TherapeuticsMD(US:TXMD)2019-05-07 01:13Financial Data and Key Metrics Changes - In Q1 2019, approximately 75,000 units of IMVEXXY were dispensed, a significant increase from approximately 47,500 units in Q4 2018 [43] - Net revenue for IMVEXXY was approximately $2 million for Q1 2019, representing a 122% increase over Q4 2018 [45] - The net loss for Q1 2019 was approximately $39.5 million, compared to a net loss of approximately $24.4 million in Q1 2018 [50] Business Line Data and Key Metrics Changes - IMVEXXY achieved a 6% market share within 10 months of launch, with an average of over three fills per patient [11][12] - Net revenue from the prescription prenatal vitamin business was approximately $1.9 million for Q1 2019, down from approximately $3.8 million in Q1 2018 [47] Market Data and Key Metrics Changes - The patient mix for IMVEXXY is over-weighted towards Medicare Part D, which currently has the lowest coverage and utilization [16] - The overall blended adjudication rate for IMVEXXY was 27% in Q1 2019, with a 41% adjudication rate for commercial plans and a 5% rate for Medicare Part D [18] Company Strategy and Development Direction - The company aims to achieve a normalized net revenue goal of $108 per unit for IMVEXXY by Q3 2020, heavily weighted towards maintenance packs [14] - The launch strategy for BIJUVA will mirror that of IMVEXXY, focusing on prescriber education and building payer coverage [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving higher net revenue as payer coverage increases, with expectations of 70% commercial payer coverage by Q3 2019 [14][45] - The company anticipates that the majority of the gap between current revenue and the target of $108 per unit will close by the end of 2019 [20] Other Important Information - The company entered into a $300 million non-dilutive term loan facility with TPG Sixth Street Partners, with initial funding of $200 million [51] - The company views ANNOVERA as a potential game changer in the contraceptive market, with a planned soft launch in Q3 2019 [35][38] Q&A Session Summary Question: Can you outline the covenants for your new debt piece? - The most important covenant allows for an additional $15 million if $11 million in revenue from all three products is reached in Q4 [62] Question: What is the current growth to net for IMVEXXY? - The target is $108 per unit, with expectations that the majority of the gap will close this year as payer contracting is completed [63] Question: Do you owe any royalties on your products? - Currently, there are no royalties, but royalties will apply to ANNOVERA once it starts selling [64] Question: Is the vitamins business a core asset? - The vitamins business serves as a feeder for ANNOVERA, connecting with new patients who may transition to contraception later [65] Question: What has been surprising about IMVEXXY's launch? - The rapid volume growth has exceeded expectations, indicating strong adoption among prescribers and patients [74] Question: When will you report to IQVIA or other databases? - Symphony data is close to actual performance, and the company is working with IQVIA for more accurate reporting [72] Question: How does the copay assistance program work? - The copay assistance program is managed through RelayHealth and Truveris, allowing the company to maintain contact with patients for compliance and education [122]