TherapeuticsMD, Inc. Q4 FY2021 earnings call

Management Statement and Operational Highlights

• Top Line Growth: Fourth quarter revenue impacted by ANNOVERA manufacturing/supply challenges, but underlying demand is strong. Implemented changes like partnering with ZS Associates for targeting analytics to optimize product portfolio.
• Capital Structure: Amended credit agreement with Sixth Street to bridge through vitaCare divestiture and refinancing of debt facility.
• Cost Reduction: Divested vitaCare, which accounted for ~$20M in 2021 operating expenses, helping achieve $60M annual cost base reduction.
• EBITDA Breakeven: Aim to achieve EBITDA breakeven by Q4 2022.
• ANNOVERA Manufacturing: Added resources at CDMO, improved production process to increase yield, resubmitted FDA manufacturing supplement, expecting FDA response by end of Q2.

Segment Performance

• ANNOVERA: Fourth quarter net revenue increased by 14% compared to Q4 2020, reaching $7.8 million. Impacted by manufacturing and supply challenges, but underlying demand remains high. Symphony data shows ANNOVERA demand is significantly higher than current fulfillment capacity.
• IMVEXXY: Net revenue decreased by 24% compared to Q4 2020, to $6.7 million. This was mainly due to a decrease in sales volume shipped to customers, offset modestly by more favorable pricing.
• BIJUVA: Mentioned about $700,000 of export sales recorded at cost in Q4, but details on revenue contribution were less prominent.

Guidance

• Intend to provide earnings guidance in Q2 when more visibility is available.
• ANNOVERA top line growth assumption not dependent on FDA approval for manufacturing supplement, but approval would accelerate goals.
• Proceeds from vitaCare divestiture to be used for refinancing Sixth Street debt to improve capital structure.

Risks

• Temporary ANNOVERA manufacturing and supply challenges could impact revenue.
• Dependence on FDA approval for ANNOVERA manufacturing supplement.
• Uncertainty in capital structure refinancing process and timing.

Question and Answer

Q: How will the new management team do things differently than the prior one? And how to think about ANNOVERA sales for Q1 2022?

A: New management focuses on forward-looking priorities. ANNOVERA had ~6,000 unfulfilled rings in Q4, Q1 sales uncertain but selling all produced rings.

Q: Confidence in resolving ANNOVERA manufacturing issues and commercial repositioning?

A: Implemented actions to reduce batch rejections (resubmitting to FDA, improving production, adding resources), commercial team reset with new targeting plans, successful pilot in Q4 showing positive momentum