MOUNTAIN VIEW, Calif., Nov. 9 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the third quarter and first nine months of fiscal 1998,
ended September 30, 1998.
For the third quarter, the company reported a net loss of $15.0 million
(basic net loss of $0.95 per share) compared to a loss of $6.1 million (basic
net loss per share of $0.43 per share) for the third quarter of 1997. For the
nine months, the company reported a net loss of $38.8 million (basic net loss
of $2.46 per share) compared to a net loss of $16.7 million (basic net loss of
$1.30 per share) for the first nine months 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.
Operating expenses in the 1998 third quarter totaled $15.1 million,
compared to $6.8 million for the third quarter of 1997 and $40.4 million for
the first nine months of 1998, compared to $18.3 million for the first nine
months of 1997. Research and development costs rose to $12.4 million in the
1998 third quarter from $5.1 million in the third quarter of 1997 and totaled
$33.1 million for the first nine months of 1998, as compared to $14.0 million
for the first nine months of 1997. The increases in research and development
costs were due primarily to clinical trial, product development and regulatory
activities. Marketing, general and administrative costs rose to $2.7 million
in the 1998 third quarter from $1.7 million in the 1997 third quarter and
totaled $7.3 million for the first nine months of 1998, as compared to
$4.3 million for the first nine months of 1997. This increase was due to
additional staffing costs and market research principally associated with
FluMist(TM).
Cash, cash equivalents, short-term investments, and long-term investments
totaled $111.9 million at September 30, 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.
The company also said further data on a study of FluMistO in 4561 healthy
working adults is expected to be presented at the International Symposium on
Influenza and Other Respiratory Viruses on Saturday, December 5. The
symposium, being held in Maui, Hawaii, is sponsored by the International
Association for Antiviral Research and the National Institute of Allergy and
Infectious Diseases, a unit of the National Institutes of Health.
Other company events during the third quarter included:
* Aviron received notice from the U.S. Food and Drug Administration that
its Product License Application/ Establishment License Application for
FluMist(TM), originally submitted to the FDA on June 30, was not accepted for
filing due to lack of data on manufacturing, validation and stability. These
developments make it highly unlikely that FluMist(TM) will be available for
the 1999/2000 flu season. Aviron intends to resubmit applications for U.S.
licensure for FluMist(TM) to prevent influenza and its complications in
children and adults.
* At the Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) on September 27, new data was presented from the second year of a
Phase 3 efficacy trial in children. The data showed that FluMist(TM) provided
86 percent protection against A/Sydney, an unexpected variant which was the
predominant strain of flu circulating during last year's flu season, and
87 percent protection against all culture-confirmed influenza. The new data
also indicated that FluMistO provided 94 percent protection against
influenza-related otitis media (ear infections) and 100 percent protection
against influenza-related lower respiratory tract disease (bronchitis,
pneumonia, wheezing).
* Dosing of FluMist(TM) began in a large clinical trial to assess the
impact of community-wide pediatric influenza immunization. The three-year
trial, taking place in Temple, Texas, is expected to enroll up to
15,000 children. It is funded by a $3 million grant from the National
Institute of Allergy and Infectious Diseases of the National Institutes of
Health awarded to the Baylor College of Medicine. The trial will evaluate the
impact of vaccinating preschool and school-age children with FluMistO on the
incidence of doctor visits for flu-related illnesses.
Early in the fourth quarter, The Cooperative Studies program of the
Department of Veterans Affairs Office of Research and Development began a
trial to evaluate the potential additional benefit of co-administration of
FluMistO with the flu shot, compared to the flu shot alone, in high-risk
patients with chronic lung disease. Volunteers in the trial will be aged
50 or older with underlying chronic obstructive pulmonary disease and
emphysema. The one-year study is planned to involve approximately
4000 volunteers at 20 participating VA medical centers nationwide.
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 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 from projections include, but are not limited to,
failure of the FDA to accept the company's PLA/ELA for FluMist(TM), or failure
of the FDA to approve FluMist(TM) 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)
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
1998 1997 1998 1997
Revenues $107 $32 $494 $446
Operating Expenses:
Research and development 12,469 5,119 33,126 14,016
Marketing, general and
administrative 2,673 1,677 7,325 4,298
Total Operating Expenses 15,142 6,796 40,451 18,314
Loss From Operations (15,035) (6,764) (39,957) (17,868)
Other Income/(Expense):
Interest income 1,668 712 4,468 1,289
Interest expense (1,606) (43) (3,267) (141)
Total Other Income, Net 62 669 1,201 1,148
Net Loss $(14,973) $(6,095) $(38,756) $(16,720)
Basic net loss per share $(0.95) $(0.43) $ (2.46) $(1.30)
Shares used in calculation
of basic net loss per share 15,643 14,350 15,739 12,932
AVIRON
CONDENSED BALANCE SHEETS
(In thousands)
ASSETS
September 30, December 31,
1998 1997
(Unaudited) (Note)
ASSETS
Cash and cash equivalents
and short-term investments $100,302 $62,524
Other current assets 1,055 1,030
Total Current Assets 101,357 63,554
Long-term investments 11,584 12,587
Property and equipment, net 17,149 7,582
Debt issuance costs, deposits
and other assets 5,728 1,602
Total Assets $135,818 $85,325
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities 10,280 8,974
Long-term debt 100,000 --
Other Long-Term Liabilities 730 609
Total Liabilities 111,010 9,583
Stockholders' Equity 24,808 75,742
Total Liabilities and
Stockholders' Equity $135,818 $85,325
Note: These amounts have been derived from audited financial statements.
SOURCE Aviron
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http://www.aviron.com
Company News On-Call:
http://www.prnewswire.com/comp/114000.html or fax,
800-758-5804, ext. 114000
CONTACT:
Karen Gilbert of Aviron, 650-919-6578; or
John Bluth or Louise Leavitt of Fleishman-Hillard, 212-453-2000,
for Aviron; or investors, Fred Kurland, 650-919-6666, or Lyn
Christenson, 650-919-3716, both of Aviron
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