Foamix (FOMX) Misses Q2 EPS by 65c

Foamix (NASDAQ: FOMX) reported Q2 EPS of ($1.05), $0.65 worse than the analyst estimate of ($0.40). Revenue for the quarter came in at $308 thousand versus the consensus estimate of $770 thousand.

“The recent FDA approval of AMZEEQ™ for moderate-to-severe acne was a major milestone for Foamix as we transition to becoming a commercial stage organization. AMZEEQ is the first FDA approved topical form of minocycline and its approval represents a significant step in our goal of enhancing the standard of care for acne sufferers in the U.S.,” said David Domzalski, Chief Executive Officer of Foamix. “Our commercial team is now in the final stages of preparing for the U.S. launch of AMZEEQ, which is on track to occur in January 2020. We were very pleased also, by the FDA acceptance of our NDA for FMX103, minocycline topical foam for moderate-to-severe papulopustular rosacea, which puts us in sight of potential approval for this product in 2020. Our pipeline continues to advance and we recently initiated a Phase II clinical trial to evaluate the safety and efficacy of our combination foam FCD105 for acne.”

“We are excited to announce today that we have entered into a definitive merger agreement with Menlo Therapeutics,” added Mr. Domzalski. “The combination of the two companies accelerates our progression to becoming a leading dermatology-focused company with several late-stage assets that can leverage the commercialization infrastructure we are building. Menlo’s lead product candidate, serlopitant for pruritus associated with prurigo nodularis, represents a breakthrough therapy for a dermatologic condition with no currently approved treatment options. Its addition means we have the potential for three commercial launches in a two year timeframe. The combination also strengthens our balance sheet. Upon closing we expect to have sufficient cash to fund operations through the first half of 2021.”

For earnings history and earnings-related data on Foamix (FOMX) click here.

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