SAN FRANCISCO, Feb. 28, 2013 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2012.
Cash, cash equivalents, and investments at December 31, 2012 were $302.2 million as compared to $414.9 million at December 31, 2011.
"As we enter 2013, Nektar is in an excellent position with five highly valuable late-stage programs across multiple therapeutic areas," said Howard W. Robin, President and Chief Executive Officer of Nektar. "With positive efficacy and safety results from the full Phase 3 KODIAC program for naloxegol, our partner AstraZeneca is preparing to submit registration filings in the U.S. and EU in the third quarter of this year. We are tremendously pleased that Bayer is scheduled to start the Phase 3 program next month for Amikacin Inhale in gram-negative pneumonia. Additionally, we expect to report key Phase 2 clinical data this summer for NKTR-181, our novel opioid analgesic, which represents a potential breakthrough for the treatment of chronic pain."
Revenue for the fourth quarter of 2012 was $21.1 million as compared to $15.8 million in the fourth quarter of 2011. Revenue for the year ended December 31, 2012 was $81.2 million as compared to $71.5 million in 2011. 2012 revenue included $10.8 million in non-cash revenues resulting from the $124 million sale of future royalties related to Cimzia® and Mircera®, which was completed in February 2012. This non-cash royalty revenue is offset by non-cash interest expense. For both the quarter and the year ended December 31, 2012, product sales increased significantly. These increases were partially offset by decreases in royalty revenues.
Total operating costs and expenses in the fourth quarter of 2012 were $64.5 million as compared to $50.3 million in the fourth quarter of 2011. Total operating costs and expenses for the year ended December 31, 2012 were $222.4 million as compared to $195.4 million in 2011. The increases in 2012 as compared to 2011 are due primarily to increased clinical development expenses as well as higher cost of goods related to increased product sales.
Research and development expense in the fourth quarter of 2012 was $46.4 million as compared to $33.3 million for the fourth quarter of 2011. For the year ended December 31, 2012, R&D expense was $148.7 million as compared to $126.8 million in 2011. R&D expense was higher in the fourth quarter and year ended December 31, 2012 as compared to the same periods in 2011 reflecting the costs of the etirinotecan pegol (NKTR-102) BEACON Phase 3 study, the production of devices for the Phase 3 study of Amikacin Inhale, the Phase 1 and Phase 2 studies for NKTR-181, and the Phase 1 study for NKTR-192.
General and administrative expense was $10.9 million in the fourth quarter of 2012 as compared to $11.5 million in the fourth quarter of 2011. G&A expense for the year ended December 31, 2012 was $41.6 million as compared to $46.8 million in 2011.
Non-cash interest expense was $5.4 million and $18.1 million in the fourth quarter and year ended December 31, 2012, respectively. The company incurred non-cash interest expense as a result of the sale of future royalties related to Cimzia® and Mircera®. No non-cash interest expense was incurred in 2011.
Net loss for the fourth quarter ended December 31, 2012 was $52.9 million or $0.46 loss per share. Net loss for the year ended December 31, 2012 was $171.9 million or $1.50 loss per share. Net loss for the fourth quarter ended December 31, 2011 was $37.5 million or $0.33 loss per share. Net loss for the year ended December 31, 2011 was $134.0 million or $1.19 loss per share.
The company also announced upcoming presentations at the following medical meetings and scientific congresses during the first half of 2013:
33rd International Symposium on Intensive Care and Emergency Medicine, Brussels, Belgium:
American Association for Cancer Research 2013 Annual Meeting, Washington, DC:
American Academy of Pain Medicine 29th Annual Meeting, Fort Lauderdale, FL:
American Pain Society 32nd Annual Scientific Meeting, New Orleans, LA:
Digestive Disease Week 2013, Orlando, FL:
4th International Congress on Neuropathic Pain, Toronto, Canada:
College on Problems of Drug Dependence 75th Annual Meeting, San Diego, CA:
Conference Call to Discuss Fourth Quarter and Year-End 2012 Financial ResultsNektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Thursday, February 28, 2013.
This 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. The web broadcast of the conference call will be available for replay through Friday, March 15, 2013.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 98224860 (Nektar Therapeutics is the host)
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 therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian and colorectal cancers.
Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development.
Nektar is headquartered in San Francisco, California, with additional 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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential future regulatory filings by AstraZeneca for naloxegol; the projected timing of the start of the Phase 3 clinical study by Bayer for Amikacin Inhale; the projected availability of Phase 2 clinical study results for NKTR-181; and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, (i) our drug candidates and those of our 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 previous preclinical and clinical studies; (ii) the timing of the commencement or end of clinical trials and the commercial launch of our drug candidates may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, 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) acceptance, review and approval decisions for new drug applications by health authorities is an uncertain and evolving process and health authorities retain significant discretion at all stages of the regulatory review and approval decision process; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more research and development programs could fail; and (v) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2012. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.Nektar Investor Inquiries:Jennifer Ruddock/Nektar Therapeutics
(415) 482-5585Susan Noonan/SA Noonan Communications, LLC
Nektar Media Inquiries:Amanda Connelly/MSL
(404) 870-6865Mike Huckman /MSL
(646) 500-7631 NEKTAR THERAPEUTICSCONDENSED CONSOLIDATED BALANCE SHEETS(In thousands)(Unaudited)ASSETSDecember 31, 2012December 31, 2011
(1)Current assets:Cash and cash equivalents
251,757225,856Accounts receivable, net
18,26912,656Other current assets
13,36317,944Total current assets
25,000-Property and equipment, net
,550LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable
8,0086,669Accrued clinical trial expenses
17,50011,953Deferred revenue, current portion
7,0831,805Convertible subordinated notes
-214,955Other current liabilities
12,4144,681Total current liabilities
78,537275,532Senior secured notes
125,000-Capital lease obligations, less current portion
11,60714,582Liability related to sale of future royalties, less current portion
128,266-Deferred revenue, less current portion
2,4043,278Other long-term liabilities
450,772408,739Commitments and contingenciesStockholders' equity:Preferred stock
1111Capital in excess of par value
1,617,7441,597,428Accumulated other comprehensive loss
(1,570,380)(1,398,525)Total stockholders' equity
47,018197,811Total liabilities and stockholders' equity
,550(1) The consolidated balance sheet at December 31, 2011 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. NEKTAR THERAPEUTICSCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except per share information)(Unaudited)Three Months EndedTwelve Months EndedDecember 31,December 31,2012201120122011Revenue: Product sales
24,864 Royalty revenues
9083,0954,87410,327 Non-cash royalty revenue related to sale of future royalties
3,896-10,791- License, collaboration and other
21,14615,78281,19171,480Operating costs and expenses: Cost of goods sold
7,2905,45030,42821,891 Research and development
46,37333,302148,675126,766 General and administrative
10,86411,49841,61446,760 Impairment of long-lived assets
--1,675-Total operating costs and expenses
64,52750,250222,392195,417Loss from operations
(43,381)(34,468)(141,201)(123,937)Non-operating income (expense): Interest income
4506612,3152,244 Interest expense
(4,682)(2,525)(15,489)(10,223) Non-cash interest expense on liability related to sale of future royalties
(5,416)-(18,057)- Other income (expense), net
70(445)983(1,044)Total non-operating expense, net
(9,578)(2,309)(30,248)(9,023)Loss before provision for income taxes
(52,959)(36,777)(171,449)(132,960)Provision (benefit) for income taxes
$ (52,926)$ (37,495)$ (171,855)$ (133,978)Basic and diluted net loss per share
(1.19)Weighted average shares outstanding used in computing basic and diluted net loss per share115,179114,446114,820112,942 NEKTAR THERAPEUTICSCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands)(Unaudited)Twelve Months Ended December 31,20122011Cash flows from operating activities:Net loss
(133,978)Adjustments to reconcile net loss to net cash used in operating activities:Non-cash interest expense on liability related to sale of future royalties
18,057-Non-cash royalty revenue related to sale of future royalties
16,19918,885Depreciation and amortization
14,50814,951Impairment of long-lived assets
1,675-Other non-cash transactions
8451,359Changes in operating assets and liabilities:Accounts receivable
1,4951,013Accrued clinical trial expenses
3,275(943)Net cash used in operating activities
(129,756)(113,742)Cash flows from investing activities:Purchases of property and equipment
(25,000)-Maturities of investments
307,887383,052Sales of investments
5,378210,089Purchases of investments
(164,662)(695,371)Net cash provided by (used in) investing activities
113,020(111,952)Cash flows from financing activities:Proceeds from issuance of senior secured notes, net
77,940-Repayment of convertible subordinated notes
(172,407)-Payment of capital lease obligations
(2,437)(1,978)Proceeds from sale of future royalties, net
119,588-Proceeds from shares issued under equity compensation plans
4,1174,530Issuance of common stock, net
-219,783Net cash provided by financing activities
26,801222,335Effect of exchange rates on cash and cash equivalents
60916Net increase (decrease) in cash and cash equivalents
10,125(2,443)Cash and cash equivalents at beginning of period
15,31217,755Cash and cash equivalents at end of period
5,312Supplemental disclosure of cash flow information:Cash paid for interest
,277Cash paid for income taxes
957Supplemental schedule of non-cash investing and financing activities:Retirement of convertible subordinated notes in exchange for senior secured notes
|SOURCE Nektar Therapeutics|
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