- PhosLo(R) Demand Remains Strong -
- Company on Track to Announce StaphVAX(R) Phase III Data Late October or
Early November -
BOCA RATON, Fla., Oct. 19 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) reported today that revenues from PhosLo(R)
(calcium acetate) in the third quarter exceeded levels reported in the first
two quarters of 2005 combined. Patient demand has remained strong despite
intense competitive activity. Reported PhosLo revenues totaled $8.1 million
and correlate to patient usage during the third quarter. Importantly, the
cash margin earned on these improved revenues helped to fund an increasing
investment in support of the anticipated commercial launch of StaphVAX(R)
[Staphylococcus aureus Polysaccharide Conjugate Vaccine] in 2006. Also today,
the company reported that it has continued to make significant progress toward
its four main goals for the remainder of 2005: report top-line results from
the StaphVAX confirmatory Phase III clinical trial; file its Biologics License
Application (BLA) for StaphVAX in the U.S. by the end of 2005; support the
review and approval of the StaphVAX license application in Europe; and
complete studies to support the broader clinical application of StaphVAX. In
total, cash and marketable securities decreased $20 million during the quarter
in support of the company's investment in these activities. At the end of the
third quarter, cash and marketable securities totaled $136.5 million.
In line with its strategy to develop and commercialize a comprehensive
healthcare-associated infections franchise, Nabi Biopharmaceuticals has
recently achieved several important milestones. The company announced
positive results from its consistency lots study evaluating the quality of
three lots of StaphVAX manufactured at commercial scale. This provided
important evidence that a reliable supply of the vaccine can be manufactured
by the company's contract manufacturing partner to support its initial launch
in Europe and in the U.S. In addition, results from a safety and
immunogenicity study in orthopedic surgery patients, when combined with
earlier data from a clinical study in cardiac surgery patients, adds to the
clinical evidence that StaphVAX could confer benefit in protecting broader
patient populations from life threatening S. aureus infections. The company
also initiated a long-term dosing study designed to evaluate the use of
StaphVAX to provide protection well beyond one year in patients who are at
chronic risk for S. aureus infections. This study is important in realizing
the company's strategic goal to commercialize a comprehensive solution to S.
aureus infections through better short- and long-term outcomes for patients,
thereby reducing the overall cost of care. Finally, Nabi Biopharmaceuticals
initiated the first human clinical study for its vaccine being developed to
prevent S. aureus type 336 infections. When combined with the current
formulation of StaphVAX, this vaccine should allow Nabi Biopharmaceuticals to
provide an approach to prevent essentially all clinically relevant S. aureus
infections.
The company also continued to make progress with European regulators
toward the approval of its Marketing Authorization Application (MAA) for the
use of StaphVAX to prevent S. aureus infections in end-stage renal disease
(ESRD) patients on hemodialysis. In support of an expected launch of StaphVAX
in the UK, Ireland and Germany in 2006, the company appointed Edwin Klumper,
M.D., as vice president of sales and marketing for Europe and Chris Tovey as
country manager in the UK and Ireland, and is hiring additional personnel. In
addition, Nabi Biopharmaceuticals continued to build relationships with key
opinion leaders across Europe and with partners who have experience in medical
education, reimbursement, and healthcare-associated infections. As a result
of these efforts, the company believes that the commercial opportunity for
StaphVAX in Europe aligns well with the recognition of the need for a
preventative approach shared by key opinion leaders and public health
officials.
"Our significant accomplishments in 2005 have brought us much closer to
achieving our goal to file our BLA and commercialize StaphVAX in Europe and
the United States," stated Thomas H. McLain, chairman, chief executive officer
and president. "Hospital-acquired infections are the fourth leading cause of
death in the United States today, according to the United States Centers for
Disease Control and Prevention. We believe our focus on developing treatments
to prevent these infections positions us in an important leadership role in
solving this serious and unmet medical need. These efforts have clearly
defined that our focus in this area is unique and that our infectious disease
franchise can provide a solution to the global burden of healthcare-associated
infections -- both from a public health perspective and an economic one."
"True to our core business strategy, we have also remained focused on
advancing our base business," continued Mr. McLain. "Refocused sales and
marketing efforts emphasizing PhosLo's proven efficacy and economic
advantages, as well as its safety profile, have resulted in a positive
prescription response and lower wholesale inventory levels. In addition, we
recently introduced our Share Program, which provides PhosLo to ESRD patients
who do not have health insurance. In just two months, almost 3,000 additional
patients are now taking this important therapy. We also remain committed to
our approach to provide solid clinical data from well-designed clinical
studies to support the advantages of our products. Towards that end, we just
completed the enrollment of the CARE2 study, a full three months ahead of
schedule. This study is expected to provide important clinical data in 2005
and 2006 in support of PhosLo's efficacy, safety and value."
Review of Operations
Sales of PhosLo were $8.1 million in the third quarter of 2005 compared to
$9.2 million in the third quarter of 2004 and $7.0 million in the first two
quarters of 2005 combined. Continued strong patient utilization of PhosLo in
the third quarter of 2005 exceeded shipments to wholesalers resulting in
reduced wholesaler inventory levels of PhosLo. As a result of reduced
inventory levels, the company reversed the deferral of $5.2 million of revenue
recorded in the second quarter when wholesaler inventories were higher. That
reversal is included in reported revenue in the third quarter. Also, the
conversion of patients to the gelcap formulation of PhosLo was virtually
completed in the third quarter with less than one month's supply of PhosLo
tablets on hand at wholesaler locations.
Sales of Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] totaled
$10.8 million in the third quarter of 2005 as compared to sales of
$13.7 million in the comparable quarter in 2004. The decrease in Nabi-HB
sales from third quarter 2004 levels is consistent with a reported decrease in
the number of HBV-positive liver transplant surgeries in 2005. Increasing use
of Nabi-HB for patients undergoing maintenance therapy following liver
transplant partially offset this trend. For the first nine months of 2005,
overall patient use of the product as reported on internal tracking data is
consistent with reported revenues.
Sales of the company's other biopharmaceutical products were $1.3 million
in the third quarter of 2005, compared to $2.1 million in the third quarter of
2004. Results in the 2005 period reflect lower sales of Aloprim(TM)
[Allopurinol sodium for injection], due to the introduction of a competitive
product in the second half of 2004, offset by increased contract manufacturing
revenue.
Sales of antibody products were $10.6 million in the quarter, compared to
$11.0 million in the corresponding quarter of 2004. This is a result of
slightly increased production of non-specific plasma and lower sales of
specialty plasmas as the company retained anti-HBs plasma for future
production of Nabi-HB, consistent with its strategy for this segment of its
operations. Also during the quarter, the company allocated some of its plasma
production capacity to produce anti-S. aureus plasma in preparation for the
manufacture of Altastaph(TM) [Staphylococcus aureus Immune Globulin
Intravenous (Human)] for use in future clinical trials.
Research and development expenses totaled $17.4 million in the quarter
compared to $17.7 million in the third quarter of 2004 and $18.6 million in
the second quarter of 2005. These expenses were driven primarily by the costs
associated with advancing the StaphVAX clinical program, including completion
of the StaphVAX confirmatory Phase III clinical trial, ongoing development of
StaphVAX manufacturing capacity and the preparation for filing the StaphVAX
BLA, which is expected by the end of 2005. Research and development expenses
also included costs related to clinical trials of next generation Gram-
positive infections programs, preparatory steps for future clinical trials of
Altastaph and clinical programs supporting PhosLo.
In line with company-established expectations, selling, general and
administrative expenses increased to $19.6 million due to activities related
to the future commercialization of StaphVAX. This included ongoing market and
pricing research, establishing commercial operations in Europe and pre-launch
marketing activities.
Other operating expenses were $2.3 million for the quarter, comparable to
2004 same quarter totals. These expenses primarily reflect amortization of
the intangible assets associated with the acquisition of PhosLo.
As a result of the above factors, the company reported a net loss of
$16.1 million, or $0.27 per share for the third quarter compared to a net loss
of $10.9 million or $0.18 per share in the comparable quarter of 2004.
Additional Outlook for 2005
Following the reduction of wholesaler customer inventory levels of PhosLo,
partially offset by the impact of a previously announced price increase, the
company now projects that full year sales of PhosLo will be in the range of
$26 million to $28 million. Considering the decrease in liver transplants,
offset by the increased use of Nabi-HB in maintenance therapy post transplant,
the company projects that Nabi-HB sales will be at least equal to 2004 sales
of $40 million. For full year 2005, biopharmaceutical revenues are now
expected to be in the range of $75 million to $79 million. Total revenues are
expected to be between $120 million and $125 million. Expectations for
research and development expense to increase up to 20% from last year are
unchanged. Related to accelerating preparations for the launch of StaphVAX in
Europe and the U.S. as well as expected increased sales and marketing, the
company now expects selling, general and administrative expenses to increase
approximately 20% from 2004 levels.
Management's discussion of third quarter 2005 results and expectations for
the remainder of 2005 can be accessed through the audio link
http://audioevent.mshow.com/254612 or at Nabi Biopharmaceuticals' website at
http://www.nabi.com . If you do not have Internet access, the U.S./Canada
call-in number is 877-569-0953 conference code 9776906, and the international
call-in number is 706-634-4967 conference code 9776906. An audio replay will
be available for U.S./Canada callers at 800-642-1687 conference code 9776906,
and for international callers at 706-645-9291 conference code 9776906. The
audio webcast will begin today at 4:30 p.m. Eastern Time and a replay of the
audio webcast will remain available through October 26, 2005 at 5:00 p.m.
Eastern Time. If you have any questions concerning the audio webcast, please
contact Nabi Biopharmaceuticals' Investor Relations Department at
561-989-5815.
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. We are poised to capture large commercial opportunities in our
core business areas: Gram-positive bacterial infections, hepatitis, kidney
disease (nephrology), and opportunistically in nicotine addiction. We have
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)] and a number of products in various stages of clinical and
preclinical development. The company filed its Marketing Authorization
Application (MAA) in Europe for its product candidate, StaphVAX(R)
[Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004.
The application was accepted for review in January 2005. StaphVAX is
currently in a confirmatory Phase III clinical trial in the U.S. StaphVAX is
designed to prevent the most dangerous and prevalent strains of S. aureus
bacterial infections. S. aureus bacteria are a major cause of hospital-
acquired infections and are becoming increasingly resistant to antibiotics.
The company also filed MAAs in Europe to market Nabi-HB(R) Intravenous
[Hepatitis B Immune Globulin (Human) Intravenous] under the trade name
HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver
transplant patients; and for PhosLo(R) (calcium acetate), which is already
marketed in the United States. The company's other products in development
include Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous
(Human)], an antibody for prevention and treatment of S. aureus infections,
NicVAX(TM) [Nicotine Conjugate Vaccine], a vaccine to treat nicotine
addiction, and Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody
for preventing hepatitis C virus re-infection in liver transplant patients.
For additional information on Nabi Biopharmaceuticals, please visit our
website at http://www.nabi.com .
This press release contains forward-looking statements that reflect the
company's current expectations regarding future events. Any such forward-
looking statements are not guarantees of future performance and involve
significant risks and uncertainties. Actual results may differ significantly
from those in the forward-looking statements as a result of any number of
factors, including, but not limited to, risks relating to the possibility that
our confirmatory Phase III clinical trial for StaphVAX or our plans to
commercialize StaphVAX in the European Union and U.S. may not be successful;
the possibility that we may not realize the value of our acquisition of
PhosLo; the ability of the company to prevail in patent litigation; ability to
raise additional capital on acceptable terms; the company's dependence upon
third parties to manufacture its products; the company's ability to utilize
the full capacity of its manufacturing facility; the impact on sales of Nabi-
HB from patient treatment protocols and the number of liver transplants
performed in HBV-positive patients; reliance on a small number of customers;
the future sales growth prospects for the company's biopharmaceutical
products; and the company's ability to obtain regulatory approval for its
products in the U.S. or abroad or to successfully develop, manufacture and
market its products. These factors are more fully discussed in the company's
Annual Report on Form 10-K for the fiscal year ended December 25, 2004 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 Nine
Months Ended Months Ended
September September September September
24, 2005 25, 2004 24, 2005 25, 2004
Sales $30,768 $43,774 $82,724 $138,367
Costs and expenses:
Costs of products sold,
excluding amortization of
intangible assets 14,328 17,495 44,559 55,033
Royalty expense 460 3,331 3,139 12,924
Gross Margin, excluding
amortization of
intangible assets 15,980 22,948 35,026 70,410
Selling, general and
administrative expense 19,627 12,009 51,259 38,846
Research and development
expense 17,410 17,718 51,242 46,301
Amortization of intangible
assets 2,223 2,105 6,734 6,424
Other operating expense,
principally freight 117 175 273 370
Operating loss (23,397) (9,059) (74,482) (21,531)
Interest income 1,266 428 2,744 1,112
Interest expense (987) (296) (2,016) (2,104)
Other income (expense), net 74 9 (111) 17
Loss before benefit
(provision) for income
taxes (23,044) (8,918) (73,865) (22,506)
Benefit (provision) for
income taxes 6,926 (2,003) 20,995 (10,832)
Net loss $(16,118) $(10,921) $(52,870) $(33,338)
Basic and diluted loss per
share $(0.27) $(0.18) $(0.89) $(0.57)
Basic and diluted weighted
average shares outstanding 59,991 59,149 59,738 58,632
SUPPLEMENTAL INFORMATION:
Sales by Operating Segment
Biopharmaceutical
Products $20,215 $32,823 $52,209 $103,307
Antibody Products:
Specialty antibodies 4,143 4,621 14,121 17,639
Non-specific
antibodies 6,410 6,330 16,394 17,421
Total antibodies 10,553 10,951 30,515 35,060
Total $30,768 $43,774 $82,724 $138,367
Nabi Biopharmaceuticals
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, amounts in thousands)
September 24, December 25,
2005 2004
Cash and cash equivalents $55,262 $94,759
Marketable securities 81,250 8,350
Restricted cash, current 803 672
Trade accounts receivable, net 15,784 32,405
Inventories, net 27,270 20,175
Prepaid expenses and other assets 32,562 6,227
Property, plant and equipment, net 114,595 115,406
Intangible assets, net 83,210 89,728
Restricted cash, noncurrent 3,564 --
Other assets, net 718 449
Total assets $415,018 $368,171
Trade accounts payable and accrued
expenses $47,681 $54,233
Notes payable and capital lease
obligations, net 13,448 23,844
2.875% Convertible Senior Notes 109,103 --
Other liabilities 8,497 5,773
Stockholders' equity 236,289 284,321
Total liabilities and stockholders' equity $415,018 $368,171
Capital expenditures were $6.6 million and $15.2 million for the nine
months ended September 24, 2005 and September 25, 2004, respectively.
Depreciation and amortization expenses were $14.3 million and
$13.2 million for the nine months ended September 24, 2005 and September
25, 2004, respectively.
Restricted cash, noncurrent, represents a lease security deposit for the
research and development facility in Gaithersburg, Maryland.
The 2004 condensed balance sheet has been derived from the audited balance
sheet for the year ended December 25, 2004. Certain items in the 2004
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
Audio:http://audioevent.mshow.com/254612
CONTACT:
Constance C. Bienfait, Vice President,
Investor Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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