BOCA RATON, Fla., March 12 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced financial results for the
fourth quarter and the full-year ended December 30, 2006.
For the full-year ended 2006, the company recorded a net loss of $58.7
million or $0.96 per share, compared to a net loss of $128.4 million or
$2.15 per share in 2005. The 2005 net loss included a $27.4 million
write-down or $0.46 per share related to our Gram-positive development
program.
Revenues for the full-year 2006 were $89.9 million, compared with $94.1
million in 2005. Revenues in 2005 included $6.2 million of sales of WinRho
SDF(R) [Rho (D) Immune Globulin Intravenous (Human)] which the company
stopped selling during 2005. Revenues for both years excluded sales of
PhosLo(R) (calcium acetate) which are included in discontinued operations.
Revenues for the fourth quarter of 2006 were $30.3 million, 54% higher than
the $19.6 million in the third quarter of 2006, reflecting strong sales of
Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], which totaled $11.5
million, a $4.5 million arbitration award related to Inhibitex, Inc., as
well as continued strength in the sales of antibody products.
During 2006, cash used by operations was $43.9 million, compared with
$89.7 million used in 2005. The company's cash equivalents and marketable
securities at year-end 2006 were $118.7 million.
Leslie Hudson, Ph.D., interim president and chief executive officer,
Nabi Biopharmaceuticals, stated, "We achieved a number of important
milestones in 2006, including a marked improvement in the cash position of
the company through the sale of PhosLo and a reduction in the company's
cost structure. We advanced our pipeline of promising product candidates
and acquired the rights to ATG-Fresenius S a valuable addition to our
transplant franchise. As a result, we enter 2007 with an improved
operational and financial position."
2007 Strategic Plan
Nabi Biopharmaceuticals also announced today that the company intends
to re-organize its current operations into two strategic business units:
Nabi Biologics and Nabi Pharmaceuticals. This will provide business clarity
to the investment community, improve operating and financial performance
and facilitate successful completion of Nabi's strategic alternatives
process, including but not limited to our work with Banc of America
Securities. Under this new structure the company will further reduce its
cost structure and cash burn in 2007.
Nabi Biologics will have responsibility for the company's protein and
immunological products and development pipeline, including Nabi-HB. The
unit will manage the operations of the company's plasma collection centers
and protein fractionation and vaccine production plant.
The financial goal for the unit is to realize full value at each level
of operation from plasma sales through to product revenue.
Our plans to further drive revenues, profits and cash flow include:
- Actively manage the life cycle of our product Nabi-HB, which provides
antibody-based passive protection following exposure to hepatitis B
virus. We will continue working with the FDA to secure approval for
Nabi-HB Intravenous for the prevention of hepatitis B (HBV)
re-infection after liver transplant.
- Secure regulatory approval for Civacir(R) [Hepatitis C Immune Globulin
(Human)], a polyclonal antibody product candidate for the prevention of
the recurrence of hepatitis C virus (HCV)-related liver disease in
HCV-positive liver transplant recipients.
- Secure regulatory approval for ATG-Fresenius S in the U.S., an
immunosuppressive polyclonal antibody which is already marketed in
Europe for the prevention and treatment of acute rejection following
organ transplantation.
Nabi Pharmaceuticals will have responsibility for our NicVAX(R)
(Nicotine Conjugate Vaccine) and StaphVAX(R) (Staphylococcus aureus
Polysaccharide Conjugate Vaccine) programs, as well as the product
Aloprim(TM) (allopurnol sodium) for Injection and our continuing
milestone-related clinical development obligations following the sale of
PhosLo.
The unit's key business objectives are to:
- Complete the on-going Phase IIB "proof-of-concept" trial for NicVAX
vaccine and secure a partner to further develop and market the product.
- Complete the on-going preclinical program for our new pentavalent
StaphVAX vaccine and attract a strategic partner for its development
and commercialization.
- Fulfill our milestone-related clinical obligations to our partner
Fresenius following the sale of PhosLo.
- Sell our product Aloprim, which no longer has strategic importance for
the business.
Leslie Hudson, Ph.D., interim president and chief executive officer,
Nabi Biopharmaceuticals, stated, "The Board of Directors and new management
team have put our new strategy into place to more rapidly and effectively
unlock the true value of the company's assets and to give both businesses a
competitive advantage. We believe that this strategy will enhance the on-
going strategic alternatives process, clarify our business and operating
strengths and enable a range of outcomes including significant redirection
of our business and the possible sale of part or all of the company.
As CEO, my role, with the senior management team, is to continue to
lead Nabi Biopharmaceuticals overall and to successfully execute this plan.
In this context, the 2007 goals for the corporation are to:
- successfully complete the strategic alternatives process
- obtain approval for Nabi-HB Intravenous in the U.S.
- announce Phase IIB trial results for NicVAX
- secure a development partnership for NicVAX and the Gram-positive
programs
- complete enrollment in the proof-of-concept clinical trial for Civacir
- resubmit the file for regulatory approval of HEBIG(TM) in Europe,
- advance the Phase III trial of ATG-Fresenius S in lung transplant
patients, and
- initiate the clinical trial of our intravenous immunoglobulin, IVIG."
2006 Milestones achieved
PhosLo(R) (calcium acetate)
- Completed sale of PhosLo and related assets to Fresenius Biotech for up
to $150 million in up-front cash, milestone payments and royalties on
new product formulation
- Completed and achieved positive results on the PhosLo CARE-2 and EPICK
studies
NicVAX(R) (Nicotine Conjugate Vaccine)
- Initiated Phase IIB proof-of-concept study to assess safety, efficacy
and optimal dose regimen; enrollment completed three months ahead of
schedule
Civacir(R) [Hepatitis C Immune Globulin (Human)]
- Entered into agreement with Kedrion S.p.A to co-develop and
commercialize product candidate
- Proof-of-concept Phase II study initiated in December 2006
Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous]
- Received a positive 9-2 ruling from the Blood Products Advisory
Committee of the U.S. Food and Drug Administration on the Biologic
License application (BLA) for Nabi-HB Intravenous
Strategic Partnerships and Commercial Alliances
- Entered into agreement with Fresenius Biotech GmbH to develop and
market ATG-Fresenius S in North America
- Obtained exclusive rights to use novel hyperimmune immunoglobulin
extraction technology from ProMetic Life Sciences
- Signed agreement with Sanofi Pasteur to fractionate human plasma used
for production of Imogam Rabies-HT
Gram-positive Program
- Announced positive Phase I clinical trial results from S. epidermidis
PS-1 and S. aureus Type 336 vaccine trials
2006 Review of Operations
Nabi-HB Revenues
Sales of Nabi-HB were $32.7 million during 2006, compared to $39.2
million in 2005, reflecting a significant decrease in product inventory at
a large wholesaler customer during 2006. We believe this customer completed
its inventory reduction during the third quarter; and during the fourth
quarter purchased our product at our estimate of its own customers' demand.
Sales of Nabi-HB were $11.5 million for the fourth quarter of 2006, 69%
higher than the $6.8 million in the third quarter of 2006.
Other Biopharmaceutical Revenues
Other biopharmaceutical revenues were $7.4 million for 2006 compared to
$9.0 million during 2005. Other biopharmaceutical revenues for 2005
included $6.2 million of sales of a product we stopped selling in 2005.
Other biopharmaceutical revenues for 2006 included a $4.5 million
arbitration award related to Inhibitex, Inc. PhosLo revenues for both years
are included in discontinued operations.
Antibody Revenues
Total antibody sales were $49.8 million during 2006, compared to $45.9
million in 2005, primarily reflecting increased sales of specialty
antibodies.
Operating Expenses
Selling, general and administrative expenses of $43.1 million in 2006
decreased by almost 17% from the $51.7 million reported in 2005. Research
and development expenses of $37.6 million in 2006 declined by more than 38%
from the $60.9 million reported in 2005. During 2005, we incurred
significant expenses related to our Gram-positive program which were
greatly reduced during 2006.
Conference Call and Webcast Information
The live webcast will take place at 4:30 p.m. (ET) and can be accessed
at http://phx.corporate-ir.net/phoenix.zhtml?p=irol-
eventDetails&c=100445&eventID=1473397 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 866-713-8310 conference code 57672232, and
the international call-in number is 617-597-5308 conference code 57672232.
An audio replay will be available for U.S./Canada callers at 888-286-8010
conference code 51818152, and for international callers at 617-801-6888
conference code 51818152.
An archived version of the webcast will be available at the same
Internet address through March 19, 2007. The audio replay will also be
available through March 19, 2007. The press release 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 and market products that fight
serious medical conditions. The company has two products on the market
today: Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM)
(allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on
developing products that address unmet medical needs and offer commercial
opportunities in our core business areas: Hepatitis and transplant,
Gram-positive bacterial infections and nicotine addiction. For a complete
list of pipeline products, please go to:
http://www.nabi.com/pipeline/index.php. The company is headquartered in
Boca Raton, Florida. For additional information about Nabi
Biopharmaceuticals, please visit our website: http://www.nabi.com.
Forward-Looking Statements
Statements in this press release about the company that are not
strictly historical are forward-looking statements and include statements
related to our plans to explore strategic alternatives and prospects. You
can identify these forward-looking statements because they involve our
expectations, beliefs, intentions, plans, projections, goals, objectives,
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 the company's ability to successfully partner with other
companies for the development and marketing of product candidates,
including NicVAX and Gram-positive products; maintain the human and
financial resources to commercialize current products and bring to market
products in development; obtain successful clinical trial results for our
pipeline products, including NicVAX, Civacir and ATG-Fresenius S; obtain
regulatory approval for its products in the U.S. and Europe, including
Nabi-HB Intravenous; successfully develop, manufacture and market its
products; generate sufficient cash flow from product sales, and milestone
and royalty payments from partners; maintain sufficient intellectual
property protection or positions; raise additional capital on acceptable
terms; re-pay its outstanding convertible senior notes when due; and
identify; and complete transactions that represent strategic alternatives
and opportunities. Many of these factors are more fully discussed, as are
other factors, in the company's Annual Report on Form 10-K for the fiscal
year ended December 31, 2005 and Quarterly Report on Form 10-Q for the
Quarter ended September 30, 2006 filed with the Securities and Exchange
Commission and the company's Annual Report on Form 10-K for the fiscal year
ended December 30, 2006 that the company plans to file with the Securities
and Exchange Commission.
Nabi Biopharmaceuticals
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, amounts in thousands, except per share data)
For the Three Months For the Twelve Months
Ended Ended
December 30, December 31, December 30, December 31,
2006 2005 2006 2005
Sales $30,343 $26,493 $89,868 $94,149
Costs and expenses:
Costs of products sold,
excluding amortization
of intangible assets 18,096 22,099 61,177 63,642
Royalty expense 510 484 1,535 3,623
Gross margin, excluding
amortization of
intangible assets 11,737 3,910 27,156 26,884
Selling, general and
administrative
expense 10,108 11,824 43,076 51,693
Research and development
expense 9,672 12,958 37,572 60,906
Amortization of
intangible assets 98 76 273 676
Other operating expense,
principally freight 68 131 495 348
Impairment of vaccine
manufacturing facility - 19,842 - 19,842
Write-off of manufacturing
right - 2,684 - 2,684
Operating loss (8,209) (43,605) (54,260) (109,265)
Interest income 1,232 1,351 4,148 4,094
Interest expense (928) (1,043) (3,724) (2,523)
Other expense, net (367) (373) (38) (483)
Loss from continuing
operations before
benefit (provision) for
income taxes (8,272) (43,670) (53,874) (108,177)
Benefit (provision)
for income taxes - (10,980) 162 2,610
Loss from continuing
operations (8,272) (54,650) (53,712) (105,567)
Discontinued operations
Income (loss) from
discontinued
operations 4,283 (11,823) (4,991) (21,180)
Benefit (provision)
for income taxes - (9,106) - (1,702)
Net income (loss) from
discontinued operations 4,283 (20,929) (4,991) (22,882)
Net loss $(3,989) $(75,579) $ (58,703) $(128,449)
Basic and diluted loss
per share
Continuing
operations $(0.13) $(0.91) $(0.88) $(1.76)
Discontinued
operations 0.06 (0.34) (0.08) (0.39)
Basic and diluted loss
per share $(0.07) $(1.25) $(0.96) $(2.15)
Basic and diluted
weighted average
shares outstanding 61,323 60,231 60,953 59,862
SUPPLEMENTAL INFORMATION:
Sales by Operating Segment
Biopharmaceutical
Products $16,644 $11,090 $40,093 $48,231
Antibody Products:
Specialty
antibodies 7,019 8,815 26,945 22,936
Non-specific
antibodies 6,680 6,588 22,830 22,982
Total
antibodies 13,699 15,403 49,775 45,918
Total $ 30,343 $ 26,493 $ 89,868 $ 94,149
Nabi Biopharmaceuticals
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, amounts in thousands)
December 30, December 31,
2006 2005
Cash and cash equivalents $86,227 $101,762
Marketable securities 32,500 5,172
Restricted cash 805 816
Trade accounts receivable, net 20,377 19,688
Inventories, net 19,260 20,500
Prepaid expenses and other assets 2,654 3,449
Assets of discontinued operations 13,244 81,215
Property, plant and equipment, net 88,329 93,865
Intangible assets, net 1,683 1,955
Other assets, net 701 914
Total assets $265,780 $329,336
Trade accounts payable and accrued expenses $24,384 $30,075
Current liabilities of discontinued operations 20,457 16,966
2.875% Senior Convertible Notes 109,313 109,145
Non-current liabilities of discontinued
operations - 10,707
Other liabilities 238 616
Stockholders' equity 111,388 161,827
Total liabilities and stockholders' equity $265,780 $329,336
Capital expenditures were $2.6 million and $8.5 million for the years
ended December 30, 2006 and December 31, 2005, respectively.
Depreciation and amortization expenses from continuing operations were
$7.9 million and $10.7 million for years ended December 30, 2006 and
December 31, 2005, respectively.
The 2005 condensed balance sheet has been derived from the audited
balance sheet for the year ended December 31, 2005. Certain items in the
2005 consolidated financial statements have been reclassified to conform to
the current year's presentation.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com/
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations of Nabi Biopharmaceuticals, +1-561-989-5800, or
ww.nabi.com
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