TherapeuticsMD, Inc. Q1 FY2021 earnings call

• ANNOVERA has strong year-over-year growth despite pandemic challenges, gained market share from birth control methods, and patent state strengthened.
• Menopause franchise achieved record net revenue per unit for IMVEXXY and BIJUVA, with progress on new lower dose BIJUVA.
• Financials: Net product revenue $19.6M, 60% YOY increase; operating expenses reduced to $44.5M, a $16M decrease YOY; net cash used in operating activities $38.4M; debt balance decreased to $183.9M.
• Digital and consumer focus: Accelerated use of digital platforms like social media, virtual events, telehealth to drive ANNOVERA prescriptions.

Product segments:

• ANNOVERA: Net product revenue for Q1 was $19.6 million, a 60% increase from Q1 2020. Year-over-year growth was 164%, sequential TRx growth 5%, net revenue per unit $1,071 in Q1 2021, expected $1,100 for 2021. 17% increase in prescribers Q1 '21 vs Q4 '20. Patent state for ANNOVERA doubled, extending exclusivity to June 2039.
• IMVEXXY: Record net revenue per unit $61 in Q1 2021, back to growth, year-over-year 39% improvement in net price, sequential quarter 13% improvement. Launched new consumer campaign 'Long May She Reign'.
• BIJUVA: Year-over-year growth, new lower 0.5/100 dose won appeal with FDA, meeting set with FDA in May.
• vitaCare: Divestiture process ongoing, new live customers, pipeline of ~20 potential new deals.

• Expect revenue growth with investments in supply chain, marketing, digital capabilities, with highest spending in Q2.
• Aim for EBITDA breakeven on a quarterly basis in the first half of 2022.

• Impact of COVID-19 on prescriber access, which is at one-third pre-COVID levels.
• Payer contract changes affecting ANNOVERA net revenue per unit.

Q: What are underlying trends for IMVEXXY net price and guidance?

A: Rob explains net price range for IMVEXXY is 65 to 70, with strong upward trend expected.

Q: ESI coverage for ANNOVERA and patent details?

A: Dawn states ESI coverage for ANNOVERA is ~15%, and patent state for ANNOVERA has six Orange Book listed patents extending IP protection to June 2039.

Q: BIJUVA low dose FDA meeting and spending guidance?

A: Rob and Dawn discuss that BIJUVA low dose won appeal with FDA, meeting set for May, and James explains OpEx spending expected to be between $45M and $48M quarterly.

Q: LMN approval time and pull through rate for ANNOVERA?

A: Rob and Dawn state LMN approval pull through rate is identical to before, with no impacts, and support for physicians in LMN process.