we
lose the services of our senior management or other key
employees, our ability to successfully implement our business
strategy could be seriously harmed. We do not maintain key
person life insurance on any of the members of our senior
management. Replacing key employees may be difficult and may
take an extended period of time because of the limited number of
individuals in our industry with the breadth of skills and
experience required to develop, gain regulatory approval of and
commercialize products successfully. Competition to hire from
this limited pool is intense, and we may be unable to hire,
train, retain or motivate these additional key personnel.
|
|
|
We have limited patent protection for our current
products, and we may not be able to obtain, maintain and protect
proprietary rights necessary for the development and
commercialization of our products or product candidates. |
Our commercial success will depend in part on obtaining and
maintaining a strong proprietary position for our products both
in the U.S., Europe and elsewhere. We currently own or have
exclusive rights to issued patents and pending patent
applications covering thalidomide from Celgene Corporation,
Vidaza, from Pfizer, Inc., satraplatin from GPC Biotech AG and
MGCD0103 from MethylGene Inc. We have limited patent
30
protection for Vidaza, currently consisting of two issued
patents covering certain polymorphic forms of Vidaza drug
substance and methods of isolating a crystalline form of Vidaza
drug substance. In addition, in May 2004 the FDA awarded orphan
drug exclusivity to Vidaza for the treatment of MDS patients,
which lasts for seven years from the date granted. Given the
limited patent protection for Vidaza, we must still rely in
large part on orphan drug exclusivity to protect and enhance our
competitive position in the U.S., and we will rely on orphan
drug designation and data exclusivity available in the E.U., if
and when Vidaza is approved for marketing in Europe. However,
orphan drug exclusivity does not prohibit competitors from
developing or marketing different drugs for an indication or
from independently developing generic versions of Vidaza for
different indications. In addition, while we are selling
thalidomide on a compassionate use and named patient basis, we
do not have orphan drug exclusivity and we must rely on our use
patent protection to prevent competitors from selling
thalidomide in our markets until we are granted a marketing
authorization. Finally, the primary European patents we have
licensed for satraplatin expire in 2009 and, therefore, we will
be relying on supplementary protection certificates to extend
patent protection and on data exclusivity available in the E.U.
if and when we achieve marketing approval for this product.
We also rely on protection derived from trade secrets, process
patents, know-how and technological innovation. To maintain the
confidentiality of trade secrets and proprietary information, we
generally seek to enter into confidentiality agreements with our
employees, consultants and collaborators upon the commencement
of a relationship with us. However, we may not obtain these
agreements in all circumstances. In addition, adequate remedies
may not exist in the event of unauthorized use or disclosure of
this information. The loss or exposure of our trade secrets,
know-how and other proprietary information could harm our
operating results, financial condition and future growth
prospects. Furthermore, others may have developed, or may
develop in the future, substantially similar or superior
know-how and technology.
We intend to seek patent protection whenever it is available for
any products or product candidates we acquire in the future.
However, any patent applications for future products or pending
applications for our existing products may not issue as patents,
and any patent issued on such products may be challenged,
invalidated, held unenforceable or circumvented. Furthermore,
the claims in patents that do ultimately issue on those patent
applications may not be sufficiently broad to prevent third
parties from commercializing competing products. In addition,
the laws of various foreign countries in which we compete may
not protect the intellectual property on which we may rely to
the same extent as do the laws of the U.S. If we fail to obtain
adequate patent protection for our products, our ability to
compete could be impaired.
|
|
|
We may undertake acquisitions in the future and any
difficulties from integrating such acquisitions could damage our
ability to attain or maintain profitability. |
We may acquire additional businesses, products or product
candidates that complement or augment our existing business. To
date, our only experience in acquiring and integrating a
business involved our acquisition of Laphal in March 2003.
Integrating any newly acquired business or product could be
expensive and time-consuming. We may not be able to integrate
any acquired business or product successfully or operate any
acquired business profitably. Moreover, if we acquire additional
businesses or products we will incur significant acquisition
costs and operating expenses, which could harm our financial
condition and operating results. In addition, we may need to
raise additional funds through public or private debt or equity
financing to make acquisitions, which may result in dilution for
stockholders and the incurrence of indebtedness.
|
|
|
Changes to financial accounting standards may affect our
results of operations and cause us to change our business
practices. |
We prepare our financial statements to conform with generally
accepted accounting principles, or GAAP, in the United States.
These accounting principles are subject to interpretation by the
American Institute of Certified Public Accountants, the
Financial Accounting Standards Board, or FASB, the SEC and
various bodies formed to promulgate and interpret appropriate
accounting policies. A change in those accounting principles or
interpretations could have a significant effect on our reported
financial results and may affect our reporting of transactions
completed before a change is announced or adopted. Changes to
those rules or the questioning of current practices may
adversely affect our reported financial results or the way we
conduct our
31
business. For example, accounting policies affecting certain
aspects of our business, including rules relating to employee
stock option grants, have recently been revised. In December
2004, the FASB issued a revision of SFAS No. 123,
Accounting for Stock-Based Compensation, which
amends SFAS No. 123 to require the recognition of
employee stock options as compensation based on their fair value
at the time of grant (with limited exceptions). As a result of
these new rules, on January 1, 2006 we changed our
accounting policies and will thereafter record an expense for
our stock-based compensation plans based on the estimated fair
value of options granted, which will result in additional
accounting charges as described in Managements Discussion
and Analysis of Financial Condition and Results of
Operations Recently Issued Accounting Standards.
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|
Our business is subject to economic, political, regulatory
and other risks associated with international sales and
operations. |
Since we sell our products in Europe, Australia and many
additional countries, our business is subject to risks
associated with conducting business internationally. We
anticipate that sales from international operations will
continue to represent a substantial portion of our total sales.
In addition, a number of our suppliers are located outside the
United States. Accordingly, our future results could be harmed
by a variety of factors, including:
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difficulties in compliance with foreign laws and regulations; |
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|
changes in foreign regulations and customs; |
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|
changes in foreign currency exchange rates and currency controls; |
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|
|
changes in a specific countrys or regions political
or economic environment; |
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|
trade protection measures, import or export licensing
requirements or other restrictive actions by the U.S. or foreign
governments; |
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|
negative consequences from changes in tax laws; |
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|
difficulties associated with staffing and managing foreign
operations; |
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|
longer accounts receivable cycles in some countries; and |
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differing labor regulations. |
Risks Related to Our Industry
|
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|
Our ability to generate sales from our products will
depend on reimbursement and drug pricing policies and
regulations. |
Our ability to achieve acceptable levels of reimbursement for
drug treatments by governmental authorities, private health
insurers and other organizations will have an effect on our
ability to successfully commercialize, and attract collaborative
partners to invest in the development of, product candidates.
The Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 together with rulemaking by the Centers for Medicare
and Medicaid Services, or CMS, changed the methodology for
Medicare reimbursement of pharmaceutical products administered
in physician offices and hospital outpatient facilities,
including Vidaza and Innohep. Under these regulations,
reimbursements are the average selling price, or ASP, of a
product plus 6%, rather than a specified discount from the
average wholesale price, or AWP, as was the case under prior
regulations. The ASP-based reimbursement regime generally
reduced the reimbursement physicians receive under Medicare for
most office-administered injectable drugs, including Vidaza and
Innohep. The changes made to date have not yet resulted in an
adverse affect on reimbursement for our products, however we
cannot predict the impact, if any, that future reimbursement
policies will adversely affect product use by physicians,
thereby reducing our sales for these products.
In other countries, particularly the countries of the European
Union, the pricing of prescription pharmaceuticals and the level
of reimbursement are subject to strict governmental control. We
cannot be sure that reimbursement in the U.S., Europe or
elsewhere will be available for any products we may develop or,
if
32
already available, will not be decreased or eliminated in the
future. If reimbursement is not available or is available only
at limited levels, we may not be able to successfully
commercialize our products, and may not be able to obtain a
satisfactory financial return on our products.
Third-party payers increasingly are challenging prices charged
for medical products and services. Also, the trend toward
managed health care in the U.S. and the changes in health
insurance programs, as well as legislative proposals to reform
health care or reduce government insurance programs, may result
in lower prices for pharmaceutical products, including any
products that may be offered by us. Cost-cutting measures that
health care providers are instituting, and the effect of any
health care reform, could harm our ability to sell any products
that are successfully developed by us and approved by
regulators. Moreover, we are unable to predict what additional
legislation or regulation, if any, relating to the health care
industry or third-party coverage and reimbursement may be
enacted in the future or what effect this legislation or
regulation would have on our business. In the event that
governmental authorities enact legislation or adopt regulations
that affect third-party coverage and reimbursement, demand for
our products may be reduced thereby harming our sales and
profitability.
|
|
|
If product liability lawsuits are brought against us, we
may incur substantial liabilities. |
The clinical testing and commercialization of pharmaceutical
products involves significant exposure to product liability
claims. If losses from such claims exceed our liability
insurance coverage, we may incur substantial liabilities.
Whether or not we were ultimately successful in product
liability litigation, such litigation could consume substantial
amounts of our financial and managerial resources, and might
result in adverse publicity, all of which would impair our
business. We may not be able to maintain our clinical trial
insurance or product liability insurance at an acceptable cost,
if at all, and this insurance may not provide adequate coverage
against potential claims or losses. If we are required to pay a
product liability claim, we may not have sufficient financial
resources to complete development or commercialization of any of
our product candidates and our business and results of
operations will be harmed.
|
|
|
If our promotional activities fail to comply with the
regulations and guidelines of the various relevant regulatory
agencies, we may be subject to warnings or enforcement action
that could harm our business. |
Physicians may prescribe drugs for uses that are not described
in the products labeling for uses that differ from those
tested in clinical studies and approved by the FDA or similar
regulatory authorities in other countries. These
off-label uses are common across medical specialties
and may constitute the best treatment for many patients in
varied circumstances. Regulatory authorities generally do not
regulate the behavior of physicians in their choice of
treatments. Regulatory authorities do, however, restrict
communications on the subject of off-label use. Companies cannot
actively promote approved drugs for off-label uses, but in some
countries outside of the E.U., including the U.S., they may
disseminate to physicians articles published in peer-reviewed
journals, like The New England Journal of Medicine
and The Lancet, that discuss off-label uses of
approved products. To the extent allowed, we may disseminate
peer-reviewed articles on our products to our physician
customers. We believe our promotional activities are currently
in compliance with the regulations and guidelines of the various
regulatory authorities. If, however, our promotional activities
fail to comply with these regulations or guidelines, we may be
subject to warnings from, or enforcement action by, these
authorities. Furthermore, if the discussion of off-label use in
peer-reviewed journals or the dissemination of these articles is
prohibited, it may harm demand for our products.
|
|
|
We are subject to numerous complex regulatory requirements
and failure to comply with these regulations, or the cost of
compliance with these regulations, may harm our business. |
The testing, development and manufacturing of our products are
subject to regulation by numerous governmental authorities in
the U.S., Europe and elsewhere. These regulations govern or
affect the testing, manufacture, safety, labeling, storage,
record-keeping, approval, advertising and promotion of our
products and product candidates, as well as safe working
conditions and the experimental use of animals. Noncompliance
with any applicable regulatory requirements can result in
refusal of the government to approve products for marketing,
criminal prosecution and fines, recall or seizure of products,
total or partial suspension of
33
production, prohibitions or limitations on the commercial sale
of products or refusal to allow us to enter into supply
contracts. Regulatory authorities typically have the authority
to withdraw approvals that have been previously granted.
The regulatory requirements relating to the manufacturing,
testing, and marketing of our products may change from time to
time. For example, at present, member states in the E.U. are in
the process of incorporating into their domestic laws the
provisions contained in the E.U. Directive on the implementation
of good clinical practice in the conduct of clinical trials. The
Directive imposes more onerous requirements in relation to
certain aspects of the conduct of clinical trials than are
currently in place in many member states. This may impact our
ability to conduct clinical trials and the ability of
independent investigators to conduct their own research with
support from us.
Risks Related to Our Common Stock
|
|
|
Our certificate of incorporation, our bylaws, Delaware law
and our employment agreements with members of our senior
management contain provisions that could discourage, delay or
prevent a change in control or management of Pharmion. |
Our amended and restated certificate of incorporation, bylaws,
Delaware law and our employment agreements with members of
senior management contain provisions which could delay or
prevent a third party from acquiring shares of our common stock
or replacing members of our board of directors, each of which
certificate of incorporation provisions can only be amended or
repealed upon the consent of 80% of our outstanding shares. Our
amended and restated certificate of incorporation allows our
board of directors to issue up to 10,000,000 shares of
preferred stock. The board can determine the price, rights,
preferences and privileges of those shares without any further
vote or action by the stockholders. As a result, our board of
directors could make it difficult for a third party to acquire a
majority of our outstanding voting stock, for example by
adopting a stockholders rights plan.
Our amended and restated certificate of incorporation also
provides that the members of the board are divided into three
classes. Each year the terms of approximately one-third of the
directors will expire. Our bylaws do not permit our stockholders
to call a special meeting of stockholders. Under the bylaws,
only our Chief Executive Officer, Chairman of the Board or a
majority of the board of directors are able to call special
meetings. The staggering of directors terms of office and
the limitation on the ability of stockholders to call a special
meeting may make it difficult for stockholders to remove or
replace the board of directors should they desire to do so.
Since management is appointed by the board of directors, any
inability to effect a change in the board may result in the
entrenchment of management. The bylaws also require that
stockholders give advance notice to our Secretary of any
nominations for director or other business to be brought by
stockholders at any stockholders meeting. These provisions
may delay or prevent changes of control or management, either by
third parties or by stockholders seeking to change control or
management.
We are also subject to the anti-takeover provisions of
Section 203 of the Delaware General Corporation Law. Under
these provisions, if anyone becomes an interested
stockholder, we may not enter into a business
combination with that person for three years without
special approval, which could discourage a third party from
making a takeover offer and could delay or prevent a change of
control. For purposes of Section 203, interested
stockholder means, generally, someone owning 15% or more
of our outstanding voting stock or an affiliate of ours that
owned 15% or more of our outstanding voting stock during the
past three years, subject to certain exceptions as described in
Section 203.
The employment agreements with members of our senior management
provide that certain benefits will be payable to the executives
in the event we undergo a change in control and the termination
of the executives employment within two years after such
change in control for any reason other than for cause,
disability, death, normal retirement or early retirement.
34
|
|
|
Our stock price has been and may continue to be volatile
and your investment in our common stock could suffer a decline
in value |
Our common stock has been and in the future may be subject to
substantial price volatility. During the period January 1,
2005 to December 31, 2005, the closing price of our common
stock ranged from a high of $44.55 per share to a low of $16.49
per share.
Some specific factors that could have a significant effect on
our common stock market price include:
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actual or anticipated fluctuations in our operating results; |
|
|
|
our announcements or our competitors announcements of
clinical trial results or regulatory approval of new products; |
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|
changes in our growth rates or our competitors growth
rates; |
|
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|
the timing or results of regulatory submissions or actions with
respect to our products; |
|
|
|
public concern as to the safety of our products; |
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|
changes in health care, drug pricing or reimbursement policies
in a country where we sell our products; |
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|
our inability to raise additional capital; |
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|
our ability to grow through successful product acquisitions and
in-licensing agreements; |
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|
conditions of the pharmaceutical industry or in the financial
markets or economic conditions in general; and |
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changes in stock market analyst recommendations regarding our
common stock, other comparable companies or the pharmaceutical
industry generally. |
|
|
Item 1B. |
Unresolved Staff Comments. |
None.
We lease approximately 29,000 square feet of space in our
headquarters in Boulder, Colorado under a lease that expires in
2008. We also lease approximately 26,000 square feet of
office space in Windsor in the United Kingdom. That lease
expires in 2010 and has a renewal option for an additional five
years. We also lease clinical development, sales and marketing,
and support offices in other parts of the U.S. and abroad. We
have no laboratory, research or manufacturing facilities. We
believe that our current facilities are adequate for our needs
for the foreseeable future and that, should it be needed,
suitable additional space will be available to accommodate
expansion of our operations on commercially reasonable terms.
|
|
Item 3. |
Legal Proceedings. |
On March 30, 2005 we filed suit against Casso
Pharmaceuticals for infringement of European
Patent EP 0 688 211, in connection with
Cassos sales of thalidomide for the treatment of
angiogenesis-mediated disorders, including multiple myeloma, in
Greece. Similarly, on April 11, 2005 we filed suit under
the same patent against IPC-Nordic in Denmark for selling the
same thalidomide product for the same disorders.
We are the exclusive sub-licensee under
EP 0 688 211 throughout Europe, pursuant to an
agreement with Celgene Corporation. Celgene is the worldwide
exclusive licensee under this patent pursuant to an agreement
with the patentee, Childrens Medical Center Corporation.
Celgene and Childrens Medical Center Corporation are
co-plaintiffs to the proceedings in Greece, while Pharmion is
the sole plaintiff in Denmark. We are seeking injunctive relief
that prevents the defendants from making any further sales of
thalidomide for the treatment of angiogenesis-mediated
disorders, including multiple myeloma, in Greece and Denmark
respec-
35
tively, and damages against the defendants. We do not expect
decisions on the merits to be rendered in the various
proceedings until late 2006 at the earliest.
No material developments to these matters have occurred during
the fourth quarter of the fiscal year ended December 31,
2005.
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|
Item 4. |
Submission of Matters to a Vote of Security
Holders. |
No matters were submitted to a vote of our security holders
through solicitation of proxies or otherwise during the fourth
quarter of the fiscal year ended December 31, 2005.
36
PART II
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|
Item 5. |
Market for Registrants Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities. |
Market Information and Holders
Our common stock is traded on the NASDAQ National Market under
the symbol PHRM. Trading of our common stock
commenced on November 6, 2003, following completion of our
initial public offering. The following table sets forth, for the
periods indicated, the high and low sales prices for our common
stock as reported by the NASDAQ National Market:
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High | |
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Low | |
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| |
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| |
Year Ended December 31, 2004
|
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|
|
|
First Quarter
|
|
$ |
24.70 |
|
|
$ |
14.72 |
|
Second Quarter
|
|
$ |
49.79 |
|
|
$ |
20.60 |
|
Third Quarter
|
|
$ |
58.49 |
|
|
$ |
40.37 |
|
Fourth Quarter
|
|
$ |
53.35 |
|
|
$ |
41.48 |
|
Year Ended December 31, 2005
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|
|
|
|
|
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First Quarter
|
|
$ |
44.55 |
|
|
$ |
28.75 |
|
Second Quarter
|
|
$ |
29.35 |
|
|
$ |
18.68 |
|
Third Quarter
|
|
$ |
30.12 |
|
|
$ |
21.05 |
|
Fourth Quarter
|
|
$ |
22.45 |
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|
$ |
16.49 |
|
On March 14, 2006, the last reported sale price of our
common stock on the NASDAQ National Market was $17.56 per
share.
American Stock Transfer and Trust Company is the transfer agent
and registrar for our common stock. As of the close of business
on March 14, 2006, we had approximately 76 holders of
record of our common stock.
Dividends
We have never paid any cash dividends on our capital stock and
do not intend to pay any such dividends in the foreseeable
future.
37
Securities Authorized for Issuance Under Equity Compensation
Plans
Equity Compensation Plan Information
As of December 31, 2005
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Number of Securities | |
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Remaining Available for | |
|
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Number of Securities | |
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Weighted-Average | |
|
Future Issuance Under | |
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to be Issued upon | |
|
Exercise Price of | |
|
Equity Compensation | |
|
|
Exercise of | |
|
Outstanding Options | |
|
Plans (Excluding | |
|
|
Outstanding Options, | |
|
Warrants and | |
|
Securities Reflected in | |
|
|
Warrants and Rights | |
|
Rights | |
|
Column (a)) | |
Plan Category |
|
(a) | |
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(b) | |
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(c) | |
|
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| |
|
| |
|
| |
Equity compensation plans approved by security holders(1)(2)
|
|
|
3,386,858 |
|
|
$ |
20.60 |
|
|
|
1,706,633 |
|
Equity compensation plans not approved by security holders
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|
|
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Total
|
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|
3,386,858 |
|
|
$ |
20.60 |
|
|
|
1,706,633 |
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(1) |
As of December 31, 2005, 5,258,000 shares were
reserved for issuance under our 2000 Stock Incentive Plan (the
2000 Plan). This number is subject to an automatic
yearly increase pursuant to an evergreen formula. Each year, on
the date of our annual meeting of stockholders, the amount of
shares reserved for issuance under the 2000 Plan will be
increased by 500,000 shares, unless our board of directors
determines that a smaller increase or no increase is necessary.
In June 2005, in addition to the 500,000 share evergreen
increase, shareholders approved an amendment to the 2000 Plan to
increase the number of shares reserved for issuance by 1,500,000
for a total increase of 2,000,000 in 2005. |
|
(2) |
As of December 31, 2005, 575,000 shares were reserved
for issuance under our 2001 Non-Employee Director Stock Option
Plan (the 2001 Plan). This number is subject to an
automatic yearly increase pursuant to an evergreen formula. Each
year, on the date of our annual meeting of stockholders, the
amount of shares reserved for issuance under the 2001 Plan will
be increased by 50,000 shares, unless our board of
directors determines that a smaller increase or no increase is
necessary. In June 2005, in addition to the 50,000 share
evergreen increase, shareholders approved an amendment to the
2001 Plan to increase the number of shares reserved for issuance
by 100,000 for a total increase of 150,000 in 2005. |
Recent Sales of Unregistered Securities
None.
Purchases of Equity Securities by the Registrant and
Affiliated Purchasers.
None.
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|
Item 6. |
Selected Financial Data. |
In the table below, we provide you with our selected
consolidated financial data which should be read in conjunction
with Managements Discussion and Analysis of
Financial Condition and Results of Operations and our
consolidated financial statements and the related notes
appearing elsewhere in this annual report. We have prepared this
information using our audited consolidated financial statements
for the years ended December 31, 2005, 2004, 2003, 2002 and
2001. The pro forma net loss attributable to common stockholders
per common share and shares used in computing pro forma net loss
attributable to common stockholders per common shares reflect
the conversion of all outstanding shares of our redeemable
convertible preferred stock as of January 1, 2001 or the
date of issuance, if later. The net loss per share data and pro
forma net loss per
38
share data do not include the effect of any options or warrants
outstanding as they would be anti-dilutive. For further
discussion of earnings per share, please see note 2 to our
consolidated financial statements.
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Years Ended December 31, | |
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| |
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2005 | |
|
2004 | |
|
2003(1)(2) | |
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2002 | |
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2001 | |
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| |
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| |
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| |
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| |
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| |
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(In thousands, except share and per share data) | |
Consolidated Statements of Operations Data:
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Net sales
|
|
$ |
221,244 |
|
|
$ |
130,171 |
|
|
$ |
25,539 |
|
|
$ |
4,735 |
|
|
$ |
|
|
Operating expenses:
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Cost of sales, inclusive of
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
royalties, exclusive of product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
rights amortization
|
|
|
59,800 |
|
|
|
43,635 |
|
|
|
11,462 |
|
|
|
1,575 |
|
|
|
|
|
|
Clinical, development and regulatory
|
|
|
42,944 |
|
|
|
28,392 |
|
|
|
24,616 |
|
|
|
15,049 |
|
|
|
6,009 |
|
|
Acquired in process research
|
|
|
21,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
83,323 |
|
|
|
66,848 |
|
|
|
36,109 |
|
|
|
23,437 |
|
|
|
8,322 |
|
|
Product rights amortization
|
|
|
9,345 |
|
|
|
3,395 |
|
|
|
1,972 |
|
|
|
375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
216,655 |
|
|
|
142,270 |
|
|
|
74,159 |
|
|
|
40,436 |
|
|
|
14,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
4,589 |
|
|
|
(12,099 |
) |
|
|
(48,620 |
) |
|
|
(35,701 |
) |
|
|
(14,331 |
) |
Other income (expense) net
|
|
|
6,474 |
|
|
|
2,415 |
|
|
|
(154 |
) |
|
|
1,109 |
|
|
|
621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before taxes
|
|
|
11,063 |
|
|
|
(9,684 |
) |
|
|
(48,774 |
) |
|
|
(34,592 |
) |
|
|
(13,710 |
) |
Income tax expense
|
|
|
8,794 |
|
|
|
7,853 |
|
|
|
1,285 |
|
|
|
105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
2,269 |
|
|
|
(17,537 |
) |
|
|
(50,059 |
) |
|
|
(34,697 |
) |
|
|
(13,710 |
) |
Accretion to redemption value of redeemable convertible
preferred stock
|
|
|
|
|
|
|
|
|
|
|
(10,091 |
) |
|
|
(8,576 |
) |
|
|
(2,458 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders
|
|
$ |
2,269 |
|
|
$ |
(17,537 |
) |
|
$ |
(60,150 |
) |
|
$ |
(43,273 |
) |
|
$ |
(16,168 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders per common
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
0.07 |
|
|
$ |
(0.63 |
) |
|
$ |
(14.70 |
) |
|
$ |
(57.58 |
) |
|
$ |
(23.99 |
) |
|
Diluted
|
|
$ |
0.07 |
|
|
$ |
(0.63 |
) |
|
$ |
(14.70 |
) |
|
$ |
(57.58 |
) |
|
$ |
(23.99 |
) |
Shares used in computing net income (loss) attributable to
common stockholders per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
31,836,783 |
|
|
|
27,933,202 |
|
|
|
4,093,067 |
|
|
|
751,525 |
|
|
|
673,822 |
|
|
Diluted
|
|
|
32,875,516 |
|
|
|
27,933,202 |
|
|
|
4,093,067 |
|
|
|
751,525 |
|
|
|
673,822 |
|
Pro forma net loss attributable to common stockholders per
common share, assuming conversion of preferred stock, basic and
diluted (unaudited)
|
|
|
N/A |
|
|
|
N/A |
|
|
$ |
(2.66 |
) |
|
$ |
(2.47 |
) |
|
$ |
(2.26 |
) |
Shares used in computing pro forma net loss attributable to
common stockholders per common share, assuming conversion of
preferred stock basic and diluted
|
|
|
N/A |
|
|
|
N/A |
|
|
|
18,791,015 |
|
|
|
14,072,707 |
|
|
|
6,060,284 |
|
39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003(1)(2) | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Consolidated Balance Sheet:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$ |
243,406 |
|
|
$ |
245,543 |
|
|
$ |
88,542 |
|
|
$ |
62,604 |
|
|
$ |
68,444 |
|
Working capital
|
|
|
226,620 |
|
|
|
233,366 |
|
|
|
86,539 |
|
|
|
60,891 |
|
|
|
66,568 |
|
Total assets
|
|
|
432,630 |
|
|
|
411,230 |
|
|
|
145,473 |
|
|
|
80,847 |
|
|
|
70,278 |
|
Convertible notes
|
|
|
|
|
|
|
|
|
|
|
13,374 |
|
|
|
|
|
|
|
|
|
Other long-term liabilities
|
|
|
3,738 |
|
|
|
3,824 |
|
|
|
8,144 |
|
|
|
190 |
|
|
|
|
|
Redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,987 |
|
|
|
87,790 |
|
Accumulated deficit
|
|
|
(135,827 |
) |
|
|
(138,096 |
) |
|
|
(120,559 |
) |
|
|
(62,950 |
) |
|
|
(19,697 |
) |
Total stockholders equity (deficit)
|
|
|
346,624 |
|
|
|
351,953 |
|
|
|
104,914 |
|
|
|
(62,216 |
) |
|
|
(19,783 |
) |
|
|
(1) |
We acquired Laphal Developpement S.A. on March 25, 2003 and
its operations are included in our results since that date. |
|
(2) |
In November 2003 we completed our initial public offering, which
resulted in $76.2 million of net proceeds through the
issuance of 6,000,000 shares of common stock. Concurrent
with effective date of the initial public offering, all
outstanding shares of our redeemable convertible preferred stock
were converted into 17,030,956 shares of our common stock. |
|
|
Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations. |
The following discussion should be read in conjunction with the
financial statements and the related notes that appear elsewhere
in this document.
Overview
We are a global pharmaceutical company focused on acquiring,
developing and commercializing innovative products for the
treatment of hematology and oncology patients. We have
established our own regulatory, development and sales and
marketing organizations covering the U.S., Europe and Australia.
We have also developed a distributor network to cover the
hematology and oncology markets in numerous additional countries
throughout Europe, the Middle East and Asia. To date, we have
acquired the rights to six products, including four that are
currently marketed or sold on a compassionate use or named
patient basis, and two products that are in varying stages of
development.
In May 2004,
Vidaza®
was approved for marketing in the U.S. and we commenced sales of
the product in July 2004. Pending positive data from an ongoing
Phase III/IV study expected to be available at the end of
2006, we plan to file for marketing approval in the European
Union (E.U.) in early 2007. Until Vidaza is approved, we intend
to sell Vidaza on a compassionate use and named patient basis
throughout the major markets in the E.U. We have filed in Europe
for approval to market Vidaza in certain international markets
and these submissions are under review by the respective
regulatory authorities. Thalidomide Pharmion
50mgtm
is being sold by us on a compassionate use or named patient
basis in Europe and other international markets while we pursue
marketing authorization in those markets. Pending our positive
review of data from a Phase III study, we also expect to
submit for marketing approval in the E.U. in early 2007. In
addition, we sell
Innohep®
in the U.S. and
Refludan®
in Europe and other international markets.
In December 2005, we entered into a co-development and license
agreement with GPC Biotech for satraplatin, the only oral
platinum-based compound in advanced clinical trials. Under the
terms of the agreement, we obtained exclusive commercialization
rights for Europe, Turkey, the Middle East, Australia and New
Zealand. Enrollment in a Phase III study examining
satraplatin as a treatment for hormone refractory prostate
cancer was completed in the fourth quarter of 2005. Data from
this study is expected in the second half of 2006 and if
positive, we expect to submit for marketing approval in the E.U.
in early 2007.
40
Subsequent to December 31, 2005, we entered into a license
and collaboration agreement with MethylGene for the research,
development and commercialization of MethylGenes histone
deacetylase (HDAC) inhibitors in North America, Europe, the
Middle East and certain other international markets, including
MGCD0103, MethylGenes lead HDAC inhibitor, which is
currently in several Phase I and Phase II clinical
trials.
With our combination of regulatory, development and commercial
capabilities, we intend to continue to build a balanced
portfolio of approved and pipeline products targeting the
hematology and oncology markets. We had total sales of
$221.2 million, $130.2 million and $25.5 million
in 2005, 2004 and 2003, respectively.
Critical Accounting Policies
We sell our products to wholesale distributors and, for certain
products, directly to hospitals and clinics. Revenue from
product sales is recognized when ownership of the product is
transferred to our customer, the sales price is fixed and
determinable, and collectibility is reasonably assured. Within
the U.S. and certain foreign countries revenue is recognized
upon shipment (freight on board shipping point) since title to
the product passes and our customers have assumed the risks and
rewards of ownership. In certain other foreign countries, it is
common practice that ownership transfers upon receipt of product
and, accordingly, in these circumstances revenue is recognized
upon delivery (freight on board destination) when title to the
product effectively transfers.
We record allowances for product returns, chargebacks, rebates
and prompt pay discounts at the time of sale, and report revenue
net of such amounts. In determining allowances for product
returns, chargebacks and rebates, we must make significant
judgments and estimates. For example, in determining these
amounts, we estimate end-customer demand, buying patterns by
end-customers and group purchasing organizations from
wholesalers and the levels of inventory held by wholesalers.
Making these determinations involves estimating whether trends
in past buying patterns will predict future product sales.
The nature of our allowances requiring accounting estimates, and
the specific considerations we use in estimating their amounts,
are as follows:
Product returns. Our customers have the right
to return any unopened product during the
18-month period
beginning 6 months prior to the labeled expiration date and
ending 12 months past the labeled expiration date. As a
result, in calculating the allowance for product returns, we
must estimate the likelihood that product sold to wholesalers
might remain in their inventory or in end-customers
inventories to within 6 months of expiration and analyze
the likelihood that such product will be returned within
12 months after expiration.
To estimate the likelihood of product remaining in our
wholesalers inventory, we rely on information from our
wholesalers regarding their inventory levels, measured
end-customer demand as reported by third party sources, and on
internal sales data. We believe the information from our
wholesalers and third party sources is a reliable indicator of
trends, but we are unable to verify the accuracy of such data
independently. We also consider our wholesalers past
buying patterns, estimated remaining shelf life of product
previously shipped and the expiration dates of product currently
being shipped.
Since we do not have the ability to track a specific returned
product back to its period of sale, our product returns
allowance is primarily based on estimates of future product
returns over the period during which customers have a right of
return, which is in turn based in part on estimates of the
remaining shelf live of our products when sold to customers.
Future product returns are estimated primarily based on
historical sales and return rates.
For the years ended December 31, 2005 and 2004,
$0.1 million and $0.2 million of product was returned
to us, representing approximately 0.04% and 0.15% of net sales
revenue, respectively. The allowance for returns was
$0.6 million at both December 31, 2005 and 2004. Due
to the small amount of returned product during 2005 and 2004,
fluctuations between our estimates and actual product returned
were minimal.
41
However, a 10% change in the provision for product returns for
the years ended December 31, 2005 and 2004 would have had
an approximate $0.1 million effect on our reported net
sales for both years.
Chargebacks and rebates. Although we sell our
products in the U.S. primarily to wholesale distributors,
we typically enter into agreements with certain governmental
health insurance providers, hospitals, clinics, and physicians,
either directly or through group purchasing organizations acting
on behalf of their members, to allow purchase of our products at
a discounted price and/or to receive a volume-based rebate. We
provide a credit to the wholesaler, or a chargeback,
representing the difference between the wholesalers
acquisition list price and the discounted price. Rebates are
paid directly to the end-customer, group purchasing organization
or government insurer.
As a result of these contracts, at the time of product shipment
we must estimate the likelihood that product sold to wholesalers
might be ultimately sold to a contracting entity or group
purchasing organization. For certain end-customers, we must also
estimate the contracting entitys or group purchasing
organizations volume of purchases.
We estimate our chargeback allowance based on our estimate of
the inventory levels of our products in the wholesaler
distribution channel that remain subject to chargebacks, and
specific contractual and historical chargeback rates. We
estimate our Medicaid rebate and commercial contractual rebate
accruals based on estimates of usage by rebate-eligible
customers, estimates of the level of inventory of our products
in the distribution channel that remain potentially subject to
those rebates, and terms of our contractual and regulatory
obligations.
At December 31, 2005 and 2004, our allowance for
chargebacks and rebates was $2.6 million and
$2.7 million, respectively. During 2005 and 2004, our
estimates, compared with actual chargebacks and rebates
processed, fluctuated by as much as 6%. A 6% change in the
provision for chargebacks and rebates for the years ended
December 31, 2005 and 2004 would have had an approximate
$0.9 million and $0.5 million effect on our reported
net sales for those years, respectively.
Prompt pay discounts. As incentive to
expedite cash flow, we offer some customers a prompt pay
discount whereby if they pay their accounts within 30 days
of product shipment, they may take a 2% discount. As a result,
we must estimate the likelihood that our customers will take the
discount at the time of product shipment. In estimating our
allowance for prompt pay discounts, we rely on past history of
our customers payment patterns to determine the likelihood
that future prompt pay discounts will be taken and for those
customers that historically take advantage of the prompt pay
discount, we increase our allowance accordingly
At December 31, 2005 and 2004, our allowance for prompt pay
discounts was $0.5 million and $0.3 million,
respectively. Fluctuations between our estimates and actual
discounts taken were minimal in 2005 and 2004, approximating 5%,
as most of our customers take advantage of the prompt pay
discount. A 5% change in our provision for prompt pay discounts
for the years ended December 31, 2005 and 2004 would have
had an approximate $0.2 million and $0.1 million
effect on our reported net sales for those years, respectively.
We have adjusted our allowances for product returns, chargebacks
and rebates and prompt pay discounts in the past based on our
actual experience, and we will likely be required to make
adjustments to these allowances in the future. We continually
monitor our allowances and make adjustments when we believe our
actual experience may differ from our estimates.
42
The following table provides a summary of activity with respect
to our allowances for the years ended December 31, 2005 and
2004 (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product | |
|
Chargebacks | |
|
Prompt Pay | |
|
|
Returns | |
|
and Rebates | |
|
Discounts | |
|
|
| |
|
| |
|
| |
Balance at December 31, 2003
|
|
$ |
84 |
|
|
$ |
634 |
|
|
$ |
14 |
|
Current year provision
|
|
|
673 |
|
|
|
8,130 |
|
|
|
1,310 |
|
Actual credits or payments issued
|
|
|
(162 |
) |
|
|
(6,087 |
) |
|
|
(1,009 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
595 |
|
|
|
2,677 |
|
|
|
315 |
|
Current year provision
|
|
|
94 |
|
|
|
14,182 |
|
|
|
3,097 |
|
Actual credits or payments issued
|
|
|
(77 |
) |
|
|
(14,273 |
) |
|
|
(2,957 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
$ |
612 |
|
|
$ |
2,586 |
|
|
$ |
455 |
|
|
|
|
|
|
|
|
|
|
|
Inventories are stated at the lower of cost or market, cost
being determined under the
first-in, first-out
method. We periodically review inventories and items considered
outdated or obsolete are reduced to their estimated net
realizable value. We estimate reserves for excess and obsolete
inventories based on inventory levels on hand, future purchase
commitments, product expiration dates and current and forecasted
product demand. If an estimate of future product demand suggests
that inventory levels are excessive, then inventories are
reduced to their estimated net realizable value. For the years
ended December 31, 2005, 2004 and 2003, we recorded a
provision to reduce the estimated net realizable value of
obsolete and short-dated inventory by $0.6 million,
$1.4 million, and $1.8 million, respectively.
Our long-lived assets consist primarily of product rights and
property and equipment. In accordance with Statement of
Financial Accounting Standards (SFAS) No. 144,
Accounting for the Impairment or Disposal of Long-Lived
Assets, we evaluate our ability to recover the carrying
value of long-lived assets used in our business, considering
changes in the business environment or other facts and
circumstances that suggest their value may be impaired. If this
evaluation indicates the carrying value will not be recoverable,
based on the undiscounted expected future cash flows estimated
to be generated by these assets, we reduce the carrying amount
to the estimated fair value. The process of calculating the
expected future cash flows involves estimating future events and
trends such as sales, cost of sales, operating expenses and
income taxes. The actual results of any of these factors could
be materially different than what we estimate. The net book
value of our product rights and property and equipment was
$110.7 million and $112.8 million at December 31,
2005 and 2004, respectively.
In association with a business acquisition in 2003 and related
milestone payments that were made in 2004 and 2005, goodwill was
created. In accordance with SFAS No. 142, Goodwill
and Other Intangible Assets, we do not amortize
goodwill. SFAS No. 142 requires us to perform an impairment
review of goodwill at least annually. If it is determined that
the value of goodwill is impaired, we will record the impairment
charge in the statement of operations in the period it is
discovered. The process of reviewing for impairment of goodwill
is similar to that of long-lived assets in that expected future
cash flows are calculated using estimated future events and
trends such as sales, cost of sales, operating expenses and
income taxes. The actual results of any of these factors could
be materially different than what we estimate. The net book
value of our goodwill was $12.9 million and
$9.4 million at December 31, 2005 and 2004,
respectively.
43
|
|
|
Acquired In-Process Research |
In December 2005, we entered into a co-development and licensing
agreement with GPC Biotech whereby we acquired commercialization
rights to a drug development candidate called satraplatin in
Europe, the Middle East, Turkey, Australia and New Zealand.
Satraplatin is in Phase III development for the treatment
of hormone refractory prostate cancer. Under terms of the
license agreement, we made an up front payment to GPC Biotech of
$37.1 million, which included $21.2 million for
reimbursement for past satraplatin development costs incurred by
GPC Biotech. This portion of the up front payment was
immediately expensed as acquired in-process research as
satraplatin has not yet achieved regulatory approval for
marketing and, absent obtaining such approval, has no
alternative future use.
Recently Issued Accounting Standards
|
|
|
Accounting for Stock-Based Compensation |
In December 2004, the Financial Accounting Standards Board
issued SFAS No. 123 (revised 2004), Share-Based
Payment, which is a revision of SFAS No. 123, Accounting
for Stock-Based Compensation. SFAS No. 123(R)
supersedes APB Opinion No. 25, Accounting for Stock
Issued to Employees, and amends SFAS No. 95,
Statement of Cash Flows. Generally, the approach in
SFAS No. 123(R) is similar to the approach described
in SFAS No. 123. However, SFAS No. 123(R)
requires all share-based payments to employees, including grants
of employee stock options, to be recognized in the income
statement based on the grant-date fair value of the award.
As permitted by SFAS No. 123, we currently account for
share-based payments to employees using the intrinsic value
provisions of APB No. 25 and, as such, generally recognized
no compensation costs for employee stock options. Accordingly,
the adoption of SFAS No. 123(R)s fair value
method is expected to impact our results of operations. The
impact of the adoption of SFAS No. 123(R) cannot be
quantified at this time because it will depend on levels of
share-based payments granted in the future. However, had we
adopted SFAS No. 123(R) in prior periods, the impact
would have approximated the impact of SFAS No. 123 as
described in the disclosure of pro forma net income and earning
per share in Note 2, Summary of Significant Accounting
Policies Accounting for Stock-Based
Compensation, of Notes to Consolidated Financial Statements,
except for the acceleration of $15.8 million of expense
reflected in the year ended December 31, 2005.
SFAS No. 123(R) also requires the benefits of tax
deductions in excess of recognized compensation cost to be
reported as a financing cash flow.
We are required to adopt the standard as of January 1,
2006. SFAS No. 123(R) permits public companies to
adopt its requirements using one of two methods:
|
|
|
|
|
A modified prospective method in which compensation
cost is recognized beginning with the effective date
(a) based on the requirements of SFAS No. 123(R)
for all share-based payments granted after the effective date
and (b) based on the requirements of SFAS No. 123
for all rewards granted to employees prior to the effective date
of SFAS No. 123(R) that remain unvested on the
effective date; or |
|
|
|
A modified retrospective method which includes the
requirements of the modified prospective method described above,
but also permits entities to restate based on the amounts
previously recognized under SFAS No. 123 for purposes
of pro forma disclosures either (a) all prior periods or
(b) prior interim periods of the year of adoption. |
At this time, we expect to use the modified prospective method.
We are also considering the implementation guidance for
SFAS No. 123(R) issued by the SEC in Staff Accounting
Bulletin No. 107 in the adoption of
SFAS No. 123(R).
44
Results of Operations
|
|
|
Comparison of Years Ended December 31, 2005, 2004 and
2003 |
Net Sales. Net sales for the years ended
December 31, 2005, 2004 and 2003 were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Net sales U.S.
|
|
$ |
130,886 |
|
|
$ |
55,642 |
|
|
$ |
3,751 |
|
Net sales Europe and other countries
|
|
$ |
90,358 |
|
|
$ |
74,529 |
|
|
$ |
21,788 |
|
|
|
|
|
|
|
|
|
|
|
Total net sales
|
|
$ |
221,244 |
|
|
$ |
130,171 |
|
|
$ |
25,539 |
|
Increase from prior year
|
|
$ |
91,073 |
|
|
$ |
104,632 |
|
|
$ |
20,804 |
|
% Change from prior year
|
|
|
70.0 |
% |
|
|
409.7 |
% |
|
|
439.4 |
% |
The increase in net sales for the year ended December 31,
2005 as compared to 2004 is the result of having a whole year of
Vidaza sales in 2005 versus one half of a year in 2004 due to
the commercial launch of Vidaza in the U.S. on July 1,
2004. Net sales of Vidaza were $125.6 million in 2005 as
compared with $47.1 million in 2004. Additionally, Europe
and other international markets experienced continued growth in
compassionate use and named patient sales of thalidomide
resulting in 2005 net sales of $79.4 million versus
$65.3 million in 2004. The factors impacting thalidomide
sales vary from country to country, however, the largest impact
on the increased sales was the result of expansion into new
markets and increase in demand. These growth drivers have been
partially offset by the strengthening of the U.S. dollar
against the euro and British pound sterling during 2005 as well
as by a decline in sales in one country due to the
implementation of new regulations that limit the reimbursement
of drugs sold without marketing authorization, such as
thalidomide. Furthermore, while both Vidaza and thalidomide
sales have increased in 2005 versus 2004, sales levels have
flattened on a sequential quarterly basis during 2005.
The increase in sales for the year ended December 31, 2004
as compared to 2003 was due primarily to the launch of Vidaza in
the U.S. on July 1, 2004 as well as growth in
compassionate use and named patient sales of thalidomide in
Europe and other international markets. Vidaza sales for 2004
totaled $47.1 million. Thalidomide sales totaled
$65.3 million in 2004, compared to $15.6 million in
2003. We began selling thalidomide on a compassionate use or
named patient basis in France and Belgium in April 2003. In July
2003, we began selling thalidomide in additional countries in
Europe and other international markets. The growth in
thalidomide sales experienced in 2004 was due both to increased
volume of product sold as well as an increase in the average
selling price of thalidomide in certain markets.
Reductions from gross to net sales, which include product
returns, chargebacks, rebates and prompt pay discounts totaled
$17.4 million, $10.1 million and $2.4 million for
the years ended, December 31, 2005, 2004 and 2003,
respectively. The $7.3 million increase in 2005 over 2004
and the $7.7 million increase in 2004 over 2003 is
attributed primarily to the launch of Vidaza in 2004 and the
increased gross revenue that was derived from it. Although the
dollar amount of reductions to gross revenues increased in 2005
and 2004, the reduction as a percentage of gross sales decreased
from 8.6% in 2003 to 7.2% in 2004 and 7.3% in 2005. This
decrease is due to the launch of Vidaza as well as increased
sales of thalidomide, as these products have fewer chargeback
and rebate agreements than our other products.
Cost of sales. Cost of sales includes the cost of product
sold, royalties due on the sales of our products and the
distribution and logistics costs related to selling our
products. However, product rights amortization is excluded from
cost of sales and included with operating expenses. Cost of
sales for the years ended December 31, 2005, 2004 and 2003
were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Cost of sales
|
|
$ |
59,800 |
|
|
$ |
43,635 |
|
|
$ |
11,462 |
|
Increase from prior year
|
|
$ |
16,165 |
|
|
$ |
32,173 |
|
|
$ |
9,887 |
|
% Change from prior year
|
|
|
37.0 |
% |
|
|
280.7 |
% |
|
|
627.7 |
% |
As a % of net sales
|
|
|
27.0 |
% |
|
|
33.5 |
% |
|
|
44.9 |
% |
45
Cost of sales increased in 2005 as compared with 2004 due to the
increase in net sales for 2005. However, cost of sales as a
percentage of net sales decreased from 33.5% in 2004 to 27.0% in
2005 due to two factors. First, we had a full year of Vidaza
sales in 2005 compared to half of a year in 2004. Vidaza is one
of our higher gross margin products with cost of sales as a
percent of net sales of approximately 26%. Second, the
renegotiation of our thalidomide license and product supply
agreements in December 2004 reduced the overall royalty and
product supply costs for thalidomide. This reduced the cost of
net sales as a percent of net sales from 34% in 2004 to 25% in
2005.
The increase in cost of sales in 2004 as compared to 2003 was
attributable to the increase in net sales for 2004. The decrease
in cost of sales as a percentage of net sales experienced in
2004 as compared to 2003 was largely due to charges totaling
$2.1 million recorded in 2003 relating to obsolete Refludan
product inventory. These charges increased cost of sales as a
percentage of net sales by approximately 8 percentage
points. The launch of Vidaza in 2004 also improved the overall
gross margin as compared to 2003, reducing 2004 cost of sales as
a percentage of net sales by approximately 4 percentage
points as the Vidaza gross margin was higher than that of our
other products on a combined basis.
Clinical, development and regulatory expenses. Clinical,
development and regulatory expenses generally consist of
regulatory, clinical and manufacturing development, and medical
and safety monitoring costs for both products in development as
well as products being sold. Clinical, development and
regulatory expenses for the years ended December 31, 2005,
2004 and 2003 were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Clinical, development and regulatory expenses
|
|
$ |
42,944 |
|
|
$ |
28,392 |
|
|
$ |
24,616 |
|
Increase from prior year
|
|
$ |
14,552 |
|
|
$ |
3,776 |
|
|
$ |
9,567 |
|
% Change from prior year
|
|
|
51.3 |
% |
|
|
15.3 |
% |
|
|
63.6 |
% |
The increase in clinical, development and regulatory expenses
for the year ended December 31, 2005 over 2004 is due
primarily to $6.1 million of increased spending on clinical
study costs related to ongoing survival and alternative dosing
studies for Vidaza, $4.0 million on further development
studies for thalidomide and $0.5 million for other
products. Additionally, employee related costs, including
compensation, travel, recruiting and relocation expenses,
increased by $1.9 million due to increased staffing levels
to support regulatory, clinical development and medical and
safety monitoring activities for Vidaza and thalidomide. The
remaining increase of $2.1 million is due to costs related
to the development of an oral formulation of Vidaza and the
establishment of an alternate production facility in Europe.
Clinical, development and regulatory expenses for the year ended
December 31, 2004 increased by $3.8 million over 2003.
This increase was due primarily to a $3.0 million increase
in medical safety and monitoring costs associated with the
selling of our products, including expanded staffing to support
the growth in sales of thalidomide as well as the
U.S. launch of Vidaza. Clinical and regulatory expenses
increased by $2.1 million in 2004 as compared to 2003. This
increase was primarily related to a $2.3 million increase
in personnel related costs as we expanded staffing to support
the regulatory and clinical development activities of
thalidomide and Vidaza, including the pursuit of European
marketing authorization approvals for those products. In
addition we incurred a net cost of $1.1 million in 2004 for
the settlement of a patent infringement suit filed by us against
Lipomed, AG. These increases in clinical and regulatory expenses
were partially offset by $1.3 million decline in clinical
development expenses for Vidaza and thalidomide in 2004, due
primarily to the completion of clinical data analysis in 2003 to
support the submission of the Vidaza new drug approval
application filed with the FDA in the fourth quarter of 2003.
Finally, manufacturing development expenses declined by
$1.3 million in 2004 due to the completion in 2003 of
Vidaza manufacturing development activities required for the
submission of the New Drug Application for Vidaza.
Due to the significant risks and uncertainties inherent in the
clinical development and regulatory approval processes, the cost
to complete projects in development is not reasonably estimable.
Results from clinical trials may not be favorable. Further, data
from clinical trials is subject to varying interpretation, and
may be deemed insufficient by the regulatory bodies reviewing
applications for marketing approvals. As such, clinical
46
development and regulatory programs are subject to risks and
changes that may significantly impact cost projections and
timelines. The licensing of commercial rights to satraplatin and
to MethylGenes HDAC inhibitors in December 2005 and
January 2006, respectively, will have a significant impact on
our clinical, development and regulatory expenses for 2006.
Pursuant to these license agreements, we are required to fund a
significant percentage of the development expenses for these
products. Combined with increased development activities for
Vidaza and thalidomide, we expect our clinical, development and
regulatory expenses for 2006 will increase by approximately 80%
over the 2005 amount.
Acquired in-process research. In December 2005, we
entered into a co-development and licensing agreement with GPC
Biotech AG whereby we acquired commercialization rights to a
drug development candidate called satraplatin in Europe, the
Middle East, Turkey, Australia and New Zealand. Satraplatin is
in Phase III development for the treatment of hormone
refractory prostate cancer. Under terms of the license
agreement, we made an up front payment to GPC Biotech of
$37.1 million in early January 2006, which included
$21.2 million for reimbursement for past satraplatin
development costs incurred by GPC Biotech. This portion of the
up front payment was immediately expensed as acquired in-process
research as satraplatin has not yet achieved regulatory approval
for marketing and, absent obtaining such approval, has no
alternative future use. No such expenses were incurred in 2004
or 2003. We will, however, record a similar charge of
approximately $20 million in the first quarter of 2006 in
connection with the up front payments made to MethylGene in
connection with the acquisition of rights to their HDAC
inhibitors.
Selling, general and administrative expenses. Selling
expenses include salaries and benefits for sales and marketing
personnel, advertising and promotional programs, professional
education programs and facility costs for our sales offices
located throughout Europe, and in Thailand and Australia.
General and administrative expenses include personnel related
costs for corporate staff, outside legal, tax and auditing
services, corporate facilities and insurance costs. Selling,
general and administrative expenses for the years ended
December 31, 2005, 2004 and 2003 were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Selling, general and administrative expenses
|
|
$ |
83,323 |
|
|
$ |
66,848 |
|
|
$ |
36,108 |
|
Increase from prior year
|
|
$ |
16,475 |
|
|
$ |
30,740 |
|
|
$ |
12,672 |
|
% Change from prior year
|
|
|
24.6 |
% |
|
|
85.1 |
% |
|
|
54.1 |
% |
Selling, general and administrative expenses have continued to
increase significantly over the three year period ended
December 31, 2005 due to the establishment and expansion of
our commercial organizations in the U.S., Europe, and Australia
to support the selling of our products in those markets. Our
general and administrative functions also expanded over this
period to support the growth of our business and the additional
requirements of becoming a publicly held company.
Sales and marketing expenses totaled $59.1 million for
2005, an increase of $12.3 million over 2004. This increase
is primarily the result of continued expansion related to our
commercial operations and the associated sales and marketing
activities due to having one full year of Vidaza sales in the
U.S. for 2005, as it was launched on July 1, 2004, and
for continued growth of thalidomide sales in our international
markets. Field sales and sales management expenses in the
U.S. increased by $3.2 million in 2005 due to having
an expanded sales force for the entire year of 2005. European
and international field sales and sales management expenses
increased by $4.4 million in 2005 due to increased selling
activities to support the increased sales growth of thalidomide.
Most of the international markets were similar to the
U.S. in that expansion of staff and related expenses
occurred during 2004, creating a partial years worth of expenses
compared to a full year of those ongoing expenses in 2005.
Marketing expenses increased by $4.7 million in 2005, due
almost entirely to the U.S. having a full year of marketing
activities for Vidaza sales versus half a year in 2004.
Sales and marketing expenses totaled $46.8 million for the
year ended December 31, 2004, an increase of
$26.0 million over 2003. Generally, this increase was due
to expansion of our commercial organization and sales and
marketing activities in the U.S. and our European and other
international markets to support the U.S. launch of Vidaza
and the significant growth in thalidomide sales. Field sales and
sales management
47
expenses in the U.S. increased by $10.7 million in
2004 due to the expansion of our sales organization to support
the launch of Vidaza. We increased our U.S. field-based
organization from approximately 30 employees to 75 employees
during 2004. Other U.S. selling expenses also increased in
connection with the Vidaza launch. European and international
field sales and sales management expenses increased by
$5.7 million in 2004. We began selling thalidomide in
Europe on a compassionate use or named patient basis in
mid-2003. The sales expense growth in 2004 reflects having these
costs for a full year in 2004 as well as increased selling
activities to support the sales growth of thalidomide. Marketing
expenses increased by $9.6 million in 2004, due primarily
to the U.S. launch of Vidaza and increased activities to
support the sales growth of thalidomide. Product marketing costs
increased by $7.5 million while non-product specific costs,
such as personnel costs and travel, increased by
$2.1 million.
General and administrative expenses totaled $24.2 million
for the year ended December 31, 2005, an increase of
$4.2 million over 2004. The continued expansion of our
corporate infrastructure to support the commercial growth of our
company caused $2.4 million of the increase in expenses. Of
the $2.4 million increase, $0.7 million was for human
resources costs related to various professional fees and
recruitment and relocation fees, $0.5 million was for
increased legal staffing and costs associated with numerous
business development projects, $0.4 million increase in
stock registration and related fees, $0.3 million increase
in directors and officers liability insurance premiums and a
$0.5 million increase in facility costs due to a newly
relocated and expanded international office. Additionally, the
remaining $1.8 million of the $4.2 million increase
relates to costs associated with the relocation of the new
international office.
General and administrative expenses totaled $20.0 million
for the year ended December 31, 2004, an increase of
$4.7 million over the prior year. This increase was
primarily due to increased costs associated with becoming a
public company with the completion of our initial public
offering in November 2003. Professional fees, including legal,
accounting, tax and Sarbanes-Oxley implementation consulting,
increased by $2.5 million during 2004. Directors and
officers liability insurance premiums increased by
$0.6 million in 2004 and the establishment of our investor
relations function increased 2004 expenses by $0.4 million.
In addition, business development costs increased by
$0.8 million in 2004 as we significantly increased our
activities associated with identifying potential product
licensing and acquisition candidates.
Product rights amortization. Product rights amortization
expense for the years ended December 31, 2005, 2004 and
2003 was as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Product rights amortization
|
|
$ |
9,345 |
|
|
$ |
3,396 |
|
|
$ |
1,972 |
|
Increase from prior year
|
|
$ |
5,949 |
|
|
$ |
1,424 |
|
|
$ |
1,597 |
|
% Change from prior year
|
|
|
175.2 |
% |
|
|
72.2 |
% |
|
|
425.9 |
% |
The increase of $5.9 million in amortization expense in
2005 as compared to 2004 is primarily due to the restructuring
of our thalidomide license and supply agreements in the fourth
quarter of 2004, which increased the thalidomide product rights
asset balance by $80 million.
The increase in amortization expense in 2004 as compared to 2003
was due primarily to having a full year of amortization of
product rights acquired through the purchase of Laphal
Developpement in April 2003. In addition, the August 2003
renegotiation of the financial terms of the Refludan product
rights resulted in an increase to the value of the capitalized
product rights and increased the related amortization expense
for all of 2004 compared to only 5 months of 2003.
48
Interest and other income (expense), net. Interest and
other income (expense), net, for the years ended
December 31, 2005, 2004 and 2003 was as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Interest and other income (expense), net
|
|
$ |
6,474 |
|
|
$ |
2,415 |
|
|
$ |
(154 |
) |
Increase (decrease) from prior year
|
|
$ |
4,059 |
|
|
$ |
2,569 |
|
|
$ |
(1,264 |
) |
% Change from prior year
|
|
|
168.1 |
% |
|
|
1,668.2 |
% |
|
|
(113.9 |
)% |
The $4.1 million increase in interest and other income,
(expense), in 2005 as compared to 2004 is due to the growth of
interest income as a result of higher balances of cash, cash
equivalents and short-term investments as well as improved
investment returns resulting from higher interest rates. The
higher cash, cash equivalents, and short-term investments
balances were maintained for all of 2005 as compared with 2004
where the increased balance did not occur until a secondary
equity offering was completed in July 2004.
Interest and other income (expense), net, increased
$2.6 million in 2004 as compared with 2003 due primarily to
increased interest income from higher balances of cash, cash
equivalents and short-term investments resulting from the equity
offerings completed in November 2003 and July 2004. In addition,
in March 2004 $14 million of 6% convertible notes,
originally issued in April 2003, were converted into shares of
our common stock, thereby eliminating the interest expense
associated with those notes.
Income tax expense. Income tax expense for the years
ended December 31, 2005, 2004 and 2003 was as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Income tax expense
|
|
$ |
8,794 |
|
|
$ |
7,853 |
|
|
$ |
1,285 |
|
Increase from prior year
|
|
$ |
941 |
|
|
$ |
6,568 |
|
|
$ |
1,180 |
|
% Change from prior year
|
|
|
12.0 |
% |
|
|
511.1 |
% |
|
|
1,123.8 |
% |
The provision for income taxes reflects managements
estimate of the effective tax rate expected to be applicable in
each of our taxing jurisdictions.
Income tax expense totaled $8.8 million for the year ended
December 31, 2005 as compared to $7.9 million for the
year ended December 31, 2004. The increase of
$0.9 million in 2005 is attributable to an increase in
taxable income in certain foreign countries as well as incurring
alternative minimum tax in the U.S. as a result of being
profitable for the first time. Alternative minimum tax was
triggered as a result of utilizing approximately
$29 million of net operating loss carry-forwards to offset
taxable income.
Income tax expense increased $6.6 million in 2004 as
compared with 2003. Although we have pre-tax losses on a
consolidated basis, certain of our foreign subsidiaries generate
taxable income, and therefore incur income tax expense. The
increase in income tax expense for 2004 as compared to 2003 was
due primarily to an increase in taxable income in certain
foreign countries.
Liquidity and Capital Resources
We achieved profitability on a full year basis for the first
time in 2005. As of December 31, 2005, we had an
accumulated deficit of $135.8 million. Although we achieved
profitability during 2005, our recent business development
transactions will significantly increase our clinical,
development and regulatory expenses. As a result, we expect we
will once again incur net losses for 2006. To date, our
operations have been funded primarily with proceeds from the
sale of preferred and common stock and net sales of our
products. Net proceeds from our preferred stock sales totaled
$125.0 million and our public offerings of common stock
completed in November 2003 and July 2004 resulted in combined
net proceeds of $314.1 million. We began generating revenue
from product sales in July 2002.
Cash, cash equivalents and short-term investments decreased from
$245.5 million at December 31, 2004 to
$243.4 million at December 31, 2005. This
$2.1 million decrease is primarily due to purchases of
product
49
rights and business acquisition payments totaling
$15.0 million, purchases of property and equipment of
$5.2 million, debt repayment of $4.2 million and a
$4.2 million decrease in translated foreign currencies due
to the strengthening of the U.S. dollar, partially offset
by $26.0 million in net cash provided by operations and
$0.5 million received as proceeds for exercise of common
stock options. Subsequent to December 31, 2005, we made
cash payments totaling $62.1 million to partners in
connection with the licensing of satraplatin and the MethylGene
HDAC inhibitors.
We expect that our cash on hand at December 31, 2005, along
with cash generated from expected product sales, will be
adequate to fund our operations for at least the next twelve
months. However, we reexamine our cash requirements periodically
in light of changes in our business. For example, in the event
that we make additional product acquisitions, we may need to
raise additional funds. Adequate funds, either from the
financial markets or other sources may not be available when
needed or on terms acceptable to us. Insufficient funds may
cause us to delay, reduce the scope of, or eliminate one or more
of our planned development, commercialization or expansion
activities. Our future capital needs and the adequacy of our
available funds will depend on many factors, including the
effectiveness of our sales and marketing activities, the cost of
clinical studies and other actions needed to obtain regulatory
approval of our products in development, and the timing and cost
of any product acquisitions.
Contractual Obligations
Our contractual obligations as of December 31, 2005 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual Obligations |
|
Total | |
|
2006 | |
|
2007 | |
|
2008 | |
|
2009 | |
|
2010 | |
|
Thereafter |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(In thousands) |
Clinical development funding
|
|
$ |
27,533 |
|
|
$ |
2,667 |
|
|
$ |
10,066 |
|
|
$ |
7,400 |
|
|
$ |
7,400 |
|
|
$ |
|
|
|
$ |
|
|
Operating leases
|
|
|
10,288 |
|
|
|
3,502 |
|
|
|
2,972 |
|
|
|
1,973 |
|
|
|
1,707 |
|
|
|
134 |
|
|
|
|
|
Inventory purchase commitments
|
|
|
8,745 |
|
|
|
8,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty payments
|
|
|
4,024 |
|
|
|
4,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product acquisition payments
|
|
|
2,000 |
|
|
|
1,000 |
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt obligations
|
|
|
146 |
|
|
|
112 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total fixed contractual obligations
|
|
$ |
52,736 |
|
|
$ |
20,050 |
|
|
$ |
14,072 |
|
|
$ |
9,373 |
|
|
$ |
9,107 |
|
|
$ |
134 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical development funding. In December 2005, we
entered into a co-development and licensing agreement for
satraplatin with GPC Biotech. Pursuant to that agreement, we
made an up front payment of $37.1 million to GPC Biotech in
early January 2006. Of that amount, $21.2 million was
allocated to acquired in-process research and charged to
expenses in 2005. The remaining amount of $15.9 million
represents a prepayment of future clinical development costs.
The licensing agreement also stipulates we provide an additional
$22.2 million for similar future development costs. This
amount is reflected in the schedule above in equal annual
amounts for 2007-2009.
We previously entered into two agreements with Celgene to
provide funding to support clinical development studies
sponsored by Celgene studying thalidomide as a treatment for
various types of cancers. Under these agreements, we paid
Celgene $4.7 million in 2005 and will pay $2.7 million
in each of 2006 and 2007.
Operating leases. Our commitment for operating leases
relates primarily to our corporate and sales offices located in
the U.S., Europe, Thailand and Australia. These lease
commitments expire on various dates through 2010.
Inventory purchase commitments. The contractual summary
above includes contractual obligations related to our product
supply contracts. Under these contracts, we provide our
suppliers with rolling
12-24 month supply
forecasts, with the initial
3-6 month periods
representing binding purchase commitments.
Product royalty payments. Pursuant to our thalidomide
product license agreements with Celgene, we are required to make
additional quarterly payments to the extent that the royalty and
license payments due
50
under those agreements do not meet certain minimums. These
minimum royalty and license payment obligations expire the
earlier of 2006 or the date we obtain regulatory approval to
market thalidomide in the E.U. The amounts reflected in the
summary above represent the minimum amounts due under these
agreements. In addition, our Innohep license agreement with LEO
Pharma requires annual minimum royalty payments through 2006.
Product acquisition payments. We have future payment
obligations associated with the June 2005 addition to
thalidomide product rights. We paid $5.0 million in June
2005, with additional $1.0 million payments due in each of
2006 and 2007.
Contingent product acquisition payments. The contractual
summary above reflects only payment obligations for product and
company acquisitions that are fixed and determinable. We also
have contractual payment obligations, the amount and timing of
which are contingent upon future events. In accordance with
U.S. generally accepted accounting principles, contingent
payment obligations are not recorded on our balance sheet until
the amount due can be reasonably determined. Under the terms of
the agreement with GPC Biotech, we will pay them up to an
additional $30.5 million based on the achievement of
certain regulatory filing and approval milestones, up to an
additional $75 million for up to five subsequent E.U.
approvals for additional indications and we will pay them sales
milestones totaling up to $105 million, based on the
achievement of significant annual sales levels in our
territories. Similarly, under the agreement with MethylGene, our
milestone payments for MGCD0103 could reach $145 million,
based on the achievement of significant development, regulatory
and sales goals, with the nearest milestone of $4 million
to be paid upon enrollment of the first patient in a
Phase II trial. Furthermore, up to $100 million for
each additional HDAC inhibitor may be paid, also based on the
achievement of significant development, regulatory and sales
milestones. Also, under the agreements with Schering AG,
payments totaling up to $7.5 million are due if milestones
relating to revenue and gross margin targets for Refludan are
achieved.
|
|
Item 7A. |
Quantitative and Qualitative Disclosures About Market
Risk. |
We currently invest our excess cash balances in short-term
investment grade securities including money market accounts that
are subject to interest rate risk. The amount of interest income
we earn on these funds will decline with a decline in interest
rates. However, due to the short-term nature of short-term
investment grade securities and money market accounts, an
immediate decline in interest rates would not have a material
impact on our financial position, results of operations or cash
flows.
We are exposed to movements in foreign exchange rates against
the U.S. dollar for inter-company trading transactions and
the translation of net assets and earnings of
non-U.S. subsidiaries.
Our primary operating currencies are the U.S. dollar,
British pound sterling, the euro, and Swiss francs. We have not
undertaken any foreign currency hedges through the use of
forward foreign exchange contracts or options. Foreign currency
exposures have been managed solely through managing the currency
denomination of our cash balances.
|
|
Item 8. |
Financial Statements and Supplementary Data. |
The financial statements required pursuant to this item are
included in Item 15 of this report and are presented
beginning on page F-1.
|
|
Item 9. |
Changes in and Disagreements With Accountants on
Accounting and Financial Disclosure. |
None.
|
|
Item 9A. |
Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures.
We carried out an evaluation under the supervision and with the
participation of our management, including our Chief Executive
Officer, or CEO, and Chief Financial Officer, or CFO, of the
effectiveness of our disclosure controls and procedures, as
defined in
Rules 13a-15(e)
and 15(d)-15(e) of the
Securities Exchange Act of 1934, as amended, or the Exchange
Act, as of the end of the period covered by this report.
51
Based on that evaluation, the CEO and CFO have concluded that
our disclosure controls and procedures are effective to provide
reasonable assurance that information required to be disclosed
by us in our periodic reports under the Exchange Act is
recorded, processed, summarized and reported within the time
periods specified in SEC rules and forms, and that such
information is accumulated and communicated to our management,
including our CEO and CFO, as appropriate, to allow timely
decisions regarding required disclosure. We have designed our
disclosure controls and procedures in such a manner that they
provide reasonable assurance that those controls and procedures
will meet their objectives. It should be noted, however, that
the design of any system of controls is based in part upon
certain assumptions about the likelihood of future events, and
can therefore only provide reasonable, not absolute assurance
that the design will succeed in achieving its stated goals.
Managements Report on Internal Control Over Financial
Reporting
The management of the company is responsible for establishing
and maintaining adequate internal control over financial
reporting, as defined in
Rules 13a-15(f)
and 15(d)-15(f) of the
Exchange Act. Our internal control system was designed to
provide reasonable assurance to our management and board of
directors regarding the preparation and fair presentation of
published financial statements. All internal control systems, no
matter how well designed, have inherent limitations. Therefore,
even those systems determined to be effective can provide only
reasonable assurance with respect to financial statement
preparation and presentation.
Our management assessed the effectiveness of the companys
internal control over financial reporting as of
December 31, 2005. In making this assessment, it used the
criteria set forth by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO) in Internal Control-Integrated
Framework. Based on this assessment management believes that, as
of December 31, 2005, our internal control over financial
reporting is effective based on those criteria.
52
Our managements assessment of the effectiveness of our
internal control over financial reporting as of
December 31, 2005, has been audited by Ernst &
Young LLP, an independent registered public accounting firm, as
stated in their report which is included in this Item 9A
immediately below.
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Pharmion
Corporation:
We have audited managements assessment, included in the
accompanying Managements Report on Internal Control Over
Financial Reporting, that Pharmion Corporation maintained
effective internal control over financial reporting as of
December 31, 2005, based on criteria established in
Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
(the COSO criteria). Pharmion Corporations management is
responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness
of internal control over financial reporting. Our responsibility
is to express an opinion on managements assessment and an
opinion on the effectiveness of the companys internal
control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, evaluating
managements assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing
such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Pharmion
Corporation maintained effective internal control over financial
reporting as of December 31, 2005, is fairly stated, in all
material respects, based on the COSO criteria. Also, in our
opinion, Pharmion Corporation maintained, in all material
respects, effective internal control over financial reporting as
of December 31, 2005, based on the COSO criteria.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Pharmion Corporation as of
December 31, 2005 and 2004, and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2005 of Pharmion Corporation and our report
dated March 16, 2006 expressed an unqualified opinion
thereon.
Denver, Colorado
March 16, 2006
53
|
|
Item 9B. |
Other Information. |
None.
PART III
|
|
Item 10. |
Directors and Executive Officers of the Registrant. |
The information required by this Item concerning our directors
is incorporated by reference from the information set forth in
the section entitled Section 16(a) Beneficial
Ownership Reporting Compliance in the Companys
definitive Proxy Statement for the 2006 Annual Meeting of
Stockholders to be filed with the Commission within
120 days after the end of our fiscal year ended
December 31, 2005 (the Proxy Statement). The
information required by this Item concerning our executive
officers is incorporated by reference from the information set
forth in the section of the Proxy Statement entitled
Executive Officers, Directors and Key Employees. The
information required by this Item concerning our standing audit
committee is incorporated by reference from the information set
forth in the section of the Proxy Statement entitled
Committees of the Board of Directors and Meetings.
We have adopted a code of conduct and ethics that applies to all
of our directors, officers and employees, including our chief
executive officer and chief financial and accounting officers.
The text of the code of conduct and ethics is available without
charge, upon request, in writing to Investor Relations at
Pharmion Corporation, 2525 28th Street, Boulder, CO 80301.
Disclosure regarding any amendments to, or waivers from,
provisions of the code of conduct and ethics that apply to our
directors, principal executive and financial officers will be
included in a Current Report on
Form 8-K filed
within four business days following the date of the amendment or
waiver, unless web site posting of such amendments or waivers is
then permitted by the rules of the SEC and the Nasdaq Stock
Market, Inc.
The information required by this Item concerning our equity
compensation plan is set forth under Item 5 of this Annual
Report on Form 10-K.
|
|
Item 11. |
Executive Compensation. |
The information required by this Item regarding executive
compensation is incorporated by reference from the information
to be set forth in the section of the Proxy Statement entitled
Executive Compensation.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters. |
The information required by this Item regarding security
ownership of certain beneficial owners and management is
incorporated by reference from the information to be set forth
in the section of the Proxy Statement entitled Security
Ownership of Certain Beneficial Owners and Management. The
information required by this Item regarding our equity
compensations plans is incorporated by reference from the
information set forth in the section of the Proxy Statement
entitled Equity Compensation Plan Information.
|
|
Item 13. |
Certain Relationships and Related Transactions. |
The information required by this Item regarding certain
relationships and related transactions is incorporated by
reference from the information to be set forth in the section of
the Proxy Statement entitled Certain Transactions.
|
|
Item 14. |
Principal Accountant Fees and Services. |
The information required by this Item regarding principal
accountant fees and services is incorporated by reference from
the information to be set forth in the sections of the Proxy
Statement entitled Report of the Audit Committee,
Ratification of Selection of Independent Auditors
and Fees Paid to Ernst & Young.
54
PART IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules. |
(a) The following documents are being filed as part of this
report:
|
|
|
(1) Consolidated Financial Statements |
|
|
|
Reference is made to the Index to Consolidated Financial
Statements of Pharmion Corporation. appearing on
page F-1 of this
report. |
|
|
|
(2) Consolidated Financial Statement Schedules |
|
|
|
The following consolidated financial statement schedule of the
Company for each of the years ended December 31, 2005, 2004
and 2003, is filed as part of this Annual Report on
Form 10-K and
should be read in conjunction with the Consolidated Financial
Statements, and the related notes thereto, of the Company. |
|
|
|
|
|
|
|
Page | |
|
|
Number | |
|
|
| |
Schedule II Valuation and Qualifying Accounts
|
|
|
S-1 |
|
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
2.1(1) |
|
|
Stock Purchase Agreement, dated March 7, 2003, by and among
Pharmion France and the shareholders of Gophar S.A.S. |
|
3.1(1) |
|
|
Amended and Restated Certificate of Incorporation. |
|
3.2(1) |
|
|
Amended and Restated Bylaws. |
|
4.1(1) |
|
|
Specimen Stock Certificate. |
|
4.2(1) |
|
|
Amended and Restated Investors Rights Agreement, dated as
of November 30, 2001, by and among the Registrant, the
founders and the holders of the Registrants Preferred
Stock. |
|
4.3(1) |
|
|
Series C Omnibus Amendment Agreement, dated as of
October 11, 2002 to Amended and Restated Investors
Rights Agreement, dated as of November 30, 2001, by and
among the Registrant, the founders and the holders of the
Registrants Preferred Stock. |
|
4.4(1) |
|
|
Amendment, dated as of April 8, 2003 to Amended and
Restated Investors Rights Agreement, dated as of
November 30, 2001, by and among the Registrant, the
founders and the holders of the Registrants Preferred
Stock. |
|
4.5(1) |
|
|
Series B Preferred Stock Purchase Warrant, dated
November 30, 2001, issued by the Registrant to Celgene
Corporation. |
|
4.6(1) |
|
|
Senior Convertible Promissory Note, dated April 8, 2003,
issued by the Registrant to Celgene Corporation. |
|
4.7(1) |
|
|
Common Stock Purchase Warrant, dated April 8, 2003, issued
by the Registrant to Celgene Corporation. |
|
4.8(1) |
|
|
Convertible Subordinated Promissory Note, dated April 11,
2003, issued by the Registrant to Penn Pharmaceuticals Holdings
Limited. |
|
4.9(1) |
|
|
Common Stock Purchase Warrant, dated April 11, 2003, issued
by the Registrant to Penn Pharmaceuticals Holdings Limited. |
|
10.1(1)* |
|
|
Amended and Restated 2001 Non-Employee Director Stock Option
Plan. |
|
10.2(1)* |
|
|
Amended and Restated 2000 Stock Incentive Plan. |
|
10.3(1) |
|
|
Securities Purchase Agreement, dated as of April 8, 2003,
by and between the Registrant and Celgene Corporation. |
|
10.4(1) |
|
|
Securities Purchase Agreement, dated as of April 11, 2003,
by and between the Registrant and Penn Pharmaceuticals Holdings
Limited. |
55
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
10.5(1) |
|
|
Amended and Restated Distribution and License Agreement, dated
as of November 16, 2001, by and between Pharmion GmbH and
Penn T Limited. |
|
10.6(1) |
|
|
Amendment No. 1, dated March 4, 2003, to Amended and
Restated Distribution and License Agreement, dated as of
November 16, 2001, by and between Pharmion GmbH and
Penn T Limited. |
|
10.7(1) |
|
|
Supplementary Agreement, dated June 18, 2003, to Amended
and Restated Distribution and License Agreement, dated as of
November 16, 2001, by and between Pharmion GmbH and
Penn T Limited. |
|
10.8(1) |
|
|
License Agreement, dated as of November 16, 2001, by and
among the Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.9(1) |
|
|
Amendment No. 1, dated March 3, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.10(1) |
|
|
Letter Agreement, dated April 2, 2003, by and among the
Registrant, Pharmion GmbH and Celgene Corporation regarding
clinical funding. |
|
10.11(1) |
|
|
Amendment No. 2, dated April 8, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.12(1) |
|
|
License and Distribution Agreement, dated as of June 21,
2002, by and between the Registrant and LEO Pharmaceutical
Products Ltd. A/S. |
|
10.13(1) |
|
|
License Agreement, dated as of June 7, 2001, by and between
the Registrant, Pharmion GmbH and Pharmacia & Upjohn
Company. |
|
10.8(1) |
|
|
License Agreement, dated as of November 16, 2001, by and
among the Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.9(1) |
|
|
Amendment No. 1, dated March 3, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.10(1) |
|
|
Letter Agreement, dated April 2, 2003, by and among the
Registrant, Pharmion GmbH and Celgene Corporation regarding
clinical funding. |
|
10.11(1) |
|
|
Amendment No. 2, dated April 8, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.12(1) |
|
|
License and Distribution Agreement, dated as of June 21,
2002, by and between the Registrant and LEO Pharmaceutical
Products Ltd. A/S. |
|
10.13(1) |
|
|
License Agreement, dated as of June 7, 2001, by and between
the Registrant, Pharmion GmbH and Pharmacia & Upjohn
Company. |
|
10.14(1) |
|
|
Interim Sales Representation Agreement, dated as of May 29,
2002, by and between Pharmion GmbH and Schering
Aktiengesellschaft. |
|
10.15(1) |
|
|
Distribution and Development Agreement, dated as of May 29,
2002, by and between Pharmion GmbH and Schering
Aktiengesellschaft. |
|
10.16(1) |
|
|
First Amendment Agreement dated August 20, 2003 by and
between Pharmion GmbH and Schering Aktiengesellschaft. |
|
10.17(3)* |
|
|
Employment Agreement, dated as of February 23, 2004, by and
between the Registrant and Patrick J. Mahaffy. |
|
10.18(3)* |
|
|
Amended and Restated Employment Agreement, dated as of
March 1, 2004, by and between the Registrant and Judith A.
Hemberger. |
|
10.19(1)* |
|
|
Non-Competition and Severance Agreement, dated as of
November 29, 2001, by and between the Registrant and
Michael Cosgrave. |
|
10.20(1)* |
|
|
Employment Agreement, dated as of January 5, 2001, by and
between the Registrant and Michael Cosgrave. |
|
10.21(3)* |
|
|
Amended and Restated Employment Agreement, dated as of
March 1, 2004, by and between the Registrant and Erle Mast. |
56
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
10.22(3)* |
|
|
Amended and Restated Employment Agreement, dated as of
March 1, 2004, by and between the Registrant and Gillian C.
Ivers-Read. |
|
10.23(1) |
|
|
Office Lease, dated as of April 24, 2002, by and between
the Registrant and Centro III, LLC. |
|
10.24(1) |
|
|
First Amendment to Lease, dated as of January 31, 2003, to
Office Lease, dated as of April 24, 2002, by and between
the Registrant and Centro III, LLC. |
|
10.25(2)* |
|
|
Addendum to Employment Agreement, dated June 15, 2004, by
and between the Registrant and Michael Cosgrave. |
|
10.26(4) |
|
|
Amendment No. 2, dated as of December 3, 2004, to
Amended and Restated Distribution and License Agreement, dated
November 16, 2001, by and between Pharmion GmbH and Celgene
U.K. Manufacturing II Limited (formerly Penn T
Limited). |
|
10.27(4) |
|
|
Letter Agreement, dated as of December 3, 2004, by and
between the Registrant, Pharmion GmbH and Celgene Corporation
amending the Letter Agreement regarding clinical funding, dated
April 2, 2003, between Registrant, Pharmion GmbH and
Celgene. |
|
10.28(4) |
|
|
Letter Agreement, dated as of December 3, 2004, by and
between the Registrant, Pharmion GmbH and Celgene Corporation
amending the License Agreement, dated November 16, 2001,
among Registrant, Pharmion GmbH and Celgene. |
|
10.29(4) |
|
|
Lease, dated as of December 21, 2004, by and between
Pharmion Limited and Alecta Pensionsförsäkring
Ömsesidigit. |
|
10.31(5) |
|
|
Supply Agreement, dated as of March 31, 2005, by and
between the Registrant and Ash Stevens, Inc. |
|
10.32(6) |
|
|
Manufacturing and Service Contract, dated as of
December 20, 2005, by and between the Registrant and Ben
Venue Laboratories, Inc. |
|
10.33(6) |
|
|
Co-Development and License Agreement, dated as of
December 19, 2005, by and between the Registrant, Pharmion
GmbH and GPC Biotech AG. |
|
10.34(6) |
|
|
Supply Agreement, dated as of December 19, 2005, by and
between the Registrant, Pharmion GmbH and GPC Biotech AG. |
|
10.35 |
|
|
Pharmion Corporation 2000 Stock Incentive Plan (Amended and
Restated effective as of February 9, 2006) |
|
23.1 |
|
|
Consent of Independent Registered Public Accounting Firm. |
|
24.1 |
|
|
Power of Attorney (reference is made to page 58) |
|
31.1 |
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for
President and Chief Executive Officer. |
|
31.2 |
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for
Chief Financial Officer. |
|
32.1 |
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certification for
President and Chief Executive Officer and Chief Financial
Officer. |
|
|
(1) |
Incorporated by reference to our Registration Statement on
Form S-1 (File
No. 333-108122)
and amendments thereto, declared effective November 5, 2003. |
|
(2) |
Incorporated by reference to our Registration Statement on
Form S-1 (File
No. 333-116252)
and amendments thereto, declared effective June 30, 2004. |
|
(3) |
Incorporated by reference to our Quarterly Report on
Form 10-Q for the
quarter ended March 31, 2004. |
|
(4) |
Incorporated by reference to the exhibits to our Annual Report
on Form 10-K for
the year ended December 31, 2004. |
|
(5) |
Incorporated by reference to our Quarterly Report on
Form 10-Q for the
quarter ended March 31, 2005. |
|
(6) |
Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to
Rule 24B-2 of the Securities Exchange Act of 1934, as
amended. |
|
|
|
|
* |
Management Contract or Compensatory Plan or Arrangement |
57
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the Company has duly caused
this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
|
|
|
|
By: |
/s/ Patrick J. Mahaffy
|
|
|
|
|
|
Patrick J. Mahaffy |
|
President and Chief Executive Officer |
Date: March 16, 2006
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each individual whose
signature appears below constitutes and appoints Patrick J.
Mahaffy and Erle T. Mast, and each of them, his true and lawful
attorneys-in-fact and
agents with full power of substitution, for him and in his name,
place and stead, in any and all capacities, to sign any and all
amendments to this
Form 10-K, and to
file the same, with all exhibits thereto and all documents in
connection therewith, with the Securities and Exchange
Commission, granting unto said
attorneys-in-fact and
agents, and each of them, full power and authority to do and
perform each and every act and thing requisite and necessary to
be done in and about the premises, as fully to all intents and
purposes as he might or could do in person, hereby ratifying and
confirming all that said
attorneys-in-fact and
agents or any of them, or his or their substitute or
substitutes, may lawfully do or cause to be done by virtue
hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, as amended, this
Form 10-K has been
signed by the following persons on behalf of the Registrant and
in the capacities and on the dates indicated.
|
|
|
|
|
|
|
Name |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Patrick J. Mahaffy
Patrick J. Mahaffy |
|
President, Chief Executive Officer and Director (Principal
Executive Officer) |
|
March 16, 2006 |
|
/s/ Erle T. Mast
Erle T. Mast |
|
Executive Vice President,
Chief Financial Officer (Principal Financial and Accounting
Officer) |
|
March 16, 2006 |
|
/s/ Judith A. Hemberger
Judith A. Hemberger |
|
Executive Vice President, Chief Operating Officer and Director |
|
March 16, 2006 |
|
/s/ Edward J. McKinley
Edward J. McKinley |
|
Director |
|
March 16, 2006 |
|
/s/ Brian G. Atwood
Brian G. Atwood |
|
Director |
|
March 16, 2006 |
|
/s/ Thorlef Spickschen
Thorlef Spickschen |
|
Director |
|
March 16, 2006 |
58
|
|
|
|
|
|
|
Name |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ M. James Barrett
M. James Barrett |
|
Director |
|
March 16, 2006 |
|
/s/ James Blair
James Blair |
|
Director |
|
March 16, 2006 |
|
/s/ Cam Garner
Cam Garner |
|
Director |
|
March 16, 2006 |
|
/s/ John C. Reed
John C. Reed |
|
Director |
|
March 16, 2006 |
59
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
Pharmion Corporation Consolidated Financial Statements:
|
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
|
F-3 |
|
|
|
|
|
F-4 |
|
|
|
|
|
F-5 |
|
|
|
|
|
F-6 |
|
|
|
|
|
F-7 |
|
|
|
|
|
S-1 |
|
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of Pharmion Corporation
We have audited the accompanying consolidated balance sheets of
Pharmion Corporation as of December 31, 2005 and 2004, and
the related consolidated statements of operations,
stockholders equity and cash flows for each of the three
years in the period ended December 31, 2005. Our audits
also included the financial statement schedule listed in the
index at Item 15(a)2. These financial statements and
schedule are the responsibility of management. Our
responsibility is to express an opinion on these financial
statements and schedule based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States).Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the consolidated
financial position of Pharmion Corporation at December 31,
2005 and 2004, and the consolidated results of its operations
and its cash flows for each of the three years in the period
ended December 31, 2005, in conformity with
U.S. generally accepted accounting principles. Also, in our
opinion, the related financial statement schedule, when
considered in relation to the basic financial statements taken
as a whole, presents fairly, in all material respects, the
information set forth therein.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of Pharmion Corporations internal control
over financial reporting as of December 31, 2005, based on
criteria established in Internal Control Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission and our report dated March 16, 2006
expressed an unqualified opinion thereon.
Denver, Colorado
March 16, 2006
F-2
PHARMION CORPORATION
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
90,442,655 |
|
|
$ |
119,657,986 |
|
|
Short-term investments
|
|
|
152,962,977 |
|
|
|
125,884,838 |
|
|
Accounts receivable, net of allowances of $3,573,249 and
$2,209,842, respectively
|
|
|
32,213,282 |
|
|
|
35,193,222 |
|
|
Inventories, net
|
|
|
11,471,925 |
|
|
|
3,687,496 |
|
|
Prepaid clinical research and development costs
|
|
|
16,020,245 |
|
|
|
|
|
|
Other current assets
|
|
|
5,778,458 |
|
|
|
4,396,282 |
|
|
|
|
|
|
|
|
Total current assets
|
|
|
308,889,542 |
|
|
|
288,819,824 |
|
Product rights, net
|
|
|
104,044,740 |
|
|
|
108,478,367 |
|
Goodwill
|
|
|
12,919,650 |
|
|
|
9,425,524 |
|
Property and equipment, net
|
|
|
6,606,144 |
|
|
|
4,283,763 |
|
Other assets
|
|
|
170,233 |
|
|
|
222,994 |
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
432,630,309 |
|
|
$ |
411,230,472 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
8,456,049 |
|
|
$ |
9,891,391 |
|
|
Accrued and other current liabilities
|
|
|
73,813,032 |
|
|
|
45,562,831 |
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
82,269,081 |
|
|
|
55,454,222 |
|
Long term liabilities:
|
|
|
|
|
|
|
|
|
|
Deferred tax liability
|
|
|
2,797,717 |
|
|
|
3,605,721 |
|
|
Other long-term liabilities
|
|
|
939,859 |
|
|
|
217,828 |
|
|
|
|
|
|
|
|
Total long term liabilities
|
|
|
3,737,576 |
|
|
|
3,823,549 |
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
86,006,657 |
|
|
|
59,277,771 |
|
|
|
|
|
|
|
|
Stockholders equity
|
|
|
|
|
|
|
|
|
|
Common stock: par value $0.001, 100,000,000 shares
authorized, 31,912,751 and 31,780,715 shares issued and
outstanding,
respectively
|
|
|
31,913 |
|
|
|
31,781 |
|
|
Preferred stock: par value $0.001, 10,000,000 shares
authorized, no shares issued and outstanding
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
482,892,598 |
|
|
|
482,660,589 |
|
|
Deferred compensation
|
|
|
(226,709 |
) |
|
|
(679,572 |
) |
|
Accumulated other comprehensive income
|
|
|
(246,657 |
) |
|
|
8,036,088 |
|
|
Accumulated deficit
|
|
|
(135,827,493 |
) |
|
|
(138,096,185 |
) |
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
346,623,652 |
|
|
|
351,952,701 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
432,630,309 |
|
|
$ |
411,230,472 |
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Net sales
|
|
$ |
221,243,681 |
|
|
$ |
130,170,640 |
|
|
$ |
25,539,248 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, inclusive of royalties, exclusive of product
rights amortization shown separately below
|
|
|
59,799,818 |
|
|
|
43,634,611 |
|
|
|
11,461,994 |
|
|
Clinical, development and regulatory
|
|
|
42,943,902 |
|
|
|
28,391,812 |
|
|
|
24,615,968 |
|
|
Acquired in-process research
|
|
|
21,242,803 |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
83,323,008 |
|
|
|
66,847,663 |
|
|
|
36,108,728 |
|
|
Product rights amortization
|
|
|
9,345,328 |
|
|
|
3,395,504 |
|
|
|
1,971,597 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
216,654,859 |
|
|
|
142,269,590 |
|
|
|
74,158,287 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
4,588,822 |
|
|
|
(12,098,950 |
) |
|
|
(48,619,039 |
) |
Interest and other income (expense), net
|
|
|
6,473,548 |
|
|
|
2,414,838 |
|
|
|
(154,390 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) before taxes
|
|
|
11,062,370 |
|
|
|
(9,684,112 |
) |
|
|
(48,773,429 |
) |
Income tax expense
|
|
|
8,793,678 |
|
|
|
7,853,067 |
|
|
|
1,285,473 |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
2,268,692 |
|
|
|
(17,537,179 |
) |
|
|
(50,058,902 |
) |
Less accretion of redeemable convertible preferred stock to
redemption value
|
|
|
|
|
|
|
|
|
|
|
(10,090,971 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders
|
|
$ |
2,268,692 |
|
|
$ |
(17,537,179 |
) |
|
$ |
(60,149,873 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders per common
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
.07 |
|
|
$ |
(.63 |
) |
|
$ |
(14.70 |
) |
|
|
Diluted
|
|
$ |
.07 |
|
|
$ |
(.63 |
) |
|
$ |
(14.70 |
) |
Weighted average number of common and common equivalent shares
used to calculate net income (loss) per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
31,836,783 |
|
|
|
27,933,202 |
|
|
|
4,093,067 |
|
|
|
Diluted
|
|
|
32,875,516 |
|
|
|
27,933,202 |
|
|
|
4,093,067 |
|
Unaudited pro forma net loss attributable to common stockholders
per common share assuming conversion of preferred stock, basic
and diluted (Note 2)
|
|
|
N/A |
|
|
|
N/A |
|
|
$ |
(2.66 |
) |
Shares used in computing unaudited pro forma net loss
attributable to common stockholders per common share assuming
conversion of preferred stock, basic and diluted (Note 2)
|
|
|
N/A |
|
|
|
N/A |
|
|
|
18,791,015 |
|
See accompanying notes.
F-4
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total | |
|
|
Common Stock | |
|
Additional | |
|
|
|
Other | |
|
|
|
Stockholders | |
|
|
| |
|
Paid-In | |
|
Deferred | |
|
Comprehensive | |
|
Accumulated | |
|
Equity | |
|
|
Shares | |
|
Amount | |
|
Capital | |
|
Compensation | |
|
Income | |
|
Deficit | |
|
(Deficit) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at January 1, 2003
|
|
|
869,177 |
|
|
$ |
869 |
|
|
$ |
|
|
|
$ |
(44,149 |
) |
|
$ |
776,938 |
|
|
$ |
(62,949,948 |
) |
|
$ |
(62,216,290 |
) |
Comprehensive Loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(50,058,902 |
) |
|
|
(50,058,902 |
) |
Foreign currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,609,244 |
|
|
|
|
|
|
|
3,609,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(46,449,658 |
) |
Exercise of stock options
|
|
|
53,190 |
|
|
|
53 |
|
|
|
73,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,648 |
|
Repurchase of unvested shares of common stock
|
|
|
(4,687 |
) |
|
|
(4 |
) |
|
|
(1,871 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,875 |
) |
Deferred compensation associated with stock option grants
|
|
|
|
|
|
|
|
|
|
|
1,740,879 |
|
|
|
(1,740,879 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
629,859 |
|
|
|
|
|
|
|
|
|
|
|
629,859 |
|
Issuance of warrants associated with convertible notes
|
|
|
|
|
|
|
|
|
|
|
729,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
729,697 |
|
Accretion of preferred stock to redemption value
|
|
|
|
|
|
|
|
|
|
|
(2,540,815 |
) |
|
|
|
|
|
|
|
|
|
|
(7,550,156 |
) |
|
|
(10,090,971 |
) |
Conversion of preferred stock to common stock
|
|
|
17,030,956 |
|
|
|
17,031 |
|
|
|
146,060,825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
146,077,856 |
|
Issuance of common stock, net of issuance costs
|
|
|
6,000,000 |
|
|
|
6,000 |
|
|
|
76,155,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76,161,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
23,948,636 |
|
|
$ |
23,949 |
|
|
$ |
222,217,779 |
|
|
$ |
(1,155,169 |
) |
|
$ |
4,386,182 |
|
|
$ |
(120,559,006 |
) |
|
$ |
104,913,735 |
|
Comprehensive Loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,537,179 |
) |
|
|
(17,537,179 |
) |
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,923,764 |
|
|
|
|
|
|
|
3,923,764 |
|
Net unrealized loss on available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(273,858 |
) |
|
|
|
|
|
|
(273,858 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,887,273 |
) |
Exercise of stock options and warrants
|
|
|
1,206,551 |
|
|
|
1,207 |
|
|
|
8,384,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,385,645 |
|
Repurchase of unvested shares of common stock
|
|
|
(6,642 |
) |
|
|
(7 |
) |
|
|
(3,979 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,986 |
) |
Conversion of debt and accrued interest to equity
|
|
|
1,342,170 |
|
|
|
1,342 |
|
|
|
14,160,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,161,491 |
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
475,597 |
|
|
|
|
|
|
|
|
|
|
|
475,597 |
|
Issuance of common stock, net of issuance costs
|
|
|
5,290,000 |
|
|
|
5,290 |
|
|
|
237,902,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
237,907,492 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
31,780,715 |
|
|
$ |
31,781 |
|
|
$ |
482,660,589 |
|
|
$ |
(679,572 |
) |
|
$ |
8,036,088 |
|
|
$ |
(138,096,185 |
) |
|
$ |
351,952,701 |
|
Comprehensive Loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,268,692 |
|
|
|
2,268,692 |
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,240,429 |
) |
|
|
|
|
|
|
(8,240,429 |
) |
Net unrealized loss on available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(42,316 |
) |
|
|
|
|
|
|
(42,316 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,014,053 |
) |
Exercise of stock options
|
|
|
134,120 |
|
|
|
134 |
|
|
|
487,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
487,603 |
|
Repurchase of unvested shares of common stock
|
|
|
(2,084 |
) |
|
|
(2 |
) |
|
|
(1,248 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,250 |
) |
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
198,651 |
|
|
|
|
|
|
|
|
|
|
|
198,651 |
|
Cancellation of deferred compensation associated with stock
option forfeitures
|
|
|
|
|
|
|
|
|
|
|
(254,212 |
) |
|
|
254,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
31,912,75 |
|
|
$ |
31,913 |
|
|
$ |
482,892,598 |
|
|
$ |
(226,709 |
) |
|
$ |
(246,657 |
) |
|
$ |
(135,827,493 |
) |
|
$ |
346,623,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$ |
2,268,692 |
|
|
$ |
(17,537,179 |
) |
|
$ |
(50,058,902 |
) |
|
Adjustments to reconcile net income (loss) to net cash provided
by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
11,758,686 |
|
|
|
5,609,395 |
|
|
|
3,516,450 |
|
|
|
Compensation expense related to stock option issuance
|
|
|
198,651 |
|
|
|
475,597 |
|
|
|
629,859 |
|
|
|
Amortization of discounts and premiums on short-term
investments, net
|
|
|
(417,331 |
) |
|
|
(331,753 |
) |
|
|
|
|
|
|
Other
|
|
|
(518,975 |
) |
|
|
(207,412 |
) |
|
|
201,675 |
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
25,005 |
|
|
|
(25,432,117 |
) |
|
|
(5,610,818 |
) |
|
|
|
Inventories
|
|
|
(8,502,763 |
) |
|
|
1,682,708 |
|
|
|
(1,733,357 |
) |
|
|
|
Other current assets
|
|
|
(17,664,045 |
) |
|
|
(39,688 |
) |
|
|
(232,363 |
) |
|
|
|
Other long-term assets
|
|
|
41,300 |
|
|
|
324,875 |
|
|
|
1,033,649 |
|
|
|
|
Accounts payable
|
|
|
(786,093 |
) |
|
|
5,215,896 |
|
|
|
(1,081,441 |
) |
|
|
|
Accrued and other current liabilities
|
|
|
39,543,872 |
|
|
|
24,176,512 |
|
|
|
5,632,587 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
|
25,946,999 |
|
|
|
(6,063,166 |
) |
|
|
(47,702,661 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(5,220,190 |
) |
|
|
(1,164,801 |
) |
|
|
(2,468,685 |
) |
|
Acquisition of business, net of cash acquired
|
|
|
(10,072,160 |
) |
|
|
(19,032 |
) |
|
|
(12,289,524 |
) |
|
Purchase of product rights
|
|
|
(5,000,00 |
) |
|
|
(80,000,000 |
) |
|
|
(1,000,000 |
) |
|
Purchase of available-for-sale investments
|
|
|
(172,896,091 |
) |
|
|
(158,593,097 |
) |
|
|
|
|
|
Sale and maturity of available-for-sale investments
|
|
|
146,020,399 |
|
|
|
32,584,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(47,168,042 |
) |
|
|
(207,192,110 |
) |
|
|
(15,758,209 |
) |
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock, net of issuance costs
|
|
|
|
|
|
|
237,907,492 |
|
|
|
76,161,469 |
|
|
Proceeds from exercise of common stock options and warrants
|
|
|
486,353 |
|
|
|
8,381,659 |
|
|
|
71,774 |
|
|
Proceeds from issuance of convertible debt and warrants
|
|
|
|
|
|
|
|
|
|
|
14,000,000 |
|
|
Payment of debt obligations
|
|
|
(4,261,246 |
) |
|
|
(3,972,033 |
) |
|
|
(1,075,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
(3,774,893 |
) |
|
|
242,317,118 |
|
|
|
89,157,319 |
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
(4,219,395 |
) |
|
|
2,054,351 |
|
|
|
241,025 |
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(29,215,331 |
) |
|
|
31,116,193 |
|
|
|
25,937,474 |
|
|
Cash and cash equivalents, beginning of period
|
|
|
119,657,986 |
|
|
|
88,541,793 |
|
|
|
62,604,319 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of year
|
|
$ |
90,442,655 |
|
|
$ |
119,657,986 |
|
|
$ |
88,541,793 |
|
|
|
|
|
|
|
|
|
|
|
Noncash items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financed product rights acquisition
|
|
|
1,869,712 |
|
|
|
|
|
|
|
8,208,071 |
|
|
Conversion of debt and accrued interest to common stock
|
|
|
|
|
|
|
14,161,491 |
|
|
|
|
|
|
Accrual of additional business acquisition consideration
|
|
|
|
|
|
|
5,457,600 |
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
|
178,057 |
|
|
|
485,787 |
|
|
|
237,421 |
|
|
Cash paid for income taxes
|
|
|
13,196,589 |
|
|
|
1,317,307 |
|
|
|
237,389 |
|
See accompanying notes.
F-6
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Pharmion Corporation (the Company) was incorporated
in Delaware on August 26, 1999 and commenced operations in
January 2000. The Company is engaged in the acquisition,
development and commercialization of pharmaceutical products for
the treatment of oncology and hematology patients. The
Companys product acquisition and licensing efforts are
focused on both development products as well as those approved
for marketing. In exchange for distribution and marketing
rights, the Company generally grants the seller royalties on
future sales and, in some cases, up front cash payments. The
Company has acquired the rights to six products, including four
that are currently marketed or sold on a compassionate use or
named patient basis, and two products that are in varying stages
of clinical development. The Company has established operations
in the United States, Europe and Australia. Through a
distributor network, the Company can reach the hematology and
oncology community in additional countries in the Middle East
and Asia.
On September 25, 2003, the Company effected a one for four
reverse stock split of its common stock. All share and per share
amounts included in these consolidated financial statements have
been retroactively adjusted for all periods presented to give
effect to the reverse stock split.
On November 12, 2003, the Company completed an initial
public offering, which resulted in net proceeds of
$76.2 million from the issuance of 6,000,000 shares of
common stock. In connection with the initial public offering,
all of the outstanding shares of the Companys preferred
stock were converted into shares of common stock.
On July 7, 2004, the Company completed a public offering of
common stock. A total of 5,290,000 shares of common stock
were sold at a price to the public of $48.00 per share,
resulting in net proceeds to the Company of $237.9 million.
|
|
2. |
Summary of Significant Accounting Policies |
The consolidated financial statements include the accounts of
Pharmion Corporation and all subsidiaries. All material
intercompany accounts and transactions have been eliminated in
consolidation.
|
|
|
Cash and Cash Equivalents |
Cash and cash equivalents consist of money market accounts and
overnight deposits. The Company considers all highly liquid
investments purchased with an original maturity of three months
or less to be cash equivalents. Interest income resulting from
cash, cash equivalents and short-term investments was
$6,883,247, $2,559,956 and $494,595 for the years ended
December 31, 2005, 2004, and 2003, respectively.
The Company has entered into several standby letters of credit
to guarantee both current and future commitments with office
lease agreements. The aggregate amount outstanding under the
letters of credit was approximately $1.6 million at
December 31, 2005 and is secured by restricted cash held in
U.S. cash accounts.
Short-term investments consist of investment grade government
agency, auction rate, and corporate debt securities due within
one year. Investments with maturities beyond one year are
classified as short-term based on their highly liquid nature and
because such investments represent the investment of cash that
is available for current operations. All investments are
classified as available-for-sale and are recorded at market
value. Unrealized gains and losses are reflected in other
comprehensive income.
F-7
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Inventories consist of Vidaza, Innohep, Refludan and
thalidomide. Vidaza is sold commercially in the U.S. and, to a
limited extent, on a compassionate use basis within
international markets. Innohep is sold exclusively in the
U.S. market, and Refludan and thalidomide are both sold
within the international markets. All of the products are
manufactured by third-party manufacturers and delivered to the
Company as finished goods. Inventories are stated at the lower
of cost or market, cost being determined under the
first-in, first-out
method. The Company periodically reviews inventories, and items
considered outdated or obsolete are reduced to their estimated
net realizable value. For the years ended December 31,
2005, 2004 and 2003, the Company recorded a provision to reduce
the estimated net realizable value of obsolete and short-dated
inventory by $0.6 million, $1.4 million, and
$1.8 million, respectively.
Inventories consisted of the following at December 31, 2005
and 2004.
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Raw material
|
|
$ |
3,444,311 |
|
|
$ |
351,263 |
|
Finished goods
|
|
|
8,027,614 |
|
|
|
3,336,233 |
|
|
|
|
|
|
|
|
Total inventory
|
|
$ |
11,471,925 |
|
|
$ |
3,687,496 |
|
|
|
|
|
|
|
|
At December 31, 2005, the Company had firm inventory
purchase commitments, due within one year, of approximately
$8.7 million.
The cost of acquiring the distribution and marketing rights of
the Companys products that are approved for commercial use
were capitalized and are being amortized on a straight-line
basis over the estimated benefit period of 10-15 years.
In association with a business acquisition in 2003 and related
milestone payments that were made in 2004 and 2005, goodwill was
created. In accordance with Statement of Financial Accounting
Standards (SFAS) No. 142, Goodwill and Other
Intangible Assets, the Company does not amortize
goodwill. SFAS No. 142 requires the Company to perform
an impairment review of goodwill at least annually. If it is
determined that the value of goodwill is impaired, the Company
will record the impairment charge in the statement of operations
in the period it is discovered. During the years ended
December 31, 2005 and 2004, the Company recorded increases
of approximately $4.8 million and $5.5 million,
respectively, to goodwill to reflect additional consideration
due the seller of the business acquired in 2003 (see
Note 4). The increase in 2005 was partially offset by a
reduction of approximately $1.3 million, due to currency
translation adjustments.
Property and equipment are stated at cost. Repairs and
maintenance are charged to operations as incurred, and
significant expenditures for additions and improvements are
capitalized. Leasehold improvements are amortized over the
economic life of the asset or the lease term, whichever is
shorter. Depreciation
F-8
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
and amortization of property and equipment are computed using
the straight-line method based on the following estimated useful
lives:
|
|
|
|
|
|
|
Estimated Useful Life | |
|
|
| |
Computer hardware and software
|
|
|
3 years |
|
Leasehold improvements
|
|
|
3-5 years |
|
Equipment
|
|
|
7 years |
|
Furniture and fixtures
|
|
|
10 years |
|
Long-lived assets, other than goodwill, consist primarily of
product rights and property and equipment. In accordance with
SFAS No. 144, Accounting for the Impairment or
Disposal of Long-Lived Assets, the recoverability of the
carrying value of long-lived assets to be held and used is
evaluated if changes in the business environment or other facts
and circumstances that suggest they may be impaired. If this
evaluation indicates the carrying value will not be recoverable,
based on the undiscounted expected future cash flows generated
by these assets, the Company reduces the carrying amount to the
estimated fair value.
The Company sells its products to wholesale distributors and,
for certain products, directly to hospitals and clinics. Revenue
from product sales is recognized when ownership of the product
is transferred to the customer, the sales price is fixed and
determinable, and collectibility is reasonably assured. Within
the U.S. and certain foreign countries revenue is recognized
upon shipment (freight on board shipping point) since title to
the product passes and the customers have assumed the risks and
rewards of ownership. In certain other foreign countries, it is
common practice that ownership transfers upon receipt of product
and, accordingly, in these circumstances revenue is recognized
upon delivery (freight on board destination) when title to the
product effectively transfers.
The Company records allowances for product returns, chargebacks,
rebates and prompt pay discounts at the time of sale, and
reports revenue net of such amounts. In determining allowances
for product returns, chargebacks and rebates, the Company must
make significant judgments and estimates. For example, in
determining these amounts, the Company estimates end-customer
demand, buying patterns by end-customers and group purchasing
organizations from wholesalers and the levels of inventory held
by wholesalers. Making these determinations involves estimating
whether trends in past buying patterns will predict future
product sales.
The nature of the Companys allowances requiring accounting
estimates, and the specific considerations the Company uses in
estimating its amounts, are as follows:
Product returns. The Companys customers have the
right to return any unopened product during the
18-month period
beginning 6 months prior to the labeled expiration date and
ending 12 months past the labeled expiration date. As a
result, in calculating the allowance for product returns, the
Company must estimate the likelihood that product sold to
wholesalers might remain in its inventory or in
end-customers inventories to within 6 months of
expiration and analyze the likelihood that such product will be
returned within 12 months after expiration.
To estimate the likelihood of product remaining in
wholesalers inventory, the Company relies on information
from its wholesalers regarding their inventory levels, measured
end-customer demand as reported by third party sources, and on
internal sales data. The Company believes the information from
its wholesalers and third party sources is a reliable indicator
of trends, but the Company is unable to verify the accuracy of
F-9
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
such data independently. The Company also considers its
wholesalers past buying patterns, estimated remaining
shelf life of product previously shipped and the expiration
dates of product currently being shipped.
Since the Company does not have the ability to track a specific
returned product back to its period of sale, the product returns
allowance is primarily based on estimates of future product
returns over the period during which customers have a right of
return. Such estimates are primarily based on historical sales
and return rates as well as estimates of the remaining shelf
life of our products sold to customers.
For the years ended December 31, 2005 and 2004,
$0.1 million and $0.2 million of product was returned
to the Company, respectively, representing approximately 0.04%
and 0.15% of net sales revenue, respectively. The allowance for
returns was $0.6 million at both December 31, 2005 and
2004.
Chargebacks and rebates. Although the Company sells its
products in the U.S. primarily to wholesale distributors,
the Company typically enters into agreements with certain
governmental health insurance providers, hospitals, clinics, and
physicians, either directly or through group purchasing
organizations acting on behalf of their members, to allow
purchase of Company products at a discounted price and/or to
receive a volume-based rebate. The Company provides a credit to
the wholesaler, or a chargeback, representing the difference
between the wholesalers acquisition list price and the
discounted price. Rebates are paid directly to the end-customer,
group purchasing organization or government insurer.
As a result of these contracts, at the time of product shipment
the Company must estimate the likelihood that product sold to
wholesalers might be ultimately sold to a contracting entity or
group purchasing organization. For certain end-customers, the
Company must also estimate the contracting entitys or
group purchasing organizations volume of purchases.
The Company estimates its chargeback allowance based on its
estimate of the inventory levels of its products in the
wholesaler distribution channel that remain subject to
chargebacks, and specific contractual and historical chargeback
rates. The Company estimates its Medicaid rebate and commercial
contractual rebate accruals based on estimates of usage by
rebate-eligible customers, estimates of the level of inventory
of its products in the distribution channel that remain
potentially subject to those rebates, and terms of its
contractual and regulatory obligations.
At December 31, 2005 and 2004, the allowance for
chargebacks and rebates was $2.6 million and
$2.7 million, respectively.
Prompt pay discounts. As incentive to expedite cash flow,
the Company offers some customers a prompt pay discount whereby
if they pay their accounts within 30 days of product
shipment, they may take a 2% discount. As a result, the Company
must estimate the likelihood that its customers will take the
discount at the time of product shipment. In estimating the
allowance for prompt pay discounts, the Company relies on past
history of its customers payment patterns to determine the
likelihood that future prompt pay discounts will be taken and
for those customers that historically take advantage of the
prompt pay discount, the Company increases the allowance
accordingly.
At December 31, 2005 and 2004, the allowance for prompt pay
discounts was $0.5 million and $0.3 million,
respectively.
The Company has adjusted the allowances for product returns,
chargebacks and rebates and prompt pay discounts in the past
based on its actual experience, and the Company will likely be
required to make adjustments to these allowances in the future.
The Company continually monitors the allowances and makes
adjustments when the Company believes actual experience may
differ from estimates.
F-10
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Cost of sales includes the cost of product sold, royalties due
on the sales of the products and the distribution and logistics
costs related to selling the products. Cost of sales does not
include product rights amortization expense as it is shown
separately.
The Company is subject to risks common to companies in the
pharmaceutical industry including, but not limited to,
uncertainties related to regulatory approvals, dependence on key
products, dependence on key customers and suppliers, and
protection of proprietary rights.
The Company expenses all advertising, promotional and
publication costs as incurred. Total advertising costs were
approximately $6.8 million, $5.6 million, and
$2.2 million for the years ended December 31, 2005,
2004 and 2003, respectively.
|
|
|
Translation of Foreign Currencies |
The functional currencies of the Companys foreign
subsidiaries are the local currencies, primarily the British
pound sterling, euro and Swiss franc. In accordance with
SFAS No. 52, Foreign Currency Translation,
assets and liabilities are translated using the current exchange
rate as of the balance sheet date. Income and expenses are
translated using a weighted average exchange rate over the
period ending on the balance sheet date. Adjustments resulting
from the translation of the financial statements of the
Companys foreign subsidiaries into U.S. dollars are
excluded from the determination of net loss and are accumulated
in a separate component of stockholders equity. Foreign
exchange transaction gains and losses which, to date have not
been significant, are included in the results of operations.
The Company reports comprehensive income in accordance with the
provisions of SFAS No. 130, Reporting Comprehensive
Income. Comprehensive income includes all changes in equity
for cumulative translation adjustments resulting from the
consolidation of foreign subsidiaries and unrealized gains and
losses on available-for-sale securities.
|
|
|
Concentration of Credit Risk |
Financial instruments which potentially subject the Company to
concentrations of credit risk are primarily cash and cash
equivalents, short-term investments and accounts receivable. The
Company maintains its cash, cash equivalent and short-term
investment balances in the form of money market accounts, debt
securities and overnight deposits with financial institutions
that management believes are creditworthy. The Company has no
financial instruments with off-balance-sheet risk of accounting
loss.
F-11
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Companys products are sold both to wholesale
distributors and directly to hospitals and clinics. Ongoing
credit evaluations of customers are performed and collateral is
generally not required. Many of the international hospitals and
clinics are government supported and may take a significant
amount of time to collect. U.S. and international accounts
receivable consisted of the following at December 31, 2005
and 2004.
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
U.S. accounts receivable, net of allowances
|
|
$ |
11,195,675 |
|
|
$ |
12,852,798 |
|
International accounts receivable, net of allowances
|
|
|
21,403,403 |
|
|
|
22,340,424 |
|
|
|
|
|
|
|
|
Total accounts receivable, net of allowances
|
|
$ |
32,213,282 |
|
|
$ |
35,193,222 |
|
|
|
|
|
|
|
|
At December 31, 2005 and 2004, the accounts receivable
balance of our customer, Oncology Supply, represented 11% and
16%, respectively, of total net accounts receivable. No other
individual customer had accounts receivable balances greater
than 10% of total net accounts receivable.
The Company maintains a reserve for potential credit losses
based on the financial condition of customers and the aging of
accounts. Losses have been within managements
expectations. The provision for bad debts for the years end
December 31, 2005, 2004 and 2003 was $0.7 million,
$0.6 million and $0.1 million, respectively.
Net sales generated as a percent of total consolidated net
sales, for the three largest customers in the U.S. were as
follows for the years ended December 31, 2005, 2004 and
2003:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended | |
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Oncology Supply
|
|
|
17% |
|
|
|
11% |
|
|
|
0% |
|
Cardinal Health
|
|
|
15% |
|
|
|
11% |
|
|
|
3% |
|
McKesson Corporation
|
|
|
14% |
|
|
|
14% |
|
|
|
3% |
|
Net sales generated from international customers were
individually less than 5% of consolidated net sales.
|
|
|
Clinical, Development and Regulatory Costs |
Clinical, development, and regulatory costs include salaries,
benefits and other personnel related expenses as well as fees
paid to third parties for clinical development and regulatory
services. Such costs are expensed as incurred.
|
|
|
Acquired In-Process Research |
In December 2005, the Company entered into a co-development and
licensing agreement with GPC Biotech whereby it acquired
commercialization rights to a drug development candidate called
satraplatin in Europe, the Middle East, Turkey, Australia and
New Zealand. Satraplatin is in Phase III development for
the treatment of hormone refractory prostate cancer. Under terms
of the license agreement, the Company made an up front payment
to GPC Biotech of $37.1 million in early January 2006,
which included $21.2 million for reimbursement for past
satraplatin development costs incurred by GPC Biotech. This
portion of the up front payment was immediately expensed as
acquired in-process research as satraplatin has not yet achieved
regulatory approval for marketing and, absent obtaining such
approval, has no alternative future use.
F-12
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
Fair Value of Financial Instruments |
Financial instruments consist of cash and cash equivalents,
short-term investments, accounts receivable, accounts payable
and accrued liabilities. The carrying values of these
instruments approximate fair value due to their short-term
nature.
The preparation of financial statements in conformity with
U.S. generally accepted accounting principles requires
management to make estimates and assumptions that affect the
amounts reported in the consolidated financial statements and
accompanying notes. Actual results could differ from those
estimates.
|
|
|
Accounting for Stock-Based Compensation |
The Company has elected to account for its stock compensation
arrangements to employees under the provisions of Accounting
Principles Board Opinion (APB) No. 25, Accounting
for Stock Issued to Employees, and its related
interpretations. Under the provisions of APB No. 25, the
company utilizes the intrinsic value method of accounting. Under
this method, compensation expense is recognized on the date of
grant if the current market price of the underlying stock
exceeds the exercise price. The difference in value between the
current market price and the exercise price is recorded as
deferred compensation and is amortized to expense over the
vesting period of the option on a straight-line basis. Pro forma
information regarding net loss is required by
SFAS No. 123, Accounting for Stock-Based
Compensation, and has been determined as if the Company had
accounted for its employee stock options under the fair value
method of that statement. The fair value for options granted was
estimated at the date of grant using the Black-Scholes valuation
model. Under this model, the following weighted average
assumptions were used:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Expected dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility
|
|
|
49 |
% |
|
|
76 |
% |
|
|
86 |
% |
Risk free interest rate
|
|
|
4.1 |
% |
|
|
2.9 |
% |
|
|
2.8 |
% |
Expected life of options
|
|
|
4.0 years |
|
|
|
4.6 years |
|
|
|
5.0 years |
|
The expected stock price volatility was estimated using
percentages reported by similar public companies within the
pharmaceutical industry prior to 2004 as well as trading history
of the Companys common stock subsequently. The
weighted-average fair value per share was $10.36, $20.67, and
$8.98, for the options granted
F-13
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
in 2005, 2004, and 2003, respectively. The difference between
the actual expense recorded and pro forma expense for all
periods presented is provided in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Net income (loss) attributable to common stockholders as reported
|
|
$ |
2,268,692 |
|
|
$ |
(17,537,179 |
) |
|
$ |
(60,149,873 |
) |
Add stock based compensation expense included in net income
(loss)
|
|
|
198,651 |
|
|
|
475,597 |
|
|
|
585,710 |
|
Deduct total stock based compensation expense determined using
the fair value method for all rewards
|
|
|
(23,618,782 |
) |
|
|
(3,821,369 |
) |
|
|
(931,910 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss attributable to common stockholders
|
|
$ |
(21,151,438 |
) |
|
$ |
(20,882,951 |
) |
|
$ |
(60,496,073 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share, basic and diluted, as
reported
|
|
$ |
.07 |
|
|
$ |
(.63 |
) |
|
$ |
(14.70 |
) |
Net income (loss) per common share, basic and diluted, pro forma
|
|
$ |
(.66 |
) |
|
$ |
(.75 |
) |
|
$ |
(14.78 |
) |
During the period January 1, 2003 through November 5,
2003, options were granted to employees and directors at
exercise prices that were less than the estimated fair value of
the underlying shares of common stock as of the grant date. In
accordance with APB No. 25, deferred compensation expense
is being recognized for the excess of the estimated fair value
of the Companys common stock as of the grant date over the
exercise price of the options and amortized to expense on a
straight-line basis over the vesting periods of the related
options, which is generally four years. The Company recorded
compensation expense totaling $198,651, $475,597 and $585,710
for the years ended December 31, 2005, 2004 and 2003,
respectively. As of December 31, 2005 and 2004, the
unamortized compensation expense recorded as deferred
compensation within the statement of stockholders equity
was $226,709 and $679,572, respectively.
Option valuation models such as the Black-Scholes value method
described above require the input of highly subjective
assumptions. Because the Companys employee stock options
have characteristics significantly different from those of
traded options, and because changes in the subjective input
assumptions can materially affect the fair value estimate, in
the opinion of the Companys management, the existing
models do not necessarily provide a reliable single measure of
the fair value of its employee stock options.
On December 6, 2005, the Board of Directors approved the
acceleration of vesting for certain unvested incentive and
non-qualified stock options granted to employees under the 2000
stock incentive plan. Vesting acceleration was performed on
employee options granted prior to April 1, 2005 with an
exercise price per share of $21.00 or higher. A total of
839,815 shares of the Companys common stock became
exercisable as a result of the vesting acceleration. The
acceleration of vesting was consummated in order to reduce the
non-cash compensation expense that would have been recorded in
future periods following the effective date of
SFAS No. 123(R). The effect of this acceleration is
the avoidance of future non-cash expenses of approximately
$15.8 million, which is included in the pro-forma net loss
for the year ended December 31, 2005.
The Company accounts for options issued to consultants using the
provisions of SFAS No. 123 and Emerging Issues Task
Force
(EITF) 96-18,
Accounting for Equity Instruments that are Issued to other
than Employees for Acquiring or in Conjunction with Selling
Goods or Services.
F-14
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
Net Income (Loss) Per Share |
Basic net income (loss) per share is computed by dividing net
income (loss) for the period by the weighted average number of
shares of common stock outstanding during the period reduced,
where applicable, for outstanding, yet unvested, shares. Diluted
net income (loss) per share is computed by dividing the net
income (loss) for the period by the weighted average number of
common and potential incremental common shares outstanding
during the period, if their effect is dilutive. Potential
incremental common shares include shares of common stock
issuable upon the exercise of stock options and warrants and
upon the conversion of convertible notes and redeemable
convertible preferred stock outstanding during the period. The
potential shares of common stock that have not been included in
the diluted net income (loss) per share calculation totaled
1,132,212, 1,599,076, and 3,625,180 for the years ended
December 31, 2005, 2004 and 2003, respectively.
|
|
|
Pro Forma Net Loss Per Share |
Immediately prior to the effective date of the Companys
initial public offering (November 12, 2003), all redeemable
convertible preferred stock shares outstanding converted into an
aggregate of 17,030,956 shares of common stock. The pro
forma net loss per share was calculated on the consolidated
statement of operations for the year ending December 31,
2003 to show the effects of this conversion on earnings per
share. It is computed by dividing net loss before accretion of
redeemable convertible preferred stock by the weighted average
number of common shares outstanding, including the pro forma
effects of conversion of all outstanding redeemable convertible
preferred stock into shares of the Companys common stock.
|
|
|
Recently Issued Accounting Standards |
In December 2004, the Financial Accounting Standards Board
issued SFAS No. 123 (revised 2004), Share-Based
Payment, which is a revision of SFAS No. 123,
Accounting for Stock-Based Compensation.
SFAS No. 123(R) supersedes APB No. 25,
Accounting for Stock Issued to Employees, and amends
SFAS No. 95, Statement of Cash Flows.
Generally, the approach in SFAS No. 123(R) is similar
to the approach described in SFAS No. 123. However,
SFAS No. 123(R) requires all share-based payments to
employees, including grants of employee stock options, to be
recognized in the income statement based on the grant-date fair
value of the award.
As permitted by SFAS No. 123, the Company currently
accounts for share-based payments to employees using the
intrinsic value provisions of APB No. 25 and, as such,
generally recognized no compensation costs for employee stock
options. Accordingly, the adoption of
SFAS No. 123(R)s fair value method is expected
to impact our results of operations. The impact of the adoption
of SFAS no. 123(R) cannot be quantified at this time because it
will depend on levels of share-based payments granted in the
future. However, had the Company adopted
SFAS No. 123(R) in prior periods, the impact would
have approximated the impact of SFAS No. 123 as
described in the disclosure of pro forma net income and earning
per share in Note 2, Summary of Significant Accounting
Policies Accounting for Stock-Based
Compensation, except for the acceleration of
$15.8 million of expense reflected in the year ended
December 31, 2005. SFAS No. 123(R) also requires
the benefits of tax deductions in excess of recognized
compensation cost to be reported as a financing cash flow.
The Company is required to adopt the standard as of
January 1, 2006. SFAS No. 123(R) permits public
companies to adopt its requirements using one of two methods:
|
|
|
|
|
A modified prospective method in which compensation
cost is recognized beginning with the effective date
(a) based on the requirements of SFAS No. 123(R)
for all share-based payments granted after the effective date
and (b) based on the requirements of SFAS No. 123
for all rewards |
F-15
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
granted to employees prior to the effective date of
SFAS No. 123(R) that remain unvested on the effective
date; or |
|
|
|
A modified retrospective method which includes the
requirements of the modified prospective method described above,
but also permits entities to restate based on the amounts
previously recognized under SFAS No. 123 for purposes
of pro forma disclosures either (a) all prior periods or
(b) prior interim periods of the year of adoption. |
At this time, the Company expects to use the modified
prospective method. The Company is also considering the
implementation guidance for SFAS No. 123(R) issued by
the SEC in Staff Accounting Bulletin No. 107 in the
adoption of SFAS No. 123(R).
|
|
3. |
Geographic Information |
Foreign and domestic financial information (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United | |
|
Foreign | |
|
|
|
|
Year | |
|
States | |
|
Entities | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
Net sales
|
|
|
2005 |
|
|
$ |
130,886 |
|
|
$ |
90,358 |
|
|
$ |
221,244 |
|
|
|
|
2004 |
|
|
|
55,642 |
|
|
|
74,529 |
|
|
|
130,171 |
|
|
|
|
2003 |
|
|
|
3,751 |
|
|
|
21,788 |
|
|
|
25,539 |
|
Operating income (loss)
|
|
|
2005 |
|
|
$ |
21,469 |
|
|
$ |
(16,880 |
) |
|
$ |
4,589 |
|
|
|
|
2004 |
|
|
|
(16,472 |
) |
|
|
4,373 |
|
|
|
(12,099 |
) |
|
|
|
2003 |
|
|
|
(32,899 |
) |
|
|
(15,720 |
) |
|
|
(48,619 |
) |
Total assets
|
|
|
2005 |
|
|
$ |
244,316 |
|
|
$ |
188,314 |
|
|
$ |
432,630 |
|
|
|
|
2004 |
|
|
|
235,958 |
|
|
|
175,272 |
|
|
|
411,230 |
|
|
|
4. |
Acquisition of Laphal Développement |
In March 2003, a subsidiary of the Company acquired 100% of the
outstanding stock of Gophar S.A.S. and its wholly owned
subsidiary, Laphal Développement S.A. (collectively,
Laphal). Laphal is a French pharmaceutical company
focused on the sale of orphan drugs primarily in France and
Belgium. Under the terms of the related Stock Purchase Agreement
(SPA), the Company paid
12 million
at closing, less the amount of Laphals net financial debt
(as defined in the SPA). The actual amount of cash paid for
Laphal, net of cash received in the acquisition and including
transaction costs incurred was approximately $12.3 million.
Two additional payments totaling
8 million
(approximately $10.3 million) were also due if certain
aggregate sales milestones were achieved. These milestones were
achieved in the fourth quarter of 2004 and the first quarter of
2005, and the payments were made in 2005. As a result of this
purchase, the Company acquired the rights to the Laphal
thalidomide formulation and access to certain European markets.
The operating results of Laphal have been included in the
results of the Company from the date of the acquisition. Product
rights relate to thalidomide and are being amortized over the
15 year period in which the Company expects to generate
significant sales from this product.
The following pro forma combined financial information for the
year ended December 31, 2003 is derived from the historical
financial statements of the Company and of Laphal for the period
then ended, adjusted to give effect to their consolidation using
the purchase method of accounting and to reflect interest costs
on the convertible notes issued by the Company to fund the
acquisition. This pro forma financial information assumes the
acquisition of Laphal occurred as of the beginning of the period
shown. It is provided for
F-16
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
illustrative purposes only and is not indicative of the
operating results that would have been achieved had the
acquisition been consummated at the date indicated, nor is it
necessarily indicative of future operating results:
|
|
|
|
|
|
|
Year Ended | |
|
|
December 31, | |
|
|
2003 | |
|
|
| |
Net sales
|
|
$ |
27,326,566 |
|
Net loss
|
|
$ |
(50,426,996 |
) |
Net loss attributable to common stockholders per common share,
basic and diluted
|
|
$ |
(14.79 |
) |
|
|
5. |
Short-term Investments |
The amortized cost, gross unrealized gains, gross unrealized
losses and fair value of available-for-sale investments by
security classification at December 31, 2005 and 2004, were
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross | |
|
Gross | |
|
Estimated Fair | |
December 31, 2005 |
|
Amortized Cost | |
|
Unrealized Gain | |
|
Unrealized Loss | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
Government agencies
|
|
$ |
57,122,513 |
|
|
$ |
|
|
|
$ |
(170,891 |
) |
|
$ |
56,951,622 |
|
Corporate debt securities
|
|
|
42,925,942 |
|
|
|
38,227 |
|
|
|
(123,893 |
) |
|
|
42,840,276 |
|
Auction rate notes
|
|
|
30,671,341 |
|
|
|
521 |
|
|
|
|
|
|
|
30,671,862 |
|
Asset backed securities
|
|
|
22,559,355 |
|
|
|
1,702 |
|
|
|
(61,840 |
) |
|
|
22,499,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
153,279,151 |
|
|
$ |
40,450 |
|
|
$ |
(356,624 |
) |
|
$ |
152,962,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
Gross | |
|
Estimated Fair | |
December 31, 2004 |
|
Amortized Cost | |
|
Unrealized Gain |
|
Unrealized Loss | |
|
Value | |
|
|
| |
|
|
|
| |
|
| |
Government agencies
|
|
$ |
77,194,609 |
|
|
$ |
|
|
|
$ |
(158,545 |
) |
|
$ |
77,036,064 |
|
Corporate debt securities
|
|
|
28,688,241 |
|
|
|
|
|
|
|
(48,763 |
) |
|
|
28,639,478 |
|
Asset backed securities
|
|
|
17,500,097 |
|
|
|
|
|
|
|
(66,550 |
) |
|
|
17,433,547 |
|
Other debt securities
|
|
|
2,775,749 |
|
|
|
|
|
|
|
|
|
|
|
2,775,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
126,158,696 |
|
|
$ |
|
|
|
$ |
(273,858 |
) |
|
$ |
125,884,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the year ended December 31, 2005 and 2004, the gross
realized gains on sales of available-for-sale securities totaled
$661 and $342,809, respectively, and the gross realized losses
totaled $(173,231) and $(181,333), respectively. The gains and
losses on available-for-sale securities are based on the
specific identification method.
The fair value of available-for-sale securities with unrealized
losses at December 31, 2005 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held less than 12 Months | |
|
Held greater than 12 Months | |
|
Total | |
|
|
| |
|
| |
|
| |
|
|
Estimated Fair | |
|
Gross | |
|
Estimated Fair | |
|
Gross | |
|
Estimated Fair | |
|
Gross | |
December 31, 2005 |
|
Value | |
|
Unrealized Loss | |
|
Value | |
|
Unrealized Loss | |
|
Value | |
|
Unrealized Loss | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Government agencies
|
|
$ |
56,951,622 |
|
|
$ |
(170,891 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
56,951,622 |
|
|
$ |
(170,891 |
) |
Corporate debt securities
|
|
|
36,710,787 |
|
|
|
(123,893 |
) |
|
|
|
|
|
|
|
|
|
|
36,710,787 |
|
|
|
(123,893 |
) |
Asset backed securities
|
|
|
13,911,826 |
|
|
|
(51,757 |
) |
|
|
3,570,430 |
|
|
|
(10,083 |
) |
|
|
17,482,256 |
|
|
|
(61,840 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
107,574,235 |
|
|
$ |
(346,541 |
) |
|
$ |
3,570,430 |
|
|
$ |
(10,083 |
) |
|
$ |
111,144,665 |
|
|
$ |
(356,624 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-17
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Unrealized losses were due to changes to interest rates
associated with securities with short maturity lives and are
deemed to be temporary.
The amortized cost and estimated fair value of the
available-for-sale securities at December 31, 2005, by
maturity, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair | |
Maturity |
|
Amortized Cost | |
|
Value | |
|
|
| |
|
| |
Due within one year
|
|
$ |
100,048,454 |
|
|
$ |
99,791,899 |
|
Due after one year through three years
|
|
|
12,369,235 |
|
|
|
12,328,580 |
|
Due after three years through five years
|
|
|
10,190,121 |
|
|
|
10,170,636 |
|
Due after five years
|
|
|
30,671,341 |
|
|
|
30,671,862 |
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
153,279,151 |
|
|
$ |
152,962,977 |
|
|
|
|
|
|
|
|
The cost value and accumulated amortization associated with the
Companys product rights were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2005 | |
|
As of December 31, 2004 | |
|
|
| |
|
| |
|
|
Gross Carrying | |
|
Accumulated | |
|
Gross Carrying | |
|
Accumulated | |
|
|
Amount | |
|
Amortization | |
|
Amount | |
|
Amortization | |
|
|
| |
|
| |
|
| |
|
| |
Amortized product rights:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thalidomide
|
|
$ |
101,837,285 |
|
|
$ |
(9,690,198 |
) |
|
$ |
97,242,280 |
|
|
$ |
(2,509,252 |
) |
Refludan
|
|
|
12,208,071 |
|
|
|
(3,560,418 |
) |
|
|
12,208,071 |
|
|
|
(2,212,732 |
) |
Innohep
|
|
|
5,000,000 |
|
|
|
(1,750,000 |
) |
|
|
5,000,000 |
|
|
|
(1,250,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product rights
|
|
$ |
119,045,356 |
|
|
$ |
(15,000,616 |
) |
|
$ |
114,450,351 |
|
|
$ |
(5,971,984 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense of $9.3 million, $3.4 million,
and $2.0 million was recorded for the years ended
December 31, 2005, 2004 and 2003, respectively. The
estimated amortization expense for the next five years is
approximately $9.7 million per year.
In 2001, the Company licensed rights relating to the development
and commercial use of thalidomide from Celgene and separately
entered into an exclusive supply agreement for thalidomide with
Celgene U.K. Manufacturing II Limited (formerly known as
Penn T Limited), or CUK, which was acquired by
Celgene in 2004. Under the agreements, as amended in December
2004, the territory licensed from Celgene is for all countries
other than the United States, Canada, Mexico, Japan and all
provinces of China (except Hong Kong).The Company pays
(i) Celgene a royalty/license fee of 8% on the
Companys net sales of thalidomide under the terms of the
license agreements, and (ii) CUK product supply payments
equal to 15.5% of the Companys net sales of thalidomide
under the terms of the product supply agreement. The agreements
with Celgene and CUK each have a ten-year term running from the
date of receipt of the Companys first regulatory approval
for thalidomide in the United Kingdom.
In December 2004, the Company amended its thalidomide agreements
with Celgene and CUK to reduce the thalidomide product supply
payment, expand the Companys licensed territory, and
eliminate certain license termination rights held by Celgene.
The Company paid Celgene a one-time payment of $80 million
in exchange for (i) the reduction in the cost of product
supply from 28.0% of net sales to 15.5% of net sales,
(ii) the addition of Korea, Hong Kong, and Taiwan to the
Companys licensed territory and, (iii) elimination
F-18
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
of Celgenes right to terminate the license agreement in
the event the Company has not obtained a marketing authorization
approval for thalidomide in the United Kingdom by November 2006.
The $80 million payment was capitalized as part of the
thalidomide product rights and is being amortized over the
remaining period the Company expects to generate significant
thalidomide sales, approximately 13 years from
December 31, 2004.
In connection with a patent dispute, associated with
thalidomide, the Company agreed to make a $5.0 million
payment in 2005, with two $1.0 million payments due in 2006
and 2007. Accordingly, these amounts increased the thalidomide
product rights.
The Company has also committed to provide funding to support
further clinical development studies of thalidomide sponsored by
Celgene. Under these agreements, the Company paid Celgene
$4.7 million, $3.0 million, and $3.0 million in
2005, 2004 and 2003, respectively, and will pay Celgene
$2.7 million in each of 2006 and 2007.
In connection with the 2003 acquisition of Laphal, the Company
acquired rights to Laphals formulation of thalidomide. The
portion of the purchase price allocated to thalidomide has been
included in product rights, net on the accompanying balance
sheet.
In 2001, the Company licensed worldwide rights to Vidaza
(azacitidine) from Pharmacia & Upjohn Company, now part
of Pfizer, Inc. Under terms of the license agreement, the
Company is responsible for all costs to develop and market
Vidaza and the Company pays Pfizer a royalty of 8% to 20% of
Vidaza net sales. No up-front or milestone payments have or will
be made to Pfizer. The license has a term extending for the
longer of the last to expire of valid patent claims in any given
country or ten years from the first commercial sale of the
product in a particular country.
In December 2005, the Company entered into a co-development and
license agreement for satraplatin. Under the terms of the
agreement, the Company obtained exclusive commercialization
rights for Europe, Turkey, the Middle East, Australia and New
Zealand, while GPC Biotech retained rights to the North American
market and all other territories. The Company made an up front
payment of $37.1 million to GPC Biotech in early January
2006, including an $21.2 million reimbursement for
satraplatin clinical development costs incurred prior to the
agreement and $15.9 million for funding of ongoing and
certain future clinical development to be conducted jointly by
the Company and GPC Biotech. The Company and GPC Biotech will
pursue a joint development plan to evaluate development
activities for satraplatin in a variety of tumor types and will
share global development costs, for which the Company has made
an additional commitment of $22.2 million, in addition to
the $37.1 million in initial payments. The Company will
also pay GPC Biotech $30.5 million based on the achievement
of certain regulatory filing and approval milestones, and up to
an additional $75 million for up to five subsequent
European approvals for additional indications. GPC Biotech will
also receive royalties on sales of satraplatin in the
Companys territories at rates of 26% to 30% on annual
sales up to $500 million, and 34% on annual sales over
$500 million. Finally, the Company will pay GPC Biotech
sales milestones totaling up to $105 million, based on the
achievement of significant annual sales levels in its
territories.
In May 2002, the Company entered into agreements to acquire the
exclusive right to market and distribute Refludan in all
countries outside the U.S. and Canada. These agreements, as
amended in August 2003, transferred all marketing authorizations
and product registrations for Refludan in the individual
countries within the Companys territories. The Company has
paid Schering an aggregate of $13 million to
F-19
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
date and has capitalized to product rights $12.2 million
which is being amortized over a 10 year period during which
the Company expects to generate revenue. Additional payments of
up to $7.5 million will be due Schering upon achievement of
certain milestones. Because such payments are contingent upon
future events, they are not reflected in the accompanying
financial statements. In addition, the Company paid Schering an
8% royalty on net sales of Refludan through December 31,
2003 and will pay a royalty of 14% of net sales of Refludan
thereafter until the aggregate royalty payments total
$12.0 million measured from January 2004. At that time, the
royalty rate will be reduced to 6%.
In June 2002, the Company entered into a ten-year agreement with
LEO Pharma A/S for the license of the low molecular weight
heparin, Innohep. Under the terms of the agreement, the Company
acquired an exclusive right and license to market and distribute
Innohep in the United States. On the closing date the Company
paid $5 million for the license, which is capitalized as
product rights and is being amortized over a 10 year period
in which the Company expects to generate significant revenues.
On the closing date, the Company paid an additional
$2.5 million, which was creditable against royalty payments
otherwise due during the period ending March 1, 2005. In
addition, the Company is obligated to pay LEO Pharma royalties
at the rate of 30% of net sales on annual net sales of up to
$20 million and at the rate of 35% of net sales on annual
net sales exceeding $20 million, less in each case the
Companys purchase price from LEO Pharma of the units of
product sold. Furthermore, the agreement contains a minimum net
sales clause that is effective for two consecutive two-year
periods. If the company does not achieve these minimum sales
levels for two consecutive years, it has the right to pay LEO
Pharma additional royalties up to the amount LEO Pharma would
have received had the company achieved these net sales levels.
If the company opts not to make the additional royalty payment,
LEO Pharma has the right to terminate the license agreement. The
second of the two-year terms will conclude on December 31,
2006.
|
|
7. |
Property and Equipment |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Property and equipment:
|
|
|
|
|
|
|
|
|
|
Computer hardware and software
|
|
$ |
5,639,872 |
|
|
$ |
5,171,173 |
|
|
Furniture and fixtures
|
|
|
1,978,234 |
|
|
|
1,497,455 |
|
|
Equipment
|
|
|
1,301,061 |
|
|
|
1,142,592 |
|
|
Leasehold improvements
|
|
|
4,498,382 |
|
|
|
1,288,820 |
|
|
|
|
|
|
|
|
|
|
|
13,417,549 |
|
|
|
9,100,040 |
|
Less accumulated depreciation
|
|
|
(6,811,405 |
) |
|
|
(4,816,277 |
) |
|
|
|
|
|
|
|
Total property and equipment, net
|
|
$ |
6,606,144 |
|
|
$ |
4,283,763 |
|
|
|
|
|
|
|
|
Depreciation expense was $2,413,358, $2,213,891, and $1,544,830
for the years ended December 31, 2005, 2004 and 2003,
respectively.
F-20
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
8. |
Accrued and Other Current Liabilities |
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Accrued and other current liabilities:
|
|
|
|
|
|
|
|
|
Royalties payable
|
|
$ |
10,696,632 |
|
|
$ |
10,695,532 |
|
Income taxes payable
|
|
|
3,175,376 |
|
|
|
7,319,821 |
|
Product rights and notes payable
|
|
|
1,141,794 |
|
|
|
4,332,811 |
|
Accrued salaries and benefits
|
|
|
6,103,501 |
|
|
|
11,107,500 |
|
Accrued operating expenses
|
|
|
15,595,729 |
|
|
|
12,107,167 |
|
Co-development and licensing agreement payable (Note 6)
|
|
|
37,100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
73,813,032 |
|
|
$ |
45,562,831 |
|
|
|
|
|
|
|
|
|
|
9. |
Other Long-term Liabilities |
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Product rights payable
|
|
$ |
1,869,712 |
|
|
$ |
3,831,399 |
|
Notes payable
|
|
|
211,941 |
|
|
|
719,240 |
|
|
|
|
|
|
|
|
|
|
|
2,081,653 |
|
|
|
4,550,639 |
|
Current portion of product rights and notes payable
|
|
|
(1,141,794 |
) |
|
|
(4,332,811 |
) |
|
|
|
|
|
|
|
Other long term liabilities
|
|
$ |
939,859 |
|
|
$ |
217,828 |
|
|
|
|
|
|
|
|
Maturities of other long-term liabilities are as follows:
|
|
|
|
|
2006
|
|
$ |
1,141,794 |
|
2007
|
|
|
937,036 |
|
2008
|
|
|
2,823 |
|
|
|
|
|
|
|
$ |
2,081,653 |
|
|
|
|
|
|
|
10. |
Convertible Notes Payable |
In April 2003, the Company issued $14 million of
6% convertible notes with interest payable annually.
Holders of the notes also received warrants to purchase an
aggregate of 424,242 shares of the Companys common
stock at a price of $11.00 per share. The value of the
warrants was reflected as an additional debt discount to be
amortized over the term of the debt or 5 years. Effective
March 1, 2004, the $14 million of convertible notes
plus accrued interest were converted into 1,342,170 shares
of common stock. The remaining unamortized debt discount was
recorded as a decrease to equity.
|
|
11. |
Leases and Other Commitments |
The Company leases office space and equipment under various
noncancelable operating lease agreements. One of these
agreements has a renewal term which allows the Company to extend
this lease up to six years, or through 2013. Rental expense was
$3,491,259, $2,874,934, and $1,561,425 for the years ended
December 31, 2005, 2004 and 2003, respectively.
F-21
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As of December 31, 2005, future minimum rental commitments,
by fiscal year and in the aggregate, for the Companys
operating leases are as follows:
|
|
|
|
|
2006
|
|
$ |
3,502,401 |
|
2007
|
|
|
2,971,781 |
|
2008
|
|
|
1,972,552 |
|
2009
|
|
|
1,707,267 |
|
2010
|
|
|
133,538 |
|
|
|
|
|
Total minimum lease payments
|
|
$ |
10,287,539 |
|
|
|
|
|
The Company accounts for income taxes in accordance with
SFAS No. 109, Accounting for Income Taxes.
Under the provisions of SFAS No. 109, a deferred tax
liability or asset (net of a valuation allowance) is provided in
the financial statements by applying the provisions of
applicable tax laws to measure the deferred tax consequences of
temporary differences that will result in net taxable or
deductible amounts in future years as a result of events
recognized in the financial statements in the current or
preceding years.
At December 31, 2005, the Company has federal, state, and
foreign net operating loss carryforwards for income tax purposes
of approximately $131 million, which will expire in the
years 2019 through 2025 if not utilized. The majority of the tax
loss carryforwards relate to the U.S. ($35.2 million)
and Switzerland ($86.7 million). The U.S. net operating
loss carryforward includes tax deductions totaling
$6.2 million attributable to the exercise of stock options.
If these benefits are realized for tax purposes, the amount of
the benefit will increase additional paid-in capital and will
not be reflected in the Companys provision for income
taxes. At December 31, 2005, the Company had research and
development and orphan drug credit carryforwards in the U.S. of
approximately $7.2 million, which will expire in the years
2021 through 2025 if not utilized.
The Tax Reform Act of 1986 contains provisions that limit the
utilization of net operating loss and tax credit carryforwards
if there has been a change of ownership as described
in Section 382 of the Internal Revenue Code. Such a change
of ownership may limit the Companys utilization of its net
operating loss and tax credit carryforwards, and could be
triggered by subsequent sales of securities by the Company or
its stockholders.
F-22
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The components of the Companys deferred tax assets and
liabilities are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Net operating loss
|
|
$ |
25,282,697 |
|
|
$ |
28,550,438 |
|
|
Credit carryforwards
|
|
|
7,212,350 |
|
|
|
6,513,802 |
|
|
Organization costs
|
|
|
2,044,141 |
|
|
|
3,406,902 |
|
|
Allowance on accounts receivable
|
|
|
1,177,160 |
|
|
|
815,237 |
|
|
Depreciation
|
|
|
326,364 |
|
|
|
140,025 |
|
|
Other
|
|
|
379,601 |
|
|
|
511,395 |
|
|
|
|
|
|
|
|
|
|
Total gross deferred tax assets
|
|
|
36,422,313 |
|
|
|
39,937,799 |
|
|
|
Valuation allowance
|
|
|
(35,758,680 |
) |
|
|
(39,205,040 |
) |
|
|
|
|
|
|
|
Deferred tax assets, net of valuation allowance
|
|
|
663,633 |
|
|
|
732,759 |
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
Amortization of product rights
|
|
|
(2,569,888 |
) |
|
|
(3,437,962 |
) |
|
Prepaid expenses
|
|
|
(891,462 |
) |
|
|
(730,964 |
) |
|
Other
|
|
|
|
|
|
|
(169,554 |
) |
|
|
|
|
|
|
|
|
|
Total gross deferred tax liabilities
|
|
|
(3,461,350 |
) |
|
|
(4,338,480 |
) |
|
|
|
|
|
|
|
|
|
|
Net deferred tax liability
|
|
$ |
(2,797,717 |
) |
|
$ |
(3,605,721 |
) |
|
|
|
|
|
|
|
A valuation allowance was recorded in 2005 and 2004 due to the
Companys inability to determine if it is more likely than
not that the deferred tax asset will be realized in future
periods.
The Companys effective tax rate differs from the federal
income tax rate for the following reasons:
|
|
|
|
|
|
|
|
|
|
|
Years Ended | |
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Expected federal income tax benefit (expense) at statutory rate
|
|
|
34.0 |
% |
|
|
34.0 |
% |
Effect of permanent differences
|
|
|
3.8 |
% |
|
|
(10.4 |
)% |
State income tax, net of federal benefit
|
|
|
3.5 |
% |
|
|
(6.4 |
)% |
Effect of tax credits
|
|
|
(6.3 |
)% |
|
|
23.9 |
% |
Effect of foreign operations
|
|
|
86.4 |
% |
|
|
(50.2 |
)% |
Utilization of U.S. tax loss carryforward
|
|
|
(84.4 |
)% |
|
|
|
|
Deferred tax asset valuation allowance
|
|
|
42.5 |
% |
|
|
(72.0 |
)% |
|
|
|
|
|
|
|
|
|
|
79.5 |
% |
|
|
(81.1 |
)% |
|
|
|
|
|
|
|
F-23
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The provision (benefit) for income taxes is comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Current provision:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
561,557 |
|
|
$ |
|
|
|
$ |
|
|
|
State
|
|
|
584,192 |
|
|
|
618,802 |
|
|
|
194,496 |
|
|
Foreign
|
|
|
8,297,133 |
|
|
|
7,647,744 |
|
|
|
1,090,977 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
9,442,882 |
|
|
|
8,266,546 |
|
|
|
1,285,473 |
|
|
|
|
|
|
|
|
|
|
|
Deferred provision:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
7,626,728 |
|
|
|
(8,283,747 |
) |
|
|
(7,067,508 |
) |
|
State
|
|
|
717,439 |
|
|
|
(714,122 |
) |
|
|
(609,273 |
) |
|
Foreign
|
|
|
(5,463,986 |
) |
|
|
(2,236,232 |
) |
|
|
(3,986,714 |
) |
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
2,880,181 |
|
|
|
(11,234,101 |
) |
|
|
(11,663,495 |
) |
Deferred tax valuation allowance
|
|
|
(3,529,385 |
) |
|
|
10,820,622 |
|
|
|
11,663,495 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
8,793,678 |
|
|
$ |
7,853,067 |
|
|
$ |
1,285,473 |
|
|
|
|
|
|
|
|
|
|
|
The Company reported income (loss) before taxes from operations
within the U.S. and foreign operations for the years ended
December 31, 2005, 2004, and 2003 as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Income (loss) before taxes from U.S. operations
|
|
$ |
33,002,080 |
|
|
$ |
(14,027,515 |
) |
|
$ |
(32,145,799 |
) |
Income (loss) before taxes from foreign operations
|
|
|
(21,939,710 |
) |
|
|
4,343,403 |
|
|
|
(16,627,650 |
) |
|
|
|
|
|
|
|
|
|
|
Total income (loss) before taxes from operations
|
|
$ |
11,062,370 |
|
|
$ |
(9,684,112 |
) |
|
$ |
(48,773,449 |
) |
|
|
|
|
|
|
|
|
|
|
No provision has been made for income taxes on the undistributed
earnings of the Companys foreign subsidiaries of
approximately $30.5 million at December 31, 2005 as
the Company intends to indefinitely reinvest such earnings.
In 2000, the Companys Board of Directors approved the 2000
Stock Incentive Plan (the 2000 Plan). At
December 31, 2005, a total of 5,258,000 shares of
common stock are reserved under the plan. The 2000 Plan provides
for awards of both nonstatutory stock options and incentive
stock options within the meaning of Section 422 of the
Internal Revenue Code of 1986, as amended, and stock purchase
rights to purchase shares of the Companys common stock. A
total of 1,417,883 shares of common stock are available for
future stock option issuance to eligible employees and
consultants of the Company as of December 31, 2005.
In 2001, the Companys Board of Directors approved the 2001
Non-Employee Director Stock Option Plan (the 2001
Plan). At December 31, 2005, 575,000 shares of
common stock are reserved under the plan. The 2001 Plan provides
for awards of nonstatutory stock options only. A total of
288,750 shares of common stock are available for future
stock option issuance to directors of the Company as of
December 31, 2005.
The 2000 Plan and the 2001 Plan are administered by the
compensation committee of the Board of Directors, which has the
authority to select the individuals to whom awards will be
granted and to determine whether and to what extent stock
options and stock purchase rights are to be granted, the number
of shares of
F-24
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
common stock to be covered by each award, the vesting schedule
of stock options, generally over a period of four years, and all
other terms and conditions of each award. The grants expire
seven and ten years from the date of grant for the 2000 and 2001
Plans, respectively.
In September 2003, the Board of Directors amended both the 2000
and 2001 plans to allow for automatic evergreen
annual additions to the stock options available for grant not to
exceed 500,000 shares and 50,000 shares, respectively.
In June 2005, shareholders approved an amendment to both the
2000 and 2001 plans to increase by 1,500,000 and
100,000 shares of common stock reserved for issuance,
respectively.
A summary of the Plans activity is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
Weighted Average | |
|
|
Options | |
|
Exercise Price | |
|
|
| |
|
| |
Balance, January 1, 2003
|
|
|
1,321,992 |
|
|
$ |
1.76 |
|
|
Granted
|
|
|
610,219 |
|
|
|
9.21 |
|
|
Exercised
|
|
|
(53,190 |
) |
|
|
1.38 |
|
|
Terminated
|
|
|
(60,809 |
) |
|
|
1.91 |
|
|
|
|
|
|
|
|
Balance, December 31, 2003
|
|
|
1,818,212 |
|
|
|
4.28 |
|
|
Granted
|
|
|
1,110,303 |
|
|
|
34.87 |
|
|
Exercised
|
|
|
(373,436 |
) |
|
|
2.22 |
|
|
Terminated
|
|
|
(154,395 |
) |
|
|
8.52 |
|
|
|
|
|
|
|
|
Balance, December 31, 2004
|
|
|
2,400,684 |
|
|
|
18.47 |
|
|
Granted
|
|
|
1,369,932 |
|
|
|
23.75 |
|
|
Exercised
|
|
|
(134,120 |
) |
|
|
3.64 |
|
|
Terminated
|
|
|
(249,638 |
) |
|
|
26.53 |
|
|
|
|
|
|
|
|
Balance, December 31, 2005
|
|
|
3,386,858 |
|
|
$ |
20.60 |
|
|
|
|
|
|
|
|
A summary of options outstanding as of December 31, 2005,
is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options | |
|
Exercisable Options | |
|
|
| |
|
| |
|
|
|
|
Weighted- | |
|
Weighted- | |
|
Shares | |
|
Weighted- | |
|
|
|
|
Average | |
|
Average | |
|
Currently | |
|
Average | |
|
|
Shares | |
|
Remaining | |
|
Exercise | |
|
Vested and | |
|
Exercise | |
Range of Exercise Prices |
|
Under Option | |
|
Contractual Life | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.40 to 1.60
|
|
|
438,762 |
|
|
|
3.42 |
|
|
$ |
1.52 |
|
|
|
428,663 |
|
|
$ |
1.52 |
|
$1.61 to 2.40
|
|
|
393,592 |
|
|
|
4.29 |
|
|
|
2.40 |
|
|
|
372,594 |
|
|
|
2.40 |
|
$2.41 to 18.20
|
|
|
398,530 |
|
|
|
5.15 |
|
|
|
14.40 |
|
|
|
167,373 |
|
|
|
14.00 |
|
$18.21 to 18.49
|
|
|
585,000 |
|
|
|
6.93 |
|
|
|
18.49 |
|
|
|
|
|
|
|
|
|
$18.50 to 23.92
|
|
|
424,832 |
|
|
|
6.02 |
|
|
|
21.68 |
|
|
|
369,232 |
|
|
|
21.49 |
|
$23.93 to 35.15
|
|
|
453,847 |
|
|
|
6.42 |
|
|
|
28.41 |
|
|
|
171,948 |
|
|
|
33.97 |
|
$35.16 to 42.34
|
|
|
538,250 |
|
|
|
5.94 |
|
|
|
41.04 |
|
|
|
538,250 |
|
|
|
41.04 |
|
$42.35 to 52.27
|
|
|
154,045 |
|
|
|
6.19 |
|
|
|
48.21 |
|
|
|
154,045 |
|
|
|
48.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
3,386,858 |
|
|
|
5.59 |
|
|
$ |
20.60 |
|
|
|
2,202,105 |
|
|
$ |
21.42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-25
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
On December 6, 2005, the Board of Directors approved the
acceleration of vesting for certain unvested incentive and
non-qualified stock options granted to employees under the 2000
stock incentive plan. Vesting acceleration was performed on
employee options granted prior to April 1, 2005 with an
exercise price per share of $21.00 or higher. A total of
839,815 shares of the Companys common stock became
exercisable as a result of the vesting acceleration. The
acceleration of vesting was consummated in order to reduce the
non-cash compensation expense that would have been recorded in
future periods following the effective date of
SFAS No. 123(R). The effect of this acceleration is
the avoidance of future non-cash expenses of approximately
$15.8 million, which is included in the pro-forma net loss
for the year ended December 31, 2005.
|
|
14. |
Redeemable Convertible Preferred Stock and Warrants |
|
|
|
Redeemable Convertible Preferred Stock |
In January 2000, the Company issued 5,069,792 shares of
redeemable convertible preferred stock (Series A
Preferred), in a first closing, to a group of private investors
at a purchase price of $1.00 per share. In December 2000
and January 2001, the Company issued 3,237,500 and
9,605,973 shares, respectively, of Series A Preferred,
in a second closing, to the same group of investors at a
purchase price of $1.50 per share. In November 2001, the
Company issued 31,071,769 shares of redeemable convertible
preferred stock (Series B Preferred) to a group of
investors at a purchase price of $2.09 per share. In
October 2002, the Company issued 19,138,756 shares of
redeemable convertible preferred stock (Series C Preferred)
at a purchase price of $2.09 per share.
All of the preferred shares had preferences before common stock
in liquidation equal to the initial preferred purchase price,
plus any accrued but unpaid noncumulative dividends. In
addition, the Series B and Series C Preferred shares
had preferences before the Series A Preferred shares and
were entitled to share on a pro rata, as if converted, basis in
the remaining assets with the common shares after preferential
liquidation payments were made to preferred shareholders.
In connection with the completion of the Companys initial
public offering in November 2003, all of the outstanding shares
of redeemable convertible preferred stock were automatically
converted into 17,030,956 shares of the Companys
common stock.
In November 2001, the Company issued a warrant to
purchase 1,701,805 shares of Series B Preferred
stock at $2.09 per share to a business partner which was
exercisable one year after the date of grant and expired seven
years from the date of grant. Based on the estimated fair value
of the warrant, development expense in the amount of $884,939
was recorded in connection with the issuance of this warrant in
2001. Upon conversion of the Companys preferred shares to
common stock in November 2003, the number of shares available
under the warrant was automatically modified to
425,451 shares of common stock at $8.36 per share.
In April 2003, the Company issued two warrants in conjunction
with the convertible debt issued in 2003. The warrants had a
life of five years and could be exercised immediately. A total
of 424,242 shares of common stock could be purchased at a
price of $11.00 per share under these warrants. The
$729,697 fair value of the warrant was classified as additional
paid-in capital with a corresponding amount treated as a debt
discount which was being amortized using the interest method.
In June 2004, a stock purchase warrant was exercised by one of
the business partners, resulting in the issuance of
44,026 shares of common stock. The option holder utilized
the cashless exercise option allowed under the warrant agreement
and surrendered 16,580 shares to the Company as
consideration for this exercise.
F-26
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In September 2004, the second business partner exercised two
stock purchase warrants which resulted in the issuance of
789,087 shares of common stock. Total exercise proceeds
received by the Company were $7.6 million.
|
|
15. |
Employee Savings Plans |
The Company sponsors an employee savings and retirement plan
which is qualified under section 401(k) of the Internal
Revenue Code for its U.S. employees. Under the sponsored
plan, the Company matches 100% of the participants
contribution up to a limit of 3% of the participants
annual salary. Matching contributions totaled $411,262,
$276,952, and $204,561 in 2005, 2004 and 2003, respectively. The
Companys international employees are eligible to
participate in retirement plans, subject to the local laws that
are in effect for each country. The Company made contributions
of $455,109, $477,695, and $321,695 for these employees in 2005,
2004 and 2003, respectively.
As part of the relocation assistance provided to three officers,
during 2002, the Company made loans totaling $400,000 to these
individuals. At December 31, 2005 the balance outstanding
for these loans is $62,500. The loans do not bear interest and
are secured by a second deed of trust on the principal
residences of each of the officers. The notes are repayable over
terms ranging from two to four years. The Company has agreed,
for as long as these officers remain employed by the Company, to
make annual bonus payments to these officers in amounts
sufficient to pay the loan amounts then due.
In January 2006, the Company entered into a license and
collaboration agreement for the research, development and
commercialization of MethylGene Inc.s HDAC inhibitors,
including its lead compound MGCD0103, in North America, Europe,
the Middle East and certain other markets. Under the terms of
the agreement, the Company made up front payments to MethylGene
totaling $25 million, consisting of a $20 million
license fee and a $5 million equity investment in
MethylGene common shares. The common shares were purchased at a
subscription price of CDN $3.125 which represented a 25% premium
over the market closing price on January 27, 2006.
Subsequent to the transaction, the Company has a 7.8% ownership
in MethylGene. The ownership interest will initially be recorded
at fair value and then accounted for as an available for sale
security.
MGCD0103 is currently in Phase I/II development and has a
number of clinical studies underway. Under the terms of the
license agreement, MethylGene will initially fund 40% of the
preclinical and clinical development for MGCD0103 (and any
additional second generation compounds) required, to obtain
marketing approval in North America, while the Company will fund
60% of such costs. MethylGene will receive royalties on net
sales in North America ranging from 13% to 21%. The royalty rate
paid to MethylGene will be determined based upon the level of
annual net sales achieved in North America and the length of
time development costs are funded by MethylGene. MethylGene will
have an option, at its sole discretion, as long as it continues
to fund development, to co-promote approved products and, in
lieu of receiving royalties, to share the resulting net profits
equally with the Company. If MethylGene exercises its right, at
its sole discretion, to discontinue development funding, the
Company will be responsible for 100% of development costs
incurred thereafter.
In all other licensed territories, which include Europe, the
Middle East, Turkey, Australia, New Zealand, South Africa and
certain countries in Southeast Asia, the Company is responsible
for development and commercialization costs and MethylGene will
receive a royalty on net sales in those markets at a rate of 10%
to 13% based on annual net sales.
F-27
PHARMION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Milestone payments to MethylGene for MGCD0103 could reach
$145 million, based on the achievement of significant
development, regulatory and sales goals. Furthermore, up to
$100 million for each additional HDAC inhibitor may be
paid, also based on the achievement of significant development,
regulatory and sales milestones. In addition, the Company will
provide one year of research support (up to $2 million) for
a team of eight MethylGene scientists dedicated to identifying
second-generation clinical candidates in addition to MGCD0103.
|
|
18. |
Quarterly Information |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
September 30, |
|
December 31, |
|
|
2005 |
|
2005 |
|
2005 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
(In thousands, except per share data) |
|
|
(Unaudited) |
Net sales
|
|
$ |
51,737 |
|
|
$ |
56,257 |
|
|
$ |
56,805 |
|
|
$ |
56,445 |
|
Cost of sales, inclusive of royalties, exclusive of product
rights amortization
|
|
|
13,947 |
|
|
|
15,120 |
|
|
|
15,355 |
|
|
|
15,378 |
|
Income (loss) from operations
|
|
|
5,408 |
|
|
|
6,492 |
|
|
|
9,725 |
|
|
|
(17,036 |
) |
Net income (loss)
|
|
|
4,270 |
|
|
|
5,554 |
|
|
|
8,828 |
|
|
|
(16,383 |
) |
Net income (loss) applicable to common shareholders per
share basic
|
|
$ |
.13 |
|
|
$ |
.17 |
|
|
$ |
.28 |
|
|
$ |
(.51 |
) |
Net income (loss) applicable to common shareholders per
share diluted
|
|
$ |
.13 |
|
|
$ |
.17 |
|
|
$ |
.27 |
|
|
$ |
(.51 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
September 30, |
|
December 31, |
|
|
2004 |
|
2004 |
|
2004 |
|
2004 |
|
|
|
|
|
|
|
|
|
Net sales
|
|
$ |
15,721 |
|
|
$ |
20,396 |
|
|
$ |
42,576 |
|
|
$ |
51,478 |
|
Cost of sales, inclusive of royalties, exclusive of product
rights amortization
|
|
|
6,309 |
|
|
|
7,453 |
|
|
|
14,169 |
|
|
|
15,704 |
|
Loss from operations
|
|
|
(8,814 |
) |
|
|
(8,221 |
) |
|
|
(1,712 |
) |
|
|
3,224 |
|
Net income (loss)
|
|
|
(9,809 |
) |
|
|
(9,983 |
) |
|
|
(355 |
) |
|
|
2,609 |
|
Net income (loss) applicable to common shareholders per
share basic and diluted
|
|
$ |
(.40 |
) |
|
$ |
(.39 |
) |
|
$ |
(.01 |
) |
|
$ |
.08 |
|
F-28
SCHEDULE II
Valuation and Qualifying Accounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Charged |
|
|
|
|
|
|
Balance at |
|
to |
|
|
|
|
|
|
Beginning |
|
Expense |
|
|
|
Balance at End |
Years Ended December 31, |
|
of Period |
|
or Sales |
|
Deductions |
|
of Period |
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances for chargebacks, product returns, cash discounts and
doubtful accounts
|
|
$ |
2,210 |
|
|
$ |
13,437 |
|
|
$ |
(12,074 |
) |
|
$ |
3,573 |
|
|
Inventory reserve
|
|
|
360 |
|
|
|
606 |
|
|
|
(924 |
) |
|
|
42 |
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances for chargebacks, product returns, cash discounts and
doubtful accounts
|
|
$ |
819 |
|
|
$ |
7,419 |
|
|
$ |
(6,028 |
) |
|
$ |
2,210 |
|
|
Inventory reserve
|
|
|
1,387 |
|
|
|
1,366 |
|
|
|
(2,393 |
) |
|
|
360 |
|
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances for chargebacks, product returns, cash discounts and
doubtful accounts
|
|
$ |
734 |
|
|
$ |
2,486 |
|
|
$ |
(2,401 |
) |
|
$ |
819 |
|
|
Inventory reserve
|
|
|
|
|
|
|
1,761 |
|
|
|
(374 |
) |
|
|
1,387 |
|
S-1
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
2.1(1) |
|
|
Stock Purchase Agreement, dated March 7, 2003, by and among
Pharmion France and the shareholders of Gophar S.A.S. |
|
3.1(1) |
|
|
Amended and Restated Certificate of Incorporation. |
|
3.2(1) |
|
|
Amended and Restated Bylaws. |
|
4.1(1) |
|
|
Specimen Stock Certificate. |
|
4.2(1) |
|
|
Amended and Restated Investors Rights Agreement, dated as
of November 30, 2001, by and among the Registrant, the
founders and the holders of the Registrants Preferred
Stock. |
|
4.3(1) |
|
|
Series C Omnibus Amendment Agreement, dated as of
October 11, 2002 to Amended and Restated Investors
Rights Agreement, dated as of November 30, 2001, by and
among the Registrant, the founders and the holders of the
Registrants Preferred Stock. |
|
4.4(1) |
|
|
Amendment, dated as of April 8, 2003 to Amended and
Restated Investors Rights Agreement, dated as of
November 30, 2001, by and among the Registrant, the
founders and the holders of the Registrants Preferred
Stock. |
|
4.5(1) |
|
|
Series B Preferred Stock Purchase Warrant, dated
November 30, 2001, issued by the Registrant to Celgene
Corporation. |
|
4.6(1) |
|
|
Senior Convertible Promissory Note, dated April 8, 2003,
issued by the Registrant to Celgene Corporation. |
|
4.7(1) |
|
|
Common Stock Purchase Warrant, dated April 8, 2003, issued
by the Registrant to Celgene Corporation. |
|
4.8(1) |
|
|
Convertible Subordinated Promissory Note, dated April 11,
2003, issued by the Registrant to Penn Pharmaceuticals Holdings
Limited. |
|
4.9(1) |
|
|
Common Stock Purchase Warrant, dated April 11, 2003, issued
by the Registrant to Penn Pharmaceuticals Holdings Limited. |
|
10.1(1)* |
|
|
Amended and Restated 2001 Non-Employee Director Stock Option
Plan. |
|
10.2(1)* |
|
|
Amended and Restated 2000 Stock Incentive Plan. |
|
10.3(1) |
|
|
Securities Purchase Agreement, dated as of April 8, 2003,
by and between the Registrant and Celgene Corporation. |
|
10.4(1) |
|
|
Securities Purchase Agreement, dated as of April 11, 2003,
by and between the Registrant and Penn Pharmaceuticals Holdings
Limited. |
|
10.5(1) |
|
|
Amended and Restated Distribution and License Agreement, dated
as of November 16, 2001, by and between Pharmion GmbH and
Penn T Limited. |
|
10.6(1) |
|
|
Amendment No. 1, dated March 4, 2003, to Amended and
Restated Distribution and License Agreement, dated as of
November 16, 2001, by and between Pharmion GmbH and
Penn T Limited. |
|
10.7(1) |
|
|
Supplementary Agreement, dated June 18, 2003, to Amended
and Restated Distribution and License Agreement, dated as of
November 16, 2001, by and between Pharmion GmbH and
Penn T Limited. |
|
10.8(1) |
|
|
License Agreement, dated as of November 16, 2001, by and
among the Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.9(1) |
|
|
Amendment No. 1, dated March 3, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.10(1) |
|
|
Letter Agreement, dated April 2, 2003, by and among the
Registrant, Pharmion GmbH and Celgene Corporation regarding
clinical funding. |
|
10.11(1) |
|
|
Amendment No. 2, dated April 8, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.12(1) |
|
|
License and Distribution Agreement, dated as of June 21,
2002, by and between the Registrant and LEO Pharmaceutical
Products Ltd. A/S. |
|
10.13(1) |
|
|
License Agreement, dated as of June 7, 2001, by and between
the Registrant, Pharmion GmbH and Pharmacia & Upjohn
Company. |
|
10.8(1) |
|
|
License Agreement, dated as of November 16, 2001, by and
among the Registrant, Pharmion GmbH and Celgene Corporation. |
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
10.9(1) |
|
|
Amendment No. 1, dated March 3, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.10(1) |
|
|
Letter Agreement, dated April 2, 2003, by and among the
Registrant, Pharmion GmbH and Celgene Corporation regarding
clinical funding. |
|
10.11(1) |
|
|
Amendment No. 2, dated April 8, 2003, to License
Agreement, dated as of November 16, 2001, by and among the
Registrant, Pharmion GmbH and Celgene Corporation. |
|
10.12(1) |
|
|
License and Distribution Agreement, dated as of June 21,
2002, by and between the Registrant and LEO Pharmaceutical
Products Ltd. A/S. |
|
10.13(1) |
|
|
License Agreement, dated as of June 7, 2001, by and between
the Registrant, Pharmion GmbH and Pharmacia & Upjohn
Company. |
|
10.14(1) |
|
|
Interim Sales Representation Agreement, dated as of May 29,
2002, by and between Pharmion GmbH and Schering
Aktiengesellschaft. |
|
10.15(1) |
|
|
Distribution and Development Agreement, dated as of May 29,
2002, by and between Pharmion GmbH and Schering
Aktiengesellschaft. |
|
10.16(1) |
|
|
First Amendment Agreement dated August 20, 2003 by and
between Pharmion GmbH and Schering Aktiengesellschaft. |
|
10.17(3)* |
|
|
Employment Agreement, dated as of February 23, 2004, by and
between the Registrant and Patrick J. Mahaffy. |
|
10.18(3)* |
|
|
Amended and Restated Employment Agreement, dated as of
March 1, 2004, by and between the Registrant and
Judith A. Hemberger. |
|
10.19(1)* |
|
|
Non-Competition and Severance Agreement, dated as of
November 29, 2001, by and between the Registrant and
Michael Cosgrave. |
|
10.20(1)* |
|
|
Employment Agreement, dated as of January 5, 2001, by and
between the Registrant and Michael Cosgrave. |
|
10.21(3)* |
|
|
Amended and Restated Employment Agreement, dated as of
March 1, 2004, by and between the Registrant and Erle Mast. |
|
10.22(3)* |
|
|
Amended and Restated Employment Agreement, dated as of
March 1, 2004, by and between the Registrant and
Gillian C. Ivers-Read. |
|
10.23(1) |
|
|
Office Lease, dated as of April 24, 2002, by and between
the Registrant and Centro III, LLC. |
|
10.24(1) |
|
|
First Amendment to Lease, dated as of January 31, 2003, to
Office Lease, dated as of April 24, 2002, by and between
the Registrant and Centro III, LLC. |
|
10.25(2)* |
|
|
Addendum to Employment Agreement, dated June 15, 2004, by
and between the Registrant and Michael Cosgrave. |
|
10.26(4) |
|
|
Amendment No. 2, dated as of December 3, 2004, to
Amended and Restated Distribution and License Agreement, dated
November 16, 2001, by and between Pharmion GmbH and Celgene
U.K. Manufacturing II Limited (formerly Penn T
Limited). |
|
10.27(4) |
|
|
Letter Agreement, dated as of December 3, 2004, by and
between the Registrant, Pharmion GmbH and Celgene Corporation
amending the Letter Agreement regarding clinical funding, dated
April 2, 2003, between Registrant, Pharmion GmbH and
Celgene. |
|
10.28(4) |
|
|
Letter Agreement, dated as of December 3, 2004, by and
between the Registrant, Pharmion GmbH and Celgene Corporation
amending the License Agreement, dated November 16, 2001,
among Registrant, Pharmion GmbH and Celgene. |
|
10.29(4) |
|
|
Lease, dated as of December 21, 2004, by and between
Pharmion Limited and Alecta Pensionsförsäkring
Ömsesidigit. |
|
10.31(5) |
|
|
.Supply Agreement, dated as of March 31, 2005, by and
between the Registrant and Ash Stevens, Inc. |
|
10.32(6) |
|
|
Manufacturing and Service Contract, dated as of
December 20, 2005, by and between the Registrant and Ben
Venue Laboratories, Inc. |
|
10.33(6) |
|
|
Co-Development and License Agreement, dated as of
December 19, 2005, by and between the Registrant, Pharmion
GmbH and GPC Biotech AG. |
|
10.34(6) |
|
|
Supply Agreement, dated as of December 19, 2005, by and
between the Registrant, Pharmion GmbH and GPC Biotech AG. |
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
10.35 |
|
|
Pharmion Corporation 2000 Stock Incentive Plan (Amended and
Restated effective as of February 9, 2006) |
|
23.1 |
|
|
Consent of Independent Registered Public Accounting Firm. |
|
24.1 |
|
|
Power of Attorney (reference is made to page 58) |
|
31.1 |
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for
President and Chief Executive Officer. |
|
31.2 |
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for
Chief Financial Officer. |
|
32.1 |
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certification for
President and Chief Executive Officer and Chief Financial
Officer. |
|
|
(1) |
Incorporated by reference to our Registration Statement on
Form S-1 (File
No. 333-108122)
and amendments thereto, declared effective November 5, 2003. |
|
(2) |
Incorporated by reference to our Registration Statement on
Form S-1 (File
No. 333-116252)
and amendments thereto, declared effective June 30, 2004. |
|
(3) |
Incorporated by reference to our Quarterly Report on
Form 10-Q for the
quarter ended March 31, 2004. |
|
(4) |
Incorporated by reference to the exhibits to our Annual Report
on Form 10-K for
the year ended December 31, 2004. |
|
(5) |
Incorporated by reference to our Quarterly Report on
Form 10-Q for the
quarter ended March 31, 2005. |
|
(6) |
Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to
Rule 24B-2 of the Securities Exchange Act of 1934, as
amended. |
|
|
|
|
* |
Management Contract or Compensatory Plan or Arrangement |