Sucampo Pharmaceuticals, Inc. Reports Fourth Quarter And Full Year 2014 Financial Results And Corporate Update

BETHESDA, Md., March 4, 2015 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today reported consolidated financial results for the fourth quarter and full year ended December 31, 2014.

For the fourth quarter of 2014, Sucampo reported year-over-year growth of 54% to $37.8 million in total revenue, including 25% growth to $18.6 million in product royalty revenue from sales of AMITIZA in the U.S. and 44% growth to $7.4 million in product sales revenue of AMITIZA in Japan. Included in total revenue and contract and collaboration revenue for the fourth quarter of 2014 is an upfront payment from Takeda Pharmaceuticals (Takeda) related to the global license, development, commercialization and supply agreement (Global Takeda Agreement) for AMITIZA^® (lubiprostone). Sucampo recognized $8.0 million of the $14.0 million of the upfront payment in the fourth quarter of 2014. Excluding this upfront payment, Sucampo reported year-over-year growth of 22% in total revenue for the fourth quarter of 2014.

Sucampo reported GAAP net income of $9.3 million and fully-diluted earnings per share (EPS) of $0.21 during the fourth quarter of 2014. Sucampo also reported GAAP net income of $13.1 million and fully-diluted EPS of $0.29 for the full year of 2014. Excluding special items, Sucampo reported non-GAAP net income of $17.9 million and fully-diluted EPS of $0.40 for the full year of 2014, both in line with prior issued guidance. Reconciliations for the fourth quarters and full years 2013 and 2014 are included in the financial section.

“In 2014, following a detailed review of our business and opportunities, Sucampo took significant steps to implement our corporate strategy by securing the foundation of our AMITIZA revenues, focusing the organization, strengthening our scientific capabilities, and prioritizing our development pipeline,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “We have already executed on these near-term priorities in our strategy, while achieving strong financial results for our shareholders. As we look to the future, we remain focused on operational excellence with an eye toward continued revenue growth and the progression and diversification of our development pipeline.”

Fourth Quarter 2014 Operational Review

AMITIZA

United States (U.S.)

• AMITIZA total prescriptions were 354,354, an increase of 5%, compared to the fourth quarter of 2013. Net sales of AMITIZA, reported by Takeda for royalty calculation purposes, increased 17% to $91.1 million for the fourth quarter of 2014, compared to $78.0 million in the same period of 2013. Net sales of AMITIZA, reported by Takeda for royalty calculation purposes, increased 18% to $331.6 million for the full year of 2014, compared to $282.1 million in the same period of 2013.
• Sucampo, Takeda and R-Tech Ueno, Ltd. (R-Tech) entered into a settlement and license agreement with Anchen Pharmaceuticals, Inc., Par Pharmaceutical, Inc. (Par) and Par Pharmaceutical Companies, Inc. that resolved the patent infringement litigation among the parties related to AMITIZA 8 mcg and 24 mcg soft gelatin capsules for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). In addition, Sucampo and Takeda amended our existing collaboration and license agreement and associated agreements covering the U.S. and Canada for AMITIZA. As a result of these agreements, among other changes, starting in 2021, Sucampo will split the gross profits from the sale of the generic or authorized generic version of AMITIZA 8 mcg and 24 mcg soft gelatin capsules for CIC and IBS-C by Par and split annual net sales revenue of the branded versions of AMITIZA with Takeda. In the event Par chooses to launch an authorized generic version, Sucampo will supply Par under a manufacturing and supply agreement at a negotiated supply price.
• Sucampo, R-Tech, Takeda, and certain affiliates of Takeda filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s) related to an Abbreviated New Drug Application (ANDA) that Dr. Reddy’s filed with the U.S. Food and Drug Administration (FDA) to market, sell and use a generic version of the 8 mcg and 24 mcg AMITIZA soft gelatin capsule products. Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit, final FDA approval of Dr. Reddy’s ANDA will be stayed up to 30 months from the date of receipt of the notice letter.

Global Markets

• In Japan, Sucampo’s revenue from sales of AMITIZA to Abbott Japan Co., Ltd. (Abbott) increased 44% to $7.4 million for the fourth quarter of 2014, compared to the same period of 2013. Sucampo’s revenue from sales of AMITIZA to Abbott increased 103% to $32.1 million for the full year of 2014, compared to the same period of 2013.
• We entered into a Global Takeda Agreement which expanded Takeda’s exclusive rights to commercialize AMITIZA in the E.U. and all other global markets outside of the U.S., Canada, Japan and the People’s Republic of China. Upon signing this agreement, we received an upfront payment of $14 million. Sucampo is responsible for the first $6 million in development expenses with Takeda responsible for all development activities and subsequent expenses. We also signed an exclusive global manufacturing and supply agreement with R-Tech for clinical and commercial supplies of AMITIZA in most global markets.
• Early in 2015, the European Mutual Recognition Procedure (MRP) for AMITIZA for the treatment of CIC was successfully completed in Austria, Belgium, Germany, Italy, Ireland, Luxembourg, Netherlands and Spain, resulting in a recommendation for marketing authorization. Following the positive MRP outcome, each member state is expected to issue a national marketing authorization. In February 2015, Ireland became the first of these countries to issue a marketing authorization.
• In Canada, Sucampo’s New Drug Submission for AMITIZA for CIC and opioid-induced constipation (OIC) indications with Health Canada was accepted. A decision is anticipated in the second half of 2015.

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