BioCryst Pharmaceuticals(BCRX) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q4 2021 was $47.2 million, with $46.2 million from net sales of ORLADEYO, marking a significant increase from $122.6 million in total revenue for the year [24][6]. - The company expects ORLADEYO revenue to grow to no less than $250 million in 2022, with a peak sales target of $1 billion [25][6]. - Operating expenses for Q4 2021 were $90.8 million, with a projected range of $440 million to $480 million for full year 2022 [24][25]. Business Line Data and Key Metrics Changes - ORLADEYO's launch has been successful, achieving $122.6 million in net revenue in its first year, and the company anticipates doubling sales in 2022 [6][9]. - The patient retention rate for ORLADEYO was reported at 70%, with nearly 80% of patients switching from Takhzyro remaining on therapy for at least six months [10][11]. Market Data and Key Metrics Changes - The company has broad coverage for ORLADEYO, with at least 80% of the HAE population in the U.S. having access to coverage [11]. - The U.S. is expected to account for the majority of ORLADEYO sales, with the company already launching in seven other countries and anticipating further regulatory approvals [13][25]. Company Strategy and Development Direction - The company aims to continue growing ORLADEYO in the U.S. and globally while advancing its pipeline, particularly focusing on the oral Factor D inhibitor, BCX9930 [8][21]. - The strategy includes investing in the Factor D program, which has the potential for multiple indications, and expanding the pipeline to develop new drugs [21][26]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $1 billion in peak global sales for ORLADEYO, supported by strong market demand for oral therapies [6][13]. - The company is focused on maximizing value creation through strategic investments in its pipeline and enhancing the ORLADEYO launch [26][25]. Other Important Information - The company ended Q4 2021 with approximately $518 million in cash and plans to draw down an additional $75 million debt tranche midyear 2022 [25][24]. - Management highlighted the importance of setting patient expectations to improve retention rates for ORLADEYO [30][31]. Q&A Session Summary Question: What best practices can improve retention rates for ORLADEYO? - Management emphasized the importance of preparing patients for potential GI effects and setting realistic expectations for therapy [30][31]. Question: What is the expected timing for data from the renal basket study? - Management indicated that the study is enrolling independently and aims to achieve proof-of-concept by the end of 2023 [33][34]. Question: Will Q1 sales for ORLADEYO be lower sequentially from Q4? - Management confirmed that Q1 is expected to have little to no growth due to seasonal reimbursement dynamics but anticipates stronger growth in subsequent quarters [37][40]. Question: How does the company view competition from gene therapy and gene editing? - Management believes that while gene therapies may be beneficial for hard-to-treat patients, ORLADEYO's once-daily oral administration will remain competitive for those controlled on the drug [66][67]. Question: What is the growth expectation for operating expenses in 2022? - Management indicated that the majority of the growth in operating expenses will be driven by R&D investments, particularly for the Factor D program [52][53].