Cornerstone Therapeutics Provides 2010 Financial Guidance

CARY, N.C., Jan. 7 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc. (Nasdaq: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today provided financial guidance for the year ending December 31, 2010.

2010 Guidance

Cornerstone's management currently anticipates net revenues in excess of $112 million in 2010. This estimate assumes that revenue contribution from branded products will increase from 40% of net revenues in 2009 to in excess of 75% of net revenues in 2010. In particular, our estimate reflects management's strong growth expectations for our branded portfolio of products, which include Spectracef®, Zyflo and our recently acquired products, Curosurf® and Factive®. We are still in the process of ramping up our commercialization efforts for Curosurf and Factive and we expect that their sales and profitability will improve as 2010 progresses.

In addition, and as anticipated, this estimate also reflects reduced revenue contribution from the Company's older products, AlleRx® and HyoMAX®, which Cornerstone expects will contribute less than 25% of 2010 net revenues, compared to approximately 60% in 2009.

    Key Financial Metrics

    $million (except per share)                            2010
                                                      In excess of
    Net Revenue                                            $112

    GAAP  income from operations                           $1.0
    Non-GAAP income from operations(1)                    $16.4
                                                      =============

    GAAP net  income                                       $0.6
    Non-GAAP net income(2)                                $10.2
                                                      =============

    GAAP net income per share, diluted                    $0.02
    Non-GAAP net income per share, diluted(3)             $0.38
                                                      =============

    (1) Non-GAAP income from operations is a non-GAAP financial measure that
    excludes expected stock-based compensation ($1.0 million) and
    amortization of product rights ($14.4 million).

    (2) Non-GAAP net income is a non-GAAP financial measure that excludes
    expected stock-based compensation ($1.0 million) and amortization of
    product rights ($14.4 million) and the income tax effects of these items
    totaling $9.6 million.

    (3) Non-GAAP net income per share, diluted is a non-GAAP financial
    measure that is calculated as non-GAAP net income divided by the diluted
    weighted-average common shares. Based on our current estimates, we have
    assumed that we will have 26.6 million diluted weighted-average common
    shares outstanding during 2010.

"In 2009, we executed on our stated strategy of acquiring products, Curosurf® and Factive®, that we expect will generate long-term, sustainable and profitable growth, and accelerate the evolution of the company," said Craig A. Collard, Cornerstone's President and Chief Executive Officer. "As we move into 2010, we anticipate further contribution from these recently acquired products and continue to seek additional products that will complement our current portfolio. Additionally, we continue to focus our development activities in areas where we believe there is limited development risk, as with CRTX 067, our extended-release antitussive product candidate, which, if approved by the Food and Drug Administration, could receive such approval by the end of 2010 or early 2011."

Conference Call Information

Cornerstone Therapeutics will host a conference call today at 8:30 AM ET to discuss its financial guidance for 2010. To participate in the live conference call, please dial 866-271-5140 (U.S. callers) or 617-213-8893 (international callers), and provide passcode 45969044. A live webcast of the call will also be available through the "Investors -- Webcasts & Presentations" section of the Company's website at www.crtx.com. Please allow extra time prior to the webcast to register for the webcast and to download and install any necessary audio software.

The webcast will be archived for 30 days, and a telephone replay of the call will be available for seven days, beginning today at 11:30 AM ET, by dialing 888-286-8010 (U.S. callers) or 617-801-6888 (international callers), and providing passcode 88256043.

Use of Non-GAAP Financial Measures

This press release highlights the Company's guidance on both a GAAP and a non-GAAP basis. The GAAP guidance includes certain costs and charges that are excluded from non-GAAP guidance. By publishing the non-GAAP financial measures, management intends to provide investors with additional information to further analyze the Company's anticipated performance, core results and underlying trends. Management evaluates results and makes operating 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.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (Nasdaq: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets. The Company currently promotes multiple marketed products in the United States to respiratory-focused physicians and key retail pharmacies with its specialty sales force. The Company also has a late-stage clinical pipeline with a recent regulatory submission filing and four additional regulatory approval submissions targeted within the next three years. Key elements of the Company's strategy are to in-license or acquire rights to underpromoted, patent-protected, branded respiratory or related pharmaceutical products, or late-stage product candidates; implement life cycle management strategies to maximize the potential value and competitive position of the Company's currently marketed products, newly acquired products and product candidates that are currently in development; grow product revenue through the Company's specialty sales force which is focused on the respiratory and related markets; and maintain and strengthen the intellectual property position of the Company's currently marketed products, newly acquired products and product candidates.

Safe Harbor Statement

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 ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products; the possibility that the Food and Drug Administration (the FDA) will take enforcement action against us or one or more of our marketed drugs that do not have FDA-approved marketing applications; 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 that do have FDA-approved marketing applications; our ability to enter into additional strategic licensing, 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 products under development and whether such results will be indicative of results obtained in later clinical trials; 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 Securities and Exchange Commission (the SEC) on March 26, 2009 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 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. 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.

AlleRx® and HyoMAX® are trademarks of Cornerstone Therapeutics Inc. All other trademarks are the property of their respective owners.

SOURCE Cornerstone Therapeutics Inc.