Company Establishes Timing for Reply to Complete Response Letter
MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the third quarter and nine months, ended September 30,
2001.
The company reported a net loss of $31.1 million (basic net loss of $1.00
per share) for the third quarter of 2001, compared to a net loss of $18.8
million (basic net loss of $0.87 per share) for the third quarter of 2000.
For the first nine months of 2001, the company reported a net loss of
$89.2 million (basic net loss of $2.97 per share), compared to a net loss of
$78.7 million (basic net loss of $3.95 per share) for the first nine months of
2000. The results for the third quarter and first nine months of 2000 were
restated to reflect the implementation of Staff Accounting Bulletin No. 101,
Revenue Recognition in Financial Statements, as of January 1, 2000.
Revenues in the 2001 third quarter totaled $3.7 million, compared to
$3.6 million for the third quarter of 2000 and $11.7 million for the first
nine months of 2001, compared to $10.2 million for the first nine months of
2000. Revenues during the third quarter and first nine months of 2001 and 2000
were comprised principally of revenue from Wyeth Lederle Vaccines, a business
unit of American Home Products Corporation, related to the clinical
development and commercialization of FluMist(TM), under the terms of our
FluMist(TM) collaboration agreement. FluMist(TM) is Aviron's investigational
intranasal influenza vaccine.
Operating expenses in the 2001 third quarter totaled $36.3 million,
compared to $22.4 million for the 2000 third quarter, and $105.7 million for
the first nine months of 2001, as compared with $74.3 million for the first
nine months of 2000.
Research and development costs increased to $31.5 million in the 2001
third quarter from $19.0 million in the 2000 third quarter and totaled
$91.5 million for the first nine months of 2001, as compared with
$54.0 million in the first nine months of 2000. The increase in research and
development costs for the third quarter and first nine months was due
primarily to increases in development activities, clinical trials and
commercial scale-up expenses associated with FluMist(TM).
General, administrative and marketing costs increased to $4.9 million in
the 2001 third quarter from $3.4 million in the 2000 third quarter, and
$14.2 million for the first nine months of 2001, as compared to $9.3 million
for the first nine months of 2000. The increase was due to growth in
infrastructure and other costs to support preparations for a potential
commercial launch of FluMist(TM).
Cash, cash equivalents, short-term investments and long-term investments
totaled $447.2 million at September 30, 2001, compared to $136.8 million at
December 31, 2000.
Company events during the third quarter and early fourth quarter of 2001
included:
Regulatory Activities
-- On July 27, the U.S. Food and Drug Administration's (FDA) Vaccines and
Related Biological Products Advisory Committee recommended that there were
adequate data to support the efficacy of FluMist(TM) for the prevention of
influenza in healthy children and healthy adults. The committee also
recommended that the data analysis completed to date was not sufficient to
support the safety of the vaccine at that time. The Biologics License
Application (BLA) for FluMist(TM) is currently under review by the FDA.
-- On August 31, we received a complete response letter from the FDA
relating to our FluMist(TM) BLA. In the complete response letter, the FDA
requested additional information and clarification regarding clinical and
manufacturing data from us in support of licensure of the product. We plan to
respond to the FDA letter by providing a complete response to the FDA by
December 31, 2001.
Senior Management
-- During September, Ed Arcuri, Ph.D., was appointed senior vice president
and chief operating officer, Carol Olson was appointed senior vice president
and chief commercial officer, Luc Hermans was named vice president and UK site
director and Michael Cowan was promoted to vice president, compliance.
Business Outlook
We anticipate our operating expenditures will be between $140 and $145
million in 2001. This increase from 2000 operating expenses is due primarily
to an increase in the size of our operations and expenses that we expect to
incur as we build infrastructure in support of potential commercialization of
FluMist(TM) in the U.S. This increase includes amortization expense
associated with our manufacturing activities in the United Kingdom. The
portion of 2001 operating expenses that is depreciation and amortization is
expected to be approximately $17.0 million, compared to $8.1 million for 2000.
Net other income for the fourth quarter of 2001 is expected to be near zero
due primarily to declines in interest rates.
Our goal is to launch FluMist(TM) in 2002 and participate in the 2002-2003
influenza season to the greatest extent possible. We already have begun
manufacturing to support a potential commercial launch in 2002.
The outcome and timing of the regulatory process will strongly influence
product revenues during our first commercial season, therefore we have not
made revenue projections for 2002, nor do we expect to generate sufficient
revenue to Aviron from FluMist(TM) sales to achieve profitability in 2002.
Any and all revenues will depend upon the outcome and timing of the regulatory
process, the labeled indications, the scope of any expanded recommendations
for influenza vaccination by important medical organizations, the number of
doses manufactured, the number of doses released and sold and the price of
FluMist(TM).
We expect capital expenditures to increase substantially as we commence
building additional manufacturing facilities and commercialization systems.
During 2001, we forecast that capital expenditures will be between $20 and
$30 million.
In conjunction with this press release, Aviron will host a conference call
that will be broadcast live over the Internet. The conference call will take
place on Friday, October 26, beginning at 8:30 a.m. EDT. To access the
webcast, visit the Aviron Web site at http://www.aviron.com and log-on to the
audio feed as instructed. The call will be archived starting at 11:00 a.m. EDT
on Friday, October 26 until 5:00 p.m. EDT on Tuesday, October 30 at
http://www.aviron.com . The information provided on the conference call and on
the webcast is only accurate at the time of the call, and Aviron will take no
responsibility for providing updated information.
Aviron is a biopharmaceutical company based in Mountain View, California,
focused on the prevention of disease through innovative vaccine technology.
The business outlook and other sections of this press release contain
forward-looking statements. These statements, which reflect management's
current beliefs and expectations, are subject to risks and uncertainties that
may cause actual results to differ materially from those projected in the
forward-looking statements. Factors that could cause actual results to differ
include, but are not limited to, the risk that the FDA will determine that the
Company needs to conduct additional clinical trials and/or provide additional
data in order to obtain licensure, determine that the Company's manufacturing
facilities are not adequate or otherwise determine that the Company's license
application for FluMist(TM) is incomplete or inadequate to approve the product
for marketing to one or more target populations, and other business risks
identified in the business outlook section of this press release and in the
Company's Annual Report on Form 10-K, as amended, for the fiscal year ended
December 31, 2000 and subsequent reports on Form 10-Q.
Additional information about the company, including recent press releases,
can be located at http://www.aviron.com .
(Tables follow)
AVIRON
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
Three Months Nine Months
Ended September 30, Ended September 30,
2001 2000 2001 2000
Revenues:
Contract revenues
and grants $3,736 $3,619 $11,665 $10,154
Operating Expenses:
Research and development 31,452 18,966 91,470 54,036
Acquisition of in process
research and development -- -- -- 10,904
General, administrative and
marketing 4,895 3,387 14,227 9,324
Total Operating
Expenses 36,347 22,353 105,697 74,264
Loss From Operations (32,611) (18,734) (94,032) (64,110)
Other Income/(Expense), net 1,511 (52) 4,863 (1,826)
Net Loss, before cumulative
effect of change in
accounting principle (31,100) (18,786) (89,169) (65,936)
Cumulative effect of
change in accounting
principle -- -- -- (12,750)
Net Loss $(31,100) $(18,786) $(89,169) $(78,686)
Basic and diluted net
loss per share:
Net Loss, before
cumulative effect of
change in accounting
principle $(1.00) $(0.87) $(2.97) $(3.31)
Cumulative effect of change
in accounting principle -- -- -- (0.64)
Net Loss $(1.00) $(0.87) $(2.97) $(3.95)
Shares used in calculation
of basic net loss
per share 31,050 21,625 30,054 19,920
AVIRON
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
September 30, December 31,
2001 2000
(Unaudited) (Note)
ASSETS
Cash and cash equivalents
and short-term investments $409,333 $132,313
Accounts receivable 5,115 23,288
Inventory 5,971 4,264
Other current assets 5,277 2,691
Total Current Assets 425,696 162,556
Long-term investments 37,843 4,506
Property and equipment, net 38,205 27,707
Intangible assets, net 43,284 48,046
Debt issuance costs, deposits and other
assets 10,561 5,924
Total Assets $555,589 $248,739
LIABILITIES and STOCKHOLDERS' EQUITY
Current liabilities $32,252 $26,361
Long-term obligations, less current
portion 227,681 89,947
Other long-term liabilities 9,331 11,845
Total Liabilities 269,264 128,153
Stockholders' Equity 286,325 120,586
Total Liabilities and
Stockholders' Equity $555,589 $248,739
Note: These amounts have been derived from the audited consolidated
financial statements.
SOURCE Aviron
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Related links:
http://www.aviron.com
Company News On-Call:
http://www.prnewswire.com/comp/114000.html
CONTACT:
media, John Bluth of Aviron, +1-650-919-3716;
or Ben Butkus of Fleishman-Hillard, +1-212-453-2000, for Aviron;
or investors, John Bluth, +1-650-919-3716, or Fred Kurland,
+1-650-919-6666, both of Aviron
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