Menlo Reports Financial Results for Subsidiary Foamix Pharmaceuticals for Year Ended December 31, 2019
March 12, 2020 at 7:00 AM EDT
Foamix Became a Wholly Owned Subsidiary of Menlo Therapeutics Upon Closing of Merger on March 9, 2020
Menlo Conference Call and Webcast Scheduled for Thursday, March 12 at 8:30am Eastern Time
BRIDGEWATER, N.J., March 12, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced financial results for its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”), for the twelve months ended December 31, 2019 and provided a corporate update. Menlo and Foamix announced the consummation of their merger transaction on March 9, 2020.
Recent pipeline highlights:
The U.S. Food and Drug Administration (FDA) approved AMZEEQ™ (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients nine years of age and older. AMZEEQ™ is the first topical formulation of minocycline to be approved by the FDA for any condition. Foamix commercially launched AMZEEQ™ in the U.S. in January 2020.
A New Drug Application (NDA) was submitted to the FDA for FMX103 (minocycline) topical foam, 1.5%, for the treatment of papulopustular rosacea in adults. The FDA set a Prescription Drug User Fee Act (PDUFA) action date of June 2, 2020. If approved, FMX103 would be the first minocycline product available for rosacea patients.
Enrollment has been completed in the ongoing Phase 2 trial for FCD105, a topical combination foam of minocycline and adapalene, currently being evaluated for the treatment of moderate-to-severe acne vulgaris. Topline data from this trial are expected in the second quarter of 2020.
Serlopitant is being evaluated in two Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis (PN). The studies are fully enrolled, with results expected in March or April 2020. Assuming successful completion of the Phase 3 clinical trials, an NDA submission for serlopitant for the treatment of pruritus in PN is planned in the second half of 2020.
Financial Results for Foamix Pharmaceuticals for the Year Ended December 31, 2019
The following financial results pertain only to Menlo's wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. Foamix Pharmaceuticals is filing its last Form 10-K this week, and Menlo does not intend to provide separate financial results for Foamix Pharmaceuticals in the future.
Total revenues, consisting primarily of royalties, decreased by $3.2 million, or 89%, from $3.6 million in the year ended December 31, 2018 to $0.4 million in the year ended December 31, 2019, due to the ongoing suspension of the manufacturing and sales of Finacea by LEO, following inadequate supply of quality-compliant batches of the API used in such product.
Research and Development Expenses
Research and development expenses for the year ended December 31, 2019 were $51.2 million, representing a decrease of $13.3 million, or 21%, compared to $64.5 million for the year ended December 31, 2018. The decrease in research and development expenses resulted primarily from a decrease of $21.4 million in clinical trial expenses due to the completion of AMZEEQ and FMX103 clinical trials, offset by an increase of $3.2 million in consulting expenses, an increase of $2.8 million in payroll and payroll-related expenses due to an increase in headcount and salaries and an increase of $2.6 million in payments related to the submission of our NDA for FMX103.
Selling, General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2019 were $45.1 million, representing an increase of $31.1 million, or 221%, compared to $14.0 million for the year ended December 31, 2018. The increase in selling, general and administrative expenses resulted primarily from an increase of $18.0 million in connection with the pre-commercialization activities, an increase of $5.4 million in payroll and payroll-related expenses due to an increase in headcount as we built out our sales and marketing organization in preparation for the AMZEEQ launch, a $3.1 million increase in costs relating to the merger transaction with Menlo and a $2.0 million increase in other advisor and consulting expenses.
Net loss for the year ended December 31, 2019 was $95.2 million, compared to $74.2 million for the year ended December 31, 2018, an increase of $21.0 million, or 28%.
Cash & Cash Equivalents
At December 31, 2019, Foamix had cash and cash equivalents of $73.4 million, compared to cash and cash equivalents of $99.4 million at December 31, 2018.
Pro Forma Cash Position for Combined Company
At December 31, 2019, the combined pro forma cash position for Menlo, assuming the merger transaction with Foamix Pharmaceuticals was completed on December 31, 2019, was approximately $150.5 million.