Cornerstone Therapeutics Reports Second Quarter 2011 Financial Results
(firmenpresse) - CARY, NC -- (Marketwire) -- 08/04/11 -- Cornerstone Therapeutics Inc. (NASDAQ: CRTX)
Management introduced a new strategic vision in the second quarter with the goal of focused growth in the respiratory, hospital and related specialty markets
The balance sheet continued to strengthen providing capital to fund the growth strategy as cash increased 82% to $92.8 million as of June 30, 2011 compared to December 31, 2010
Strategic products' net product sales grew 3% and 11% for the three and six months ended June 30, 2011, respectively, compared to the same periods in 2010
Curosurf volume achieved an all-time high in the month of June and increased 6.2% in the second quarter compared to the second quarter of 2010
Cornerstone Therapeutics Inc. (NASDAQ: CRTX) today reported net product sales from strategic products were 67% of total net product sales, or $18.7 million, for the second quarter of 2011, an increase from the 64% of total net product sales, or $18.1 million, for the second quarter of 2010. Net product sales from strategic products were 68% of total net product sales, or $39.7 million, for the first six months of 2011, an increase from the 55% of total net product sales, or $35.6 million, for the first six months of 2010. Overall, total net revenues were $28.0 million for the second quarter of 2011, compared to $28.5 million for the second quarter of 2010, and total net revenues for the first six months of 2011 were $58.0 million, compared to $64.9 million for the same period in 2010.
Net income was $0.2 million, or $0.01 per diluted share, for the second quarter of 2011, compared to a net loss of $0.4 million, or negative $0.02 per diluted share, for the second quarter of 2010. For the first six months of 2011, net income was $1.9 million, or $0.07 per diluted share, compared to net income of $4.6 million, or $0.18 per diluted share, for the first six months of 2010. On a non-GAAP basis, net income was $2.8 million, or $0.11 per diluted share, for the second quarter of 2011, compared to non-GAAP net income of $2.5 million, or $0.10 per diluted share, for the second quarter of 2010. For the first six months of 2011, on a non-GAAP basis, net income was $8.8 million, or $0.34 per diluted share, compared to non-GAAP net income of $9.4 million, or $0.36 per diluted share, for the first six months of 2010. Non-GAAP net income and net income per diluted share exclude amortization of product rights and stock-based compensation expense.
"During the second quarter, we made advances in the execution of our strategy as we increased market penetration with our strategic products and focused our development pipeline," said Craig A. Collard, Cornerstone's President and Chief Executive Officer. "With available cash exceeding $92 million and no debt, we continue to evaluate opportunities to invest funds to drive our future growth."
A breakdown of net revenues for the second quarter and first half of 2011 (in thousands, except percentages) follows:
Gross margin (exclusive of license and royalty agreement revenues and amortization of product rights) was 75% for the second quarter of 2011, compared to 71% for the comparable period of 2010. The lower gross margin for the second quarter of 2010 was due to additional reserves for potential product returns of approximately $3.0 million.
Selling, general and administrative expenses decreased $1.2 million, or 9%, in the second quarter of 2011 compared to the second quarter of 2010. The decrease was primarily due to reduced marketing and promotional spending for FACTIVE and decreases in co-promotion expenses related to our propoxyphene/acetaminophen products, which were withdrawn from the market in November of 2010.
Royalty expenses decreased $0.5 million, or 19%, during the second quarter of 2011 compared to the second quarter of 2010. The reduction in royalty expense was primarily due to the reduction in net product sales from our HYOMAX products and the voluntary withdrawal of our propoxyphene/acetaminophen products, partially offset by increased net product sales of ALLERX Dose Pack products.
Research and development expenses decreased $1.2 million, or 66%, during the second quarter of 2011 compared to the second quarter of 2010. The reduction in R&D expense was primarily due to decreased expenses related to CRTX 067 and the timing of other product development expenses, consistent with our development plan.
As of June 30, 2011, we had $92.8 million in cash and cash equivalents, an increase of $41.8 million compared to December 31, 2010. The increase in cash for the first half of 2011 was driven primarily by collections of receivables in connection with the ALLERX Dose Pack products.
Cornerstone Therapeutics will host a conference call today at 8:30 AM ET to discuss its financial results for the quarter ended June 30, 2011. To participate in the live conference call, please dial 800-817-8867 (U.S. callers) or 913-981-5572 (international callers), and provide passcode 8822874. A live webcast of the call will also be available through the Investors -- Webcasts & Presentations section of the Company's website at . Please allow extra time prior to the webcast to register and to download and install any necessary audio software.
The conference call and the webcast will be archived for 30 days. The telephone replay of the call will be available today at 11:30 AM ET, by dialing 888-203-1112 (U.S. callers) or 719-457-0820 (international callers), and providing passcode 8822874.
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products for the respiratory, hospital and related specialty markets. Key elements of the Company's strategy are to focus on identifying therapeutic niches within respiratory, hospital and related specialty markets to leverage existing business and create new opportunities; promote the Company's current products to high prescribing physicians through the Company's respiratory sales force and to hospital-based healthcare professionals through the Company's hospital sales force; license or acquire rights to existing patent- or trade secret-protected, branded products, which can be promoted through the same channels to generate on-going high-value earnings streams; advance the Company's development projects and further build a robust pipeline; and generate revenues by marketing approved generic products through the Company's wholly owned subsidiary, Aristos Pharmaceuticals, Inc.
This press release highlights the Company's financial results on both a GAAP and a non-GAAP basis. The GAAP results include certain costs and charges that are excluded from non-GAAP results. By publishing the non-GAAP financial measures, management intends to provide investors with additional information to further analyze the Company's performance and underlying trends. Management evaluates results and makes operating and compensation decisions using both GAAP and non-GAAP measures included in this press release. Non-GAAP results are not prepared in accordance with GAAP, and non-GAAP information should be considered a supplement to, and not a substitute for, financial statements prepared in accordance with GAAP. Investors and potential investors are encouraged to review the reconciliation of non-GAAP financial measures to their most directly comparable GAAP measures attached to this press release. For more information about these non-GAAP measures, please see Part I, Item 2 of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 12, 2011.
Statements in this press release regarding the progress and timing of our product development programs and related trials; our future opportunities; our strategy, future operations, anticipated financial position, future revenues and projected costs; our management's prospects, plans and objectives; and any other statements about management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Any statements that are not statements of historical fact (including, without limitation, statements containing the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements.
There are a number of important factors that could cause our actual results or events to differ materially from those indicated by such forward-looking statements, including risks relating to our "critical accounting estimates"; our ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products; our ability to replace the revenues from our marketed unapproved products, which we ceased manufacturing and distributing at the end of 2010, and from our propoxyphene products, which we voluntarily withdrew from the U.S. market in November 2010 at the request of the U.S. Food and Drug Administration, or FDA; patient, physician and third-party payor acceptance of our products as safe and effective therapeutic products; our heavy dependence on the commercial success of a relatively small number of currently marketed products; our ability to maintain regulatory approvals to market and sell our products with FDA-approved marketing applications; our ability to obtain FDA approval to market and sell our products under development; our ability to enter into additional strategic licensing product acquisition, collaboration or co-promotion transactions on favorable terms, if at all; our ability to maintain compliance with NASDAQ listing requirements; adverse side effects experienced by patients taking our products difficulties relating to clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our product candidates and whether such results will be indicative of results obtained in later clinical trials; our ability to develop and commercialize our product candidates before our competitors develop and commercialize competing products; our ability to satisfy FDA and other regulatory requirements; our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the SEC on March 3, 2011 and in our subsequent filings with the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.
In addition, the statements in this press release reflect our expectations and beliefs only as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.
Curosurf® is owned by Chiesi Farmaceutici S.p.A. Spectracef® is owned by Meiji Seika Kaisha Ltd. Factive® is owned by LG Life Sciences, Ltd. Curosurf, Spectracef and Factive are licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States and, with respect to Factive, certain other countries.
Investor Relations Contacts:
Westwicke Partners
John Woolford
+1-443-213-0506
Westwicke Partners
Stefan Loren, Ph.D.
+1-443-213-0507
Media Relations Contact:
Fleishman-Hillard
Andrea Moody
+1-919-457-0743
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Datum: 04.08.2011 - 05:30 Uhr
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