BioCryst Pharmaceuticals(BCRX) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported $50 million in total revenue for Q2 2021, with $28.5 million coming from ORLADEYO net revenue [7][16] - Operating expenses for the quarter, excluding non-cash stock compensation, were $72 million, and the company ended Q2 with $223 million in cash [16][17] - The company expects ORLADEYO sales to reach no less than $100 million for the year, with a potential trajectory to exceed $500 million in global peak sales [9][18] Business Line Data and Key Metrics Changes - ORLADEYO's launch has been successful, with a 50% increase in prescribers in Q2 and 60% of new patients switching from other prophylactic therapies [11][12] - The APeX-2 trial data showed an 80% reduction in attacks for patients on ORLADEYO after 96 weeks, indicating strong efficacy [11][46] - The company is advancing the BCX9930 program into pivotal trials for PNH, with expectations of significant benefits over existing therapies [10][22] Market Data and Key Metrics Changes - The company has made significant progress in payer coverage, with approximately 70% of the HAE market having coverage policies for ORLADEYO [14][33] - Launches of ORLADEYO are underway in Japan and Germany, with plans for additional launches in the UK, France, and other markets over the next 12 months [15][56] Company Strategy and Development Direction - The company aims to continue growing ORLADEYO while pursuing approvals and launches for BCX9930 across various complement-mediated diseases [10][29] - The focus is on developing a pipeline of oral medicines for rare diseases, demonstrating commercial capabilities in this area [10][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least $100 million in sales for ORLADEYO, despite uncertainties related to patient visits and COVID-19 impacts [18][71] - The company is monitoring the effects of summer vacation schedules and COVID-19 on patient uptake and physician interactions [71][72] Other Important Information - The company has established a strong foundation for the second half of the year, with cash runway extending into 2023 [17][18] - Management highlighted the importance of patient retention and compliance, with current trends aligning with clinical trial data [46][47] Q&A Session Summary Question: Commentary on patient starts and pacing - Management noted strong and consistent new patient starts since launch, with 70% of patients now on reimbursed product [32][33] Question: On-demand versus prophylactic therapy outlook - Management indicated a shift towards prophylactic therapy, with potential market share settling at 80/20 or even 90/10 in favor of prophylactic options [37] Question: Enrollment timing for pivotal trials - Management emphasized the importance of selecting high-quality sites for enrollment in pivotal trials, with enthusiasm from leading hematologists [84] Question: Gross to net adjustments - Management reported improving gross to net adjustments as more patients transition to reimbursed products, expecting to reach 15% to 20% range [42][56] Question: Impact of COVID-19 on patient uptake - Management acknowledged variability in COVID-19 prevalence affecting face-to-face interactions but did not observe direct trends impacting patient uptake [74]