Xeris Biopharma(US:XERS)2021-03-03 17:48Financial Data and Key Metrics Changes - For the full year 2020, net revenues from sales of KEVEYIS increased by $9 million or 41.5% from $21.7 million in 2019 to $30.7 million in 2020 [21] - Gross margins improved to 93% for 2020 compared to 82% in 2019 [21] - Selling, general and administrative expenses decreased to $40.9 million in 2020 from $49.1 million in 2019 [22] - Research and development expenses decreased to $25.8 million in 2020 from $30.9 million in 2019 [23] - The company ended 2020 with approximately $87.5 million in cash, expecting to have more than one year's worth of cash at the time of potential RECORLEV FDA approval [25][26] Business Line Data and Key Metrics Changes - KEVEYIS revenues for Q4 2020 were $8.2 million, exceeding the projected guidance range of $28 million to $29 million for the full year [14] - The company is actively preparing for the launch of RECORLEV, having submitted its New Drug Application to the FDA [9][12] Market Data and Key Metrics Changes - The company is focused on the Cushing's syndrome market, which has an estimated 8,000 patients in the US who are treated with prescription therapy [10] - The competitive landscape includes ISTURISA, which has been benchmarked against RECORLEV [32] Company Strategy and Development Direction - The company aims to leverage its rare disease commercialization expertise to bring RECORLEV to market [13] - There is a focus on maintaining and growing the active patient base for KEVEYIS while preparing for RECORLEV's launch [15][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of KEVEYIS despite the challenges posed by the COVID-19 pandemic [8] - The company anticipates that increased vaccination rates will improve patient access to healthcare providers, potentially leading to more diagnoses and treatments [16][82] - Management remains optimistic about the potential approval of RECORLEV and its market positioning [12][74] Other Important Information - The interim safety and efficacy results from the Phase 3 LOGICS study will be presented at the Endocrine Society's ENDO 2021 Annual Meeting [12] - The company is actively working on its go-to-market strategy for RECORLEV, including market access activities and healthcare provider research [18][19] Q&A Session Summary Question: What are the expectations for the Cushing's syndrome landscape and how does RECORLEV compare to ISTURISA? - Management believes RECORLEV has a competitive profile and sees opportunities in the underserved female population [33][34] Question: Can you provide updates on KEVEYIS performance during the pandemic? - Management attributes KEVEYIS's strong performance to proactive engagement with healthcare providers and patients [52][53] Question: What are the plans for Veldoreotide? - Management is still evaluating options for Veldoreotide and will provide updates in the future [41][42] Question: What can be expected from the ENDO presentation? - The presentation will provide detailed efficacy and safety analyses from the LOGICS study [50] Question: How many patients are currently being treated with KEVEYIS? - Management has not disclosed the exact number of patients but estimates there are 4,000 to 5,000 diagnosed PPP patients in the market [94][95] Question: What additional launch preparedness activities are needed for RECORLEV? - Key activities include market access, advocacy, and optimizing sales force structure [96][100]