Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
______________________
FORM
10-Q
______________________
ý
|
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
|
For
the quarterly period ended March 31, 2010
or
¨
|
|
TRANSITION
REPORTS PURSUANT TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
|
For
the transition period from _______________ to _______________
Commission
File Number: 0-24006
______________________
NEKTAR
THERAPEUTICS
(Exact
name of registrant as specified in its charter)
______________________
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 þ 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 þ
|
|
Non-accelerated
filer ¨
(Do
not check if a smaller reporting company)
|
|
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 þ
The
number of outstanding shares of the registrant’s Common Stock, $0.0001 par
value, was 94,058,037 on April 30, 2010.
NEKTAR
THERAPEUTICS
INDEX
PART
I: FINANCIAL INFORMATION
|
1
|
|
|
Item
1. Condensed Consolidated Financial Statements —
Unaudited:
|
1
|
|
|
Condensed
Consolidated Balance Sheets — March 31, 2010 and December 31,
2009
|
1
|
|
|
Condensed
Consolidated Statements of Operations for the three months ended March 31,
2010 and 2009
|
2
|
|
|
Condensed
Consolidated Statements of Cash Flows for the three months ended March 31,
2010 and 2009
|
3
|
|
|
Notes
to Condensed Consolidated Financial Statements
|
4
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
|
11
|
|
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
15
|
|
|
Item
4. Controls and Procedures
|
15
|
|
|
PART
II: OTHER INFORMATION
|
17
|
|
|
Item
1. Legal Proceedings
|
17
|
|
|
Item
1A. Risk Factors
|
17
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
27
|
|
|
Item
3. Defaults Upon Senior Securities
|
27
|
|
|
Item
4. Submission of Matters to a Vote of Security Holders
|
28
|
|
|
Item
5. Other Information
|
28
|
|
|
Item
6. Exhibits
|
28
|
|
|
Signatures
|
29
|
This
report includes “forward-looking statements” within the meaning of Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section
21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All
statements other than statements of historical fact are “forward-looking
statements” for purposes of this quarterly report on Form 10-Q, including any
projections of earnings, revenue or other financial items, any statements
regarding the plans and objectives of management for future operations
(including, but not limited to, pre-clinical development, clinical trials and
manufacturing), any statements concerning proposed drug candidates or other new
products or services, any statements regarding future economic conditions or
performance, any statements regarding 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, Inc. 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, any statement regarding our plans and objectives for our
collaboration with Bayer Healthcare LLC entered into in August 2007 for
BAY41-6551 (NKTR-061 or Amikacin Inhale), including plans and objectives to
initiate Phase 3 clinical trials, any statements regarding the plans and timing
of any transaction regarding NKTR-102, and any statements of assumptions
underlying any of the foregoing. In some cases, forward-looking statements can
be identified by the use of terminology such as “may,” “will,” “expects,”
“plans,” “anticipates,” “estimates,” “potential” or “continue,” or the negative
thereof or other comparable terminology. Although we believe that the
expectations reflected in the forward-looking statements contained herein are
reasonable, such expectations or any of the forward-looking statements may prove
to be incorrect and actual results could differ materially from those projected
or assumed in the forward-looking statements. Our future financial condition and
results of operations, as well as any forward-looking statements, are subject to
inherent risks and uncertainties, including, but not limited to, the risk
factors set forth in Part II, Item 1A “Risk Factors” below and for the reasons
described elsewhere in this quarterly report on Form 10-Q. All forward-looking
statements and reasons why results may differ included in this report are made
as of the date hereof and we do not intend to update any forward-looking
statements except as required by law or applicable regulations. Except where the
context otherwise requires, in this quarterly report on Form 10-Q, the
“Company,” “Nektar,” “we,” “us,” and “our” refer to Nektar Therapeutics, a
Delaware corporation, and, where appropriate, its subsidiaries.
Trademarks
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.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except per share information)
(Unaudited)
|
|
March
31,
2010
|
|
|
December
31,
2009
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
20,572 |
|
|
$ |
49,597 |
|
Short-term
investments
|
|
|
341,386 |
|
|
|
346,614 |
|
Accounts
receivable, net of allowance of $306 at March 31, 2010
and
nil at December 31, 2009, respectively
|
|
|
7,709 |
|
|
|
4,801 |
|
Inventory
|
|
|
8,703 |
|
|
|
6,471 |
|
Other
current assets
|
|
|
7,101 |
|
|
|
6,183 |
|
Total
current assets
|
|
$ |
385,471 |
|
|
$ |
413,666 |
|
Property
and equipment, net
|
|
|
82,650 |
|
|
|
78,263 |
|
Goodwill
|
|
|
76,501 |
|
|
|
76,501 |
|
Other
assets
|
|
|
3,887 |
|
|
|
7,088 |
|
Total
assets
|
|
$ |
548,509 |
|
|
$ |
575,518 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
5,664 |
|
|
$ |
3,066 |
|
Accrued
compensation
|
|
|
5,704 |
|
|
|
10,052 |
|
Accrued
clinical trial expenses
|
|
|
13,615 |
|
|
|
14,167 |
|
Accrued
expenses
|
|
|
5,708 |
|
|
|
4,354 |
|
Deferred
revenue, current portion
|
|
|
90,465 |
|
|
|
115,563 |
|
Other
current liabilities
|
|
|
4,489 |
|
|
|
5,814 |
|
Total
current liabilities
|
|
$ |
125,645 |
|
|
$ |
153,016 |
|
Convertible
subordinated notes
|
|
|
214,955 |
|
|
|
214,955 |
|
Capital
lease obligations
|
|
|
18,352 |
|
|
|
18,800 |
|
Deferred
revenue
|
|
|
75,339 |
|
|
|
76,809 |
|
Deferred
gain
|
|
|
4,808 |
|
|
|
5,027 |
|
Other
long-term liabilities
|
|
|
4,656 |
|
|
|
4,544 |
|
Total
liabilities
|
|
$ |
443,755 |
|
|
$ |
473,151 |
|
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 March 31, 2010
and December 31, 2009
|
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 300,000 shares authorized; 93,918 shares and
93,281 shares issued and outstanding at March 31, 2010 and December 31,
2009, respectively
|
|
|
9 |
|
|
|
9 |
|
Capital
in excess of par value
|
|
|
1,336,462 |
|
|
|
1,327,942 |
|
Accumulated
other comprehensive income
|
|
|
1,022 |
|
|
|
1,025 |
|
Accumulated
deficit
|
|
|
(1,232,739
|
) |
|
|
(1,226,609
|
) |
Total
stockholders’ equity
|
|
|
104,754 |
|
|
|
102,367 |
|
Total
liabilities and stockholders’ equity
|
|
$ |
548,509 |
|
|
$ |
575,518 |
|
The accompanying notes are an
integral part of these condensed consolidated financial
statements.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share information)
(Unaudited)
|
|
Three
months ended
March 31,
|
|
|
|
2010
|
|
|
2009
|
|
Revenue:
|
|
|
|
|
|
|
Product
sales and royalties
|
|
$ |
3,584 |
|
|
$ |
6,470 |
|
License,
collaboration, and other
|
|
|
29,653 |
|
|
|
3,241 |
|
Total
revenue
|
|
|
33,237 |
|
|
|
9,711 |
|
Operating
costs and expenses:
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
4,296 |
|
|
|
5,626 |
|
Research
and development
|
|
|
23,286 |
|
|
|
23,363 |
|
General
and administrative
|
|
|
9,013 |
|
|
|
11,020 |
|
Total
operating costs and expenses
|
|
|
36,595 |
|
|
|
40,009 |
|
Loss
from operations
|
|
|
(3,358 |
) |
|
|
(30,298 |
) |
Non-operating
income (expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
463 |
|
|
|
1,650 |
|
Interest
expense
|
|
|
(2,951 |
) |
|
|
(3,337 |
) |
Other
income (expense), net
|
|
|
24 |
|
|
|
45 |
|
Total
non-operating expense
|
|
|
(2,464 |
) |
|
|
(1,642 |
) |
Loss
before provision for income taxes
|
|
|
(5,822 |
) |
|
|
(31,940 |
) |
Provision
for (benefit from) income taxes
|
|
|
308 |
|
|
|
(133 |
) |
Net
loss
|
|
$ |
(6,130 |
) |
|
$ |
(31,807 |
) |
Basic
and diluted net loss per share
|
|
$ |
(0.07 |
) |
|
$ |
(0.34 |
) |
Shares
used in computing basic and diluted net loss per share
|
|
|
93,631 |
|
|
|
92,516 |
|
The accompanying
notes are an integral part of these condensed consolidated financial statements.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
|
|
Three
months ended
March 31,
|
|
|
|
2010
|
|
|
2009
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(6,130 |
) |
|
$ |
(31,807 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
4,149 |
|
|
|
3,615 |
|
Stock-based
compensation
|
|
|
3,744 |
|
|
|
2,325 |
|
Other
non-cash transactions
|
|
|
(235 |
) |
|
|
115 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(2,908 |
) |
|
|
5,365 |
|
Inventory
|
|
|
(2,232 |
) |
|
|
(4,073 |
) |
Other
assets
|
|
|
(883 |
) |
|
|
496 |
|
Accounts
payable
|
|
|
1,748 |
|
|
|
(8,095 |
) |
Accrued
compensation
|
|
|
(4,348 |
) |
|
|
(6,133 |
) |
Accrued
clinical trial expenses
|
|
|
(552 |
) |
|
|
(2,640 |
) |
Accrued
expenses
|
|
|
1,354 |
|
|
|
3,364 |
|
Deferred
revenue
|
|
|
(26,568 |
) |
|
|
(3,029 |
) |
Other
liabilities
|
|
|
(1,302 |
) |
|
|
(1,897 |
) |
Net
cash used in operating activities
|
|
$ |
(34,163 |
) |
|
$ |
(42,394 |
) |
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases
of investments
|
|
|
(115,277 |
) |
|
|
(85,298 |
) |
Maturities
of investments
|
|
|
112,074 |
|
|
|
104,458 |
|
Sales
of investments
|
|
|
8,197 |
|
|
|
- |
|
Purchases
of property and equipment
|
|
|
(3,973 |
) |
|
|
(5,104 |
) |
Transaction
costs from Novartis pulmonary asset sale
|
|
|
- |
|
|
|
(4,766 |
) |
Net
cash provided by investing activities
|
|
$ |
1,021 |
|
|
$ |
9,290 |
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Payments
of loan and capital lease obligations
|
|
|
(359 |
) |
|
|
(302 |
) |
Proceeds
from issuances of common stock
|
|
|
4,776 |
|
|
|
61 |
|
Net
cash provided by (used in) financing activities
|
|
$ |
4,417 |
|
|
$ |
(241 |
) |
Effect
of exchange rates on cash and cash equivalents
|
|
|
(300 |
) |
|
|
61 |
|
Net
decrease in cash and cash equivalents
|
|
$ |
(29,025 |
) |
|
$ |
(33,284 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
49,597 |
|
|
|
155,584 |
|
Cash
and cash equivalents at end of period
|
|
$ |
20,572 |
|
|
$ |
122,300 |
|
The accompanying notes are an
integral part of these condensed consolidated financial statements.
NEKTAR
THERAPEUTICS
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March
31, 2010
(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
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 Sheets. To date, such cumulative translation adjustments
have not been material to our consolidated financial position.
Revenue,
expenses, assets, and liabilities can vary during each quarter of the year.
Therefore, the results and trends in these interim Condensed Consolidated
Financial Statements may not be the same as those for the full
year.
The
accompanying Condensed Consolidated Balance Sheet as of March 31, 2010, the
Condensed Consolidated Statements of Operations for the three months ended March
31, 2010 and 2009, and the Condensed Consolidated Statements of Cash Flows for
the three months ended March 31, 2010 and 2009 are unaudited. The Condensed
Consolidated Balance Sheet data as of December 31, 2009 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 2, 2010. 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, 2009.
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
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 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.
License,
collaboration and other
We enter
into technology license agreements and collaborative research and development
arrangements with pharmaceutical and biotechnology partners that may involve
multiple deliverables. Our arrangements may contain one or more of the following
elements: upfront fees, contract research, milestone payments, manufacturing and
supply, royalties, and license fees. Each deliverable in the arrangement is
evaluated to determine whether it meets the criteria to be accounted for as a
separate unit of accounting or whether it should be combined with other
deliverables. Revenue is recognized for each element when there is
persuasive evidence that an arrangement exists, delivery has occurred, the price
is fixed or determinable, and collection is reasonably assured.
Upfront
fees received for license and collaborative agreements are recognized ratably
over our expected performance period under the
arrangement. Management makes its best estimate of the period over
which we expect to fulfill our performance obligations, which may include
technology transfer assistance, clinical development activities, and
manufacturing activities from development through the commercialization of the
product. Given the uncertainties of research and development
collaborations, significant judgment is required to determine the duration of
the performance period.
Performance
milestones payments received are deferred and recorded as revenue ratably over
the period of time from the achievement of the milestone and our estimated date
on which the next milestone will be achieved. Management makes its
best estimate of the period of time until the next milestone is
reached. Final milestone payments are recorded and recognized upon
achieving the respective milestone, provided that collection is reasonably
assured.
The
original estimated amortization periods for upfront fees and milestone payments
are periodically evaluated to determine if circumstances have caused the
estimate to change and if so, amortization of revenue is adjusted
prospectively.
Income
Taxes
We
recorded a net income tax provision for our operations in India at an effective
tax rate of 34%. The U.S. Federal deferred tax asset generated from
our net operating loss has been fully reserved.
We
account for income taxes under the liability method, in which deferred tax
assets and liabilities are determined based on differences between the financial
reporting and tax reporting bases of assets and liabilities and are measured
using enacted tax rates and laws that are expected to be in effect when the
differences are expected to reverse. Realization of deferred tax assets is
dependent upon future earnings, the timing and amount of which are
uncertain.
Recent
Accounting Pronouncements
In
October 2009, the FASB published FASB Accounting Standards Update (ASU) 2009-13,
which amends the criteria to identify separate units of accounting within
Subtopic 605-25, “Revenue Recognition-Multiple-Element Arrangements”. The
revised guidance also expands the disclosure required for multiple-element
revenue arrangements. FASB ASU No. 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 results of operations.
FASB
ASU 2010-17, Revenue Recognition - Milestone Method (Topic 605): Milestone
Method of Revenue Recognition
In April
2010, the FASB codified the consensus reached in Emerging Issues Task Force
Issue No. 08-09, “Milestone Method of Revenue Recognition.” FASB ASU
No. 2010-17 provides guidance on defining a milestone and determining when it
may be appropriate to apply the milestone method of revenue recognition for
research and development transactions. FASB ASU No. 2010 – 17 is
effective for fiscal years beginning on or after June 15, 2010, and is effective
on a prospective basis for milestones achieved 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
results of operations.
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
|
|
|
|
March
31,
2010
|
|
|
December
31,
2009
|
|
Cash
and cash equivalents
|
|
$
|
20,572
|
|
|
$
|
49,597
|
|
Short-term
investments (less than one year to maturity)
|
|
|
341,386
|
|
|
|
346,614
|
|
Total
cash, cash equivalents, and available-for-sale investments
|
|
$
|
361,958
|
|
|
$
|
396,211
|
|
Our
portfolio of cash, cash equivalents, and available-for-sale investments includes
(in thousands):
|
|
Estimated
Fair Value at
|
|
|
|
March
31,
2010
|
|
|
December
31,
2009
|
|
Cash
and money market funds
|
|
$
|
20,572
|
|
|
$
|
33,104
|
|
Obligations
of U.S. corporations
|
|
|
175,022
|
|
|
|
160,458
|
|
Obligations
of U.S. government agencies
|
|
|
99,451
|
|
|
|
125,731
|
|
U.S.
corporate commercial paper
|
|
|
61,912
|
|
|
|
71,923
|
|
Obligations
of U.S. states and municipalities
|
|
|
5,001
|
|
|
|
4,995
|
|
Total
cash, cash equivalents, and available-for-sale investments
|
|
$
|
361,958
|
|
|
$
|
396,211
|
|
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. We use a market approach to value our Level 2
investments. The disclosed fair value related to our investments is
based primarily on the reported fair values in our period-end brokerage
statements. We independently validate these fair values using
available market quotes and other information.
Our
investments in debt securities are subject to interest rate risk. To minimize
the exposure due to an adverse shift in interest rates, we invest in short-term
securities and maintain a weighted average maturity of one year or less. At
March 31, 2010 and December 31, 2009, the average portfolio duration was
approximately five months and the contractual maturity of any single investment
did not exceed twelve months.
Gross
unrealized gains and losses were insignificant at March 31, 2010 and at December
31, 2009. The gross unrealized losses were primarily due to changes
in interest rates on fixed income securities. Based on our available cash and
our expected operating cash requirements we do not intend to sell these
securities and it is more likely than not that we will not be required to sell
these securities before we recover the amortized cost basis. Accordingly, we
believe there are no other-than-temporary impairments on these securities and
have not recorded a provision for impairment.
The
following table represents the fair value hierarchy for our financial assets
measured at fair value on a recurring basis as of March 31, 2010 (in
thousands):
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
Total
|
|
Money
market funds
|
|
$
|
16,315
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,315
|
|
Obligations
of U.S. corporations
|
|
|
—
|
|
|
|
175,022
|
|
|
|
—
|
|
|
|
175,022
|
|
Obligations
of U.S. government agencies
|
|
|
—
|
|
|
|
99,451
|
|
|
|
—
|
|
|
|
99,451
|
|
U.S.
corporate commercial paper
|
|
|
—
|
|
|
|
61,912
|
|
|
|
—
|
|
|
|
61,912
|
|
Obligations
of U.S. states and municipalities
|
|
|
—
|
|
|
|
5,001
|
|
|
|
—
|
|
|
|
5,001
|
|
Cash
equivalents and available-for-sale investments
|
|
$
|
16,315
|
|
|
$
|
341,386
|
|
|
$
|
—
|
|
|
$
|
357,701
|
|
Cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,257
|
|
Cash,
cash equivalents, and available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
361,958
|
|
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.
|
Inventory
consists of the following (in thousands):
|
|
March
31,
2010
|
|
|
December
31,
2009
|
|
Raw
materials
|
|
$
|
6,195
|
|
|
$
|
5,937
|
|
Work-in-process
|
|
|
2,110
|
|
|
|
—
|
|
Finished
goods
|
|
|
398
|
|
|
|
534
|
|
Total
|
|
$
|
8,703
|
|
|
$
|
6,471
|
|
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 $4.8 million and $3.3
million as of March 31, 2010 and December 31, 2009, 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 - 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, rulings, advice
of legal counsel, and other information and events pertaining to a particular
case. Litigation is inherently unpredictable. If any unfavorable ruling were to
occur in any specific period, there exists the possibility of a material adverse
impact on the results of operations of that period or on our cash flows and
liquidity.
As part
of our collaboration agreements with our partners related to the license,
development, manufacture and supply of drugs based on our proprietary
technologies, we generally agree to defend, indemnify and hold harmless our
partners from and against third party liabilities arising out of the applicable
agreements, 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 March
31, 2010 or December 31, 2009.
Note 5 —License and Collaboration
Agreements
We have
entered into various license agreements and collaborative research and
development agreements with pharmaceutical and biotechnology companies. Under
these arrangements, we are entitled to receive license fees, upfront payments,
milestone payments when and if certain development or regulatory milestones are
achieved, and/or reimbursement for research and development activities. All of
our research and development agreements are generally cancelable by our partners
without significant financial penalty to the partner. Our costs of performing
these services are included in Research and development expense.
In
accordance with these agreements, we recorded License, collaboration and other
revenue as follows (in thousands):
|
|
|
|
Three
months ended
March 31,
|
|
Partner
|
|
Agreement
|
|
2010
|
|
|
2009
|
|
AstraZeneca
AB
|
|
NKTR-118
and NKTR-119
|
|
$ |
25,726 |
|
|
$ |
— |
|
Bayer
Healthcare LLC
|
|
BAY41-6651
(NKTR-061, Amikacin Inhale)
|
|
|
887 |
|
|
|
1,396 |
|
F.
Hoffmann La-Roche
|
|
Pegasys
|
|
|
1,283 |
|
|
|
20 |
|
Other
|
|
|
|
|
1,757 |
|
|
|
1,825 |
|
License,
collaboration, and other revenue
|
|
|
|
$ |
29,653 |
|
|
$ |
3,241 |
|
In
addition, we have recorded deferred revenue relating to these agreements in our
Condensed Consolidated Balance Sheets as follows (in thousands):
|
|
|
|
March
31,
|
|
|
December
31,
|
|
Partner
|
|
Agreement
|
|
2010
|
|
|
2009
|
|
AstraZeneca
AB
|
|
NKTR-118
and NKTR-119
|
|
$ |
76,042 |
|
|
$ |
101,389 |
|
Bayer
Healthcare LLC
|
|
BAY41-6651
(NKTR-061, Amikacin Inhale)
|
|
|
32,900 |
|
|
|
33,786 |
|
F.
Hoffmann La-Roche
|
|
Pegasys
|
|
|
29,503 |
|
|
|
30,785 |
|
Other
|
|
|
|
|
27,359 |
|
|
|
26,412 |
|
Total
Deferred Revenue
|
|
|
|
|
165,804 |
|
|
|
192,372 |
|
Less:
current portion
|
|
|
|
|
(90,465 |
) |
|
|
(115,563 |
) |
Deferred
Revenue, non-current
|
|
|
|
$ |
75,339 |
|
|
$ |
76,809 |
|
AstraZeneca
AB
NKTR-118
and NKTR-119
On
September 20, 2009, we entered into a License Agreement with AstraZeneca AB, a
Swedish corporation (AstraZeneca), under which we granted AstraZeneca a
worldwide, exclusive, perpetual, royalty-bearing, and sublicensable license
under our patents and other intellectual property to develop, sell and otherwise
commercially exploit Oral NKTR-118 and NKTR-119. AstraZeneca will
bear all costs associated with research, development and commercialization and
will control product development and commercialization decisions for Oral
NKTR-118 and NKTR-119.
Under the
terms of the agreement, AstraZeneca paid us an upfront payment of $125.0
million. We expect to amortize the remaining deferred revenue over the
performance obligation period which is expected to conclude with the completion
of the technology transfer at the end of 2010.
Bayer
Healthcare LLC
BAY41-6651
(NKTR-061, Amikacin Inhale)
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
(BAY41-6651). We are responsible for any future development of the nebulizer
device included in the Amikacin product through the completion of Phase 3
clinical trial, scale-up for commercialization, and commercial manufacturing and
supply. Bayer Healthcare LLC is responsible for most future clinical development
and commercialization costs, all activities to support worldwide regulatory
filings, approvals and related activities, further development of BAY41-6651 and
final product packaging.
We
received an upfront payment of $40.0 million in 2007 and performance milestone
payments of $20.0 million. We expect to amortize the remaining
deferred revenue related to the upfront payment through July 2021, the estimated
end of the life of the agreement. We expect to amortize the remaining
deferred revenue related to the milestone payments through December
2010.
F.
Hoffmann La-Roche Ltd and Hoffmann-LaRoche Inc.
PEGASYS
In
February 1997, we entered into a license, manufacturing and supply agreement
with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), under which we
granted Roche a worldwide, exclusive license to use certain PEGylation materials
in the manufacture of PEGASYS. As a result of Roche exercising a license
extension option in December 2009, beginning in 2010 Roche has the right to
manufacture all of its requirements for our proprietary PEGylation materials for
PEGASYS and we would perform additional manufacturing, if any, only on an as
requested basis.
In
connection with Roche’s exercise of the license option extension in December
2009, we received a payment of $31.0 million. We expect to
amortize the remaining deferred revenue through December 2015, which is the
period through which we are required to provide back-up manufacturing and supply
services on an as-requested basis.
Note
6 – Stock-Based Compensation
Total
stock-based compensation expense was recorded in our Condensed Consolidated
Financial Statements as follows (in thousands):
|
|
Three
months ended
March 31,
|
|
|
|
2010
|
|
|
2009
|
|
Cost
of goods sold, net of inventory change
|
|
$ |
38 |
|
|
$ |
75 |
|
Research
and development expense
|
|
|
1,461 |
|
|
|
662 |
|
General
and administrative expense
|
|
|
2,245 |
|
|
|
1,588 |
|
Total
stock-based compensation costs
|
|
$ |
3,744 |
|
|
$ |
2,325 |
|
|
|
|
|
|
|
|
|
|
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
March 31, 2010
|
|
2010
(remaining 9 months)
|
|
$ |
11,858 |
|
2011
|
|
|
13,999 |
|
2012
|
|
|
9,503 |
|
2013
|
|
|
6,671 |
|
2014
and thereafter
|
|
|
617 |
|
|
|
$ |
42,648 |
|
Summary
of Stock Option Activity
During
the three months ended March 31, 2010 and 2009, we granted 3,756,925 and
3,202,200 stock options, respectively. The weighted average grant-date fair
value of options granted during the three-months ended March 31, 2010 and 2009
was $5.97 per share and $2.41 per share, respectively.
Black-Scholes
Assumptions
The fair
values of stock-based awards are based on estimates as of the date of grant
using the Black-Scholes option valuation model with the following
weighted-average assumptions:
|
Three months ended March
31,
|
|
2010
|
|
2009
|
Average
risk-free interest rate
|
1.9%
|
|
1.5%
|
Volatility
factor
|
63.0%
|
|
59.7%
|
Dividend
yield
|
0.0%
|
|
0.0%
|
Weighted
average expected life
|
4.8
years
|
|
5.0
years
|
The
average risk-free interest rate is based on the U.S. treasury yield curve in
effect at the time of grants for periods commensurate with the expected term of
the stock-based award. Our estimate of expected volatility is based
on the daily historical trading data of our common stock over a historical
period commensurate with the expected term of the stock-based
award. We have never paid dividends, nor do we expect to pay
dividends in the foreseeable future; therefore, we used a dividend yield of
0.0%.
For the
three months ended March 31, 2010, we estimated the weighted-average expected
life based on the contractual and vesting terms of the stock options, as well as
historic cancellation and historic exercise data. Previously, the
weighted-average expected life was determined using the “simplified” method, in
which the expected life was based on the average of the vesting term and the
contractual term of the option, as permitted under Staff Accounting Bulletin
Topic 14.D.2. The change did not result in a material difference in
weighted average expected life.
For the
three months ended March 31, 2010, the estimated annual forfeiture rate for
director options and restricted stock units awards (RSU), employee options and
RSU awards, and performance-based RSU awards utilized was 0%, 11%, and 25%
respectively. For the three months ended March 31, 2009, the
estimated annual forfeiture rate for director options and RSU awards, employee
options, and employee RSU awards was estimated to be 15%, 11%, and 25%,
respectively.
Note
7—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 March
31,
|
|
|
|
2010
|
|
|
2009
|
|
Convertible
subordinated notes
|
|
|
9,989 |
|
|
|
9,989 |
|
Stock
options
|
|
|
8,544 |
|
|
|
14,585 |
|
Total
|
|
|
18,533 |
|
|
|
24,574 |
|
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
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 targeted at 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 substantially improve the pharmacokinetics, half-life, oral
bioavailability, metabolism or distribution of drugs to improve their
therapeutic efficacy.
We
continue to make substantial investments to advance our pipeline of drug
candidates from early stage discovery research through clinical development. We
have several Phase 2 clinical trials for NKTR-102 (PEGylated irinotecan)
directed at a number of different oncology indications including ovarian,
breast, and colorectal cancers. In addition, we have an ongoing Phase
1 clinical trial for NKTR-105 (PEGylated docetaxel) for patients with refractory
solid tumors. We also have other products in early discovery research
or preclinical 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 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 the timing and outcome of clinical
trial 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.
We decide
on a program-by-program 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 global
markets. To date, we have partnered our proprietary drug development
programs prior to Phase 3 clinical development. We intend to explore
a variety of structures for a collaboration partnership for NKTR-102 in order to
seek to maximize the value of this drug candidate. Whether we
ultimately enter into a collaboration agreement for NKTR-102 will depend on the
partnership and other opportunities that may be available to us. The
financial 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. There can be no assurance that any future collaborations
will be available to us for NKTR-102 or other of our development programs, on
commercially favorable terms or at all.
We also
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), UCB’s CIMZIA, Roche’s MIRCERA and Affymax’s Hematide, among others,
will together have a material impact on our long-term financial results and
financial condition, 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 numerous risks and uncertainties, there is a
risk that our future revenue from one or more of these agreements will be less
than we anticipate.
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 are 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.
Key
Developments and Trends in Liquidity and Capital Resources
At March
31, 2010, we had approximately $362.0 million in cash, cash equivalents, and
short-term investments and $240.5 million in indebtedness. We may from time to
time purchase or retire convertible subordinated notes through cash purchase or
exchanges for our other securities 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 approximately $100.0
million in par value of our 3.25% convertible subordinated notes for an
aggregate purchase price of $47.8 million. 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.
In 2010,
we plan to relocate all of our functions currently located in San Carlos,
California, including our corporate headquarters, to a facility in the Mission
Bay area of San Francisco, California, which we have subleased from Pfizer
Inc. In 2010, in connection with the move, we expect to spend
approximately $25.0 million for tenant improvements to complete the Mission Bay
Facility and office and laboratory equipment.
We have
financed our operations primarily through revenue from product sales and
royalties, development and commercialization collaboration contracts and debt
and equity financings. In October 2009, we received a payment of $125.0 million
from AstraZeneca under the license agreement we entered with AstraZeneca AB
dated September 20, 2009 (AstraZeneca License) as an upfront payment for the
worldwide rights to further develop and commercialize Oral NKTR-118 and
NKTR-119. In December 2009, we also received a payment of $31.0
million from the exercise of a license option extension by one of our existing
collaboration partners. Similar to 2009, the results of our
collaboration partnering efforts will also have a material impact on our cash
position at the end of 2010. 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.
Results
of Operations
Three
Months Ended March 31, 2010 and 2009
Revenue
(in thousands, except percentages)
|
|
Three
months
ended
March 31, 2010
|
|
|
Three
months
ended
March 31, 2009
|
|
|
Increase
/
(Decrease)
2010 vs. 2009
|
|
|
Percentage
Increase
/
(Decrease)
2010 vs. 2009
|
|
Product
sales and royalties
|
|
$ |
3,584 |
|
|
$ |
6,470 |
|
|
$ |
(2,886 |
) |
|
|
(45 |
%) |
License,
collaboration and other
|
|
|
29,653 |
|
|
|
3,241 |
|
|
|
26,412 |
|
|
>100
|
% |
Total
revenue
|
|
$ |
33,237 |
|
|
$ |
9,711 |
|
|
$ |
23,526 |
|
|
>100
|
% |
Product
Sales and Royalties
Product
sales include cost-plus and fixed price manufacturing and supply agreements with
our collaboration partners. We also receive royalty revenue from
certain of our collaboration partners based on their net sales once their
products are approved for commercial sale.
The
decrease in product sales and royalties for the three months ended March 31,
2010 compared to the three months ended March 31, 2009 is primarily attributable
to lower product sales volumes to our collaboration partners. The
timing of shipments is based on the demand and requirements of our collaboration
partners and is not ratable through the year. We expect quarterly
product sales volumes to increase in the remainder of 2010.
License,
Collaboration and Other
License,
collaboration and other revenue includes amortization of upfront payments and
performance milestone payments received in connection with our license and
collaboration agreements and reimbursed research and development
expenses. The level of license, collaboration and other revenue
depends in part upon the estimated amortization period of the upfront and
milestone payments, the achievement of future milestones, the continuation of
existing collaborations, the amount of reimbursed research and development work,
and the signing of new collaborations.
For the
three months ended March 31, 2010, the increase in license, collaboration and
other revenue compared to the three months ended March 31, 2009 is primarily
attributable to the $25.3 million recognized of the $125.0 million upfront
payment received from AstraZeneca in October 2009 for NKTR-118 and
NKTR-119.
|
|
Three
months
ended
March 31, 2010
|
|
|
Three
months
ended
March 31, 2009
|
|
|
Increase
/
(Decrease)
2010 vs. 2009
|
|
|
Percentage
Increase
/
(Decrease)
2010 vs. 2009
|
|
Cost
of goods sold
|
|
$ |
4,296 |
|
|
$ |
5,626 |
|
|
$ |
(1,330 |
) |
|
|
(24 |
%) |
Product
gross profit
|
|
$ |
(712 |
) |
|
$ |
844 |
|
|
$ |
(1,556 |
) |
|
>(100
|
%) |
Product
gross margin
|
|
|
(20 |
%) |
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
Three
months
ended
March 31, 2010
|
|
|
Three
months
ended
March 31, 2009
|
|
|
Increase
/
(Decrease)
2010 vs. 2009
|
|
|
Percentage
Increase
/
(Decrease)
2010 vs. 2009
|
|
Research
and development expense
|
|
$ |
23,286 |
|
|
$ |
23,363 |
|
|
$ |
(77 |
) |
|
|
0 |
% |
Research
and development expense consists primarily of personnel costs, including
salaries, benefits, and stock-based compensation, clinical studies performed by
contract research organizations, materials and supplies, licenses and fees, and
overhead allocations consisting of various support and facilities related
costs. While research and development expense remained at a
consistent level for the three months ended March 31, 2010 compared to the three
months ended March 31, 2009, the components of research and development expense
changed after we entered into the AstraZeneca License for NKTR-118 and NKTR-119
and the completion of our research and development facility in
India.
Research
and development expense related to NKTR-118 and NKTR-119 for the three months
ended March 31, 2009 totaled approximately $4.4 million compared to $0.5 million
in the same period of 2010. In addition, outside spending with
contract manufacturing and contract research organizations decreased by
approximately $0.6 million for the three months ended March 31, 2010 compared to
the three months ended March 31, 2009. These decreases were off-set
by the following increases: $1.0 million increase for the NKTR-102 program as we
continue the Phase 2 clinical trials for our breast, ovarian and colorectal
cancer programs; $0.8 million increase for our India operations after the
completion of the India research facility; $1.7 million increase in U.S.
employee costs as a result of headcount additions and salary and benefit cost
increases; and $0.8 million increase in non-cash stock-based compensation
expense.
|
|
Three
months
ended
March 31, 2010
|
|
|
Three
months
ended
March 31, 2009
|
|
|
Increase
/
(Decrease)
2010 vs. 2009
|
|
|
Percentage
Increase
/
(Decrease)
2010 vs. 2009
|
|
General
and administrative expense
|
|
$ |
9,013 |
|
|
$ |
11,020 |
|
|
$ |
(2,007 |
) |
|
|
(18 |
%) |
General
and administrative expense is associated with administrative staffing, business
development, marketing, and legal. For the three months ended March 31, 2010
compared to the three months ended March 31, 2009, the decrease is attributable
to reductions in headcount and outside professional
services. Allocation of corporate-wide overhead costs, including
facilities, human resources, information systems, and procurement, to general
and administrative expense decreased as a result of the decreased headcount in
general and administrative departments, while total company headcount remained
at a consistent level. Outside professional services related to
legal, accounting, market research, recruiting, and other consulting decreased
by $1.3 million for the three months ended March 31, 2010 compared to the three
months ended March 31, 2009. Partially off-setting these
decreases, non-cash stock-based compensation expense increased by $0.7 million
due to additional stock option and RSU grants and higher stock
price.
|
|
Three
months
ended
March 31, 2010
|
|
|
Three
months
ended
March 31, 2009
|
|
|
Increase
/
(Decrease)
2010 vs. 2009
|
|
|
Percentage
Increase
/
(Decease)
2010 vs. 2009
|
|
Interest
income
|
|
$ |
463 |
|
|
$ |
1,650 |
|
|
$ |
(1,187 |
) |
|
|
(72 |
%) |
Interest
expense
|
|
$ |
(2,951 |
) |
|
$ |
(3,337 |
) |
|
$ |
(386 |
) |
|
|
(12 |
%) |
The
decrease in interest income for the three months ended March 31, 2010 compared
to the three months ended March 31, 2009 is a result of decreased market
interest rates received for our cash and short-term investments.
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
$362.0 million and indebtedness of $240.5 million, including $215.0 million of
3.25% convertible subordinated notes due September 2012, $20.0 million in
capital lease obligations, and $5.5 million in other liabilities as of March 31,
2010.
Due to
the continuing adverse environment 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 March 31, 2010, the average time to
maturity of the investments held in our portfolio was approximately five 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 more likely than not that we will not be
required to sell these securities before we recover the amortized cost basis.
Accordingly, we believe there are no other-than-temporary impairments on these
securities and have not recorded a provision for impairment.
Cash
flows used in operating activities for the three months ended March 31, 2010
totaled $34.2 million, which includes $7.2 million for employee bonus payments
related to services performed in 2009, $3.5 million for interest payments on our
convertible subordinated notes, and $23.5 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.
For the
three months ended March 31, 2009, cash used in operations included $4.7 million
for employee bonus payments related to services performed in 2008, $3.5 million
for interest payments on our convertible subordinated notes, $2.7 million for
severance payments, and $31.5 million of other net operating cash
uses.
Cash
flows from investing activities
We
purchased $4.0 million and $5.1 million of property and equipment in the three
months ended March 31, 2010 and 2009, respectively. During the three months
ended March 31, 2009, we paid $4.8 million of previously expensed transaction
costs related to the sale of certain assets related to our pulmonary business,
associated technology and intellectual property to Novartis, which was completed
on December 31, 2008.
Cash
flows from financing activities
We
received $4.8 million from issuances of common stock to employees during the
three months ended March 31, 2010, resulting in net cash provided by financing
activities. Cash used in financing activities was not significant for the three
months ended March 31, 2009.
Contractual
Obligations
There
were no material changes during the three months ended March 31, 2010 to the
summary of contractual obligations included in our Annual Report on Form 10-K
for the year ended December 31, 2009.
Off-Balance
Sheet Arrangements
We do not
utilize off-balance sheet financing arrangements as a source of liquidity or
financing.
Recent
Accounting Pronouncements
In
October 2009, the FASB published FASB Accounting Standards Update (ASU) 2009-13,
which amends the criteria to identify separate units of accounting within
Subtopic 605-25, “Revenue Recognition-Multiple-Element Arrangements”. The
revised guidance also expands the disclosure required for multiple-element
revenue arrangements. FASB ASU No. 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 results of operations.
FASB
ASU 2010-17, Revenue Recognition - Milestone Method (Topic 605): Milestone
Method of Revenue Recognition
In April
2010, the FASB codified the consensus reached in Emerging Issues Task Force
Issue No. 08-09, “Milestone Method of Revenue Recognition.” FASB ASU
No. 2010-17 provides guidance on defining a milestone and determining when it
may be appropriate to apply the milestone method of revenue recognition for
research and development transactions. FASB ASU No. 2010 – 17 is
effective for fiscal years beginning on or after June 15, 2010, and is effective
on a prospective basis for milestones achieved 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
results of operations.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Our
market risks at March 31, 2010 have not changed significantly from those
discussed in Item 7A of our Annual Report on Form 10-K for the year ended
December 31, 2009 on file with the Securities and Exchange
Commission.
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 March 31, 2010 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.
In the
three months ended March 31, 2010, the Audit Committee of the Board of Directors
approved approximately $12,300 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
Reference
is hereby made to our disclosures in “Legal Matters” under Note 4 of the Notes
to Condensed Consolidated Financial Statements in this Quarterly Report on Form
10-Q and the information under the heading “Legal Matters” is incorporated by
reference herein.
Investors
in Nektar Therapeutics should carefully consider the risks described below
before making an investment decision. The risks described below may not be the
only ones relating to our company. This description includes any material
changes to and supersedes the description of the risk factors associated with
our business previously disclosed in Item 1A of our Annual Report on Form 10-K
for the twelve months ended December 31, 2009. 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, 2009, 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 highly uncertain processes. It will take us, or our
collaborative partners, several years to complete clinical trials. Drug
development is an uncertain scientific and medical endeavor and failure can
unexpectedly occur at any stage of clinical development even after early
preclinical or mid-stage clinical results suggest that the drug candidate has
potential as a new therapy that may benefit patients and health authority
approval would be anticipated. Typically, there is a high rate of attrition for
product candidates in preclinical and clinical trials due to scientific
feasibility, safety, efficacy, changing standards of medical care and other
variables. We or our partners have a number of important product
candidates in mid- to late-stage development such as Bayer’s Amikacin Inhale,
Oral NKTR-118 (oral PEGylated naloxol) and NKTR-119 which we partnered with
AstraZeneca, Affymax’s Hematide, and NKTR-102 (PEGylated irinotecan) in a number
of oncology indications including breast, colorectal and ovarian
cancers. We also have an ongoing Phase 1 clinical trial for NKTR-105
(PEGylated docetaxel) for patients with refractory solid tumors. Any
one of these trials could fail at any time as clinical development of drug
candidates presents numerous unpredictable risks and is very uncertain at all
times prior to regulatory approval by one or more health authorities in major
markets.
Even with success in preclinical
testing and clinical trials, the risk of clinical failure remains high prior
to regulatory approval.
A number
of companies in the pharmaceutical and biotechnology industries have suffered
significant unforeseen setbacks in later stage clinical trials (i.e., Phase 2 or
Phase 3 trials) due to factors such as inconclusive efficacy results and adverse
medical events, even after achieving positive results in earlier trials that
were satisfactory both to them and to reviewing regulatory agencies. Although we
announced positive Phase 2 clinical results for Oral NKTR-118 (oral PEGylated
naloxol) in 2009, there are still substantial risks and uncertainties associated
with the future commencement and outcome of a Phase 3 clinical trial and the
regulatory review process even following the AstraZeneca
transaction. While NKTR-102 (PEGylated irinotecan) continues in Phase
2 clinical development for multiple cancer indications, it is possible this
product candidate could fail in one or all of the cancer indications in which it
is currently being studied due to efficacy, safety or other commercial or
regulatory factors. In the quarter ended March 31, 2010, we announced
preliminary positive results from stage one of our Phase 2 trial for ovarian
cancer patients. These results were based on preliminary data only
and such results could change based on final data gathering and analysis review
procedures. In addition, the preliminary results from stage 1 of the
NKTR-102 clinical study for ovarian cancer is not necessarily indicative or
predictive of the future results from stage 2 of this clinical study or the
other cancer indication where we are studying NKTR-102. As a result,
there remains a significant uncertainty as to the success or failure of NKTR-102
and whether this drug candidate will eventually receive regulatory approval or
be a commercial success even if approved by one or more health authorities in
any of the cancer indications for which it is being studied. The risk
of failure is increased for our product candidates that are based on new
technologies, such as the application of our advanced polymer conjugate
technology to small molecules, including 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 portion of our research and development expenses and develop and
commercialize our product candidates, including NKTR-102. In September 2009, we
entered into a license agreement with AstraZeneca for NKTR-118 and NKTR-119
which included an upfront payment of $125.0 million. The completion
of the AstraZeneca transaction was critical to our financial results and
financial condition for the year ended December 31, 2009. We intend
to explore a variety of transaction structures for a collaboration partner for
NKTR-102. Whether we ultimately enter into a collaboration agreement for
NKTR-102 will depend on the partnership and other opportunities that may be
available to us. Our ability to successfully conclude a collaboration
partnership for NKTR-102 on commercially favorable terms, or at all, will have a
significant impact on our business and financial position in 2010. 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, our business, results of operations and financial
condition could suffer.
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.
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 100 U.S. and approximately 380 foreign patents and a number of
pending patent applications that cover various aspects of our technologies. We
have filed patent applications, and plan to file additional patent applications,
covering various aspects of our PEGylation and advanced polymer conjugate
technologies and our proprietary product candidates. There can be no assurance
that patents that have issued will be valid and enforceable or that patents for
which we apply will issue with broad coverage, if at all. The coverage claimed
in a patent application can be significantly reduced before the patent is issued
and, as a consequence, our patent applications may result in patents with narrow
coverage. 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.
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 milestone payments could be significantly diminished
and would negatively impact our revenue, results of operations and financial
condition.
Our revenue is exclusively derived
from our collaboration agreements, which can result in significant fluctuation in
our revenue from period to period, and our past revenue is therefore not
necessarily indicative of our future revenue.
Our
revenue is derived from our collaboration agreements with partners, under which
we may receive contract research payments, milestone payments based on clinical
progress, regulatory progress or net sales achievements, royalties or
manufacturing revenue. Significant variations in the timing of receipt of cash
payments and our recognition of revenue can result from the nature of
significant milestone payments based on the execution of new collaboration
agreements, the timing of clinical, regulatory or sales events which result in
single milestone payments and the timing and success of the commercial launch of
new drugs by our collaboration partners. The amount of our revenue derived from
collaboration agreements in any given period will depend on a number of
unpredictable factors, including our ability to find and maintain suitable
collaboration partners, the timing of the negotiation and conclusion of
collaboration agreements with such partners, whether and when we or our partner
achieve clinical and sales milestones, whether the partnership is exclusive or
whether we can seek other partners, the timing of regulatory approvals in one or
more major markets and the market introduction of new drugs or generic versions
of the approved drug, as well as other factors.
If our partners, on which we depend
to obtain regulatory approvals for and to commercialize our partnered products,
are not successful, or if such collaborations fail, the development
or commercialization of our partnered products may be delayed or
unsuccessful.
When we
sign a collaborative development agreement or license agreement to develop a
product candidate with a pharmaceutical or biotechnology company, the
pharmaceutical or biotechnology company is generally expected
to:
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design
and conduct large scale clinical
studies;
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prepare
and file documents necessary to obtain government approvals to sell a
given product candidate; and/or
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market
and sell our products when and if they are
approved.
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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 partners
may have extension or renewal rights) that we believe are not on
commercially reasonable terms or consistent with our current business
strategy;
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partners
may be unable to pay us as expected;
and
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partners
may terminate their agreements with us unilaterally for any or no reason,
in some cases with the payment of a termination fee penalty and in other
cases with no termination fee
penalty.
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Given
these risks, the success of our current and future partnerships is highly
unpredictable and can have a substantial negative or positive impact on our
business. We have entered into collaborations in the past that have been
subsequently terminated, such as our collaboration with Pfizer for the
development and commercialization of inhaled insulin that was terminated by
Pfizer in November 2007. If other collaborations are suspended or terminated,
our ability to commercialize certain other proposed product candidates could
also be negatively impacted. If our collaborations fail, our product development
or commercialization of product candidates could be delayed or cancelled, which
would negatively impact our business, results of operations and financial
condition.
If we or our partners do not obtain
regulatory approval for our product candidates on a timely basis, 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 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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On
September 20, 2009, we entered into a worldwide exclusive license agreement with
AstraZeneca for the further development and commercialization of NKTR-118 and
NKTR-119. In addition, we have also entered into complex commercial
agreements with Novartis in connection with the sale of certain assets related
to our pulmonary business, associated technology and intellectual property to
Novartis (the Novartis Pulmonary Asset Sale), which was completed on December
31, 2008. Our agreements with AstraZeneca and Novartis contain complex
representations and warranties, covenants and indemnification obligations that
could result in substantial future liability and harm our financial condition if
we breach any of our agreements with AstraZeneca or Novartis or any third party
agreements impacted by this complex transaction. As part of the Novartis
Pulmonary Asset Sale, we entered an exclusive license agreement with Novartis
Pharma pursuant to which Novartis Pharma grants back to us an exclusive,
irrevocable, perpetual, royalty-free and worldwide license under certain
specific patent rights and other related intellectual property rights necessary
for us to satisfy certain continuing contractual obligations to third parties,
including in connection with development, manufacture, sale and
commercialization activities related to our partnered program for 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 provided 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 collaboration agreements, transaction documents, or third party
license agreements that may ultimately result in costly litigation and
unfavorable interpretation of contract terms, which would have a material
adverse impact on our business, results of operations or financial
condition.
If we or our partners are not able to
manufacture drugs or drug substances in quantities and at costs that are commercially feasible,
we may fail to meet our contractual obligations or our proprietary and partnered
product candidates may
experience clinical delays or constrained commercial supply which could significantly harm our
business.
If we are
not able to scale-up manufacturing to meet the drug quantities required to
support large clinical trials or commercial manufacturing in a timely manner or
at a commercially reasonable cost, we risk delaying our clinical trials or those
of our partners and may breach contractual obligations and incur associated
damages and costs, and reduce or even eliminate associated
revenues. In some cases, we may subcontract manufacturing or other
services. Pharmaceutical manufacturing involves significant risks and
uncertainties related to the demonstration of adequate stability, sufficient
purification of the drug substance and drug product, the identification and
elimination of impurities, optimal formulations, process validation, and
challenges to controlling for all of these factors during manufacturing scale-up
for large clinical trials and commercial manufacturing and supply. In
addition, we have faced and may in the future face significant difficulties,
delays and unexpected expenses as we validate third party contract manufacturers
required for scale-up to clinical or commercial quantities. Failure
to manufacture products in quantities or at costs that are commercially feasible
could cause us not to meet our supply requirements, contractual obligations or
other requirements for our proprietary product candidates and, as a result,
would significantly harm our business, results of operations and financial
condition.
For
instance, we entered a service agreement with Novartis pursuant to which we
subcontract to Novartis certain important services to be performed in relation
to our partnered program for 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. Further, we have experienced delays in starting
the Phase 3 clinical development program for BAY41-6551 as we work to finalize
the device design with a demonstrated capability to be manufactured at
commercial scale. This work is ongoing. Drug/device combination
products 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, reliability and cost of
manufacturing, regulatory approval requirements and standards and other
important factors. There continues to be substantial and
unpredictable risk and uncertainty related to manufacturing and supply until
such time as the commercial supply chain is validated and proven.
We purchase some of the starting
material for drugs and drug candidates from a single source or a limited
number of suppliers, and the partial or complete loss of one of these
suppliers could cause production delays, clinical trial delays, substantial loss of
revenue and contract liability to third parties.
We often
face very limited supply of a critical raw material that can only be obtained
from a single, or a limited number of, suppliers, which could cause production
delays, clinical trial delays, substantial lost revenue opportunity or contract
liability to third parties. For example, there are only a limited number of
qualified suppliers, and in some cases single source suppliers, for the raw
materials included in our PEGylation and advanced polymer conjugate drug
formulations, and any interruption in supply or failure to procure such raw
materials on commercially feasible terms could harm our business by delaying our
clinical trials, impeding commercialization of approved drugs or increasing
operating loss to the extent we cannot pass on increased costs to a
manufacturing customer.
We rely on trade secret protection
and other unpatented proprietary rights for important proprietary technologies,
and any loss of such rights could harm our business, results of operations and
financial condition.
We rely
on trade secret protection for our confidential and proprietary information. No
assurance can be given that others will not independently develop substantially
equivalent confidential and proprietary information or otherwise gain access to
our trade secrets or disclose such technology, or that we can meaningfully
protect our trade secrets. In addition, unpatented proprietary rights, including
trade secrets and know-how, can be difficult to protect and may lose their value
if they are independently developed by a third party or if their secrecy is
lost. Any loss of trade secret protection or other unpatented proprietary rights
could harm our business, results of operations and financial
condition.
We expect to continue to incur
substantial losses and negative cash flow from operations and may not achieve or
sustain profitability in the future.
For the
three months ended March 31, 2010, we reported a net loss of $6.1
million. If and when we achieve profitability depends upon a number
of factors, including the timing and recognition of milestone payments and
royalties received, the timing of revenue under our collaboration agreements,
the amount of investments we make in our proprietary product candidates and the
regulatory approval and market success of our product candidates. We may not be
able to achieve and sustain profitability.
Other
factors that will affect whether we achieve and sustain profitability include
our ability, alone or together with our partners, to:
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develop
products utilizing our technologies, either independently or in
collaboration with other pharmaceutical or biotech
companies;
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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
March 31, 2010, we had cash, cash equivalents, and short-term investments in
marketable securities valued at approximately $362.0 million and approximately
$240.5 million of indebtedness, including approximately $215.0 million in
convertible subordinated notes due September 2012, $20.0 million in capital
lease obligations, and $5.5 million of other liabilities.
Our
substantial indebtedness has and will continue to impact us by:
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making
it more difficult to obtain additional
financing;
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constraining
our ability to react quickly in an unfavorable economic
climate;
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constraining
our stock price; and
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constraining
our ability to invest in our 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.,
Novo Nordisk A/S (formerly assets held by Neose Technologies, Inc.), and NOF
Corporation. Several other chemical, biotechnology and pharmaceutical companies
may also be developing PEGylation technologies or technologies that have similar
impact on target drug molecules. Some of these companies license or provide the
technology to other companies, while others are developing the technology for
internal use.
There are
several competitors for our proprietary product candidates currently in
development. For 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 and breast 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 or breast
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. In October 2008, a
federal court ruled in favor of Amgen, issuing a permanent injunction preventing
Roche from marketing or selling MIRCERA in the U.S. In December 2009, the
U.S. District court for the District of Massachusetts entered a final judgment
and permanent injunction, and Roche and Amgen entered into a settlement and
limited license agreement which allows Roche to begin selling MIRCERA in the
U.S. in July 2014.
Third-party
claims 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 own and lease offices
in Hyderabad, India. There are no backup facilities for our manufacturing
operations located in Huntsville, Alabama. In the event of an earthquake or
other natural disaster, political instability, or terrorist event in any of
these locations, our ability to manufacture and supply materials for drug
candidates in development and our ability to meet our manufacturing obligations
to our customers would be significantly disrupted and our business, results of
operations and financial condition would be harmed. Our collaborative partners
may also be subject to catastrophic events, such as hurricanes and tornadoes,
any of which could harm our business, results of operations and financial
condition. We have not undertaken a systematic analysis of the potential
consequences to our business, results of operations and financial condition from
a major earthquake or other catastrophic event, such as a fire, sustained loss
of power, terrorist activity or other disaster, and do not have a recovery plan
for such disasters. In addition, our insurance coverage may not be sufficient to
compensate us for actual losses from any interruption of our business that may
occur.
We have implemented certain
anti-takeover measures, which make it more difficult to acquire us, even though
such acquisitions may be beneficial to our stockholders.
Provisions
of our certificate of incorporation and bylaws, as well as provisions of
Delaware law, could make it more difficult for a third party to acquire us, even
though such acquisitions may be beneficial to our stockholders. These
anti-takeover provisions include:
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•
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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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•
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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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•
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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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•
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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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•
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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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•
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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 quarter ended March 31, 2010, based on closing bid
prices on the NASDAQ Global Select Market, our stock price ranged from $9.39 to
$15.52 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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•
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announcements
by collaboration partners as to their plans or expectations related to
products using our technologies;
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•
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announcements
or terminations of collaboration agreements by us or our
competitors;
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•
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fluctuations
in our results of operations;
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•
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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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•
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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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•
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announcements
of changes in governmental regulation affecting us or our
competitors;
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•
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hedging
activities by purchasers of our convertible senior
notes;
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•
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litigation
brought against us or third parties to whom we have indemnification
obligations;
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•
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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 March 31, 2010.
None.
Item
5. Other Information
None.
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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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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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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Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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By:
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/s/ John
Nicholson |
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John
Nicholson |
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Senior
Vice President and Chief Financial Officer
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Date:
May 5, 2010
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By:
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/s/ Jillian
B. Thomsen |
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Jillian
B. Thomsen
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Senior
Vice President and Chief Accounting Officer
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Date:
May 5, 2010
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EXHIBIT
INDEX
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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|
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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.
|
*
|
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.
|
Unassociated Document
Exhibit
31.1
I, Howard
W. Robin, certify that:
1.
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I
have reviewed this Quarterly Report on Form 10-Q of Nektar
Therapeutics;
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2.
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Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
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Based
on my knowledge, the financial statements and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
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4.
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The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)), for the registrant and
have:
|
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a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
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b)
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Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
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c)
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
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d)
|
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting.
|
5.
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The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|
|
a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
|
b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date: May
5, 2010
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/s/
Howard
W. Robin
|
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Howard
W. Robin
|
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Chief
Executive Officer, President and
Director
|
Unassociated Document
Exhibit
31.2
I, John
Nicholson, certify that:
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of Nektar
Therapeutics;
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4.
|
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)), for the registrant and
have:
|
|
a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
|
|
b)
|
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
|
c)
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
|
d)
|
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting.
|
5.
|
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|
|
a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
|
b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date: May
5, 2010
|
/s/
John
Nicholson
|
|
John
Nicholson
|
|
Senior
Vice President and Chief Financial
Officer
|
Exhibit
32.1
SECTION
1350 CERTIFICATIONS*
Pursuant
to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of
1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18
of the United States Code (18 U.S.C. §1350), Howard W. Robin, Chief Executive
Officer, President, and Director of Nektar Therapeutics (the “Company”), and
John Nicholson, Senior Vice President and Chief Financial Officer of the
Company, each hereby certifies that, to the best of his knowledge:
1. The
Company’s Quarterly Report on Form 10-Q for the three months ended March 31,
2010, to which this Certification is attached as Exhibit 32.1 (the “Periodic
Report”), fully complies with the requirements of Section 13(a) or Section 15(d)
of the Exchange Act; and
2. The
information contained in the Periodic Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
Dated:
May 5, 2010
/s/ Howard
W. Robin
Howard
W. Robin
Chief Executive Officer,
President and Director
|
/s/ John
Nicholson
John
Nicholson
Senior Vice President and
Chief Financial
Officer
|
____________
*
|
This
certification accompanies the Form 10-Q to which it relates, is not deemed
filed with the Securities and Exchange Commission and is not to be
incorporated by reference into any filing of the Company under the
Securities Act of 1933, as amended, or the Securities Exchange Act of
1934, as amended (whether made before or after the date of the Form 10-Q),
irrespective of any general incorporation language contained in such
filing.
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