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BOCA RATON, Fla., Feb 19, 2003 /PRNewswire-FirstCall via COMTEX/ -- Year End Cash Position Of $52 Million To Support Strategic Initiatives Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced its financial results for the
year and fourth quarter ended December 28, 2002. The company reported net income
of $2.1 million for the year ended December 28, 2002, or $0.05 per share. For
the fourth quarter of 2002, net income was $1.1 million, or $0.03 per share.
These results were in line with external expectations. At December 28, 2002,
cash and cash equivalents were $51.7 million which compares to cash and cash
equivalents, net of outstanding indebtedness, of $52.7 million at December 29,
2001.
Biopharmaceutical product sales achieved a record level of $89.5 million in
2002, an increase of 22% from 2001 levels, driven by continued strong growth in
sales of Nabi-HB(R) [Hepatitis B Immune Globulin (Human)]. Biopharmaceutical
sales were $73.4 million in 2001. In the fourth quarter of 2002,
biopharmaceutical product sales were $27.6 million compared to $25.0 million in
the fourth quarter of 2001, an increase of 11%.
Earnings generated from higher margin biopharmaceutical product sales funded an
increase in research and development spending of $5.8 million compared to 2001
levels, or a total of $21.1 million for 2002. In 2002, two new Nabi
Biopharmaceuticals products entered human clinical trials, Civacir(TM)
[Hepatitis C Immune Globulin (Human)], for use in treating hepatitis C liver
transplant patients, and NicVAX(TM) (Nicotine Conjugate Vaccine), a vaccine for
fighting nicotine addiction. In addition, the company announced encouraging
results from the initial boosting trial for StaphVAX(R) (Staphylococcus aureus
Polysaccharide Conjugate Vaccine), the company's investigational vaccine for the
prevention of staph infections, and the filing of a Biologics License
Application for Nabi-HB(R) Intravenous to prevent re- infection with hepatitis B
in liver transplant patients. In the fourth quarter of 2002, research and
development spending was $6.2 million.
"Our 2002 results reinforce our ability to drive operating value from our
business model and achieve our clinical objectives," said David J. Gury,
chairman and chief executive officer of Nabi Biopharmaceuticals. "In 2002, we
successfully generated earnings before interest, taxes, depreciation and
amortization of $13.5 million, enabling us to drive development of our research
and development programs and fund capital expenditures, while maintaining our
strong financial position to support future strategic initiatives."
2002 Corporate Milestones
* Nabi Biopharmaceuticals filed a Biologic License Application for Nabi-
HB Intravenous in November 2002, which was granted priority review in
January 2003.
* Nabi Biopharmaceuticals completed transfer of clinical scale
manufacturing and analytical technology to Dow Biopharmaceuticals
Contract Manufacturing Services ("Dow") facility. In December, Dow
completed manufacture of the initial clinical scale lot of StaphVAX for
use in the confirmatory phase III clinical trial planned for 2003.
* Also in December, Dow completed fermentation and purification of the
carrier protein and polysaccharide antigen at commercial scale, key
steps in the process of establishing commercial scale manufacture of
StaphVAX.
* Encouraging results from the StaphVAX booster study were announced in
June 2002 suggesting that a booster dose of StaphVAX can increase and
sustain antibody levels for patients at chronic risk of S.aureus
infection.
* The first phase I/II trial of Civacir in hepatitis C transplant
patients was successfully initiated in March 2002 and fully enrolled in
2002.
* In December 2002, Civacir received Orphan Drug Designation from the
U.S. Food and Drug Administration ("FDA").
* The first phase I trial of NicVAX was successfully initiated in May
2002. Preliminary results demonstrated that a single dose of NicVAX was
safe, resulted in a rapid immune response and generated nicotine
specific antibodies.
* The company established its global biopharmaceutical presence entering
into four distribution agreements to introduce Nabi-HB manufactured at
its Boca Raton manufacturing plant into international markets.
* Nabi Biopharmaceuticals strengthened its management team with the
promotion of Thomas McLain to president and chief operating officer and
the addition of Daniel Greenleaf as senior vice president, operations.
* The company eliminated its outstanding indebtedness through redemption
of its 6.5% Convertible Notes in April 2002 for $78.5 million avoiding
$3.7 million in interest expense in 2002. Nabi Biopharmaceuticals
remains debt-free at December 28, 2002.
Review of Annual Operating Results
For the full year 2002, Nabi Biopharmaceuticals reported net income of $2.1
million or $0.05 per share compared to $104.7 million or $2.36 per share in
2001. Net income in 2001 included the gain from sale of the majority of the
antibody collection business of $104.2 million.
Total sales in 2002 were $196.0 million, a decrease from $234.8 million in 2001.
This decrease was expected, as sales of antibody products were $106.5 million in
2002 compared to $161.4 million in 2001 reflecting the sale of the majority of
the antibody collection business in September 2001. In 2002, total non-specific
antibody sales of $73.8 million included sales of $55.6 million to one customer
which the company did not collect at its centers. These sales are recorded under
an arrangement whereby the purchaser of the majority of the antibody collection
business supplies the company non- specific antibodies, which the company then
sells to the customer at no incremental margin. The company continues to record
revenue on these sales because it retains the credit risk related to this
customer. This arrangement ends in May 2003. In 2002, revenue from non-specific
antibodies collected at the company's retained antibody collection centers
totaled $18.2 million.
Biopharmaceutical product sales were $89.5 million in 2002 compared to $73.4
million in 2001.
Sales of Nabi-HB increased to $41.2 million in 2002 from $30.3 million in 2001.
Strong growth in patient use of Nabi-HB combined with the company's success in
transitioning to product manufactured at its Boca Raton manufacturing facility
in 2002 drove increased sales.
Sales of WinRho SDF(R), [Rho (D) Immune Globulin Intravenous (Human)] were $34.0
million in 2002 compared to $34.8 million in 2001. Patient demand for this
product was at record levels in 2002. Increased patient demand and continued
reliable supply of the product from the manufacturer has resulted in Nabi
Biopharmaceuticals working with its customers to reduce inventory levels of
WinRho SDF at wholesalers and distributors from 2001 levels.
Sales of other biopharmaceutical products, which include Autoplex(R)T
[Anti-Inhibitor Coagulant Complex, Heat Treated] and Aloprim(TM) [(Allopurinol
sodium) for injection], were $14.3 million in 2002 compared to $8.4 million in
2001. This increase in sales was driven by increased patient demand and receipt
of back-ordered product for Aloprim as well as increased product supply for
Autoplex T.
Operating income in 2002 was $3.7 million compared to $12.8 million in 2001,
after adjusting for the gain of $104.2 million reported in 2001. Operating
income in 2002 included research and development spending of $21.1 million, an
increase of $5.8 million from the prior year. Research and development expenses
included costs for the clinical development of StaphVAX, including costs to
transfer the manufacturing process to Dow's facility and support of the booster
trial, and preparation of the Biologics License Application for Nabi-HB
Intravenous that was filed with the FDA in November 2002. Research and
development expense also included costs in support of initial clinical trials of
Civacir and NicVAX and preparation for additional clinical trials of Altastaph
scheduled for 2003.
Outlook for 2003
"Our primary objective in 2003 will be to continue to generate a strong cash
return from our existing operations to further advance the transition of Nabi
Biopharmaceuticals to become a leading immune therapy company," commented David
Gury. "We will drive towards this objective by increasing the value derived from
sales of our biopharmaceutical products and further leveraging our
biopharmaceutical manufacturing plant. In 2003, the major focus of our research
and development activities will be on the continued clinical development of
StaphVAX. We will also advance the clinical development of our lead
antibody-based research and development pipeline products, Civacir and Altastaph
and our vaccine to fight nicotine addiction, NicVAX. We are already underway in
these efforts. This February, NicVAX entered its first clinical trial in a
smoking population in conjunction with the University of Maastricht in the
Netherlands."
Nabi Biopharmaceuticals expects biopharmaceutical product sales to increase
approximately 5% in 2003 over 2002 levels. Projected sales in 2003 reflect
double digit growth in sales of WinRho SDF in line with increased patient demand
reported in 2002 and demand for Nabi-HB in line with patient use reported in the
latter part of 2002. Sales of Autoplex T and Aloprim may be limited in 2003 by
product supply from the manufacturers of these products.
Antibody sales in 2003 are expected to be approximately 70% of 2002 levels. This
decrease reflects completion of the company's obligation to a single customer in
May 2003, discussed earlier, and will have no impact on gross margin generated
from antibody operations.
Reflecting the increased level of Nabi-HB sales achieved in 2002, production of
Nabi-HB is expected to increase in 2003 driving higher utilization of the Boca
Raton facility. As a result, Nabi Biopharmaceuticals expects a decrease in
excess manufacturing capacity expense at the Boca Raton facility to
approximately $2 million in 2003 compared to $3.5 million in 2002.
Selling, general and administrative expense in 2003 is expected to decrease 5%
from 2002 levels, reflecting continued efficiencies from operations.
Research and development expenditures in 2003 are expected to increase more than
30% from 2002 levels. This spending will support ongoing clinical programs for
StaphVAX, Altastaph, Civacir and NicVAX.
Earnings from current operations are expected to be positive for the full year
2003, although the company may incur losses in certain quarters, including the
first quarter, due to the timing of research and development spending.
Capital expenditures, primarily related to the build out of laboratory and
freezer storage facilities in Boca Raton, Florida, are expected to be
approximately $8 million.
The original agreement to ready Dow's facility for the manufacture of StaphVAX
has been extended to March 2003. Nabi Biopharmaceuticals expects to conclude an
amendment to this contract with Dow to complete readying the facility for its
intended use, the commercial manufacture of StaphVAX. This contract modification
will require Nabi Biopharmaceuticals to make significant additional payments
relating to the acquisition of the intangible asset, a Manufacturing Right, in
2003.
Based on cash generated from operations and cash resources on hand, the company
believes it has the resources to make strategic investments in its research and
development pipeline and make the investment required for the commercial scale
manufacture of StaphVAX in the upcoming year. As well, these resources may be
targeted to execute business development opportunities that will generate future
cash flows. The company expects to further strengthen its financial position in
2003 by entering into a new credit facility.
Management's discussion of 2002 results, expectations for 2003 and other
business developments can be accessed through a link at Nabi Biopharmaceuticals
audio website at www.nabi.com. The audio webcast will begin today at 4:30 p.m.
Eastern Time and a replay of the audio webcast will remain available through
February 26th at 5:00 p.m. Eastern Time. The audio webcast can also be accessed
at www.companyboardroom.com. 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 discovers, develops, manufactures and markets products
that power the immune system to help people with serious, unmet medical needs.
The company has a broad product portfolio and significant research capabilities
focused on developing and commercializing novel vaccines and antibody-based
therapies that prevent and treat infectious, autoimmune and addictive diseases,
such as Staphylococcus aureus and hepatitis infections, ITP, and nicotine
addiction. Nabi Biopharmaceuticals has several products in clinical trials, as
well as four marketed products, including Nabi-HB(R) [Hepatitis B Immune
Globulin (Human)], for the prevention of hepatitis B infections and WinRho
SDF(R), [Rho (D) Immune Globulin Intravenous (Human)], for the treatment of
acute, chronic and HIV-related immune thrombocytopenia purpura. The company is
headquartered in Boca Raton, Florida, with principal R&D offices and
laboratories in Rockville, Maryland. Additional information about Nabi
Biopharmaceuticals may be obtained on the company's website at 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 costs of research
and development; the company's dependence upon third parties to manufacture its
products; the impact of current industry supply and demand factors on the
company and its products; the future sales growth prospects for the company's
biopharmaceutical products; and the likelihood that any product in the company's
research pipeline can receive regulatory approval in the U.S. or abroad or be
successfully developed, manufactured and marketed. These factors are more fully
discussed in the company's most recent Form 10-K filed with the Securities and
Exchange Commission and any subsequent filings.
Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, amounts in thousands, except per share data)
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Three Months Ended
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Twelve Months Ended
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Dec. 28, 2002
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Dec. 29, 2001
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Dec. 28, 2002
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Dec. 29, 2001
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Sales
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$58,095
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$54,760
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$195,966
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$234,829
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Costs and expenses:
Costs of products sold
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37,521
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28,398
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119,170
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152,613
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Royalty expense
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2,778
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3,965
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12,883
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12,093
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Gross margin
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17,796
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22,397
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63,913
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70,123
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Selling, general and
administrative expense
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10,225
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10,916
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38,380
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40,501
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Research and development
expense
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6,157
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5,164
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21,096
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15,330
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Other operating expense,
principally freight
and amortization
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216
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230
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767
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1,500
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Gain on disposition of
assets
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--
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--
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--
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(104,219)
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Operating income
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1,198
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6,087
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3,670
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117,011
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Other income (expense), net
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123
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(97)
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(1,000)
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(952)
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Income before provision for
income taxes
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1,321
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5,990
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2,670
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116,059
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Provision for income taxes
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(251)
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(4,544)
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(615)
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(11,377)
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Net income
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$1,070
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$1,446
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$2,055
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$104,682
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Basic earnings per share
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$0.03
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$0.04
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$0.05
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$2.76
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Diluted earnings per share
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$0.03
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$0.04
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$0.05
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$2.36
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Basic weighted average shares
outstanding
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38,805
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38,092
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38,670
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37,980
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Diluted weighted average shares
outstanding
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39,728
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39,787
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39,641
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44,872
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SUPPLEMENTAL INFORMATION:
Sales by Operating Segment
Biopharmaceutical Products
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$27,648
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$25,017
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$89,466
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$73,439
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Antibody Products:
Specialty antibodiesles
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8,402
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7,331
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32,749
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46,846
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Non-specific antibodies
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22,045
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22,412
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73,751
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114,544
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30,447
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29,743
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106,500
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161,390
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Total
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$58,095
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$54,760
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$195,966
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$234,829
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Nabi Biopharmaceuticals
CONDENSED BALANCE SHEETS
(unaudited, amounts in thousands)
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December 28, 2002
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December 29, 2001
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Cash and cash equivalents
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$51,737
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$131,192
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Trade accounts receivable, net
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36,326
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36,039
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Inventories, net
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19,388
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18,138
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Prepaid expenses and other assets
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5,595
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13,469
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Property, plant and equipment, net
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103,706
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107,866
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Other assets, net
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16,064
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7,920
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Total assets
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$232,816
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$314,624
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Trade accounts payable and accrued
expenses
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$38,551
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$44,413
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Notes payable
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--
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78,500
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Other liabilities
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5,236
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4,505
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Stockholders' equity
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189,029
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187,206
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Total liabilities and stockholders'
equity
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$232,816
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$314,624
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Capital expenditures and acquired intangible assets were $12.2 million for
the twelve months ended December 28, 2002.
Depreciation and amortization expenses were $10.1 million for the twelve
months ended December 28, 2002.
The 2001 condensed balance sheet has been derived from the audited balance
sheet for the year ended December 29, 2001.
SOURCE Nabi Biopharmaceuticals
CONTACT: David J. Gury, Chairman and CEO, or Mark L. Smith, Sr. VP,
Finance and CFO, or Mark A. Soufleris, Vice President, Investor & Public
Relations, all of Nabi Biopharmaceuticals, +1-561-989-5800
URL: http://www.nabi.com
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Copyright (C) 2003 PR Newswire. All rights reserved.
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