SAN DIEGO, Oct. 28 /PRNewswire/ -- Spiros Development Corporation II, Inc.
(Spiros Corp. II) (Nasdaq: SDCOZ) today reported a net loss of $13.9 million,
or $2.20 per share, for the third quarter of 1999 compared to a net loss of
$11.7 million, or $1.86 per share, for the third quarter of 1998. For the
first nine months of 1999, the net loss totaled $38.1 million, or $6.02 per
share, compared to $32.3 million, or $5.10 per share, for the same period in
1998. Spiros Corp. II is developing selected respiratory drugs for delivery
in Spiros(R), a proprietary new pulmonary drug delivery system.
"In October, Spiros Corp. II and Dura Pharmaceuticals, Inc. (Dura)
(Nasdaq: DURA) announced the initiation of the Beclomethasone Spiros(TM) and
Budesonide Spiros(TM) clinical programs," stated David S. Kabakoff, Ph.D.,
Chairman, President and Chief Executive Officer of Spiros Corp. II. "With
respect to Albuterol Spiros(TM), we continue to address chemistry,
manufacturing and control issues for the product with the goal of initiating
clinical studies by year-end 1999. The Spiros clinical programs and
regulatory reviews, if successful, should allow for three product launches in
the 2001-2002 time frame, if each product is approved by the U.S. Food and
Drug Administration (FDA)."
The Spiros line of respiratory products is being developed by Dura, on
behalf of Spiros Corp. II, as a novel means of delivering medication to the
lung. The Spiros delivery system is comprised of two components, an inhaler
that aerosolizes powdered drug and a powder storage cassette that stores
pre-measured doses of drug. The Spiros 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. The Spiros system is designed to
address the limitations of other inhalation delivery systems currently on the
market, such as metered dose inhalers and other dry powder inhalers. The
Spiros system is designed to deliver a consistent drug dose to the lung over a
wide range of inspiratory flow rates, to minimize need for patient
coordination, and is free of chlorofluorocarbon (CFC) propellants.
Spiros Development Corporation II, Inc. is a public company formed
primarily for the continued development of Spiros, a proprietary pulmonary
drug delivery system, for selected respiratory medications.
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 proprietary 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 initiation and
successful completion of the clinical trial programs for the Spiros products,
the ability to obtain adequate funding to complete the clinical trial programs
for the Spiros products, the timely FDA approval of the Spiros products, if at
all, our dependence on third parties for marketing, manufacturing and
development, the competitiveness of the pharmaceutical industry, 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.
STATEMENT OF OPERATIONS DATA
In Thousands, Except Per Share Data
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
1999 1998 1999 1998
REVENUES:
Interest Income $1,258 $1,995 $4,255 $6,434
EXPENSES:
Research and
Development 14,891 13,443 41,499 37,788
General and
Administrative 293 239 849 781
Total Expenses 15,184 13,682 42,348 38,569
OPERATING LOSS BEFORE
INCOME TAXES (13,926) (11,687) (38,093) (32,135)
PROVISION FOR
INCOME TAXES 60 146
NET LOSS $(13,926) $(11,747) $(38,093) $(32,281)
NET LOSS PER BASIC
AND DILUTED SHARE $(2.20) $(1.86) $(6.02) $(5.10)
WEIGHTED AVERAGE NUMBER
OF COMMON SHARES --
BASIC AND DILUTED 6,325 6,325 6,325 6,325
BALANCE SHEET DATA
(unaudited)
September 30, December 31,
1999 1998
CASH AND SHORT-TERM INVESTMENTS $87,738 $123,604
OTHER CURRENT ASSETS 119 192
TOTAL ASSETS $87,857 $123,796
CURRENT LIABILITIES $6,728 $4,878
SHAREHOLDERS' EQUITY 81,129 118,918
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY $87,857 $123,796
SOURCE Spiros Development Corporation II, Inc.
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http://www.durapharm.com
Company News On-Call:
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.,
858-457-2553
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