MOUNTAIN VIEW, Calif., March 2 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the fourth quarter and year ended December 31, 1999.
For the fourth quarter, the company reported a net loss of $22.6 million
(basic net loss of $1.40 per share) compared to a net loss of $16.0 million
(basic net loss of $1.03 per share) for the fourth quarter of 1998. For the
fiscal year, the company reported a net loss of $61.9 million (basic net loss
of $3.90 per share) compared to a net loss of $54.8 million (basic net loss of
$3.49 per share) for fiscal 1998.
Revenues in the 1999 fourth quarter totaled $2.4 million, compared to
$0.3 million for the 1998 fourth quarter. Revenue for fiscal 1999 was
$22.2 million, as compared to $0.7 million for the fiscal 1998. Fourth
quarter 1999 revenues were comprised principally of expense reimbursement from
Wyeth-Ayerst Laboratories (Wyeth), the pharmaceutical division of American
Home Products Corporation (NYSE: AHP), under the FluMist(TM)collaboration
agreement, combined with revenues from other contracts for services rendered
to other biotechnology companies. Aviron and Wyeth are collaborating on the
development and marketing of FluMist(TM), an investigational intranasal
influenza vaccine. Fiscal 1999 revenues also included a non-refundable
initial payment of $15.0 million from Wyeth, combined with other revenues from
contracts and research grants. Revenues during 1998 were primarily revenues
from contracts for services rendered to other biotechnology companies and from
research grants.
Operating expenses in the 1999 fourth quarter totaled $24.0 million,
compared to $16.2 million for the 1998 fourth quarter. Operating expenses for
fiscal 1999 were $81.4 million, as compared with $56.7 million for fiscal
1998. Research and development costs rose to $20.3 million in the 1999 fourth
quarter from $13.5 million in the 1998 fourth quarter and totaled $68.2
million for fiscal 1999, as compared with $46.6 million in fiscal 1998. The
increases in research and development costs were due primarily to increases in
development activities, depreciation, documentation, validation and other
expenses associated with the commercial scale-up of the manufacturing
facilities associated with FluMist(TM). General, administrative and
marketing costs rose to $3.7 million in the 1999 fourth quarter from $2.8
million in the 1998 fourth quarter, and $13.2 million for fiscal 1999, as
compared to $10.1 million for fiscal 1998. The increases were due to
additional staffing, legal and other infrastructure costs necessary to support
the development of FluMist(TM) and other products.
Cash, cash equivalents, short-term investments, and long-term investments
totaled $52.3 million at December 31, 1999, compared to $94.9 million at
December 31, 1998.
Other company events during the fourth quarter and early first quarter
2000, included:
-- On November 14, 1999, the company announced it would not submit a
Biologics License Application (BLA) for FluMist(TM), its
investigational influenza vaccine, to the U.S. Food and Drug
Administration (FDA) in 1999 due to issues that arose in routine
validation tests during the vaccine manufacturing process.
Separately, Medeva Pharma Limited, a subsidiary of Medeva PLC
(NYSE: MDV), which manufactures components of the vaccine, notified
Aviron of facilities compliance issues at its facility near Liverpool,
England.
The company plans to submit a BLA in 2000. The specific timing of a
BLA submission will depend on the information obtained from ongoing
inquiries into the foregoing issues.
-- On December 6, 1999, the company named C. Boyd Clarke as President and
Chief Executive Officer.
-- Also in the fourth quarter, the company raised $11.3 million through
equity financings with a financial institution and American Home
Products. The company issued press releases on the financings on
November 18 and December 16.
-- In December 1999, the company received $15.4 million in debt financing
under credit facilities announced during the third quarter.
-- Aviron announced in early January, that it received a commitment for up
to $48 million in equity financing from Acqua Wellington Asset
Management; these funds are available, at Aviron's discretion, at a
small discount to the market. Net proceeds from any sales will be used
to fund operating costs, capital expenditures and working capital
needs.
-- On February 17, 2000, Aviron announced that it has reached an amended
agreement with the University of Michigan to accelerate the issuance of
a warrant to the university, which allows it to purchase 340,000 shares
of Aviron common stock. As a result of this amendment, Aviron will
record a one-time charge of $10.9 million in the first quarter of 2000.
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. Aviron and Wyeth
Lederle Vaccines, a business unit of American Home Products, are collaborating
on the development and marketing of FluMist(TM) worldwide except for
Australia, New Zealand, Korea and certain other South Pacific region
countries.
This press release contains forward-looking statements. Actual results
may differ materially from the forward-looking statements contained in this
release. Factors that could cause actual results to differ include, but are
not limited to, failure in a clinical trial, failure to demonstrate stability
or failure to validate 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, 1998 and Aviron's Registration Statement on Form S-3
(No. 333-87185) filed on September 16, 1999.
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)
(In thousands, except per share data)
Three Months Year
Ended Ended
December 31, December 31,
1999 1998 1999 1998
Revenues:
Contract revenues and grants $2,394 $251 $22,232 $745
Operating Expenses:
Research and development 20,252 13,457 68,212 46,583
General, administrative and
marketing 3,724 2,760 13,159 10,085
Total Operating Expenses 23,976 16,217 81,371 56,668
Loss From Operations (21,582) (15,966) (59,139) (55,923)
Other Income/(Expense):
Interest income 556 1,535 3,633 6,003
Interest expense (1,587) (1,615) (6,364) (4,882)
Total Other
Income/(Expense), Net
(1,031) (80) (2,731) 1,121
Net Loss $(22,613) $(16,046) $(61,870) $(54,802)
Basic net loss per share $(1.40) $(1.03) $(3.90) $(3.49)
Shares used in
computing basic net
loss per share 16,126 15,677 15,848 15,724
AVIRON
CONDENSED BALANCE SHEETS
(In thousands)
ASSETS
December 31, December 31,
1999 1998
(Unaudited) (Note)
ASSETS
Cash, cash equivalents
and short-term investments $52,316 $88,856
Accounts receivable 3,241 75
Inventory 2,082 --
Other current assets 1,009 1,228
Total Current Assets 58,648 90,159
Long-term investments -- 6,002
Property and equipment, net 25,635 18,521
Debt issuance costs, deposits and other
assets 7,411 6,303
Total Assets $91,694 $120,985
LIABILITIES and STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities 16,433 10,790
Long-term debt 112,657 100,000
Other long-term liabilities 2,223 1,229
Total Liabilities 131,313 112,019
Stockholders' Equity (Deficit) (39,619) 8,966
Total Liabilities and
Stockholders' Equity (Deficit) $91,694 $120,985
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 Camela Stuby of Fleishman-Hillard, 212-453-2000, for Aviron;
or investors, John Bluth, 650-919-3716, or Fred Kurland,
650-919-6666, both of Aviron
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