MOUNTAIN VIEW, Calif., Nov. 14 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the third quarter of fiscal 1999, ended September 30,
1999.
For the third quarter, the company reported a net loss of $22.6 million
(basic net loss of $1.43 per share) compared to a loss of $15.0 million (basic
net loss of $0.95 per share) for the third quarter of 1998. For the nine
months, the company reported a net loss of $39.3 million (basic net loss of
$2.49 per share) compared to a net loss of $38.8 million (basic net loss of
$2.46 per share) for the first nine months of 1998.
Revenues in the 1999 third quarter totaled $1.4 million, compared to
$0.1 million for the 1998 third quarter and $19.8 million for the first nine
months of 1999, as compared to $0.5 million for the first nine months of 1998.
Third 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 research grants and
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.
The first nine months 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 third quarter totaled $23.2 million,
compared to $15.1 million for the 1998 third quarter and $57.4 million for the
first nine months of 1999, as compared with $40.5 million for the first nine
months of 1998. Research and development costs rose to $19.6 million in the
1999 third quarter from $12.5 million in the 1998 third quarter and totaled
$48.0 million for the first nine months of 1999, as compared with
$33.1 million in the first nine months of 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
$3.6 million in the 1999 third quarter from $2.7 million in the 1998 third
quarter, and $9.4 million for the first nine months of 1999, as compared to
$7.3 million for the first nine months of 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 $48.9 million at September 30, 1999, compared to $94.9 million at
December 31, 1998.
Other company events during the third quarter included:
-- On August 11, the company announced the completion of a Phase 1
clinical trial of an investigational vaccine against Epstein-Barr virus (EBV)
performed under its collaboration with SmithKline Beecham Biologicals. The
study showed that the vaccine tested was safe and well tolerated whether or
not subjects had been exposed to EBV prior to the study. Although the study
was not designed to evaluate the efficacy of the vaccine, laboratory tests
showed evidence of immune response in vaccine recipients.
The trial was a randomized, double-blind study to evaluate safety and
immunogenicity of two formulations of intramuscularly injected vaccines in
healthy young adults. It was conducted at University Hospital of Liege,
Belgium. The vaccine was administered to 67 subjects. The vaccine under
development is based on the single surface antigen responsible for most of the
neutralizing antibodies stimulated by EBV infection, and combines Aviron's
antigen with SmithKline's proprietary adjuvant technology.
-- Also in September, Aviron secured a $17 million line of credit with
FINOVA Capital Corporation, the principal operating subsidiary of the Finova
Group, Inc.
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.
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 Nine Months
Ended Ended
September 30, September 30,
1999 1998 1999 1998
Revenues:
Contract revenues
and grants $1,363 $107 $19,838 $494
Operating Expenses:
Research and development 19,593 12,469 47,960 33,126
General, administrative and
Marketing 3,602 2,673 9,435 7,325
Total Operating
Expenses 23,195 15,142 57,395 40,451
Loss From Operations (21,832) (15,035) (37,557) (39,957)
Other Income/(Expense):
Interest income 804 1,668 3,077 4,468
Interest expense (1,590) (1,606) (4,777) (3,267)
Total Other
Income/(Expense),
Net
(786) 62 (1,700) 1,201
Net Loss $(22,618) $(14,973) $(39,257) $(38,756)
Basic net loss per share $(1.43) $(0.95) $(2.49) $(2.46)
Shares used in calculation
of basic net loss per share
15,814 15,643 15,755 15,739
AVIRON
CONDENSED BALANCE SHEETS
(In thousands)
ASSETS
September 30, December 31,
1999 1998
(Unaudited) (Note)
ASSETS
Cash, cash equivalents
and short-term investments $44,537 $88,856
Accounts receivable 4,011 75
Inventory 2,029 --
Other current assets 797 1,228
Total Current Assets 51,374 90,159
Long-term investments 4,360 6,002
Property and equipment, net 25,762 18,521
Debt issuance costs, deposits and other
assets
7,484 6,303
Total Assets $88,980 $120,985
LIABILITIES and STOCKHOLDERS' EQUITY
(DEFICIT)
Current liabilities 16,283 10,790
Long-term debt 100,000 100,000
m Other long-term liabilities 1,978 1,229
Total Liabilities 118,261 112,019
Stockholders' Equity (Deficit) (29,281) 8,966
Total Liabilities and
Stockholders' Equity (Deficit) $88,980 $120,985
Note: These amounts have been derived from audited financial statements.
SOURCE Aviron
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CONTACT:
media, Karen Gilbert, 650-919-6578, or
investors, John Bluth, 650-919-3716, or Fred Kurland,
650-919-6666, all of Aviron; or media, Louise Leavitt of
Fleishman-Hillard, 212-453-2000
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