SAN FRANCISCO, March 1, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2010.
Cash, cash equivalents, and short-term investments at December 31, 2010 were $315.9 million. The cash balance at December 31, 2010 does not include proceeds of $220.4 million received from the completion of a public equity offering in January 2011.
Revenue for the fourth quarter of 2010 increased to $45.3 million as compared to $39.0 million in the fourth quarter of 2009. Revenue for the full year 2010 increased to $159.0 million as compared to $71.9 million for the full year 2009. The increase in revenue year over year is the result of amortization of a $125.0 million milestone payment received from AstraZeneca in September 2009 under the partnership agreement for NKTR-118.
Total operating costs and expenses in the fourth quarter of 2010 were $65.9 million compared to $44.5 million in the fourth quarter 2009. The increase in total operating costs and expenses in fourth quarter 2010 was primarily due to increased research and development expenses and a non-cash facilities impairment charge of $12.6 million.
Research and development expenses increased to $31.5 million in the fourth quarter of 2010 as compared to $24.7 million for the same quarter in 2009. For the full year 2010, research and development expenses increased to $108.1 million as compared to $95.1 million in 2009. General and administrative expense was $11.6 million in the fourth quarter 2010 as compared to $11.0 million in the fourth quarter of 2009. For the full year 2010, general and administrative expense was flat year-over-year at $41.0 million.
"2010 was a year of great advancement for Nektar,” said Howard W. Robin, President and Chief Executive Officer of Nektar. “Our lead oncology program, NKTR-102, demonstrated positive results in Phase 2 studies in both ovarian and breast cancers, and we plan to move into Phase 3 in 2011. NKTR-118, partnered with AstraZeneca, and NKTR-061, partnered with Bayer, are both planned to move into Phase 3 this year as well. Lastly, Nektar’s research pipeline is on track to deliver one new clinical candidate each year, and we are looking forward to starting Phase 1 clinical studies of NKTR-181, our novel opioid analgesic, this month."
Net loss for the fourth quarter ended December 31, 2010 was $22.6 million or $0.24 per share, as compared to a net loss of $7.7 million or $0.08 per share in the fourth quarter of 2009. The fourth quarter 2010 net loss includes a non-cash impairment charge of $12.6 million, or $0.13 per share, for the write-down related to the move to Nektar’s new San Francisco, California Mission Bay R&D center from its San Carlos facility. Net loss for the full year 2010 improved to $37.9 million, or $0.40 per share, as compared to a net loss of $102.5 million, or $1.11 per share, in 2009.
Conference Call to Discuss Fourth Quarter and Year End 2010 Financial Results
A conference call to review the financial results will be held today, Tuesday, March 1, 2011 at 2 PM Pacific Time/5 PM Eastern time.
Details are below:
The press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.nektar.com.
To access the conference call, follow these instructions:
Dial: 1-866-713-8307; 617-597-5307 (international)
Passcode: 79375407 (Nektar Therapeutics is the host)
An audio replay will also be available shortly following the call through Tuesday, March 29, 2011 and can be accessed by dialing (888) 286-8010 (U.S.); or (617) 801-6888 (international) with a passcode of 10590598.
In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.
Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for Nektar's oral NKTR-118 late-stage development program to treat opioid-induced constipation and its NKTR-119 earlier stage development program for the treatment of pain without constipation side effects. NKTR-181, a novel mu-opioid analgesic molecule, is scheduled to enter Phase 1 clinical studies in the first part of 2011. In oncology, NKTR-102, a novel topoisomerase I-inhibitor, is being evaluated in Phase 2 clinical studies for the treatment of breast, ovarian and colorectal cancers. NKTR-105, a novel anti-mitotic agent, is in a Phase 1 clinical study in cancer patients with refractory solid tumors.
Nektar's technology has enabled seven approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia(R) for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS(R) for hepatitis C and Amgen's Neulasta(R) for neutropenia.
Nektar is headquartered in San Francisco, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
This press release contains forward-looking statements that reflect management's current views regarding the value and potential of Nektar's drug candidate pipeline and the plan to move new drug candidates into clinical development, the planned start of the Phase 3 programs for NKTR-118 and Amikacin Inhale, and the timing of the commencement of the Phase 1 clinical trial for NKTR-181. These forward-looking statements involve numerous risks and uncertainties, including but not limited to: (i) Nektar's product candidates and those of its collaboration partners are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval for numerous reasons including safety and efficacy findings even after positive findings in preclinical and clinical studies; (ii) the timing of the commencement or end of clinical trials and the successful commercial launch of our drug candidates may be delayed or unsuccessful due to slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, regulatory delay, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iii) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of Nektar's technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (iv) Nektar's patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required in the future; (v) the outcome of any future intellectual property or other litigation related to Nektar's proprietary product candidates or complex commercial agreements; and (vi) certain other important risks and uncertainties set forth in Nektar's Annual Report on Form 10-K and Current Report on Form 8-K filed with the Securities and Exchange Commission on March 1, 2011. Actual results could differ materially from the forward-looking statements contained in this press release. Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise.
Nektar Investor Inquiries:
Jennifer Ruddock/Nektar Therapeutics
Susan Noonan/SA Noonan Communications, LLC
Nektar Media Inquiries:
Karen Bergman/BCC Partners
Michelle Corral/BCC Partners
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, 2010
December 31, 2009
Cash and cash equivalents
Other current assets
Total current assets
Property and equipment, net
LIABILITIES AND STOCKHOLDERS' EQUITY
Accrued clinical trial expenses
Deferred revenue, current portion
Other current liabilities
Total current liabilities
Convertible subordinated notes
Capital lease obligations
Other long-term liabilities
Commitments and contingencies
Capital in excess of par value
Accumulated other comprehensive income
Total stockholders' equity
Total liabilities and stockholders' equity
(1) The consolidated balance sheet at December 31, 2009 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles in the United States for complete financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
Three Months Ended
Twelve Months Ended
Product sales and royalties
License, collaboration and other
Operating costs and expenses:
Cost of goods sold
Research and development
General and administrative
Impairment of long-lived assets
Total operating costs and expenses
Loss from operations
Non-operating income (expense):
Other income, net
Total non-operating expense
Loss before provision (benefit) for income taxes
Provision (benefit) for income taxes
Basic and diluted net loss per share
Weighted average shares outstanding used in
computing basic and diluted net loss per
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Twelve Months Ended December 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Depreciation and amortization
Other non-cash transactions
Impairment of long-lived assets
Changes in operating assets and liabilities:
Accrued clinical trial expenses
Net cash (used in) provided by operating activities
Cash flows from investing activities:
Purchases of investments
Sales of investments
Maturities of investments
Purchases of property and equipment
Advance payments for property and equipment
Transaction costs from Novartis pulmonary asset sale
Net cash provided by (used in) investing activities
Cash flows from financing activities:
Payments of loan and capital lease obligations
Proceeds from issuances of common stock
Net cash provided by financing activities
Effect of exchange rates on cash and cash equivalents
Net decrease in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
SOURCE Nektar Therapeutics