Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
R
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
|
|
For
the quarterly period ended September 30, 2009
|
|
|
or
|
|
£
|
TRANSITION REPORTS PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
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For
the transition period from ________ to
_______
|
Commission
File Number: 0-24006
NEKTAR
THERAPEUTICS
(Exact
name of registrant as specified in its charter)
Delaware
|
94-3134940
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer
Identification
No.)
|
201
Industrial Road
San
Carlos, California 94070
(Address
of principal executive offices)
650-631-3100
(Registrant’s
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 R No £
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 £ No £
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.
Large accelerated filer £
|
Accelerated filer R
|
Non-accelerated filer £
|
Smaller reporting company £
|
|
(Do not check if a smaller reporting company)
|
Indicate
by check mark whether the registrant is a shell company (as defined by Rule
12b-2 of the Exchange Act). Yes £ No R
The
number of outstanding shares of the registrant’s Common Stock, $0.0001 par
value, was 93,197,705 on October 30, 2009.
NEKTAR
THERAPEUTICS
INDEX
PART
I: FINANCIAL INFORMATION
|
4
|
Item
1. Condensed Consolidated Financial Statements —
Unaudited:
|
4
|
Condensed
Consolidated Balance Sheets — September 30, 2009 and December 31,
2008
|
4
|
Condensed
Consolidated Statements of Operations for the three months and nine months
ended September 30, 2009 and 2008
|
5
|
Condensed
Consolidated Statements of Cash Flows for the nine months ended September
30, 2009 and 2008
|
6
|
Notes
to Condensed Consolidated Financial Statements
|
7
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
15
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
21
|
Item
4. Controls and Procedures
|
21
|
PART
II: OTHER INFORMATION
|
22
|
Item
1. Legal Proceedings
|
22
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Item
1A. Risk Factors
|
22
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
33
|
Item
3. Defaults Upon Senior Securities
|
33
|
Item
4. Submission of Matters to a Vote of Security Holders
|
33
|
Item
5. Other Information
|
33
|
Item
6. Exhibits
|
33
|
Signatures
|
34
|
Forward-Looking
Statements
This
report includes “forward-looking statements” within the meaning of Section 27A
of the Securities Act of 1933, as amended (the “1933 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
regarding the plans and objectives of management for future operations, any
statements concerning proposed new products or services, any statements
regarding future economic conditions or performance, any statements regarding
expected benefits from the closing of the sale of pulmonary assets to Novartis
on December 31, 2008, any statements regarded the timing of the move of our
corporate headquarters to, and the estimated costs of, the facility subject to
the Sublease with Pfizer dated September 30, 2009, any statements regarding the
success of our collaborations, including in relation to the License Agreement
with AstraZeneca AB dated September 20, 2009, 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, there can be no assurance that such expectations or any of the
forward-looking statements will prove to be correct 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
All
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, registered
trademarks and service marks of other companies that are the property of their
respective owners.
PART
I: FINANCIAL INFORMATION
Item 1. Condensed Consolidated
Financial Statements — Unaudited:
NEKTAR
THERAPEUTICS
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except per share information)
(Unaudited)
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
32,777 |
|
|
$ |
155,584 |
|
Short-term
investments
|
|
|
242,901 |
|
|
|
223,410 |
|
Accounts
receivable, net of allowance of nil at September 30, 2009 and $92 at
December 31, 2008, respectively
|
|
|
6,330 |
|
|
|
11,161 |
|
Inventory
|
|
|
8,930 |
|
|
|
9,319 |
|
Other
current assets
|
|
|
7,275 |
|
|
|
6,746 |
|
Total
current assets
|
|
$ |
298,213 |
|
|
$ |
406,220 |
|
Property
and equipment, net
|
|
|
74,624 |
|
|
|
73,578 |
|
Goodwill
|
|
|
76,501 |
|
|
|
76,501 |
|
Other
assets
|
|
|
3,313 |
|
|
|
4,237 |
|
Total
assets
|
|
$ |
452,651 |
|
|
$ |
560,536 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
6,397 |
|
|
$ |
13,832 |
|
Accrued
compensation
|
|
|
9,711 |
|
|
|
11,570 |
|
Accrued
clinical trial expenses
|
|
|
13,012 |
|
|
|
17,622 |
|
Accrued
expenses
|
|
|
7,132 |
|
|
|
9,923 |
|
Deferred
revenue, current portion
|
|
|
9,547 |
|
|
|
10,010 |
|
Other
current liabilities
|
|
|
3,558 |
|
|
|
5,417 |
|
Total
current liabilities
|
|
$ |
49,357 |
|
|
$ |
68,374 |
|
Convertible
subordinated notes
|
|
|
214,955 |
|
|
|
214,955 |
|
Capital
lease obligations
|
|
|
19,228 |
|
|
|
20,347 |
|
Deferred
revenue
|
|
|
53,308 |
|
|
|
55,567 |
|
Deferred
gain
|
|
|
5,245 |
|
|
|
5,901 |
|
Other
long-term liabilities
|
|
|
4,458 |
|
|
|
5,238 |
|
Total
liabilities
|
|
$ |
346,551 |
|
|
$ |
370,382 |
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.0001 par value; 10,000 shares authorized Series A; 3,100 shares
designated; no shares issued or outstanding at September 30, 2009 and
December 31, 2008
|
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 300,000 shares authorized; 93,124 shares and
92,503 shares issued and outstanding at September 30, 2009 and December
31, 2008, respectively
|
|
|
9 |
|
|
|
9 |
|
Capital
in excess of par value
|
|
|
1,323,907 |
|
|
|
1,312,796 |
|
Accumulated
other comprehensive income
|
|
|
1,117 |
|
|
|
1,439 |
|
Accumulated
deficit
|
|
|
(1,218,933 |
) |
|
|
(1,124,090 |
) |
Total
stockholders’ equity
|
|
|
106,100 |
|
|
|
190,154 |
|
Total
liabilities and stockholders’ equity
|
|
$ |
452,651 |
|
|
$ |
560,536 |
|
The accompanying notes are an
integral part of these condensed consolidated financial
statements.
NEKTAR
THERAPEUTICS
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share information)
(Unaudited)
|
|
Three months ended
September 30,
|
|
|
Nine months ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales and royalties
|
|
$ |
7,461 |
|
|
$ |
9,474 |
|
|
$ |
24,456 |
|
|
$ |
28,855 |
|
Collaboration
and other
|
|
|
2,762 |
|
|
|
11,965 |
|
|
|
8,466 |
|
|
|
32,977 |
|
Total
revenue
|
|
|
10,223 |
|
|
|
21,439 |
|
|
|
32,922 |
|
|
|
61,832 |
|
Operating
costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
5,691 |
|
|
|
5,349 |
|
|
|
21,021 |
|
|
|
18,020 |
|
Other
cost of revenue
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
6,821 |
|
Research
and development
|
|
|
23,474 |
|
|
|
38,265 |
|
|
|
71,514 |
|
|
|
109,138 |
|
General
and administrative
|
|
|
9,917 |
|
|
|
12,386 |
|
|
|
30,024 |
|
|
|
37,661 |
|
Total
operating costs and expenses
|
|
|
39,082 |
|
|
|
56,000 |
|
|
|
122,559 |
|
|
|
171,640 |
|
Loss
from operations
|
|
|
(28,859 |
) |
|
|
(34,561 |
) |
|
|
(89,637 |
) |
|
|
(109,808 |
) |
Non-operating
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
560 |
|
|
|
2,375 |
|
|
|
3,160 |
|
|
|
10,578 |
|
Interest
expense
|
|
|
(2,928 |
) |
|
|
(3,988 |
) |
|
|
(9,213 |
) |
|
|
(11,835 |
) |
Other
income (expense), net
|
|
|
120 |
|
|
|
(588 |
) |
|
|
368 |
|
|
|
483 |
|
Total
non-operating income (expense)
|
|
|
(2,248 |
) |
|
|
(2,201 |
) |
|
|
(5,685 |
) |
|
|
(774 |
) |
Loss
before provision for income taxes
|
|
|
(31,107 |
) |
|
|
(36,762 |
) |
|
|
(95,322 |
) |
|
|
(110,582 |
) |
(Benefit)
provision for income taxes
|
|
|
(140 |
) |
|
|
276 |
|
|
|
(479 |
) |
|
|
536 |
|
Net
loss
|
|
$ |
(30,967 |
) |
|
$ |
(37,038 |
) |
|
$ |
(94,843 |
) |
|
$ |
(111,118 |
) |
Basic
and diluted net loss per share
|
|
$ |
(0.33 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.02 |
) |
|
$ |
(1.20 |
) |
Shares
used in computing basic and diluted net loss per share
|
|
|
92,789 |
|
|
|
92,425 |
|
|
|
92,621 |
|
|
|
92,413 |
|
The accompanying notes are an
integral part of these condensed consolidated financial
statements.
NEKTAR
THERAPEUTICS
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
|
|
Nine
months ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(94,843 |
) |
|
$ |
(111,118 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
11,076 |
|
|
|
18,610 |
|
Stock-based
compensation
|
|
|
7,290 |
|
|
|
6,955 |
|
Other
non-cash transactions
|
|
|
(124 |
) |
|
|
759 |
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease
(increase) in trade accounts receivable
|
|
|
4,505 |
|
|
|
13,122 |
|
Decrease
(increase) in inventory
|
|
|
389 |
|
|
|
2,326 |
|
Decrease
(increase) in other assets
|
|
|
(1,272 |
) |
|
|
2,659 |
|
Increase
(decrease) in accounts payable
|
|
|
(4,047 |
) |
|
|
(1,476 |
) |
Increase
(decrease) in accrued compensation
|
|
|
(1,859 |
) |
|
|
(229 |
) |
Increase
(decrease) in accrued clinical trial expenses
|
|
|
(4,610 |
) |
|
|
4,659 |
|
Increase
(decrease) in accrued expenses to contract manufacturers
|
|
|
— |
|
|
|
(40,444 |
) |
Increase
(decrease) in accrued expenses
|
|
|
(1,413 |
) |
|
|
(1,390 |
) |
Increase
(decrease) in deferred revenue
|
|
|
(2,722 |
) |
|
|
(11,972 |
) |
Increase
(decrease) in other liabilities
|
|
|
(2,823 |
) |
|
|
2,474 |
|
Net
cash used in operating activities
|
|
$ |
(90,453 |
) |
|
$ |
(115,065 |
) |
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases
of investments
|
|
|
(298,054 |
) |
|
|
(411,417 |
) |
Sales
of investments
|
|
|
11,923 |
|
|
|
28,590 |
|
Maturities
of investments
|
|
|
266,202 |
|
|
|
506,348 |
|
Transaction
costs from Novartis pulmonary asset sale
|
|
|
(4,440 |
) |
|
|
— |
|
Purchases
of property and equipment
|
|
|
(10,763 |
) |
|
|
(15,064 |
) |
Investment
in Pearl Therapeutics Inc.
|
|
|
— |
|
|
|
(4,236 |
) |
Net
cash (used in) provided by investing activities
|
|
$ |
(35,132 |
) |
|
$ |
104,221 |
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Payments
of loan and capital lease obligations
|
|
|
(935 |
) |
|
|
(1,910 |
) |
Proceeds
from issuances of common stock
|
|
|
3,821 |
|
|
|
477 |
|
Net
cash provided by (used in) financing activities
|
|
$ |
2,886 |
|
|
$ |
(1,433 |
) |
Effect
of exchange rates on cash and cash equivalents
|
|
|
(108 |
) |
|
|
(303 |
) |
Net
decrease in cash and cash equivalents
|
|
$ |
(122,807 |
) |
|
$ |
(12,580 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
155,584 |
|
|
|
76,293 |
|
Cash
and cash equivalents at end of period
|
|
$ |
32,777 |
|
|
$ |
63,713 |
|
The accompanying notes are an
integral part of these condensed consolidated financial
statements.
NEKTAR
THERAPEUTICS
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(Unaudited)
Note 1—Organization and Summary of
Significant Accounting Policies
Organization
We are a
clinical-stage biopharmaceutical company headquartered in San Carlos, 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 therapeutic benefits of drugs.
Basis
of Presentation and Principles of Consolidation
Our
condensed consolidated financial statements include the financial position,
results of operations and cash flows of our wholly-owned subsidiaries: Nektar
Therapeutics AL, Corporation (Nektar AL), Nektar Therapeutics (India) Private
Limited, Nektar Therapeutics UK, Ltd. (Nektar UK) and Aerogen, Inc. All
intercompany accounts and transactions have been eliminated in consolidation.
The merger of Nektar AL, an Alabama corporation, with and into its parent
corporation, Nektar Therapeutics, was made effective July 31, 2009. As of the
effective date, the separate existence of the Alabama corporation ceased, and
all rights, privileges, powers and franchises of the Alabama corporation are
vested in Nektar Therapeutics, the surviving corporation.
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”) 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 subsidiary’s
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 Sheet. 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.
Therefore, the results and trends in these interim Condensed Consolidated
Financial Statements may not be the same as those for the full year. We
completed the sale of certain assets related to our pulmonary business,
associated technology and intellectual property to Novartis Pharma AG and
Novartis Pharmaceuticals Corporation (together referred to as “Novartis”) on
December 31, 2008; as a result, our results of operations for the three and nine
months ended September 30, 2009 are not comparable to the three and nine month
periods ended September 30, 2008.
The
accompanying Condensed Consolidated Balance Sheet as of September 30, 2009, the
Condensed Consolidated Statements of Operations for the three months and nine
months ended September 30, 2009 and 2008, and the Condensed Consolidated
Statements of Cash Flows for the nine months ended September 30, 2009 and 2008
are unaudited. The Condensed Consolidated Balance Sheet data as of December 31,
2008 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 6, 2009.
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, 2008.
We
evaluated subsequent events through November 4, 2009, the date on which this
Quarterly Report on Form 10-Q was filed with the Securities and Exchange
Commission.
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 from these
estimates.
Reclassifications
Certain
items previously reported in specific financial statement captions have been
reclassified to conform to the current period presentation. Such
reclassifications do not impact previously reported revenue, operating loss or
net loss or total assets, liabilities or stockholders’ equity.
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 production
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 collaborative
research 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.
We are
dependent on our partners and vendors to provide raw materials, drugs and
devices of appropriate quality and reliability and to meet applicable regulatory
requirements. 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
We enter
into collaborative research and development arrangements and technology license
agreements with pharmaceutical and biotechnology partners that may involve
multiple deliverables. Our arrangements may contain the following elements:
upfront fees, contract research, milestone payments, manufacturing and supply,
royalties, and license fees. We evaluate and account for our revenue
arrangements as required by the
Revenue Recognition Topic of the Financial Accounting Standards Board
(“FASB”) Accounting Standards
Codification (“ASC”).
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. Allowances are established for estimated sales returns and
uncollectible amounts. 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.
Product
sales and royalties
Product
sales are primarily derived from cost-plus manufacturing and supply agreements
with our collaboration partners, and revenue is recognized in accordance with
the terms of the related collaboration 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 once
their products are approved for commercial sale. We recognize royalty
revenue when the cash is received or when the royalty amount to be received is
estimable and collection is reasonably assured.
Collaboration
and other
Collaborative
research and development arrangements
Upfront
fees received 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 from the
arrangement. In collaborative research and development agreements we
may have performance responsibilities through a certain phase of clinical
development or through the commercial life of the product; the amortization
period for upfront fees received may be as short as the development period,
which is generally four to six years, or as long as the contractual life of the
agreement, which is generally 10 to 12 years from the first commercial sale, or
the end of the patent life, which is frequently 15 to 17 years. Given
the uncertainties of research and development collaborations, significant
judgment is required to determine the duration of the performance
period.
Contract
research revenue from collaborative research and development arrangements is
recorded when earned based on the performance requirements of the contract.
Advance payments for research and development revenue received in excess of
amounts earned are classified as deferred revenue until earned. Amounts received
under these arrangements are generally non-refundable even if the research
effort is unsuccessful.
In
arrangements in which we have a performance obligation, payments received for
performance milestones achieved are deferred and recorded as revenue ratably
over the period of time from the achievement of the milestone for which we
received payment and our estimate of the date on which the next milestone will
be achieved. Management makes its best estimate of the period of time until the
next milestone is reached. The estimate affects the recognition of revenue for
completion of the previous milestone. The original estimate is periodically
evaluated to determine if circumstances have caused the estimate to change and
if so, amortization of revenue is adjusted prospectively. Final milestone
payments are recorded and recognized upon achieving the respective milestone,
provided that collection is reasonably assured.
License
Agreements
We have
granted licenses for certain of our intellectual property assets for use in
developing new molecules. We do not recognize revenue unless delivery has
occurred. We consider delivery to have occurred when the license is granted on
an exclusive basis and the license is for the duration of the intellectual
property life. If we have performance obligations beyond delivery of
the license, such as to assist in the technology transfer process, we recognize
revenue ratably over the estimated performance obligation period.
Income
Taxes
Our
net income tax benefit is primarily comprised of a foreign income tax provision
for India at an effective tax rate of 34% and a U.S. Federal income tax benefit
relating to a refundable credit under the American Recovery and Reinvestment Act
of 2009.
We
account for income taxes under the liability method as prescribed by the Income
Taxes Topic of the FASB
ASC. Under this method, deferred tax assets and liabilities are
determined based on differences between 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.
Recent
Accounting Pronouncements
FASB
Accounting Standards Update 2009-13, Revenue Recognition (Topic 605) –
Multiple-Deliverable Revenue Arrangements
In
October 2009, the FASB published FASB Accounting Standards Update 2009-13, which
amends the criteria to identify separate units of accounting within Subtopic
605-25, Revenue Recognition-Multiple-Element Arrangements. The
revised guidance also expands the disclosure required for multiple-element
revenue arrangements. FASB Accounting Standards Update 2009-13 is
effective for fiscal years beginning on or after June 15, 2010, and may be
applied retrospectively for all periods presented or prospectively to
arrangements entered into or materially modified after the adoption
date. Early adoption is permitted provided that the revised guidance
is retroactively applied to the beginning of the year of adoption. We
are currently evaluating the impact of adoption on our financial position and
our results of operations.
FASB
Accounting Standards Codification
In June
2009, the FASB issued SFAS No. 168, The FASB Accounting Standards
CodificationTM and the Hierarchy of Generally Accepted Accounting
Principles—a replacement of FASB Statement No. 162 (“SFAS 168”). The statement confirmed that
the FASB Accounting
Standards Codification
(the “Codification”) has become the single official source of
authoritative U.S. GAAP (other than guidance issued by the SEC), superseding
existing FASB, American Institute of Certified Public Accountants, Emerging
Issues Task Force (“EITF”), and related literature. Only one level of
authoritative U.S. GAAP exists. All other literature is now considered
non-authoritative. The Codification did not change U.S. GAAP; instead, it
introduced a new structure. The Codification, which changed the referencing of
financial standards, became effective for interim and annual periods ending on
or after September 15, 2009. We have applied the Codification beginning in this
third quarter 2009 Form 10-Q and as a result, the majority of references to
historically issued accounting pronouncements are now superseded by references
to the FASB ASC. Certain accounting pronouncements, such as SFAS 168, will
remain authoritative until they are integrated into the codification standard.
The adoption of SFAS 168 has not had a substantive impact on our Condensed
Consolidated Financial Statements or related footnotes.
Note 2—Cash, Cash Equivalents, and
Available-For-Sale Investments
Cash,
cash equivalents, and available-for-sale investments are as follows (in
thousands):
|
|
Estimated Fair Value at
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
Cash
and cash equivalents
|
|
$ |
32,777 |
|
|
$ |
155,584 |
|
Short-term
investments (less than one year to maturity)
|
|
|
242,901 |
|
|
|
223,410 |
|
Total
cash, cash equivalents, and available-for-sale investments
|
|
$ |
275,678 |
|
|
$ |
378,994 |
|
Our
portfolio of cash, cash equivalents, and available-for-sale investments includes
(in thousands):
|
|
Estimated Fair Value at
|
|
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
Cash
and money market funds
|
|
$ |
30,767 |
|
|
$ |
145,394 |
|
Obligations
of U.S. government agencies
|
|
|
120,386 |
|
|
|
91,667 |
|
Obligations
of U.S. corporations
|
|
|
89,523 |
|
|
|
26,275 |
|
U.S.
corporate commercial paper
|
|
|
29,976 |
|
|
|
115,658 |
|
Obligations
of U.S. states and municipalities
|
|
|
5,026 |
|
|
|
— |
|
Total
cash, cash equivalents, and available-for-sale investments
|
|
$ |
275,678 |
|
|
$ |
378,994 |
|
The
primary objective of our investment activities is to preserve principal while at
the same time maximizing yields without significantly increasing risk. To
achieve this objective, 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
September 30, 2009, the average portfolio duration was approximately six months
and the contractual maturity of any single investment did not exceed twelve
months. At December 31, 2008, the average portfolio duration was approximately
two months and the contractual maturity of any single investment did not exceed
twelve months.
Gross
unrealized gains and losses were insignificant at September 30, 2009 and at
December 31, 2008. 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 not more likely than not that we will 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.
The
following table represents the fair value hierarchy for our financial assets
measured at fair value on a recurring basis as of September 30, 2009 (in
thousands):
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
Money
market funds
|
|
$ |
27,537 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
27,537 |
|
Obligations
of U.S. government agencies
|
|
|
— |
|
|
|
120,386 |
|
|
|
— |
|
|
|
120,386 |
|
Obligations
of U.S. corporations
|
|
|
— |
|
|
|
89,523 |
|
|
|
— |
|
|
|
89,523 |
|
U.S.
corporate commercial paper
|
|
|
— |
|
|
|
29,976 |
|
|
|
— |
|
|
|
29,976 |
|
Obligations
of U.S. states and municipalities
|
|
|
— |
|
|
|
5,026 |
|
|
|
— |
|
|
|
5,026 |
|
Cash
equivalents and available-for-sale investments
|
|
$ |
27,537 |
|
|
$ |
244,911 |
|
|
$ |
— |
|
|
$ |
272,448 |
|
Cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,230 |
|
Cash,
cash equivalents, and available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
275,678 |
|
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.
|
Note 3 —Inventory
Inventory
consists of the following (in thousands):
|
|
September 30, 2009
|
|
|
December 31, 2008
|
|
Raw
materials
|
|
$ |
5,864 |
|
|
$ |
6,964 |
|
Work-in-process
|
|
|
207 |
|
|
|
1,743 |
|
Finished
goods
|
|
|
2,859 |
|
|
|
612 |
|
Total
|
|
$ |
8,930 |
|
|
$ |
9,319 |
|
Inventory
is manufactured upon receipt of firm purchase orders from our licensing
partners. Inventory includes direct materials, direct labor, and manufacturing
overhead and is computed on a first-in, first-out basis. Inventory is stated at
the lower of cost or market and is net of reserves of $4.4 million and $5.0
million as of September 30, 2009 and December 31, 2008, 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
4—Mission Bay Facility
On
September 30, 2009, we entered into an operating sublease with Pfizer, Inc. for
a 102,283 square foot facility located at 455 Mission Bay Boulevard, San
Francisco, California (the “Mission Bay Facility”). The Mission Bay
Facility is currently under construction and is scheduled to be completed in the
second half of 2010. When completed, the Mission Bay Facility will
include an R&D center with biology, chemistry, pharmacology, and clinical
development capabilities, as well as all of our functions currently located in
San Carlos, California, including our corporate headquarters. We are
currently working with our architects and general contractor to complete our
tenant improvement design for the Mission Bay Facility and the related
scope, cost and timing of construction.
Under the
terms of the sublease, we will begin making non-cancelable lease payments in
2014, four years following the earliest of (i) our substantial completion of the
tenant improvements, (ii) our occupancy of the Mission Bay Facility, or (iii)
August 1, 2010. The Sublease term ends 114 months after occupancy but
in no event later than January 30, 2020. Rent expense will be
recognized ratably over the sublease term. In addition, throughout
the term of the Sublease, we are responsible for paying certain costs and
expenses specified in the sublease, including insurance costs and a pro rata
share of operating expenses and applicable taxes for the Mission Bay
Facility. Our future minimum lease payments under the Mission Bay
sublease total $21.3 million for the years 2014 through 2020.
Note
5 - Commitments and Contingencies
Legal
Matters
From time
to time, we may be involved in lawsuits, claims, investigations and proceedings,
consisting of intellectual property, commercial, employment and other matters,
which arise in the ordinary course of business. In accordance with the
Contingencies Topic of the FASB
ASC, we make a provision for a liability when it is both probable that a
liability has been incurred and the amount of the loss can be reasonably
estimated. These provisions are reviewed at least quarterly and adjusted to
reflect the impact of negotiations, settlements, ruling, 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 agreement 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 closed on 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 was determined that we breached any 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
the obligations cannot be reasonably estimated. No liabilities have been
recorded for these obligations on our Consolidated Balance Sheets as of
September 30, 2009 or December 31, 2008.
Note 6—Collaborative
Agreements
On August
1, 2007, we entered into a co-development, license and co-promotion agreement
with Bayer Healthcare LLC to develop a specially-formulated inhaled Amikacin
(BAY41-6551). We are responsible for any future development of the nebulizer
device included in the Amikacin product through the completion of Phase 3
clinical trials and scale-up for commercialization. Bayer Healthcare LLC is
responsible for most future clinical development (other than $10.0 million of
Phase 3 clinical trial costs to be reimbursed by Nektar) and commercialization
costs, all activities to support worldwide regulatory filings, approvals and
related activities, further development of BAY41-6551 and final product
packaging. We received an upfront payment of $40.0 million and performance
milestone payments of $20.0 million, of which the second performance milestone
of $10.0 million will be used to reimburse Bayer for Phase 3 clinical trial
costs. We recognized milestone revenue of $1.2 million and $5.2 million during
the three month periods ended September 30, 2009 and 2008, respectively, and
$3.9 million and $8.4 million during the nine month periods ended September 30,
2009 and 2008, respectively, included in Collaboration and other revenue in our
Condensed Consolidated Statement of Operations. As of September 30, 2009 and
December 31, 2008, $34.8 million and $38.7 million, respectively, of
collaborative revenue was recorded as deferred revenue in our Condensed
Consolidated Balance Sheets. We are entitled to development milestones and sales
milestones upon achievement of certain annual sales targets and royalties based
on annual worldwide net sales of BAY41-6551.
Note
7 – Stock based compensation
Total
stock-based compensation expense was recorded in our Condensed Consolidated
Financial Statements as follows (in thousands):
|
|
Three months ended
September 30,
|
|
|
Nine months ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Cost
of goods sold, net of inventory change
|
|
$ |
58 |
|
|
$ |
91 |
|
|
$ |
211 |
|
|
$ |
212 |
|
Other
cost of revenue
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
23 |
|
Research
and development expense
|
|
|
931 |
|
|
|
1,590 |
|
|
|
2,415 |
|
|
|
2,700 |
|
General
and administrative expense
|
|
|
1,610 |
|
|
|
1,411 |
|
|
|
4,664 |
|
|
|
4,020 |
|
Total
stock-based compensation expense
|
|
$ |
2,599 |
|
|
$ |
3,092 |
|
|
$ |
7,290 |
|
|
$ |
6,955 |
|
Aggregate
Unrecognized Stock-Based Compensation Expense
Aggregate
total unrecognized stock-based compensation expense is expected to be recognized
as follows (in thousands):
Fiscal Year
|
|
As of
September 30, 2009
|
|
2009
(remaining 3 months)
|
|
$ |
2,694 |
|
2010
|
|
|
9,245 |
|
2011
|
|
|
7,738 |
|
2012
|
|
|
3,203 |
|
2013
and thereafter
|
|
|
1,154 |
|
|
|
$ |
24,034 |
|
Note 8—Net 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 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
|
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Convertible
subordinated notes
|
|
|
9,989 |
|
|
|
14,638 |
|
|
|
9,989 |
|
|
|
14,638 |
|
Stock
options
|
|
|
9,886 |
|
|
|
14,740 |
|
|
|
14,155 |
|
|
|
13,944 |
|
Total
|
|
|
19,875 |
|
|
|
29,378 |
|
|
|
24,144 |
|
|
|
28,582 |
|
Note
9—Subsequent Events
License
Agreement with AstraZeneca AB
On
September 20, 2009, we entered into a License Agreement (the “Agreement”) with
AstraZeneca AB, a Swedish corporation (“AstraZeneca”), in which we granted a
worldwide exclusive license to NKTR-118 and NKTR-119. The Agreement
was reviewed by the U. S. Government under the Hart-Scott-Rodino Act (the “HSR
Act”). We received early termination of the waiting period under the
HSR Act and the Agreement became effective on October 8, 2009.
Under the
terms of the Agreement, Nektar and AstraZeneca agree to cooperate in researching
and developing products derived from the application of Nektar’s proprietary
product candidates Oral NKTR-118 (PEGylated naloxol), a peripheral opioid
antagonist in clinical development for the treatment of opioid-induced
constipation (OIC) and other manifestations of opioid bowel dysfunction (OBD),
and the Oral NKTR-119 program which combines Oral NKTR-118 with certain opioid
compounds.
Under the
terms of the Agreement, AstraZeneca agreed to pay us an upfront payment of
$125.0 million, which we received on October 16, 2009. In relation to
NKTR-118, we are eligible to receive up to $235.0 million in development
milestones and up to $375.0 million in additional sales milestones as the
product achieves certain commercial sales levels. AstraZeneca will
use commercially reasonable efforts to develop one product based on NKTR-119 and
has rights to develop multiple products based on NKTR-119. For each
of the first two initial products based on NKTR-119, Nektar is eligible to
receive for each of such products up to $75.0 million in development milestones
and up to $310.0 million in additional sales milestones. We are also
eligible to receive significant and escalating double-digit royalty payments,
varying by country of sale and based on annual net sales. Our right
to receive royalties (subject to certain adjustments) in any particular country
will expire upon the later of (a) specified period of time after the first
commercial sale of the product in that country (or in the European Union if the
country is in the European Union) or (b) the expiration of patent rights in that
particular country.
On an
interim basis, we will supply AstraZeneca with its requirements for NKTR-118
clinical study material on a cost plus basis, until a technology transfer
enabling AstraZeneca to undertake such manufacture is
completed. AstraZeneca is responsible for all other clinical
manufacturing and all commercial manufacturing. We granted
AstraZeneca a worldwide, exclusive, perpetual, royalty-bearing, sublicensable
license under our patents and know-how to develop, sell and otherwise exploit
NKTR-118 and NKTR-119. AstraZeneca will bear all costs associated
with research, development and commercialization and will control product
development and commercialization decisions. Each party retains
rights to its own intellectual property and an equal, undivided interest in
jointly-developed intellectual property in connection with the work conducted
under or in connection with the Agreement.
Pursuant
to the terms of the Agreement, each of Nektar and AstraZeneca agrees, for a
period of five years from the first commercial sale of a product in the United
States or two other specified markets, not to conduct late stage development of,
or commercialize, certain competing products for the prevention, treatment or
amelioration of opioid-induced constipation or opioid-induced bowel
dysfunction. The Agreement includes various representations,
warranties, covenants, indemnities and other provisions customary for
transactions of this nature. AstraZeneca may terminate the Agreement
(i) for certain specified safety, efficacy or regulatory reasons, and (ii) on a
country by country basis, in the event of certain intellectual property
infringement events. Either party may terminate the Agreement in the
event of an uncured material breach.
Item 2. Management’s 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
1A—Risk 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 to improve the therapeutic benefits of drugs. Our proprietary product
pipeline is comprised of drug candidates across a number of therapeutic areas,
including oncology, pain, anti-infectives and immunology. We create our
innovative product candidates by using our proprietary chemistry platform to
modify the chemical structure of drugs using unique polymer conjugates.
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 the attributes of our customized polymer chemistry. Our drug candidates are
designed to correct deficiencies in the pharmacokinetics, half-life, oral
bioavailability, metabolism or distribution of drugs to improve their
therapeutic efficacy.
During
2009, we have continued to make substantial investments to advance our pipeline
of drug candidates from early stage discovery research through clinical
development. On March 2, 2009, we announced that we were terminating our Phase 2
clinical trial for Oral NKTR-118 (oral PEGylated naloxol) as a result of
positive preliminary results and on September 20, 2009, we entered into a
License Agreement with AstraZeneca (the “AstraZeneca License”) for the worldwide
development and commercialization of products based on NKTR-118 and NKTR-119 (a
co-formulated product candidate including a long-acting opioid and NKTR-118). We
also have several Phase 2 clinical trials for NKTR-102 (PEGylated irinotecan)
directed at a number of different indications in the oncology therapeutic area
that have been ongoing or scheduled to begin during 2009. In addition, on
February 17, 2009, we announced that we had dosed the first patient in a Phase 1
clinical trial for NKTR-105 (PEGylated docetaxel) for patients with refractory
solid tumors. We also have several other products in the early discovery or
preclinical stage that we are preparing to move into clinical
development.
Our focus
on research and clinical development requires substantial investments that
continue to increase as we advance each drug candidate through the development
cycle. While we believe that our strategy 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 development is an inherently uncertain process and there is a high
risk of failure at every stage prior to approval and clinical results are very
difficult to predict. Clinical development success and failures can have an
unpredictable and disproportionate positive or negative impact on our scientific
and medical prospects, financial prospects, financial condition, and market
value.
Historically,
we entered into a number of license and supply contracts under which we
manufactured and supplied 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. As a result, whenever possible, we are
renegotiating or not seeking renewal of legacy manufacturing supply arrangements
that do not include a strategic development or commercialization
component. While this will result in some revenue loss in the
short-term, product sales from these legacy agreements is generally
low-margin. Our strategy allows us to focus our proprietary
manufacturing expertise and capacity on drugs and drug candidates where we have
significant future economic opportunity.
We intend
to decide on a product-by-product basis whether we wish to continue development
into Phase 3 pivotal clinical trials and commercialize products on our own, or
seek a partner, or pursue a combination of these approaches. Following
completion of Phase 2 development, or earlier in the development cycle in
certain circumstances, we will generally be seeking collaborations with one or
more biotechnology or pharmaceutical companies to conduct Phase 3 clinical
development, to be responsible for the regulatory approval process and, if such
drug candidate is approved, to market and sell the drug in one or more world
markets. The commercial terms of such future collaborations, if any, including,
without limitation, upfront payments, development and sales milestone payments,
and royalty rates, will be critical to the future prospects of our business and
financial condition. For example, the success of our collaboration with
AstraZeneca under the AstraZeneca License, which includes an upfront payment of
$125.0 million that we received from AstraZeneca in October 2009 and significant
potential development milestones, sales milestones and royalties on commercial
sales for each of NKTR-118 and NKTR-119, will impact our financial condition.
There can be no assurance that any future collaborations will be available to us
on favorable terms.
We have a
number of existing license and collaboration agreements with third parties who
have licensed our proprietary technologies for drugs that have either received
regulatory approval in one or more markets or drug candidates that are still in
the clinical development stage. For example, the future clinical and commercial
success of Bayer’s Amikacin Inhale (BAY41-6551 or NKTR-061), AstraZeneca’s
development and commercialization of NKTR-118 and NKTR-119, UCB’s CIMZIA™,
Roche’s MIRCERA and Affymax’s Hematide, among others, will together have a
material impact on our long-term revenue prospects, as will the success of
Bayer’s Cipro Inhale program, in relation to which we have certain royalty
rights. Because drug development and commercialization is subject to a number of
risks and uncertainties, there is a risk that our future revenue from one or
more of these agreements will be less than we anticipate.
Key
Developments and Trends in Liquidity and Capital Resources
At
September 30, 2009, we had approximately $275.7 million in cash, cash
equivalents, and short-term investments and $241.0 million in indebtedness. We
may from time to time purchase or retire convertible subordinated notes through
cash purchase or exchanges for other securities of the Company in open market or
privately negotiated transactions, depending on, among other factors, our levels
of available cash and the price at which such convertible notes are available
for purchase. For instance, in the fourth quarter of 2008, we repurchased $100.0
million of the principal amount of our 3.25% convertible subordinated notes. We
will evaluate similar future transactions, if any, in light of then-existing
market conditions. These transactions, individually or in the aggregate, may be
material to our business.
We have
financed our operations primarily through revenue from product sales and
royalties and research and development contracts and public and private
placements of debt and equity. In October 2009, we received a payment of $125.0
million from AstraZeneca under the AstraZeneca License as an upfront payment for
the worldwide rights to further develop and commercialize NKTR-118 and
NKTR-119. To date we have incurred substantial debt as a result of
our issuances of subordinated notes that are convertible into our common stock.
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 new drugs. 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.
Our
substantial investment in our preclinical and clinical research and any
potential new licensing or partnership agreements, if any, will be the key
drivers of our results of operations and financial position during 2009. One of
our collaboration partners has a one-time license extension option exercisable
in December 2009. If this partner elects to exercise this license extension
option right, we will receive a cash payment of $31.0 million in December
2009.
Results
of Operations
Three
Months and Nine Months Ended September 30, 2009 and 2008
Revenue
(in thousands, except percentages)
|
|
Three months
ended
September 30, 2009
|
|
|
Three months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Product
sales and royalties
|
|
$ |
7,461 |
|
|
$ |
9,474 |
|
|
$ |
(2,013 |
) |
|
|
(21 |
)% |
Collaboration
and other
|
|
|
2,762 |
|
|
|
11,965 |
|
|
|
(9,203 |
) |
|
|
(77 |
)% |
Total
revenue
|
|
$ |
10,223 |
|
|
$ |
21,439 |
|
|
$ |
(11,216 |
) |
|
|
(52 |
)% |
|
|
Nine months
ended
September 30, 2009
|
|
|
Nine months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Product
sales and royalties
|
|
$ |
24,456 |
|
|
$ |
28,855 |
|
|
$ |
(4,399 |
) |
|
|
(15 |
)% |
Collaboration
and other
|
|
|
8,466 |
|
|
|
32,977 |
|
|
|
(24,511 |
) |
|
|
(74 |
)% |
Total
revenue
|
|
$ |
32,922 |
|
|
$ |
61,832 |
|
|
$ |
(28,910 |
) |
|
|
(47 |
)% |
Our
revenue is derived from our collaboration agreements, under which we may receive
contract research payments, milestone payments based on clinical progress,
regulatory progress or net sales achievements, royalties or product sales
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 often result in single milestone
payments and the timing and success of the commercial launch of new drugs by our
collaboration partners.
The
decrease in total revenue for the three months and nine months ended September
30, 2009 compared to the three months and nine months ended September 30, 2008,
is primarily attributable to lower product sales to our collaboration partners,
the termination of our Tobramycin Inhalation Powder (“TIP”) collaboration
agreement with Novartis Vaccines and Diagnostics Inc., and the assignment of our
Cipro Inhale collaboration agreement with Bayer Schering Pharma AG to Novartis.
Pursuant to the terms of the transaction in which we assigned this collaboration
agreement to Novartis, we maintain the right to receive certain potential
royalties in the future based on net product sales if Cipro Inhale receives
regulatory approval and is successfully commercialized.
In
October 2009, we received a $125.0 million upfront payment from AstraZeneca in
connection with the AstraZeneca License for NKTR-118 and NKTR-119. We
will begin amortizing the $125.0 million upfront payment in the fourth quarter
of 2009 over our estimated performance period.
In
December, if one of our collaboration partners elects to exercise a one-time
license extension option, we would receive a $31.0 million payment and we would
expect to recognize the revenue over our estimated performance obligation period
of the agreement.
Product
sales and royalties
The
decrease in product sales and royalties for the three months and nine months
ended September 30, 2009 compared to the three months and nine months ended
September 30, 2008 is primarily attributable to lower product sales volumes to
our collaboration partners. We expect product sales and royalties in the last
quarter of 2009 to remain at a consistent level as the three months ended
September 30, 2009.
Collaboration
and other
Collaboration
and other revenue includes reimbursed research and development expenses,
amortization of deferred upfront payments and milestone payments received from
our collaboration partners, and intellectual property license fee revenue.
Collaboration revenue fluctuates from year to year, and therefore future
collaboration revenue cannot be predicted accurately. The level of collaboration
and other revenue depends in part upon the continuation of existing
collaborations, the stage of program development, and the achievement of
milestones. The timing and future success of our product development programs
are subject to a number of risks and uncertainties.
The
decrease in collaboration and other revenue for the three months and nine months
ended September 30, 2009 compared to the three months and nine months ended
September 30, 2008 is primarily attributable to the termination of our TIP
collaboration agreement and the assignment of the Cipro Inhale collaboration
agreement as part of the Novartis asset sale transaction,
which. These agreements accounted for approximately $5.6 million and
$19.3 million of collaboration and other revenue, respectively, for the three
months and nine months ended September 30, 2008. We do not expect to recognize
any revenue related to these two agreements in 2009. Additionally, milestone
revenue recognized from Bayer under our collaborative agreement for Amikacin
Inhale decreased by $4.0 million and $4.5 million, respectively, for the three
months and nine months ended September 30, 2009 compared to the same periods in
2008 due to changes in our estimates of clinical development progress for this
program.
Cost
of Goods Sold and Product Gross Margin (in thousands, except
percentages)
|
|
Three months
ended
September 30, 2009
|
|
|
Three months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Cost
of goods sold
|
|
$ |
5,691 |
|
|
$ |
5,349 |
|
|
$ |
342 |
|
|
|
6 |
% |
Product
gross profit
|
|
$ |
1,770 |
|
|
$ |
4,125 |
|
|
$ |
(2,355 |
) |
|
|
(57 |
)% |
Product
gross margin
|
|
|
24 |
% |
|
|
44 |
% |
|
|
|
|
|
|
|
|
|
|
Nine months
ended
September 30, 2009
|
|
|
Nine months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Cost
of goods sold
|
|
$ |
21,021 |
|
|
$ |
18,020 |
|
|
$ |
3,001 |
|
|
|
(17 |
)% |
Product
gross profit
|
|
$ |
3,435 |
|
|
$ |
10,835 |
|
|
$ |
(7,400 |
) |
|
|
(68 |
)% |
Product
gross margin
|
|
|
14 |
% |
|
|
38 |
% |
|
|
|
|
|
|
|
|
For the
three months and nine months ended September 30, 2009 compared to the three
months and nine months ended September 30, 2008, the decrease in product gross
margin is primarily attributable to a shift in product mix and decreased
manufacturing volume; the decreased manufacturing volume resulted in increased
unabsorbed manufacturing overhead that was recognized as cost of goods
sold. Additionally, for the nine months ended September 30, 2009,
product gross margin decreased primarily due to a $2.1 million payment that
became due during the first quarter of 2009 to one of our former consulting
firms as the final payment under the agreement.
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 manufacturing orders from our customers.
Other
Cost of Revenue (in thousands, except percentages)
Other
cost of revenue of $6.8 million for the nine months ended September 30, 2008
includes the costs of maintaining our Exubera manufacturing capacity after the
termination of the Pfizer agreements on November 9, 2007 through the termination
of our inhaled insulin programs in April 2008. There were no such
costs in 2009.
Research
and Development Expense (in thousands, except percentages)
|
|
Three months
ended
September 30, 2009
|
|
|
Three months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Research
and development expense
|
|
$ |
23,474 |
|
|
$ |
38,265 |
|
|
$ |
(14,791 |
) |
|
|
(39 |
)% |
|
|
Nine months
ended
September 30, 2009
|
|
|
Nine months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Research
and development expense
|
|
$ |
71,514 |
|
|
$ |
109,138 |
|
|
$ |
(37,624 |
) |
|
|
(34 |
)% |
Research
and development expenses consist primarily of personnel costs, including
salaries, benefits, and stock-based compensation, clinical studies performed by
contract research organizations (CROs), materials and supplies, licenses and
fees, and overhead allocations consisting of various support and facilities
related costs.
The
decrease in research and development expense for the three months and nine
months ended September 30, 2009 compared to the three months and nine months
ended September 30, 2008, is primarily attributable to the completion of the
sale of certain assets related to our pulmonary business, associated property,
and intellectual property to Novartis on December 31, 2008 (referred to as the
“Novartis Pulmonary Asset Sale”) and the workforce reduction executed in
February 2008. As part of the Novartis Pulmonary Asset Sale, we transferred
approximately 140 of our personnel dedicated to our pulmonary operations and our
San Carlos research and manufacturing facility to Novartis. In addition, we
ceased research activities on the TIP research and development program, the
Cipro Inhale program and certain other proprietary pulmonary development
programs, resulting in a decrease in outside direct costs of $2.0 million and
$4.3 million, respectively, for the three months and nine months ended September
30, 2009 compared to the corresponding periods of 2008. For the three
months and nine months ended September 30, 2009 compared to the three months and
nine months ended September 30, 2008, personnel costs decreased by approximately
$6.3 million and $22.3 million, respectively, and facilities costs decreased by
approximately $3.2 million and $9.6 million, respectively.
General
and Administrative Expense (in thousands, except percentages)
|
|
Three months
ended
September 30, 2009
|
|
|
Three months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
General
and administrative expense
|
|
$ |
9,917 |
|
|
$ |
12,386 |
|
|
$ |
(2,469 |
) |
|
|
(20 |
)% |
|
|
Nine months
ended
September 30, 2009
|
|
|
Nine months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
General
and administrative expense
|
|
$ |
30,024 |
|
|
$ |
37,661 |
|
|
$ |
(7,637 |
) |
|
|
(20 |
)% |
General
and administrative expense is associated with administrative staffing, business
development and marketing. For the three months and nine months ended September
30, 2009 compared to the three months and nine months ended September 30, 2008,
personnel costs decreased by approximately $1.0 million and $3.8 million,
respectively, primarily due to headcount reductions made as part of our February
2008 workforce reductions and other operating efficiencies achieved after the
Novartis Pulmonary Asset Sale, marketing costs decreased by approximately $0.2
million and $1.2 million, respectively, professional outside service costs
decreased by approximately $0.5 million and $1.3 million, respectively, and
travel, lodging and meals decreased by $0.2 million and $0.7 million,
respectively.
Interest
Income and Interest Expense (in thousands, except percentages)
|
|
Three months
ended
September 30, 2009
|
|
|
Three months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Interest
income
|
|
$ |
560 |
|
|
$ |
2,375 |
|
|
$ |
(1,815 |
) |
|
|
(76 |
)% |
Interest
expense
|
|
$ |
(2,928 |
) |
|
$ |
(3,988 |
) |
|
$ |
(1,060 |
) |
|
|
(27 |
)% |
|
|
Nine months
ended
September 30, 2009
|
|
|
Nine months
ended
September 30, 2008
|
|
|
Increase /
(Decrease)
2009 vs. 2008
|
|
|
Percentage
Increase /
(Decrease)
2009 vs. 2008
|
|
Interest
income
|
|
$ |
3,160 |
|
|
$ |
10,578 |
|
|
$ |
(7,418 |
) |
|
|
(70 |
)% |
Interest
expense
|
|
$ |
(9,213 |
) |
|
$ |
(11,835 |
) |
|
$ |
(2,622 |
) |
|
|
(22 |
)% |
The
decrease in interest income for the three months and nine months ended September
30, 2009, compared to the three months and nine months ended September 30, 2008,
is primarily attributable to lower interest rates and a lower average balance of
cash, cash equivalents, and short-term investments. The decrease in interest
expense for the three months and nine months ended September 30, 2009, compared
to the three months and nine months ended September 30, 2008, is primarily
attributable to a lower average balance of convertible subordinated notes
outstanding during 2009. We repurchased $100.0 million of the principal amount
of our 3.25% convertible subordinated notes in the fourth quarter of
2008.
Liquidity
and Capital Resources
We have
financed our operations primarily through revenue from partner 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
$275.7 million and indebtedness of $241.0 million, including $215.0 million of
3.25% convertible subordinated notes due September 2012, $20.7 million in
capital lease obligations, and $5.3 million in other liabilities as of September
30, 2009.
Due to
the recent adverse developments in the credit markets, 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 September 30, 2009, the average time to maturity of
the investments held in our portfolio was approximately six months and the
contractual maturity of any single investment did not 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 not more likely than not that we will 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 nine months ended September 30, 2009
totaled $90.5 million, which includes $4.9 million for employee bonus payments
related to services performed in 2008, $7.0 million for interest payments on our
convertible subordinated notes, $2.7 million for severance payments for
employees terminated in December 2008, and $75.9 million of other net operating
cash uses. 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. In October 2009, we received an upfront payment
of $125.0 million under the AstraZeneca License for the worldwide rights to
further develop and commercialize NKTR-118 and
NKTR-119. Additionally, one of our collaboration partners has a
one-time license extension option exercisable in December 2009. If this partner
elects to exercise this license extension option right, we will receive a cash
payment of $31.0 million in December 2009.
For the
nine months ended September 30, 2008, cash used in operations includes payments
to Bespak Europe Ltd. and Tech Group North America, Inc. of $39.9 million for
amounts due under our termination agreements with those companies related to the
Exubera inhaler contract manufacturing agreement, all of which was recorded as
an expense in 2007, $5.0 million to maintain Exubera inhaler manufacturing
capacity at Tech Group’s facility, and $5.3 million for severance, employee
benefits, and outplacement services in connection with our workforce reduction
plans.
Cash
flows from investing activities
We
purchased $10.8 million and $15.1 million of property and equipment in the nine
months ended September 30, 2009 and 2008, respectively. During the nine months
ended September 30, 2009, we paid $4.4 million of previously expensed
transaction costs related to the Novartis Pulmonary Asset Sale, which was
completed on December 31, 2008.
Cash
flows from financing activities
We
received $3.8 million from issuances of common stock to employees during the
nine months ended September 30, 2009, resulting in net cash provided by
financing activities. Cash used in financing activities were not
significant for the nine months ended September 30, 2008.
Contractual
Obligations
In the
three months ended September 30, 2009, we entered into a sublease for the
Mission Bay Facility which resulted in an increase of $21.3 million, in the
aggregate, in our contractual obligations for the years 2014 through
2020. Other than the Mission Bay Sublease, there were no other
material changes during the three or nine months ended September 30, 2009 to the
summary of contractual obligations included in our Annual Report on Form 10-K
for the year ended December 31, 2008.
Off-Balance
Sheet Arrangements
We do not
utilize off-balance sheet financing arrangements as a source of liquidity or
financing.
Recent
Accounting Pronouncements
FASB
Accounting Standards Update 2009-13, Revenue Recognition (Topic 605) –
Multiple-Deliverable Revenue Arrangements
In
October 2009, the FASB published FASB Accounting Standards Update 2009-13, which
amends the criteria to identify separate units of accounting within Subtopic
605-25, Revenue Recognition-Multiple-Element Arrangements. The
revised guidance also expands the disclosure required for multiple-element
revenue arrangements. FASB Accounting Standards Update 2009-13 is
effective for fiscal years beginning on or after June 15, 2010, and may be
applied retrospectively for all periods presented or prospectively to
arrangements entered into or materially modified after the adoption
date. Early adoption is permitted provided that the revised guidance
is retroactively applied to the beginning of the year of adoption. We
are currently evaluating the impact of adoption on our financial position and
our results of operations.
FASB
Accounting Standards Codification
In June
2009, the FASB issued SFAS No. 168, The FASB Accounting Standards
CodificationTM and the Hierarchy of Generally Accepted Accounting
Principles—a replacement of FASB Statement No. 162 (SFAS 168). The statement confirmed that
the FASB Accounting
Standards Codification
(the Codification) has become the single official source of authoritative
U.S. GAAP (other than guidance issued by the SEC), superseding existing FASB,
American Institute of Certified Public Accountants, Emerging Issues Task Force
(EITF), and related literature. Only one level of authoritative U.S. GAAP
exists. All other literature is now considered non-authoritative. The
Codification did not change U.S. GAAP; instead, it introduced a new structure.
The Codification, which changed the referencing of financial standards, became
effective for interim and annual periods ending on or after September 15, 2009.
We have applied the Codification beginning in this third quarter 2009 Form 10-Q
and as a result, the majority of references to historically issued accounting
pronouncements are now superseded by references to the FASB ASC. Certain
accounting pronouncements, such as SFAS 168, will remain authoritative until
they are integrated into the codification standard. The adoption of SFAS 168 has
not had a substantive impact on our Condensed Consolidated Financial Statements
or related footnotes.
Subsequent
Events
We
evaluated subsequent events through November 4, 2009, the date on which this
Quarterly Report on Form 10-Q was filed with the Securities and Exchange
Commission.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Our
market risks at September 30, 2009 have not changed significantly from those
discussed in Item 7A of our Annual Report on Form 10-K for the year ended
December 31, 2008 on file with the Securities and Exchange
Commission.
Item
4. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our Securities Exchange Act reports is
recorded, processed, summarized, and reported within the time periods specified
in the SEC’s rules and forms, 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 September 30, 2009 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
In the
three months ended September 30, 2009, the Audit Committee of the Board of
Directors approved approximately $32,500 in non-audit related services
related to tax compliance and advisory services to be provided by Ernst &
Young LLP, our independent registered public accounting firm.
PART
II: OTHER INFORMATION
Item
1. Legal Proceedings
Reference
is hereby made to our disclosures in “Legal Matters” under Note 5 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.
Item 1A. Risk
Factors
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, 2008. 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 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, 2008, 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 and there is a high risk of failure at every stage of development
and development failures can significantly harm our
business.
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 a 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 clinical results suggest that the drug candidate has potential as
a new therapy that may benefit patients. 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 early to mid-stage development such as Bayer’s Amikacin
Inhale, Oral NKTR-118 (oral PEGylated naloxol) and NKTR-119, Affymax’s Hematide,
and NKTR-102 (PEGylated irinotecan) in a number of oncology
indications. 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 risks and is very
uncertain.
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
recently announced positive Phase 2 clinical results for Oral NKTR-118 (oral
PEGylated naloxol), there are still substantial risks associated with the future
outcome of a Phase 3 clinical trial and the regulatory review process even
following our recent development and commercialization agreement with
AstraZeneca. In addition, although NKTR-102 (PEGylated irinotecan) continues in
active Phase 2 clinical development, there remains a significant uncertainty as
to clinical development results in all of the indications in which this drug
candidate is being studied and whether this drug candidate will eventually
receive regulatory approval or be a commercial success even if approved in any
of the 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 without limitation Oral NKTR-118, Oral NKTR-119, NKTR-102, NKTR-105
and other drug candidates currently in the discovery research or preclinical
development phases. If our PEGylation and advanced polymer conjugate
technologies fail to generate new drug candidates with positive clinical trial
results and approved drugs, our business, results of operations, and financial
condition would be materially harmed.
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 substantial portion of our research and development expenses and
develop and commercialize our product candidates. The timing of any future
partnership, as well as the terms and conditions of the partnership, will affect
our ability to benefit from the relationship. 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 or result in less future revenue than we anticipate,
our business, results of operations and financial condition could suffer. While
we received an upfront payment of $125.0 million pursuant to the AstraZeneca
license agreement we entered on September 20, 2009, we currently expect
revenue to decrease in 2009 as a result of the termination of our collaboration
agreements with Novartis Vaccines and Diagnostics, Inc. for Tobramycin
inhalation powder (“TIP”) and our assignment of our rights and obligations,
other than certain royalty rights, related to the Cipro Inhale program partnered
with Bayer AG, both of which occurred as a result of the Novartis
Pulmonary Asset Sale transaction. Revenue from the TIP and Cipro Inhale
collaboration agreements was $2.7 million and $2.9 million, or 13% and 13% of
revenue, respectively for the three months ended September 30, 2008 and $11.6
million and $7.7 million, or 19% and 12% of revenue, respectively, for the nine
months ended September 30 2008. We will not receive any revenue related to these
programs in 2009.
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 anticipated, 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 milestones 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.
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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 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 partner
companies 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.
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Given
these risks, the success of our current and future partnerships is highly
unpredictable and can have 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, if 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, if 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 to terminate clinical
trials, require additional clinical development or other testing at any phase of
development, 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, including in connection
with the Novartis Pulmonary Asset Sale, 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.
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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 (Novartis Pulmonary
Asset Sale), which was completed on December 31, 2008. Our agreements with
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
Novartis or any third party agreements impacted by this complex transaction. In
addition to the asset purchase, 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 BAY41-6551
with Bayer Healthcare LLC . We also entered into a service agreement pursuant to
which we have subcontracted to Novartis certain services to be performed related
to our partnered program for BAY41-6551 and a transition services agreement
pursuant to which Novartis and we will provide each other with specified
services for limited time periods following the closing of the Novartis
Pulmonary Asset Sale to facilitate the transition of the acquired assets and
business from us to Novartis.
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 in the future
regarding our collaborative contracts or the Novartis Pulmonary Asset Sale 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.
If we or our partners are not able to
manufacture drugs in quantities and at costs that are commercially feasible,
our proprietary and partnered product candidates may experience clinical
delays or constrained commercial supply which could significantly harm our
business.
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. In some cases, we may subcontract manufacturing or other
services. 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 BAY41-6551 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 BAY41-6551 and the Cipro Inhale program, require
significant device design, formulation development work and manufacturing
scale-up activities. As such, drug and device combinations are particularly
complex, expensive, time-consuming and uncertain due to the number of variables
involved in the final product design, including ease of patient/doctor use,
maintenance of clinical efficacy, cost of manufacturing, regulatory approval
requirements and standards and other important factors. 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
negatively impact our business, results of operations and financial
condition.
We purchase some of the raw 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
operating loss to the extent we cannot pass on increased costs to a
manufacturing customer.
The current crisis in global credit
and financial markets could materially and adversely affect our business,
results of operations and financial condition.
Financial
markets have experienced extreme disruption in recent months, including, among
other things, extreme volatility in security prices, severely diminished
liquidity and credit availability, rating downgrades of certain investments and
declining valuations. There could be further deterioration in credit and
financial markets and confidence in economic conditions. While we do not
currently require access to credit markets to finance our operations, these
economic developments are likely to affect our business in various ways. The
current tightening of credit in financial markets may harm the ability of our
partners to finance operations and they may dedicate fewer resources to our
partnered product candidates, which could result in delays in the regulatory
approval process and increase the estimated time to commercialization of our
product candidates. Since we expect that licensing deals, comprised of a
combination of upfront and contract research fees, milestones, manufacturing
product sales and product royalties, will represent the majority of our revenue
in 2009, such delays could harm our business, results of operations and
financial condition. Further, our partners may be unable to continue to develop
our partnered product candidates, and some partners may terminate our
collaborations. In addition, to date all of our revenue has come from payments
from partners, and it may become more difficult to collect any payments due from
our partners on a timely basis, or at all. The economic crisis may also affect
the ability of suppliers of starting materials to meet our capacity requirements
or cause them to increase the price of starting materials. We are unable to
predict the likely duration and severity of the current disruption in financial
markets and adverse economic conditions in the U.S. and other countries. As a
result of the worldwide economic slowdown, it is extremely difficult for us and
our partners to forecast future sales levels based on historical information and
trends.
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
approximately 80 U.S. and approximately 335 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. 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
to these changes. 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.
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 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. The failure to obtain licenses on commercially reasonable
terms, or at all, if needed, would have a material adverse effect on
us.
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 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.
In the
three months and nine months ended September 30, 2009, we reported net losses of
$31.0 million and $94.8 million, respectively. If and when we achieve
profitability depends upon a number of factors, including the timing and
recognition of milestone payments and license fees received, the timing of
revenue under 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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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.
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If we do not generate sufficient cash
flow through increased revenue or raising additional capital, we may not be
able to meet our substantial debt obligations.
As of
September 30, 2009, we had cash, cash equivalents, and short-term investments in
marketable securities valued at approximately $275.7 million and approximately
$241.0 million of indebtedness, including approximately $215.0 million in
convertible subordinated notes due September 2012, $20.7 million in capital
lease obligations, and $5.3 million of other long-term liabilities. We expect to
use a substantial portion of our cash to fund our ongoing operations over the
next few years. In October and November 2008, we repurchased approximately
$100.0 million in par value of our 3.25% convertible subordinated notes for an
aggregate purchase price of $47.8 million.
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 proprietary product development
programs.
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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 subordinated notes, since the market price of our common
stock is significantly below the conversion price, the holders of our
outstanding convertible subordinated 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 subordinated 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 otherwise restructure our obligations. Any such
financing or restructuring may not be available to us on commercially acceptable
terms, if at all.
If we cannot raise additional
capital, our financial condition will suffer.
We have
no material credit facility or other material committed sources of capital. To
the extent operating and capital resources are insufficient to meet our future
capital needs, we will have to raise additional funds from new collaboration
partnerships or the capital markets to continue the marketing and development of
our technologies and proprietary products. Such funds may not be available on
favorable terms, if at all. We may be unable to obtain suitable new
collaboration partners on attractive terms and our substantial indebtedness may
limit our ability to obtain additional capital markets financing. If adequate
funds are not available on reasonable terms, we may be required to curtail
operations significantly or obtain funds by entering into financing, supply or
collaboration agreements on unattractive terms. Our inability to raise capital
could harm our business and our stock price. To the extent that additional
capital is raised through the sale of equity or convertible debt securities, the
issuance of such securities would result in dilution to our
stockholders.
If government and private insurance
programs do not provide 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 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 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. Though we rely heavily on these parties for successful
execution of our clinical trials and 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.
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.,
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 BAY41-6551 (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 Oral NKTR-118 (PEGylated naloxol), there are
currently several alternative therapies used to address opioid-induced
constipation (OIC) and opioid-induced bowel dysfunction (OBD), including
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., Pfizer (via Wyeth acquisition completed in 2009),
Mundipharma Int. Limited, Sucampo Pharmaceuticals and Takeda Pharmaceutical
Company Limited. For NKTR-102 (PEG-irinotecan), there are a number of approved
therapies for the treatment of colorectal cancer, including Eloxatin, Camptosar,
Avastin, Erbitux, Vectibux, Xeloda, Adrucil and Wellcovorin. 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 are
also a number of chemotherapies and cancer therapies approved today and in
various stages of clinical development for ovarian, breast and cervical cancers
including but not limited to: Avastin® (bevacizumab), Camptosar® (irinotecan),
Doxil® (doxorubicin HCl ), Ellence® (epirubicin), Gemzar® (gemcitabine),
Herceptin® (trastuzumab), Hycamtin® (topotecan), Paraplatin®
(carboplatin), and Taxol® (paclitaxel). These therapies are only partially
effective in treating ovarian, breast or cervical cancers. Major
pharmaceutical or biotechnology companies with approved drugs or drugs in
development for these cancers include Bristol-Meyers Squibb, Genentech, Inc.,
GlaxoSmithKline plc, Johnson and Johnson, Pfizer, Inc., Eli Lilly & Co., and
many others.
There can
be no assurance that we or our partners will successfully develop, obtain
regulatory approvals 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. The third party often bases its
assertions on a claim that its patents cover our technology. 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 Roche’s proposed marketing and sale of
MIRCERA to treat chemotherapy anemia in the U.S. Amgen prevailed in this lawsuit
and a U.S. federal district court issued an injunction preventing Roche from
marketing and selling MIRCERA in the U.S. Third-party claims 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
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. 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 or products that we would not otherwise
relinquish.
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. 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 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 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 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.
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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
senior convertible debt are expected to remain volatile.
Our stock
price is volatile. During the three months ended September 30, 2009, based on
closing bid prices on the NASDAQ Global Select Market, our stock price ranged
from $5.89 to $10.47 per share. We expect our stock price to remain volatile. In
addition, as our convertible senior 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 senior 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 senior
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.
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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 or the future issuances of
securities.
We may
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 adversely affect the price of our
securities.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
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 September 30, 2009.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Submission of Matters to a Vote of Security Holders
None.
Item
5. Other Information
None.
Item 6. Exhibits
Except as
so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Quarterly Report on Form 10-Q.
Exhibit
Number
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Description of Documents
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10.1(1)
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License
Agreement by and between AstraZeneca AB and Nektar Therapeutics, dated
September 20, 2009.+
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10.2(1)
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Sublease,
dated as of September 30, 2009, between Pfizer Inc. and Nektar
Therapeutics.+
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31.1(1)
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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(1)
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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(1)*
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Section
1350
Certifications.
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+
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Confidential
treatment with respect to specific portions of this Exhibit has been
requested, and such portions are omitted and have been filed separately
with the SEC.
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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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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.
By:
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/s/ John
Nicholson
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John
Nicholson
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Senior
Vice President and Chief Financial Officer
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Date:
November 4, 2009
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By:
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/s/ Jillian B.
Thomsen
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Jillian
B. Thomsen
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Vice
President and Chief Accounting Officer
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Date:
November 4, 2009
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Except as
so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference in, this Quarterly Report on Form 10-Q.
Exhibit
Number
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Description of Documents
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10.1(1)
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License
Agreement by and between AstraZeneca AB and Nektar Therapeutics, dated
September 20, 2009.+
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10.2(1)
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Sublease,
dated as of September 30, 2009, by and between Pfizer Inc. and Nektar
Therapeutics.+
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31.1(1)
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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(1)
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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(1)*
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Section
1350
Certifications.
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+
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Confidential
treatment with respect to specific portions of this Exhibit has been
requested, and such portions are omitted and have been filed separately
with the SEC.
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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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