Financial Data and Key Metrics Changes - TYMLOS net revenue for Q3 2021 was $56.8 million, a 13% increase from $50.4 million in Q3 2020, driven by increased unit volume and net price [19] - Total net revenue for Q3 2021 decreased by $21 million or 27% compared to Q3 2020, primarily due to a $27.4 million upfront licensing payment received in Q3 2020 related to the Menarini agreement [19] - Adjusted EBITDA for Q3 2021 was a loss of $10.9 million, compared to a positive $9.3 million in Q3 2020, reflecting a roughly $20 million swing due to the prior year's licensing revenue [20][21] - Year-to-date total net revenue decreased by $10.9 million, attributed to a $16.4 million decrease in licensing revenue, offset by a $5.5 million increase in TYMLOS net revenue [21][22] Business Line Data and Key Metrics Changes - The R&D expenses decreased by $4 million year-over-year due to the wind-down of Phase 3 trials, with expectations for further declines in 2022 [19] - Selling, general, and administrative expenses increased by $2 million due to one-time professional fees related to the implementation of a new ERP system [20] - TYMLOS new patient shipments grew by 10% year-over-year, indicating continued growth in patient cohorts [33] Market Data and Key Metrics Changes - The company adjusted its full-year 2021 TYMLOS revenue forecast to a range of $210 million to $220 million, down from a previous forecast of $240 million [23] - The company has a cash balance of $110 million as of September 30, 2021, exceeding expectations due to timing on an expected payment [24] Company Strategy and Development Direction - The company is focused on expanding the commercial footprint of TYMLOS and preparing for the introduction of a male indication for abaloparatide [10][11] - The partnership with Menarini for Elacestrant is a key focus, with plans for regulatory submissions in both the U.S. and Europe [11][27] - The company aims to manage its capital structure actively and is looking to utilize milestone payments to strengthen it [70] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the need to improve patient conversion rates and persistence on therapy as critical areas for growth [46][49] - The company is optimistic about the potential of Elacestrant and anticipates significant opportunities from its partnership with Menarini [95][96] - Management emphasized the importance of building a culture around exceptional teamwork and executing plans in a high-quality manner [13][14] Other Important Information - The company has completed enrollment in three pivotal studies and is awaiting readouts from the third [14] - The Elacestrant asset has a robust intellectual property portfolio, with multiple patents and potential regulatory exclusivity [25] Q&A Session Summary Question: Proportion of surgical osteoporosis cases receiving anabolic therapy - Management indicated that there are between 1.5 million and 3 million fracture PMO patients in the U.S., with a low overall market share for anabolics [40][41] Question: Factors driving changes in revenue guidance - Management cited patient conversion and persistence as key factors affecting revenue guidance, with ongoing efforts to improve these metrics [46][49] Question: Milestone payments related to Elacestrant - Management clarified that development milestones are related to monotherapy progress, while royalties and sales milestones are based on any utilization of the molecule [50] Question: Strategies to improve patient persistence - Management highlighted the importance of communication with healthcare providers and patients, as well as minimizing administrative hurdles to improve persistence [76][77] Question: Percentage of anabolic eligible patients not on therapy due to injection fear - Estimates suggest that 10% to 20% of patients eligible for anabolic therapy refuse due to needle phobia, representing a significant market opportunity [85][86] Question: Commercial strategy for abaloparatide transdermal system - Management indicated that the transdermal system will target needle-averse patients and will be positioned as an additive opportunity rather than a switching option [63][88]
Radius Recycling(RDUS) - 2021 Q3 - Earnings Call Transcript