Foresee Pharmaceuticals posted consolidated revenue of NT$116 million in October, marking a 358% month-over-month increase and an 810% year-over-year growth. This surge represents the company’s highest single-month revenue since it recognized a significant milestone payment for the U.S. launch of CAMCEVI’s six-month formulation in April 2022.
The impressive revenue growth in October was primarily driven by deferred licensing income and sales royalties recognized under IFRS15. Following Foresee’s recent submission of a New Drug Application (NDA) for CAMCEVI’s three-month formulation to the U.S. FDA, the company recorded NT$105 million in deferred licensing income, along with NT$9.93 million in sales royalties from CAMCEVI’s six-month formulation in the U.S. market.
No commercial sales revenue was recognized from product shipments in October, as shipments to the U.S. distributor are on an as-needed basis.
Foresee reported that CAMCEVI’s six-month formulation sold 2,111 units in the U.S. market in October, representing an 8% increase from September’s 1,954 units and a 24% increase year-over-year. The company remains optimistic about continued market share growth.
Looking ahead, Foresee anticipates U.S. FDA approval for CAMCEVI’s three-month formulation in 2025, followed by the issuance of a CMS J-code to facilitate reimbursement and a targeted U.S. market launch in the first half of 2026. This new formulation is expected to drive a new wave of milestone payments and royalties, potentially boosting the sales volume of the existing six-month formulation.
According to IQVIA data, demand for three-month formulations in the U.S. is more than twice that for six-month formulations. Foresee aims to meet this demand by submitting an NDA for the three-month formulation with scaled production data to the FDA.
Internationally, Foresee plans to submit a marketing authorization application for CAMCEVI’s three-month formulation to the EMA in the first quarter of next year. Licensing partner Accord Healthcare aims to launch CAMCEVI’s six-month formulation in Germany by the end of this year and in Canada next year. In China, Jinsai Pharmaceutical intends to file for marketing approval of CAMCEVI’s six-month formulation with the NMPA based on pre-NDA meeting conclusions. Phase III trials for the six-month formulation targeting pediatric central precocious puberty and premenopausal breast cancer are also progressing actively.
With the ongoing development of CAMCEVI’s new formulations, expanded markets, and additional indications, Foresee expects its revenue to achieve substantial and sustained growth over the medium to long term.
Resource (mandarin): 逸達10月營收1.16億元 創近30個月新高
