TherapeuticsMD(US:TXMD)2020-02-20 20:29Financial Data and Key Metrics Changes - In Q4 2019, total net revenue from product sales increased by 94% to $15.9 million from $8.2 million in Q3 2019, exceeding the upper end of guidance by $650,000 [30] - The net loss for Q4 2019 was $49.4 million, compared to a net loss of $32 million in Q3 2019, which included license revenue [35] - Operating cash burn for Q4 was $51 million, with a cash balance of $160.8 million as of December 31, 2019 [36] Business Line Data and Key Metrics Changes - IMVEXXY's net revenue grew by 33% to $6.3 million in Q4 2019, driven by an increase in net revenue per unit from $35 to $51 [31] - BIJUVA's net revenue was $1.2 million in Q4 2019, a 147% increase over Q3, with units sold increasing by 37% [32] - ANNOVERA generated $5.8 million in net revenue in Q4 2019, with an average net revenue per unit of approximately $1,350 [33] Market Data and Key Metrics Changes - IMVEXXY achieved 72% unrestricted commercial coverage, while BIJUVA secured 56% unrestricted commercial coverage [10][12] - ANNOVERA achieved 75% commercial coverage within four months of its limited launch [9] Company Strategy and Development Direction - The company aims to pivot from a clinical development focus to a fully integrated commercial sales and marketing organization in 2020 [13] - The strategy for 2020 includes prioritizing ANNOVERA as the lead product, with a focus on consumer advertising and expanding patient access through new channels [18][22] - The company plans to create a revenue inflection point for its portfolio, with substantial payer coverage and a well-trained sales force [13][28] Management's Comments on Operating Environment and Future Outlook - Management anticipates that 2020 will be a transformative year, projecting net revenue between $90 million to $110 million, with significant growth expected in the second half of the year [38] - The company expects Q1 revenue to be impacted by high deductible and annual copay resets, projecting it to be below Q4 2019 revenue [38] Other Important Information - The company received the first $50 million tranche of additional borrowing under its term loan facility [36] - The full launch of ANNOVERA is scheduled for March 1, 2020, with increased marketing spend planned for IMVEXXY and ANNOVERA [39] Q&A Session Summary Question: Can you quantify ANNOVERA stocking and the $90 million to $110 million sales guidance for 2020? - The goal was to sell 2,800 units for ANNOVERA, and demand has been strong, with over 1,000 prescriptions sold in the first five weeks of 2020. The sales guidance is not broken out by product [43][44][45] Question: How do you expect net price to trend for IMVEXXY and BIJUVA? - The company believes it can achieve a net revenue target of over $100 for IMVEXXY, with several factors influencing pricing [49][50] Question: What are the pushes and pulls to revenue guidance? - The guidance accounts for expected coverage decisions from major Part D payers and the reorganization of the sales force, which is expected to enhance brand focus [54][55] Question: What percentage of patients will use ANNOVERA for continuous use? - The company does not promote off-label use and cannot quantify the percentage of patients using it continuously, but there is significant interest in the long-lasting option [87][88][90]