MOUNTAIN VIEW, Calif., Aug. 5 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the second quarter and first half of fiscal 1999, ended
June 30, 1999.
For the second quarter, the company reported a net loss of $15.1 million
(basic net loss of $0.96 per share) compared to a loss of $13.1 million (basic
net loss of $0.84 per share) for the second quarter of 1998. For the first
half, the company reported a net loss of $16.6 million (basic net loss of
$1.06 per share) compared to a net loss of $23.8 million (basic net loss of
$1.51 per share) for the first half of 1998.
Revenues in the 1999 second quarter totaled $2.9 million, compared to $0.1
million for the 1998 second quarter and $18.5 million for the first half of
1999, as compared to $0.4 million for the first half of 1998. Second quarter
1999 revenues were comprised principally of $2.8 million in 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. The first half 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 second quarter totaled $17.5 million,
compared to $13.5 million for the 1998 second quarter and $34.2 million for
the first half of 1999, as compared with $25.3 million for the first half of
1998. Research and development costs rose to $14.4 million in the 1999 second
quarter from $10.9 million in the 1998 second quarter and totaled $28.4
million for the first half of 1999, as compared with $20.7 million in the
first half 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 $3.2 million in the 1999
second quarter from $2.6 million in the 1998 second quarter, and $5.8 million
for the first half of 1999, as compared to $4.7 million for the first half 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 $71.1 million at June 30, 1999, compared to $94.9 million at December
31, 1998.
Other company events during the second and early third quarters included:
-- On June 9, Aviron announced that a bridging study on FluMist(TM) had
been completed and the preliminary analysis indicated that the results
appeared to meet all of the company's objectives.
The study was designed to compare one lot of FluMist(TM) blended and
filled at Aviron's facility at Packaging Coordinators, Inc. (PCI) in
Philadelphia, to one lot of vaccine manufactured with the process used for
earlier clinical trials, blended and filled by Medeva Pharma Limited, a
subsidiary of Medeva PLC (Medeva Pharma) near Liverpool, England.
The study's primary endpoint was to show that the lot of FluMist(TM)
blended and filled at Aviron's PCI facility had similar immunogenicity for all
three 1997-98 influenza strains to the lot of vaccine blended and filled at
Medeva Pharma. The secondary endpoint was to show that the two lots of
vaccine had similar safety and tolerability profiles. Aviron will include
data from this clinical study in Aviron's FluMist(TM) Biological License
Application (BLA) to be filed with the U.S. Food and Drug Administration
(FDA).
-- On July 14, results of a Phase 3 study in healthy working adults
published in the Journal of the American Medical Association showed that study
participants receiving FluMist(TM), experienced reductions in illness-
associated missed work days and health care provider visits, as well as
prescription and over-the-counter medication use associated with illness.
The double-blind, placebo-controlled study of 4,561 healthy working adults
was conducted at 13 clinical sites nationwide during the 1997-98 flu season.
The report was authored by a team lead by Kristin L. Nichol, M.D., M.P.H.,
chief of medicine, Minneapolis Veterans Affairs Medical Center, Minneapolis,
MN, head of the trial's analysis committee.
The participants, aged 18 to 65, each received one dose of vaccine.
FluMist(TM) recipients had reduced illness by multiple definitions including
days of febrile illness (22.9 percent less), days of severe febrile illness
(27.3 percent less) and days of febrile upper respiratory tract illness (24.8
percent less).
Reductions in illness-associated absenteeism and health resource use were
seen across several illness definitions. For example, those receiving
FluMist(TM) missed 28.4 percent fewer work days due to febrile upper
respiratory illness and had a 40.9 percent reduction in health care provider
visits. In addition, FluMist(TM) recipients experienced a 45.2 percent
reduction in days of prescription antibiotic use and 28.0 percent fewer days
of OTC medication due to febrile upper respiratory illness. Data from this
study will also be included in Aviron's FluMist(TM) BLA.
-- In July, the company said that it plans to file its FluMist(TM) BLA
with the FDA in the fall of 1999 if current manufacturing validation exercises
are successful.
-- In July, the company announced extension of its collaboration with
Medeva Pharma covering the manufacturing of key components of FluMist(TM).
The new contract will extend through December 2005, and Medeva Pharma received
$1 million upon execution. Medeva Pharma will receive specified payments for
supplying the vaccine components of FluMist(TM) on a price-per-dose basis and
Medeva Pharma could receive up to $40 million from a combination of milestone
payments, facilities usage fees and other payments over the course of the
agreement. Medeva Pharma could receive additional payments for meeting
quantity-based production targets in the later years of the contract.
-- Also in July, Aviron executed a $10 million general line of credit with
Transamerica Technology Finance, a division of Transamerica Business Credit
Corporation.
-- Recent management changes include the following:
* Edward J. Arcuri, Ph.D., has joined the company as Vice President,
Manufacturing. Dr. Arcuri will have responsibility for all Aviron
manufacturing activities at Medeva Pharma and PCI. He joins Aviron from
North American Vaccine, Inc., where he most recently served as Vice
President, Manufacturing Operations and Process Development.
* Raysam S. Prasad has joined Aviron as Vice President, Technical Affairs.
Mr. Prasad will have responsibility for a new department which brings
together all Aviron activities in the areas of quality control, quality
assurance and regulatory compliance. He joins Aviron from Chiron
Vaccines, the global vaccines business unit of Chiron Corporation, where
he most recently served as a Head of Regulatory, Quality and Drug
Safety.
* Victor Jegede, Ph.D., who has served the company as Vice President,
Technical Affairs since 1995, has decided to leave the company,
effective August 31, 1999. Dr. Jegede will continue to work with the
company for a period of time as a consultant.
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 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.
(Tables follow)
AVIRON
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
Three Months Six Months
Ended Ended
June 30, June 30,
1999 1998 1999 1998
Revenues:
Contract revenues
and grants $2,944 $134 $18,475 $387
Operating Expenses:
Research and development 14,362 10,874 28,367 20,657
General, administrative
and marketing 3,151 2,591 5,833 4,652
Total Operating Expenses 17,513 13,465 34,200 25,309
Loss From Operations (14,569) (13,331) (15,725) (24,922)
Other Income/(Expense):
Interest income 1,062 1,847 2,273 2,800
Interest expense (1,613) (1,618) (3,187) (1,661)
Total Other Income
/(Expense), Net (551) 229 (914) 1,139
Net Loss $(15,120) $(13,102) $(16,639) $(23,783)
Basic net loss
per share $(0.96) $(0.84) $(1.06) $(1.51)
Shares used in
calculation of basic
net loss per share 15,749 15,571 15,726 15,787
AVIRON
CONDENSED BALANCE SHEETS
(In thousands)
ASSETS
June 30, December 31,
1999 1998
(Unaudited) (Note)
ASSETS
Cash, cash equivalents and short-term
investments $62,552 $88,856
Accounts receivable 2,810 75
Inventory 956 --
Other current assets 1,012 1,228
Total Current Assets 67,330 90,159
Long-term investments 8,514 6,002
Property and equipment, net 23,443 18,521
Debt issuance costs, deposits and other
assets 7,010 6,303
Total Assets $106,297 $120,985
LIABILITIES and STOCKHOLDERS' EQUITY (Deficit)
Current liabilities 11,996 10,790
Long-term debt 100,000 100,000
Other long-term liabilities 1,754 1,229
Total Liabilities 113,750 112,019
Stockholders' Equity (Deficit) (7,453) 8,966
Total Liabilities and
Stockholders' Equity $106,297 $120,985
Note: These amounts have been derived from audited financial statements.
SOURCE Aviron
 back to top
Related links:
http://www.aviron.com
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
of Aviron, 650-919-6666
|
