Foresee Pharmaceuticals recently announced consolidated revenue of NT$8.85 million in July, representing a month-on-month decline of 77.2% and a year-on-year decrease of 75.2%. The company attributed the drop primarily to the absence of product supply to distributors during the month, coupled with changes in distributor customer mix. Looking ahead, Foresee expects growth in the second half of the year, supported by milestone payments upon anticipated U.S. FDA approval of Camcevi’s three-month formulation on the target date of August 29.

For the period from January to July 2024, Foresee reported consolidated revenue of approximately NT$231 million, comparable to NT$234 million during the same period last year. July’s consolidated revenue consisted of NT$8.31 million in profit sharing from U.S. terminal market sales of the six-month Camcevi formulation, and NT$0.54 million in service revenue tied to regulatory consulting progress for the three-month formulation’s U.S. NDA submission.

According to Foresee, U.S. terminal market sales volume of the six-month Camcevi formulation in July reached 1,932 units, down about 16% from 2,297 units in June, largely due to distributor customer mix changes. Cumulative sales from January to July totaled 14,033 units, representing a 2.1% increase compared to the same period last year. The average profit per unit in July also normalized, returning to standard levels after being unusually high in the prior two months due to favorable results from annual adjustments.

Looking ahead to the second half of the year, Camcevi-related revenues are expected to grow significantly compared with the same period last year, boosted by milestone payments tied to the anticipated U.S. approval of the three-month formulation (PDUFA target date: August 29).

In addition, Foresee announced that clinical research results on Camcevi for prostate cancer have been accepted for publication by the official medical journal of the Large Urology Group Practice Association (LUGPA). The study confirmed that the three-month formulation of Camcevi [FP-001 21 mg (leuprolide mesylate)]—a prefilled, ready-to-use, long-acting injectable that requires no reconstitution prior to administration—is an effective and safe androgen deprivation therapy (ADT) for the treatment of advanced prostate cancer.

Resource: 逸達Camcevi三個月劑型美國藥證 目標8月29日通過上市許可