Foamix Pharmaceuticals Ltd (FOMX)

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Foamix Reports Fiscal Year 2018 Financial Results and Provides Corporate Update
GlobeNewswire•February 28, 2019

Conference Call Scheduled for Friday, March 1 at 8:30am Eastern Time

REHOVOT, Israel and BRIDGEWATER, N.J., Feb. 28, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix Pharmaceuticals” or the “Company”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced financial results for the year ended December 31, 2018 and provided key corporate updates.

“Late last year, we reached a major milestone with the filing of our first NDA for our most advanced candidate, FMX101, for acne,” said David Domzalski, CEO of Foamix. “This puts us in sight of our first potential commercial approval in the fourth quarter this year. We plan to file a second NDA, for FMX103 for rosacea, in mid-year. Both of these candidates address dermatological indications with large patient populations in need of differentiated, more effective treatment alternatives. We have both the resources and management team in place to transition to commercialization, and we see a great opportunity to serve the dermatology community as well as create value for our shareholders.”

Fourth Quarter 2018 and Recent Corporate & Regulatory Update:

Submitted a New Drug Application (NDA), via a 505(b)(2) regulatory pathway, to the U.S. Food and Drug Administration (FDA) seeking approval for FMX101 for the treatment of moderate-to-severe acne.
Announced topline results from its Phase 3 program evaluating FMX103 1.5% minocycline foam, in the treatment of moderate-to-severe papulopustular rosacea.
Studies FX2016-11 and FX2016-12 met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment (“IGA”) treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.
Reported data from study FX2016-13 evaluating the long-term safety of FMX103 in moderate-to-severe papulopustular rosacea demonstrating positive safety data for its Phase 3 open-label safety with continuing development of efficacy beyond the initial 12 weeks of therapy.
Announced, during an R&D Day in New York on January 24th 2019, the company plans to initiate a Phase 2 study during Q2, 2019, for FCD105, a minocycline plus adapalene combination foam product for acne.
Strengthened Board of Directors and Management Team
Matt Wiley appointed as Chief Commercial Officer. In this newly created position, Mr. Wiley is responsible for the development and execution of commercial strategies of the Company’s product portfolio, including the planned launches of FMX101 for acne and FMX103 for rosacea.
Sharon Barbari and Anthony Bruno appointed to Board of Directors.

Financial Results for the Year Ended December 31, 2018
Revenues
Total revenues for the year ended December 31, 2018 were $3.6 million, compared to $3.7 million in the year ended December 31, 2017. The revenues for the year ended December 31, 2018 consisted of royalty payments in the amount of $3.5 million and $62 thousand from contingent payments.

Research and Development Expenses
Research and development expenses for the year ended December 31, 2018 were $64.5 million, an increase of $6.7 million, or 11.6%, compared to $57.8 million for the year ended December 31, 2017. The increase in research and development expenses resulted primarily from an increase of $5 million in costs relating predominantly to FMX101 and FMX103 clinical trials; an increase of $0.6 million in consultant expenses and an increase of $0.4 million in payroll and payroll related expenses mostly due to increase in headcount, bonuses and share based compensation expenses.

Selling, General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2018 were $14.0 million, an increase of $2.5 million, or 21.7%, compared to $11.5 million for the year ended December 31, 2017. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.1 million in consultant expenses mostly relating to pre-commercialization activities and an increase of $0.7 million in payroll and other payroll-related expenses mostly due to increase in headcount, bonuses and share based compensation expenses.

Net Loss
Net loss for the year ended December 31, 2018 was $74.2 million, or ($1.70) per diluted share, compared to $65.7 million, or ($1.76) per diluted share for the year ended December 31, 2017.

Cash & Cash Equivalents
At December 31, 2018, the Company had $99.4 million in cash and investments compared to $76.4 million at the end of December 2017. The Company currently anticipates that its existing cash and investments we will be able to fund planned operating expenses and capital expenditure requirements through mid-2020. These planned expenses include: (a) any pre-commercialization and launch preparations for FMX101, assuming the Company receives regulatory approval, (b) full development and filing of an NDA for FMX103, which the Company expects to submit in mid-2019 and (c) certain pipeline development activities.

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Conference ID: 13687390
Webcast: http://public.viavid.com/index.php?id=133210

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Conference ID: 13687390