SAN DIEGO, April 26 /PRNewswire/ -- Spiros Development Corporation II,
Inc. (Spiros Corp. II) (Nasdaq: SDCOZ) today reported a net loss of
$12.0 million, or $1.90 per share, for the first quarter of 1999 compared to a
net loss of $8.9 million, or $1.41 per share, for the first quarter of 1998.
Spiros Corp. II is a developer of respiratory drugs for delivery in Spiros(R),
a proprietary new pulmonary drug delivery technology. The Company ended the
first quarter of 1999 with cash and short-term investments of $112.1 million.
"In consultation with the U.S. Food and Drug Administration (FDA), we have
determined the remaining requirements for the Albuterol Spiros(TM) clinical
trial program and defined the major outstanding chemistry, manufacturing and
control (CMC) issues to support the resubmission of the new drug application
(NDA) with the FDA," stated David S. Kabakoff, Ph.D., Chairman, President and
Chief Executive Officer of Spiros Corp. II. "As previously reported, the
Company plans to develop Beclomethasone Spiros(TM) on nearly a parallel track
with Albuterol Spiros. Our goal remains to resume clinical trials for
Beclomethasone Spiros and Albuterol Spiros and to initiate clinical trials for
Budesonide Spiros(TM) in the fourth quarter of 1999."
The Spiros(R) line of respiratory products, including Albuterol
Spiros(TM), Beclomethasone Spiros(TM) and Budesonide Spiros(TM), is being
developed by Dura on behalf of Spiros Corp. II as a novel means of delivering
medication to the lungs. The Spiros(R) delivery system is comprised of two
components, an inhaler that aerosolizes powdered drug, and a powder storage
system, such as a cassette, that stores pre-measured doses of drug. The
Spiros(R) products, pending approval, are expected to compete in the U.S.
market for inhaled asthma medications, which totaled approximately $2 billion
in 1998. Metered dose inhalers (MDIs) currently represent the most common
method of respiratory drug delivery to the lungs. Most MDIs contain
chlorofluorocarbon (CFC) propellants, which deplete the ozone layer and are
subject to worldwide regulations aimed at eliminating their use. MDIs also
generally require press-and-breathe coordination that many patients are unable
to properly perform.
Dura Pharmaceuticals, Inc. is a San Diego based developer and marketer of
prescription pharmaceutical products for the treatment of allergies, asthma,
pneumonia and related respiratory conditions. Dura has focused on the U.S.
respiratory market because of its size and growth opportunities through two
major strategies: (1) acquiring prescription pharmaceuticals and/or businesses
developing or marketing such pharmaceuticals to support its marketing presence
in high-prescribing respiratory physicians' offices and/or the hospital
market, and (2) developing Spiros(R), a pulmonary drug delivery system for
both topical and systemic delivery of medications.
Spiros Development Corporation II, Inc. is a public company formed
primarily to fund the continued development of Spiros(R), a proprietary
pulmonary drug delivery system of Dura Pharmaceuticals, Inc., and to conduct
formulation work, clinical trials and commercialization for defined
respiratory drugs in the Spiros(R) inhalation system.
Except for the historical and factual information contained herein, the
matters discussed in this press release may contain forward-looking statements
which involve risks and uncertainties, including the timely development and
FDA approval of Spiros(R), if at all, the need for significant additional
development of Spiros(R) which is costly and time consuming, lack of
sufficient funds to complete the development of Spiros(R) products, our
dependence on Dura, and other risks detailed from time to time in Spiros Corp.
II's filings with the Securities and Exchange Commission. Actual results may
differ materially from those projected. Any forward-looking statements
represent Spiros Corp. II's judgment as of the date of this release. Spiros
Corp. II disclaims, however, any intent or obligation to update these forward-
looking statements.
In Thousands, Except Per Share Data
STATEMENT OF OPERATIONS DATA (unaudited)
Three Months Ended Three Months Ended
March 31, 1998 March 31, 1999
REVENUE:
Interest Income $2,333 $1,587
OPERATING COSTS AND EXPENSES:
Research and Development 10,985 13,316
General and Administrative 264 277
Total Operating Costs and Expenses 11,249 13,593
OPERATING LOSS BEFORE INCOME TAXES (8,916) (12,006)
PROVISION FOR INCOME TAXES 26 --
NET LOSS $(8,942) $(12,006)
NET LOSS PER BASIC AND DILUTED SHARE $(1.41) $(1.90)
WEIGHTED AVERAGE NUMBER OF COMMON
AND COMMON EQUIVALENT SHARES 6,325 6,325
BALANCE SHEET DATA
(unaudited)
December 31, 1998 March 31, 1999
CASH AND SHORT-TERM INVESTMENTS $123,604 $112,117
OTHER CURRENT ASSETS 192 168
TOTAL ASSETS $123,796 $112,285
CURRENT LIABILITIES $4,878 $5,193
SHAREHOLDERS' EQUITY 118,918 107,092
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY $123,796 $112,285
SOURCE Spiros Development Corporation II, Inc.
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CONTACT: Erle Mast, Chief Financial Officer of Spiros Development Corporation II, Inc., 619-457-2553
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