TAINAN, Taiwan, Feb. 14, 2017 /PRNewswire/ -- ScinoPharm Taiwan, Ltd (TWSE: 1789), an active pharmaceutical ingredient (API) and formulation specialty company, announced unaudited financial results for its fiscal year 2016. The consolidated revenue was NT$4.031 billion (US$125 million), after-tax net profits were NT$659 million (US$20.4 million). The after-tax earnings per share was NT$0.87
(US$0.027).
In 2016, overall revenue increased by 2% compared to 2015 primarily as a result of the sales boost of generic APIs, including an increased market share of Gemcitabine combined with more flexible strategies, increased shipments of Paclitaxel, as well as greater customer needs of Entecavir (HBV) and Riluzole (ALS) in anticipation for commercial launch. In terms of contract research services (CRO), several customers have achieved favorable clinical results in their Phase III trials, suggesting an increased shipment volumes and revenues. Meanwhile, revenue from contract manufacturing services (CMO) suffered a sharp reduction due to lower order volume of anti-depressants and anti-obesity drugs, but the overall performance of 2016 has been promising.
Increased profit is evident in an overall gross profit margin of 45%; this is a result of a favorable blend of products and clients, especially with increased sales volume of higher profit oncology products and CRO projects. The strategic entry of oncology API Gemcitabine also contributed strongly in the company's gross margin increase. ScinoPharm also demonstrated profitability improvement by tighter cost control, process optimization, and enhanced management efficiency.
ScinoPharm continues to pursue strategic alliances in order to enhance its position as a developer and manufacturer of innovative products with high added value. Currently, two ANDA submissions have been filed: an oncology injectable drug jointly developed with U.S.-based SAGENT Pharmaceuticals, and ScinoPharm-developed Fondaparinux. Product partnerships based on co-development and profit-sharing models have been established for eleven products. Furthermore, ScinoPharm is currently negotiating with major international companies for exclusive distribution rights in Europe and the U.S for the drug products indicated for cancer, multiple sclerosis, osteoporosis, diabetes mellitus, etc. To this end, investments were made to enable a GMP-compliant manufacturing plant for injectable products. The injectable plant is being positioned to prepare its first registration batch this year, file ANDA submission by the end of 2018, and expect a USFDA on-site inspection in 2019.
The Changshu site in Jiangsu, China, initiated full-scale operations, contributing to ScinoPharm's overall revenues. In efforts to expand the existing CRAM business operations, the company is focusing on mid- to late-phase projects. The current portfolio includes agents in the indications of oncology, anti-hypertension, diabetes, and other therapeutics. The Changshu site is also seeking large-volume generic APIs and intermediates to increase production utilization and is exploring partnerships with generic formulation firms to maximize market share in China via joint development and registration.
Oncology products continue to be the mainstay of the company's portfolio. The three primary products in the last year include Paclitaxel for ovarian, lung, and breast cancer, Irinotecan for colorectal cancer, and Gemcitabine for small cell lung and breast cancer. These three products retained ScinoPharm's market share dominance worldwide, which reaffirms the company position as a global leader in oncology product supply. ScinoPharm's regulatory presence in oncology is demonstrated and strengthened by the number of completed drug master files (DMF): The Company has applied for 733 DMFs worldwide, including 55 in the US. Of the 55 US DMFs, 32 are for oncology products. This is an unparalleled number of total DMFs among the independent global providers of APIs and proof of the company's persistent efforts in oncology products.
To date, ScinoPharm has developed 72 generic APIs, including 25 marketed products. Numerous others are awaiting the subsequent expiration of active patents. In 2017, ScinoPharm anticipates launching 2 APIs for generic, 1 API for CMO project, and 1 co-developed generic injectable drug, primarily in the US and European markets. These drugs are for the indications of polyuria, benign prostatic hyperplasia, infections, and oncology.
About ScinoPharm
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 mainland 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 oncology injectable formulations. For more information, please visit the Company's website at http://www.scinopharm.com
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In 2016, overall revenue increased by 2% compared to 2015 primarily as a result of the sales boost of generic APIs, including an increased market share of Gemcitabine combined with more flexible strategies, increased shipments of Paclitaxel, as well as greater customer needs of Entecavir (HBV) and Riluzole (ALS) in anticipation for commercial launch. In terms of contract research services (CRO), several customers have achieved favorable clinical results in their Phase III trials, suggesting an increased shipment volumes and revenues. Meanwhile, revenue from contract manufacturing services (CMO) suffered a sharp reduction due to lower order volume of anti-depressants and anti-obesity drugs, but the overall performance of 2016 has been promising.
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Increased profit is evident in an overall gross profit margin of 45%; this is a result of a favorable blend of products and clients, especially with increased sales volume of higher profit oncology products and CRO projects. The strategic entry of oncology API Gemcitabine also contributed strongly in the company's gross margin increase. ScinoPharm also demonstrated profitability improvement by tighter cost control, process optimization, and enhanced management efficiency.
ScinoPharm continues to pursue strategic alliances in order to enhance its position as a developer and manufacturer of innovative products with high added value. Currently, two ANDA submissions have been filed: an oncology injectable drug jointly developed with U.S.-based SAGENT Pharmaceuticals, and ScinoPharm-developed Fondaparinux. Product partnerships based on co-development and profit-sharing models have been established for eleven products. Furthermore, ScinoPharm is currently negotiating with major international companies for exclusive distribution rights in Europe and the U.S for the drug products indicated for cancer, multiple sclerosis, osteoporosis, diabetes mellitus, etc. To this end, investments were made to enable a GMP-compliant manufacturing plant for injectable products. The injectable plant is being positioned to prepare its first registration batch this year, file ANDA submission by the end of 2018, and expect a USFDA on-site inspection in 2019.
The Changshu site in Jiangsu, China, initiated full-scale operations, contributing to ScinoPharm's overall revenues. In efforts to expand the existing CRAM business operations, the company is focusing on mid- to late-phase projects. The current portfolio includes agents in the indications of oncology, anti-hypertension, diabetes, and other therapeutics. The Changshu site is also seeking large-volume generic APIs and intermediates to increase production utilization and is exploring partnerships with generic formulation firms to maximize market share in China via joint development and registration.
Oncology products continue to be the mainstay of the company's portfolio. The three primary products in the last year include Paclitaxel for ovarian, lung, and breast cancer, Irinotecan for colorectal cancer, and Gemcitabine for small cell lung and breast cancer. These three products retained ScinoPharm's market share dominance worldwide, which reaffirms the company position as a global leader in oncology product supply. ScinoPharm's regulatory presence in oncology is demonstrated and strengthened by the number of completed drug master files (DMF): The Company has applied for 733 DMFs worldwide, including 55 in the US. Of the 55 US DMFs, 32 are for oncology products. This is an unparalleled number of total DMFs among the independent global providers of APIs and proof of the company's persistent efforts in oncology products.
To date, ScinoPharm has developed 72 generic APIs, including 25 marketed products. Numerous others are awaiting the subsequent expiration of active patents. In 2017, ScinoPharm anticipates launching 2 APIs for generic, 1 API for CMO project, and 1 co-developed generic injectable drug, primarily in the US and European markets. These drugs are for the indications of polyuria, benign prostatic hyperplasia, infections, and oncology.
About ScinoPharm
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 mainland 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 oncology injectable formulations. For more information, please visit the Company's website at http://www.scinopharm.com
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SOURCE ScinoPharm Taiwan, Ltd.
