MOUNTAIN VIEW, Calif., July 26 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced results for the second quarter and first half of fiscal 2000, ended
June 30, 2000.
For the second quarter of 2000, the company reported a net loss of
$18.9 million (basic net loss of $0.90 per share) compared to a loss of
$15.1 million (basic net loss of $0.96 per share) for the second quarter of
1999. For the first half of 2000, the company reported a net loss of
$48.7 million (basic net loss of $2.55 per share) compared to a net loss of
$16.6 million (basic net loss of $1.06 per share) for the first half of 1999.
Revenues in the 2000 second quarter totaled $2.4 million, compared to
$2.9 million for the 1999 second quarter and $5.0 million for the first half
of 2000, compared to $18.5 million for the first half of 1999. Revenues
during the 2000 second quarter and first half were comprised principally of
payments from Wyeth Lederle Vaccines (Wyeth), a business unit of American Home
Products Corporation (AHP), related to the clinical development of
FluMist(TM), under the terms of our FluMist(TM) collaboration agreement.
Revenues during the 1999 second quarter also were comprised primarily of
payments from Wyeth related to the clinical development of FluMist(TM). First
half 1999 revenues included a non-refundable initial payment of $15.0 million
from Wyeth, combined with other revenues from contract and research grants.
Aviron and Wyeth are collaborating on the development and marketing of
FluMist(TM), Aviron's investigational intranasal influenza vaccine.
Operating expenses in the 2000 second quarter totaled $20.8 million,
compared to $17.5 million for the 1999 second quarter and $51.9 million for
the first half of 2000, as compared with $34.2 million for the first half of
1999. Research and development costs rose to $17.5 million in the 2000 second
quarter from $14.4 million in the 1999 second quarter and totaled
$35.1 million for the first half of 2000, as compared with $28.4 million in
the first half of 1999. The increase in research and development costs for
the second quarter and first half was due primarily to increases in
development activities, documentation, validation and other commercial
scale-up expenses associated with FluMist(TM). These increases were partially
offset by reductions in spending on clinical trials.
In addition, we recognized a one-time, non-cash charge for the acquisition
of in-process research and development in the amount of $10.9 million in the
first quarter of 2000 due to the amendment of our agreement with the
University of Michigan to accelerate the issuance of a warrant to the
university. General, administrative and marketing costs rose to $3.4 million
in the 2000 second quarter from $3.2 million in the 1999 second quarter, and
$5.9 million for the first half of 2000, as compared to $5.8 million for the
first half of 1999. The increase was due to an increase in infrastructure and
support activities.
Cash, cash equivalents, short-term investments and long-term investments
totaled $113.6 million at June 30, 2000, compared to $52.3 million at
December 31, 1999. Cash needs to meet operating and capital expenditures
during the first half of 2000 were offset by the receipt of net proceeds of
$98.7 million from financing transactions which generated $18.0 million in the
first quarter and $80.7 million in the second quarter. Details of the second
quarter transactions are discussed below.
In December 1999, the Securities and Exchange Commission (SEC) issued
Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements
(SAB 101), which includes the SEC staff's view on accounting for
non-refundable up-front fees received in connection with collaboration
agreements. We have determined that a change in accounting policy is
necessary for the $15.0 million up-front license fee received from Wyeth,
recognized as revenue in the first quarter of 1999. Based on recent guidance
from the SEC staff on the implementation of SAB 101, we expect to make this
change in our accounting policy in the fourth quarter of 2000, which will
result in a charge to operations for the cumulative effect of the change as of
January 1, 2000. This amount will be recorded as deferred revenue and
recognized as revenue in future periods. Prior financial statements will not
be restated.
Company events during the second quarter and early third quarter included
several financings, personnel announcements and clinical developments.
Financing transactions
-- On April 10, we sold 2,200,000 shares of our common stock in a public
offering at a price of $22.50 per share. Concurrent with this public
offering, AHP purchased 686,160 shares of our common stock at
$21.38 per share, the price equal to the net proceeds per share to the
company in the public offering. Aggregate net proceeds to the company
from both the public offering and the AHP transaction, after expenses
and underwriters' discounts and commissions, were approximately
$60.7 million.
-- On June 12, we announced that Acqua Wellington Asset Management LLC
(Acqua Wellington) had increased its equity financing commitment from
$48 million to $84 million through February 2001. These funds are
available, at Aviron's discretion, at a small discount to the market
price of our common stock.
-- In four separate equity financings from April 13 through July 11, we
sold 1,103,136 shares of our common stock to Acqua Wellington at an
average price of $25.38 per share for aggregate proceeds of
$28.0 million ($20.0 million in the second quarter and $8.0 million in
July).
Personnel
-- On April 14, we announced the appointment of Charlene A. Friedman to
the position of vice president and general counsel.
-- On May 11, we announced the promotion of Edward J. Arcuri, Ph.D. to
senior vice president, operations.
-- On May 11, we announced the election of Alan C. Mendelson, senior
partner at the law firm of Latham & Watkins, to our board of directors.
Mr. Mendelson had served as Aviron's corporate secretary since 1992.
Charlene Friedman was appointed the new corporate secretary.
Clinical
-- On June 23, we announced an extension of our cooperative research and
development agreement for the development of FluMist(TM) with the
National Institute of Allergy and Infectious Diseases of the National
Institutes of Health through June 2003.
-- On June 30, we announced the initiation of clinical testing with our
vaccine candidates to prevent infection with cytomegalovirus (CMV), the
leading infectious cause of birth defects in the United States.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on the prevention of disease through innovative vaccine technology.
Actual results may differ materially from forward-looking statements
contained in this release. Factors that could cause actual results to differ
include, but are not limited to, failure to validate the manufacturing
processes, facilities or equipment for the company's vaccines, and the
assessment by regulatory agencies that the company's future license
applications for its vaccines are incomplete or inadequate to approve the
products for marketing to one or more target populations. Additional
information concerning factors that could cause such a difference is contained
in Aviron's SEC filings, including its Annual Report on Form 10-K for the year
ended December 31, 1999.
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 CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
Three Months Six Months
Ended Ended
June 30, June 30,
2000 1999 2000 1999
Revenues:
Contract revenues and
grants $2,378 $2,944 $5,035 $18,475
Operating Expenses:
Research and development 17,476 14,362 35,070 28,367
Acquisition of in process
research and development -- -- 10,904 --
General, administrative
and marketing 3,369 3,151 5,937 5,833
Total Operating Expenses 20,845 17,513 51,911 34,200
Loss From Operations (18,467) (14,569) (46,876) (15,725)
Other Income/(Expense):
Interest income 1,648 1,062 2,370 2,273
Interest expense (2,056) (1,613) (4,145) (3,187)
Total Other
Income/(Expense), Net (408) (551) (1,775) (914)
Net Loss $(18,875) $(15,120) $(48,651) $(16,639)
Basic net loss per share $(0.90) $(0.96) $(2.55) $(1.06)
Shares used in calculation of
basic net loss per share 21,039 15,749 19,067 15,726
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
ASSETS
June 30, December 31,
2000 1999
(Unaudited) (Note)
ASSETS
Cash and cash equivalents
and short-term investments $113,567 $52,316
Accounts receivable 3,768 3,241
Inventory 2,082 2,082
Other current assets 1,179 1,009
Total Current Assets 120,596 58,648
Property and equipment, net 24,800 25,635
Debt issuance costs, deposits
and other Assets 6,762 7,411
Total Assets $152,158 $91,694
LIABILITIES and STOCKHOLDERS' EQUITY
Current Liabilities 14,054 16,433
Long-term debt 111,191 112,657
Other Long-Term Liabilities 1,888 2,223
Total Liabilities 127,133 131,313
Stockholders' Equity 25,025 (39,619)
Total Liabilities and
Stockholders' Equity $152,158 $91,694
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:
press, John Bluth of Aviron, 650-919-3716; or
Claudette Hibbert of Fleishman-Hillard, 212-453-2000, for Aviron;
or investors, John Bluth, 650-919-3716, or Fred Kurland,
650-919-6666, both of Aviron
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