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): November 5, 2009

 

 

NABI BIOPHARMACEUTICALS

(Exact Name of Registrant as specified in its charter)

 

 

 

Delaware		000-04829		59-1212264
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

12276 Wilkins Avenue, Rockville, Maryland		20852
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (301) 770-3099

Not Applicable

(Registrant’s name or former address, if change since last report)

 

 

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 (see General Instruction A.2. below):

 

¨	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))

 

 

 

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Item 2.02.

Results of Operations and Financial Condition

On November 5, 2009, Nabi Biopharmaceuticals (the “Company”) issued a press release announcing its results of operations for the three and nine months ended September 26, 2009. A copy of the press release announcing these results is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 and the exhibit attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liability of that section, and it shall not be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

 

Item 9.01.

Financial Statements and Exhibits

 

Exhibit number		Description
99.1		Earnings Press Release

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SIGNATURE

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.

 

Date: November 5, 2009

Exhibit 99.1

 

		NEWS RELEASE
Investor Relations 301-770-3099 | www.nabi.com

FOR IMMEDIATE RELEASE

Nabi Biopharmaceuticals Announces Third Quarter 2009 Financial Results

Rockville, Maryland, November 5, 2009 – Nabi Biopharmaceuticals (NASDAQ: NABI) today announced its third quarter financial results for the quarter ended September 26, 2009. The Company reported a net loss from continuing operations of $7.0 million, or $0.14 per share, compared to a net loss of $4.6 million, or $0.09 per share, for the period ended September 27, 2008.

General and Administrative expenses were $2.4 million for the third quarter 2009 compared to $2.1 million in the prior year period. The increase primarily reflects legal expenses related to our strategic alternatives process. This increase was offset in part by a reduction in stock-based compensation expense. Research and Development expenses increased to $4.7 million in the third quarter 2009 compared to $3.4 million in 2008, primarily reflecting preparation for Phase III NicVAX testing which was initiated in the fourth quarter.

For the nine months ended September 26, 2009, the Company’s net loss from continuing operations was $19.8 million, or $0.39 cents per share, compared to $17.9 million, or $0.34 cents per share, for the nine months ended September 27, 2008. General and Administrative expenses for the current nine-month period were $7.8 million compared to $10.1 million in 2008 while Research and Development expenses were $11.9 million for the current nine-month period compared to $9.9 million for the comparable 2008 period. The 2008 results have been adjusted to reflect the retrospective application of new accounting rules for convertible debt instruments that were adopted in the first quarter of 2009.

Net cash used in operating activities from continuing operations was $18.1 million for the first nine months ended September 26, 2009 compared to $16.0 million used in the first nine months of 2008. Cash, cash equivalents and marketable securities totaled $103.3 million at September 26, 2009 compared to $130.3 million at the end of 2008. In addition to cash used in operating activities the decline is attributable to $10.1 million for debt repurchase and $3.5 million of stock repurchases, partially offset by the release of $4.5 million of restricted cash earlier this year. The cash balance at September 26, 2009 excludes $5.7 million of restricted cash which was subsequently released to Nabi after the close of the third quarter.

We recently announced the following accomplishments:

 

•

The U.S. National Institute on Drug Abuse (NIDA) awarded the Company a $10 million grant that will partially fund the Phase III clinical program for NicVAX. In conjunction with the NIDA grant we also initiated the Phase III trial.

 

•

The Department of Defense Deployment Related Medical Research Program (DRMRP) awarded the Company a $472 thousand grant in support of a Phase I clinical trial for the toxoid antigen components of PentaStaph.

 

•

The Company received $21.5 million in the fourth quarter from closing the sale of its Staph program assets to GlaxoSmithKline (GSK). Nabi will receive an additional $26 million from the successful completion of four milestones associated with this asset sale.

 

•

Biotest withdrew its remaining indemnification claim and authorized the release to us of the full $5.7 million, which was held in escrow.

“I am very pleased with our recent accomplishments,” said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. “We closed the PentaStaph asset sale with GSK, and we settled our dispute with Biotest. With receipt of the NIDA grant, we initiated the first pivotal Phase III clinical trial of NicVAX. Initiation of this trial will help us maintain our lead in bringing the first smoking cessation vaccine to market as we continue to pursue a strategic partnership to develop and commercialize this product. We are encouraged by our recent advances and the interest in the program.”

 

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Financial Results Conference Call and Webcast Information

The webcast can be accessed at: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=100445&eventID=2516830 (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your browser. Remove the space if one exists) or 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 866-730-5769 and the international call-in number is 857-350-1593. The passcode is 98986853. An audio replay will be available for U.S./Canada callers at 888-286-8010 and for international callers at 617-801-6888. The replay passcode is 73872856. An audio replay of this call will be available through November 12, 2009. 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 areas of nicotine addiction and gram-positive bacterial infections. 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, and PentaStaph^TM (Pentavalent S. aureus Vaccine), a vaccine designed to prevent the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://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: complete the PentaStaph sale milestones; partner with third parties to fund, develop, manufacture and/or commercialize our products in development; initiate and conduct clinical trials and studies; raise sufficient new capital resources to fully develop and commercialize our products in development; attract, retain and motivate key employees; collect further milestone and royalty payments under the PhosLo Agreement; obtain regulatory approval for our products in the U.S. or other markets; successfully contract with third party manufacturers for the

 

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manufacture and supply of NicVAX; and comply with reporting and payment obligations under government rebate and pricing programs. 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 27, 2008 and our Quarterly Reports on Form 10-Q for the period ended March 28, 2009 and June 27, 2009 filed with the Securities and Exchange Commission.

 

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Nabi Biopharmaceuticals

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands)

 

		September 26, 2009				December 27, 2008 (as adjusted)
ASSETS
Current assets:
Cash and cash equivalents		$	28,148			$	106,438
Marketable securities			75,145				23,900
Prepaid expenses and other current assets			1,863				1,430
Assets of discontinued operations (including restricted cash)			5,677				10,409
Total current assets			110,833				142,177
Property and equipment, net			966				1,315
Other assets			376				730
Total assets		$	112,175			$	144,222
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,505			$	1,226
Accrued expenses and other current liabilities			2,164				3,030
Current liabilities of discontinued operations			3,016				3,381
Total current liabilities			6,685				7,637
2.875% convertible senior notes, net			5,862				15,202
Total liabilities			12,547				22,839
Commitments and contingencies
Stockholders’ equity:
Convertible preferred stock			—				—
Common stock			6,271				6,239
Capital in excess of par value			364,201				363,001
Treasury stock			(45,321	)			(42,187	)
Other comprehensive income			12				60
Accumulated deficit			(225,535	)			(205,730	)
Total stockholders’ equity			99,628				121,383
Total liabilities and stockholders' equity		$	112,175			$	144,222

 

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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 26, 2009				September 27, 2008 (as adjusted)				September 26, 2009				September 27, 2008 (as adjusted)
Operating expenses:
General and administrative expenses		$	2,351			$	2,086			$	7,796			$	10,146
Research and development expenses			4,651				3,356				11,857				9,905
Operating loss			(7,002	)			(5,442	)			(19,653	)			(20,051	)
Interest income			50				831				320				4,086
Interest expense			(139	)			(799	)			(636	)			(3,502	)
Other income (expense), net			108				(183	)			132				(905	)
Loss from continuing operations before income taxes			(6,983	)			(5,593	)			(19,837	)			(20,372	)
Benefit from income taxes			—				1,023				—				2,518
Loss from continuing operations			(6,983	)			(4,570	)			(19,837	)			(17,854	)
Discontinued operations:
Income from discontinued operations, net of tax provision			—				1,570				—				3,865
Income from discontinued operations			—				1,570				—				3,865
Net loss		$	(6,983	)		$	(3,000	)		$	(19,837	)		$	(13,989	)
Basic and diluted (loss) income per share:
Continuing operations		$	(0.14	)		$	(0.09	)		$	(0.39	)		$	(0.34	)
Discontinued operations			0.00				0.03				0.00			$	0.07
Basic and diluted (loss) income per share		$	(0.14	)		$	(0.06	)		$	(0.39	)		$	(0.27	)
Basic and diluted weighted average shares outstanding			50,339				51,592				50,802				52,021

 

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Nabi Biopharmaceuticals

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

		For the Nine Months Ended
		September 26, 2009				September 27, 2008 (as adjusted)
Cash flow from operating activities:
Loss from continuing operations		$	(19,837	)		$	(17,854	)
Adjustments to reconcile loss from continuing operations to net cash used in operating activities from continuing operations:
Depreciation and amortization			380				464
Non-cash intra-period tax allocation			—				(2,518	)
Accretion of discount on convertible senior notes			393				2,025
Non-cash compensation			1,347				2,526
Other			6				1,122
Changes in assets and liabilities:
Prepaid expenses and other assets			(168	)			1,560
Accounts payable, accrued expenses and other			(255	)			(3,338	)
Total adjustments			1,703				1,841
Net cash used in operating activities from continuing operations			(18,134	)			(16,013	)
Net cash provided by operating activities from discontinued operations			4,366				299
Net cash used in operating activities			(13,768	)			(15,714	)
Cash flow from investing activities:
Proceeds from sales of marketable securities			240				1,600
Purchases of marketable securities			(75,963	)			—
Maturities of marketable securities			24,461				—
Capital expenditures			—				(20	)
Other			—				91
Net cash provided by (used in) investing activities from continuing operations			(51,262	)			1,671
Net cash provided by investing activities from discontinued operations			—				2,500
Net cash provided by (used in) investing activities			(51,262	)			4,171
Cash flow from financing activities:
Proceeds from issuances of common stock for employee benefit plans			297				69
Purchase of common stock for treasury			(3,466	)			(18,658	)
Repurchase of convertible senior notes			(10,091	)			(35,119	)
Other financing activities			—				(83	)
Net cash used in financing activities from continuing operations			(13,260	)			(53,791	)
Net cash used in financing activities from discontinued operations			—				(23	)
Net cash used in financing activities			(13,260	)			(53,814	)
Net decrease in cash and cash equivalents			(78,290	)			(65,357	)
Cash and cash equivalents at beginning of period			106,438				217,606
Cash and cash equivalents at end of period		$	28,148			$	152,249

 

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