SAN DIEGO, July 29 /PRNewswire/ -- Spiros Development Corporation II, Inc.
(Spiros Corp. II) (Nasdaq: SDCOZ) today reported a net loss of $12.2 million,
or $1.92 per share, for the second quarter of 1999 compared to a net loss of
$11.6 million, or $1.83 per share, for the second quarter of 1998. For the
first six months of 1999, the net loss totaled $24.2 million, or $3.82 per
share, compared to $20.5 million, or $3.25 per share, for the same period in
1998. Spiros Corp. II develops respiratory drugs for delivery in Spiros(R), a
proprietary new pulmonary drug delivery technology. The Company also
announced development advancements made by Dura Pharmaceuticals, Inc. (Dura)
(Nasdaq: DURA) on Spiros Corp. II's behalf for the Spiros(R) respiratory
products in preparation for Spiros(R) clinical programs.
"During the second quarter, we continued to advance development of the
Spiros(R) respiratory products in preparation for the initiation of clinical
trials," stated David S. Kabakoff, Ph.D., Chairman, President and Chief
Executive Officer of Spiros Corp. II. "We have placed priority on
Beclomethasone and Budesonide Spiros(TM), two inhaled steroid products, and
plan to begin clinical studies in each product in the fourth quarter. With
respect to Albuterol Spiros(TM), work is also ongoing as we continue to
address chemistry, manufacturing and control issues for the product. Our goal
remains to initiate Albuterol Spiros(TM) clinical studies before year-end as
well. All three products are expected to be commercially launched in the U.S.
in the 2001-2002 time frame, if clinical programs and regulatory reviews are
successful and if each product is approved by the U.S. Food and Drug
Administration (FDA)."
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. The Spiros(R) delivery system
is a novel means of delivering medication to the lungs and 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, if approved by the FDA, 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 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
perform properly.
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.
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.
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 and successful
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, the
Company's dependence on Dura, and other risks detailed from time to time in
the Company's filings with the Securities and Exchange Commission. Actual
results may differ materially from those projected. Any forward-looking
statements represent the Company's judgment as of the date of this release.
The Company disclaims, however, any intent or obligation to update these
forward-looking statements.
STATEMENT OF OPERATIONS DATA
In Thousands, Except Per Share Data
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
1999 1998 1999 1998
REVENUES:
Interest Income $1,410 $2,106 $2,997 $4,439
EXPENSES:
Research and
Development 13,292 13,360 26,608 24,345
General and
Administrative 279 278 556 542
Total Expenses 13,571 13,638 27,164 24,887
OPERATING LOSS
BEFORE INCOME
TAXES (12,161) (11,532) (24,167) (20,448)
PROVISION FOR
INCOME TAXES -- 60 -- 86
NET LOSS $(12,161) $(11,592) $(24,167) $(20,534)
NET LOSS PER BASIC
AND DILUTED SHARE $(1.92) $(1.83) $(3.82) $(3.25)
WEIGHTED AVERAGE
NUMBER OF COMMON
SHARES -- BASIC
AND DILUTED 6,325 6,325 6,325 6,325
BALANCE SHEET DATA
(unaudited)
June 30, 1999 December 31, 1998
Cash and Short-term Investments $99,956 $123,604
Other Current Assets 144 192
TOTAL ASSETS $100,100 $123,796
Current Liabilities $5,143 $4,878
Shareholders' Equity 94,957 118,918
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY $100,100 $123,796
SOURCE Spiros Development Corporation II, Inc.
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http://www.prnewswire.com/comp/197051.html or fax,
800-758-5804, ext. 197051
CONTACT:
Erle T. Mast, Vice President and Chief
Financial Officer of Spiros Development Corporation II, Inc.,
619-457-2553
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