Cornerstone Therapeutics Inc. announced it had entered into a license and distribution agreement with Digestive Care, Inc. pursuant to which the company acquired exclusive U.S. rights to market PERTZYE®, pancreatic enzyme product for the treatment of Exocrine Pancreatic Insufficiency due to cystic fibrosis. The PERTZYE formulation was previously marketed by DCI for more than a decade under the trade name PANCRECARB® MS-16. The license agreement includes the right of first refusal to negotiate a license to any alternative, substitute, successor or improvement to PERTZYE that DCI may develop. The license agreement contains a non-competition covenant under which the Company may not manufacture, promote, market, sell or distribute in the United States any pancreatic enzyme product that is indicated for the treatment of patients with CF for the duration of the license agreement. The license agreement will remain in force for an initial term of ten years from the effective date, or May 9, 2023.

Cornerstone Therapeutics Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the quarter, the company’s net revenues were $37,980,000 compared to $22,161,000 a year ago. Income from operations was $4,643,000 compared to loss from operations of $3,043,000 a year ago. Income before income taxes was $3,509,000 compared to loss before income taxes of $3,045,000 a year ago. Net income was $2,415,000 or $0.09 per basic and diluted share compared to net loss of $1,825,000 or $0.07 per basic and diluted share a year ago. Net cash provided by operating activities was $8,389,000 compared to net cash used in operating activities of $2,709,000 a year ago. Purchase of property and equipment was $364,000 compared to $80,000 a year ago. On a non-GAAP basis, net income was $7,105,000 or $0.24 per diluted share compared to non-GAAP net income of $1,307,000 or $0.05 per diluted share a year ago. Non-GAAP income from operations was $12,576,000 compared to $2,183,000 a year ago.

Cornerstone Therapeutics Inc., Q1 2013 Earnings Call, May 09, 2013