MOUNTAIN VIEW, Calif., Aug. 11 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the second quarter and first half of fiscal 1998, ended
June 30, 1998.
For the second quarter, the company reported a net loss of $13.1 million
(basic net loss of $0.84 per share) compared to a loss of $5.6 million (basic
net loss per share of $0.43 per share) for the second quarter of 1997. For the
first half, the company reported a net loss of $23.8 million (basic net loss
of $1.51 per share) compared to a net loss of $10.6 million (basic net loss of
$0.87) for the first half 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 intranasal influenza virus vaccine.
Operating expenses in the 1998 second quarter totaled $13.5 million,
compared to $6.1 million for the second quarter of 1997 and $25.3 million for
the first half of 1998, compared to $11.5 million for the first half of
1997. Research and development costs rose to $10.9 million in the 1998 quarter
from $4.6 million in the second quarter of 1997 and totaled $20.7 million for
the first half of 1998, as compared to $8.9 million for the first half of
1997. The increases in research and development costs were due primarily to
clinical trials, increases in product development and regulatory activities.
Marketing, general and administrative costs rose to $2.6 million in the
1998 second quarter from $1.5 million in the 1997 second quarter and totaled
$4.7 million for the first half of 1998, as compared to $2.6 million for the
first half of 1997. This increase was due to additional staffing and market
research principally associated with FluMist(TM).
Cash, cash equivalents, short-term investments, and long-term investments
totaled $124.8 million at June 30, 1998, compared to $75.1 million at
December 31, 1997. The increase was due to the completion, on March 30, 1998,
of a $100 million convertible debt offering. The company used $13.3 million of
the proceeds of the debt offering for the repurchase of 530,831 shares of its
common stock from Sang-A Pharm. Co. Ltd., a subsidiary of the Hanbo Group, a
Korean pharmaceutical company currently under court-ordered reorganization. In
addition, the company used $23.9 million for operating purposes and
$9.4 million for capital expenditures during the first half of 1998.
During the second quarter, Aviron announced the signing of an agreement
with CSL Limited, Australia, a recognized leader in influenza vaccines, to
develop, sell and distribute FluMist(TM) in Australia, New Zealand and certain
countries in the south Pacific region. Under the agreement, CSL and Aviron
will jointly carry out additional trials in Australia for Aviron's
cold-adapted FluMist(TM) intranasal influenza vaccine.
On June 30, Aviron submitted its first Product License
Application/Establishment License Application to the U.S. Food and Drug
Administration for FluMist(TM). Aviron is seeking U.S. licensure for
FluMist(TM) to prevent influenza and its complications in children and adults.
In addition, the company is seeking licensure for FluMist(TM), when
coadministered with inactivated vaccine (flu shots), in high risk adults such
as the elderly.
In July, Aviron and its manufacturing partner, Packaging Coordinators,
Inc. (PCI), a subsidiary of Cardinal Health, opened a 34,000-square-foot
manufacturing suite in Philadelphia at PCI's site. Upon receipt of regulatory
approval, the PCI facility will be used for blending, filling, packaging,
labeling and final shipment of FluMist(TM).
In early August, the company announced a preliminary analysis of the
second year of a two-year study of 1358 children during the 1997-98 flu season
with FluMist(TM). The preliminary analysis indicated that FluMist provided
protection against culture-confirmed influenza, even though the predominant
strain of influenza circulating during last year's flu season, A/Sydney, was
not included in last year's flu vaccines, including the preparation of
FluMist(TM) used in the clinical trial.
This past flu season, children involved in a pivotal Phase 3 trial in the
1996-97 flu season were invited to participate in a follow-up trial. Children
were vaccinated with a single dose of FluMist(TM) formulated to match the
1997-98 flu shot or placebo. Investigators were evaluating study participants
to test the safety and efficacy of vaccination in subsequent flu seasons.
Final data are currently being analyzed and investigators expect to present
the results at the Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC), September 24-27, in San Diego.
Results from the year-one study (1996-97 flu season) showed only one
percent (14 of 1070) of the children who received FluMist(TM) developed
culture-confirmed influenza, versus 18 percent (95 of 532) of the children who
received placebo -- a protection rate of 93 percent. The trial was conducted
under a Collaborative Research and Development Agreement (CRADA) between
Aviron and the National Institute of Allergy and Infectious Diseases (NIAID)
of the National Institutes of Health. It involved ten sites nationwide,
including six Vaccine and Treatment Evaluation Units (VTEUs) supported by
NIAID and four sites supported by Aviron.
Also in August, the company announced receipt of a $750,000 Phase II Small
Business Innovation Research (SBIR) grant to support development of its live,
attenuated vaccine for the prevention of disease caused by human
cytomegalovirus (CMV) from the NIAID. This is the second grant Aviron has
received for CMV. The award will be used to produce recombinant CMV vaccine
candidates for human testing and to determine their safety and immunogenicity
in a Phase l clinical trial in collaboration with the NIAID.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is to develop vaccines 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. FluMist(TM) is currently under review
by the U.S. Food and Drug Administration. Products in clinical development
include parainfluenza (PIV-3) and, in collaboration with SmithKline Beecham
Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a
major cause of infectious mononucleosis. Products in pre-clinical development
include vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV)
and genital herpes (HSV-2).
This press release contains forward-looking statements. Actual results may
differ materially from those suggested here. 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
Statement of Operations
(unaudited; in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
1998 1997 1998 1997
Revenue $134 $109 $387 $414
Operating expenses
Research and
development 10,874 4,606 20,657 8,897
Marketing, general
and administrative 2,591 1,461 4,652 2,621
Total operating
expenses 13,465 6,067 25,309 11,518
Loss from operations (13,331) (5,958) (24,922) (11,104)
Other income
/ (expense)
Interest income 1,847 355 2,800 577
Interest expense (1,618) (45) (1,661) (98)
229 310 1,139 479
Net loss $(13,102) $(5,648) $(23,783) $(10,625)
Basic net loss
per share $(0.84) $(0.43) $(1.51) $(0.87)
Weighted average
shares of
common stock
outstanding 15,571 13,059 15,787 12,224
Aviron
Condensed Balance Sheets
(in thousands)
June 30, 1998 Dec. 31, 1997
(unaudited) (Note)
ASSETS
Cash, cash equivalents
and short-term
investments $108,238 $62,524
Other current assets 1,144 1,030
Total Current Assets 109,382 63,554
Long-term investments 16,593 12,587
Property and equipment, net 15,942 7,582
Other assets 5,325 1,602
Total Assets $147,242 $85,325
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $7,035 $8,974
Long-term debt 100,000 --
Other long-term
liabilities 684 609
Total Liabilities 107,719 9,583
Stockholders' Equity 39,523 75,742
Total Liabilities
and Stockholders'
Equity $ 147,242 $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 or
fax, 800-758-5804, ext. 114000
CONTACT:
media, Karen Gilbert of Aviron, 650-919-6578;
or John Bluth of Fleishman-Hillard, 212-453-2000, for Aviron; or
investors, Lyn Christenson of Aviron, 650-919-3716
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