Sunny Pharmtech Chairman Yon-Lian Wu stated at the annual shareholders' meeting on June 27 that the company has signed multiple international distribution authorization contracts for pharmaceutical products this year and secured CDMO orders for the U.S. market. The company will continue to focus on developing new products and accelerating global market expansion, striving towards profitability targets.
Sunny Pharmtech's revenue last year reached NT$428 million, a 19.2% year-on-year increase, setting a new historical record. Benefiting from an increased proportion of project milestone payments, EBITDA (earnings before interest, taxes, depreciation, and amortization) turned positive, significantly reducing the annual loss to NT$0.44 per share.
Regarding the key U.S. market, Wu noted that the company obtained two U.S. drug approvals in the fourth quarter of last year. Shipment volumes have gradually increased since the beginning of this year, with cumulative revenue for the first five months reaching NT$210 million, a 37.4% year-on-year growth. In February, Sunny Pharmtech submitted an ANDA for CIT-I (osteoporosis treatment), followed by an ANDA for SEL-I (special nutritional deficiency treatment) in April, both of which could potentially be approved within a year. The company plans to submit applications for two more drug certifications within a year, potentially contributing to future revenue growth.
Furthermore, Sunny Pharmtech has signed a U.S. market sales contract with Company S for NTN, a pulmonary fibrosis drug jointly developed with domestic partners. NTN is a P4 generic drug in the U.S., with the original drug's U.S. market sales reaching $2.4 billion last year. Sunny Pharmtech plans to submit a drug application to the FDA in the second quarter of next year, aiming to capture market share through its strategic partner's marketing channel advantages.
In terms of multi-certification strategy, Sunny Pharmtech submitted applications for TIT-T (Wilson's disease treatment) in Taiwan and CPT-I (treatment for miscarriage and postpartum hemorrhage) in China in the second half of last year. The company plans to submit four more drug certification applications in Taiwan, the UK, and the Middle East within a year. Sunny Pharmtech has also completed several distribution authorization contracts outside the U.S., including sales contracts for CPT-I in the UK and Middle East markets, and NFT-C (anti-infective drug) in the UK market, positioning itself early for opportunities outside the U.S.
In the CDMO sector, Sunny Pharmtech successfully secured a contract in the first half of this year to manufacture soft capsules for prostate cancer treatment, targeting a U.S. market opportunity worth over $10 billion. After completing technology and process transfers, shipments will be made in batches according to orders and production schedules, expected to contribute to revenue starting from the first quarter of next year.
Regarding production line development, PTD API, CPA-I, and AMA-S passed FDA inspection in July last year, while TIT API and suspension formulation passed TFDA inspection in September. TIT and ITN soft capsules completed TFDA inspection procedures in April and June this year, respectively. SEL-I inspection is expected to take place in July.
Sunny Pharmtech's newly elected directors include Yon-Lian Wu, Jung-Yi Huang (representative of Fubon Financial Holding Venture Capital), Chi-Jui Li (representative of China Investment & Development), Tsung-Jung Li, Tung-He Lin, and independent directors Chih-Hung Liu, Lien-Tsu Li, Yi-Ming Sun, and Pei-Fen Chou.
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