Unassociated Document
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K
  
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
  
Date of report (Date of earliest event reported): March 2, 2010
 
NEKTAR THERAPEUTICS
(Exact Name of Registrant as Specified in Charter)
 
Delaware
 
0-24006
 
94-3134940
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
201 Industrial Road
San Carlos, California 94070
(Address of Principal Executive Offices and Zip Code)
 
Registrant’s telephone number, including area code: (650) 631-3100
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
 
Item 2.02
Results of Operations and Financial Condition

On March 2, 2010, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its year-end 2009 financial results.   A copy of the Press Release is furnished herewith as Exhibit 99.1.

On February 23, 2010, Nektar announced that management would hold a conference call on March 2, 2010 to review its 2009 year-end financial results and provide an update on Nektar’s business.  On this conference call, management expects to make certain forward-looking statements regarding certain pre-clinical and clinical development results and progress for certain of Nektar’s proprietary drug development programs, the value of Nektar’s pegylation and advanced polymer chemistry technology platform, the timing and availability of future clinical development program results, potential future revenues that may be realized in the future under certain of the Nektar’s collaboration agreements, and management’s financial guidance for 2010.  These forward-looking statements involve substantial risks and uncertainties including but not limited to: (i) Nektar’s proprietary drug candidates, including NKTR-118, NKTR-102 and NKTR-105, are in early to mid-stage clinical development and the risk of failure remains high and can unexpectedly occur at any stage prior to regulatory approval due to lack of efficacy, safety issues or other factors; (ii) the preliminary Phase 2 results for NKTR-102 in ovarian cancer patients in stage 1 announced by Nektar in January 2010 represent preliminary data only and this data remains subject to final data gathering and analysis review procedures; (iii) the preliminary results from stage 1 of the NKTR-102 clinical study for ovarian cancer are not necessarily indicative or predictive of the future results from stage 2 of this clinical study or the results of NKTR-102 in any of other cancer indications for which it is currently being studied (i.e. breast and colorectal cancers), (iv) the amount and timing of future payments that may become payable to Nektar under the license agreement with AstraZeneca for NKTR-118 and NKTR-119 is subject to a number of development, regulatory and commercial risks such as the risk of failure to obtain regulatory  approval for NKTR-118 and/or NKTR-119 based on safety, efficacy or other issues, the risk of a lack of government or private insurance reimbursement limiting commercial potential, the risk of competition from alternative competing therapies, and other important risks and uncertainties described or incorporated by reference herein; (v) the timing or success of the commencement or end of clinical trials and commercial launch of new drugs may be delayed or unsuccessful due to regulatory delays, clinical trial design, slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more important markets;  (vi) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of Nektar’s technology platforms to potential new drug candidates is therefore very uncertain and unpredictable and one or more research and development programs could fail; (vii) management’s financial projections for the Nektar’s 2010 annual revenue, cash used in operations and year-end cash position are subject to the significant risk of unplanned revenue short-falls and unplanned expenses, which could adversely affect Nektar’s actual 2010 annual financial results and end of year cash position; (viii) Nektar’s patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or intellectual property licenses from third parties may be required in the future; (ix) the outcome of any existing or future intellectual property or other litigation related to Nektar’s proprietary product candidates or partner product candidates where Nektar has indemnification responsibility; (x) the market sizes for Nektar’s proprietary and partnered product programs are based on management’s current estimates only and actual market sizes may differ materially and adversely; (xi) if Nektar is unable to establish and maintain collaboration partnerships (such as for NKTR-102 in 2010) on attractive commercial terms, our business, results of operations and financial condition could suffer; (xii) the timing of any 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, and numerous other unpredictable factors that can delay, impede or prevent partnering transactions; and (xiii) certain other important risks and uncertainties set forth in Nektar’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.  Actual results could differ materially from the forward-looking statements made by management during the conference call and in the press release attached as Exhibit 99.1 hereto.  Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise

The information in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by Nektar Therapeutics, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01
Financial Statements and Exhibits

Exhibit
No.
  
Description
   
99.1  
  
Press release titled “Nektar Therapeutics Reports Year-End 2009 Financial Results” issued by Nektar Therapeutics on March 2, 2010.
 
 

 

SIGNATURES
  
Pursuant to the requirement 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/ Gil M. Labrucherie
   
Gil M. Labrucherie
   
General Counsel and Secretary
     
Date:   March 2, 2010
 

 

EXHIBIT INDEX

Exhibit
No.
  
Description
   
99.1  
  
Press release titled “Nektar Therapeutics Reports Year-End 2009 Financial Results” issued by Nektar Therapeutics on March 2, 2010.

 

 
Unassociated Document
 
Exhibit 99.1
    
    

News Release
 
Nektar Therapeutics Reports Year-End 2009 Financial Results
 
SAN CARLOS, Calif., March 2 /PRNewswire-FirstCall/ --  Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2009. Cash, cash equivalents, and short-term investments at December 31, 2009 increased to $396.2 million as compared to $379.0 million at the end of 2008.

Revenue for the fourth quarter of 2009 increased to $39.0 million as compared to $28.4 million in the fourth quarter of 2008.  For the year ended December 31, 2009, total revenue was $71.9 million versus $90.2 million.  The decrease in revenue year over year is largely the result of lower contract research and manufacturing revenues primarily resulting from the sale of certain of the company's pulmonary assets to Novartis which occurred on December 31, 2008.

Total operating costs and expenses in the fourth quarter of 2009 declined by 37% to $44.5 million, compared to $70.8 million in the fourth quarter 2008, excluding a $69.6 million gain on sale of pulmonary assets.  For the full year 2009, total operating costs and expenses declined 31% to $167.1 million as compared to $242.4 million for the full year 2008, excluding the $69.6 million pulmonary sale gain.
 
Research and development expense was $24.7 million in the fourth quarter of 2009 as compared to $45.3 million for the same quarter in 2008.  For the year ended December 31, 2009, research and development expense was $95.1 million as compared to $154.4 million in 2008.  Included in the $95.1 million of overall research and development expenses in 2009 is approximately $50.0 million of outside investment in Nektar preclinical and clinical development programs.

"2009 was a transformative year for Nektar Therapeutics.  Impressive Phase 2 data for NKTR-118 provided clinical validation of our advanced polymer conjugate platform with small molecules and led to a groundbreaking partnership with AstraZeneca," said Howard W. Robin, President and Chief Executive Officer of Nektar.  "We begin this year in an extremely strong position to execute against our objectives, with a solid balance sheet and a deep pipeline of programs in oncology and pain."

Net loss for the fourth quarter ended December 31, 2009 was $7.7 million or $0.08 per share.

 

 
 
Conference Call to Discuss Year End 2009 Financial Results
 
A conference call to review results will be held today, Tuesday, March 2, 2010 at 2 PM Pacific Time.

Details are below:

Howard Robin, president and chief executive officer, and John Nicholson, chief financial officer, will host a conference call beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT) on Tuesday, March 2, 2010.

    To access the conference call, follow these instructions:

    Dial: 800-510-9836 (U.S.); 617-614-3670 (international)
    Passcode: 24115373 (Nektar Therapeutics)

An audio replay will also be available shortly following the call through Wednesday, March 16, 2010 and can be accessed by dialing 888-286-8010 (U.S.); or 617-801-6888 (international) with a passcode of 16395633.

About Nektar

Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar's technology and drug development expertise have enabled nine approved products in the U.S. or Europe for leading biopharmaceutical company partners, 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 has created a robust pipeline of potentially high-value therapeutics to address unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules. In addition to the releasable polymer technology, Nektar is the first company to create a permanent small molecule-polymer conjugate with enhanced oral bioavailability and restricted entry into the CNS. Nektar is currently conducting clinical and preclinical programs in oncology, pain and other therapeutic areas. Nektar recently entered into an exclusive worldwide license agreement with AstraZeneca for its oral NKTR-118 program to treat opioid-induced constipation and its NKTR-119 program for the treatment of pain without constipation side effects. NKTR-102 is being evaluated in Phase 2 clinical studies for the treatment of ovarian, breast and colorectal cancers. NKTR-105 is in a Phase 1 clinical study in cancer patients with refractory solid tumors.

Nektar is headquartered in San Carlos, 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 progress and potential of Nektar's pipeline of proprietary drug candidates, the value and potential of the Nektar's technology platform, and the value and potential of certain of Nektar’s collaborations with third parties.  These forward-looking statements involve numerous risks and uncertainties, including but not limited to: (i) Nektar's proprietary 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 of development prior to regulatory approval for numerous reasons including, without limitation, safety and efficacy findings even after initial preclinical and clinical results have been positive; (ii) the timing or success of the commencement or end of clinical trials and commercial launch of partnered products may be delayed or unsuccessful due to slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical trial design, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more important markets; (iii) Nektar's patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or intellectual property licenses from third parties may be required in the future; (iv) the outcome of any future intellectual property or other litigation related to Nektar's proprietary product candidates or complex commercial agreements; (v) if Nektar is unable to establish and maintain collaboration partnerships on attractive commercial terms, our business, results of operations and financial condition could suffer; and (vi) certain other important risks and uncertainties set forth in Nektar’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 filed on November 5, 2009, the Current Report on Form 8-K filed today, and the  most recent Annual Report on Form 10-K for the year ended December 31, 2009 to be filed on or about March 2, 2010.  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
(650) 631-4954

Susan Noonan/SA Noonan Communications, LLC
(212) 966-3650

Nektar Media Inquiries:
Karen Bergman/BCC Partners
(650) 575-1509

Michelle Corral/BCC Partners
(415) 794-8662

# # #

 

 

NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(unaudited)

   
December 31, 2009
   
December 31, 2008
 
ASSETS
           
Current assets:
           
Cash and cash equivalents
  $ 49,597     $ 155,584  
Short-term investments
    346,614       223,410  
Accounts receivable, net of allowance
    4,801       11,161  
Inventory
    6,471       9,319  
Other current assets
    6,183       6,746  
Total current assets
    413,666       406,220  
                 
Property and equipment, net
    78,263       73,578  
Goodwill
    76,501       76,501  
Other assets
    7,088       4,237  
Total  assets
  $ 575,518     $ 560,536  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
                 
Current liabilities:
               
Accounts payable
  $ 3,066     $ 13,832  
Accrued compensation
    10,052       11,570  
Accrued clinical trial expenses
    14,167       17,622  
Accrued expenses
    4,354       9,923  
Deferred revenue, current portion
    115,563       10,010  
Other current liabilities
    5,814       5,417  
Total current liabilities
    153,016       68,374  
                 
Convertible subordinated notes
    214,955       214,955  
Capital lease obligations, less current portion
    18,800       20,347  
Deferred revenue, less current portion
    76,809       55,567  
Deferred gain
    5,027       5,901  
Other long-term liabilities
    4,544       5,238  
Total liabilites
    473,151       370,382  
                 
Commitments and contingencies
               
                 
Stockholders' equity:
               
Preferred stock
    -       -  
Common stock
    9       9  
Capital in excess of par value
    1,327,942       1,312,796  
Accumulated other comprehensive income
    1,025       1,439  
Accumulated deficit
    (1,226,609 )     (1,124,090 )
Total stockholders' equity
    102,367       190,154  
Total liabilities and stockholders' equity
  $ 575,518     $ 560,536  
 
 

 

NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
(unaudited)

   
Three-Months Ended
December 31,
   
Twelve-Months Ended
December 31,
 
   
2009
   
2008
   
2009
   
2008
 
Revenue:
                       
Product sales and royalties
  $ 10,832     $ 12,400     $ 35,288     $ 41,255  
License, collaboration and other
    28,177       15,952       36,643       48,930  
Total revenue
    39,009       28,352       71,931       90,185  
                                 
Operating costs and expenses:
                               
Cost of goods sold
    8,809       10,196       30,948       28,216  
Other cost of revenue
    -       -       -       6,821  
Research and development
    24,713       45,279       95,109       154,417  
General and administrative
    10,982       13,835       41,006       51,497  
Impairment of long-lived assets
    -       1,458       -       1,458  
Gain on sale of pulmonary assets
    -       (69,572 )     -       (69,572 )
Total operating costs and expenses
    44,504       1,196       167,063       172,837  
                                 
(Loss) Income from operations
    (5,495 )     27,156       (95,132 )     (82,652 )
                                 
Non-operating income (expense):
                               
Interest income
    528       1,917       3,688       12,495  
Interest expense
    (2,963 )     (3,357 )     (12,176 )     (15,192 )
Other income (expense), net
    480       (425 )     848       58  
Gain on extinguishment of debt
    -       50,149       -       50,149  
Total non-operating income (expense), net
    (1,955 )     48,284       (7,640 )     47,510  
                                 
(Loss) Income before (benefit) provision for income taxes
    (7,450 )     75,440       (102,772 )     (35,142 )
                                 
(Benefit) provision for income taxes
    226       (1,342 )     (253 )     (806 )
                                 
Net (loss) income
  $ (7,676 )   $ 76,782     $ (102,519 )   $ (34,336 )
                                 
Basic and diluted net (loss) income per share
  $ (0.08 )   $ 0.83     $ (1.11 )   $ (0.37 )
                                 
Shares used in computing basic and diluted net (loss) income per share (1)
    93,219       92,473       92,772       92,407  

Notes to Consolidated Statements of Operations
(1)  For the three-months ended December 31, 2008, there were approximately 81 dilutive shares outstanding.
 
 

 

NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)

   
Twelve-Months Ended December 31,
 
   
2009
   
2008
 
Cash flows provided from operating activities:
           
Net loss
  $ (102,519 )   $ (34,336 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
               
Depreciation and amortization
    14,881       22,489  
Stock-based compensation
    10,326       9,871  
Gain on sale of pulmonary assets
    -       (69,572 )
Gain on extinguishment of debt
    -       (50,149 )
Impairment of long-lived assets
    -       1,458  
Other non-cash transactions
    (657 )     1,251  
Changes in assets and liabilities:
               
Decrease (increase) in trade accounts receivable
    6,034       10,476  
Decrease (increase) in inventory
    2,848       2,868  
Decrease (increase) in other assets
    (200 )     1,166  
Increase (decrease) in accounts payable
    (8,046 )     6,181  
Increase (decrease) in accrued compensation
    (1,518 )     (3,382 )
Increase (decrease) in accrued clinical trial expenses
    (3,455 )     14,727  
Increase (decrease) in accrued expenses to contract manufacturers
    -       (40,444 )
Increase (decrease) in accrued expenses
    (4,191 )     (1,332 )
Increase (decrease) in deferred revenue
    126,795       (15,392 )
Increase (decrease) in other liabilities
    (559 )     (1,662 )
Net cash provided by (used in) operating activities
    39,739       (145,782 )
                 
Cash flows from investing activities:
               
Purchases of property and equipment
    (16,390 )     (18,855 )
Advance payments for property and equipment
    (4,312 )     -  
Maturities of investments
    310,707       588,168  
Sales of investments
    17,318       70,060  
Purchases of investments
    (451,918 )     (475,316 )
Proceeds from sale of pulmonary assets, net of transaction costs
    (4,440 )     114,831  
Investment in Pearl Therapeutics
    -       (4,236 )
Net cash provided by (used in) investing activities
    (149,035 )     274,652  
                 
Cash flows from financing activities:
               
Issuance of common stock, net of issuance costs
    4,820       384  
Payments of loan and capital lease obligations
    (1,285 )     (2,368 )
Repayments of convertible subordinated notes
    -       (47,757 )
Net cash provided by (used) in financing activities
    3,535       (49,741 )
Effect of exchange rates on cash and cash equivalents
    (226 )     162  
Net (decrease) increase in cash and cash equivalents
  $ (105,987 )   $ 79,291  
                 
Cash and cash equivalents at beginning of year
    155,584       76,293  
Cash and cash equivalents at end of year
  $ 49,597     $ 155,584