- Company Provides R&D Pipeline Update -
IRVINE, Calif., March 6 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today reported financial results for the year ended December 31, 2007. ISTA reported net revenue of $58.9 million for the year ended December 31, 2007, a 78% increase over the full-year 2006 results of $33.0 million. Net revenue in the fourth quarter of 2007 increased 56% over the fourth quarter of 2006.
"2007 was a year of success and challenges. On the commercial front, we more than doubled our Xibrom revenues in 2007 as compared to 2006. Xibrom has significant momentum in the ophthalmic market, and this growth is expected to continue in 2008. Istalol continues to gain share on its branded competitor in a highly genericized therapeutic category," stated Vicente Anido Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "On the clinical front, we announced positive results from ISTA's Phase II/III Bepreve study and committed ourselves to accelerating the remainder of its clinical development program, which is now fully enrolled. With the in-licensing of the rights to nasal bepotastine, we also have added another key asset to ISTA's pipeline. We believe nasal bepotastine will be a cornerstone of our future growth, as we explore ISTA's commercial options outside ophthalmology."
Dr. Anido continued, "As Xibrom is our lead product, we completed the clinical development for Xibrom QD and filed the NDA for this once-daily formulation at the end of last year. In reviewing the file, the FDA requested additional data comparing Xibrom QD to the currently marketed Xibrom twice- daily formulation, and ISTA has therefore administratively withdrawn the clinical section of the NDA in order to incorporate this data. The nonclinical and CMC sections of the NDA remain on file, and the Company has been informed these sections are being reviewed as pre-submissions in anticipation of our resubmission of the clinical section. ISTA intends to announce top-line results of the additional clinical data in the second quarter, as well as complete the resubmission of the clinical section in the second quarter. We continue to expect the Xibrom QD NDA to be approved prior to the expiration of the patent on the twice-daily formulation early next year.
"Regarding the T-Pred NDA, we believe the Company's recent communications with the FDA have resulted in substantial progress, and we see a reasonable path forward. This includes an additional clinical study and additional in vitro work that we expect can be completed in four to six months. We are pleased with the progress we have made in the discussions with the FDA, and expect to file the amendment to the NDA as soon as possible after the studies are completed."
Dr. Anido concluded, "We have much to accomplish this year; however, we
remain confident ISTA will achieve the goal of profitability in 2009. This
commitment has been integrated into our entire organization and will be the
theme you hear from me, and from all of ISTA's employees, throughout the
year. As a team, we will continue to build sales, establish new physician
relationships, and complete the Bepreve clinical studies in order to submit
the NDA this year. We are excited about our prospects, and while we know
future challenges may arise, we believe we have the people, the strategies,
and the right outlook to succeed."
(in millions, except percentage data)
December 31, 2007 December 31, 2006 % Change
Xibrom $42.1 $20.2 108%
Istalol 11.3 8.3 36%
Vitrase 5.2 4.2 24%
Other 0.3 0.3 0%
Total Net Revenue $58.9 $33.0 78%
Fourth Quarter and Year End Operating Details
Gross margin for the fourth quarter and year ended December 31, 2007 was 72% (or $13.7 million) and 73% (or $43.0 million), respectively, as compared to 73% (or $9.0 million) and 70% (or $23.1 million), respectively, for the same periods in 2006. The change in gross margin for the 2007 periods was due primarily to shifts in revenue mix.
Research and development expenses for the fourth quarter and year ended December 31, 2007, were $11.6 million and $32.5 million, respectively, as compared to $6.1 million and $23.8 million during the same periods of 2006. The increase in research and development expenses for 2007 was primarily the result of an increase in clinical development costs, which include FDA filing fees, clinical investigator fees, study monitoring costs, and data management costs, primarily related to the Xibrom QD Phase III clinical trial costs and NDA filing with the FDA and Bepreve clinical and other studies. Research and development expenses for the fourth quarter of 2007 in the amount of $11.6 million exceeded management's guidance of $8 to $10 million primarily due to timing and acceleration of certain clinical trials, including the Bepreve Phase III and ocular safety studies, and an increase in stock-based compensation expense. Stock-based compensation expenses included in R&D for the fourth quarter and year ended December 31, 2007, were $0.3 million and $1.0 million, respectively.
Selling, general, and administrative expenses for the fourth quarter and year ended December 31, 2007, were $11.5 million and $46.6 million, respectively, as compared to $9.0 million and $37.4 million for the corresponding periods in 2006. The 2007 increase primarily resulted from higher sales and marketing expenses associated with the expansion of ISTA's sales force in early 2007. Stock-based compensation expenses included in SG&A for the fourth quarter and for the year ended December 31, 2007 were $0.8 million and $2.5 million, respectively.
The net loss for the fourth quarter and year ended December 31, 2007,
was $9.9 million (or $0.30 per share) and $38.2 million (or $1.29 per
share), respectively, compared with a net loss of $6.4 million (or $0.25
per share) and $38.4 million (or $1.48 per share) for the same periods in
2006. At December 31, 2007, ISTA had cash and short-term investments of
2007 Corporate Highlights
-- Increased net revenue by 56% and 78% as compared to the fourth quarter
of 2006, and year ended December 31, 2006, respectively
-- Filed an NDA with the FDA for Xibrom QD (once-daily) in December of
2007 after announcing, earlier in the year, positive Phase III results
for Xibrom QD as a treatment for inflammation, pain, and photophobia
following cataract surgery
-- Announced statistically significant Phase II/III study results for
Bepreve in treating ocular itching and clinical improvement in redness
and initiated both the Bepreve ocular safety study and the second
Phase III study
-- Announced positive results from the ecabet sodium Phase IIb study for
the treatment of dry eye syndrome
-- Successfully completed $36.7 million financing through the private
placement of 5.25 million shares of common stock with institutional
accredited investors at a purchase price of $7.00 per share
-- Expanded pipeline in allergy treatments by licensing exclusive North
American rights to nasal dosage forms of bepotastine, an
investigational product for the treatment of allergy symptoms
2008 Financial Outlook
-- We expect our net revenue for 2008 will be approximately $75 to $82
-- We expect our gross margin for 2008 will be approximately 70% to 73%,
subject to quarterly fluctuations based on revenue mix.
-- Depending upon the progress of our clinical and pre-clinical programs,
we expect our research and development expenses in 2008 will be
approximately $34 to $38 million, including stock-based compensation
expense, which we estimate will be approximately $1.5 to $2 million.
-- We anticipate our selling, general, and administrative expenses for
2008 will be approximately $50 to $54 million, including stock-based
compensation expense, which we estimate will be approximately $2.5 to
ISTA will host a conference call with a simultaneous webcast today, March 6, 2008, at 5:00 PM Eastern Time, to discuss its fourth quarter and full-year 2007 results. To access the live conference call, U.S. and Canadian participants may dial 866-831-6270; international participants may dial 617-213-8858. The access code for the live call is 99457780. To access the 24-hour audio replay, U.S. and Canadian participants may dial 888-286-8010; international participants may dial 617-801-6888. The access code for the call is 57762235. This conference call will also be webcast live and archived on ISTA's website for 30 days at http://www.istavision.com.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $4.7 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share. The Company's product development and commercialization strategy is to launch a new product every 12 to 18 months, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com.
Any statements contained in this press release that refer to future
events or other non-historical matters are forward-looking statements.
Without limiting the foregoing, but by way of example, statements contained
in this press release related to the completion of a clinical study in
support of the Xibrom QD NDA, the resubmission of the clinical section of
the Xibrom QD NDA, the launch of Xibrom QD prior to the expiration of the
twice-daily patent, the goals to continue to build sales, establish new
physician relationships, and complete the Bepreve clinical studies in order
to submit the NDA in 2008, 2008 financial guidance and ISTA's goals of
reaching profitability in 2009 and beyond, bringing a new product to market
every 12 to 18 months, and becoming the leading niche ophthalmic
pharmaceutical company are forward-looking statements. Except as required
by law, ISTA disclaims any intent or obligation to update any
forward-looking statements. These forward-looking statements are based on
ISTA's expectations as of the date of this press release and are subject to
risks and uncertainties that could cause actual results to differ
materially. Important factors that could cause actual results to differ
from current expectations include, among others: timely and successful
implementation of ISTA's strategic initiatives; delays and uncertainties
related to ISTA's research and development programs (including the
difficulty of predicting the timing or outcome of product development
efforts and the FDA or other regulatory agency approval or actions);
uncertainties and risks regarding market acceptance of and demand for
ISTA's approved products and the impact of competitive products and
pricing; uncertainties and risks related to ISTA's ability to properly
manage its growth; uncertainties and risks regarding the continued timely
performance by ISTA's strategic partners of their respective obligations
under existing collaborations and licensing arrangements; uncertainties and
risks related to the continued availability of third party sourced products
and raw materials on commercially reasonable terms, or at all;
uncertainties and risks related to successful compliance with FDA and or
other governmental regulations applicable to ISTA's facilities, products
and/or business; uncertainties and risks related to the scope, validity,
and enforceability of patents related to ISTA's products and technologies
and the impact of patents and other intellectual property rights held by
third parties; and such other risks and uncertainties as detailed from time
to time in ISTA's public filings with the U.S. Securities and Exchange
Commission, including but not limited to ISTA's Annual Report on Form 10-K
for the year ended December 31, 2006, and its Forms 10-Q for the quarters
ended March 31, 2007, June 30, 2007, and September 30, 2007.
ISTA Pharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
2007 2006 2007 2006 Revenue:
Product sales, net $ 19,092 $ 12,190 $ 58,589 $ 32,729
License revenue 70 70 278 278 Total revenue 19,162 12,260 58,867 33,007 Cost of products sold 5,447 3,253 15,864 9,943 Gross profit margin 13,715 9,007 43,003 23,064 Costs and expenses:
Research and development 11,572 6,066 32,492 23,826
Selling, general, and
administrative 11,503 8,997 46,603 37,357 Total costs and expenses 23,075 15,063 79,095 61,183 Loss from operations (9,360) (6,056) (36,092) (38,119) Interest income 655 615 2,141 1,879 Interest expense (1,151) (992) (4,270) (2,179) Net loss $ (9,856) $ (6,433) $ (38,221) $ (38,419) Net loss per common share,
basic and diluted $ (0.30) $ (0.25) $ (1.29) $ (1.48) Shares used in computing
net loss per common share,
basic and diluted 32,884 26,074 29,621 26,011
ISTA Pharmaceuticals, Inc.
Summary of Consolidated Balance Sheets Data
December 31, December 31,
2007 2006 Cash and short-term investments $ 46,140 $ 38,934 Restricted cash 2,400 5,600 Working capital 32,686 27,998 Total assets 71,716 59,743 Total stockholders' deficit (1,308) (4,559)
|SOURCE ISTA Pharmaceuticals, Inc.|
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