VYNE Therapeutics Inc. Q3 FY2020 earnings call

• Rebranded to VYNE Therapeutics in September with a new ticker symbol, aligning with core values. - FDA approved AMZEEQ and ZILXI; ZILXI is the first minocycline product for rosacea. - AMZEEQ prescription counts recovered and grew, eclipsing pre-COVID levels. - FCD105 had positive Phase 2 results, with an end of Phase 2 meeting with the FDA this quarter. - Appointed Patrick LePore to the Board; his experience will aid business growth. - Commercial execution for AMZEEQ and ZILXI continued despite pandemic challenges.

In the third quarter, revenues totaled $3.3 million. Product sales from AMZEEQ accounted for $2.9 million, and royalty revenue from Finacea Foam (out-licensed to LEO Pharma) was $0.4 million. AMZEEQ prescription volume in Q3 was 26,900 NRXx and 32,700 TRxs, representing 49% and 52% growth over Q2 respectively. ZILXI was launched in October, with progress on payer coverage such as a contract with Express Scripts.

• Expect to end the $75 cash pay market access program for AMZEEQ in the first half of 2021 after final PBM negotiations. - Tightened expected net value per prescription for AMZEEQ from $200-$400 to $200-$250. - Cash, cash equivalents, and investments totaled $77 million as of September 30, 2020, providing cash runway through end of 2021.

• Impact of COVID-19 on sales and healthcare provider access. - Uncertainties in PBM negotiations and achieving full commercial coverage. - Regulatory risks related to the Phase 3 trial timeline and costs for FCD105.

Q: After completing negotiations with the last remaining major PBM, what is the plan to increase coverage? What are scenarios for FCD105 Phase 2 meeting and impact on timeline/costs? Any plans for serlopitant?

A: Focus is on AMZEEQ and ZILXI launches; serlopitant not a current direct investment focus. For FCD105, end of Phase 2 meeting this quarter; details on Phase 3 timeline and costs will be known post-meeting.

Q: Where will ZILXI patients be pulled from? Patient mix for AMZEEQ?

A: ZILXI patients primarily from metronidazole and doxycycline. AMZEEQ is disrupting various products in the market, with a broad patient mix.

Q: ZILXI managed care timing, net pricing, breakeven prescriptions?

A: PBM timing for ZILXI is optimistic, aiming for similar coverage to AMZEEQ. Net pricing for ZILXI is expected to be similar to AMZEEQ. Breakeven related to combined AMZEEQ and ZILXI prescriptions, with normalized pricing depending on growth.

Q: COVID impact and seasonality?

A: COVID creates uncertainty; field force deployment varies by region. Acne volume rebounding, rosacea has seasonality driven by weather changes.