On February 28, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix Pharmaceuticals" 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 fiscal year ended December 31, 2017 (Press release, Foamix, FEB 28, 2018, View Source [SID1234524231]).
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Clinical and Corporate Update:
FMX101, the Company’s minocycline foam 4% is currently being evaluated in a third Phase 3 study (Study 22) in patients with moderate-to severe acne.
Top-line results are expected in the third quarter of 2018.
The expected timing of an NDA filing for FMX101 is planned for the end of 2018.
FMX103, 1.5% minocycline foam, is currently being evaluated in two Phase 3 studies (Studies 11 and 12) in patients with moderate-to severe papulopustular rosacea. Long term safety is concurrently being evaluated in the open label Study 13.
Top-line results are expected in late third quarter or early fourth quarter of 2018.
Enrollment in the open-label long term safety study (Study 13) continues to progress as scheduled. A significant number of patients have enrolled into this study and we continue to observe low discontinuation rates.
The expected timing of an NDA filing for FMX103 is planned for 2019.
In January and February 2018, Bayer and Foamix filed joint complaints against each of Teva and Perrigo, respectively, alleging patent infringement under U.S. patent laws arising out of the submissions by Teva and Perrigo of ANDAs seeking approval to manufacture and sell generic versions of Bayer’s Finacea Foam. We are committed to defending our own intellectual property rights globally, including patents we have licensed to other pharmaceutical companies as part of our collaboration efforts.
In January 2018, as part of the orderly transition in management, CEO David Domzalski was appointed to the Board of Directors to replace former CEO and co-founder Dr. Dov Tamarkin.
In January 2018, the Company changed its filing status with the SEC and Nasdaq from a "Foreign Private Issuer" to a U. S. Domestic filer.
FMX101 Open Label Safety Study Results
A total of 657 patients were enrolled in the open-label safety extension after an initial 12 weeks of double-blinded therapy in Phase 3 studies 04 and 05. Of these, 291 completed an additional 40-weeks for a total of 52 weeks on FMX101 therapy. The primary endpoint was safety.
As previously communicated, no serious drug-related adverse events were reported during the open-label safety extension, validating earlier data demonstrating that FMX101 appears to be well tolerated with an acceptable safety profile. Specific findings included:
Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portion of Studies 04 and 05, with the most frequently reported treatment-emergent adverse event being nasopharyngitis (common cold).
Application-site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment. Four patients discontinued the study for an application-site adverse event.
In the assessment of facial dermal tolerability at week 52, more than 95% of patients had "none" or "mild" scoring of erythema, dryness, hyperpigmentation, peeling, and itching. No severe local tolerability scores were recorded.
Efficacy Results at 52 weeks:
Efficacy was also measured as a secondary endpoint in the open-label study for FMX101. During the study, patients were allowed to discontinue therapy with FMX101 if they believed their acne had sufficiently improved. Patients could re-start therapy as needed and were also allowed to use other acne medications concomitantly.
The following summarizes efficacy results for subjects who had been assigned FMX101 therapy for 52 weeks:
At week 52, 37.7% of patients from Study 04 had an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear); 50.3% of subjects from Study 05 had an IGA score of 0 or 1.
At week 52, patients from Study 04 had a 64.3% reduction in inflammatory lesions; patients from Study 05 had a 78% reduction in inflammatory lesions.
At week 52, patients from Study 04 had a 52.5% reduction in non-inflammatory lesions; patients from Study 05 had a 59.6% reduction in non-inflammatory lesions.
Details on the open-label study results for FMX101 are contained within the most recent Investor Presentation, available on the Company’s website at View Source
Financial Results for the Year Ended December 31, 2017
Revenues
Revenues for the year ended December 31, 2017 were $3.7 million, compared with $5.5 million for the same period in 2016. The decrease is mainly due to a decrease of $2.5 million in contingent payments from Bayer, that were payable for 2016 due to Bayer’s achievement of certain sale targets during that year, offset by an increase in royalty payments in the amount of $565,000 from Bayer for the sales of Finacea Foam.
Operating Expenses
Research and Development Expenses
Research and development expenses for the year were $57.8 million, compared to $25.9 million in 2016. The increase in research and development expenses resulted primarily from an increase of $28.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $3.0 million in payroll and payroll related expenses primarily due to an increase in headcount.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year were $11.5 million, compared to $9.2 million in 2016. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.9 million in payroll and other payroll-related expenses mostly due to an increase in headcount and salary raises.
Net Loss
For the year ended December 31, 2017, the Company recorded a net loss of $65.7 million, or $1.76 per share, basic and diluted, compared with a loss of $29.3 million or $0.91 per share, basic and diluted, for the year ended December 31, 2016.
Cash & Cash Equivalents
At December 31, 2017, the Company had $76.4 million in cash and investments compared to $131 million at the end of December 2016. 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.
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