Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today
financial results for the first quarter ended March 31, 2011,
reporting a net loss of $17.6 million or ($0.21) per common share,
as compared to a net loss of $14.8 million, or ($0.18) per common
share, for the same period in 2010. The Company’s first quarter
2011 results included a $12.2 million restructuring charge
associated with the discontinuation of the Company’s pulmonary
therapeutic operations and other related infrastructure
reductions.
Total revenue for the first quarter of 2011 was $21.1 million,
as compared to $22.1 million for the first quarter of 2010. Revenue
from AZASITE® (azithromycin ophthalmic solution) 1% totaled $10.9
million in the first quarter of 2011, an increase of 26% compared
to $8.7 million recognized in the first quarter of 2010. Inspire
estimates that approximately $1 million of the first quarter 2010
AZASITE revenue was associated with hospital usage of AZASITE as a
substitute therapy during a temporary supply shortage of
erythromycin ophthalmic ointment (0.5%).
Total product co-promotion and royalty revenue, comprised of
royalty revenue from net sales of RESTASIS® (cyclosporine
ophthalmic emulsion) 0.05% and net sales of DIQUAS™ Ophthalmic
Solution 3% (diquafosol tetrasodium), and co-promotion revenue from
net sales of ELESTAT® (epinastine HCl ophthalmic solution) 0.05%,
was $10.2 million in the first quarter of 2011 compared to $13.4
million for the first quarter of 2010. Royalty revenue for the
first quarter of 2011 from RESTASIS® was $7.2 million compared to
$9.8 million in the first quarter of 2010, reflecting a reduction
in the applicable royalty rate associated with an amendment to the
agreement with Allergan, Inc., which was previously announced in
August 2010. Co-promotion revenue from ELESTAT in the first quarter
of 2011 was $2.7 million as compared to $3.6 million recognized in
the first quarter of 2010. Additionally, the Company recognized
$316,000 of DIQUAS royalty revenue in 2011, its first revenue from
Japanese sales of the product that was launched in mid- December
2010.
Operating expenses for the first quarter of 2011 totaled $38.8
million, as compared to $36.5 million for the same period in 2010.
The increase in first quarter 2011 operating expenses was primarily
due to $12.2 million of restructuring charges related to the
discontinuation of the Company’s pulmonary therapeutic operations
and its related corporate restructuring in February 2011. These
increases were partially offset by both a decrease in research and
development expenses and a decrease in general and administrative
expenses. After excluding the 2011 restructuring charges, which are
expected to be the full extent of costs associated with the change
in strategic focus and operations of the Company, operating
expenses for the first quarter of 2011 were $26.6 million, and
reflected a $9.9 million decrease from operating expenses incurred
in the first quarter of 2010.
Cash, cash equivalents and investments totaled $77.8 million at
March 31, 2011, reflecting a $16.4 million utilization of cash and
investments during the first quarter. The Company’s cash and
investments utilization was slightly less than its first quarter
2011 operating plan.
“During the quarter, we made progress towards achieving our 2011
objectives,” said Adrian Adams, President and CEO of Inspire. “We
increased AZASITE prescription and revenue growth, continued
enrollment in the Phase 2 blepharitis trial, completed a corporate
restructuring and reorganization and delivered another quarter of
strong financial performance. Furthermore, we were pleased to
announce the proposed acquisition of Inspire by Merck and believe
that this, when completed, represents the best prospect for
enhancing stockholder value and realizing the potential of our
ophthalmology products and product candidates.”
Recent Updates Include (February 18, 2011 through May 10,
2011):
Ophthalmic Research &
Development
- Continued enrolling patients in the
exploratory Phase 2 clinical trial (Trial 044-103) comparing
AZASITE to vehicle for the treatment of blepharitis.
Sales and Marketing
- Increased first quarter 2011 AZASITE
prescription volume and revenue by approximately 10% and 26%,
respectively, as compared to first quarter 2010;
- Announced that an Abbreviated New Drug
Application (“ANDA”) for a generic version of AZASITE was filed
with the U.S. Food and Drug Administration (“FDA”) by Sandoz, Inc.;
and
- On May 2, 2011, Cypress Laboratories
announced the launch of a generic form of epinastine, resulting in
the termination of the co-promotion agreement between the Company
and Allergan, Inc. regarding Elestat.
Corporate
- Announced that Merck & Co., Inc.
(“Merck”) and the Company entered into an Agreement and Plan of
Merger, whereby Merck, through a subsidiary, has offered to
purchase all of the outstanding shares of common stock of the
Company at a price of $5.00 per share, which represented a 26%
premium to the closing stock price on April 4, 2011.
Due to the pending merger with Merck, Inspire is no longer
providing 2011 financial guidance.
About Inspire
Inspire is a specialty pharmaceutical company focused on
developing and commercializing ophthalmic products. Inspire's
specialty eye care sales force generates revenue from the promotion
of AZASITE® (azithromycin ophthalmic solution) 1% for bacterial
conjunctivitis. Inspire receives royalties based on net sales of
RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% and DIQUAS™
Ophthalmic Solution 3% (diquafosol tetrasodium) in Japan. For more
information, visit www.inspirepharm.com.
Important Information about the Tender Offer
The description contained in this press release is neither an
offer to purchase nor a solicitation of an offer to sell
securities. Any offers to purchase or solicitation of offers to
sell will be made only pursuant to a tender offer statement and a
solicitation and recommendation statement filed with the Securities
and Exchange Commission ("SEC"). The tender offer statement
(including an offer to purchase, a related letter of transmittal
and other tender offer documents) and the
solicitation/recommendation statement contain important information
that should be read carefully before making any decision to tender
securities in the tender offer. Those materials have been made
available to the Company's stockholders at no expense to them. In
addition, all of those materials (and all other tender offer
documents filed with the SEC) are made available at no charge on
the SEC's website at www.sec.gov.
Forward-Looking Statements
The forward-looking statements in this news release relating to
management's expectations and beliefs are based on preliminary
information and management assumptions. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements, including: statements regarding the
expected completion of the tender offer or merger, including the
timing thereof, and satisfaction of the conditions necessary for
the consummation of the tender offer; the timing and full extent of
costs associated with the Company’s change in strategic focus and
operations; the Company’s ability to develop and commercialize its
ophthalmology business; any statements of expectation or belief;
and any statements of assumptions underlying any of the foregoing.
Investors and security holders are cautioned not to place undue
reliance on these forward-looking statements. Such forward-looking
statements are subject to a wide range of risks and uncertainties
that could cause results to differ in material respects, including
uncertainties as to the timing of the tender offer and merger;
uncertainties as to how many of Inspire stockholders will tender
their stock in the tender offer; the risk that competing offers
will be made; the possibility that various closing conditions for
the tender offer or merger may not be satisfied or waived,
including that a governmental entity may prohibit, delay or refuse
to grant approval for the consummation of the tender offer or
merger; the effects of disruption from the tender offer or merger,
making it more difficult to maintain relationships with employees,
licensees, other business partners or governmental entities; risks
relating to product development, revenue, expense and earnings
expectations, intellectual property rights, competitive products,
results and timing of clinical trials, success of marketing
efforts, the need for additional research and testing, delays in
manufacturing, funding, and the timing and content of decisions
made by regulatory authorities, including the U.S. Food and Drug
Administration; other business effects, including the effects of
industry, economic or political conditions outside of the Company's
control; transaction costs; actual or contingent liabilities; and
other risks and uncertainties discussed in documents filed with the
SEC by the Company. Further information regarding factors that
could affect Inspire's results is included in the Company 's
filings with the SEC. The Company does not undertake any obligation
to update any forward-looking statements as a result of new
information, future developments or otherwise, except as expressly
required by law.
-- Financial tables follow --
INSPIRE PHARMACEUTICALS, INC.
Condensed Statements of
Operations
(in thousands, except per share
amounts)
(Unaudited)
Three MonthsEnded March 31,
2011 2010 Revenues: Product sales, net $
10,937 $ 8,696 Product co-promotion and royalty
10,157 13,372 Total
revenue 21,094 22,068 Operating expenses: Cost of sales 4,615 3,015
Research and development 3,600 9,593 Selling and marketing 12,841
13,694 General and administrative 5,551 10,236 Restructuring
12,215 -- Total
operating expenses
38,822
36,538 Loss from operations (17,728 ) (14,470 )
Other income/(expense): Interest income 106 169 Interest expense
--- (486
) Other income/(expense), net
106
(317 ) Net loss
$ (17,622
) $
(14,787 ) Basic and diluted
net loss per common share
$
(0.21 )
$ (0.18
) Weighted average common shares used in
computing basic and diluted net loss per common share
83,212 82,402
INSPIRE PHARMACEUTICALS, INC.
Selected Balance Sheet
Information
(in thousands)
March 31,
2011
December 31,
2010
Cash, cash equivalents and investments $ 77,840 $ 94,251 Trade
receivables 16,301 22,442 Inventories, net 1,126 776 Total assets
113,808 142,499 Working capital 61,230 72,491 Total stockholders'
equity 79,178 95,238 Shares of common stock outstanding 83,279
83,159
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