Foresee Pharmaceuticals reported that its August consolidated revenue reached NT$142 million, marking the second-highest monthly record, with a remarkable year-on-year increase of 640.8%. Cumulative revenue from January to August totaled NT$373 million, up 47.4% year-on-year. The growth was largely driven by milestone payments linked to the U.S. approval of Camcevi’s three-month formulation.

The August revenue breakdown included NT$130 million from milestone payments recognized following the FDA approval of Camcevi ETM (three-month formulation), NT$7.65 million from sales profit-sharing of Camcevi’s six-month formulation in the U.S. end market, and NT$4.18 million from service income.

Foresee Pharmaceuticals stated that the U.S. end-market sales of Camcevi’s six-month formulation in August totaled 1,967 units, a slight increase of approximately 1.8% from July’s 1,932 units. The three-month formulation is scheduled for U.S. launch in the second half of next year after completing three validation batches, with its distributor, Accord BioPharma, applying for a new J-Code with the U.S. federal healthcare system, allowing flexible pricing. The projected timeline mirrors the approximately 11-month period between FDA approval and market launch of the six-month formulation, which was approved in May 2021 and launched in April 2022.

For context, Foresee’s long-acting Leuprolide injections for advanced prostate cancer are available in one-, three-, four-, and six-month formulations. The three-month formulation, the largest segment, has an annual U.S. sales volume of approximately 450,000 units, twice that of the six-month formulation. Globally outside the U.S., sales of the three-month formulation significantly exceed the six-month formulation.

To meet growing demand from the upcoming global launches of Camcevi’s six-month and three-month formulations, Foresee has actively planned capacity expansion and supply chain resilience, including technology transfer to its European and U.S. licensing partner Intas’ facility in India, and to its China licensing partner JinSai. The French contract manufacturer Fareva will optimize its production line and conduct phased equipment upgrades to comply with the latest EU GMP Annex 1 standards, ensuring seamless transfer between the existing and new Camcevi six-month formulation processes.

Additionally, Intas has received EU EMA approval to produce Camcevi at its new India facility, establishing a dual production base with France.

Foresee noted that before these technology transfers are fully implemented, supply to the U.S., China, Canada, and other markets will continue to rely on Fareva’s existing capacity in France. During Fareva’s equipment upgrades, temporary adjustments to production lines may affect the commercial supply schedule for Camcevi’s six-month formulation to licensing partners, potentially causing short-term fluctuations in sales profit-sharing.

Foresee emphasized that although short-term supply and royalty income may be impacted, investments in equipment and capacity expansion will enhance supply stability and scale efficiency. As Camcevi’s three-month and six-month formulations gradually enter multiple major global markets, these improvements are expected to drive sustainable medium- to long-term revenue growth.

Resource: Camcevi藥證里程金助攻 逸達8月營收1.42億 創次高