On May 8, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology,reported financial results for the first quarter ended March 31, 2018 (Press release, Foamix, MAY 8, 2018, View Source [SID1234526228]).
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Clinical and Corporate Update:
• The final patient has been enrolled and dosed in the third Phase 3 study (FX2017-22) investigating FMX101, the Company’s minocycline foam 4%, in patients with moderate-to severe acne.
Top-line results are expected in the third quarter of 2018.
The expected NDA filing for FMX101 is planned for the end of 2018.
• In April 2018, the Company raised aggregate gross proceeds of approximately $16.2 million through a direct registered offering of approximately 2.9 million shares at a price of $5.50 per share to OrbiMed Partners Master Fund Limited.
• On February 14th, 2018, the Company conducted a Type B pre-NDA meeting with the FDA to discuss the submission of a 505(b)(2) application for FMX101.
• In January 2018, the Company announced positive safety data for the Phase 3 open-label safety extension study of FMX101 in moderate-to-severe acne for a treatment period of up to one year.
Details on the open-label study results for FMX101, including efficacy results at 52 weeks, are contained within the most recent Investor Presentation, available on the Company’s website at View Source
Financial Results for the First Quarter Ended March 31, 2018
Revenues
Revenues for the first quarter of 2018 were $906,000, a decrease of $21,000, or 2.3%, from $927,000 in the first quarter of 2017. The decrease is mainly due to a decrease in royalty payments in the amount of $83,000 from Bayer for sales of Finacea Foam.
Operating Expenses
Research and Development Expenses
Research and development expenses for the first quarter were $22.8 million, compared to $12.7 million in the first quarter of 2017. The increase in research and development expenses resulted primarily from an increase of $9.1 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $634,000 in payroll and payroll-related expenses (including share-based compensation) primarily due to a change in the measurement of share-based compensation expenses of a consultant and the increase in headcount and salary raises.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the first quarter of 2018 were $3.8 million, compared to $2.8 million in in the first quarter of 2017. The increase in selling, general and administrative expenses resulted primarily from an increase in payroll and other payroll-related expenses (including share-based compensation) mostly due to an increase in headcount, salary raises and accounting modification relating to share-based compensation of a consultant.
Net Loss
For the quarter ended March 31, 2018, the Company recorded a net loss of $26.0 million, or $0.69 per share, basic and diluted, compared with a loss of $14.4 million or $0.39 per share, basic and diluted, for the quarter ended March 31, 2017.
Cash & Cash Equivalents
At March 31, 2018, the Company had $53.1 million in cash and investments compared to $76.4 million at December 31, 2017. Subsequent to the end of the first quarter, the Company raised gross proceeds of $16.2 million in a registered share offering with OrbiMed Partners Master Fund Limited. The Company believes, based on its current business plan, that its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements throughout the completion of its third pivotal Phase 3 clinical trial for its lead product candidate FMX101 and its two pivotal Phase 3 clinical trials for FMX103.
Conference Call & Webcast
Wednesday, May 9 @ 8:30am Eastern Time
Toll Free: 800-289-0438
International: 323-794-2423
Conference ID: 5805126
Webcast: View Source
Replays, Available through May 23:
Toll-Free: 844-512-2921
International: 412-317-6671
Conference ID: 5805126
A replay will also be archived on the Company’s website at www.foamix.com promptly after the conference call.