Foamix Pharmaceuticals Ltd., a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, announced that it has secured up to $64 million in financing from Perceptive Advisors and OrbiMed. The financing consists of term loans of up to $50 million under a Credit Agreement, with $15 million provided immediately upon satisfaction of certain closing conditions, $20 million available upon the achievement of certain regulatory milestones and $15 million available upon the achievement of certain revenue milestones.

Additionally, the Company will receive $14 million in gross proceeds from Perceptive Advisors through a direct registered offering of the Company’s ordinary shares. Proceeds from the transactions are expected to be used to fund the Company’s filing of a New Drug Application (“NDA”) with the FDA for FMX103 for the treatment of papulopustular rosacea as well as, assuming FDA approval is received, the anticipated product launches of FMX101 for the treatment of moderate to severe acne and FMX103, as well as for working capital and general corporate purposes.  The FDA has established October 20th, 2019 as the Prescription Drug User Fee Act (PDUFA) action date for FMX101, and Foamix is in the final stages of preparation for the NDA submission for FMX103.

“Perceptive Advisors and OrbiMed are our largest shareholders and we are grateful for the ongoing support from these top-tier healthcare investment firms,” said David Domzalski, CEO of Foamix.  “As we manage the transition of Foamix to becoming a fully integrated commercial organization it is important that the Company is financed appropriately.  Combined with our current cash position, we believe these initial investments, along with future access to capital which this transaction provides, will allow us to fund the commercial launches for FMX101 and FMX103, pending FDA approval.”

Under the Credit Agreement and Guaranty between Foamix and affiliates of Perceptive Advisors and OrbiMed, there are no required payments of principal amounts until July 2023. In connection with the Credit Agreement, Foamix issued to affiliates of Perceptive Advisors and OrbiMed warrants to purchase up to an aggregate of 1,100,000 of its ordinary shares, par value NIS 0.16 per share, at an exercise price of $2.09 per share, which represents the 5-day volume weighted average price as of the trading day immediately prior to the closing.