This filing is made pursuant to
Rule 424(b)(3) under the Securities
Act of 1933 in connection with
Registration Statement No. 333-64444.
PROSPECTUS
$8,400,000
OF
NEOTHERAPEUTICS, INC.
COMMON STOCK
We may from time to time offer shares of our common stock having a
maximum aggregate public offering price of $8,400,000. The securities will be
offered through Cantor Fitzgerald & Co. as underwriter as part of a Controlled
Equity Offering, or CEO(sm). Upon agreement between us and Cantor Fitzgerald &
Co. to sell securities on certain terms, Cantor Fitzgerald & Co. will use its
commercially reasonable efforts to sell the securities up to the amount agreed
upon, but will not be required to sell any specific number or dollar amount of
securities. The net proceeds from the sale will be the aggregate sales price at
which the securities were sold after deduction for Cantor Fitzgerald & Co.'s 4%
commission/discount on the aggregate sales price of the securities. Additional
information on the CEO(sm) arrangement is set forth in the prospectus.
Our common stock is traded on the Nasdaq National Market under the
symbol "NEOT."
----------------------
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 3.
----------------------
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
accuracy or adequacy of the prospectus. Any representation to the contrary is a
criminal offense.
----------------------
[CANTOR FITZGERALD & CO. LOGO]
THE DATE OF THIS PROSPECTUS IS OCTOBER 19, 2001.
NO DEALER, SALESPERSON OR OTHER INDIVIDUAL HAS BEEN AUTHORIZED TO GIVE
ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS OTHER THAN CONTAINED OR
INCORPORATED BY REFERENCE IN THIS PROSPECTUS, AND IF GIVEN OR MADE, SUCH
INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED
BY NEOTHERAPEUTICS, INC. OR ANY UNDERWRITER. THIS PROSPECTUS DOES NOT CONSTITUTE
AN OFFER OR SOLICITATION BY ANYONE IN ANY JURISDICTION IN WHICH SUCH OFFER OR
SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH OFFER IS NOT
QUALIFIED TO DO SO OR TO ANYONE TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR
SOLICITATION. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE
HEREUNDER SHALL, UNDER ANY CIRCUMSTANCE, CREATE ANY IMPLICATION THAT THERE HAS
NOT BEEN ANY CHANGE IN THE AFFAIRS OF NEOTHERAPEUTICS SINCE THE DATE HEREOF.
TABLE OF CONTENTS
PAGE
----
FORWARD-LOOKING STATEMENTS .............................................. 1
WHERE YOU CAN FIND MORE INFORMATION ..................................... 1
ABOUT NEOTHERAPEUTICS ................................................... 3
RISK FACTORS ............................................................ 3
USE OF PROCEEDS ......................................................... 11
PLAN OF DISTRIBUTION .................................................... 11
VALIDITY OF COMMON STOCK ................................................ 13
EXPERTS ................................................................. 13
LIMITATION ON LIABILITY AND DISCLOSURE OF SEC POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES .................................. 13
FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference into this
prospectus contain forward-looking statements that are based on current
expectations, estimates and projections about our industry, management's
beliefs, and assumptions made by management. Words such as "anticipates,"
"expects," "intends," "plans," "believes," "seeks," "estimates," and variations
of such words and similar expressions are intended to identify such
forward-looking statements. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties and assumptions that
are difficult to predict; therefore, actual results may differ materially from
those expressed or forecasted in any forward-looking statements. The risks and
uncertainties include those noted in "Risk Factors" above and in the documents
incorporated by reference. Unless otherwise specified or required by context,
references in this prospectus to "we," "us," "our" and "NeoTherapeutics" refer
to NeoTherapeutics, Inc. and its subsidiaries on a consolidated basis.
We undertake no obligation to update publicly any forward-looking
statements, whether as a result of new information, future events or otherwise,
except to the extent that we are required to do so by law. We also may make
additional disclosures in our Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K that we may file from time to time
with the Securities and Exchange Commission, or SEC. Please also note that we
provide a cautionary discussion of risks and uncertainties under the section
entitled "Risk Factors" in our Annual Report on Form 10-K. These are factors
that we think could cause our actual results to differ materially from expected
results. Other factors besides those listed here could also adversely affect us.
This discussion is provided as permitted by the Private Securities Litigation
Reform Act of 1995.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file at
the SEC's public reference room at 450 Fifth Street, N.W., Washington, D.C.,
20549. Please call the SEC at 1-800-SEC-0330 for further information on the
public reference room. Our SEC filings are also available to the public at the
SEC's web site at http://www.sec.gov.
The SEC allows us to "incorporate by reference" the information we file
with them which means that we can disclose important information to you by
referring you to those documents instead of having to repeat the information in
this prospectus. The information incorporated by reference is considered to be
part of this prospectus, and later information that we file with the SEC will
automatically update and supersede this information. We incorporate by reference
the documents listed below and any future filings made with the SEC under
Sections 13(a), 13(c), 14, or 15(d) of the Securities Exchange Act of 1934 until
the offering is terminated:
- Our annual report on Form 10-K for the fiscal year ended
December 31, 2000, as amended by Form 10-K/A filed on April 25,
2001;
- Our quarterly reports on Form 10-Q for the quarters ended March
31, 2001, and June 30, 2001, filed on May 14, 2001, and August
14, 2001, respectively;
- Our current reports on Form 8-K filed on February 16, 2001,
March 14, 2001, May 21, 2001, August 15, 2001, August 27, 2001
and September 24, 2001;
- Our definitive proxy statement filed on April 30, 2001, pursuant
to Section 14 of the Exchange Act in connection with our 2001
Annual Meeting of Stockholders; and
- The description of our common stock contained in the
Registration of Securities of Certain Successor Issuers filed
pursuant to Section 12(g) of the Exchange Act on Form 8-B on
June 27, 1997, including any amendment or reports filed for the
purpose of updating such description.
1
You can request a copy of these filings, at no cost, by writing or
telephoning us at the following address:
NeoTherapeutics, Inc.
Attn: Investor Relations
157 Technology Drive
Irvine, California 92618
(949) 788-6700
You should rely only on the information contained in this prospectus or
any supplement and in the documents incorporated by reference. We have not
authorized anyone else to provide you with different information. The selling
stockholders will not make an offer of these shares in any state where the offer
is not permitted. You should not assume that the information in this prospectus
or any supplement or in the documents incorporated by reference is accurate on
any date other than the date on the front of those documents.
This prospectus is part of a registration statement we filed with the
SEC (Registration No. 333-64444). That registration statement and the exhibits
filed along with the registration statement contain more information about the
shares sold by the selling stockholders. Because information about contracts
referred to in this prospectus is not always complete, you should read the full
contracts which are filed as exhibits to the registration statement. You may
read and copy the full registration statement and its exhibits at the SEC's
public reference rooms or their web site.
2
ABOUT NEOTHERAPEUTICS
NeoTherapeutics, Inc. is a development stage biopharmaceutical company
engaged in the discovery and development of novel therapeutic drugs intended to
treat neurological diseases and conditions, such as memory deficits associated
with Alzheimer's disease and aging, spinal cord injuries, Parkinson's disease,
other degenerative diseases that affect the nervous system and psychiatric
diseases. We have also recently become engaged in research involving functional
genomics, or the study of how genes function in the body, and the development of
drugs for the treatment of cancer. Our lead product candidate, Neotrofin(TM)
(also known as AIT-082 or leteprinim potassium), and other compounds under
development, are based on our patented technology. This technology uses small
synthetic molecules to create non-toxic compounds, intended to be administered
orally or by injection, that are capable of passing through the blood-brain
barrier, which is a layer of cells that prevents some molecules that may be
harmful from entering the brain, to rapidly act upon specific target cells in
specific locations in the central nervous system, including the brain. Animal
and laboratory tests have shown that Neotrofin(TM) appears to selectively
increase the production of certain neurotrophic factors, a type of large protein
involved in nerve cell proliferation, differential and survival, in selected
areas of the brain and in the spinal cord. These neurotrophic factors regulate
nerve cell growth and function. Our technology has been developed to capitalize
on the beneficial effects of these proteins, which have been widely acknowledged
to be closely involved in the early formation and differentiation of the central
nervous system. We believe that Neotrofin(TM) could have therapeutic and
regenerative effects. We have observed no serious negative side effects in
patients receiving Neotrofin(TM) in our clinical trials, however, patients have
reported experiencing fatigue, headache, nausea, confusion and depression at
rates consistent with those normally seen in the elderly Alzheimer's disease
test population. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics,
Inc., is engaged in functional genomics research. On November 16, 2000, we
formed another subsidiary, NeoOncoRx, Inc., for the purpose of in-licensing
anti-cancer compounds which are in the clinical trial stages of development.
We currently have no marketable products, and do not expect to have any
products commercially available for at least two years, if at all. We have
incurred substantial losses since our inception, and expect our losses to
continue for at least the next several years. The pharmaceutical marketplace in
which we operate is highly competitive, and includes many large,
well-established companies pursuing treatments for Alzheimer's disease and some
of the other applications we are pursuing. See "Risk Factors" below.
This prospectus relates to the offering from time to time of shares of
our common stock having a maximum aggregate public offering price of $8,400,000.
The securities will be offered through Cantor Fitzgerald & Co. as underwriter as
part of a Controlled Equity Offering, or CEO. See "Plan of Distribution" on page
11 for more information.
We were incorporated in Colorado in December 1987 and reincorporated in
Delaware in June 1997. Our executive offices are located at 157 Technology
Drive, Irvine, California 92618. Our telephone number is (949) 788-6700. Our web
site address is www.neotherapeutics.com. Information contained in our web site
does not constitute part of this prospectus.
RISK FACTORS
Your investment in our common stock involves a high degree of risk. You
should consider the risks described below and the other information contained in
this prospectus carefully before deciding to invest in our common stock. If any
of the following risks actually occur, our business, financial condition and
operating results would be significantly harmed. As a result, the trading price
of our common stock could decline, and you could lose a part or all of your
investment.
OUR LOSSES WILL CONTINUE TO INCREASE AS WE EXPAND OUR DEVELOPMENT EFFORTS, AND
OUR EFFORTS MAY NEVER RESULT IN PROFITABILITY.
Our cumulative losses during the period from our inception in 1987
through June 30, 2001 were approximately $108.4 million, almost all of which
consisted of research and development and general and administrative expenses.
We lost approximately $11.6 million in 1998, $26.0 million in 1999,
approximately $46.4 million in 2000 and approximately $12.1 million in the six
months ended June 30, 2001. We expect our losses to decrease in the year 2001 as
compared to the year 2000 due to anticipated savings of approximately $10.0
million from our transition to managing our clinical trials ourselves rather
than contracting with third parties for this function. However, we expect our
losses to increase in the future as we expand our clinical trials and increase
our research and development activities. Moreover, we may not realize the
anticipated savings
3
from the changes in our clinical trial program. We currently do not sell any
products and we may never achieve significant revenues or become profitable.
Even if we eventually generate revenues from sales, we nevertheless expect to
incur significant operating losses over the next several years.
OUR POTENTIAL DRUG PRODUCTS ARE IN AN EARLY STAGE OF CLINICAL AND PRECLINICAL
DEVELOPMENT AND MAY NOT PROVE SAFE OR EFFECTIVE ENOUGH TO OBTAIN REGULATORY
APPROVAL TO SELL ANY OF THEM.
We currently are testing our first potential drug product,
Neotrofin(TM), in human clinical trials. We are currently conducting three
clinical trials of Neotrofin(TM) for Alzheimer's disease, spinal cord injury and
Parkinson's disease, and we expect to complete these trials before the end of
the first quarter of 2002. Through our subsidiary, NeoOncoRx, Inc., we have
acquired rights to two anti-cancer drugs that are in clinical trials. We expect
that we will need to complete additional trials before we will be able to apply
for regulatory approval to sell Neotrofin(TM) or any of our other drug products.
Our other proposed products are in preclinical development. We cannot be certain
that any of our potential or proposed products will prove to be safe or
effective in treating disorders of the central nervous system or any other
diseases. All of our potential drugs will require additional research and
development, testing and regulatory clearance before we can sell them. We cannot
be certain that we will receive regulatory approval to sell any of our potential
drugs. We do not expect to have any products commercially available for at least
two years, if at all.
IF WE ARE UNABLE TO OBTAIN SUBSTANTIAL ADDITIONAL FUNDING ON ACCEPTABLE TERMS,
WE MAY HAVE TO DELAY OR ELIMINATE ONE OR MORE OF OUR DEVELOPMENT PROGRAMS.
We currently are spending cash at a rate in excess of approximately $2.3
million per month, and we expect this rate of spending to continue for at least
the following 12 months. On April 17, 2001, we entered into an agreement with
two investors which provided for a sale of common stock by us to the investors
for proceeds of $6.0 million, obligated the investors to buy from us convertible
debentures, or debt obligations convertible into shares of our common stock, in
two blocks, one of $10 million in May 2001 and a second one of $8 million in
November 2001. The agreement provided for a penalty payment by us of up to $1
million if we declined to sell the convertible debentures (see Note 15 to the
audited financial statements in our Amendment No. 1 on Form 10-K/A our Annual
Report on Form 10-K filed on April 25, 2001). In May 2001 we declined to sell
the first $10 million block of convertible debentures, and instead agreed to
sell common stock and warrants to the investors for proceeds of $5.95 million
and to reduce the penalty payment to $405,000, which has been paid. We believe
that, together with periodic sales of common stock such as the four sales
totaling approximately $22.5 million in February through August 2001, and
assuming that the holders of our Class B Warrants continue to exercise our Class
B Warrants in response to our call notices, our cash and capital resources will
satisfy our current funding requirements for at least the next twelve months. If
the market price of our common stock is less than $2.00 per share, we may not be
able to use our Class B Warrants as a financing source. As of June 21, 2001,
Class B Warrants have been exercised for 586,400 shares and gross proceeds of
approximately $5.1 million. We have not issued any call notices under our Class
B Warrants since November 2000. Should we not be able to continue periodic sales
of our common stock or utilize our Class B Warrants, we may have to seek
additional funding. We may not be able to obtain additional funds on acceptable
terms or at all. If adequate funds are not available, we will have to delay or
eliminate one or more of our development programs.
We expect that we will need substantial additional funds to complete
development and clinical trials of Neotrofin(TM), our lead drug candidate,
before we will be able to submit it to the FDA for approval for commercial sale,
and to support the continued development of our other potential products. Since
we currently have no products available for commercial sale and essentially no
revenues, we must use capital to fund our operating expenses. Our operating
expenses, and consequently our capital requirements, will depend on many
factors, including:
- continued scientific progress in research and development to identify
and develop additional product candidates beyond our lead compound
Neotrofin(TM);
- the costs and progress of preclinical and clinical testing of
Neotrofin(TM) and additional drug candidates;
- the cost involved in filing, prosecuting and enforcing patent claims;
and
- the time and cost involved in obtaining regulatory approvals for our
potential products.
4
In addition, if we are successful in obtaining regulatory approval of one or
more of our potential products, we will require additional capital to cover
costs associated with commercializing our products.
We expect to seek additional funding through public or private
financings or collaborative or other arrangements with third parties. We may not
obtain additional funds on acceptable terms, if at all. If adequate funds are
not available, we will have to delay or eliminate one or more of our development
programs.
COMPETITION FOR PATIENTS IN CONDUCTING CLINICAL TRIALS AND EXTENSIVE REGULATIONS
GOVERNING THE CONDUCT OF CLINICAL TRIALS MAY PREVENT OR DELAY APPROVAL OF A DRUG
CANDIDATE AND STRAIN OUR LIMITED FINANCIAL RESOURCES.
Many pharmaceutical companies are conducting clinical trials in patients
with Alzheimer's disease. As a result, we must compete with them for clinical
sites, physicians and the limited number of patients with Alzheimer's disease
who fulfill the stringent requirements for participation in clinical trials. Due
to a lack of available information about the condition of Alzheimer's disease
sufferers in the United States, we cannot be certain how many of the over 4
million patients with Alzheimer's disease in the United States would meet the
requirements for participating in our clinical trials. In addition, due to the
confidential nature of clinical trials, we cannot be certain how many of these
patients may be enrolled in competing studies and consequently not available to
us. This competition may increase costs of our clinical trials and delay the
introduction of our potential products.
ANY FAILURE TO COMPLY WITH EXTENSIVE GOVERNMENTAL REGULATION COULD PREVENT OR
DELAY PRODUCT APPROVAL OR CAUSE GOVERNMENTAL AUTHORITIES TO DISALLOW OUR
PRODUCTS AFTER APPROVAL AND SUBJECT US TO CRIMINAL OR CIVIL LIABILITIES.
The U.S. Food and Drug Administration, or FDA, and comparable agencies
in foreign countries impose many requirements on the introduction of new drugs
through lengthy and detailed clinical testing procedures, and other costly and
time consuming compliance procedures. These requirements apply to every stage of
the clinical trial process and make it difficult to estimate when Neotrofin(TM)
or any other of our potential products will be available commercially, if at
all.
Our proprietary compounds will require substantial clinical trials and
FDA review as new drugs. Even if we successfully enroll patients in our clinical
trials, patients may not respond to our potential drug products. We think it is
prudent to expect setbacks. While we believe that we are currently in compliance
with applicable FDA regulations, if we fail to comply with the regulations
applicable to our clinical testing, the FDA may delay, suspend or cancel our
clinical trials, or the FDA might not accept the test results. The FDA, or any
comparable regulatory agency in another country, may suspend clinical trials at
any time if it concludes that the trials expose patients participating in such
trials to unacceptable health risks. Further, human clinical testing may not
show any current or future product candidate to be safe and effective to the
satisfaction of the FDA or comparable regulatory agencies or the data derived
therefrom may be unsuitable for submission to the FDA or other regulatory
agencies.
We cannot predict with certainty when we might submit any of our
proposed products currently under development for the regulatory approval
required in order to commercially sell the products. Once we submit a proposed
product for commercial sale approval, the FDA or other regulatory agencies may
not issue their approvals on a timely basis, if at all. If we are delayed or
fail to obtain these approvals, our business may be significantly damaged. If we
fail to comply with regulatory requirements, either prior to seeking approval or
in marketing our products after approval, we could be subject to regulatory or
judicial enforcement actions. These actions could result in:
- product recalls or seizures;
- injunctions;
- civil penalties;
- criminal prosecution;
- refusals to approve new products and withdrawal of existing approvals;
and
5
- enhanced exposure to product liabilities.
THE LOSS OF KEY RESEARCHERS OR MANAGERS COULD HINDER OUR DRUG DEVELOPMENT
PROCESS SIGNIFICANTLY AND MIGHT CAUSE OUR BUSINESS TO FAIL.
Our success depends upon the contributions of our key management and
scientific personnel, especially Dr. Alvin Glasky, our Chief Executive Officer
and Chief Scientific Officer. Dr. Glasky has led our research and business
developments since founding our business in 1987 and is the inventor on several
of our patents. Our loss of the services of Dr. Glasky or any other key
personnel could delay or preclude us from achieving our business objectives.
Although we currently have key-man life insurance on Dr. Glasky in the face
amount of $2 million, we believe that the loss of Dr. Glasky's services would
damage our research and development efforts substantially. Dr. Glasky has an
employment agreement with us that provides for a three year term expiring
December 31, 2003, with automatic renewals thereafter unless we or Dr. Glasky
gives notice of intent not to renew at lease 90 days in advance of the renewal
date.
In addition to Dr. Glasky, the loss of Dr. Luigi Lenaz, our Vice
President, Oncology Division and President of our subsidiary NeoOncoRx, Inc.,
would damage the development of our anti-cancer business substantially, and the
loss of the services of Dr. Olivier Civelli, consultant to our subsidiary
NeoGene, Inc., would harm the development of our functional genomics business
substantially. We also will need substantial additional expertise in finance and
marketing and other areas in order to achieve our business objectives.
Competition for qualified personnel among pharmaceutical companies is intense,
and the loss of key personnel, or the inability to attract and retain the
additional skilled personnel required for the expansion of our business, could
significantly damage our business.
IF WE CANNOT PROTECT OR ENFORCE OUR INTELLECTUAL PROPERTY RIGHTS ADEQUATELY, THE
VALUE OF OUR RESEARCH COULD DECLINE AS OUR COMPETITORS APPROPRIATE PORTIONS OF
OUR RESEARCH.
We actively pursue patent protection for our proprietary products and
technologies. We hold rights to seven U.S. patents and currently have fifteen
U.S. patent applications pending, including two which have been allowed. Our
issued patents expire between 2009 and 2019. In addition, we have numerous
foreign patents issued and patent applications pending corresponding to our U.S.
patents. However, our patents may not protect us against our competitors. We may
have to file suit to protect our patents or to defend our use of our patents
against infringement claims brought by others. Because we have limited cash
resources, we may not be able to afford to pursue or defend against litigation
in order to protect our patent rights.
We also rely on trade secret protection for our unpatented proprietary
technology. However, trade secrets are difficult to protect. While we enter into
proprietary information agreements with our employees and consultants, these
agreements may not successfully protect our trade secrets or other proprietary
information.
WE ARE A SMALL COMPANY RELATIVE TO OUR PRINCIPAL COMPETITORS AND OUR LIMITED
FINANCIAL AND RESEARCH RESOURCES MAY LIMIT OUR ABILITY TO DEVELOP AND MARKET NEW
PRODUCTS.
Many companies, both public and private, including well-known
pharmaceutical companies such as Amgen, Inc., Bayer AG, Eli Lilly and Co.,
Novartis AG, Bristol-Meyers Squibb Company, Pfizer, Inc., Janssen Pharmaceutica,
Inc. and Shire Pharmaceuticals Group plc, are developing products to treat
Alzheimer's disease and certain of the other applications we are pursuing. Most
of these companies have substantially greater financial, research and
development, manufacturing and marketing experience and resources than us. As a
result, our competitors may be more successful than us in developing their
products and obtaining regulatory approvals. While we believe, based on recent
industry publications, that Neotrofin(TM) is more advanced in the drug
development process than most other drugs seeking to use neurotrophic factors to
treat Alzheimer's disease, we cannot be certain that Neotrofin(TM) will be the
first of these drugs to receive FDA approval, if it receives approval at all. In
addition, there are four drugs currently approved for the treatment of
Alzheimer's disease in the United States, all of which use a different approach
to the disease than Neotrofin(TM). If these treatments are successful, or if
other drugs using the neurotrophic factor approach are approved before
Neotrofin(TM), the market for Neotrofin(TM) could be reduced or eliminated.
6
OUR LACK OF EXPERIENCE AT CONDUCTING CLINICAL TRIALS OURSELVES MAY DELAY THE
TRIALS AND INCREASE OUR COSTS.
We have begun to conduct, and intend to conduct in the future, some
clinical trials ourselves rather than hiring outside contractors. We believe
this conversion may reduce the costs associated with the trials and give us more
control over the trials. However, while some of our management has had
experience at conducting clinical trials, we have never done so as a company.
While we have not experienced significant delays or increased costs to date due
to this conversion, as we move forward with our first self-conducted clinical
trials, our lack of experience may delay the trials and increase our costs. We
think it is prudent to expect setbacks as we make this transition.
HOLDERS OF OUR DEBENTURES AND WARRANTS COULD ENGAGE IN SHORT SELLING TO INCREASE
THE NUMBER OF SHARES OF COMMON STOCK ISSUABLE UPON CONVERSION OR EXERCISE OF THE
SECURITIES AND DECREASE THE EXERCISE PRICE OF THE WARRANTS. IF THIS OCCURS, THE
MARKET PRICE OF OUR COMMON STOCK MAY DECLINE.
Short selling is a practice in which an investor borrows shares from a
stockholder to sell in the trading market, with an obligation to deliver the
same number of shares back to the lending stockholder at a future date. Short
sellers make a profit if the price of our common stock declines, allowing the
short sellers to sell the borrowed shares at a higher price than they have to
pay for shares delivered to the lending stockholder. Short selling increases the
number of shares of our common stock available for sale in the trading market,
putting downward pressure on the market price of our common stock.
We have issued a number of securities that may be converted into or
exercised for shares of our common stock based on a floating conversion or
exercise price related to the market price of our common stock. The holders of
these securities may benefit from the downward price pressures caused by short
selling due to the increased number of shares of common stock issuable upon
conversion of convertible securities at a lower conversion price, or the reduced
exercise price that must be paid to obtain shares of common stock upon exercise.
On April 17, 2001, we entered into an agreement with two institutional
investors that commit these investors to purchase convertible debentures of
NeoTherapeutics. If issued, the convertible debentures will generally be
convertible into common stock at a conversion price equal to an initial
conversion price of 120% of the average per share market value of our common
stock over the five trading days preceding the date of issuance or, after 90
days from the date of issuance, the lesser of the initial conversion price or
101% of the average of the ten lowest closing bids of our common stock in the
previous 30 trading days from the date of conversion.
As a result of the terms of these securities, the number of shares of
common stock issuable upon conversion of the debentures, if issued, will vary
with the market price of our stock. The number of shares of our common stock
that are issuable upon conversion of these securities increases as the price of
our common stock decreases. Increased sales volume of our common stock could put
downward pressure on the market price of our common stock. This fact could
encourage holders of the securities to sell short our common stock prior to
conversion of the securities, thereby potentially causing the market price to
decline and a greater number of shares to become issuable upon conversion of the
debentures. The holders of the securities could then convert their securities
and use the shares of common stock received upon conversion to replace the
shares sold short. The holders of the securities could thereby profit by the
decline in the market price of the common stock caused by their short selling.
Similarly, the exercise price of our outstanding Class B Warrants, if we
deliver a redemption notice, is equal to the lesser of $33.75 per share (subject
to adjustment for stock splits, reverse splits and combinations) and
7
97% (or 95% if the market price of our common stock is less than $5.00 per
share) of the closing bid price of our common stock on the trading day after the
redemption notice is delivered. This fact could give the holders of our Class B
Warrants incentive to sell short our common stock after receipt of a redemption
notice, which could cause the market price to decline. The holders of the Class
B Warrants could then exercise their Class B Warrants and use the shares of
common stock received upon exercise to replace the shares sold short and thereby
profit by the decline in the market price of the common stock caused by their
short selling. There are currently outstanding Class B Warrants exercisable for
3,413,600 shares of common stock.
Montrose Investments Ltd. and Strong River Investments, Inc. each hold
Class B Warrants to purchase 1,706,800 shares of our common stock. No other
investors hold Class B Warrants. In addition, Montrose Investments Ltd. and
Strong River Investments, Inc. are the investors under our April 17, 2001
agreement for the purchase of convertible debentures. These facts give these two
investors greater influence over the market price of our stock, however, each of
these investors make independent investment decisions, and each has agreed to
vote any and all shares of our common stock that they own as recommended by our
board of directors in any meeting of our stockholders.
THE TRADING PRICE OF OUR COMMON STOCK AND THE TERMS OF OUR CONVERTIBLE
SECURITIES AND WARRANTS MUST COMPLY WITH THE LISTING REQUIREMENTS OF THE NASDAQ
NATIONAL MARKET OR WE COULD BE DELISTED AND THE LIQUIDITY OF OUR COMMON STOCK
WOULD DECLINE.
Our common stock is listed on the Nasdaq National Market. To remain
listed on this market, we must meet Nasdaq's listing maintenance standards and
abide by Nasdaq's rules governing listed companies. If the price of our common
stock falls below $1.00 per share for an extended period, or if we fail to meet
other Nasdaq standards, including minimum market capitalization and minimum
total assets, or violate Nasdaq rules, our common stock could be delisted from
the Nasdaq National Market.
Nasdaq has established rules regarding the issuance of "future priced
securities" or securities convertible into common stock based on a floating
conversion price, so that the number of shares of common stock issuable upon
conversion of the securities is not known when the securities are sold. These
rules may apply to the convertible debentures we may issue pursuant to the April
17, 2001 agreement, because the number of shares of our common stock issuable
upon conversion of these securities is based upon a future price of our common
stock. Nasdaq's concerns regarding these securities include the potential
dilution to our existing stockholders if the price of our common stock goes down
causing a large number of shares to be issued upon conversion of the securities,
and the corresponding potential for excessive return on investment for the
purchaser of the convertible securities. In addition, since the holders of
future priced securities may benefit from a decrease in the market price of our
common stock, those holders may have greater incentive to engage in manipulative
practices. In light of these concerns, Nasdaq has indicated that the following
rules may be implicated by future priced securities:
Stockholders must approve significant issuances of listed securities at
a discount to market or book value. Nasdaq rules prohibit an issuer of listed
securities from issuing 20% or more of its outstanding capital stock at less
than the greater of book value or the then current market value without
obtaining prior stockholder consent. We did not obtain stockholder consent prior
to signing the April 17, 2001 agreement. However, no debentures have been issued
pursuant to this agreement and we obtained stockholder approval of this
transaction at our Annual Meeting of Stockholders held on June 11, 2001.
Public interest concerns. Nasdaq may terminate the listing of a security
if necessary to prevent fraudulent and manipulative acts and practices or to
protect investors and the public interest. With respect to future priced
securities, Nasdaq has indicated that it may delist a security if the returns
with respect to the future priced security become excessive compared to the
returns being earned by public investors in the issuer's securities.
Furthermore, some requirements for continued listing, such as the $1.00
minimum bid price requirement, are outside of our control. Accordingly, there is
a risk that Nasdaq may delist our common stock.
8
If our common stock is delisted, we would likely seek to list our common
stock on the Nasdaq SmallCap Market or for quotation on the American Stock
Exchange or a regional stock exchange. However, listing or quotation on such
market or exchange could reduce the market liquidity for our common stock. If
our common stock were not listed or quoted on another market or exchange,
trading of our common stock would be conducted in the over-the-counter market on
an electronic bulletin board established for unlisted securities or in what are
commonly referred to as the "pink sheets." As a result, an investor would find
it more difficult to dispose of, or to obtain accurate quotations for the price
of, our common stock. In addition, delisting from the Nasdaq National Market and
failure to obtain listing or quotation on such other market or exchange would
subject our common stock to so-called "penny stock" rules. These rules impose
additional sales practice and market-making requirements on broker-dealers who
sell and/or make a market in such securities. Consequently, if our common stock
is delisted from the Nasdaq National Market and we fail to obtain listing or
quotation on another market or exchange, broker-dealers may be less willing or
able to sell and/or make a market in our common stock and purchasers of our
common stock may have more difficulty selling such common stock in the secondary
market. In either case, the market liquidity of our common stock would decline.
THERE ARE A SUBSTANTIAL NUMBER OF SHARES OF OUR COMMON STOCK ELIGIBLE FOR FUTURE
SALE IN THE PUBLIC MARKET. THE SALE OF THESE SHARES COULD CAUSE THE MARKET PRICE
OF OUR COMMON STOCK TO FALL. ANY FUTURE EQUITY ISSUANCES BY US MAY HAVE DILUTIVE
AND OTHER EFFECTS ON OUR EXISTING STOCKHOLDERS.
There were 21,862,772 shares of our common stock outstanding as of
October 2, 2001. In addition, security holders held options and warrants as of
October 2, 2001 which, if exercised, would obligate us to issue up to an
additional 8,593,877 shares of common stock, of which 2,515,000 shares are
subject to options or warrants which are currently exercisable at the sole
election of the holder. Many of these shares, if issued, would likely be issued
at a discount to the prevailing market price. A substantial number of those
shares, when we issue them upon exercise, will be available for immediate resale
in the public market. In addition, we have the ability to sell up to
approximately $25 million of our common stock pursuant to a shelf registration
that will be eligible for immediate resale in the market. The market price of
our common stock could fall as a result of such resales due to the increased
number of shares available for sale in the market. If all 8,593,877 shares were
issued without any increase in our market capitalization, the market price per
share of our common stock may be reduced by approximately 28%.
We have financed our operations, and we expect to continue to finance
our operations, by issuing and selling equity securities. Any issuances by us of
equity securities may be at or below the prevailing market price of our common
stock and may have a dilutive impact on our other stockholders. These issuances
would also cause our net income or loss per share to decrease in future periods.
As a result, the market price of our common stock could drop.
WE MAY BE SUBJECT TO PRODUCT LIABILITY CLAIMS, AND MAY NOT HAVE SUFFICIENT
PRODUCT LIABILITY INSURANCE TO COVER ANY CLAIMS, WHICH MAY EXPOSE US TO
SUBSTANTIAL LIABILITIES.
We may be exposed to product liability claims from patients who
participate in our clinical trials, or, if we are able to obtain FDA approval
for one or more of our potential products, from consumers of our products.
Although we currently carry product liability insurance in the amount of $5
million per occurrence, it is possible that the amounts of this coverage will be
insufficient to protect us from future claims. Further, we cannot be certain
that we will be able to obtain or maintain additional insurance on acceptable
terms for our clinical and commercial activities or that such additional
insurance would be sufficient to cover any potential product liability claim or
recall. Failure to maintain sufficient insurance coverage could have a material
adverse effect on our business and results of operations if claims are made that
exceed our coverage.
9
THE USE OF HAZARDOUS MATERIALS IN OUR RESEARCH AND DEVELOPMENT EFFORTS IMPOSES
CERTAIN COMPLIANCE COSTS ON US AND MAY SUBJECT US TO LIABILITY FOR CLAIMS
ARISING FROM THE USE OR MISUSE OF THESE MATERIALS.
Our research and development efforts involve the use of hazardous
materials, including biological materials, chemicals and radioactive materials.
We are subject to federal, state and local laws and regulations governing the
storage, use and disposal of these materials and some waste products. We believe
that our safety procedures for handling and disposing of these materials comply
with the standards prescribed by federal, state and local regulations. However,
we cannot completely eliminate the risk of accidental contamination or injury
from these materials. If there were to be an accident, we could be held liable
for any damages that result, which could exceed our financial resources. We
currently maintain insurance coverage of up to $1,000,000 per occurrence for
injuries resulting from the hazardous materials we use, and up to $25,000 per
occurrence for pollution clean up and removal, however, future claims may exceed
these amounts. Currently the costs of complying with federal, state and local
regulations are not significant, and consist primarily of waste disposal
expenses. We may incur substantially increased costs to comply with regulations,
particularly environmental regulations, if we develop our own commercial
manufacturing facility.
THE MARKET PRICE AND VOLUME OF OUR COMMON STOCK FLUCTUATE SIGNIFICANTLY AND
COULD RESULT IN SUBSTANTIAL LOSSES FOR INDIVIDUAL INVESTORS.
The stock market from time to time experiences significant price and
volume fluctuations that are unrelated to the operating performance of
particular companies. These broad market fluctuations may cause the market price
of our common stock to decrease. In addition, the market price of our common
stock is highly volatile. Factors that may cause the market price of our common
stock to decrease include fluctuations in our results of operations, timing and
announcements of our technological innovations or new products or those of our
competitors, FDA and foreign regulatory actions, developments with respect to
patents and proprietary rights, public concern as to the safety of products
developed by us or others, changes in health care policy in the United States
and in foreign countries, changes in stock market analyst recommendations
regarding our common stock, the pharmaceutical industry generally and general
market conditions. In addition, the market price of our common stock may
decrease if our results of operations fail to meet the expectations of stock
market analysts and investors. During the last year, the price of our common
stock has ranged between $13.50 and $2.22, and the daily trading volume has been
as high as 2,006,000 shares and as low as 10,600 shares, with a recent average
of approximately 100,000 shares.
OUR DIRECTORS AND EXECUTIVE OFFICERS OWN A SUBSTANTIAL PERCENTAGE OF OUR COMMON
STOCK. THEIR OWNERSHIP COULD ALLOW THEM TO EXERCISE SIGNIFICANT CONTROL OVER
CORPORATE DECISIONS AND TO IMPLEMENT CORPORATE ACTS THAT ARE NOT IN THE BEST
INTERESTS OF OUR STOCKHOLDERS AS A GROUP.
Our directors and executive officers beneficially own approximately
11.6% of our outstanding common stock as of October 2, 2001. In addition,
several of our stockholders, including Montrose Investments Ltd. and Strong
River Investments, Inc. and Societe Generale have agreed that they will vote any
and all shares of our common stock that they own as recommended by our board of
directors in any meeting of our stockholders. As of October 2, 2001, these
stockholders collectively held 579,098 shares of our common stock, or
approximately 2.6% of the number of shares outstanding, and held warrants which
could result in the issuance of up to 4,498,145 additional shares, for a total
of 5,077,243 shares or 19.3% of the total number outstanding if all of those
securities were converted or exercised. Of the additional shares, only 173,320,
or approximately 0.8%, could be issued at the option of the holder within 60
days of October 2, 2001. As a result of these holdings, our directors and
executive officers, if they acted together, could exert substantial influence
over matters requiring approval by our stockholders. These matters would include
the election of directors and the approval of mergers or other business
combination transactions. This concentration of ownership and voting power may
discourage or prevent someone from acquiring our business.
CERTAIN CHARTER AND BYLAWS PROVISIONS AND STOCKHOLDER RIGHTS PLAN MAY MAKE IT
MORE DIFFICULT FOR SOMEONE TO ACQUIRE CONTROL OF US OR REPLACE CURRENT
MANAGEMENT.
Certain provisions of our Certificate of Incorporation and Bylaws may
make it more difficult for someone to acquire control of us or replace our
current management. These provisions may make it more difficult for stockholders
to take certain corporate actions and could delay, discourage or prevent someone
from acquiring our
10
business or replacing our current management, even if doing so would benefit our
stockholders. These provisions could limit the price that certain investors
might be willing to pay for shares of our common stock.
On December 13, 2000, we adopted a Stockholder Rights Plan pursuant to
which we have distributed rights to purchase units of our capital Series B
Junior Participating Preferred Stock. The rights become exercisable upon the
earlier of ten days after a person or group of affiliated or associated persons
has acquired 20% or more of the outstanding shares of our common stock or ten
days after a tender offer has commenced that would result in a person or group
beneficially owning 20% or more of our outstanding common stock. These rights
could delay or discourage someone from acquiring our business, even if doing so
would benefit our stockholders.
USE OF PROCEEDS
Unless otherwise indicated in a supplement to this prospectus, we
anticipate that any net proceeds from the sale of the securities will be used
for general corporate purposes which may include but are not limited to working
capital, capital expenditures, research and development and general and
administrative expenses. We may also use a portion of the net proceeds for the
acquisition of, or investment in, companies, technologies or assets that
complement our business. However, we have no present understandings,
commitments or agreements to enter into any potential acquisitions or
investments. Net proceeds from the sale of the offered securities initially may
be temporarily invested in short-term interest-bearing securities.
PLAN OF DISTRIBUTION
On June 12, 2001, we entered into a Sales Agreement (the "Sales
Agreement") with Cantor Fitzgerald & Co. ("Cantor") to act as underwriter for an
offering from time to time of up to $8.4 million worth of our common stock in
one or more placements. As part of this offering, Cantor may make sales "at the
market" or directly into the Nasdaq National Market, the existing trading market
for our common stock, including sales made to or through a market maker or
through an electronic communications network, at the prevailing market price at
the time of sale or at prices related to those prevailing market prices or at
negotiated prices. The transactions in the shares may be effected during or
after regular trading hours by one or more of the following methods: ordinary
brokerage transactions and transactions in which the broker solicits purchasers;
block trades in which the broker or dealer will attempt to sell the shares as
agent but may position and attempt to resell a portion of the block as principal
in order to facilitate the transaction; purchases by a broker or dealer as
principal; privately negotiated transactions; and any other method permitted by
law. The brokers or dealers may receive compensation in the form of discounts,
concessions or commissions. We will provide a prospectus supplement to describe
any transaction to the extent required by the federal securities laws.
Pursuant to the Sales Agreement, we may, but we are under no obligation
to, elect to notify Cantor that we want to sell shares of common stock and the
proposed terms under which we would make the sale. Cantor may, but is under no
obligation to, accept the offer from us. If we agree with Cantor on the terms of
a proposed placement, including the number of shares of common stock to be
offered in the placement and any minimum price below which sales may not be
made, Cantor has agreed to use its commercially reasonable efforts, consistent
with its normal trading and sales practices, to try to sell such shares in
accordance with such terms. In the event that sales are made, Cantor will
provide written notice to us and we will deliver such shares on the third
business day following the date of such sale, unless otherwise specified by the
parties. The Sales Agreement is terminable by either Cantor or us after one
year, provided that Cantor may terminate the Sales Agreement earlier upon the
occurrence of certain events.
Cantor, and any broker or dealer that participates in the distribution
(collectively, "Distribution Participants"), is an underwriter within the
meaning of Section 2 (a) (11) of the Securities Act, and any commissions
received by these brokers or dealers and any profit realized on the resale of
the securities sold by them while acting as principal might be deemed to be
underwriting discounts or commissions under the Securities Act. As underwriters
they would be required to comply with the requirements of the Securities Act and
the Securities Exchange Act of 1934, as amended, or the Exchange Act, including,
without limitation, Rule 415 (a) (4) under the Securities Act and Rule 10b-5 and
Regulation M under the Exchange Act. These rules and regulations may limit the
timing of purchases and sales of shares of common stock by "Distribution
Participants". Under these rules and regulations, Distribution Participants:
- may not engage in any stabilization activity in connection with
our securities; and
11
- may not bid for or purchase any of our securities or attempt to
induce any person to purchase any of our securities, other than
as permitted under the Exchange Act, until such Distribution
Participant has completed its participation in the distribution.
Cantor has informed us that if permitted under the federal securities
laws it may purchase and sell shares of our common stock for its own account, as
market maker or otherwise, at the same time as it is making sales of shares of
our common stock under the Sales Agreement.
We have agreed that, without the written consent of Cantor, we will not,
directly or indirectly, offer to sell, sell, contract to sell, grant any option
to sell or otherwise dispose of any shares of our common stock, securities
convertible into or exchangeable for our common stock, warrants or any rights to
acquire our common stock during the period beginning on the fifth trading day
preceding the date on which we and Cantor agree to the terms of a placement
under the Sales Agreement and ending on the fifth trading day after the
settlement of the final sale made as part of that placement.
In connection with any sales made pursuant to the Sales Agreement,
Cantor is to receive compensation of 4% of the gross proceeds and warrants to
purchase shares of common stock in an amount equal to 10% of the number of
shares sold by Cantor at an exercise price equal to 130% of the volume weighted
average sales price of the shares of common stock sold by Cantor (the
"Warrants").
The Warrants are exercisable for five years, contain a cashless exercise
provision commencing one year after issuance and are not transferable for a
period of one year following their issuance except to officers and partners of
Cantor or Distribution Participants other than Cantor. We have also granted
Cantor limited demand and piggyback registration rights with respect to the
common stock underlying the Warrants, which registration rights also commence
one year after the issuance of the Warrants. Pursuant to the applicable rules of
the Corporate Finance Department of the National Association of Securities
Dealers ("NASD"), the Warrants may not be sold, transferred, assigned, pledged
or hypothecated for a period of one year from the effective date of the
offering, except to officers or partners (not directors) of Cantor and any
Distribution Participants and/or their officers or partners; and Cantor and any
Distribution Participants may not receive Warrants in excess of 10% of the
shares of Common Stock sold in this offering.
Simultaneous with entering into the Sales Agreement, we entered into
another agreement with Cantor on a similar basis (the "Other Agreement") for up
to $25 million worth of our common stock that is currently registered under our
Registration Statement on Form S-3, registration number 333-53108. As with the
Sales Agreement, any sales under the Other Agreement shall be subject to our
agreeing with Cantor, in each instance, as to the terms and conditions of such
sale. However, unlike the Sales Agreement, Cantor may not make sales pursuant to
the Other Agreement directly into the Nasdaq National Market or otherwise in a
manner that may be deemed to be an "at the market" offering as defined in Rule
415 under the Securities Act. In connection with any sales under the Other
Agreement, Cantor is to receive compensation of 4.00% on the first $10 million
gross proceeds, 3.50% on the next $10 million gross proceeds and 3.00% on the
next $5 million and Warrants with the same terms and provisions as provided
for under the Sales Agreement.
In addition to the cash compensation and the Warrants, we have also
agreed to reimburse Cantor for its out-of-pocket expenses incurred in connection
with the Sales Agreement up to an aggregate of $60,000, all or part of which may
be refundable. An additional $60,000 of expenses is reimbursable by us in
connection with the offering contemplated by the Other Agreement.
In addition, we have entered into an agreement with Cantor, pursuant to
which Cantor has been engaged to provide investment banking and other financial
services. The agreement is terminable at the will of either party. The agreement
provides that Cantor is to receive an annual retainer of $75,000 and
reimbursement of its out-of-pocket expenses incurred in connection with services
rendered thereunder. Upon execution of the agreement, we
12
paid Cantor a $75,000 annual retainer and $50,000 as a non-refundable deposit
against our reimbursement obligation. $62,500 or one-half of such aggregate
amount has been allocated to each of this Offering and the Offering
contemplated by the Other Agreement. Pursuant to the applicable NASD rules,
Cantor and any NASD member participating in the distribution may not receive
compensation greater than 8%, as determined by the Corporate Finance Department
of the NASD.
The following table shows the maximum aggregate fees payable by us to
Cantor, assuming the sale of $8.4 million of our common stock, exclusive of
Warrants, expense reimbursement and fees payable under the advisory agreement:
Underwriting fees paid by NeoTherapeutics
under the Sales Agreement: $336,000
In addition, we estimate that our share of the total expenses of this
offering, excluding the underwriting discount, will be approximately $308,440.
We have agreed to indemnify Cantor against certain liabilities,
including liabilities under the Securities Act, or to contribute to payments
Cantor may be required to make in respect thereof.
VALIDITY OF COMMON STOCK
Latham & Watkins, Costa Mesa, California, will pass on the validity of
the issuance of the common stock offered by this prospectus.
EXPERTS
The financial statements incorporated by reference in this registration
statement, to the extent and for the periods indicated in their report, have
been audited by Arthur Andersen LLP, independent public accountants, and are
included herein in reliance upon the authority of said firm as experts in giving
said report. Reference is made to said report which states that the Company is
in the development stage, as described in Note 1 to the consolidated financial
statements.
LIMITATION ON LIABILITY AND DISCLOSURE OF SEC POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Our bylaws provide for indemnification of our directors and officers to
the fullest extent permitted by law. Insofar as indemnification for liabilities
under the Securities Act may be permitted to directors, officers or controlling
persons of the Company pursuant to the Company's Certificate of Incorporation,
as amended, bylaws and the Delaware General Corporation Law, the Company has
been informed that in the opinion of the SEC such indemnification is against
public policy as expressed in such Act and is therefore unenforceable.
13
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SHARES OF COMMON STOCK
NEOTHERAPEUTICS, INC.
PROSPECTUS
OCTOBER 19, 2001
NO DEALER, SALESPERSON OR OTHER INDIVIDUAL HAS BEEN AUTHORIZED TO GIVE
ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS OTHER THAN CONTAINED OR
INCORPORATED BY REFERENCE IN THIS PROSPECTUS, AND IF GIVEN OR MADE, SUCH
INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED
BY THE COMPANY OR ANY UNDERWRITER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER
OR SOLICITATION BY ANYONE IN ANY JURISDICTION IN WHICH SUCH OFFER OR
SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH OFFER IS NOT
QUALIFIED TO DO SO OR TO ANYONE TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR
SOLICITATION. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE
HEREUNDER SHALL, UNDER ANY CIRCUMSTANCE, CREATE ANY IMPLICATION THAT THERE HAS
NOT BEEN ANY CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE HEREOF.
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