e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
or
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TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________ to __________
Commission File Number: 0-24006
NEKTAR THERAPEUTICS
(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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94-3134940
(IRS Employer
Identification No.) |
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455 Mission Bay Boulevard South
San Francisco, California 94158
(Address of principal executive offices)
415-482-5300
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
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 whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of
the Exchange Act). Yes o No þ
The number of outstanding shares of the registrants Common Stock, $0.0001 par value, was
114,073,353 on April 25, 2011.
NEKTAR THERAPEUTICS
INDEX
2
Forward-Looking Statements
This report includes forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities
Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of
historical fact are forward-looking statements for purposes of this quarterly report on Form
10-Q, including any projections of earnings, revenue or other financial items, any statements of
the plans and objectives of management for future operations (including, but not limited to,
pre-clinical development, clinical trials and manufacturing), any statements concerning proposed
drug candidates or other new products or services, any statements regarding future economic
conditions or performance, any statements regarding the success of our collaboration arrangements,
any statements regarding our plans and objectives to initiate Phase 3 clinical trials, and any
statements of assumptions underlying any of the foregoing. In some cases, forward-looking
statements can be identified by the use of terminology such as may, will, expects, plans,
anticipates, estimates, potential or continue, or the negative thereof or other comparable
terminology. Although we believe that the expectations reflected in the forward-looking statements
contained herein are reasonable, such expectations or any of the forward-looking statements may
prove to be incorrect and actual results could differ materially from those projected or assumed in
the forward-looking statements. Our future financial condition and results of operations, as well
as any forward-looking statements, are subject to inherent risks and uncertainties, including, but
not limited to, the risk factors set forth in Part II, Item 1A Risk Factors below and for the
reasons described elsewhere in this quarterly report on Form 10-Q. All forward-looking statements
and reasons why results may differ included in this report are made as of the date hereof and we do
not intend to update any forward-looking statements except as required by law or applicable
regulations. Except where the context otherwise requires, in this quarterly report on Form 10-Q,
the Company, Nektar, we, us, and our refer to Nektar Therapeutics, a Delaware
corporation, and, where appropriate, its subsidiaries.
Trademarks
The Nektar brand and product names, including but not limited to Nektar®, contained in this
document are trademarks, registered trademarks or service marks of Nektar Therapeutics in the
United States (U.S.) and certain other countries. This document also contains references to
trademarks and service marks of other companies that are the property of their respective owners.
3
PART I: FINANCIAL INFORMATION
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Item 1. |
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Condensed Consolidated Financial Statements Unaudited: |
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share information)
(Unaudited)
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March 31, 2011 |
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December 31, 2010 |
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ASSETS
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Current assets: |
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Cash and cash equivalents |
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$ |
22,485 |
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$ |
17,755 |
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Short-term investments |
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496,157 |
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298,177 |
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Accounts receivable |
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2,160 |
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25,102 |
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Inventory |
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11,712 |
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7,266 |
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Other current assets |
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6,859 |
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5,679 |
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Total current assets |
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539,373 |
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353,979 |
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Property and equipment, net |
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87,628 |
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89,773 |
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Goodwill |
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76,501 |
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76,501 |
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Other assets |
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976 |
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972 |
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Total assets |
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$ |
704,478 |
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$ |
521,225 |
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities: |
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Accounts payable |
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$ |
3,481 |
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$ |
7,194 |
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Accrued compensation |
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7,680 |
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9,252 |
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Accrued expenses |
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9,231 |
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8,540 |
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Accrued clinical trial expenses |
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13,649 |
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12,144 |
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Deferred revenue, current portion |
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19,974 |
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20,584 |
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Other current liabilities |
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4,865 |
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6,394 |
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Total current liabilities |
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58,880 |
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64,108 |
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Convertible subordinated notes |
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214,955 |
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214,955 |
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Capital lease obligations, less current portion |
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16,448 |
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17,014 |
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Deferred revenue, less current portion |
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122,818 |
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124,763 |
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Deferred gain |
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3,934 |
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4,152 |
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Other long-term liabilities |
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6,205 |
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5,571 |
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Total liabilities |
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423,240 |
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430,563 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock, 10,000 shares authorized Series A,
$0.0001 par value; 3,100 shares designated; no shares
issued or outstanding at March 31, 2011 and December
31, 2010 |
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Common stock, $0.0001 par value; 300,000 authorized;
114,023 shares and 94,517 shares issued and
outstanding at March 31, 2011 and December 31, 2010,
respectively |
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11 |
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9 |
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Capital in excess of par value |
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1,580,990 |
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1,354,232 |
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Accumulated other comprehensive income |
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818 |
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968 |
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Accumulated deficit |
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(1,300,581 |
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(1,264,547 |
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Total stockholders equity |
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281,238 |
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90,662 |
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Total liabilities and stockholders equity |
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$ |
704,478 |
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$ |
521,225 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
4
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
(Unaudited)
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Three months ended |
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March 31, |
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2011 |
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2010 |
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Revenue: |
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Product sales and royalties |
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$ |
4,793 |
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$ |
3,584 |
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License, collaboration and other |
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6,506 |
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29,653 |
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Total revenue |
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11,299 |
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33,237 |
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Operating costs and expenses: |
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Cost of goods sold |
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3,263 |
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4,296 |
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Research and development |
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30,176 |
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23,286 |
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General and administrative |
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11,727 |
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9,013 |
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Total operating costs and expenses |
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45,166 |
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36,595 |
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Loss from operations |
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(33,867 |
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(3,358 |
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Non-operating income (expense): |
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Interest income |
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432 |
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463 |
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Interest expense |
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(2,585 |
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(2,951 |
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Other income, net |
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134 |
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24 |
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Total non-operating expense |
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(2,019 |
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(2,464 |
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Loss before provision for income taxes |
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(35,886 |
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(5,822 |
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Provision for income taxes |
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148 |
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308 |
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Net loss |
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$ |
(36,034 |
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$ |
(6,130 |
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Basic and diluted net loss per share |
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$ |
(0.33 |
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$ |
(0.07 |
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Weighted average shares outstanding used in computing basic and diluted net loss per share |
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108,677 |
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93,631 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
5
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Three months ended |
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March 31, |
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2011 |
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2010 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(36,034 |
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$ |
(6,130 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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3,856 |
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4,149 |
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Stock-based compensation |
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4,802 |
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3,744 |
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Other non-cash transactions |
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309 |
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(235 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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22,942 |
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(2,908 |
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Inventory |
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(4,446 |
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(2,232 |
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Other assets |
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(1,199 |
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(883 |
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Accounts payable |
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(2,895 |
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1,748 |
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Accrued compensation |
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(1,572 |
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(4,348 |
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Accrued expenses |
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1,961 |
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1,354 |
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Accrued clinical trial expenses |
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1,505 |
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(552 |
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Deferred revenue |
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(2,555 |
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(26,568 |
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Other liabilities |
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(1,544 |
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(1,302 |
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Net cash used in operating activities |
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$ |
(14,870 |
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$ |
(34,163 |
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Cash flows from investing activities: |
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Purchases of investments |
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(372,723 |
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(115,277 |
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Sales of investments |
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61,368 |
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8,197 |
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Maturities of investments |
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113,235 |
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112,074 |
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Purchases of property and equipment |
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(3,765 |
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(3,973 |
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Net cash (used in) provided by investing activities |
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$ |
(201,885 |
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$ |
1,021 |
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Cash flows from financing activities: |
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Payments of loan and capital lease obligations |
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(459 |
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(359 |
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Issuance of common stock, net of issuance costs |
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221,958 |
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4,776 |
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Net cash provided by financing activities |
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$ |
221,499 |
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$ |
4,417 |
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Effect of exchange rates on cash and cash equivalents |
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(14 |
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(300 |
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Net increase (decrease) in cash and cash equivalents |
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$ |
4,730 |
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$ |
(29,025 |
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Cash and cash equivalents at beginning of period |
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17,755 |
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49,597 |
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Cash and cash equivalents at end of period |
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$ |
22,485 |
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$ |
20,572 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
6
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2011
(Unaudited)
Note 1Organization and Summary of Significant Accounting Policies
Organization
We are a clinical-stage biopharmaceutical company headquartered in San Francisco, California
and incorporated in Delaware. We are developing a pipeline of drug candidates that utilize our
PEGylation and advanced polymer conjugate technology platforms designed to improve the benefits of
drugs for patients.
Basis of Presentation and Principles of Consolidation
Our consolidated financial statements include the financial position, results of operations
and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics (India) Private Limited
(Nektar India) and Nektar Therapeutics UK Limited (Nektar UK) and Aerogen, Inc. All intercompany
accounts and transactions have been eliminated in consolidation. On December 2, 2010, we completed
the dissolution of Aerogen, Inc. and all remaining assets were transferred to Nektar Therapeutics.
We prepared our Condensed Consolidated Financial Statements following the requirements of the
Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules,
certain footnotes or other financial information that are normally required by U.S. generally
accepted accounting principles (GAAP) for annual periods can be condensed or omitted. In the
opinion of management, these financial statements include all normal and recurring adjustments that
we consider necessary for the fair presentation of our financial position and operating results.
Our Condensed Consolidated Financial Statements are denominated in U.S. dollars. Accordingly,
changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect
the translation of each foreign subsidiarys financial results into U.S. dollars for purposes of
reporting our consolidated financial results. Translation gains and losses are included in
accumulated other comprehensive income in the stockholders equity section of the Condensed
Consolidated Balance Sheets. To date, such cumulative translation adjustments have not been
material to our consolidated financial position.
Revenue, expenses, assets, and liabilities can vary during each quarter of the year. The
results and trends in these interim Condensed Consolidated Financial Statements may not be
indicative of the results to be expected for the full year or any other periods.
The accompanying Condensed Consolidated Balance Sheet as of March 31, 2011, the Condensed
Consolidated Statements of Operations for the three months ended March 31, 2011 and 2010, and the
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2011 and 2010
are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2010 was derived
from the audited consolidated financial statements which are included in our Annual Report on Form
10-K filed with the SEC on March 1, 2011. The information included in this quarterly report on Form
10-Q should be read in conjunction with the consolidated financial statements and the accompanying
notes to those financial statements included in our Annual Report on Form 10-K for the year ended
December 31, 2010.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenue and expenses during the reporting period. Actual results could differ
materially from these estimates. On an ongoing basis, we evaluate our estimates, including those
related to deferred revenue recognition periods, inventories, the impairment of investments and
long-lived assets, restructuring and contingencies, stock-based compensation, and litigation,
amongst others. We base our estimates on historical experience and on other assumptions that
management believes are reasonable under the circumstances. These estimates form the basis for
making judgments about the carrying values of assets and
7
liabilities when these values are not readily apparent from other sources.
Segment Information
We operate in one business segment which focuses on applying our technology platforms to
improve the performance of established and novel medicines. We operate in one segment because our
business offerings have similar economics and other characteristics, including the nature of
products and manufacturing processes, types of customers, distribution methods and regulatory
environment. We are comprehensively managed as one business segment by our Chief Executive Officer
and his management team.
Significant Concentrations
Our customers are primarily pharmaceutical and biotechnology companies that are located in the
U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables
from product sales, royalties, and
amounts due under
collaborative research and development agreements. We provide
for an allowance for doubtful accounts by reserving for specifically identified doubtful accounts.
We generally do not require collateral from our customers. We regularly review our customers
payment histories and associated credit risk. We have not experienced significant credit losses
from our accounts receivable and therefore recorded no allowance for doubtful accounts at both
March 31, 2011 and December 31, 2010.
We are dependent on our suppliers and contract manufacturers to provide raw materials, drugs
and devices of appropriate quality and reliability and to meet applicable regulatory requirements.
In certain cases, we rely on single sources of supply. Consequently, in the event that supplies are
delayed or interrupted for any reason, our ability to develop and produce our products could be
impaired, which could have a material adverse effect on our business, financial condition and
results of operations.
Revenue
Product sales and royalties
Product sales are primarily derived from cost-plus and fixed price manufacturing and supply
agreements with our collaboration partners and revenue is recognized in accordance with the terms
of the related agreement. We have not experienced any significant returns from our customers.
Generally, we are entitled to royalties from our partners based on their net sales of approved
products. We recognize royalty revenue when the cash is received or when the royalty amount to be
received is estimable and collection is reasonably assured.
License, collaboration and other
We enter into license
and manufacturing
agreements and collaborative research and development arrangements with
pharmaceutical and biotechnology partners that may involve multiple deliverables. Our arrangements
may contain one or more of the following elements: upfront fees, contract research and development,
milestone payments, manufacturing and supply, royalties, and license fees. Each deliverable in the
arrangement is evaluated to determine whether it meets the criteria to be accounted for as a
separate unit of accounting or whether it should be combined with other deliverables. Revenue is
recognized for each element when there is persuasive evidence that an arrangement exists, delivery
has occurred, the price is fixed or determinable, and collection is reasonably assured.
On January 1, 2011, we adopted on a prospective basis Accounting Standards Update (ASU)
2009-13, which amends the criteria to identify separate units of accounting within Subtopic 605-25,
Revenue Recognition-Multiple-Element Arrangements. The adoption of the standard did not impact
our financial position or results of operations as of and for the three month period ended March
31, 2011 as we did not enter into or materially modify any multiple-element arrangements during that period. However, the adoption of
8
this standard may result in revenue recognition patterns for future agreements that are
materially different from those recognized for our existing multiple-element arrangements.
Upfront fees received for license and collaborative agreements entered into prior to January
1, 2011 are recognized ratably over our expected performance period under the arrangement.
Management makes its best estimate of the period over which we expect to fulfill our performance
obligations, which may include technology transfer assistance, clinical development activities, and
manufacturing activities from development through the commercialization of the product. Given the
uncertainties of research and development collaborations, significant judgment is required to
determine the duration of the performance period.
On January 1, 2011, we elected to prospectively adopt ASU 2010-17, Milestone Method of
Revenue Recognition. Under the milestone method,
contingent consideration received from the achievement of a substantive milestone is recognized in
its entirety in the period in which the milestone is achieved,
which we believe is more consistent with the substance of our
performance under our various
license and collaboration agreements. A milestone is defined as an event
(i) that can only be achieved based in whole or in part on either the entitys performance or on
the occurrence of a specific outcome resulting from the entitys performance, (ii) for which there
is substantive uncertainty at the date the arrangement is entered into that the event will be
achieved, and (iii) that would result in additional payments being due to the entity. A milestone
is substantive if the consideration earned from the achievement of the milestone is consistent with
our performance required to achieve the milestone or the increase in value to the collaboration
resulting from our performance, relates solely to our past performance, and is reasonable relative
to all of the other deliverables and payments within the arrangement.
Our license and
collaboration agreements with our partners provide for payments to us upon the achievement of
development milestones, such as the completion of clinical trials or regulatory approval for drug
candidates.
As of January 1, 2011, our agreements with partners included potential future payments
for development milestones as defined in the respective agreements
totaling approximately $183.8 million, including potential milestone
payments totaling $60.0 million from our agreement with
Bayer Healthcare LLC. Given the challenges inherent in developing and obtaining
approval for pharmaceutical and biologic products, there was substantial uncertainty whether any
such milestones would be achieved at the time these licensing and collaboration agreements were
entered into. In addition, we evaluated whether the development milestones met the remaining
criteria to be considered substantive. As a result of our analysis, we consider our development
milestones to be substantive and, accordingly, we expect to recognize as revenue future payments
received from such milestones as we achieve each milestone. The election to adopt the milestone
method did not impact our financial position or results of operations as of and for the three month
period ended March 31, 2011. However, this policy election may result in revenue recognition
patterns for future milestones that are materially different from those recognized for milestones
received prior to adoption.
Milestone payments received prior to January 1, 2011 have been deferred and are recognized as revenue ratably over
the period of time from the achievement of the milestone to our estimated date on which the next
milestone will be achieved. Management makes its best estimate of the period of time until the next
milestone is expected to be reached. Final milestone payments are recorded and recognized upon
achieving the respective milestone, provided that collection is reasonably assured. The Company
will continue to recognize milestones payments received prior to
January 1, 2011 in this manner. As of March 31, 2011, we have deferred revenue of approximately $0.7 million from milestone
payments received prior to January 1, 2011
that we estimate will be recognized ratably
through 2013.
Our license and
collaboration agreements with certain partners also provide for contingent payments to us
based solely upon the performance of our partner. In particular, our agreement with AstraZeneca AB includes
contingent payments of $235.0 million based on development activities to be completed solely by AstraZeneca since
we have no further performance obligations under this agreement. For such contingent payments we expect to
recognize the payments as revenue upon receipt, provided that collection is reasonably assured.
Our license and collaboration agreements with our partners also provide for payments to us
upon the achievement of specified sales volumes of commercialized products. We consider these
payments to be similar to royalty payments and we recognize such sales-based payments upon
achievement of the milestone, provided that collection is reasonably assured.
Income Taxes
We account for income taxes under the liability method, in which deferred tax assets and
liabilities are determined based on differences between the financial reporting and tax reporting
bases of assets and liabilities and are measured using enacted tax rates and laws that are expected
to be in effect when the differences are expected to reverse. Realization of deferred tax assets is
dependent upon future earnings, the timing and amount of which are uncertain. We record a valuation
allowance against deferred tax assets to reduce their carrying value to an amount that is more
likely than not to be realized.
For the three month periods ended March 31, 2011 and 2010, we recorded an income tax provision
for our operations in India at an effective tax rate of 33% and 34%, respectively. The U.S. Federal
deferred tax assets generated from our net operating losses have been fully reserved as we believe
it is not more likely than not that the benefit will be realized.
Note 2Cash, Cash Equivalents, and Available-For-Sale Investments
Cash, cash equivalents, and available-for-sale investments are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
Cash and cash equivalents |
|
$ |
22,485 |
|
|
$ |
17,755 |
|
Short-term investments |
|
|
496,157 |
|
|
|
298,177 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
518,642 |
|
|
$ |
315,932 |
|
|
|
|
|
|
|
|
9
Our portfolio of cash, cash equivalents, and available-for-sale investments includes (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
Corporate notes and bonds |
|
$ |
340,866 |
|
|
$ |
190,527 |
|
U.S. corporate commercial paper |
|
|
136,794 |
|
|
|
82,361 |
|
Obligations of U.S. government agencies |
|
|
22,003 |
|
|
|
25,289 |
|
Cash and money market funds |
|
|
18,979 |
|
|
|
17,755 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
518,642 |
|
|
$ |
315,932 |
|
|
|
|
|
|
|
|
We invest in liquid, high quality debt securities. Our investments in debt securities are
subject to interest rate risk. To minimize the exposure due to an adverse shift in interest rates,
we invest in short-term securities and maintain a weighted average maturity of one year or less. At
March 31, 2011 and December 31, 2010, our average portfolio duration was approximately six months
and five months, respectively, and the maturity of any single investment did not exceed twelve
months.
During the three month periods ended March 31, 2011 and 2010, we sold available-for-sale
securities totaling $61.4 million and $8.2 million, respectively, and realized gains and losses of
less than $0.1 million in each of the periods. The cost of securities sold is based on the
specific identification method.
Gross unrealized gains and losses were not significant at March 31, 2011 and December 31,
2010. The gross unrealized losses were primarily due to changes in interest rates on fixed income
securities. Based on our available cash and our expected operating cash requirements, we do not
intend to sell these securities and it is more likely than not that we will not be required to sell
these securities before we recover the amortized cost basis. Accordingly, we believe there are no
other-than-temporary impairments on these securities and have not recorded a provision for
impairment.
We use a market approach to value our Level 2 investments as described in the table below. The
disclosed fair value related to our investments is based primarily on the reported fair values in
our period-end brokerage statements. We independently validate these fair values using available
market quotes and other information.
The following table represents the fair value hierarchy for our financial assets measured at
fair value on a recurring basis as of March 31, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Corporate notes and bonds |
|
$ |
|
|
|
$ |
340,866 |
|
|
$ |
|
|
|
$ |
340,866 |
|
U.S. corporate commercial paper |
|
|
|
|
|
|
136,794 |
|
|
|
|
|
|
|
136,794 |
|
Obligations of U.S. government agencies |
|
|
|
|
|
|
22,003 |
|
|
|
|
|
|
|
22,003 |
|
Money market funds |
|
|
18,578 |
|
|
|
|
|
|
|
|
|
|
|
18,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents and available-for-sale investments |
|
$ |
18,578 |
|
|
$ |
499,663 |
|
|
$ |
|
|
|
$ |
518,241 |
|
Cash |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
518,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
Quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level 2
|
|
Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the assets or liabilities. |
|
|
|
Level 3
|
|
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of
the assets or liabilities. |
10
Note 3Inventory
Inventory consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
Raw materials |
|
$ |
7,482 |
|
|
$ |
6,101 |
|
Work-in-process |
|
|
2,083 |
|
|
|
|
|
Finished goods |
|
|
2,147 |
|
|
|
1,165 |
|
|
|
|
|
|
|
|
Total |
|
$ |
11,712 |
|
|
$ |
7,266 |
|
|
|
|
|
|
|
|
Inventory is manufactured upon receipt of firm orders from our licensing partners. Inventory
includes direct materials, direct labor, and manufacturing overhead and is determined on a
first-in, first-out basis. Inventory is stated at the lower of cost or market and is net of
reserves of $2.5 million and $4.0 million as of March 31, 2011 and December 31, 2010, respectively.
Reserves are determined using specific identification plus an estimated reserve for potential
defective or excess inventory based on historical experience or projected usage.
Note 4Commitments and Contingencies
Legal Matters
From time to time, we are involved in lawsuits, arbitrations, claims, investigations and
proceedings, consisting of intellectual property, commercial, employment and other matters, which
arise in the ordinary course of business. We make provisions for liabilities when it is both
probable that a liability has been incurred and the amount of the loss can be reasonably estimated.
Such provisions, if necessary, are reviewed at least quarterly and adjusted to reflect the impact
of settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other
information and events pertaining to a particular case. Litigation is inherently unpredictable. If
any unfavorable ruling were to occur in any specific period, there exists the possibility of a
material adverse impact on the results of operations of that period or on our cash flows and
liquidity.
Indemnifications in Connection with Commercial Agreements
As part of our collaboration agreements with our partners related to the license, development,
manufacture and supply of drugs based on our proprietary technologies, we generally agree to
defend, indemnify and hold harmless our partners from and against third party liabilities arising
out of the agreement, including product liability (with respect to our activities) and infringement
of intellectual property to the extent the intellectual property is developed by us and licensed to
our partners. The term of these indemnification obligations is generally perpetual any time after
execution of the agreement. There is generally no limitation on the potential amount of future
payments we could be required to make under these indemnification obligations.
As part of our pulmonary asset sale to Novartis that was effective as of December 31, 2008, we
and Novartis made representations and warranties and entered into certain covenants and ancillary
agreements which are supported by an indemnity obligation. In the event it were determined that we
breached certain of the representations and warranties or covenants and agreements made by us in the
transaction documents, we could incur an indemnification liability depending on the timing, nature,
and amount of any such claims.
To date we have not incurred costs to defend lawsuits or settle claims related to these
indemnification obligations. If any of our indemnification obligations is triggered, we may incur
substantial liabilities. Because the obligated amount under these agreements is not explicitly
stated, the overall maximum amount of any such obligations cannot be reasonably estimated. No
liabilities have been recorded for these obligations on our Condensed Consolidated Balance Sheets
as of March 31, 2011 or December 31, 2010.
Note 5 Stockholders Equity
On January 24, 2011, we completed the issuance and sale of 19,000,000 shares of our common
stock for aggregate gross proceeds to the Company of approximately $220.4 million. Additionally,
we incurred approximately $0.6 million in legal and accounting fees, filing fees, and other
offering expenses.
11
Note 6License and Collaboration Agreements
We have entered into various license
and manufacturing
agreements and collaborative research and development
agreements with pharmaceutical and biotechnology companies. Under these arrangements, we are
entitled to receive license fees, upfront payments, milestone payments when and if certain
development or regulatory milestones are achieved,
royalties, sales milestones,
payment for the manufacture and supply of
certain drug materials, and/or reimbursement for research and development activities. All of our
research and development agreements are generally cancelable by our partners without significant
financial penalty to the partner. Our costs of performing these services are included in research
and development expense in the accompanying Condensed Consolidated Statements of Operations.
In accordance with these agreements, we recorded license, collaboration and other revenue as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
Partner |
|
Agreement |
|
|
2011 |
|
|
2010 |
|
F. Hoffmann-LaRoche |
|
PEGASYS® |
|
$ |
1,283 |
|
|
$ |
1,283 |
|
Amgen, Inc. |
|
Neulasta® |
|
|
1,250 |
|
|
|
|
|
Bayer Healthcare LLC |
|
BAY41-6651 (Amikacin Inhale) |
|
|
750 |
|
|
|
887 |
|
AstraZeneca AB |
|
NKTR-118 and NKTR-119 |
|
|
241 |
|
|
|
25,726 |
|
Other |
|
|
|
|
|
|
2,982 |
|
|
|
1,757 |
|
|
|
|
|
|
|
|
|
|
|
|
License, collaboration, and other revenue |
|
$ |
6,506
|
|
|
$ |
29,653
|
|
|
|
|
|
|
|
|
|
|
|
|
F. Hoffmann-LaRoche Ltd and Hoffmann-LaRoche Inc.
PEGASYS®
In February 1997, we entered into a license, manufacturing and supply agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), under which we granted Roche a worldwide,
exclusive license to use certain PEGylation materials in the manufacture of PEGASYS. As a result of
Roche exercising a license extension option in December 2009, Roche has the right to manufacture
all of its requirements for our proprietary PEGylation materials for PEGASYS and we will perform
additional manufacturing, if any, only on an as requested basis. In connection with Roches
exercise of the license option extension in December 2009, we received a payment of $31.0 million.
As of March 31, 2011, we have deferred revenue of approximately $24.4 million, which we expect to
amortize through December 2015, which is the period through which we are required to provide
back-up manufacturing and supply services on an as-requested basis.
Amgen, Inc.
Neulasta®
On October 29, 2010, we amended and restated an existing supply and license agreement by
entering into a supply, dedicated suite and manufacturing guarantee agreement (the amended and
restated agreement) and a license agreement with Amgen Inc. and Amgen Manufacturing, Limited
(together referred to as Amgen). Under the terms of the amended and restated agreement, we
guarantee the manufacture and supply of our proprietary PEGylation materials (Polymer Materials) to
Amgen in an existing manufacturing suite to be used exclusively for the manufacture of Polymer
Materials for Amgen (the Manufacturing Suite) in our manufacturing facility in Huntsville, Alabama
(Facility). This supply arrangement is on a non-exclusive basis (other than the use of the
Manufacturing Suite and certain equipment) whereby Nektar is free to manufacture and supply the
Polymer Materials to any other third party and Amgen is free to procure the Polymer Materials from
any other third party. Under the terms of the amended and restated agreement, we received a $50.0
million payment
in the fourth quarter of 2010
in return for our guaranteeing the supply of certain quantities of Polymer
Materials to Amgen including without limitation the Additional Rights described below and
manufacturing fees that are calculated based on fixed and variable components applicable to the
Polymer Materials ordered by Amgen and delivered by us. Amgen has no minimum purchase commitments.
If quantities of the Polymer Materials ordered by Amgen exceed specified quantities, significant
additional payments become payable to us in return for our guaranteeing the supply of additional
quantities of the Polymer Materials.
The term of the amended and restated agreement ends on October 29, 2020. In the event we
become subject to a bankruptcy or insolvency proceeding, we cease to own or control the Facility,
we fail to manufacture and supply or certain other events, Amgen or
12
its designated third party will have the right to elect, among certain other options, to take
title to the dedicated equipment and access the Facility to operate the Manufacturing Suite solely
for the purpose of manufacturing the Polymer Materials (the Additional Rights). Amgen may terminate
the amended and restated agreement for convenience or due to an uncured material default by us.
As of March 31, 2011, we have deferred revenue of approximately $47.9 million, which we expect
to amortize through October 2020, the estimated end of our obligations under amended and restated
agreement.
Bayer Healthcare LLC
BAY41-6651 (Amikacin Inhale)
On August 1, 2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC (Bayer) to develop a specially-formulated inhaled Amikacin. We are responsible
for development of the nebulizer device included in the Amikacin product through the completion of
the Phase 3 clinical trial, scale-up for commercialization, and commercial manufacturing and
supply. Bayer is responsible for most future clinical development and commercialization costs, all
activities to support worldwide regulatory filings, approvals and related activities, further
development of Amikacin Inhale and final product packaging and distribution. We received an upfront
payment of $40.0 million in 2007 and performance milestone payments of $20.0 million, of which
$10.0 million will be used to reimburse Bayer for Phase 3 clinical trial costs. We are entitled to
development milestones and sales milestones upon achievement of certain development milestones and
annual sales targets and royalties based on annual worldwide net sales of Amikacin Inhale. As of
March 31, 2011, we have deferred revenue of approximately $29.7 million, which we expect to
amortize through July 2021, the estimated end of our obligations under this agreement.
AstraZeneca AB
NKTR-118 and NKTR-119
On September 20, 2009, we entered into a License Agreement with AstraZeneca AB, a Swedish
corporation (AstraZeneca), under which we granted AstraZeneca a worldwide, exclusive, perpetual,
royalty-bearing, and sublicensable license under our patents and other intellectual property to
develop, sell and otherwise commercially exploit NKTR-118 and NKTR-119. AstraZeneca is responsible
for all costs associated with research, development and commercialization and will control drug
development and commercialization decisions for NKTR-118 and NKTR-119. Under the terms of the
agreement, AstraZeneca paid us an upfront payment of $125.0 million, which we received in the
fourth quarter of 2009. We are also entitled to development milestones, sales milestones and royalties based on annual worldwide net sales of
NTKR-118 and NKTR-119 products. As of December 31, 2010, we completed our obligations under the
license agreement and related manufacturing technology transfer agreement. The upfront payment was
amortized over approximately 15 months beginning in October 2009 in accordance with our performance
obligation period and was fully recognized as of December 31, 2010.
Note 7Stock-Based Compensation
Total stock-based compensation cost was recorded in our Condensed Consolidated Financial
Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
Cost of goods sold |
|
$ |
332 |
|
|
$ |
207 |
|
Research and development expense |
|
|
1,969 |
|
|
|
1,566 |
|
General and administrative expense |
|
|
2,501 |
|
|
|
1,971 |
|
|
|
|
|
|
|
|
Total stock-based compensation cost |
|
$ |
4,802 |
|
|
$ |
3,744 |
|
|
|
|
|
|
|
|
During the three months ended March 31, 2011 and 2010, we granted 2,128,055 and 3,756,925
stock options, respectively. The weighted average grant-date fair value of options granted during
the three-months ended March 31, 2011 and 2010 was $5.74 per share and $5.97 per share,
respectively. During the three months ended March 31, 2011 and 2010, we issued 505,700 and 637,664
common shares, respectively, as a result of
stock issuances under
our equity compensation plans.
13
Note 8Net Loss Per Share
Basic net loss per share is calculated based on the weighted-average number of common shares
outstanding during the periods presented. For all periods presented in the accompanying Condensed
Consolidated Statements of Operations, the net loss available to common stockholders is equal to
the reported net loss. Basic and diluted net loss per share are the same due to our historical net
losses and the requirement to exclude potentially dilutive securities which would have an
anti-dilutive effect on net loss per share. The weighted average of these potentially dilutive
securities has been excluded from the diluted net loss per share calculation and is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
Convertible subordinated notes |
|
|
9,989 |
|
|
|
9,989 |
|
Stock options |
|
|
11,135 |
|
|
|
8,544 |
|
|
|
|
|
|
|
|
Total |
|
|
21,124 |
|
|
|
18,533 |
|
|
|
|
|
|
|
|
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
The following discussion contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those discussed here. Factors that
could cause or contribute to such differences include, but are not limited to, those discussed in
this section as well as factors described in Part II, Item 1ARisk Factors.
Overview
Strategic Direction of Our Business
We are a clinical-stage biopharmaceutical company developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms, which are designed
to improve the benefits of drugs for patients. Our current proprietary product pipeline is
comprised of drug candidates across a number of therapeutic areas, including oncology, pain,
anti-infectives, anti-viral and immunology. Our research and development activities involve small
molecule drugs, peptides and other potential biologic drug candidates. We create our innovative
drug candidates by using our proprietary advanced polymer conjugate technologies and expertise to
modify the chemical structure of drugs to create new molecular entities. Polymer chemistry is a
science focused on the synthesis or bonding of polymer architectures with drug molecules to alter
the properties of the molecule when it is bonded with polymers. Additionally, we may utilize
established pharmacologic targets to engineer a new drug candidate relying on a combination of the
known properties of these targets and our proprietary polymer chemistry technology and expertise.
Our drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life,
bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a
drug for the patient. Our objective is to apply our advanced polymer
conjugate technology platforms
to create new drugs in multiple therapeutic areas.
We have a number of existing license and collaboration agreements with third parties in which
we have an economic interest and which could have a material impact on our business, results of
operations and financial condition. In particular, the future clinical and commercial success or
failure of our collaborations, described below, with AstraZeneca AB for NKTR-118 and NKTR-119 and
Bayer Healthcare LLC (Bayer) for BAY41-6551 (Amikacin Inhale) will have a material impact on our business and
financial condition over the next several years. In addition, the amount of revenue that we derive
from UCBs CIMZIA®,
Roches MIRCERA®,
Maps Levadextm and Affymaxs
Hematidetm,
among other of our collaboration agreements, could together have a
material impact on our business, financial results and cash position. Because drug development and
commercialization is subject to numerous risks and uncertainties, there is a substantial risk that
our future revenue from one or more of these agreements will be less than our projections.
Our most advanced proprietary product candidate, NKTR-118 (oral PEG-naloxol), is a peripheral
opioid antagonist that is currently being evaluated for the treatment of opioid-induced
constipation. In September 2009, we entered into an exclusive worldwide license agreement with
AstraZeneca for the global development and commercialization of NKTR-118 and NKTR-119. NKTR-119 is
an early stage research and development program that is designed to combine various opioids with
NKTR-118. On March 15, 2011,
14
AstraZeneca announced enrollment of the first patient in the Phase 3 clinical study for
NKTR-118. This Phase 3 clinical program is designed to investigate the safety and efficacy of
NKTR-118 as a medicine to relieve opioid-induced constipation, a common side effect of prescription
opioids.
We have a collaboration with Bayer for Amikacin Inhale, an inhaled solution of
amikacin, an aminoglycoside antibiotic, that has completed Phase 2 development.
Preparations for a Phase 3 clinical study, which we currently expect
to start in the second half of 2012, are
continuing. We originally developed the liquid aerosol inhalation platform and product, and, in
August 2007, we entered into a collaboration agreement with Bayer for the further
development and commercialization of Amikacin Inhale. The program is significantly behind schedule due to our
plan with Bayer to finalize the design of the nebulizer device for commercial manufacturing prior to
initiating Phase 3 clinical development, with the objective of commencing Phase 3 clinical trials
as soon as possible following completion of this work.
We continue to make substantial investments in our drug candidate pipeline from
early stage discovery research through clinical development. We continue to advance Phase 2
clinical trials for NKTR-102 (topoisomerase I inhibitor-polymer conjugate) in metastatic breast
cancer, platinum resistant/refractory ovarian cancer and metastatic colorectal cancer. The Phase 2
clinical trial for metastatic breast cancer was fully enrolled in 2010, with patients continuing in
the study into 2011. In 2010, we expanded the Phase 2 clinical trial
in platinum
resistant/refractory ovarian cancer by 50 patients and, on March 1, 2011, we announced that we
intended to further expand the clinical study in platinum resistant/refractory ovarian cancer by up
to 60 additional patients. We expect this expansion trial to continue to enroll throughout 2011.
The Phase 2 clinical study in metastatic colorectal cancer patients is still enrolling. Enrollment
in the colorectal cancer study has been challenging due to the fact that the comparator arm of this
study, single-agent irinotecan, is not the standard of care for second line metastatic colorectal
therapy in the United States or Europe.
In December 2010, we announced that we were planning to move into Phase 3 clinical development
of NKTR-102 prior to seeking a collaboration partner. We are currently developing a Phase 3
clinical study design for NKTR-102 in metastatic breast cancer and
platinum resistant/refractory ovarian cancer. The size, scope and timing of our investment in comparative Phase 3 clinical
studies in metastatic breast cancer and platinum resistant/refractory ovarian cancer will depend
upon a number of important variables, including our evaluation of the final Phase 2 study results
for these indications, discussions with health authorities and key opinion leaders, evolving
regulatory standards and requirements, the estimated cost of these studies, and our prioritization
of research and development opportunities.
The start dates for our Phase 3 trials for NKTR-102 will depend on
our final development plans for each indication and
our communications with the United States Food and Drug Administration
(FDA).
We anticipate our Phase 3 development plans for NKTR-102
to require substantial investment over the next several years.
Our focus on research and clinical development requires substantial investments that continue
to increase as we advance each drug candidate through each phase of the development cycle. In
addition to advancing our proprietary programs that are currently in clinical development, we are
committed to continuing to make significant investments to advance new opportunities from our
earlier stage research discovery pipeline. For example, we started a Phase 1 clinical study for
NKTR-181 on March 21, 2011. While we believe that our substantial investment in research and
development has the potential to create significant value if one or more of our drug candidates
demonstrates positive clinical results and/or receives regulatory approval in one or more major
markets, drug research and development is an inherently uncertain process and there is a high risk
of failure at every stage prior to approval and the timing and outcome of clinical trial results is
extremely difficult to predict. In addition, we continually prioritize our programs, and as
a result of prioritization of our drug candidate pipeline opportunities, we do not currently intend
to advance NKTR-105 (PEGylated docetaxel), currently in an ongoing Phase I clinical study, into Phase 2 clinical studies.
Clinical development successes and failures can have a disproportionate positive or negative impact
on our scientific and medical prospects, financial prospects, financial condition, and market
value.
Historically, we have entered into a number of license and supply contracts under which we
manufactured and supplied our proprietary PEGylation reagents on a cost-plus or fixed price basis.
Our current strategy is to manufacture and supply PEGylation reagents to support our proprietary
drug candidates or for third party collaborators where we have a strategic development and
commercialization relationship or where we derive substantial economic benefit. As a result,
whenever possible, we are renegotiating
15
or not seeking renewal of legacy manufacturing supply arrangements that do not include a
strategic development or commercialization component. For example, in October 2010 we entered into
a supply, dedicated suite and manufacturing guarantee agreement with Amgen Inc. and Amgen
Manufacturing, Limited, which has significantly amended economic and other terms in the
non-exclusive supply and license agreement we previously entered into with Amgen in July 1995. In
addition, in December 2010, we entered into an amended manufacturing and supply agreement with
Merck (through its acquisition of Schering-Plough Corporation) to provide for transfer to an
alternative manufacturer and revised economics for an interim supply arrangement until that
transition is completed.
Key Developments and Trends in Liquidity and Capital Resources
On January 24, 2011, we completed a public offering of our common stock with proceeds of
approximately $220.4 million. As part of the public offering, we incurred approximately $0.6
million in legal and accounting fees, filing fees, and other offering expenses. At March 31, 2011,
we had approximately $518.6 million in cash, cash equivalents, and short-term investments and
$240.6 million in indebtedness. We have $215.0 million in outstanding convertible subordinated
notes due September 2012. We do not have sufficient resources to fund our current research and
development plans and repay these convertible notes. We have no material credit facility or other
material committed sources of capital. We expect the Phase 3 clinical studies of NKTR-102 to
require significant resources as we anticipate bearing a majority or all of the development costs
for that drug candidate. Prior to the maturity of the convertible notes, we plan to explore a
number of alternatives to repayment of the notes, including restructuring the notes.
Historically, we have financed our operations primarily through revenue from product sales and
royalties, license and collaboration agreements and debt and equity
financings. While in the past we have received a number of significant payments from license and
collaboration agreements and other significant transactions, we do not currently anticipate
completing new transactions with substantial upfront payments in the near future. In addition, we
have substantial debt, represented by our outstanding convertible subordinated notes. Our
substantial debt, the market price of our securities, and the general economic climate, among other
factors, could have material consequences for our financial condition and could affect our sources
of short-term and long-term funding. Our ability to meet our ongoing operating expenses and repay
our outstanding indebtedness is dependent upon our and our partners ability to successfully
complete clinical development of, obtain regulatory approvals for and successfully commercialize
drug candidates. Even if we or our partners are successful, we may require additional capital to
continue to fund our operations and repay our debt obligations as they become due. There can be no
assurance that additional funds, if and when required, will be available to us on favorable terms,
if at all.
Results of Operations
Three Months Ended March 31, 2011 and 2010
Revenue (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Three months |
|
|
|
|
|
|
Percentage |
|
|
|
ended |
|
|
ended |
|
|
Increase / |
|
|
Increase / |
|
|
|
March 31, |
|
|
March 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2011 |
|
|
2010 |
|
|
2011 vs. 2010 |
|
|
2011 vs. 2010 |
|
Product sales and royalties |
|
$ |
4,793 |
|
|
$ |
3,584 |
|
|
$ |
1,209 |
|
|
|
34 |
% |
License, collaboration and other |
|
|
6,506 |
|
|
|
29,653 |
|
|
|
(23,147 |
) |
|
|
(78 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
11,299 |
|
|
$ |
33,237 |
|
|
$ |
(21,938 |
) |
|
|
(66 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our revenue is derived from our collaboration agreements, under which we may receive product
sales revenue, royalties, license fees, milestone payments or contract research payments. Revenue
is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred,
the price is fixed or determinable, and collection is reasonably assured. Upfront fees received for
license and collaborative agreements are recognized ratably over our expected performance period
under the arrangement. Milestones achieved are deferred and recorded as revenue ratably over the
period of time from the achievement of the milestone and our estimated date on which the next
milestone is expected to be achieved. As a result, there may be significant variations in the
timing of receipt of cash payments and our recognition of revenue. Management makes its best
estimate of the period over which we expect to fulfill our performance obligations and the period
of time until the next milestone is achieved. Given the uncertainties in research and development
collaborations, significant judgment is required by management to determine the amortization
periods.
16
Product Sales and Royalties
Product sales include cost-plus and fixed price manufacturing and supply agreements with our
collaboration partners. We also receive royalty revenue from certain of our collaboration partners
based on their net sales of approved products.
Product sales and royalties increased in the three months ended March 31, 2011 compared to the
three months ended March 31, 2010 as a result of $0.6 million of increased product sales and $0.6
million of increased royalties. The timing of product shipments is based on the demand and
requirements of our collaboration partners and is not ratable throughout the year. We expect
product sales and royalties to decrease over the remaining nine month period of 2011 compared to
the last nine months of 2010 due to decreased product sales partially offset by increased royalty
revenues.
License, Collaboration and Other
License, collaboration and other revenue includes amortization of upfront payments and
milestone payments received in connection with our license and collaboration agreements and
reimbursed research and development expenses. The level of license, collaboration and other revenue
depends in part upon the estimated amortization period of the upfront and milestone payments, the
achievement of future milestones, the continuation of existing collaborations, the amount of
reimbursed research and development work, and the signing of new collaborations.
For the three months ended March 31, 2011, the decrease in license, collaboration and other
revenue compared to the three months ended March 31, 2010 is primarily attributable to the complete
amortization as of December 31, 2010 of the $125.0 million upfront payment received in 2009 from
AstraZeneca in connection with NKTR-118 and NKTR-119. Under the AstraZeneca License, we recognized
$25.3 million of the $125.0 million upfront payment in the three months ended March 31, 2010
compared to nil in the three months ended March 31, 2011.
Cost of Goods Sold and Product Gross Margin (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
March 31, |
|
March 31, |
|
(Decrease) |
|
(Decrease) |
|
|
2011 |
|
2010 |
|
2011 vs. 2010 |
|
2011 vs. 2010 |
Cost of goods sold |
|
$ |
3,263 |
|
|
$ |
4,296 |
|
|
$ |
(1,033 |
) |
|
|
(24 |
)% |
Product gross profit |
|
$ |
1,530 |
|
|
$ |
(712 |
) |
|
$ |
2,242 |
|
|
|
>100 |
% |
Product gross margin |
|
|
32 |
% |
|
|
(20 |
)% |
|
|
|
|
|
|
|
|
For the three months ended March 31, 2011 compared to the three months ended March 31, 2010,
the increase in product gross profit and product gross margin is
primarily attributable to the $0.6
million increase in royalties and the increased absorption of overhead costs as a
result of increased manufacturing activity.
As a result of the fixed cost base associated with our manufacturing activities, we expect
product gross margin to fluctuate in future periods depending on the level of our manufacturing
requirements.
Research and Development Expense (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
March 31, |
|
March 31, |
|
(Decrease) |
|
(Decrease) |
|
|
2011 |
|
2010 |
|
2011 vs. 2010 |
|
2011 vs. 2010 |
Research and development expense |
|
$ |
30,176 |
|
|
$ |
23,286 |
|
|
$ |
6,890 |
|
|
|
30 |
% |
Research and development expense consists primarily of personnel costs, including salaries,
benefits, and stock-based compensation, materials and supplies, outside services, licenses and
fees, and overhead allocations consisting of various support and facilities related costs. Research
and development expense is not expected to be ratable over the four quarters of the year, however
we expect research and development expense to increase throughout 2011 compared to 2010 as we
continue to advance our pipeline of drug candidates.
17
For the three months ended March 31, 2011 compared to the three months ended March 31, 2010,
direct research and development program costs increased by approximately $1.8 million, primarily
due to the initiation of our Phase 1 NKTR-181 single dose trial in March 2011. Additionally,
research and development expense increased in the three months ended March 31, 2011 compared to the
three months ended March 31, 2010 by $2.0 million in salaries and employee benefits due to
increased headcount to support our expanded clinical efforts and further investment in and
development of our research capabilities and pipeline, by $1.8 million in support and
facilities-related costs and by $0.4 million in non-cash stock-based compensation expense.
Other than as described in the Overview section above, there have been no material changes to
the status of clinical programs in the three months ended March 31, 2011 from the activities
discussed in our Annual Report on Form 10-K for the year ended December 31, 2010 on file with the
Securities and Exchange Commission.
General and Administrative Expense (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
March 31, |
|
March 31, |
|
(Decrease) |
|
(Decrease) |
|
|
2011 |
|
2010 |
|
2011 vs. 2010 |
|
2011 vs. 2010 |
General and administrative expense |
|
$ |
11,727 |
|
|
$ |
9,013 |
|
|
$ |
2,714 |
|
|
|
30 |
% |
General and administrative expense is associated with administrative staffing, business
development, marketing, and legal. For the three months ended March 31, 2011 compared to the three
months ended March 31, 2010, general and administrative expense increased by $0.5 million in
non-cash stock-based compensation expense and by $0.5 million in support and facilities-related
costs. The remaining increase primarily consists of increases to personnel-related, professional
and other administrative costs.
Interest Income and Interest Expense (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
March 31, |
|
March 31, |
|
(Decrease) |
|
(Decrease) |
|
|
2011 |
|
2010 |
|
2011 vs. 2010 |
|
2011 vs. 2010 |
Interest income |
|
$ |
432 |
|
|
$ |
463 |
|
|
$ |
(31 |
) |
|
|
(7 |
)% |
Interest expense |
|
$ |
(2,585 |
) |
|
$ |
(2,951 |
) |
|
$ |
(366 |
) |
|
|
(12 |
)% |
The slight decrease in interest income for the three months ended March 31, 2011 compared to
the three months ended March 31, 2010 is a result of decreased market interest rates received for
our cash and short-term investments partially offset by higher average balances for the period.
The decrease in interest expense for the three months ended March 31, 2011 compared to the
three months ended March 31, 2010 is primarily attributable to the complete amortization of
deferred financing costs during 2010 from our 3.25% convertible subordinated notes due September
2012.
Liquidity and Capital Resources
We have financed our operations primarily through
cash from licensing, collaboration
and manufacturing agreements, public and private placements of debt and equity securities, and
financing of equipment acquisitions and certain tenant leasehold improvements.
We had cash, cash equivalents and short-term investments in marketable securities of $518.6
million and indebtedness of $240.6 million, including $215.0 million of 3.25% convertible
subordinated notes due September 2012, $18.5 million in capital lease obligations, and $7.1 million
in other liabilities as of March 31, 2011.
Due to the potential for continued uncertainty in the credit markets in 2011, we may
experience reduced liquidity with respect to some of our short-term investments. These investments
are generally held to maturity, which is less than one year. However, if the need arose to
liquidate such securities before maturity, we may experience losses on liquidation. At March 31,
2011, the average time to maturity of the investments held in our portfolio was approximately six
months and the maturity of any single investment did not
18
exceed twelve months. To date we have not experienced any liquidity issues with respect to
these securities, but should such issues arise, we may be required to hold some, or all, of these
securities until maturity. We believe that, even allowing for potential liquidity issues with
respect to these securities, our remaining cash, cash equivalents, and short-term investments will
be sufficient to meet our anticipated cash needs for at least the next twelve months. Based on our
available cash and our expected operating cash requirements, we do not intend to sell these
securities and it is more likely than not that we will not be required to sell these securities
before we recover the amortized cost basis. Accordingly, we believe there are no
other-than-temporary impairments on these securities and have not recorded a provision for
impairment.
Cash flows from operating activities
Cash flows used in operating activities for the three months ended March 31, 2011 totaled
$14.9 million, which includes $3.5 million for a semi-annual interest payment on our convertible subordinated
notes, and $31.4 million of other net operating cash uses, partially offset by the receipt of $20.0
million from collaboration agreements executed in prior years. Because of the nature and timing of
certain cash receipts and payments, net cash utilization is not expected to be ratable over the
four quarters of the year. We expect cash flows used in operating activities, excluding upfront
payments received, if any, will increase throughout the remainder of 2011 compared to the same
period in 2010 as a result of increased spending on our research and development
programs.
Cash flows used in operating activities for the three months ended March 31, 2010 totaled
$34.2 million, which includes $3.5 million for a semi-annual interest payment on our convertible subordinated
notes and $30.7 million of other net operating cash uses.
Cash flows from investing activities
We purchased $3.8 million and $4.0 million of property and equipment in the three months ended
March 31, 2011 and 2010, respectively.
Cash flows from financing activities
On January 24, 2011, we completed a public offering of our common stock with proceeds of
approximately $220.4 million. As part of the public offering, we incurred approximately $0.6
million in legal and accounting fees, filing fees, and other offering expenses.
We received $2.2 million and $4.8 million, respectively, from issuances of common stock to
employees during the three months ended March 31, 2011 and 2010.
Contractual Obligations
There were no material changes during the three months ended March 31, 2011 to the summary of
contractual obligations included in our Annual Report on Form 10-K for the year ended December 31,
2010 on file with the Securities and Exchange Commission.
Off-Balance Sheet Arrangements
We do not utilize off-balance sheet financing arrangements as a source of liquidity or financing.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity with U.S. Generally Accepted Accounting Principles
(GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period.
We base our estimates on historical experience and on various other assumptions that we believe to be
reasonable under the circumstances, the results of which form our basis for making judgments about the carrying
value of assets and liabilities that are not readily apparent from other sources, and evaluate our estimates on an
ongoing basis. Actual results may differ from those estimates under different assumptions or conditions. With the
exception of the updates to the following critical accounting policies and estimates, there have been no material
changes to our critical accounting policies and estimates discussed in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2010.
On January 1, 2011, we adopted on a prospective basis Accounting Standards Update (ASU) 2009-13, which
amends the criteria to identify separate units of accounting within Subtopic 605-25, Revenue
Recognition-Multiple-Element Arrangements and we also elected to prospectively adopt ASU 2010-17, Milestone Method of
Revenue Recognition. The adoption of these standards did not impact our financial position or results of
operations as of and for the three month period ended March 31, 2011. However, the adoption of these standards
may result in revenue recognition patterns for future agreements and milestones that are materially different from
those recognized for our existing multiple-element arrangements and for milestones received prior to adoption.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures about Market Risk |
Our market risks at March 31, 2011 have not changed significantly from those discussed in Item
7A of our Annual Report on Form 10-K for the year ended December 31, 2010 on file with the
Securities and Exchange Commission.
|
|
|
Item 4. |
|
Controls and Procedures |
Disclosure Controls and Procedures
19
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Securities Exchange Act of 1934 (Exchange Act) reports is recorded,
processed, summarized, and reported within the time periods specified in the rules and forms of the
Securities and Exchange Commission, and that such information is accumulated and communicated to
management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to
allow timely decisions regarding required financial disclosure.
As of the end of the period covered by this report, we carried out an evaluation, under the
supervision and with the participation of our management, including our Chief Executive Officer and
Chief Financial Officer, of the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon, and as of the date of,
this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our
disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
We continuously seek to improve the efficiency and effectiveness of our internal controls.
This results in refinements to processes throughout the Company. However, there was no change in
our internal control over financial reporting that occurred in the three months ended March 31,
2011 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
Limitations on the Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not
expect that our disclosure controls and procedures or our internal control over financial reporting
will prevent all error and all fraud. A control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are
met. Because of the inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if any, within the
company have been detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes.
Additionally, controls can be circumvented by the individual acts of some persons, by collusion of
two or more people or by management override of the control. The design of any system of controls
also is based in part upon certain assumptions about the likelihood of future events, and there can
be no assurance that any design will succeed in achieving its stated goals under all potential
future conditions. Over time, controls may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may deteriorate. Because of the inherent
limitations in a cost-effective control system, misstatements due to error or fraud may occur and
not be detected.
Approval of Non-Audit Services
None.
PART II: OTHER INFORMATION
|
|
|
Item 1. |
|
Legal Proceedings |
Reference is hereby made to our disclosures in Legal Matters under Note 4 of the Notes to
Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q and the
information under the heading Legal Matters is incorporated by reference herein.
Investors in Nektar Therapeutics should carefully consider the risks described below
before making an investment decision. The risks described below may not be the only ones relating
to our company. This description includes any material changes to and supersedes the description of
the risk factors associated with our business previously disclosed in Item 1A of our Annual Report
on Form 10-K for the twelve months ended December 31, 2010. Additional risks that we currently
believe are immaterial may also impair our business operations. Our business, results of operation,
financial condition, cash flow and future prospects and the
trading price of our common stock and our abilities to repay our convertible notes could be
harmed as a result of any of these risks, and investors may lose all or part of their investment.
In assessing these risks, investors should also refer to the other information
20
contained or incorporated by reference in this Quarterly Report on Form 10-Q and our
Annual Report on Form 10-K for the year ended December 31, 2010, including our consolidated
financial statements and related notes, and our other filings made from time to time with the
Securities and Exchange Commission (SEC).
Risks Related to Our Business
Drug development is an inherently uncertain process with a high risk of failure at every stage of
development.
We have a number of proprietary product candidates and partnered product candidates in
research and development ranging from the early discovery research phase through preclinical
testing and clinical trials. Preclinical testing and clinical trials are long, expensive and highly
uncertain processes. It will take us, or our collaborative partners, several years to complete
clinical trials. Drug development is an uncertain scientific and medical endeavor, and failure can
unexpectedly occur at any stage of clinical development even after early preclinical or mid-stage
clinical results suggest that the drug candidate has potential as a new therapy that may benefit
patients and that health authority approval would be anticipated. Typically, there is a high rate
of attrition for product candidates in preclinical and clinical trials due to scientific
feasibility, safety, efficacy, changing standards of medical care and other variables. We or our
partners have a number of important product candidates in mid- to late-stage development, such as
Amikacin Inhale which we partnered with Bayer, NKTR-118 (oral PEGylated naloxol) and NKTR-119, which we partnered with
AstraZeneca, and NKTR-102 (topoisomerase I inhibitor-polymer conjugate). We also have an ongoing
Phase 1 clinical trial for NKTR-105 (PEGylated docetaxel) for patients with refractory solid
tumors. Any one of these trials could fail at any time, as clinical development of drug candidates
presents numerous unpredictable and significant risks and is very uncertain at all times prior to
regulatory approval by one or more health authorities in major markets.
Even with success in preclinical testing and clinical trials, the risk of clinical failure remains
high prior to regulatory approval.
A number of companies in the pharmaceutical and biotechnology industries have suffered
significant unforeseen setbacks in later stage clinical trials (i.e., Phase 2 or Phase 3 trials)
due to factors such as inconclusive efficacy results and adverse medical events, even after
achieving positive results in earlier trials that were satisfactory both to them and to reviewing
regulatory agencies. Although we announced positive preliminary Phase 2 clinical results for
NKTR-118 (oral PEGylated naloxol) in 2009, there are still substantial risks and uncertainties
associated with the outcomes of Phase 3 clinical trials and the regulatory review process even
following our partnership with AstraZeneca. While NKTR-102 (topoisomerase I inhibitor-polymer
conjugate) continues in Phase 2 clinical development for multiple cancer indications, it is
possible this product candidate could fail in one or all of the cancer indications in which it is
currently being studied due to efficacy, safety or other commercial or regulatory factors. In 2010
and in January 2011, we announced preliminary positive results from our Phase 2 trials for NKTR-102
in ovarian and breast cancer. These results were based on preliminary data only, and such results
could change based on final audit and verification procedures. In addition, the preliminary results
from the NKTR-102 clinical studies for ovarian and breast cancer are not necessarily indicative or
predictive of the future results from the completed ovarian or breast cancer trials, anticipated
Phase 3 trials in these indications or clinical trials in the other cancer indications for which we
are studying NKTR-102. There remains a significant uncertainty as to the success or failure of
NKTR-102 and whether this drug candidate will eventually receive regulatory approval or be a
commercial success even if approved by one or more health authorities in any of the cancer
indications for which it is being studied. The risk of failure is increased for our product
candidates that are based on new technologies, such as the application of our advanced polymer
conjugate technology to small molecules, including NKTR-118, NKTR-119, NKTR-102, NKTR-105 and other
drug candidates currently in the discovery research or preclinical development phases.
The results from the expanded Phase 2 clinical trial for NKTR-102 in women with
platinum-resistant/refractory ovarian cancer are unlikely to result in a review or an approval of
an NDA by the United States Food and Drug Administration (FDA), and the future results from this
trial are difficult to predict.
In 2010, we expanded the NKTR-102 Phase 2 study by 50 patients in women with
platinum-resistant/refractory ovarian cancer with the potential for us to consider an early NDA
submission after we evaluate these expanded study results. On March 1, 2011, we announced that we
intended to further expand this Phase 2 study by up to an additional 60 patients. The FDA almost
always requires a sponsor to conduct Phase 3 clinical trials prior to consideration and approval of
an NDA, and, as a result, review or approval of an NDA by the FDA based on the expanded Phase 2
study prior to completion of successful Phase 3 clinical studies, if such NDA is submitted, would
be unusual and is highly unlikely. In February 2011, the FDA held a public meeting with the
Oncology Drug Products Advisory Committee and certain representatives from pharmaceutical companies
to examine the outcomes, requirements, and prerequisites for accelerated approval of oncology
drugs. The FDA requirements for accelerated approval are very stringent and also remain very
uncertain and difficult to predict. Further, this expansion of our Phase 2 study will necessarily
change the final
21
efficacy (e.g., overall response rates, progression-free survival, overall survival) and
safety (i.e., frequency and severity of serious adverse events) results, and, accordingly, the
final results in this study remain subject to substantial change and could be materially and
adversely different from previously announced results. If the clinical studies for NKTR-102 in
women with platinum-resistant/refractory ovarian cancer are not successful, it could significantly
harm our business, results of operations and financial condition.
We may not be able to obtain intellectual property licenses related to the development of our
technology on a commercially reasonable basis, if at all.
Numerous pending and issued U.S. and foreign patent rights and other proprietary rights owned
by third parties relate to pharmaceutical compositions, medical devices and equipment and methods
for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any
certainty which, if any, patent references will be considered relevant to our or our collaborative
partners technology or drug candidates by authorities in the various jurisdictions where such
rights exist, nor can we predict with certainty which, if any, of these rights will or may be
asserted against us by third parties. In certain cases, we have existing licenses or cross-licenses
with third parties, however the scope and adequacy of these licenses is very uncertain and can
change substantially during long development and commercialization cycles for biotechnology and
pharmaceutical products. There can be no assurance that we can obtain a license to any technology
that we determine we need on reasonable terms, if at all, or that we could develop or otherwise
obtain alternate technology. If we are required to enter into a license with a third party, our
potential economic benefit for the products subject to the license will be diminished. If a license
is not available on commercially reasonable terms or at all, our business, results of operations,
and financial condition could be significantly harmed and we may be prevented from developing and
selling the product.
If any of our pending patent applications do not issue, or are deemed invalid following issuance,
we may lose valuable intellectual property protection.
The patent positions of pharmaceutical, medical device and biotechnology companies, such as
ours, are uncertain and involve complex legal and factual issues. We own greater than 100 U.S. and
380 foreign patents and a number of pending patent applications that cover various aspects of our
technologies. We have filed patent applications, and plan to file additional patent applications,
covering various aspects of our PEGylation and advanced polymer conjugate technologies and our
proprietary product candidates. There can be no assurance that patents that have issued will be
valid and enforceable or that patents for which we apply will issue with broad coverage, if at all.
The coverage claimed in a patent application can be significantly reduced before the patent is
issued and, as a consequence, our patent applications may result in patents with narrow coverage
that may not prevent competition from similar products or generics. Since publication of
discoveries in scientific or patent literature often lags behind the date of such discoveries, we
cannot be certain that we were the first inventor of inventions covered by our patents or patent
applications. As part of the patent application process, we may have to participate in interference
proceedings declared by the U.S. Patent and Trademark Office, which could result in substantial
cost to us, even if the eventual outcome is favorable. Further, an issued patent may undergo
further proceedings to limit its scope so as not to provide meaningful protection and any claims
that have issued, or that eventually issue, may be circumvented or otherwise invalidated. Any
attempt to enforce our patents or patent application rights could be time consuming and costly. An
adverse outcome could subject us to significant liabilities to third parties, require disputed
rights to be licensed from or to third parties or require us to cease using the technology in
dispute. Even if a patent is issued and enforceable, because development and commercialization of
pharmaceutical products can be subject to substantial delays, patents may expire early and provide
only a short period of protection, if any, following commercialization of related products.
There are many laws, regulations and judicial decisions that dictate and otherwise influence
the manner in which patent applications are filed and prosecuted and in which patents are granted
and enforced. Changes to these laws, regulations and judicial decisions are subject to influences
outside of our control and may negatively affect our business, including our ability to obtain
meaningful patent coverage or enforcement rights to any of our issued patents. New laws,
regulations and judicial decisions may be retroactive in effect, potentially reducing or
eliminating our ability to implement our patent-related strategies. Changes to laws, regulations
and judicial decisions that affect our business are often difficult or impossible to foresee, which
limits our ability to adequately adapt our patent strategies to these changes.
If we or our partners are not able to manufacture drugs or drug substances in quantities and at
costs that are commercially feasible, we may fail to meet our contractual obligations or our
proprietary and partnered product candidates may experience clinical delays or constrained
commercial supply which could significantly harm our business.
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If we are not able to scale-up manufacturing to meet the drug quantities required to support
large clinical trials or commercial manufacturing in a timely manner or at a commercially
reasonable cost, we risk delaying our clinical trials or those of our partners and may breach
contractual obligations and incur associated damages and costs, and reduce or even eliminate
associated revenues. In some cases, we may subcontract manufacturing or other services.
Pharmaceutical manufacturing involves significant risks and uncertainties related to the
demonstration of adequate stability, sufficient purification of the drug substance and drug
product, the identification and elimination of impurities, optimal formulations, process
validation, and challenges in controlling for all of these factors during manufacturing scale-up
for large clinical trials and commercial manufacturing and supply. In addition, we have faced and
may in the future face significant difficulties, delays and unexpected expenses as we validate
third party contract manufacturers required for scale-up to clinical or commercial quantities.
Failure to manufacture products in quantities or at costs that are commercially feasible could
cause us not to meet our supply requirements, contractual obligations or other requirements for our
proprietary product candidates and, as a result, would significantly harm our business, results of
operations and financial condition.
For instance, we entered a service agreement with Novartis pursuant to which we subcontract to
Novartis certain important services to be performed in relation to our partnered program for
Amikacin Inhale with Bayer Healthcare LLC. If our subcontractors do not dedicate adequate resources
to our programs, we risk breach of our obligations to our partners. Building and validating large
scale clinical or commercial-scale manufacturing facilities and processes, recruiting and training
qualified personnel and obtaining necessary regulatory approvals is complex, expensive and time
consuming. In the past we have encountered challenges in scaling up manufacturing to meet the
requirements of large scale clinical trials without making modifications to the drug formulation,
which may cause significant delays in clinical development. Further, our drug and device
combination products, such as Amikacin Inhale and the Cipro Inhale program, require significant
device design, formulation development work and manufacturing scale-up activities. We have
experienced repeated significant delays in starting the Phase 3 clinical development program for
Amikacin Inhale as we seek to finalize the device design with a demonstrated capability to be
manufactured at commercial scale. This work is ongoing and there remains significant risk in
finalizing the device until those activities are completed. Drug/device combination products are
particularly complex, expensive and time-consuming to develop due to the number of variables
involved in the final product design, including ease of patient/doctor use, maintenance of clinical
efficacy, reliability and cost of manufacturing, regulatory approval requirements and standards and
other important factors. There continues to be substantial and unpredictable risk and uncertainty
related to manufacturing and supply until such time as the commercial supply chain is validated and
proven.
We will need to restructure our convertible notes or raise substantial additional capital to repay
the notes and fund operations, and we may be unable to restructure the notes or raise such capital
when needed and on acceptable terms.
We have $215.0 million in outstanding convertible subordinated notes due September 2012. We do
not have sufficient resources to fund the development of the drug candidates in our current
research and development pipeline, complete late stage clinical development of NKTR-102 and repay
these convertible notes. We have no material credit facility or other material committed sources of
capital. We expect the Phase 3 clinical trials of NKTR-102 to require particularly significant
resources because we anticipate bearing a majority or all of the development costs for that drug
candidate. Prior to the maturity of the notes, we plan to explore a number of alternatives to
provide for the repayment of the notes, including restructuring the notes. Despite these efforts,
we may be unable to find a commercially acceptable alternative or any alternative to repaying the
notes by September 2012. Our future capital requirements will depend upon numerous factors,
including:
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the progress, timing, cost and results of our clinical development programs, including
our clinical development of NKTR-102; |
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patient enrollment in our current and future clinical studies, including clinical
development of NKTR-102; |
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whether and when we receive potential milestone payments and royalties, particularly from
the product candidates that are subject to our collaboration agreements with AstraZeneca for
NKTR-118 and Bayer for Amikacin Inhale; |
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the success, progress, timing and costs of our business development efforts to implement
new business collaborations, licenses and other strategic transactions; |
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the cost, timing and outcomes of regulatory reviews of our product candidates (e.g.,
NKTR-102) and those of our collaboration partners (e.g., NKTR-118, Amikacin Inhale); |
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our general and administrative expenses, capital expenditures and other uses of cash; |
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disputes concerning patents, proprietary rights, or license and collaboration agreements; |
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the availability and scope of coverage from government and private insurance payment or
reimbursement for our drug candidates partnered with collaboration partners and any future
drug candidates that may receive regulatory approval in the future; and |
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the size, design (i.e., primary and secondary endpoints) and number of clinical studies
required by the government health authorities in order to consider for approval our product
candidates and those of our collaboration partners. |
Although we believe that our cash, cash equivalents and short-term investments in marketable
securities of $518.6 million as of March 31, 2011 will be sufficient to meet our liquidity
requirements through at least the next 12 months, we will likely need to restructure our notes or
obtain additional funds through one or more financing or collaboration partnership transactions. If
adequate funds are not available or are not available on acceptable terms when we need them, we may
need to delay or reduce one or more of our Phase 3 clinical trials of NKTR-102 or otherwise make
changes to our operations to cut costs.
If we are unable either to create sales, marketing and distribution capabilities or to enter into
agreements with third parties to perform these functions, we will be unable to commercialize our
products successfully.
We currently have no sales, marketing or distribution capabilities. To commercialize any of
our products that receive regulatory approval for commercialization, we must either develop
internal sales, marketing and distribution capabilities, which would be expensive and time
consuming, or enter into collaboration arrangements with third parties to perform these services.
If we decide to market our products directly, we must commit significant financial and managerial
resources to develop a marketing and sales force with technical expertise and with supporting
distribution, administration and compliance capabilities. Factors that may inhibit our efforts to
commercialize our products directly or indirectly with our partners include:
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our inability to recruit and retain adequate numbers of effective sales and marketing
personnel; |
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the inability of sales personnel to obtain access to or persuade adequate numbers of
physicians to use or prescribe our products; |
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the lack of complementary products or multiple product pricing arrangements may put us at
a competitive disadvantage relative to companies with more extensive product lines; and |
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unforeseen costs and expenses associated with creating and sustaining an independent
sales and marketing organization. |
If we, or our partners through our collaboration, are not successful in recruiting sales and
marketing personnel or in building a sales and marketing infrastructure, we will have difficulty
commercializing our products, which would adversely affect our business, results of operations and
financial condition.
To the extent we rely on other pharmaceutical or biotechnology companies with established sales,
marketing and distribution systems to market our products, we will need to establish and maintain
partnership arrangements, and we may not be able to enter into these arrangements on acceptable
terms or at all. To the extent that we enter into co-promotion or other arrangements, any revenues
we receive will depend upon the efforts of third parties, which may not be successful and are only
partially in our control. In the event that we market our products without a partner, we would be
required to build a sales and marketing organization and infrastructure, which would require a
significant investment and we may not be successful in building this organization and
infrastructure in a timely or efficient manner.
If we are unable to establish and maintain collaboration partnerships on attractive commercial
terms, our business, results of operations and financial condition could suffer.
We intend to continue to seek partnerships with pharmaceutical and biotechnology partners to
fund a portion of our research and development expenses and develop and commercialize certain of our product
candidates. In September 2009, we entered into a license agreement with AstraZeneca for NKTR-118
and NKTR-119 which included an upfront payment of $125.0 million.
The timing of new collaboration partnerships is difficult to predict
due to availability of clinical data, the number of potential partners that need to complete due
diligence and approval processes, the definitive agreement negotiation process and numerous other
unpredictable factors that can delay, impede or prevent significant transactions. If we are unable
to find suitable partners or to negotiate collaborative arrangements with favorable commercial
terms with respect to our existing and future product candidates or the licensing of our
technology, or if any arrangements we negotiate, or have negotiated, are terminated, our business,
results of operations and financial condition could suffer.
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The commercial potential of a drug candidate in development is difficult to predict and if the
market size for a new drug is significantly smaller than we anticipate, it could significantly and
negatively impact our revenue, results of operations and financial condition.
It is very difficult to estimate the commercial potential of product candidates due to factors
such as safety and efficacy compared to other available treatments, including potential generic
drug alternatives with similar efficacy profiles, changing standards of care, third party payer
reimbursement, patient and physician preferences, the availability of competitive alternatives that
may emerge either during the long drug development process or after commercial introduction, and
the availability of generic versions of our successful product candidates following approval by
health authorities based on the expiration of regulatory exclusivity or our inability to prevent
generic versions from coming to market in one or more geographies by the assertion of one or more
patents covering such approved drug. If due to one or more of these risks the market potential for
a product candidate is lower than we anticipated, it could significantly and negatively impact the
commercial terms of any collaboration partnership potential for such product candidate or, if we
have already entered into a collaboration for such drug candidate, the revenue potential from
royalty and milestone payments could be significantly diminished and would negatively impact our
revenue, results of operations and financial condition.
Our revenue is exclusively derived from our collaboration agreements, which can result in
significant fluctuation in our revenue from period to period, and our past revenue is therefore
not necessarily indicative of our future revenue.
Our revenue is derived from our collaboration agreements with partners, under which we may
receive contract research payments, milestone payments based on clinical progress, regulatory
progress or net sales achievements, royalties or manufacturing revenue. Significant variations in
the timing of receipt of cash payments and our recognition of revenue can result from the nature of
significant milestone payments based on the execution of new collaboration agreements, the timing
of clinical, regulatory or sales events which result in single milestone payments and the timing
and success of the commercial launch of new drugs by our collaboration partners. The amount of our
revenue derived from collaboration agreements in any given period will depend on a number of
unpredictable factors, including our ability to find and maintain suitable collaboration partners,
the timing of the negotiation and conclusion of collaboration agreements with such partners,
whether and when we or our partner achieve clinical and sales milestones, whether the partnership
is exclusive or whether we can seek other partners, the timing of regulatory approvals in one or
more major markets and the market introduction of new drugs or generic versions of the approved
drug, as well as other factors.
If our partners, on which we depend to obtain regulatory approvals for and to commercialize our
partnered products, are not successful, or if such collaborations fail, the development or
commercialization of our partnered products may be delayed or unsuccessful.
When we sign a collaborative development agreement or license agreement to develop a product
candidate with a pharmaceutical or biotechnology company, the pharmaceutical or biotechnology
company is generally expected to:
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design and conduct large scale clinical studies; |
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prepare and file documents necessary to obtain government approvals to sell a given
product candidate; and/or |
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market and sell our products when and if they are approved. |
Our reliance on collaboration partners poses a number of risks to our business, including
risks that:
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we may be unable to control whether, and the extent to which, our partners devote
sufficient resources to the development programs or commercial marketing and sales efforts; |
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disputes may arise or escalate in the future with respect to the ownership of rights to
technology or intellectual property developed with partners; |
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disagreements with partners could lead to delays in, or termination of, the research,
development or commercialization of product candidates or to litigation or arbitration
proceedings; |
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contracts with our partners may fail to provide us with significant protection, or to be
effectively enforced, in the event one of our partners fails to perform; |
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partners have considerable discretion in electing whether to pursue the development of
any additional product candidates and may pursue alternative technologies or products either
on their own or in collaboration with our competitors; |
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partners with marketing rights may choose to devote fewer resources to the marketing of
our partnered products than they do to products of their own development or products
in-licensed from other third parties; |
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the timing and level of resources that our partners dedicate to the development program
will affect the timing and amount of revenue we receive; |
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we do not have the ability to unilaterally terminate agreements (or partners may have
extension or renewal rights) that we believe are not on commercially reasonable terms or
consistent with our current business strategy; |
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partners may be unable to pay us as expected; and |
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partners may terminate their agreements with us unilaterally for any or no reason, in
some cases with the payment of a termination fee penalty and in other cases with no
termination fee penalty. |
Given these risks, the success of our current and future partnerships is highly unpredictable
and can have a substantial negative or positive impact on our business. We have entered into
collaborations in the past that have been subsequently terminated, such as our collaboration with
Pfizer for the development and commercialization of inhaled insulin that was terminated by Pfizer
in November 2007. If other collaborations are suspended or terminated, our ability to commercialize
certain other proposed product candidates could also be negatively impacted. If our collaborations
fail, our product development or commercialization of product candidates could be delayed or
cancelled, which would negatively impact our business, results of operations and financial
condition.
If we or our partners do not obtain regulatory approval for our product candidates on a timely
basis, or at all, or if the terms of any approval impose significant restrictions or limitations
on use, our business, results of operations and financial condition will be negatively affected.
We or our partners may not obtain regulatory approval for product candidates on a timely basis, or
at all, or the terms of any approval (which in some countries includes pricing approval) may impose
significant restrictions or limitations on use. Product candidates must undergo rigorous animal and
human testing and an extensive FDA mandated or equivalent foreign authorities review process for
safety and efficacy. This process generally takes a number of years and requires the expenditure of
substantial resources. The time required for completing testing and obtaining approvals is
uncertain, and the FDA and other U.S. and foreign regulatory agencies have substantial discretion,
at any phase of development, to terminate clinical trials, require additional clinical development
or other testing, delay or withhold registration and marketing approval and mandate product
withdrawals, including recalls. In addition, undesirable side effects caused by our product
candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and
could result in a more restricted label or the delay or denial of regulatory approval by regulatory
authorities.
Even if we or our partners receive regulatory approval of a product, the approval may limit
the indicated uses for which the product may be marketed. Our partnered products that have obtained
regulatory approval, and the manufacturing processes for these products, are subject to continued
review and periodic inspections by the FDA and other regulatory authorities. Discovery from such
review and inspection of previously unknown problems may result in restrictions on marketed
products or on us, including withdrawal or recall of such products from the market, suspension of
related manufacturing operations or a more restricted label. The failure to obtain timely
regulatory approval of product candidates, any product marketing limitations or a product
withdrawal would negatively impact our business, results of operations and financial condition.
We are a party to numerous collaboration agreements and other significant agreements which contain
complex commercial terms that could result in disputes, litigation or indemnification liability
that could adversely affect our business, results of operations and financial condition.
We currently derive, and expect to derive in the foreseeable future, all of our revenue from
collaboration agreements with biotechnology and pharmaceutical companies. These collaboration
agreements contain complex commercial terms, including:
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clinical development and commercialization obligations that are based on certain
commercial reasonableness performance standards that can often be difficult to enforce if
disputes arise as to adequacy of performance; |
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research and development performance and reimbursement obligations for our personnel and
other resources allocated to partnered product development programs; |
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clinical and commercial manufacturing agreements, some of which are priced on an actual
cost basis for products supplied by us to our partners with complicated cost allocation
formulas and methodologies; |
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intellectual property ownership allocation between us and our partners for improvements
and new inventions developed during the course of the partnership; |
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royalties on end product sales based on a number of complex variables, including net
sales calculations, geography, patent life, generic competitors, and other factors; and |
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indemnity obligations for third-party intellectual property infringement, product
liability and certain other claims. |
On September 20, 2009, we entered into a worldwide exclusive license agreement with
AstraZeneca for the further development and commercialization of NKTR-118 and NKTR-119. In
addition, we have also entered into complex commercial agreements with Novartis in connection with
the sale of certain assets related to our pulmonary business, associated technology and
intellectual property to Novartis (the Novartis Pulmonary Asset Sale), which was completed on
December 31, 2008. As part of the Novartis Pulmonary Asset Sale, we entered an exclusive license
agreement with Novartis Pharma pursuant to which Novartis Pharma grants back to us an exclusive,
irrevocable, perpetual, royalty-free and worldwide license under certain specific patent rights and
other related intellectual property rights necessary for us to satisfy certain continuing
contractual obligations to third parties, including in connection with development, manufacture,
sale and commercialization activities related to our partnered program for Amikacin Inhale with
Bayer. We also entered into a service agreement pursuant to which we have
subcontracted to Novartis certain services to be performed related to our partner program for
Amikacin Inhale. Our agreements with AstraZeneca and Novartis contain complex representations and
warranties, covenants and indemnification obligations that could result in substantial future
liability and harm our financial condition if we breach any of our agreements with AstraZeneca or
Novartis or any third party agreements impacted by these complex transactions.
From time to time, we have informal dispute resolution discussions with third parties
regarding the appropriate interpretation of the complex commercial terms contained in our
agreements. One or more disputes may arise or escalate in the future regarding our collaboration
agreements, transaction documents, or third-party license agreements that may ultimately result in
costly litigation and unfavorable interpretation of contract terms, which would have a material
adverse impact on our business, results of operations or financial condition.
We purchase some of the starting material for drugs and drug candidates from a single source or a
limited number of suppliers, and the partial or complete loss of one of these suppliers could
cause production delays, clinical trial delays, substantial loss of revenue and contract liability
to third parties.
We often face very limited supply of a critical raw material that can only be obtained from a
single, or a limited number of, suppliers, which could cause production delays, clinical trial
delays, substantial lost revenue opportunity or contract liability to third parties. For example,
there are only a limited number of qualified suppliers, and in some cases single source suppliers,
for the raw materials included in our PEGylation and advanced polymer conjugate drug formulations,
and any interruption in supply or failure to procure such raw materials on commercially feasible
terms could harm our business by delaying our clinical trials, impeding commercialization of
approved drugs or increasing our costs to the extent we cannot pass on increased costs to a
manufacturing customer.
We rely on trade secret protection and other unpatented proprietary rights for important
proprietary technologies, and any loss of such rights could harm our business, results of
operations and financial condition.
We rely on trade secret protection for our confidential and proprietary information. No
assurance can be given that others will not independently develop substantially equivalent
confidential and proprietary information or otherwise gain access to our trade secrets or disclose
such technology, or that we can meaningfully protect our trade secrets. In addition, unpatented
proprietary rights, including trade secrets and know-how, can be difficult to protect and may lose
their value if they are independently developed by a third party or
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if their secrecy is lost. Any loss of trade secret protection or other unpatented proprietary
rights could harm our business, results of operations and financial condition.
We expect to continue to incur substantial losses and negative cash flow from operations and may
not achieve or sustain profitability in the future.
For the year ended December 31, 2010 and the three months ended March 31, 2011, we reported a
net loss of $37.9 million and $36.0 million, respectively. If and when we achieve profitability
depends upon a number of factors, including the timing and recognition of milestone payments and
royalties received, the timing of revenue under our collaboration agreements, the amount of
investments we make in our proprietary product candidates and the regulatory approval and market
success of our product candidates. We may not be able to achieve and sustain profitability.
Other factors that will affect whether we achieve and sustain profitability include our
ability, alone or together with our partners, to:
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develop products utilizing our technologies, either independently or in collaboration
with other pharmaceutical or biotech companies; |
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effectively estimate and manage clinical development costs, particularly the cost of
NKTR-102 since we expect to bear a majority or all of such costs; |
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receive necessary regulatory and marketing approvals; |
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maintain or expand manufacturing at necessary levels; |
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achieve market acceptance of our partnered products; |
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receive royalties on products that have been approved, marketed or submitted for
marketing approval with regulatory authorities; and |
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maintain sufficient funds to finance our activities. |
If we do not generate sufficient cash through raising additional capital and do not restructure
our convertible notes, we may be unable to meet our substantial debt obligations.
As of March 31, 2011, we had cash, cash equivalents, and short-term investments in marketable
securities valued at approximately $518.6 million and indebtedness of approximately $240.6 million,
including approximately $215.0 million in convertible subordinated notes due September 2012, $18.5
million in capital lease obligations, and $7.1 million of other liabilities.
Our substantial indebtedness has and will continue to impact us by:
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making it more difficult to obtain additional financing; |
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constraining our ability to react quickly in an unfavorable economic climate; |
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constraining our stock price; and |
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constraining our ability to invest in our research and development programs. |
Currently, we are not generating positive cash flow. If we are unable to satisfy our debt
service requirements, substantial liquidity problems could result. In relation to our convertible
notes, since the market price of our common stock is significantly below the conversion price, the
holders of our outstanding convertible notes are unlikely to convert the notes to common stock in
accordance with the existing terms of the notes. If we do not generate sufficient cash from
operations to repay principal or interest on our remaining convertible notes, or satisfy any of our
other debt obligations, when due, we may have to raise additional funds from the issuance of equity
or debt securities or entry into collaboration partnerships or otherwise restructure our
obligations. Any such
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financing or restructuring may not be available to us on commercially acceptable terms, if at
all.
If government and private insurance programs do not provide payment or reimbursement for our
partnered products or proprietary products, those products will not be widely accepted, which
would have a negative impact on our business, results of operations and financial condition.
In both domestic and foreign markets, sales of our partnered and proprietary products that
have received regulatory approval will depend in part on market acceptance among physicians and
patients, pricing approvals by government authorities and the availability of payment or
reimbursement from third-party payers, such as government health administration authorities,
managed care providers, private health insurers and other organizations. Such third-party payers
are increasingly challenging the price and cost effectiveness of medical products and services.
Therefore, significant uncertainty exists as to the pricing approvals for, and the payment or
reimbursement status of, newly approved healthcare products. Moreover, legislation and regulations
affecting the pricing of pharmaceuticals may change before regulatory agencies approve our proposed
products for marketing and could further limit pricing approvals for, and reimbursement of, our
products from government authorities and third-party payers. A government or third-party payer
decision not to approve pricing for, or provide adequate coverage and reimbursements of, our
products would limit market acceptance of such products.
We depend on third parties to conduct the clinical trials for our proprietary product candidates
and any failure of those parties to fulfill their obligations could harm our development and
commercialization plans.
We depend on independent clinical investigators, contract research organizations and other
third-party service providers to conduct clinical trials for our proprietary product candidates. We
rely heavily on these parties for successful execution of our clinical trials. Though we are
ultimately responsible for the results of their activities, many aspects of their activities are
beyond our control. For example, we are responsible for ensuring that each of our clinical trials
is conducted in accordance with the general investigational plan and protocols for the trial, but
the independent clinical investigators may prioritize other projects over ours or communicate
issues regarding our products to us in an untimely manner. Third parties may not complete
activities on schedule or may not conduct our clinical trials in accordance with regulatory
requirements or our stated protocols. The early termination of any of our clinical trial
arrangements, the failure of third parties to comply with the regulations and requirements
governing clinical trials or our reliance on results of trials that we have not directly conducted
or monitored could hinder or delay the development, approval and commercialization of our product
candidates and would adversely affect our business, results of operations and financial condition.
Our manufacturing operations and those of our contract manufacturers are subject to governmental
regulatory requirements, which, if not met, would have a material adverse effect on our business,
results of operations and financial condition.
We and our contract manufacturers are required in certain cases to maintain compliance with
current good manufacturing practices (cGMP), including cGMP guidelines applicable to active
pharmaceutical ingredients, and are subject to inspections by the FDA or comparable agencies in
other jurisdictions to confirm such compliance. We anticipate periodic regulatory inspections of
our drug manufacturing facilities and the manufacturing facilities of our contract manufacturers
for compliance with applicable regulatory requirements. Any failure to follow and document our or
our contract manufacturers adherence to such cGMP regulations or satisfy other manufacturing and
product release regulatory requirements may disrupt our ability to meet our manufacturing
obligations to our customers, lead to significant delays in the availability of products for
commercial use or clinical study, result in the termination or hold on a clinical study or delay or
prevent filing or approval of marketing applications for our products. Failure to comply with
applicable regulations may also result in sanctions being imposed on us, including fines,
injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our
products, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of
products, operating restrictions and criminal prosecutions, any of which could harm our business.
The results of these inspections could result in costly manufacturing changes or facility or
capital equipment upgrades to satisfy the FDA that our manufacturing and quality control procedures
are in substantial compliance with cGMP. Manufacturing delays, for us or our contract
manufacturers, pending resolution of regulatory deficiencies or suspensions would have a material
adverse effect on our business, results of operations and financial condition.
Significant competition for our polymer conjugate chemistry technology platforms and our partnered
and proprietary products and product candidates could make our technologies, products or product
candidates obsolete or uncompetitive, which would negatively impact our business, results of
operations and financial condition.
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Our PEGylation and advanced polymer conjugate chemistry platforms and our partnered and
proprietary products and product candidates compete with various pharmaceutical and biotechnology
companies. Competitors of our PEGylation and polymer conjugate chemistry technologies include The
Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Mountain View
Pharmaceuticals, Inc., Novo Nordisk A/S (formerly assets held by Neose Technologies, Inc.), and NOF
Corporation. Several other chemical, biotechnology and pharmaceutical companies may also be
developing PEGylation technologies or technologies that have similar impact on target drug
molecules. Some of these companies license or provide the technology to other companies, while
others are developing the technology for internal use.
There are several competitors for our proprietary product candidates currently in development.
For Amikacin Inhale, the current standard of care includes several approved intravenous antibiotics
for the treatment of either hospital-acquired pneumonia or ventilator-associated pneumonia in
patients on mechanical ventilators. For NKTR-118 (oral PEGylated naloxol), there are currently
several alternative therapies used to address opioid-induced constipation (OIC) and opioid-induced
bowel dysfunction (OBD), including subcutaneous Relistor® (methylnaltrexone bromide) and oral and
rectal over-the-counter laxatives and stool softeners such as docusate sodium, senna and milk of
magnesia. In addition, there are a number of companies developing potential products which are in
various stages of clinical development and are being evaluated for the treatment of OIC and OBD in
different patient populations, including Adolor Corporation, GlaxoSmithKline plc, Progenics
Pharmaceuticals, Inc. in collaboration with Salix Pharmaceuticals, Ltd., Mundipharma Int. Limited,
Sucampo Pharmaceuticals, Alkermes, Inc. and Takeda Pharmaceutical Company Limited. For NKTR-102
(topoisomerase I inhibitor-polymer conjugate), there are a number of chemotherapies and cancer
therapies approved today and in various stages of clinical development for ovarian and breast
cancers including but not limited to: Avastin® (bevacizumab), Camptosar® (irinotecan), Doxil®
(doxorubicin HCl), Ellence® (epirubicin), Gemzar® (gemcitabine), Herceptin® (trastuzumab),
Hycamtin® (topotecan), Iniparib, Paraplatin® (carboplatin), and Taxol® (paclitaxel). Major
pharmaceutical or biotechnology companies with approved drugs or drugs in development for these
cancers include Bristol-Meyers Squibb, Eli Lilly & Co., Roche, GlaxoSmithKline plc, Johnson and
Johnson, Pfizer, Inc., Sanofi Aventis, and many others. There are approved therapies for the
treatment of colorectal cancer, including Eloxatin® (oxaliplatin), Camptosar® (irinotecan),
Avastin® (bevacizumab), Erbitux® (cetuximab), Vectibix® (panitumumab), Xeloda® (capecitabine),
Adrucil® (fluorouracil), and Wellcovorin ® (leucovorin). In addition, there are a number of drugs
in various stages of preclinical and clinical development from companies exploring cancer therapies
or improved chemotherapeutic agents to potentially treat colorectal cancer, including, but not
limited to, products in development from Bristol-Myers Squibb Company, Pfizer, Inc.,
GlaxoSmithKline plc, Antigenics, Inc., F. Hoffmann-La Roche Ltd, Novartis AG, Cell Therapeutics,
Inc., Neopharm Inc., Meditech Research Ltd, Alchemia Limited, Enzon Pharmaceuticals, Inc. and
others.
There can be no assurance that we or our partners will successfully develop, obtain regulatory
approvals for and commercialize next-generation or new products that will successfully compete with
those of our competitors. Many of our competitors have greater financial, research and development,
marketing and sales, manufacturing and managerial capabilities. We face competition from these
companies not just in product development but also in areas such as recruiting employees, acquiring
technologies that might enhance our ability to commercialize products, establishing relationships
with certain research and academic institutions, enrolling patients in clinical trials and seeking
program partnerships and collaborations with larger pharmaceutical companies. As a result, our
competitors may succeed in developing competing technologies, obtaining regulatory approval or
gaining market acceptance for products before we do. These developments could make our products or
technologies uncompetitive or obsolete.
We could be involved in legal proceedings and may incur substantial litigation costs and
liabilities that will adversely affect our business, results of operations and financial
condition.
From time to time, third parties have asserted, and may in the future assert, that we or our
partners infringe their proprietary rights, such as patents and trade secrets, or have otherwise
breached our obligations to them. The third party often bases its assertions on a claim that its
patents cover our technology or that we have misappropriated its confidential or proprietary
information. Similar assertions of infringement could be based on future patents that may issue to
third parties. In certain of our agreements with our partners, we are obligated to indemnify and
hold harmless our partners from intellectual property infringement, product liability and certain
other claims, which could cause us to incur substantial costs if we are called upon to defend
ourselves and our partners against any claims. If a third party obtains injunctive or other
equitable relief against us or our partners, they could effectively prevent us, or our partners,
from developing or commercializing, or deriving revenue from, certain products or product
candidates in the U.S. and abroad. For instance, F. Hoffmann-La Roche Ltd, to which we license our
proprietary PEGylation reagent for use in the MIRCERA product, was a party to a significant patent
infringement lawsuit brought by Amgen Inc. related to Roches proposed marketing and sale of
MIRCERA to treat chemotherapy anemia in the U.S. In October 2008, a federal court ruled in favor of
Amgen, issuing a
30
permanent injunction preventing Roche from marketing or selling MIRCERA in the U.S. In
December 2009, the U.S. District court for the District of Massachusetts entered a final judgment
and permanent injunction, and Roche and Amgen entered into a settlement and limited license
agreement which allows Roche to begin selling MIRCERA in the U.S. in July 2014.
Third-party claims involving proprietary rights or other matters could also result in the
award of substantial damages to be paid by us or a settlement resulting in significant payments to
be made by us. For instance, a settlement might require us to enter a license agreement under which
we pay substantial royalties or other compensation to a third party, diminishing our future
economic returns from the related product. In 2006, we entered into a litigation settlement related
to an intellectual property dispute with the University of Alabama in Huntsville pursuant to which
we paid $11.0 million and agreed to pay an additional $10.0 million in equal $1.0 million
installments over ten years ending with the last payment due on July 1, 2016. We cannot predict
with certainty the eventual outcome of any pending or future litigation. Costs associated with such
litigation, substantial damage claims, indemnification claims or royalties paid for licenses from
third parties could have a material adverse effect on our business, results of operations and
financial condition.
If product liability lawsuits are brought against us, we may incur substantial liabilities.
The manufacture, clinical testing, marketing and sale of medical products involve inherent
product liability risks. If product liability costs exceed our product liability insurance
coverage, we may incur substantial liabilities that could have a severe negative impact on our
financial position. Whether or not we are ultimately successful in any product liability
litigation, such litigation would consume substantial amounts of our financial and managerial
resources and might result in adverse publicity, all of which would impair our business.
Additionally, 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.
Our future depends on the proper management of our current and future business operations and
their associated expenses.
Our business strategy requires us to manage our business to provide for the continued
development and potential commercialization of our proprietary and partnered product candidates.
Our strategy also calls for us to undertake increased research and development activities and to
manage an increasing number of relationships with partners and other third parties, while
simultaneously managing the expenses generated by these activities. Our decision to bear a majority
or all of the clinical development costs of NKTR-102 substantially increases our expenses. If we
are unable to manage effectively our current operations and any growth we may experience, our
business, financial condition and results of operations may be adversely affected. If we are unable
to effectively manage our expenses, we may find it necessary to reduce our personnel-related costs
through further reductions in our workforce, which could harm our operations, employee morale and
impair our ability to retain and recruit talent. Furthermore, if adequate funds are not available,
we may be required to obtain funds through arrangements with partners or other sources that may
require us to relinquish rights to certain of our technologies, products or future economic rights
that we would not otherwise relinquish or require us to enter into other financing arrangements on
unfavorable terms.
We are dependent on our management team and key technical personnel, and the loss of any key
manager or employee may impair our ability to develop our products effectively and may harm our
business, operating results and financial condition.
Our success largely depends on the continued services of our executive officers and other key
personnel. The loss of one or more members of our management team or other key employees could
seriously harm our business, operating results and financial condition. The relationships that our
key managers have cultivated within our industry make us particularly dependent upon their
continued employment with us. We are also dependent on the continued services of our technical
personnel because of the highly technical nature of our products and the regulatory approval
process. Because our executive officers and key employees are not obligated to provide us with
continued services, they could terminate their employment with us at any time without penalty. We
do not have any post-employment noncompetition agreements with any of our employees and do not
maintain key person life insurance policies on any of our executive officers or key employees.
Because competition for highly qualified technical personnel is intense, we may not be able to
attract and retain the personnel we need to support our operations and growth.
We must attract and retain experts in the areas of clinical testing, manufacturing,
regulatory, finance, marketing and distribution and develop additional expertise in our existing
personnel. In particular, additional highly
qualified personnel will be required for late stage development of NKTR-102. We face intense competition from other biopharmaceutical
companies, research and academic institutions and other organizations for qualified personnel. Many
of the organizations with which we compete for qualified personnel have greater resources than we
have. Because competition for skilled personnel in our industry is intense, companies such
31
as ours sometimes experience high attrition rates with regard to their skilled employees.
Further, in making employment decisions, job candidates often consider the value of the stock
options they are to receive in connection with their employment. Our equity incentive plan and
employee benefit plans may not be effective in motivating or retaining our employees or attracting
new employees, and significant volatility in the price of our stock may adversely affect our
ability to attract or retain qualified personnel. If we fail to attract new personnel or to retain
and motivate our current personnel, our business and future growth prospects could be severely
harmed.
If earthquakes and other catastrophic events strike, our business may be harmed.
Our corporate headquarters, including a substantial portion of our research and development
operations, are located in the San Francisco Bay Area, a region known for seismic activity and a
potential terrorist target. In addition, we own facilities for the manufacture of products using
our PEGylation and advanced polymer conjugate technologies in Huntsville, Alabama and own and lease
offices in Hyderabad, India. There are no backup facilities for our manufacturing operations
located in Huntsville, Alabama. In the event of an earthquake or other natural disaster, political
instability, or terrorist event in any of these locations, our ability to manufacture and supply
materials for drug candidates in development and our ability to meet our manufacturing obligations
to our customers would be significantly disrupted and our business, results of operations and
financial condition would be harmed. Our collaborative partners may also be subject to catastrophic
events, such as hurricanes and tornadoes, any of which could harm our business, results of
operations and financial condition. We have not undertaken a systematic analysis of the potential
consequences to our business, results of operations and financial condition from a major earthquake
or other catastrophic event, such as a fire, sustained loss of power, terrorist activity or other
disaster, and do not have a recovery plan for such disasters. In addition, our insurance coverage
may not be sufficient to compensate us for actual losses from any interruption of our business that
may occur.
We have implemented certain anti-takeover measures, which make it more difficult to acquire us,
even though such acquisitions may be beneficial to our stockholders.
Provisions of our certificate of incorporation and bylaws, as well as provisions of Delaware
law, could make it more difficult for a third party to acquire us, even though such acquisitions
may be beneficial to our stockholders. These anti-takeover provisions include:
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establishment of a classified board of directors such that not all members of the board
may be elected at one time; |
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lack of a provision for cumulative voting in the election of directors, which would
otherwise allow less than a majority of stockholders to elect director candidates; |
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the ability of our board to authorize the issuance of blank check preferred stock to
increase the number of outstanding shares and thwart a takeover attempt; |
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prohibition on stockholder action by written consent, thereby requiring all stockholder
actions to be taken at a meeting of stockholders; |
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establishment of advance notice requirements for nominations for election to the board of
directors or for proposing matters that can be acted upon by stockholders at stockholder
meetings; and |
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limitations on who may call a special meeting of stockholders. |
Further, we have in place a preferred share purchase rights plan, commonly known as a poison
pill. The provisions described above, our poison pill and provisions of Delaware law relating to
business combinations with interested stockholders may discourage, delay or prevent a third party
from acquiring us. These provisions may also discourage, delay or prevent a third party from
acquiring a large portion of our securities or initiating a tender offer or proxy contest, even if
our stockholders might receive a premium for their shares in the acquisition over the then current
market prices. We also have a change of control severance benefits plan which provides for certain
cash severance, stock award acceleration and other benefits in the event our employees are
terminated (or, in some cases, resign for specified reasons) following an acquisition. This
severance plan could discourage a third party from acquiring us.
Risks Related to Our Securities
The price of our common stock and convertible debt are expected to remain volatile.
32
Our stock price is volatile. During the quarter ended March 31, 2011, based on closing bid
prices on The NASDAQ Global Select Market, our stock price ranged from $8.58 to $12.53 per share.
We expect our stock price to remain volatile. In addition, as our convertible notes are convertible
into shares of our common stock, volatility or depressed prices of our common stock could have a
similar effect on the trading price of our notes. Also, interest rate fluctuations can affect the
price of our convertible notes. A variety of factors may have a significant effect on the market
price of our common stock or notes, including:
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announcements of data from, or material developments in, our clinical trials or those of
our competitors, including delays in clinical development, approval or launch; |
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announcements by collaboration partners as to their plans or expectations related to
products using our technologies; |
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announcements or terminations of collaboration agreements by us or our competitors; |
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fluctuations in our results of operations; |
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developments in patent or other proprietary rights, including intellectual property
litigation or entering into intellectual property license agreements and the costs
associated with those arrangements; |
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announcements of technological innovations or new therapeutic products that may compete
with our approved products or products under development; |
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announcements of changes in governmental regulation affecting us or our competitors; |
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hedging activities by purchasers of our convertible notes; |
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litigation brought against us or third parties to whom we have indemnification
obligations; |
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public concern as to the safety of drug formulations developed by us or others; and |
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general market conditions. |
Our stockholders may be diluted, and the price of our common stock may decrease, as a result of
the exercise of outstanding stock options and warrants, the restructuring of our convertible
notes, or the future issuances of securities.
We may restructure our convertible notes or issue additional common stock, preferred stock,
restricted stock units or securities convertible into or exchangeable for our common stock.
Furthermore, substantially all shares of common stock for which our outstanding stock options or
warrants are exercisable are, once they have been purchased, eligible for immediate sale in the
public market. The issuance of additional common stock, preferred stock, restricted stock units or
securities convertible into or exchangeable for our common stock or the exercise of stock options
or warrants would dilute existing investors and could lower the price of our common stock.
Restructuring of our convertible notes or raising additional funds by issuing equity securities
could cause significant dilution to existing stockholders; restructured or additional debt
financing may restrict our operations.
If we raise additional funds through the restructuring of our convertible notes or issuance of
equity or convertible debt securities, the percentage ownership of our stockholders could be
diluted significantly, and these restructured or newly issued securities may have rights,
preferences or privileges senior to those of our existing stockholders. If we restructure our notes
or incur additional debt financing, the payment of principal and interest on such indebtedness may
limit funds available for our business activities, and we could be subject to covenants that
restrict our ability to operate our business and make distributions to our stockholders. These
restrictive covenants may include limitations on additional borrowing and specific restrictions on
the use of our assets, as well as prohibitions on the ability of us to create liens, pay dividends,
redeem our stock or make investments.
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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None, including no purchases of any class of our equity securities by us or any affiliate
pursuant to any publicly announced repurchase plan in the three months ended March 31, 2011.
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Item 3. |
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Defaults Upon Senior Securities |
None.
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Item 4. |
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(Removed and Reserved) |
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Item 5. |
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Other Information |
None.
Except as so indicated in Exhibits 32.1 and 101, the following exhibits are filed as part of,
or incorporated by reference into, this Quarterly Report on Form 10-Q.
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Exhibit |
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Number |
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Description of Documents |
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3.1 |
(1) |
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Amended and Restated Bylaws of Nektar Therapeutics, dated April 5, 2011. |
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31.1 |
(2) |
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Certification of Nektar Therapeutics principal executive officer
required by Rule 13a-14(a) or Rule 15d-14(a). |
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31.2 |
(2) |
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Certification of Nektar Therapeutics principal financial officer
required by Rule 13a-14(a) or Rule 15d-14(a). |
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32.1 |
(2)* |
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Section 1350 Certifications. |
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101 |
** |
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The following materials from Nektar Therapeutics Quarterly Report on
Form 10-Q for the quarter ended March 31, 2011, formatted in XBRL
(Extensible Business Reporting Language): (i) the unaudited Condensed
Consolidated Balance Sheets, (ii) the unaudited Condensed Consolidated
Statements of Operations, (iii) the unaudited Condensed Consolidated
Statements of Cash Flows, and (iv) Notes to Condensed Consolidated
Financial Statements. |
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(1) |
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Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current
Report on Form 8-K, filed on April 11, 2011. |
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(2) |
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Filed herewith. |
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* |
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Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
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** |
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Exhibit 101 is being furnished and, in accordance with Rule 406T of Regulation S-T, shall
not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, or otherwise subject to liability of that section, nor shall such exhibit be
deemed to be incorporated by reference in any registration statement or other document filed
under the Securities Act of 1933, as amended, or the Securities Exchange Act. |
34
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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By:
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/s/ John Nicholson
John Nicholson
Senior Vice President and Chief Financial Officer
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Date:
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April 29, 2011 |
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By:
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/s/ Jillian B. Thomsen
Jillian B. Thomsen
Senior Vice President and Chief Accounting Officer
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Date:
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April 29, 2011 |
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35
EXHIBIT INDEX
Except as so indicated in Exhibits 32.1 and 101, the following exhibits are filed as part of,
or incorporated by reference in, this Quarterly Report on Form 10-Q.
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Exhibit |
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Number |
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Description of Documents |
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3.1 |
(1) |
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Amended and Restated Bylaws of Nektar Therapeutics, dated April 5, 2011. |
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31.1 |
(2) |
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Certification of Nektar Therapeutics principal executive officer
required by Rule 13a-14(a) or Rule 15d-14(a). |
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31.2 |
(2) |
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Certification of Nektar Therapeutics principal financial officer
required by Rule 13a-14(a) or Rule 15d-14(a). |
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32.1 |
(2)* |
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Section 1350 Certifications. |
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101 |
** |
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The following materials from Nektar Therapeutics Quarterly Report on
Form 10-Q for the quarter ended March 31, 2011, formatted in XBRL
(Extensible Business Reporting Language): (i) the unaudited Condensed
Consolidated Balance Sheets, (ii) the unaudited Condensed Consolidated
Statements of Operations, (iii) the unaudited Condensed Consolidated
Statements of Cash Flows, and (iv) Notes to Condensed Consolidated
Financial Statements. |
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(1) |
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Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current
Report on Form 8-K, filed on April 11, 2011. |
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(2) |
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Filed herewith. |
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* |
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Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
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** |
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Exhibit 101 is being furnished and, in accordance with Rule 406T of Regulation S-T, shall not
be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or otherwise subject to liability of that section, nor shall such exhibit be deemed
to be incorporated by reference in any registration statement or other document filed under
the Securities Act of 1933, as amended, or the Securities Exchange Act. |
36