Financial Data and Key Metrics Changes - For Q3 2021, the company reported revenue of $41 million, with $37 million coming from net sales of ORLADEYO [29] - The company expects full-year net revenue from ORLADEYO to be between $115 million and $120 million [8][30] - Operating expenses for the quarter were $72.5 million, excluding non-cash stock compensation [29] Business Line Data and Key Metrics Changes - ORLADEYO has shown strong growth, with more than half of new patients switching from other prophylactic treatments [11][76] - The prescriber base for ORLADEYO grew by 25% in Q3, with nearly half of the top 500 HAE treaters now prescribing the drug [11] - The average patient now receives paid product within 30 days, indicating improved access [12][46] Market Data and Key Metrics Changes - The company is launching ORLADEYO in multiple international markets, including the UK, Germany, France, Japan, and the UAE [16][30] - The UK market is expected to see a significant uptake due to favorable NICE recommendations, allowing broader patient access [16][35] - The company anticipates that international revenue will become more meaningful in 2022 [30] Company Strategy and Development Direction - The company aims to leverage its discovery platform to develop more oral drugs for rare diseases, with BCX9930 as the next candidate [9][23] - The strategy includes expanding the use of ORLADEYO globally while continuing to advance the Factor D program [30] - The company is focused on building a strong pipeline of therapies for rare diseases, with ongoing clinical trials for BCX9930 [23][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in exceeding the global peak sales target of $500 million for ORLADEYO [9] - The company noted that the launch of ORLADEYO has exceeded expectations, even during the pandemic [7] - Management highlighted the importance of in-person interactions and live meetings to enhance physician engagement and patient education [68] Other Important Information - The company ended Q3 with $204 million in cash, providing a strong financial position to support global launches and R&D efforts [30] - The gross-to-net adjustments for ORLADEYO are improving, with a target of 15% to 20% of peak sales [29][52] Q&A Session Summary Question: What is the current status of ORLADEYO sales in Europe? - Management indicated that sales are starting in Germany and France, with expectations for a slower ramp-up due to COVID impacts on patient-doctor interactions [34] Question: How is enrollment for the PNH studies proceeding? - Management noted that enrollment is on track, with no significant barriers anticipated, but the competitive landscape makes it hard to predict exact timelines [37] Question: Can you provide more details on the prescriber base growth? - The prescriber base grew by 25% in Q3, with a doubling of repeat prescriptions among top prescribers, indicating strong adoption [43] Question: What is the current access situation for ORLADEYO? - Payer access is improving, with most patients receiving paid product within 30 days, and continued progress is expected into the next year [46] Question: What percentage of patients are currently on free drug? - As of Q3, about one-third of patients are on free drug, with expectations that more than half will transition to paid products over time [85]
BioCryst Pharmaceuticals(BCRX) - 2021 Q3 - Earnings Call Transcript