TherapeuticsMD, Inc. Q3 FY2021 earnings call

Key Points - Rob Finizio announced Hugh O'Dowd as the new CEO, transitioning to Vice Chairman of the Board. - Hugh O'Dowd outlined priorities including achieving EBITDA break even in the second half of 2022, a $40 million cost savings initiative (with an additional $20 million from potential VitaCare divestiture), streamlined senior leadership by eliminating 3 executive roles, and a renewed commercial focus on healthcare professionals. - James D'Arecca discussed net product revenue growth, gross profit margin of 79% in Q3 2021, operating expenses of $60 million (including $7.2 million in severance), and cash position with $104.8 million in cash as of September 30, 2021. - Mark Glickman highlighted commercial activities focusing on healthcare providers, shifted marketing programs from consumer to provider, simplified sales data orientation, and initial results showing increased calls to targeted physicians and growth in ANNOVERA prescriptions.

The net product revenue for the third quarter was $24.5 million. ANNOVERA contributed $11.8 million, which is approximately 48.16% of the total net product revenue. Vaccine net revenue was $8 million, accounting for about 32.65% of the total net product revenue.

Guidance - Aim to achieve positive EBITDA in the second half of 2022. - Announced a cost savings initiative to reduce annual costs in 2022 by at least $40 million (excluding potential VitaCare divestiture savings of ~$20 million). - Will provide full-year guidance starting in the first quarter of 2022.

Risks - Manufacturing issues with ANNOVERA due to a narrow FDA-approved release specification, which could impact product supply. - Reliance on managed care coverage and potential challenges in maintaining or expanding that coverage. - Capital structure risks related to restrictive revenue and cash covenants, and the need to address the capital structure for greater financial flexibility.

Q: Why the CEO change now? Any inflection points? What's different from Rob's strategy? SG&A progression?

A: Rob Finizio transitioned to Vice Chairman, Hugh O'Dowd was hired as CEO. Hugh emphasized driving top-line growth, achieving EBITDA break even in H2 2022, cost savings, and addressing capital structure. SG&A expected to be below $50 million in Q4 2021 and ramp down, with $40 million cost savings in 2022 and potential $20 million from VitaCare divestiture.

Q: About top-line performance, HCP focus, cost savings composition, capital structure?

A: Mark Glickman discussed HCP focus for IMVEXXY, emphasizing awareness and education. Cost savings include reducing DTC media ad spend. Capital structure plans involve divesting VitaCare first, then refinancing to address covenants.

Q: Manufacturing change for ANNOVERA, accountability meaning?

A: FDA NDA supplement submission with PDUFA date 12/12/2021 to address release specification. Accountability means clear plans, executing against them, activity and performance metrics, and solution selling being non-negotiable.