CORNERSTONE THERAPEUTICS, INC. 
By | Cornerstone Therapeutics Reports First Quarter 2013 Financial Results | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CARY, NC--(Marketwired - May 9, 2013) - Cornerstone Therapeutics Inc. (NASDAQ: CRTX)
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the U.S. hospital and adjacent specialty markets, today announced results for the first quarter ended March 31, 2013. Total net product sales were $38.0 million for the first quarter of 2013 compared to $22.2 million in the first quarter of 2012, an increase of 71%. Net sales of the ZYFLO® (zileuton) family of products amounted to $14.6 million for the first quarter of 2013, an increase of 17% over the first quarter of 2012. CUROSURF® (poractant alfa) net product sales totaled $9.5 million during the quarter, representing an increase of 25% compared to the first quarter of 2012. CARDENE® I.V. (nicardipine hydrochloride) net sales were $13.8 million for the first quarter of 2013. There were no comparable sales for CARDENE I.V. in the first quarter of 2012 as Cornerstone acquired the product rights to CARDENE I.V. as a result of its acquisition of EKR in June 2012. Net income for the first quarter of 2013 was $2.4 million, or $0.09 per diluted share, compared to a net loss of $1.8 million, or $(0.07) per diluted share, in the first quarter of 2012. On a non-GAAP basis, net income for the first quarter was $7.1 million, or $0.24 per diluted share, up from $1.3 million, or $0.05 per diluted share, in the first 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. "In the first quarter, we gained momentum as a result of executing our strategic plan to focus exclusively on the hospital and related market segments. We believe that strategy is starting to really pay off," said Craig A. Collard, Cornerstone's Chief Executive Officer. "Increased sales of our products in addition to improved gross margins and profitability show that our strategy is working. We are confident that Cornerstone is well positioned for continued growth." A breakdown of net revenues by product for the three months ended March 31, 2013 (in thousands, except percentages) follows:
Gross margin (exclusive of license and royalty agreement revenues and amortization of product rights) for the first quarter of 2013 was 68%, up from 61% in the comparable quarter of 2012. This sharp increase was primarily due to the addition of CARDENE I.V., whose gross margin significantly exceeds CUROSURF's gross margin. A decrease in estimated rates of chargebacks and price adjustments for CUROSURF also aided gross margin. Selling, general and administrative expenses were $13.1 million during the first quarter of 2013, a 20% increase over $10.9 million in the comparable quarter of 2012. This was driven by increases in compensation, travel and other related employee benefits due to the continued growth of the company's products and related sales force, as well as an increase in advertising and promotional expenses related to CARDENE I.V. and the anticipated launch of BETHKIS® (tobramycin inhalation solution). As of March 31, 2013, Cornerstone had $63.4 million in cash and cash equivalents, an increase of $7.1 million from December 31, 2012. "We remain focused on growing revenue organically and expanding our product offerings through licensing and acquisition opportunities that align with our vision for growth," continued Mr. Collard. "This is evident in our acquisition of the exclusive U.S. rights to market PERTZYE. We believe that the combination of PERTZYE and BETHKIS, which is scheduled to launch later this year, will represent a strong product portfolio addressing needs of cystic fibrosis patients. We plan to promote these products using a specialized group within our hospital sales force. These are the types of synergies you can expect to see from Cornerstone." Conference Call Information Cornerstone Therapeutics will host a conference call today at 8:30 AM ET to discuss financial results for the three months ended March 31, 2013. To participate in the live conference call, please dial 888-523-1228 (U.S. callers) or 719-325-2432 (international callers), and provide passcode 8910700. A live webcast of the call will also be available through the Investor Relations section 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 8910700. IMPORTANT SAFETY INFORMATION ABOUT PERTZYE PERTZYE (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth. Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment. Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE. The most common adverse reactions ( Share
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