Nabi Biopharmaceuticals Announces Third Quarter 2011 Financial Results


ROCKVILLE, Md., Nov. 2, 2011 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) today announced its third quarter financial results for the quarter ended September 24, 2011. The Company's net loss from continuing operations for the third quarter of 2011 was $2.9 million, or $0.07 per share, compared to net income of $5.1 million, or $0.12 per share, for the third quarter of 2010. Nabi also had $3.0 million, or $0.07 per share, in net income from discontinued operations for the third quarter ended September 24, 2011. Nabi had no results from discontinued operations in the third quarter of 2010.

Third quarter 2011 revenue was $1.1 million, including $0.6 million of deferred revenue amortization from the NicVAX agreement, and $0.5 million for services under the PentaStaph and NicVAX agreements. Total revenue in the third quarter of 2010 was $12.3 million including $8 million in PentaStaph milestones, $3.2 million of deferred revenue amortization from the PentaStaph and NicVAX agreements and $1.1 million for services under the PentaStaph and NicVAX agreements.

Research and development expenses were $4.4 million in the third quarter 2011 compared to $6.8 million in 2010. This decrease primarily reflects decreased costs after completion of the first NicVAX Phase III clinical trial in July 2011. There were no cost reimbursements from government grants to offset research and development expenses in the current quarter compared to $2.7 million of cost reimbursements in the third quarter of 2010. General and administrative expenses were $1.2 million for the third quarter 2011 compared to $1.4 million in the prior year period reflecting management's efforts to reduce expenses in light of the recent results of the first NicVAX Phase III trial. 

For the nine months ended September 24, 2011, the Company's net loss from continuing operations was $5.4 million, or $0.13 cents per share, compared to net income of $7.2 million, or $0.16 cents per share, for the nine months ended September 25, 2010. Research and development expenses were $16.2 million for the current nine-month period compared to $19.2 million for the comparable 2010 period while general and administrative expenses for the current nine-month period were $4.1 million compared to $4.4 million in 2010.  Including results from discontinued operations, Nabi had a net loss of $2.5 million for the nine month period ended September 24, 2011. Nabi had no results from discontinued operations for the comparable 2010 period.

Net cash used in operating activities for the nine months ended September 24, 2011 was $14.5 million, compared to cash provided by operating activities of $41.5 million for the nine months ended September 25, 2010.  The decrease is primarily the result of a reduction in the amount of the payments received from GSK, principally the $40 million payment received in March 2010 at the close of the NicVAX agreement.

Cash, cash equivalents and marketable securities totaled $102.0 million at September 24, 2011 compared to $110.7 million at the end of 2010. The decline is primarily the result of our net cash used in operations offset in part by the $5 million Phoslyra milestone. 

"I am clearly disappointed with the results of the first NicVAX Phase III trial that was announced earlier in the quarter," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "Immediately after announcing the results, we have intensified our efforts to reduce our operating costs and the financial results of the third quarter, in part, reflect that effort. In the quarter, we received a $5 million milestone related to the launch of Phoslyra from Fresenius. We expect results from the second Phase III trial around the end of the year, which may shed some additional light as to the reasons for the failed study. Finally, we continue to closely monitor the Dutch study of NicVAX in combination with varenicline to evaluate the relapse-prevention potential of NicVAX."

Recent and Upcoming Events

  • In July 2011, reported that the first NicVAX Phase III clinical trial failed to meet its primary endpoint.
  • In July 2011, we received a $5 million Phoslo milestone from Fresenius after the first commercial sale of the new liquid formulation, Phoslyra
  • Anticipate results from the second NicVAX Phase III trial by the end of this year.                                                             

Financial Results Conference Call and Webcast Information

The Company will host a live webcast at 4:30 p.m. EDT today to discuss these results.  The live webcast can be accessed at:

http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=100445&eventID=4220891

Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your browser. The webcast is also available via the Nabi Biopharmaceuticals website at http://www.nabi.com. ;

If you do not have Internet access, the U.S./Canada call-in number is 800-261-3417 and the international call-in number is 617-614-3673. The passcode is 44549064. An audio replay will be available through November 9, 2011 for U.S./Canada callers at 888-286-8010 and for international callers at 617-801-6888. The replay passcode is 42793625.

The press release and an archived version of the webcast will be available on the company's website at http://www.nabi.com. ;

About Nabi Biopharmaceuticals

Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the area of nicotine addiction. Nabi Biopharmaceuticals is currently developing NicVAX® (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit www.nabi.com

Forward-Looking Statements

Statements in this release that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to conduct and obtain successful results from our two Phase III clinical trials for NicVAX (our first Phase III clinical trial failed to meet its primary endpoint) or our Dutch study of NicVAX in combination with varenicline; GlaxoSmithKline Biologicals (GSK) failure to exercise its option for and successfully commercialize NicVAX; GSK's failure to successfully develop and commercialize any future generation candidate nicotine vaccine; our ability to commercialize NicVAX if GSK does not exercise its option for NicVAX; our ability to raise sufficient new capital resources to fully develop and commercialize NicVAX if GSK does not exercise its option for NicVAX; our ability to identify an alternative partner or to raise sufficient new capital resources to fully develop and commercialize NicVAX if GSK does not exercise the NicVAX option; our ability to successfully contract with and obtain manufactured NicVAX product from contract manufacturing organizations; our ability to attract, retain and motivate key employees; our ability to collect royalty payments under the PhosLo agreement; the ability to obtain regulatory approval for NicVAX and any future generation candidate nicotine vaccine in the U.S. or other markets; our ability to comply with reporting and payment obligations under government rebate and pricing programs; and loss of full use of our net operating loss carryforwards. Some of these factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 25, 2010 filed with the Securities and Exchange Commission. We do not undertake to update any of these forward-looking statements or to announce the results of any revisions to these forward-looking statements except as required by law.

Nabi Biopharmaceuticals 
CONDENSED CONSOLIDATED BALANCE SHEETS 
(Unaudited)
(In thousands)
     
  September 24,
2011
December 25,
2010
ASSETS    
Current assets:    
Cash and cash equivalents  $ 92,948  $ 53,564
Marketable securities  9,065  54,603
Receivables  891  1,030
Prepaid expenses and other current assets  873  829
Total current assets  103,777  110,026
     
Marketable securities  --   2,500
Property and equipment, net  274  597
Other assets  --   748
Total assets  $ 104,051  $ 113,871
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current liabilities:    
Accounts payable  $ 983  $ 552
Accrued expenses and other current liabilities  4,564  7,377
Deferred revenue  2,526  7,797
Liabilities of discontinued operations  1,817  2,207
Total current liabilities  9,890  17,933
Deferred revenue  33,474  35,368
Total liabilities  43,364  53,301
     
Stockholders' equity:    
Series A Junior participating preferred stock  --   -- 
Common stock  6,358  6,321
Capital in excess of par value  372,985  370,366
Treasury stock  (92,567)  (92,567)
Other comprehensive loss  (1)  (3)
Accumulated deficit  (226,088)  (223,547)
Total stockholders' equity  60,687  60,570
Total liabilities and stockholders' equity  $ 104,051  $ 113,871
 
Nabi Biopharmaceuticals 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
(Unaudited)
(In thousands, except per share amounts)
         
  For the Three Months Ended  For the Nine Months Ended 
  September 24,
2011
September 25,
2010
September 24,
2011
September 25,
2010
         
Revenue:        
Revenue  $ 1,086  $ 12,335  $ 14,003  $ 30,925
Operating expenses:        
Costs of services  344  843  1,518  2,128
Research and development expenses  4,388  6,801  16,179  19,236
General and administrative expenses  1,291  1,415  4,059  4,380
Total operating expenses  6,023  9,059  21,756  25,744
Operating income (loss)  (4,937)  3,276  (7,753)  5,181
Interest income  32  75  154  166
Interest expense  --  (13)  --  (200)
Other income (expense), net  (17)  32  58  297
Income (loss) from continuing operations before income taxes  (4,922)  3,370  (7,541)  5,444
Benefit from income taxes  2,018  1,765  2,018  1,765
Income (loss) from continuing operations  (2,904)  5,135  (5,523)  7,209
Income from discontinued operations, (net of tax provision of $2.0 million)  2,982  --  2,982  --
Net income (loss)  $ 78  $ 5,135  $ (2,541)  $ 7,209
         
Basic income (loss) per share        
Continuing operations  $ (0.07)  $ 0.12  $ (0.13)  $ 0.16
Discontinued operations  $ 0.07  $ --   $ 0.07  $ -- 
         
Diluted income (loss) per share        
Continuing operations  $ (0.07)  $ 0.12  $ (0.13)  $ 0.16
Discontinued operations  $ 0.07  $ --   $ 0.07  $ -- 
         
Basic weighted average shares outstanding  42,397  42,356  42,269  45,084
Diluted weighted average shares outstanding  42,397  42,538  42,269  45,304
 
Nabi Biopharmaceuticals 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 
(Unaudited)
(In thousands)
     
  For the Nine Months Ended 
  September 24, 2011 September 25, 2010
     
Cash flow from operating activities:    
Net income (loss) from continuing operations  $ (5,523)  $ 7,209
Adjustments to reconcile net income (loss) from continuing operations to net cash provided by (used in) operating activities from continuing operations:    
Depreciation and amortization  130  302
Non-cash intra-period tax allocation  (2,018)  --
Accretion of discount on convertible senior notes  --  99
Share-based compensation  2,011  1,895
Loss (gain) on sale of property and equipment  29  (4)
Changes in assets and liabilities:    
Receivables  139  5,135
Prepaid expenses and other assets  704  (1,485)
Accounts payable, accrued expenses and other liabilities  (2,375)  952
Deferred revenue  (7,165)  27,985
Net cash provided by (used in) operating activities from continuing operations  (14,068)  42,088
     
Net cash used in operating activities from discontinued operations  (391)  (609)
Net cash provided by (used in) operating activities   (14,459)  41,479
     
Cash flow from investing activities:    
Proceeds from maturities of marketable securities  59,680  103,615
Purchases of marketable securities  (11,640)  (118,966)
Proceeds from sales of property and equipment  158  50
Capital expenditures  (1)  (3)
Net cash provided by (used in) investing activities from continuing operations  48,197  (15,304)
     
Net cash provided by investing activities from discontinued operations  5,000  --
Net cash provided by (used in) investing activities  53,197  (15,304)
     
Cash flow from financing activities:    
Proceeds from issuances of common stock for employee benefit plans  646  413
Purchase of common stock for treasury  --  (42,768)
Repurchase of convertible senior notes  --  (6,050)
Net cash provided by (used in) financing activities  646  (48,405)
     
Net increase (decrease) in cash and cash equivalents  39,384  (22,230)
Cash and cash equivalents at beginning of period  53,564  59,510
Cash and cash equivalents at end of period  $ 92,948  $ 37,280


            

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