TAINAN, February 3, 2015 /PRNewswire/ — ScinoPharm Taiwan, Ltd (TWSE: 1789), an active pharmaceutical ingredient (API) and formulation specialty company, today announced unaudited financial results for its fiscal year 2014. The consolidated revenue was NT$4.098 billion (US$135 million), after-tax net profits were NT$0.484 billion (US$16 million), and after-tax earnings per share was NT$0.69 (US$0.02).
ScinoPharm’s revenues from its generic API sales and from its contract manufacturing business did not meet expectations in 2014 due to market conditions and supplier issues. Orders for ScinoPharm’s Topiramate, the API used in the weight loss drug Qsymia, fell as market demand for Qsymia was weak in the US; also, the raw material cost for ScinoPharm’s two main anti-cancer products, Paclitaxel and Docetaxel, increased significantly, coupled with supply shortages, negatively affecting revenues and profits. Additionally, the recently completed large Changshu plant in China, scheduled for a US FDA inspection late this year or early next year, is currently not yet approved for commercial production, resulting in idle capacity and addition to amortization and depreciation expenses. The price erosion on existing generic APIs further affected ScinoPharm’s performance over the past year.
Dr. Yung-Fa Chen, President and CEO of ScinoPharm said, "Faced with ever increasing competitive challenges, ScinoPharm plans to accelerate the process of new product development and expand its product pipleline, expediting its corporate transformation by creating new products with its own research and development capabilities and through collaboration with its global strategic partners. ScinoPharm also aims to expand its Contract Research and Manufacturing (CRAM) services to carry out projects with diversified manufacturing processes and indications for international new drug development companies, thus leveraging risks, improving capacity utilization, and cultivating future volume sales for the yet-to-be inspected Changshu plant in China. Moreover, ScinoPharm will continue to optimize its manufacturing processes and operational efficiency to create more value."
ScinoPharm’s main products continue to be market leaders. Its API for colorectal cancer drug, Irinotecan, holds 60 to 70 percent of the global market share, its API for non-small cell lung and breast cancer drug, Docetaxel, enjoys 40 to 50 percent of the global market share; and ScinoPharm’s API for ovarian, lung, and breast cancer drug, Paclitaxel, accounts for 20-30 percent market share. Up until the end of last year, ScinoPharm had registered a total of 694 drug master files (DMF) worldwide, with 50 of those registered in the US, making ScinoPharm the top ranked DMF-holder among all stand-alone API companies. Also, with 24 anti-cancer DMFs, ScinoPharm holds the most oncology DMFs among stand-alone API peers in this specialty and wins over unique oncology business from those big generic drug makers.
The ScinoPharm Changshu plant in China has already obtained 9 drug manufacturing licenses and is expected to achieve commercial production after passing an FDA plant inspection late this year or early 2016. ScinoPharm currently has 12 products under review for drug licenses with the China Food and Drug Administration, 10 of which were imported from Taiwan while the other 2 produced locally. Operations at the Changshu plant are ramping up gradually as the plant is currently working on 7 new drug CRAM projects, all in Phase II or Phase III clinical trials. The market has sustained rapid growth alongside China’s economic development and promotion of health reform policies, and ScinoPharm will continue to synergize resources from their Taiwan and mainland China plants to expand their geographic reach globally.
Regarding the construction progress of ScinoPharm’s sterile injectable plants, the first liquid vial line is expected to commence pilot runs this year. In the early stage ScinoPharm will actively pursue contract manufacturing opportunities for new drugs while simultaneously producing registration batches of its own self-developed generic drugs. The first generic drug application is expected to be filed in the first quarter of 2017 and approved by US FDA in 2018. Commercial productions of formulation products will then start to fulfill customer needs for one-stop shopping and elevate ScinoPharm’s value creation in the anti-cancer field.
ScinoPharm Taiwan, Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With research and manufacturing facilities in both Taiwan and China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities for brand companies as well as APIs for the generic industry. The Company also is aggressively pursuing a vertically integrated, one-stop-shopping service for drug product customers by expanding into the field of sterile oncological injectable formulations. For more information, please visit the Company’s website at http://www.scinopharm.com.
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