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TXMD

TherapeuticsMD, Inc.

TherapeuticsMD, Inc. Q3 FY2020 earnings call

November 9, 2020 · fiscal period ended 2020-09

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Summary

Generated 2020-11-09

Management highlights

· Strong Q3 operational execution with $19.3 million in total net revenue, an 80% increase over the second quarter. ANNOVERA had a 115% rise in prescriptions dispensed QoQ, and menopausal products saw double-digit growth in new and total prescriptions. · Fortified ANNOVERA’s patent portfolio with three Orange Book-listed patents, providing exclusivity through 2039; IMVEXXY and BIJUVA also received new patents. · Reduced operating expenses, with cash burn minimized. · Identified vitaCare Prescription Services as a potential non-dilutive funding source via divestiture, with enterprise value potentially upwards of $100 million. · Made payer progress: ANNOVERA added to Caremark at non-preferred status, West Virginia Medicaid made ANNOVERA unrestricted, Medi-Cal added ANNOVERA, Anthem moved BIJUVA to preferred, and IMVEXXY gained preferred coverage with a major PBM. · Navigated COVID impact by adapting consumer and prescriber initiatives, using virtual engagement for educational programs and sales force access improvement.

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Segment performance

The third quarter saw strong performance across product segments. ANNOVERA achieved a 115% increase in total prescriptions dispensed over the second quarter, with total net revenue contributing significantly. Its net revenue per unit was $1,339. For the menopausal portfolio, IMVEXXY had a 35% increase in net revenue and a net revenue per unit of $51, while BIJUVA saw a 22% increase in net revenue with a per unit of $47. Menopausal products overall realized double-digit growth in both new and total prescriptions compared to the previous quarter. Product net revenue from sales to wholesalers and pharmacies was $17.3 million, a 62% increase from the second quarter, driven largely by ANNOVERA's 250% net revenue growth.

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Guidance

· On track to meet the $20 million Q4 revenue covenant. · Aim to achieve EBITDA breakeven in Q4 2021. · VitaCare divestiture presents a potential significant source of non-dilutive capital. · A major PBM will exclude competitors of ANNOVERA and IMVEXXY from its formulary starting January 1, offering market share opportunities.

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Risks

· Potential volume fluctuations due to COVID-19-related delays in patient visits to OB/GYN offices and sales force access. · Dependence on lender covenants; while the cash balance requirement was lowered, additional funding may still be needed. · Impact of regulatory changes, such as those from the NASEM Report on compounding practices, on product categories.

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Q&A highlights

Q: Can you frame what might happen if you missed upcoming revenue requirements, and how should we think about upcoming inflections of IMVEXXY and ANNOVERA products with reduced cash requirement?

A: Rob Finizio states they're on track for Q4 revenue covenant, feel good about EBITDA breakeven in Q4 2021, and the reduced cash requirement from lender is a cooperative move with runway for vitaCare divestiture.

Q: What's the overlap in sales force and marketing channels for ANNOVERA, IMVEXXY, and BIJUVA, and what's the optimal gross to net target for ANNOVERA?

A: Rob Finizio and Dawn Halkuff explain significant overlap in top prescribers, no need for additional sales force growth, and ANNOVERA's gross to net target is between current levels and $1,200, with growth potential from military and public health channels once COVID eases.

Q: Update on COVID headwinds in office volumes, telemedicine contribution, and Symphony data for ANNOVERA?

A: Rob Finizio notes reduced switching behavior due to COVID, doctors limiting reps, but we're off May lows, and telemedicine contributes ~18%-22% of revenue. Symphony data shows underreporting of ANNOVERA volume, with trends consistent.

Q: Thoughts on ANNOVERA seasonality and IMVEXXY reimbursement tactical decisions?

A: Rob Finizio mentions back-to-school seasonality trends, ANNOVERA likely to do well due to state and federal laws, and IMVEXXY has preferred coverage with PBM to improve gross-to-net.

Q: PBM strategy, IMVEXXY refill rate?

A: Dawn Halkuff says PBM strategy varies by payer, IMVEXXY has a 6.5 refill rate per patient on average, and preferred coverage with PBM helps improve market share.

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Transcript

November 9, 2020

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