- Revenues Increase 16% -
- Strategic Initiatives Continue to Advance -
BOCA RATON, Fla., July 26 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today that total revenues were
$29.9 million for the second quarter of 2006, compared to total revenues of
$25.9 million in the second quarter of 2005. The increase was driven by
improved pricing and strong patient demand for PhosLo(R) (calcium acetate).
Net loss reported for the quarter ended July 1, 2006 was $14.8 million or a
loss of $0.24 per share, compared to a net loss of $20.9 million or a loss
of $0.35 per share during the same period in 2005, which also included a
tax benefit of $7.4 million. On a pre-tax basis, the loss in the second
quarter of 2006 was $14.8 million, a 48% improvement from the $28.3 million
loss in the second quarter of 2005. This improved performance was driven by
increased margins from sales and a 23% reduction in operating expenses.
Consistent with management expectations, cash equivalents and marketable
securities were $70.2 million at the end of the second quarter of 2006.
During the second quarter of 2006, cash used in operations was $11.5
million, a 48% improvement compared to the first quarter of 2006.
"We continued to make progress in achieving our important strategic
objectives in the second quarter," said Thomas H. McLain, chairman, chief
executive officer and president, Nabi Biopharmaceuticals. "We are delighted
with the recent vote by the BPAC, recommending FDA approval of our BLA for
Nabi-HB Intravenous. This is a major step toward approval of this product
for its use in liver transplant patients in the U.S. In addition, we just
reported results from a study that further demonstrates the superiority of
PhosLo in controlling serum phosphorus levels in patients with end-stage
renal disease, when compared to the leading competitive product. These
announcements, coupled with new product and manufacturing alliances and the
signing of a significant partnering agreement during the second quarter,
provide momentum for the second half of 2006," stated Mr. McLain.
Earlier this year, Nabi Biopharmaceuticals established three strategic
objectives -- optimizing value from operations, building incremental value
through partnerships and alliances, and developing proof-of-concept
evidence for our key pipeline programs. Listed below are a number of recent
accomplishments directly aligned with these objectives.
Strategic Goal Review:
Accomplishment Related Objective Strategic Significance
Blood Products Advisory Optimizes value from Supports approval of
Committee recommendation operations. indication for a key
to Food and Drug marketed product that
Administration for has been granted Orphan
approval of Nabi-HB(TM) Drug Status.
Intravenous [Hepatitis B
Immune Globulin (Human)
Intravenous] in the U.S.
Initiation of Phase IIB Develops proof-of- Trial will identify
proof-of-concept concept evidence for optimal formulation of
clinical trial for key pipeline NicVAX and establish
NicVAX(R) (Nicotine programs. proof-of-concept
Conjugate Vaccine). efficacy for a vaccine
approach to smoking
cessation.
Strategic partnership Builds value through Provides funding and
with Kedrion S.p.A. for partnerships and resources for clinical
development and for the alliances. development. Also
commercialization of positions European
Civacir(R) [Hepatitis C commercialization with
Immune Globulin (Human)] established partner
Europe. having significant
market presence.
Alliance with Fresenius Builds value through Strengthens transplant
Biotech to in-license partnerships and franchise with a product
ATG-Fresenius S for alliances. Develops having proven efficacy.
development and proof-of-concept
commercialization in the evidence for key
U.S. and Canada. pipeline programs.
Partnership with Sanofi Builds value through Increases manufacturing
Pasteur for contract partnerships and facility utilization and
manufacturing of anti- alliances and cash return on assets.
rabies product. optimizes value of
operations.
Reported results from Optimizes value from Further demonstrates
study on control of operations. superiority of PhosLo
serum phosphorus at the versus leading
European Renal competitive product.
Association and
European Dialysis
Transplant Association
Congress, Glasgow,
Scotland.
Milestone Update:
Product/Product Upcoming Milestone(s) Expected Timing
Candidate
PhosLo European Approval H2 2006, pending
inspection by EU
regulators
PhosLo Announce CARE-2 trial H2 2006
results
PhosLo Announce EPICK study H2 2006
results
PhosLo File for Chronic Kidney H2 2006
Disease (Stage 4)
indication in
U.S. and EU
Nabi-HB Intravenous U.S. approval H2 2006
for liver transplant
indication
Civacir Initiate Phase II H2 2006
proof-of-concept trial
NicVAX Execute Phase II Data mid-2007
proof-of-concept trial
HEBIG(TM) [Hepatitis European Approval 2007
B Immune Globulin
(Human)]
Multi-Valent With partner, initiate 2007
StaphVAX(R) Phase III study
(Staphylococcus
aureus Polysaccharide
Conjugate Vaccine)
Multi-Valent With outside funding, 2007
Altastaph(R) initiate Phase II
[Staphylococcus proof-of-concept study
aureus Immune
Globulin Intravenous
(Human)]
ATG-Fresenius S in Data from Phase III H2 2008
solid organ trial
transplant patients
Review of Operations:
PhosLo Revenues
During the second quarter of 2006, PhosLo revenues were $9.6 million,
compared with $3.2 million for the same period in 2005. During the month of
May 2006, the number of PhosLo prescriptions reached an all-time record
high. Sales for the second quarter reflected the benefit of price increases
in the third quarter of 2005 and strong patient demand. Customer inventory
levels were consistent with first quarter 2006 levels. In the second
quarter of 2005, we elected to defer $5.2 million of PhosLo sales based on
inventory levels at our wholesaler customers.
Nabi-HB Revenues
Sales of Nabi-HB were $7.2 million for the second quarter of 2006,
compared to $10.9 million for the same period in 2005. During the second
quarter of 2006, patient demand for Nabi-HB remained above prior year
levels. However, Nabi-HB revenue decreased from prior year levels because
of the negotiation of a new supply agreement with one of our significant
customers. As a result, we shipped a minimal amount of Nabi-HB to that
customer and estimated inventory levels at wholesalers decreased by
approximately two months during the second quarter.
Other Biopharmaceutical Product Revenues
Second quarter 2006 revenues of the company's other biopharmaceuticals
were $1.0 million, compared to second quarter 2005 revenues of $0.4
million.
Antibody Revenues
Sales of antibody products were $12.2 million in second quarter of
2006, compared to $11.4 million during the same period in 2005, reflecting
increased specialty antibody sales, primarily anti-D and anti-rabies
antibodies, which resulted in increased gross margins.
Operating Expenses
Research and development expense for the second quarter of 2006 was
$10.7 million, a decrease of 42% as compared to the same period for 2005.
During the second quarter of 2005, a large portion of our research and
development expense was incurred for the development of StaphVAX. Research
and development expense for the second quarter of 2006 primarily reflects
activities related to the initiation of our NicVAX Phase II
proof-of-concept clinical trial, ongoing expenses related to clinical
development of ATG- Fresenius S and clinical trials to support PhosLo.
Selling, general and administrative expense decreased to $16.5 million
in the second quarter 2006 from $17.2 million for the same period of 2005.
Selling, general and administrative expense in 2005 reflected activities
relating to the planned European launch of StaphVAX. Reduced spending in
2006 was partially offset by the costs of retention and equity based
compensation programs and the costs for ongoing compliance efforts related
to sales rebates.
Tax Expense
No tax benefit was recorded in the second quarter of 2006 and none is
expected to be recorded for the full year as we continue to record a full
valuation allowance against all of our deferred tax assets. During the
second quarter of 2005, the company recorded a tax benefit of $7.4 million
based on a tax planning strategy to utilize those assets at that time.
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 three products on the market
today: PhosLo(R) (calcium acetate), 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, kidney disease (nephrology), 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 Statement
Statements in this press release about the company that are not
strictly historical are forward-looking statements and include statements
about our products in development, the market for such products, and
regulatory approval of our product candidates. You can identify these
forward-looking statements because they involve our expectations, beliefs,
intentions, plans, projections, 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 advance the
development of products currently in the pipeline or in clinical trials;
maintain the human and financial resources to commercialize current
products and bring to market products in development; obtain regulatory
approval for its products in the U.S., Europe or other markets;
successfully develop, manufacture and market its products; successfully
partner with other companies; realize future sales growth for its
biopharmaceutical products; maintain sufficient intellectual property
protection or positions; raise additional capital on acceptable terms; and
re-pay its outstanding convertible senior notes when due. 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 April 1, 2006 filed
with the Securities and Exchange Commission.
Nabi Biopharmaceuticals
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, amounts in thousands, except per share data)
For the Three For the Six
Months Months
Ended Ended
July 1, June 25, July 1, June 25,
2006 2005 2006 2005
Sales $29,935 $25,879 $57,483 $51,956
Costs and expenses:
Costs of products sold,
excluding amortization of
intangible assets 15,188 15,368 30,441 30,231
Royalty expense 343 480 700 2,679
Gross Margin, excluding
amortization of intangible
assets 14,404 10,031 26,342 19,046
Selling, general and
administrative expense 16,544 17,231 33,353 31,633
Research and development
expense 10,686 18,577 21,613 33,832
Amortization of intangible
assets 2,131 2,222 4,262 4,511
Other operating expense,
principally freight 79 122 258 155
Operating loss (15,036) (28,121) (33,144) (51,085)
Interest income 945 924 2,008 1,478
Interest expense (1,050) (891) (2,148) (1,029)
Other income (expense), net 317 (215) 383 (184)
Loss before benefit for
income taxes (14,824) (28,303) (32,901) (50,820)
Benefit for income taxes -- 7,373 -- 14,068
Net loss $(14,824) $(20,930) $(32,901) $(36,752)
Basic and diluted loss
per share $(0.24) $(0.35) $(0.54) $(0.62)
Basic and diluted weighted
average shares outstanding 60,977 59,695 60,653 59,612
SUPPLEMENTAL INFORMATION:
Sales by Operating Segment
Biopharmaceutical
Products $17,721 $14,500 $33,617 $31,994
Antibody Products:
Specialty antibodies 7,791 6,240 13,669 9,978
Non-specific
antibodies 4,423 5,139 10,197 9,984
Total antibodies 12,214 11,379 23,866 19,962
Total $29,935 $25,879 $57,483 $51,956
Nabi Biopharmaceuticals
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, amounts in thousands)
July 1, December 31,
2006 2005
Cash and cash equivalents $31,121 $101,762
Marketable securities 39,097 5,172
Restricted cash, current 819 816
Trade accounts receivable, net 25,570 22,322
Inventories, net 23,144 22,323
Prepaid expenses and other assets 3,622 3,611
Property, plant and equipment, net 90,564 94,084
Intangible assets, net 74,070 78,332
Other assets, net 826 914
Total assets $288,833 $329,336
Trade accounts payable and accrued
expenses $37,339 $44,429
Notes payable and capital lease
obligations, net 10,715 13,557
2.875% Convertible Senior Notes 109,229 109,145
Other liabilities 232 378
Stockholders' equity 131,318 161,827
Total liabilities and stockholders' equity $288,833 $329,336
Capital expenditures were $1.1 million and $4.5 million for the six
months ended July 1, 2006 and June 25, 2005, respectively.
Depreciation and amortization expenses were $8.6 million and $9.5 million
for the six months ended July 1, 2006 and June 25, 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
http://www.nabi.com/pipeline/index.php
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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