VYNE Therapeutics Inc. Q1 FY2021 earnings call

• Commercial Execution: Focus on expanding trials of AMZEEQ and ZILXI; AMZEEQ had over 34,000 new prescriptions in Q1, ZILXI saw increasing prescriptions despite COVID-19 hurdles.
• Operational Leverage: Leverage overlap between acne and rosacea prescribers, control expenses, and prioritize resources.
• Pipeline Development: Unveiled FMX114 for atopic dermatitis, preparing for Phase 2a study in Q3 with top-line results expected by year-end; FCD105 for acne is Phase 3 ready.

In the first quarter of 2021, VYNE Therapeutics generated revenue of $4.1 million. Of this, $3.9 million came from product sales of AMZEEQ and ZILXI, and $0.2 million from royalty revenue. AMZEEQ had over 34,000 new prescriptions and over 44,000 total prescriptions in Q1, with the number of prescribers reaching nearly 5,200. ZILXI had over 11,000 total prescriptions since its October 2020 launch, with 7,200 prescriptions in Q1 and nearly 2,300 prescribers.

• Anticipate AMZEEQ and ZILXI market access to be 70%-75% of commercial lives for the balance of 2021.
• Plan to initiate FMX114 Phase 2a study in Q3 and expect top-line results by year-end.
• Target operating costs at $20M-$25M per quarter.

• Impact of COVID-19 on sales and access, including constraints on face-to-face interactions.
• Payer landscape challenges, such as CVS Caremark's national formulary decision affecting coverage.
• Uncertainties in patient access programs and potential impact on volume and profitability.

Q: How are you thinking about gross to net overtime and payer landscape?

A: Andrew Saik discussed commercial covered lives and impact of Caremark's decision, noting moderate change in coverage from 80%-85% to 70%-75%.

Q: How to think about seasonality in sales and rosacea marketplace?

A: Dave Domzalski and Matt Wiley talked about seasonality, anticipating influx of patients into dermatology offices and leveraging peer-to-peer events for ZILXI.

Q: Details on patient access programs and prior auths?

A: Matt Wiley discussed synthetic access programs, prior authorization adjudication, and adjustments to co-pay programs for AMZEEQ and ZILXI