Cornerstone Therapeutics Reports Third Quarter 2013 Financial Results
(firmenpresse) - CARY, NC -- (Marketwired) -- 11/07/13 -- . (NASDAQ: CRTX)
Record quarterly net revenue of $53.7 million, up 43% compared to the third quarter of 2012
Diluted earnings per share of $0.31, up $0.26 per share compared to third quarter of 2012
Gross margin of 76%, a sharp rise from 62% in third quarter of 2012
Initiated sales of PERTZYE® (pancrelipase) and our generic equivalent of Tussionex® (hydrocodone polistirex and chlorpheniramine polistirex)
. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the U.S. hospital and adjacent specialty markets, today announced results for the third quarter ended September 30, 2013.
Total net revenues were $53.7 million for the third quarter of 2013, compared to $37.5 million in the third quarter of 2012, an increase of 43%. CARDENE® I.V. (nicardipine hydrochloride) net sales were $20.7 million for the third quarter of 2013 compared to sales of $12.8 million for the third quarter of 2012. The substantial increase in CARDENE I.V. sales largely reflects Cornerstone's ability to supply the market while generic manufacturers suffered product shortages. CUROSURF® (poractant alfa) net product sales totaled $11.2 million in the third quarter of 2013, representing an increase of 13% compared to the third quarter of 2012. Net sales of the ZYFLO® (zileuton) family of products amounted to $19.8 million for the third quarter of 2013, an increase of 36% over the third quarter of 2012.
Cornerstone initiated sales and marketing efforts for PERTZYE® (pancrelipase) on July 29, 2013, and launched its generic equivalent of Tussionex®, Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Suspension product (HP/CP ER Suspension) on September 23, 2013. PERTZYE's net revenue (including copromotion revenue) totaled $620,000 during the third quarter of 2013. Net product sales for the Company's HP/CP ER Suspension product totaled $246,000 during the same period.
Net income for the third quarter of 2013 was $9.6 million, or $0.31 per diluted share, compared to net income of $1.2 million, or $0.05 per diluted share, in the third quarter of 2012. On a non-GAAP basis, net income for the third quarter was $14.3 million, or $0.46 per diluted share, up from $5.6 million, or $0.19 per diluted share, in the third quarter of 2012.
Non-GAAP net income and net income per diluted share exclude stock-based compensation expense, amortization of product rights, transaction-related expenses, acquisition adjustments related to inventory sold, the change in acquisition-related contingent payments and the gain on the divestiture of certain product rights.
"This was another strong quarter for Cornerstone. Each of our products performed well, with CARDENE I.V. in particular posting record quarterly sales largely due to shortages of the generic products," said Craig A. Collard, Cornerstone's Chief Executive Officer. "In addition to posting record revenue for the third straight quarter, we also launched two products, PERTZYE and our generic equivalent of Tussionex. We plan to launch our BETHKIS® (Tobramycin Inhalation Solution) product later this year."
A breakdown of net revenues by product for the three and nine months ended September 30, 2013 follows (in thousands, except percentages):
Gross margin (exclusive of other revenues and amortization of product rights) for the third quarter of 2013 was 76%, up from 62% in the comparable quarter of 2012. This sharp increase was primarily a result of the growth in CARDENE net product sales due to shortages of generic products also supported by lower estimated rates of certain sales allowances.
Selling, general and administrative expenses were $16.4 million during the third quarter of 2013, a 27% increase over $12.9 million in the comparable quarter of 2012. This increase was primarily due to higher legal fees related to ongoing patent litigation, as well as compensation, travel and other related employee benefits due to the continued growth of the Company's products and related sales force. This increase was also driven by spending on advertising and promotion related to the addition of PERTZYE and the upcoming launch of BETHKIS, as well as marketed product stability costs.
As of September 30, 2013, Cornerstone had $69.6 million in cash and cash equivalents, an increase of $13.4 million from December 31, 2012.
Cornerstone Therapeutics will host a conference call at 8:30 a.m. ET today to discuss its financial results for the third quarter of 2013. To participate in the live conference call, please dial 888-505-4368 (U.S. callers) or 719-325-2420 (international callers), and provide passcode1373925. A live webcast of the call will also be available through the of the Company's website. Please allow extra time prior to the webcast to register, 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 approximately two hours after completion of the call by dialing 888-203-1112 (U.S. callers) or 719-457-0820 (international callers), and providing passcode 1373925.
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit .
To supplement the consolidated financial statements presented in accordance with GAAP, the Company uses non-GAAP measures of certain components of financial performance. These non-GAAP measures include non-GAAP operating income, non-GAAP net income and non-GAAP net income per diluted share. The Company's management regularly uses supplemental non-GAAP financial measures to understand, manage and evaluate its business and make operating and compensation decisions. These non-GAAP measures are among the primary factors management uses in planning for and forecasting future periods.
These non-GAAP measures are not in accordance with, or an alternative to, measures prepared in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. The additional non-GAAP financial information presented in this press release should be considered in conjunction with, and not as a substitute for, or superior to, the financial information presented in accordance with GAAP (such as operating income (loss), net income (loss) and earnings (loss) per share) and should not be considered measures of the Company's liquidity. These non-GAAP measures should only be used to evaluate the Company's results of operations in conjunction with the corresponding GAAP measures.
The non-GAAP financial measures reflect adjustments for stock-based compensation expense, amortization of product rights, transaction-related expenses, acquisition adjustments related to inventory sold, changes in acquisition-related contingent payments and the gain on the divestiture of certain product rights. Transaction-related expenses consist of (1) costs incurred to complete product or company acquisitions or other strategic transactions, including due diligence and legal, consulting and other related fees; (2) integration costs related to the Company's completed transactions; and (3) transaction-related fees associated with transactions that are not consummated. The Company excludes these expenses from its non-GAAP measures because it believes that their exclusion provides an additional means to assess the extent to which the Company's efforts and execution of its strategy are reflected in its operating results. In particular, stock-based compensation expense is excluded primarily because it is a non-cash expense that is determined based on subjective assumptions; amortization of product rights is excluded because it is not reflective of the cash-settled expenses incurred related to product sales; and the transaction-related expenses, acquisition adjustments related to inventory sold, changes in acquisition contingent payments and the Company's gain on the divestiture of certain product rights are excluded because management believes they have no direct correlation to current operating results. Management believes that these non-GAAP measures, when shown in conjunction with the corresponding GAAP measures, enhance investors' and management's overall understanding of the Company's current financial performance and its prospects for the future.
The non-GAAP measures are subject to inherent limitations because (1) they do not reflect all of the expenses associated with the results of operations as determined in accordance with GAAP and (2) the exclusion of these expenses involves the exercise of judgment by management. Even though the Company has excluded stock-based compensation expense, amortization of product rights, transaction-related expenses, acquisition adjustments related to inventory sold, changes in acquisition-related contingent payments and the gain from the divestiture of product rights from the non-GAAP financial measures, stock-based compensation is an integral part of the Company's compensation structure, the acquisition of additional companies and/or product rights and the divestiture of the Company's anti-infective product rights are an important part of its business strategy and transaction-related expenses, whether or not the transaction is successfully closed, may be significant cash expenses.
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," "project," "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; patient, physician and third-party payer 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; our ability to obtain U.S. Food and Drug Administration, or FDA, approval to manufacture, market and sell our products and product candidates, including RETAVASE® (Reteplase); our ability to successfully and effectively launch BETHKIS and manage the launch of our HP/CP ER Suspension product; our ability to enter into additional strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all; our ability to manage and control unknown liabilities in connection with any acquisitions; our ability to successfully manage growth or integrate acquired businesses and operations; 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 substantial indebtedness and debt covenants; our entry into the Agreement and Plan of Merger, or the Merger Agreement, with Chiesi Farmaceutici S.p.A., or Chiesi, and Chiesi U.S. Corporation, or Merger Sub, pursuant to which we have agreed to merge with Merger Sub and become a wholly owned subsidiary of Chiesi, which we refer to as the Chiesi Merger, including our ability to consummate the Chiesi Merger, uncertainties associated with the Chiesi Merger, the impact of the Chiesi Merger on our ability to attract and retain personnel, and the effect of contractual restrictions on the conduct of our business prior to the completion of the Chiesi Merger and on our ability to make certain business decisions; and 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 14, 2013 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 may be 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 or make, except that in particular circumstances as specifically indicated we may address the potential impact of the Chiesi Merger. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.
ZYFLO CR® and ZYFLO® are registered trademarks of Cornerstone Therapeutics Inc. CARDENE® I.V. and RETAVASE® are registered trademarks of EKR Therapeutics, Inc., Cornerstone Therapeutics Inc.'s wholly owned subsidiary. CUROSURF® and BETHKIS® are owned by Chiesi Farmaceutici S.p.A. and licensed to Cornerstone Therapeutics Inc. for sales and marketing purposes in the United States. PERTZYE® is a registered trademark of Digestive Care, Inc. and is licensed to Cornerstone Therapeutics Inc. for sales and marketing purposes in the United States. Tussionex® is a registered trademark of UCB Manufacturing, Inc.
This document may be deemed to be proxy solicitation material in respect of the proposed Chiesi Merger. In connection with the proposed Chiesi Merger, the Company filed preliminary proxy materials with the SEC on October 17, 2013. A definitive proxy statement will be sent to the Company's stockholders seeking their approval of the proposed Chiesi Merger.
Investors will be able to obtain a free copy of documents filed with the SEC at the SEC's website at . In addition, investors may obtain a free copy of the Company's filings with the SEC from the Company's website at .
The Company and its directors, executive officers and certain other members of management and employees of the Company may be deemed to be "participants" in the solicitation of proxies from stockholders of the Company in favor of the proposed Chiesi Merger. Information regarding the persons who are, under the rules of the SEC, participants in the solicitation of the stockholders of the Company in connection with the proposed Chiesi Merger, and their direct or indirect interests, by security holdings or otherwise, which may be different from those of the Company's stockholders generally, is set forth in the preliminary proxy statement and the other relevant documents filed by the Company with the SEC. Information regarding the Company's directors and executive officers is available in its Annual Report on Form 10-K for the year ended December 31, 2012 filed on March 14, 2013, as amended by a Form 10-K/A filed with the SEC on April 11, 2013, and in the definitive proxy statement for the Company's 2013 annual meeting of stockholders filed by the Company with the SEC on October 3, 2013.
G-Q413-06
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Datum: 07.11.2013 - 06:01 Uhr
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