Dainippon Sumitomo Pharma Co., Ltd. reported consolidated earnings results for the fourth quarter and year ended March 31, 2013. For the year, the company reported net sales of ¥347.7 billion, operating income of ¥25.0 billion, net income of ¥10.0 billion or ¥25.28 per share against net sales of ¥350.4 billion, operating income of ¥20.4 billion, net income of ¥8.6 billion or ¥21.72 per share a year ago. Income before income taxes and minority interests was ¥18.2 billion against ¥16.3 billion a year ago. Ordinary income was ¥24.5 million against ¥18.9 million a year ago. Income before minority interests was ¥10.0 billion against ¥8.6 billion a year ago. EBITDA was ¥60.3 billion against ¥59.9 billion a year ago. Net cash provided by operating activities was ¥49.9 billion against ¥48.4 billion a year ago. Return on equity was 3.0% against 2.7% a year ago. Capital expenditures was ¥10.4 billion against ¥8.7 billion a year ago. For the quarter, the company reported net sales of ¥78.5 billion, operating loss of ¥7.7 billion, net loss of ¥6.8 billion or ¥42.45 per share against net sales of ¥85.2 billion, operating loss of ¥1.9 billion, net income of ¥1.6 billion or ¥25.86 per share a year ago. Loss before income taxes and minority interests was ¥10.2 billion against ¥3.3 billion a year ago. Ordinary loss was ¥8.2 million against ¥3.1 million a year ago. For the second quarter of fiscal year 2013, the company expects net sales of ¥178 billion, operating income of ¥10 billion, net income of ¥5 billion and earnings per share of ¥12.58 per share, ordinary income of ¥10.0 billion and EBITDA of ¥25.0 billion. For the fiscal year 2013, the company expects net sales of ¥369 billion, operating income of ¥26 billion, net income of ¥13 billion and earnings per share of ¥32.72 per share, ordinary income of ¥25.0 billion and EBITDA of ¥54.0 billion. The company expects capital expenditure of ¥15 billion.

Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced that it has signed a research, development and commercial license agreement for the territory of Japan with Edison Pharmaceuticals, Inc. (Edison) for EPI-743 and EPI-589, therapeutic agents under development by Edison for mitochondrial disease. Under the terms of the agreement, DSP obtains exclusive research, development and commercial rights in Japan for EPI-743 and EPI-589. Edison will receive USD 35 million in an upfront payment and USD 15 million as an R&D support fee for the development of EPI-589. In addition, Edison will receive USD 10-35 million in milestone payments per indication associated with successful development. After launch, Edison will receive royalties based on sales amounts and up to USD 460 million in milestone payments in accordance with sales goals. Edison is currently conducting a Phase 2B clinical trial of EPI-743 in the U.S. and Europe for Leigh syndrome-a mitochondrial disease which currently has no treatments. EPI-743 is expected to be a world first treatment for mitochondrial diseases beginning with Leigh syndrome. EPI-589 is a next-generation redox cofactor modeled after EPI-743. Edison is conducting pre-clinical studies on EPI-589 and intends to advance its development for neuropsychiatric indications that share as common etiology disorders of redox biochemistry.

Dainippon Sumitomo Pharma Co., Ltd. and Nippon Shinyaku Co. Ltd. announced they have concluded a license agreement for exclusive rights to develop, manufacture and commercialize SMP-986 in Japan, a new therapeutic agent for overactive bladder created by DSP. Completing Phase 2 studies in Japan, Europe and the U.S., DSP was searching for a partner with a strong presence in urology. As a result, DSP chose Nippon Shinyaku as its best partner for the Japanese market. Under this agreement, Nippon Shinyaku obtains exclusive rights to develop, manufacture and commercialize SMP-986 in Japan for general urological diseases. In return, Nippon Shinyaku will pay DSP an upfront fee and make development milestone payments. In addition, after launch Nippon Shinyaku will also pay DSP royalties according to sales amounts and milestone payments in accordance with sales goals. SMP-986 possesses the dual pharmacological actions of muscarinic receptor antagonism and inhibition through Na+-channel blockade. In the future, Nippon Shinyaku plans to proceed with the development of SMP-986 to obtain approval for the indication of nocturia. Nippon Shinyaku hopes that by promoting the development of SMP-986 and providing it to the medical field as soon as possible it can better the lives of patients.