SAN DIEGO, July 15 /PRNewswire/ -- Dura Pharmaceuticals, Inc. (Dura)
(Nasdaq: DURA) today reported total revenues of $68.0 million for the second
quarter and $139.3 million for the first six months of 1999, increases of
31% and 38% over the second quarter and first six months of 1998,
respectively. Net income totaled $7.6 million, or $0.17 per diluted share for
the second quarter and $15.3 million, or $0.34 per diluted share for the first
six months of 1999, compared to net income of $8.2 million, or $0.17 per
diluted share in the second quarter and $15.3 million, or $0.32 per diluted
share for the first six months of 1998. Operating income was $11.6 million
for the second quarter and $23.5 million for the first six months of 1999,
increases of 15% and 26% over the respective periods last year.
Pharmaceutical sales totaled $51.3 million for the second quarter and
$106.4 million for the first six months of 1999, representing increases of
47% and 50% over the respective periods last year. The increase in
pharmaceutical sales was principally attributed to the impact of the addition
of Maxipime(R) (cefepime) for Injection and Azactam(R) (aztreonam) for
Injection to Dura's product portfolio at the beginning of this year and to the
continued growth in prescription demand for the Company's key respiratory
brands, Ceclor(R) CD (cefaclor extended release tablets) and Nasarel(R)
(flunisolide) Nasal Solution 0.025% during the quarter. Contract revenue for
the second quarter of 1999, generated primarily from development activity of
Spiros(R) products on behalf of both Spiros Development Corporation II, Inc.
(Nasdaq: SDCOZ) and Eli Lilly and Company (NYSE: LLY), totaled $16.7 million
for the second quarter and $32.9 million for the first six months of 1999,
compared to $17.0 million in the second quarter and $29.9 million in the first
six months of 1998.
"We are pleased overall with the quarter's results as they demonstrate
that we are making steady progress toward our sales and earnings goals for the
year," said Cam L. Garner, Dura's Chairman and CEO. "In terms of our key
promoted prescription products, Nasarel(R) sales are running modestly ahead of
our plan on an annualized basis, as the prescription volume and revenues for
the product have performed very well during this spring allergy season.
Ceclor(R) CD market share is lower than we would like and we are currently
tracking slightly behind our annual sales target for the brand. We are
enthusiastic about the potential of our hospital products, Maxipime(R) and
Azactam(R), which are currently marketed through our co-promotion agreement
with Bristol-Myers Squibb Company (NYSE: BMY), and we are on track to achieve
our goal of $65 million in combined sales this year. In aggregate, our
year-to-date performance is in line to meet our expectations for the full
year."
"Also during the second quarter, we advanced development of our Spiros(R)
respiratory products in preparation for their clinical programs," noted Mr.
Garner. "We've prioritized the effort on our inhaled steroid products,
Beclomethasone and Budesonide Spiros(TM), and expect to commence clinical
trials for each in the fourth quarter. Work with respect to Albuterol
Spiros(TM) is also ongoing, as we continue to address chemistry, manufacturing
and control (CMC) issues for the product. Our goal remains to initiate
Albuterol Spiros(TM) clinical studies before year-end. The 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. Additionally, our collaboration with Eli Lilly and
Company to develop inhaled insulin in our Spiros system continues to progress
steadily. We are committed to the Spiros(R) platform, as we see the
opportunity to significantly benefit patients with asthma, COPD and other
conditions such as diabetes."
Mr. Garner continued, "Our management team remains intently focused on
achieving our key goals for the balance of 1999, which include: continued
growth of both our primary care and acute care pharmaceutical product lines;
commencement of clinical trials for three Spiros(R) respiratory products,
beclomethasone, budesonide and albuterol; continued progress in the
development of inhaled insulin; and the completion of a significant product
and/or company acquisition that fits our primary care or hospital marketing
channels. Our financial position is strong, with over $270 million in cash
available to support the execution of our acquisition strategy."
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 development and
FDA approval of Spiros(R), if at all, the competitiveness of the
pharmaceutical industry, dependence on third parties for manufacturing and
development, the timely establishment of a hospital sales force and marketing
capability, and other risks detailed from time to time in Dura's filings with
the Securities and Exchange Commission. Actual results may differ materially
from those projected. Any forward-looking statements represent Dura's
judgment as of the date of this release. Dura disclaims, however, any intent
or obligation to update these forward-looking statements.
CONSOLIDATED STATEMENTS 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:
Sales $51,321 $34,912 $106,402 $70,798
Contract 16,685 17,026 32,850 29,906
Total Revenues 68,006 51,938 139,252 100,704
OPERATING COSTS
AND EXPENSES:
Cost of Sales 10,379 7,457 20,870 15,550
Clinical, Development
and Regulatory 12,474 11,488 23,965 21,077
Selling, General
and Administrative 33,587 22,946 70,877 45,461
Total Operating Costs
and Expenses 56,440 41,891 115,712 82,088
OPERATING INCOME 11,566 10,047 23,540 18,616
OTHER INCOME
(EXPENSE) - net (78) 2,349 (67) 4,638
INCOME BEFORE
INCOME TAXES 11,488 12,396 23,473 23,254
PROVISION FOR
INCOME TAXES 3,905 4,219 8,125 7,913
NET INCOME $7,583 $8,177 $15,348 $15,341
NET INCOME
PER SHARE - diluted $0.17 $0.17 $0.34 $0.32
WEIGHTED AVERAGE
NUMBER OF COMMON AND
COMMON EQUIVALENT
SHARES - diluted 45,085 48,073 45,328 48,321
CONSOLIDATED BALANCE SHEET DATA (unaudited)
June 30, December 31,
1999 1998
CASH AND SHORT-TERM INVESTMENTS $270,278 $269,412
OTHER CURRENT ASSETS 47,048 33,633
LICENSE AGREEMENTS, PRODUCT RIGHTS,
AND OTHER 542,871 522,414
TOTAL ASSETS $860,197 $825,459
CURRENT LIABILITIES $82,514 $62,248
LONG-TERM LIABILITIES 351,712 352,839
SHAREHOLDERS' EQUITY 425,971 410,372
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY $860,197 $825,459
News releases from Dura Pharmaceuticals are available at no charge on
Dura's website at http://www.durapharm.com and through PR Newswire's On-Call fax
service by calling 800-758-5804, extension 197051.
SOURCE Dura Pharmaceuticals, Inc.
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CONTACT:
Michael T. Borer, Sr. Vice President and
Chief Financial Officer of Dura Pharmaceuticals, Inc.,
619-457-2553
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