MOUNTAIN VIEW, Calif., Feb. 17 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for fiscal 1998 and the 1998 fourth quarter, ended
December 31, 1998.
Aviron reported a net loss of $54.8 million (basic net loss of $3.49 per
share) in 1998 compared to a net loss of $26.5 million (basic net loss of
$1.94 per share) in 1997. For the fourth quarter, the company reported a net
loss of $16.0 million (basic net loss of $1.03 per share) compared to a loss
of $9.8 million (basic net loss per share of $0.61 per share) for the fourth
quarter of 1997. The increase in net loss was primarily due to significant
increases in operating expenses associated with the continued development of
FluMist(TM), the company's investigational intranasal influenza virus vaccine.
Revenues for fiscal 1998 totaled $0.7 million, compared to $1.5 million
for fiscal 1997 and $0.3 million for the fourth quarter of 1998 as compared to
$1.0 million for the fourth quarter of 1997. Revenues for the 1998 fourth
quarter and fiscal year were comprised of payments under governmental research
grants and revenue from rental of a portion of the company's animal research
facilities. Revenues in the 1997 fourth quarter and fiscal year were
principally payments for research support and milestones due to the company
under its license and development agreement with SmithKline Beecham for
Aviron's Epstein-Barr virus vaccine.
Operating expenses for fiscal 1998 totaled $56.7 million, compared to
$30.2 million for fiscal 1997 and $16.2 million for the fourth quarter of
1998, compared to $11.9 million for the fourth quarter of 1997. Research and
development costs rose to $46.6 million in 1998 from $24.3 million in 1997 and
totaled $13.5 million for the fourth quarter of 1998, as compared to
$10.2 million for the fourth quarter of 1997. The increase in research and
development costs on a year-to-year basis was due primarily to clinical trial,
product development and regulatory activities. The increase in research and
development costs for the fourth quarter of 1998 as compared with the 1997
fourth quarter was due primarily to product development and regulatory
activities which was partially offset by a decrease in clinical trial
activities. General, administrative and marketing costs rose to $10.1 million
in 1998 from $6.0 million in 1997 and totaled $2.8 million for the fourth
quarter of 1998, as compared to $1.7 million for the fourth quarter of 1997.
Increases in staffing and infrastructure costs contributed to the increases in
General, administrative and marketing expenses for the fourth quarter and year
of 1998, as compared with the respective periods of 1997. The 1998 fiscal
year costs also included market research activities principally associated
with FluMist(TM), which were not present in 1997.
Cash, cash equivalents, short-term investments, and long-term investments
totaled $94.9 million at December 31, 1998, compared to $75.1 million at
December 31, 1997. On March 30, 1998, the company completed a $100 million
convertible debt offering, which generated net proceeds of approximately
$96 million after deducting expenses associated with the financing.
Other company events during the fourth quarter and early in the 1999 first
quarter included:
* Aviron announced a worldwide collaboration for the marketing of
FluMist(TM) with Wyeth Lederle Vaccines, a business unit of Wyeth-Ayerst
Laboratories (the pharmaceutical division of American Home Products
Corporation). The agreement is subject to Hart-Scott-Rodino review.
Under the agreement, Aviron is granting Wyeth Lederle Vaccines worldwide
rights to market FluMist(TM). Wyeth Lederle Vaccines and Aviron will
co-promote FluMist(TM) in the U.S., while Wyeth will have the exclusive right
to market the product ex-U.S. In each case, Wyeth will have marketing rights
for up to 11 years. The collaboration excludes Korea, Australia, New Zealand
and certain South Pacific countries where Aviron has existing partnerships.
The companies will collaborate on the regulatory, clinical, and marketing
programs for the product.
* On December 10, Aviron reported on a meeting with the U.S. Food and Drug
Administration Center for Biologics Evaluation and Research (CBER) regarding
plans for submission of Aviron's license applications for its FluMist(TM)
intranasal influenza vaccine. Requirements for completion of the submission
include data on manufacturing, validation and stability. In addition, Aviron
is conducting a bridging study designed to evaluate clinical equivalence of
vaccine blended and filled at Aviron's new Pennsylvania facility as compared
to vaccine used in earlier clinical trials. This 225-person trial is now
fully enrolled and underway in Australia in collaboration with CSL Limited,
Aviron's Australian marketing partner for FluMist(TM). Aviron will include
safety and immunogenicity data from this clinical study in its licensing
applications for the vaccine. The company's goal is to submit its application
by the summer or fall of 1999.
* On December 5, the company announced data from three clinical studies
presented at the International Symposium on Influenza and Other Respiratory
Viruses:
* Preliminary results from a Phase 3 trial in 4,561 healthy working adults
showed that those receiving FluMist(TM) experienced reductions in
illness-associated missed work days and health-care provider visits, as well
as in prescription and over-the-counter medication use associated with
illness.
* Results reported from a trial suggested that FluMist(TM) could be useful
in prevention of A/H1N1, a third strain of flu that had not circulated during
the two years of Aviron's successful pediatric Phase 3 efficacy trial.
* Also presented were results of Aviron's first Phase 2 clinical study of
an intranasal vaccine against parainfluenza virus type 3 (PIV-3), a common
childhood virus. The trial met the company's pre-determined objectives for
safety and immunogenicity. Based on this data, the company intends to move
forward with additional clinical trials.
* Aviron announced that the company has leased a 69,000-square-foot
building in Santa Clara, CA. The facility will provide additional
manufacturing, laboratory, pilot plant and office space to accommodate
Aviron's growth.
* The company also announced several management changes:
* C. Jo White, M.D., Senior Vice President, Medical Affairs, has resigned
effective February 26, to pursue other opportunities.
* Martin L. Bryant, M.D., Ph.D., Vice President, Research, resigned in
late 1998.
* Ann M. Arvin, M.D., a member of Aviron's Scientific Advisory Board, is
leading the company's early-stage research programs as Principal Research
Consultant during 1999 while on sabbatical from Stanford University School of
Medicine, where she is the Lucile Salter Packard Professor of Pediatrics,
Microbiology and Immunology.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is to develop products which
offer cost-effective prevention of a wide range of infections that affect the
general population. The majority of Aviron's products under development are
live vaccines against viral infections. These include intranasal vaccines
under development for respiratory infections and their complications
-- influenza, parainfluenza (PIV-3), and respiratory syncytial virus (RSV),
and injectable vaccines to prevent cytomegalovirus (CMV) and genital herpes
(HSV-2). Aviron is also developing, in collaboration with SmithKline Beecham
Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a
major cause of infectious mononucleosis.
This press release contains forward-looking statements. Actual results
may differ materially from those suggested here. Factors that could cause
actual results to differ include, but are not limited to, failure in a
clinical trial, failure to demonstrate stability or to validate equipment or
the manufacturing process. Risk factors also include the assessment by the
regulatory agencies that the company's future license applications for its
intranasal influenza vaccine are incomplete or inadequate to approve the
product for marketing to one or more target populations. Additional
information concerning factors that could cause such a difference is contained
in Aviron's Annual Report on Form 10-K for the year ended December 31, 1997.
To receive an index and copies of recent press releases, call Aviron's
News-On-Call toll-free fax service, 800-758-5804, extension 114000.
Additional information about the company can be located at
http://www.aviron.com.
AVIRON
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited except where noted)
(In thousands, except per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
1998 1997 1998 1997
(Note)
Revenues $251 $1,031 $745 $1,477
Operating Expenses:
Research and development 13,457 10,238 46,583 24,254
General, administrative
and marketing 2,760 1,680 10,085 5,978
Total Operating Expenses 16,217 11,918 56,668 30,232
Loss From Operations (15,966) (10,887) (55,923) (28,755)
Other Income/(Expense):
Interest income 1,535 1,144 6,003 2,433
Interest expense (1,615) (39) (4,882) (180)
Total Other Income/(Expense),
Net (80) 1,105 1,121 2,253
Net Loss $(16,046) $(9,782) $(54,802) $(26,502)
Basic and diluted net loss
per share $(1.03) $(0.61) $ (3.49) $(1.94)
Shares used in calculation
of basic net loss per share 15,677 15,937 15,724 13,684
Note: These amounts have been derived from audited financial statements.
AVIRON
CONDENSED BALANCE SHEETS
(In thousands)
ASSETS
December 31, December 31,
1998 1997
(Unaudited) (Note)
ASSETS
Cash and cash equivalents
and short-term investments $88,856 $62,524
Other current assets 1,303 1,030
Total Current Assets 90,159 63,554
Long-term investments 6,002 12,587
Property and equipment, net 18,521 7,582
Debt issuance costs, deposits
and other assets 6,303 1,602
Total Assets $120,985 $85,325
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities 10,790 8,974
Long-term debt 100,000 --
Other Long-Term Liabilities 1,229 609
Total Liabilities 112,019 9,583
Stockholders' Equity 8,966 75,742
Total Liabilities and Stockholders'
Equity $120,985 $85,325
Note: These amounts have been derived from audited financial statements.
SOURCE Aviron
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Company News On-Call:
http://www.prnewswire.com/comp/114000.html or fax,
800-758-5804, ext. 114000
CONTACT:
media, Karen Gilbert of Aviron, 650-919-6578;
or John Bluth, 415-356-1000, or Louise Leavitt, 212-453-2000,
both of Fleishman-Hillard, for Aviron; or investors, Fred
Kurland, 650-919-6666, or Lyn Christenson, 650-919-3716, both of
Aviron
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