Foresee Pharmaceuticals recently announced consolidated revenue of NT$25.26 million for September, reflecting a year-on-year decline of 58.37%. This decrease was due to the higher base from September of last year, when all third-quarter royalties were recognized at once. However, for the first three quarters of this year, the company posted a significant revenue growth of 120%, with total consolidated revenue reaching NT$278 million. Foresee plans to file a New Drug Application (NDA) with the U.S. FDA this month for its 3-month formulation of CAMCEVI 21 mg, a treatment for prostate cancer, and expects approval in 2025.
Sales of the 6-month formulation of CAMCEVI in the U.S. market reached 1,954 units in September, remaining stable compared to August’s 1,970 units, and marking a 23% year-on-year growth. The total third-quarter sales volume reached 6,179 units, setting a new quarterly sales record. Looking ahead, the company expects its market share to continue its upward trend.
September's consolidated revenue of NT$25.26 million was primarily driven by CAMCEVI 6-month formulation sales to U.S. distributors, which generated NT$17.4 million, and revenue sharing from U.S. end-market sales, which contributed NT$7.44 million. The significant year-on-year decline of 58.37% is attributed to the change in royalty recognition: last year, royalties were recognized quarterly, but starting from October 1, 2022, they have been recognized monthly. As a result, last September's revenue included royalties from July to September, while this year’s September revenue only included royalties for that month.
Foresee plans to submit the NDA for CAMCEVI 21 mg (3-month formulation) to the FDA this month. Once the application is submitted, the company will recognize deferred licensing milestone payments under IFRS 15. Approval for the new formulation is anticipated in 2025, with sales expected to begin in the first half of 2026 following the issuance of a J-code by the CMS (Centers for Medicare & Medicaid Services). According to IQVIA data, the U.S. market demand for the 3-month formulation is more than double that of the 6-month version. To meet this higher demand, Foresee is applying to the FDA for approval based on scaled-up batch data.
Outside the U.S., Foresee’s licensing partner, Accord Healthcare, plans to launch the CAMCEVI 42 mg (6-month formulation) in Germany by the end of this year, followed by Canada and other countries in 2025. In China, Foresee's licensing partner, Changchun Jinsai Pharmaceutical, is expected to submit the NDA for the CAMCEVI 6-month formulation to the National Medical Products Administration (NMPA) around the end of this year. Additionally, Phase III clinical trials of CAMCEVI for treating central precocious puberty in children and premenopausal breast cancer are progressing actively.
Resource (mandarin): 逸達前三季營收大增120%，前列腺癌三個月劑型本月向美FDA提藥證申請
