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Dec 31, 2019
VYNE Q4 2019 Earnings Report
Menlo Therapeutics reported fourth quarter and full year 2019 financial results, highlighting a net loss for Q4 and approval of the merger with Foamix.
Key Takeaways
Menlo Therapeutics reported a net loss of $21.5 million for the fourth quarter of 2019, compared to a net loss of $17.6 million for the same period in 2018. The company's shareholders approved the merger with Foamix, expected to close on or about March 9, 2020.
Merger with Foamix was approved by shareholders of both companies.
The combined company will focus on dermatology therapeutics.
Menlo reported a net loss of $21.5 million for Q4 2019.
Phase 3 clinical trial results for serlopitant expected in March or April 2020.
VYNE
VYNE
Forward Guidance
Menlo is anticipating several key catalysts in the near term, including clinical trial results and regulatory action dates, but also faces risks related to the merger and ongoing clinical trials.
Positive Outlook
- Phase 3 clinical trial results for serlopitant in prurigo nodularis expected in March or April 2020
- PDUFA action date of June 2, 2020 for FMX103 for rosacea treatment
- Phase 2 clinical trial results for FCD105 for acne treatment expected in Q2 2020
- New Drug Application submission for serlopitant for pruritus in prurigo nodularis expected in the second half of 2020 (assuming successful Phase 3 trials)
- Upcoming merger with Foamix
Challenges Ahead
- Conditions to the closing of the merger may not be satisfied
- The merger may involve unexpected costs, liabilities or delays
- Menlo or Foamix may be adversely affected by other economic, business, and/or competitive factors
- The outcome of any legal proceedings related to the merger
- Risks relating to the planned merger with Foamix and risks resulting from the unpredictability of the regulatory process and regulatory developments in the United States and foreign countries.