e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2010
or
|
|
|
o |
|
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
|
|
(IRS Employer |
incorporation or organization)
|
|
Identification No.) |
201 Industrial Road
San Carlos, California 94070
(Address of principal executive offices)
650-631-3100
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90 days. Yes
þ No o
Indicate by check mark whether the registrant has submitted electronically
and posted on its corporate Web site, if any, every Interactive Data File required to be submitted
and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was required to submit and post such
files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of
large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer þ
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined by
Rule 12b-2 of the Exchange Act). Yes o No þ
The number of outstanding shares of the registrants Common Stock, $0.0001
par value, was 94,331,912 on October 31, 2010.
NEKTAR THERAPEUTICS
INDEX
2
Forward-Looking Statements
This report includes forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of
the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than
statements of historical fact are forward-looking statements for purposes of this quarterly
report on Form 10-Q, including any projections of earnings, revenue or other financial items, any
statements 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 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 of our 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.
3
PART I: FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements Unaudited:
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share information)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,906 |
|
|
$ |
49,597 |
|
Short-term investments |
|
|
290,396 |
|
|
|
346,614 |
|
Accounts receivable |
|
|
5,553 |
|
|
|
4,801 |
|
Inventory |
|
|
11,460 |
|
|
|
6,471 |
|
Other current assets |
|
|
6,119 |
|
|
|
6,183 |
|
|
|
|
|
|
|
|
Total current assets |
|
$ |
326,434 |
|
|
$ |
413,666 |
|
Property and equipment, net |
|
|
97,686 |
|
|
|
78,263 |
|
Goodwill |
|
|
76,501 |
|
|
|
76,501 |
|
Other assets |
|
|
1,855 |
|
|
|
7,088 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
502,476 |
|
|
$ |
575,518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,403 |
|
|
$ |
3,066 |
|
Accrued compensation |
|
|
10,552 |
|
|
|
10,052 |
|
Accrued expenses |
|
|
12,352 |
|
|
|
4,354 |
|
Accrued clinical trial expenses |
|
|
12,759 |
|
|
|
14,167 |
|
Deferred revenue, current portion |
|
|
40,232 |
|
|
|
115,563 |
|
Interest payable |
|
|
58 |
|
|
|
1,805 |
|
Other current liabilities |
|
|
4,476 |
|
|
|
4,009 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
$ |
84,832 |
|
|
$ |
153,016 |
|
Convertible subordinated notes |
|
|
214,955 |
|
|
|
214,955 |
|
Capital lease obligations |
|
|
17,402 |
|
|
|
18,800 |
|
Deferred revenue |
|
|
69,033 |
|
|
|
76,809 |
|
Deferred gain |
|
|
4,371 |
|
|
|
5,027 |
|
Other long-term liabilities |
|
|
4,936 |
|
|
|
4,544 |
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
395,529 |
|
|
$ |
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 September 30, 2010 and
December 31, 2009 |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 300,000 shares
authorized; 94,273 shares and 93,281 shares issued and
outstanding at September 30, 2010 and December 31,
2009, respectively |
|
|
9 |
|
|
|
9 |
|
Capital in excess of par value |
|
|
1,347,800 |
|
|
|
1,327,942 |
|
Accumulated other comprehensive income |
|
|
1,105 |
|
|
|
1,025 |
|
Accumulated deficit |
|
|
(1,241,967 |
) |
|
|
(1,226,609 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
106,947 |
|
|
|
102,367 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
502,476 |
|
|
$ |
575,518 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and royalties |
|
$ |
7,230 |
|
|
$ |
7,461 |
|
|
$ |
21,968 |
|
|
$ |
24,456 |
|
License, collaboration and other |
|
|
30,695 |
|
|
|
2,762 |
|
|
|
91,757 |
|
|
|
8,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
37,925 |
|
|
|
10,223 |
|
|
|
113,725 |
|
|
|
32,922 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
6,245 |
|
|
|
6,134 |
|
|
|
15,430 |
|
|
|
22,139 |
|
Research and development |
|
|
27,724 |
|
|
|
23,031 |
|
|
|
76,610 |
|
|
|
70,396 |
|
General and administrative |
|
|
10,181 |
|
|
|
9,917 |
|
|
|
29,401 |
|
|
|
30,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
44,150 |
|
|
|
39,082 |
|
|
|
121,441 |
|
|
|
122,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(6,225 |
) |
|
|
(28,859 |
) |
|
|
(7,716 |
) |
|
|
(89,637 |
) |
Non-operating income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
369 |
|
|
|
560 |
|
|
|
1,225 |
|
|
|
3,160 |
|
Interest expense |
|
|
(2,826 |
) |
|
|
(2,928 |
) |
|
|
(8,686 |
) |
|
|
(9,213 |
) |
Other income, net |
|
|
249 |
|
|
|
120 |
|
|
|
436 |
|
|
|
368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-operating expense |
|
|
(2,208 |
) |
|
|
(2,248 |
) |
|
|
(7,025 |
) |
|
|
(5,685 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for income taxes |
|
|
(8,433 |
) |
|
|
(31,107 |
) |
|
|
(14,741 |
) |
|
|
(95,322 |
) |
Provision (benefit) for income taxes |
|
|
278 |
|
|
|
(140 |
) |
|
|
617 |
|
|
|
(479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,711 |
) |
|
$ |
(30,967 |
) |
|
$ |
(15,358 |
) |
|
$ |
(94,843 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.09 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.16 |
) |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
used in computing basic and diluted
net loss per share |
|
|
94,213 |
|
|
|
92,789 |
|
|
|
93,972 |
|
|
|
92,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,358 |
) |
|
$ |
(94,843 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
12,499 |
|
|
|
11,076 |
|
Stock-based compensation |
|
|
12,716 |
|
|
|
7,290 |
|
Deferred rent |
|
|
1,084 |
|
|
|
|
|
Other non-cash transactions |
|
|
(1,260 |
) |
|
|
(124 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(752 |
) |
|
|
4,505 |
|
Inventory |
|
|
(4,989 |
) |
|
|
389 |
|
Other assets |
|
|
1 |
|
|
|
(1,272 |
) |
Accounts payable |
|
|
1,755 |
|
|
|
(4,047 |
) |
Accrued compensation |
|
|
500 |
|
|
|
(1,859 |
) |
Accrued expenses |
|
|
4,090 |
|
|
|
(4,610 |
) |
Accrued clinical trial expenses |
|
|
(1,408 |
) |
|
|
(1,413 |
) |
Deferred revenue |
|
|
(83,107 |
) |
|
|
(2,722 |
) |
Other liabilities |
|
|
(2,049 |
) |
|
|
(2,823 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(76,278 |
) |
|
$ |
(90,453 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of investments |
|
|
(315,160 |
) |
|
|
(298,054 |
) |
Sales of investments |
|
|
10,290 |
|
|
|
11,923 |
|
Maturities of investments |
|
|
360,906 |
|
|
|
266,202 |
|
Purchases of property and equipment |
|
|
(22,160 |
) |
|
|
(10,763 |
) |
Transaction costs from Novartis pulmonary asset sale |
|
|
|
|
|
|
(4,440 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
$ |
33,876 |
|
|
$ |
(35,132 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments of loan and capital lease obligations |
|
|
(1,119 |
) |
|
|
(935 |
) |
Proceeds from issuances of common stock |
|
|
7,142 |
|
|
|
3,821 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
$ |
6,023 |
|
|
$ |
2,886 |
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(312 |
) |
|
|
(108 |
) |
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
$ |
(36,691 |
) |
|
$ |
(122,807 |
) |
Cash and cash equivalents at beginning of period |
|
|
49,597 |
|
|
|
155,584 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
12,906 |
|
|
$ |
32,777 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2010
(Unaudited)
Note 1Organization 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 (India)
Private Limited, Nektar Therapeutics UK Limited (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 were 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 subsidiarys financial results into U.S.
dollars for purposes of reporting our consolidated financial results. Translation gains and losses
are included in accumulated other comprehensive income in the stockholders equity section of the
Condensed Consolidated Balance Sheets. To date, such cumulative translation adjustments have not
been material to our consolidated financial position.
Revenue, expenses, assets, and liabilities can vary during each quarter of
the year. The results and trends in these interim Condensed Consolidated Financial Statements may
not be the same as those for the full year or any other periods.
The accompanying Condensed Consolidated Balance Sheet as of September 30,
2010, the Condensed Consolidated Statements of Operations for the three months and nine months
ended September 30, 2010 and 2009, and the Condensed Consolidated Statements of Cash Flows for the
nine months ended September 30, 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.
7
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2010
(Unaudited)
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 and our allowance for doubtful accounts was nil at both September 30,
2010 and December 31, 2009.
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 and fixed price
manufacturing and supply agreements with our collaboration partners and revenue is recognized in
accordance with the terms of the related agreement. We have not experienced any significant returns
from our customers.
Generally, we are entitled to royalties from our partners based on their net
sales 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 intellectual property 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.
Milestone 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 expected to be 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, the amortization of revenue is adjusted prospectively.
Income Taxes
For the three and nine months ended September 30, 2010, 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. For the three and
nine months ended September 30, 2009, we recorded an overall benefit for income taxes, comprised of
a U.S. federal and state income tax benefit relating primarily to a refundable credit under the
American Recovery and Reinvestment Tax Act of 2009 and a foreign income tax provision for India.
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.
8
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2010
(Unaudited)
New Accounting Standards Not Yet Adopted
FASB Accounting Standards Update 2009-13, Revenue Recognition (Topic 605)
Multiple-Deliverable Revenue Arrangements
In October 2009, the FASB published 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. We do not expect this ASU will have a material impact on our financial position or
results of operations when we adopt it on January 1, 2011.
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. We do not expect this ASU will
have a material impact on our financial position or results of operations when we adopt it on
January 1, 2011.
Note 2Cash, Cash Equivalents, and Available-For-Sale Investments
Cash, cash equivalents, and available-for-sale investments are as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Cash and cash equivalents |
|
$ |
12,906 |
|
|
$ |
49,597 |
|
Short-term investments (less than one year to maturity) |
|
|
290,396 |
|
|
|
346,614 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and
available-for-sale investments |
|
$ |
303,302 |
|
|
$ |
396,211 |
|
|
|
|
|
|
|
|
Our portfolio of cash, cash equivalents, and available-for-sale investments
includes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Corporate notes and bonds |
|
$ |
202,013 |
|
|
$ |
160,458 |
|
U.S. corporate commercial paper |
|
|
55,308 |
|
|
|
71,923 |
|
Obligations of U.S. government agencies |
|
|
33,075 |
|
|
|
125,731 |
|
Cash and money market funds |
|
|
12,906 |
|
|
|
33,104 |
|
Obligations of U.S. states and municipalities |
|
|
|
|
|
|
4,995 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents,
and available-for-sale investments |
|
$ |
303,302 |
|
|
$ |
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 as described in the table below. The disclosed fair value related to our
investments is based primarily on the reported fair values in our period-end brokerage statements.
We independently validate these fair values using available market quotes and other information.
Our investments in debt securities are subject to interest rate risk. To
minimize the exposure due to an adverse shift in interest rates, we invest in short-term securities
and maintain a weighted average maturity of one year or less. At September 30, 2010 and December
31, 2009, the average portfolio duration was approximately 4 months and 5 months, respectively, and
the maturity of any single investment did not exceed twelve months.
9
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2010
(Unaudited)
Gross unrealized gains and losses were insignificant at September 30, 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 September 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Corporate notes and bonds |
|
$ |
|
|
|
$ |
202,013 |
|
|
$ |
|
|
|
$ |
202,013 |
|
U.S. corporate commercial paper |
|
|
|
|
|
|
55,308 |
|
|
|
|
|
|
|
55,308 |
|
Obligations of U.S. government agencies |
|
|
|
|
|
|
33,075 |
|
|
|
|
|
|
|
33,075 |
|
Money market funds |
|
|
9,393 |
|
|
|
|
|
|
|
|
|
|
|
9,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents and available-for-sale investments |
|
$ |
9,393 |
|
|
$ |
290,396 |
|
|
$ |
|
|
|
$ |
299,789 |
|
Cash |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,513 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
303,302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 -
|
|
Observable inputs, such as quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level 2 -
|
|
Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted
prices for similar assets or liabilities; quoted prices in markets that are not active; or
other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities. |
|
|
|
Level 3 -
|
|
Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities. |
Note 3Inventory
Inventory consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Raw materials |
|
$ |
8,256 |
|
|
$ |
5,937 |
|
Work-in-process |
|
|
1,789 |
|
|
|
|
|
Finished goods |
|
|
1,415 |
|
|
|
534 |
|
|
|
|
|
|
|
|
Total |
|
$ |
11,460 |
|
|
$ |
6,471 |
|
|
|
|
|
|
|
|
Inventory is manufactured upon receipt of firm orders from our customers.
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 $5.1 million and $3.3 million as of September 30, 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 4Commitments and Contingencies
Legal Matters
From time to time, we are involved in lawsuits, claims, investigations and
proceedings, consisting of intellectual property, commercial, employment and other matters, which
arise in the ordinary course of business. We record 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.
10
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2010
(Unaudited)
Indemnifications in Connection with Commercial Agreements
As part of our collaboration agreements with our partners related to the
license, development, manufacture and supply of drugs based on our proprietary technologies, we
generally agree to defend, indemnify and hold harmless our partners from and against third
party liabilities arising out of the applicable agreements, including product
liability (with respect to our activities) and infringement of third party intellectual property to
the extent the intellectual property relates to a drug candidate or proprietary drug material that
is developed by us and supplied to our license and supply partners. The term of these
indemnification obligations is generally perpetual. There is generally no limitation on the
potential amount of future payments we could be required to make under these indemnification
obligations.
As part of our pulmonary asset sale to Novartis that was effective as of
December 31, 2008, we and Novartis made representations and warranties and entered into certain
covenants and ancillary agreements which are supported by an indemnity obligation. In the event it
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 are
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 Condensed
Consolidated Balance Sheets as of September 30, 2010 or December 31, 2009.
Note 5License 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, payment for the manufacture and
supply of certain drug materials, and/or reimbursement for research and development activities. All
of our research and development agreements are generally cancelable by our partners without
significant financial penalty to the partner. Our costs of performing these services are included
in Research and development expense in the accompanying Condensed Consolidated Statements of
Operations.
In accordance with these agreements, we recorded License, collaboration and
other revenue as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
|
|
September 30, |
|
|
September 30, |
|
Partner |
|
Agreement |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
AstraZeneca AB |
|
NKTR-118 and NKTR-119 |
|
$ |
26,788 |
|
|
$ |
|
|
|
$ |
80,094 |
|
|
$ |
|
|
Bayer Healthcare LLC |
|
BAY41-6651 (NKTR-061, Amikacin Inhale) |
|
|
818 |
|
|
|
1,239 |
|
|
|
2,523 |
|
|
|
3,868 |
|
F. Hoffmann La-Roche |
|
Pegasys |
|
|
1,283 |
|
|
|
3 |
|
|
|
3,849 |
|
|
|
27 |
|
Other |
|
|
|
|
1,806 |
|
|
|
1,520 |
|
|
|
5,291 |
|
|
|
4,571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License, collaboration, and other revenue |
|
$ |
30,695 |
|
|
$ |
2,762 |
|
|
$ |
91,757 |
|
|
$ |
8,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In addition, we have recorded deferred revenue relating to these agreements
in our Condensed Consolidated Balance Sheets as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
Partner |
|
Agreement |
|
2010 |
|
|
2009 |
|
AstraZeneca AB |
|
NKTR-118 and NKTR-119 |
|
$ |
25,348 |
|
|
$ |
101,389 |
|
Bayer Healthcare LLC |
|
BAY41-6651 (NKTR-061, Amikacin Inhale) |
|
|
31,264 |
|
|
|
33,786 |
|
F. Hoffmann La-Roche |
|
Pegasys |
|
|
26,939 |
|
|
|
30,785 |
|
Other |
|
|
|
|
25,714 |
|
|
|
26,412 |
|
|
|
|
|
|
|
|
|
|
Total Deferred revenue |
|
|
|
|
109,265 |
|
|
|
192,372 |
|
Less: current portion |
|
|
|
|
(40,232 |
) |
|
|
(115,563 |
) |
|
|
|
|
|
|
|
|
|
Deferred revenue, non-current |
|
|
|
$ |
69,033 |
|
|
$ |
76,809 |
|
|
|
|
|
|
|
|
|
|
11
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2010
(Unaudited)
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 is responsible for all costs associated with research, development and
commercialization and maintains control over drug 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 are recognizing the remaining deferred revenue over the performance obligation
period, which is estimated to conclude with the completion of technology transfer to AstraZeneca 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 development of the nebulizer device included in the Amikacin
product through the completion of the Phase 3 clinical trial, scale-up for commercialization, and
commercial manufacturing and supply of the nebulizer devices. 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 and distribution.
We received an upfront payment of $40.0 million in 2007 and performance
milestone payments of $20.0 million, of which the second performance milestone of $10.0 million
will be used to reimburse Bayer for Phase 3 clinical trial costs. We expect to amortize the
remaining deferred revenue related to the upfront payment through July 2021, the estimated end of
our performance obligations under the agreement. We expect to recognize the remaining deferred
revenue related to the first $10 million milestone payment through June 2011.
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 was given the expanded right to manufacture all of its requirements for our proprietary
PEGylation materials for PEGASYS and we will perform additional manufacturing, if any, only on an
as requested basis.
In connection with Roches exercise of the license option extension in
December 2009, we received a payment of $31.0 million. 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 6Stock-Based Compensation
Total stock-based compensation expense was recorded in our Condensed
Consolidated Financial Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Cost of goods sold, net of inventory change |
|
$ |
258 |
|
|
$ |
88 |
|
|
$ |
693 |
|
|
$ |
273 |
|
Research and development expense |
|
|
1,967 |
|
|
|
888 |
|
|
|
5,268 |
|
|
|
2,519 |
|
General and administrative expense |
|
|
2,386 |
|
|
|
1,623 |
|
|
|
6,755 |
|
|
|
4,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation costs |
|
$ |
4,611 |
|
|
$ |
2,599 |
|
|
$ |
12,716 |
|
|
$ |
7,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2010
(Unaudited)
Aggregate Unrecognized Stock-Based Compensation Expense
Aggregate total unrecognized stock-based compensation expense is expected to
be recognized as follows (in thousands):
|
|
|
|
|
|
|
As of |
|
Fiscal Year |
|
September 30, 2010 |
|
2010 (remaining 3 months) |
|
$ |
4,707 |
|
2011 |
|
|
16,896 |
|
2012 |
|
|
11,251 |
|
2013 |
|
|
8,241 |
|
2014 and thereafter |
|
|
1,203 |
|
|
|
|
|
|
|
$ |
42,298 |
|
|
|
|
|
Summary of Stock Option Activity
During the three months ended September 30, 2010 and 2009, we granted
560,320 and 165,400 stock options, respectively. The weighted average grant-date fair value of
options granted during the three months ended September 30, 2010 and 2009 was $6.75 per share and
$3.13 per share, respectively.
During the nine months ended September 30, 2010 and 2009, we granted
5,035,475 and 4,085,050 stock options, respectively. The weighted average grant-date fair value of
options granted during the nine months ended September 30, 2010 and 2009 was $6.24 per share and
$2.60 per share, respectively.
Note 7Net Loss Per Share
Basic net loss per share is calculated based on the weighted-average number
of common shares outstanding during the periods presented. For all periods presented in the
accompanying Condensed Consolidated Statements of Operations, the net loss available to common
stockholders is equal to the reported net loss. Basic and diluted net loss per share are the same
due to our historical net losses and the requirement to exclude potentially dilutive securities
which would have an anti-dilutive effect on net loss per share. The weighted average of these
potentially dilutive securities has been excluded from the diluted net loss per share calculation
and is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Convertible subordinated notes |
|
|
9,989 |
|
|
|
9,989 |
|
|
|
9,989 |
|
|
|
9,989 |
|
Stock options |
|
|
9,142 |
|
|
|
9,886 |
|
|
|
9,273 |
|
|
|
14,155 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
19,131 |
|
|
|
19,875 |
|
|
|
19,262 |
|
|
|
24,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 8 Subsequent Event
On October 29, 2010, we entered into a Supply, Dedicated Suite and Manufacturing Guarantee
Agreement (the Agreement) with Amgen Inc. and Amgen Manufacturing, Limited (collectively
Amgen). Under the terms of the Agreement, we will receive a non-refundable $50.0 million payment
in the fourth quarter of 2010 and we will also receive manufacturing fees on future orders, if any,
submitted by Amgen for polymer materials to be manufactured and supplied by us. Amgen has no
minimum purchase commitment under the Agreement. If quantities of the polymer materials ordered by
Amgen exceed specified quantities (with each specified quantity representing a small portion of the
quantity that we have historically supplied to Amgen), significant additional payments become
payable to us in return for our guarantee of the supply of additional quantities of the polymer
materials. The terms and conditions of the Agreement are more fully described in our Current
Report on Form 8-K filed with the SEC on November 2, 2010.
13
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those discussed here. Factors that
could cause or contribute to such differences include, but are not limited to, those discussed in
this section as well as factors described in Part II, Item 1ARisk Factors.
Overview
Strategic Direction of Our Business
We are a clinical-stage biopharmaceutical company developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms 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 are
exploring a variety of
structures for a potential 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 and intellectual property 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 NKTR-118 and NKTR-119
partnered with AstraZeneca and Bayers Amikacin Inhale (BAY41-6551 or NKTR-061) will likely have a
material impact on our long-term financial results and financial condition. We also have other
partnered programs including, among others, UCB Pharmas CIMZIA, Roches MIRCERA, Affymaxs
Hematide, MAP Pharmaceuticals Levadex, and Bayers Cipro Inhale program, which taken together
could have a material impact on our financial condition. 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.
14
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, for third party collaborators where we have a strategic development and
commercialization relationship, or where we have contractual obligations. 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 September 30, 2010, we had approximately $303.3 million in cash, cash equivalents, and
short-term investments and $240.0 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 late 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 (the Mission Bay Facility), which we have subleased from Pfizer, Inc. In
2010, we expect to spend approximately $23.0 million for tenant improvements for the Mission Bay
Facility and office and related laboratory equipment. Depending on
the status of our sublease efforts,
we may record a non-cash impairment charge of up to $15.0 million for our San Carlos assets
when we move to the Mission Bay Facility in the fourth quarter of 2010.
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
(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 business development efforts will also have a
material impact on our cash position at the end of 2010. We expect to receive a $50.0 million
payment in November 2010, in connection with a Supply, Dedicated Suite and Manufacturing Guarantee
Agreement we entered into with Amgen Inc. and Amgen Manufacturing, Limited (collectively Amgen)
on October 29, 2010.
In addition, our ability to successfully complete a partnership for NKTR-102, and if we are successful, the structure of the partnership, will have
a substantial impact on our liquidity position.
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 and Nine Months Ended September 30, 2010 and 2009
Revenue (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Three months |
|
|
|
|
|
|
Percentage |
|
|
|
ended |
|
|
ended |
|
|
Increase / |
|
|
Increase / |
|
|
|
September 30, |
|
|
September 30, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2010 |
|
|
2009 |
|
|
2010 vs. 2009 |
|
|
2010 vs. 2009 |
|
Product sales and royalties |
|
$ |
7,230 |
|
|
$ |
7,461 |
|
|
$ |
(231 |
) |
|
|
(3 |
)% |
License, collaboration and other |
|
|
30,695 |
|
|
|
2,762 |
|
|
|
27,933 |
|
|
|
>100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
37,925 |
|
|
$ |
10,223 |
|
|
$ |
27,702 |
|
|
|
>100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months |
|
|
Nine months |
|
|
|
|
|
|
Percentage |
|
|
|
ended |
|
|
ended |
|
|
Increase / |
|
|
Increase / |
|
|
|
September 30, |
|
|
September 30, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2010 |
|
|
2009 |
|
|
2010 vs. 2009 |
|
|
2010 vs. 2009 |
|
Product sales and royalties |
|
$ |
21,968 |
|
|
$ |
24,456 |
|
|
$ |
(2,488 |
) |
|
|
(10 |
)% |
License, collaboration and other |
|
|
91,757 |
|
|
|
8,466 |
|
|
|
83,291 |
|
|
|
>100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
113,725 |
|
|
$ |
32,922 |
|
|
$ |
80,803 |
|
|
|
>100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our revenue is derived from our collaboration agreements, under which we may receive
product sales revenue, royalties, license fees, milestone payments or contract research payments.
Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has
occurred, the price is fixed or determinable, and collection is reasonably assured. Upfront fees
received for license and collaborative agreements are recognized ratably over our expected
performance period under the arrangement. Milestones achieved are deferred and recorded as revenue
ratably over the period of time from the achievement of the milestone and our estimated date on
which the next milestone is expected to be achieved. As a result, there may be significant
variations in the timing of
receipt of cash payments and our recognition of revenue. Management makes its best estimate of
the period over which we expect to fulfill our performance obligations and the period of time until
the next milestone is achieved. Given the uncertainties in research and development collaborations,
significant judgment is required by management to determine the amortization periods.
15
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.
Product sales and royalties remained at a consistent level in the three months ended September
30, 2010 compared to the three months ended September 30, 2009.
The decrease in product sales and royalties for the nine months ended September 30, 2010
compared to the nine months ended September 30, 2009 is attributable to decreased product sales of
$4.1 million partially offset by increased royalty revenue of $1.7 million. The timing of shipments
is based on the demand and requirements of our collaboration partners and is not ratable throughout
the year. In the fourth quarter of 2010, we expect product sales volumes to increase compared to
the quarter ended September 30, 2010.
License, Collaboration and Other
License, collaboration and other revenue includes amortization of upfront payments and
milestone payments received in connection with our license and collaboration agreements and
reimbursed research and development expenses. The level of License, collaboration and other revenue
depends in part upon the estimated amortization period of the upfront and milestone payments, the
achievement of future milestones, the continuation of existing collaborations, the amount of
reimbursed research and development work, and the signing of new collaborations.
For the three months and nine months ended September 30, 2010, the increase in License,
collaboration and other revenue compared to the three months and nine months ended September 30,
2009 is primarily attributable to amortization of the $125.0 million upfront payment received from
AstraZeneca for NKTR-118 and NKTR-119, contract research and other revenue from AstraZeneca, and
the amortization of the $31.0 million license extension option payment received in December 2009.
Under the AstraZeneca License, we recognized $25.3 million and $76.0 million, respectively, of the
$125.0 million upfront payment and $1.4 million and $4.0 million, respectively, of contract
research and other revenue for the three months and nine months ended September 30, 2010. We
recognized $1.3 million and $3.8 million, respectively, of the license extension option payment for
the three months and nine months ended September 30, 2010.
Cost of Goods Sold and Product Gross Margin (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
Cost of goods sold |
|
$ |
6,245 |
|
|
$ |
6,134 |
|
|
$ |
111 |
|
|
|
2 |
% |
Product gross profit |
|
$ |
985 |
|
|
$ |
1,327 |
|
|
$ |
(342 |
) |
|
|
(26 |
)% |
Product gross margin |
|
|
14 |
% |
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months |
|
Nine months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
Cost of goods sold |
|
$ |
15,430 |
|
|
$ |
22,139 |
|
|
$ |
(6,709 |
) |
|
|
(30 |
)% |
Product gross profit |
|
$ |
6,538 |
|
|
$ |
2,317 |
|
|
$ |
4,221 |
|
|
|
>100 |
% |
Product gross margin |
|
|
30 |
% |
|
|
9 |
% |
|
|
|
|
|
|
|
|
For the three months ended September 30, 2010 compared to the three months ended
September 30, 2009, the decrease in product gross margin is primarily attributable to a change in
product mix and lower royalties received from our collaboration partners.
For the nine months ended September 30, 2010 compared to the nine months ended September 30,
2009, the increase in product gross margin is primarily attributable to higher manufacturing
volumes, an increase in royalties received from our collaboration partners, and a change in product
mix. Higher manufacturing volumes in both the three months and nine months ended September 30, 2010
compared to 2009 resulted in less unabsorbed manufacturing overhead. Gross margin was also lower in
the nine months ended September 30, 2009, as a result of a $2.1 million success fee that became due
to one of our former consulting firms as the final payment due under the agreement, which was
recognized during the first quarter of 2009.
16
As a result of the fixed cost base associated with our manufacturing activities, we expect
product gross margin to fluctuate in future periods depending on the level of manufacturing
requirements of our customers.
Research and Development Expense (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
Research and development expense |
|
$ |
27,724 |
|
|
$ |
23,031 |
|
|
$ |
4,693 |
|
|
|
20 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months |
|
Nine months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
Research and development expense |
|
$ |
76,610 |
|
|
$ |
70,396 |
|
|
$ |
6,214 |
|
|
|
9 |
% |
Research and development expense consists primarily of personnel costs, including
salaries, benefits, and stock-based compensation, materials and supplies, outside services,
licenses and fees, and overhead allocations consisting of various support and facilities related
costs. Research and development expense is not expected to be ratable over the four quarters of
the year and we expect Research and development expense in the fourth quarter of 2010 to increase compared to the three months ended September 30, 2010.
For the three months and nine months ended September 30, 2010 compared to the same periods in
2009, research and development expense increased by $1.3 million and $3.1 million, respectively,
for our India operations after the completion of the India research facility, by $1.6 million and
$4.9 million, respectively, in U.S. employee costs as a result of headcount additions and salary
and benefit cost increases, and by $0.9 million and $2.6 million, respectively, in non-cash
stock-based compensation expense. Additionally, research expense on pre-clinical programs increased
by approximately $2.2 million and $3.0 million, respectively, for the three months and nine months ended September
30, 2010 compared to the three months and nine months ended September 30, 2009.
These increases are partially offset by lower expenses for the NKTR-118 and NKTR-119 programs
as a result of our successful completion of Phase 2 clinical studies and the AstraZeneca License
transaction in September 2009. NKTR-118 and NKTR-119 expenses totaled approximately $2.1 million
and $8.6 million, respectively, for the three months and nine months ended September 30, 2009
compared to $1.1 million and $2.4 million, respectively, for the three months and nine months ended
September 30, 2010. In addition, NKTR-102 program costs decreased by approximately $0.4 million for
both the three months and nine months ended September 30, 2010 compared to the three months and
nine months ended September 30, 2009.
General and Administrative Expense (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
General and administrative expense |
|
$ |
10,181 |
|
|
$ |
9,917 |
|
|
$ |
264 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months |
|
Nine months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
General and administrative expense |
|
$ |
29,401 |
|
|
$ |
30,024 |
|
|
$ |
(623 |
) |
|
|
(2 |
)% |
General and administrative expense is associated with administrative staffing, business
development, marketing, and legal. For the three months and nine months ended September 30, 2010,
general and administrative expense remained at a relatively consistent level compared to the three
months and nine months ended September 30, 2009.
For the three months and nine months ended September 30, 2010 compared to the same periods in
2009, non-cash stock-based compensation expense increased by $1.1 million and $3.0 million,
respectively, and non-cash rent expense increased by $0.5 million and $1.0 million,
respectively, for the Mission Bay Facility. Although we will not pay rent until 2014, we have recognized rent expense on a straight line basis over the life of the lease since April 1,
2010, when our tenant improvement construction period commenced. The increase in non-cash costs are
partially offset by decreased outside professional services related to legal, patent, accounting,
market research, recruiting, and other consulting.
17
Interest Income and Interest Expense (in thousands, except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
Interest income |
|
$ |
369 |
|
|
$ |
560 |
|
|
$ |
(191 |
) |
|
|
(34 |
)% |
Interest expense |
|
$ |
(2,826 |
) |
|
$ |
(2,928 |
) |
|
$ |
(102 |
) |
|
|
(3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months |
|
Nine months |
|
|
|
|
|
Percentage |
|
|
ended |
|
ended |
|
Increase / |
|
Increase / |
|
|
September 30, |
|
September 30, |
|
(Decrease) |
|
(Decrease) |
|
|
2010 |
|
2009 |
|
2010 vs. 2009 |
|
2010 vs. 2009 |
Interest income |
|
$ |
1,225 |
|
|
$ |
3,160 |
|
|
$ |
(1,935 |
) |
|
|
(61 |
)% |
Interest expense |
|
$ |
(8,686 |
) |
|
$ |
(9,213 |
) |
|
$ |
(527 |
) |
|
|
(6 |
)% |
The decrease in interest income for the three months and nine months ended September 30, 2010
compared to the three months and nine months ended September 30, 2009 is a result of decreased
market interest rates received for our cash and short-term investments and lower average balances
for the period.
Liquidity and Capital Resources
We have financed our operations primarily through cash 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 $303.3
million and indebtedness of $240.0 million, including $215.0 million of 3.25% convertible
subordinated notes due September 2012, $19.2 million in capital lease obligations, and $5.8 million
in other liabilities as of September 30, 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 September 30, 2010, the average time
to maturity of the investments held in our portfolio was approximately four months and the 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 from operating activities
Cash
flows used in operating activities for the nine months ended September 30, 2010, totaled
$76.3 million, which includes $7.2 million for employee bonus payments related to services
performed in 2009, $7.0 million for interest payments on our convertible subordinated notes, and
$62.1 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. We expect cash flows from operating activities will be positive as a result of the $50.0
million payment from Amgen expected in the fourth quarter in connection with the Supply, Dedicated
Suite and Manufacturing Guarantee Agreement entered on October 29, 2010.
For the nine months ended September 30, 2009, cash used in operations totaled $90.5 million
and included $4.7 million for employee bonus payments related to services performed in 2008, $7.0
million for interest payments on our convertible subordinated notes, $2.7 million for severance
payments, and $76.1 million of other net operating cash uses.
Cash flows from investing activities
We purchased $22.2 million and $10.8 million of property and equipment in the nine months
ended September 30, 2010 and 2009, respectively. For the nine months ended September 30, 2010,
cash paid for leasehold improvements and equipment for the Mission Bay Facility totaled
approximately $14.0 million; we expect to spend an additional $9.0 million on the Mission Bay
Facility in the fourth quarter of 2010. During the nine months ended September 30, 2009, we paid
$4.4 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 $7.1 million and $3.8 million, respectively, from issuances of common stock to
employees during the nine months ended September 30, 2010 and 2009, resulting in net cash provided
by financing activities.
18
Contractual Obligations
There were no material changes during the three months ended September 30,
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.
New Accounting Standards Not Yet Adopted
FASB Accounting Standards Update 2009-13, Revenue Recognition (Topic 605)
Multiple-Deliverable Revenue Arrangements
In October 2009, the FASB published 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. We do not expect this ASU will have a material impact on our financial position or
results of operations when we adopt it on January 1, 2011.
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. We do not expect this ASU will
have a material impact on our financial position or results of operations when we adopt it on
January 1, 2011.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our market risks at September 30, 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.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure
that information required to be disclosed in our Securities Exchange Act of 1934 (Exchange Act)
reports is recorded, processed, summarized, and reported within the time periods specified in the
SECs rules and forms, and that such information is accumulated and communicated to management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required financial disclosure.
As of the end of the period covered by this report, we carried out an
evaluation, under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of
our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon, and as of
the date of, this evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
We continuously seek to improve the efficiency and effectiveness of our
internal controls. This results in refinements to processes throughout the Company. However, there
was no change in our internal control over financial reporting that occurred in the three months
ended September 30, 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.
Approval of Non-Audit Services
None.
19
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
Reference is hereby made to our disclosures in Legal Matters under Note 4 of the Notes to
Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q and the
information under the heading Legal Matters is incorporated by reference herein.
Item 1A. Risk Factors
Investors in Nektar Therapeutics should carefully consider the risks described below before
making an investment decision. The risks described below may not be the only ones relating to our
company. This description includes any material changes to and supersedes the description of the
risk factors associated with our business previously disclosed in Item 1A of our Annual Report on
Form 10-K for the twelve months ended December 31, 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 with a high risk of failure at every
stage of development.
We have a number of proprietary product candidates and partnered product candidates in
research and development ranging from the early discovery research phase through preclinical
testing and clinical trials. Preclinical testing and clinical trials are long, expensive and highly
uncertain processes. It will take us, or our collaborative partners, several years to complete
clinical trials. Drug development is an uncertain scientific and medical endeavor and failure can
unexpectedly occur at any stage of clinical development even after early preclinical or mid-stage
clinical results suggest that the drug candidate has potential as a new therapy that may benefit
patients and that health authority approval would be anticipated. Typically, there is a high rate of
attrition for product candidates in preclinical and clinical trials due to scientific feasibility,
safety, efficacy, changing standards of medical care and other variables. We or our partners have
a number of important product candidates in mid- to late-stage development such as Bayers Amikacin
Inhale, Oral NKTR-118 (oral PEGylated naloxol) and NKTR-119 which we partnered with AstraZeneca,
and NKTR-102 (PEGylated irinotecan). 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 our partnership with AstraZeneca. 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 2010, we announced
preliminary positive results from our Phase 2 trial for NKTR-102 in ovarian cancer. 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 the NKTR-102 clinical study for
ovarian cancer is not necessarily indicative or predictive of the future results from the completed
ovarian cancer trial or the other cancer indications for which we are studying NKTR-102. Further, we have expanded the NKTR-102 Phase 2 study in women with platinum-resistant/refractory
ovarian cancer and this expansion will necessarily change the final efficacy (e.g. overall response
rates, progression-free survival, overall survival etc.) and safety (i.e. frequency of serious
adverse events) results and, as such, the final results in this study remain subject to substantial
change and could be materially and adversely different from previously announced results. 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 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.
20
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. The timing of new collaboration partnerships is difficult to
predict due to availability of clinical data, the number of potential partners that need to
complete due diligence and approval processes, the definitive agreement negotiation process and
numerous other unpredictable factors that can delay, impede or prevent significant transactions. If
we are unable to find suitable partners or to negotiate collaborative arrangements with favorable
commercial terms with respect to our existing and future product candidates or the licensing of our
technology, or if any arrangements we negotiate, or have negotiated, are terminated, our business,
results of operations and financial condition could suffer.
We may not be able to obtain intellectual property licenses related to the development of our
technology on a commercially reasonable basis, if at all.
Numerous pending and issued U.S. and foreign patent rights and other proprietary rights owned
by third parties relate to pharmaceutical compositions, medical devices and equipment and methods
for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any
certainty which, if any, patent references will be considered relevant to our or our collaborative
partners technology or drug candidates by authorities in the various jurisdictions where such
rights exist, nor can we predict with certainty which, if any, of these rights will or may be
asserted against us by third parties. In certain cases, we have existing licenses or
cross-licenses with third parties, however the scope and adequacy of these licenses is very
uncertain and can change substantially during long development and commercialization cycles for
biotechnology and pharmaceutical products. There can be no assurance that we can obtain a license
to any technology that we determine we need on reasonable terms, if at all, or that we could
develop or otherwise obtain alternate technology. If we are required to enter into a license with a
third party, our potential economic benefit for the products subject to the license will be
diminished. 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 greater than 100 U.S. and
380 foreign patents and a number of pending patent applications that cover various aspects of our
technologies. We have filed patent applications, and plan to file additional patent applications,
covering various aspects of our PEGylation and advanced polymer conjugate technologies and our
proprietary product candidates. There can be no assurance that patents that have issued will be
valid and enforceable or that patents for which we apply will issue with broad coverage, if at all.
The coverage claimed in a patent application can be significantly reduced before the patent is
issued and, as a consequence, our patent applications may result in patents with narrow coverage.
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.
21
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.
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 in controlling for all of these factors during manufacturing scale-up
for large clinical trials and commercial manufacturing and supply. In addition, we have faced and
may in the future face significant difficulties, delays and unexpected expenses as we validate
third party contract manufacturers required for scale-up to clinical or commercial quantities.
Failure to manufacture products in quantities or at costs that are commercially feasible could
cause us not to meet our supply requirements, contractual obligations or other requirements for our
proprietary product candidates and, as a result, would significantly harm our business, results of
operations and financial condition.
For instance, we entered a service agreement with Novartis pursuant to which we subcontract to
Novartis certain important services to be performed in relation to our partnered program for
Amikacin Inhale with Bayer Healthcare LLC. If our subcontractors do not dedicate adequate resources to
our programs, we risk breach of our obligations to our partners. Building and validating large
scale clinical or commercial-scale manufacturing facilities and processes, recruiting and training
qualified personnel and obtaining necessary regulatory approvals is complex, expensive and time
consuming. In the past we have encountered challenges in scaling up manufacturing to meet the
requirements of large scale clinical trials without making modifications to the drug formulation,
which may cause significant delays in clinical development. Further, our drug and device
combination products, such as 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 Amikacin Inhale 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 and time-consuming to develop due to the number of variables involved in the final
product design, including ease of patient/doctor use, maintenance of clinical efficacy, reliability
and cost of manufacturing, regulatory approval requirements and standards and other important
factors. There continues to be substantial and unpredictable risk and uncertainty related to
manufacturing and supply until such time as the commercial supply chain is validated and proven.
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.
22
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:
|
|
|
design and conduct large scale clinical studies; |
|
|
|
|
prepare and file documents necessary to obtain government approvals to sell a given
product candidate; and/or |
|
|
|
|
market and sell our products when and if they are approved. |
Our reliance on collaboration partners poses a number of risks to our business, including
risks that:
|
|
|
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; |
|
|
|
|
disputes may arise in the future with respect to the ownership of rights to technology
or intellectual property developed with partners; |
|
|
|
|
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; |
|
|
|
|
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; |
|
|
|
|
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; |
|
|
|
|
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; |
|
|
|
|
the timing and level of resources that our partners dedicate to the development program
will affect the timing and amount of revenue we receive; |
|
|
|
|
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; |
|
|
|
|
partners may be unable to pay us as expected; and |
|
|
|
|
partners may terminate their agreements with us unilaterally for any or no reason, in
some cases with the payment of a termination fee penalty and in other cases with no
termination fee penalty. |
Given these risks, the success of our current and future partnerships is highly unpredictable
and can have a substantial negative or positive impact on our business. We have entered into
collaborations in the past that have been subsequently terminated, such as our collaboration with
Pfizer for the development and commercialization of inhaled insulin that was terminated by Pfizer
in November 2007. If other collaborations are suspended or terminated, our ability to commercialize
certain other proposed product candidates could also be negatively impacted. If our collaborations
fail, our product development or commercialization of product candidates could be delayed or
cancelled, which would negatively impact our business, results of operations and financial
condition.
If we or our partners do not obtain regulatory approval for our product candidates on a timely
basis, 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.
23
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:
|
|
|
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; |
|
|
|
|
research and development performance and reimbursement obligations for our personnel
and other resources allocated to partnered product development programs; |
|
|
|
|
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; |
|
|
|
|
intellectual property ownership allocation between us and our partners for improvements
and new inventions developed during the course of the partnership; |
|
|
|
|
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 |
|
|
|
|
indemnity obligations for third-party intellectual property infringement, product
liability and certain other claims. |
On September 20, 2009, we entered into a worldwide exclusive license agreement with
AstraZeneca for the further development and commercialization of NKTR-118 and NKTR-119. In
addition, we have also entered into complex commercial agreements with Novartis in connection with
the sale of certain assets related to our pulmonary business, associated technology and
intellectual property to Novartis (the Novartis Pulmonary Asset Sale), which was completed on
December 31, 2008. Our agreements with AstraZeneca and Novartis contain complex representations and
warranties, covenants and indemnification obligations that could result in substantial future
liability and harm our financial condition if we breach any of our agreements with AstraZeneca or
Novartis or any third party agreements impacted by these complex
transactions. 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 partner program for Amikacin Inhale.
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.
24
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 and nine months ended September 30, 2010, we reported a net loss of $8.7 million
and $15.4 million, respectively. If and when we achieve profitability depends upon a number of
factors, including the timing and recognition of milestone payments and royalties received, the
timing of revenue under our collaboration agreements, the amount of investments we make in our
proprietary product candidates and the regulatory approval and market success of our product
candidates. We may not be able to achieve and sustain profitability.
Other factors that will affect whether we achieve and sustain profitability include our
ability, alone or together with our partners, to:
|
|
|
develop products utilizing our technologies, either independently or in collaboration
with other pharmaceutical or biotech companies; |
|
|
|
|
receive necessary regulatory and marketing approvals; |
|
|
|
|
maintain or expand manufacturing at necessary levels; |
|
|
|
|
achieve market acceptance of our partnered products; |
|
|
|
|
receive royalties on products that have been approved, marketed or submitted for
marketing approval with regulatory authorities; and |
|
|
|
|
maintain sufficient funds to finance our activities. |
If we do not generate sufficient cash flow through increased revenue or raising additional capital,
we may not be able to meet our substantial debt obligations.
As of September 30, 2010, we had cash, cash equivalents, and short-term investments in
marketable securities valued at approximately $303.3 million and approximately $240.0 million of
indebtedness, including approximately $215.0 million in convertible subordinated notes due
September 2012, $19.2 million in capital lease obligations, and $5.8 million of other liabilities.
Our substantial indebtedness has and will continue to impact us by:
|
|
|
making it more difficult to obtain additional financing; |
|
|
|
|
constraining our ability to react quickly in an unfavorable economic climate; |
|
|
|
|
constraining our stock price; and |
|
|
|
|
constraining our ability to invest in our proprietary product development programs. |
Currently, we are not generating positive cash flow. If we are unable to satisfy our debt
service requirements, substantial liquidity problems could result. In relation to our convertible
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.
25
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.
26
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 for and commercialize next-generation or new products that will successfully compete with
those of our competitors. Many of our competitors have greater financial, research and development,
marketing and sales, manufacturing and managerial capabilities. We face competition from these
companies not just in product development but also in areas such as recruiting employees, acquiring
technologies that might enhance our ability to commercialize products, establishing relationships
with certain research and academic institutions, enrolling patients in clinical trials and seeking
program partnerships and collaborations with larger pharmaceutical companies. As a result, our
competitors may succeed in developing competing technologies, obtaining regulatory approval or
gaining market acceptance for products before we do. These developments could make our products or
technologies uncompetitive or obsolete.
We could be involved in legal proceedings and may incur substantial litigation costs and
liabilities that will adversely affect our business, results of operations and financial condition.
From time to time, third parties have asserted, and may in the future assert, that we or our
partners infringe their proprietary rights. 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 Roches proposed marketing
and sale of MIRCERA to treat chemotherapy anemia in the U.S. In October 2008, a federal court
ruled in favor of Amgen, issuing a 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.
27
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.
28
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:
|
|
|
establishment of a classified board of directors such that not all members of the board
may be elected at one time; |
|
|
|
|
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; |
|
|
|
|
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; |
|
|
|
|
prohibition on stockholder action by written consent, thereby requiring all stockholder
actions to be taken at a meeting of stockholders; |
|
|
|
|
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 |
|
|
|
|
limitations on who may call a special meeting of stockholders. |
Further, we have in place a preferred share purchase rights plan, commonly known as a poison
pill. The provisions described above, our poison pill and provisions of Delaware law relating to
business combinations with interested stockholders may discourage, delay or prevent a third party
from acquiring us. These provisions may also discourage, delay or prevent a third party from
acquiring a large portion of our securities or initiating a tender offer or proxy contest, even if
our stockholders might receive a premium for their shares in the acquisition over the then current
market prices. We also have a change of control severance benefits plan which provides for certain
cash severance, stock award acceleration and other benefits in the event our employees are
terminated (or, in some cases, resign for specified reasons) following an acquisition. This
severance plan could discourage a third party from acquiring us.
29
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 September 30, 2010, based on closing bid
prices on the NASDAQ Global Select Market, our stock price ranged from $11.60 to $15.21 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:
|
|
|
announcements of data from, or material developments in, our clinical trials or those
of our competitors, including delays in clinical development, approval or launch; |
|
|
|
|
announcements by collaboration partners as to their plans or expectations related to
products using our technologies; |
|
|
|
|
announcements or terminations of collaboration agreements by us or our competitors; |
|
|
|
|
fluctuations in our results of operations; |
|
|
|
|
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; |
|
|
|
|
announcements of technological innovations or new therapeutic products that may compete
with our approved products or products under development; |
|
|
|
|
announcements of changes in governmental regulation affecting us or our competitors; |
|
|
|
|
hedging activities by purchasers of our convertible senior notes; |
|
|
|
|
litigation brought against us or third parties to whom we have indemnification
obligations; |
|
|
|
|
public concern as to the safety of drug formulations developed by us or others; and |
|
|
|
|
general market conditions. |
Our stockholders may be diluted, and the price of our common stock may decrease, as a result of the
exercise of outstanding stock options and warrants or the future issuances of securities.
We may issue additional common stock, preferred stock, restricted stock units or securities
convertible into or exchangeable for our common stock. Furthermore, substantially all shares of
common stock for which our outstanding stock options or warrants are exercisable are, once they
have been purchased, eligible for immediate sale in the public market. The issuance of additional
common stock, preferred stock, restricted stock units or securities convertible into or
exchangeable for our common stock or the exercise of stock options or warrants would dilute
existing investors and could adversely affect the price of our securities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None, including no purchases of any class of our equity securities by us or any affiliate
pursuant to any publicly announced repurchase plan in the three months ended September 30, 2010.
Item 3. Defaults Upon Senior Securities
None.
Item 5. Other Information
None.
30
Item 6. Exhibits
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Quarterly Report on Form 10-Q.
|
|
|
Exhibit |
|
|
Number |
|
Description of Documents |
31.1(1)
|
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
|
|
|
31.2(1)
|
|
Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule 15d-14(a). |
|
|
|
32.1(1)*
|
|
Section 1350 Certifications. |
|
|
|
(1) |
|
Filed herewith. |
|
* |
|
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. |
31
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
|
|
By: |
/s/ John Nicholson
|
|
|
|
John Nicholson |
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
|
Date: November 4, 2010
|
|
|
By: |
/s/ Jillian B. Thomsen
|
|
|
|
Jillian B. Thomsen |
|
|
|
Senior Vice President and Chief Accounting Officer |
|
|
|
|
|
|
|
Date: November 4, 2010
|
|
32
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 |
|
Description of Documents |
31.1(1)
|
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
|
|
|
31.2(1)
|
|
Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule 15d-14(a). |
|
|
|
32.1(1)*
|
|
Section 1350 Certifications. |
|
|
|
(1) |
|
Filed herewith. |
|
* |
|
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. |
33