Release Date: August 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioCryst Pharmaceuticals Inc (BCRX, Financial) reported a strong second quarter with ORLADEYO generating over $108 million in global revenue, surpassing expectations.
- The company increased its annual revenue guidance for ORLADEYO to between $420 million and $435 million, reflecting strong demand and operational improvements.
- BioCryst Pharmaceuticals Inc (BCRX) achieved an operating profit of $21.9 million, excluding non-cash stock compensation, indicating effective cost management.
- The company is on track to file for approval of the oral granule formulation of ORLADEYO for younger children, addressing a significant unmet need in the HAE patient population.
- BioCryst Pharmaceuticals Inc (BCRX) is progressing with its pipeline, including the KLK5 inhibitor BCX17725 for Netherton syndrome and the avoralstat for DME, with plans to start dosing patients soon.
Negative Points
- The development of BCX10013, an oral Factor D inhibitor, has been discontinued due to insufficient efficacy compared to other therapies on the market.
- Despite strong performance, the company still faces challenges in achieving GAAP operating profits, including non-cash stock compensation.
- The paid patient rate, while improving, still has room for growth, particularly among Medicare patients, which may impact revenue projections.
- BioCryst Pharmaceuticals Inc (BCRX) faces competition from other injectable prophylaxis therapies, which could impact its market share and growth potential.
- The company’s reliance on operational improvements and market expansion to sustain growth may pose risks if these strategies do not yield the expected results.
Q & A Highlights
Q: Based on these results, including the updated guidance for ORLADEYO and maintaining expectations around operating expenses, can you discuss your level of feeling around if you could reach GAAP operating profits in 2024 and not just full-year operating profits, excluding non-cash stock compensation?
A: Anthony Doyle, CFO: Q2 was terrific in terms of both revenue and our control on operating expenses. We are still guiding to achieving operating profits excluding non-cash stock compensation. There is a chance we could achieve GAAP operating profits, but it depends on revenue and OpEx for the remainder of the year. Our confidence in achieving operating profits excluding non-cash stock compensation has increased.
Q: Within the raised guidance for ORLADEYO, can you discuss in more detail your underlying assumptions around new patient starts, the percent of patients on paid drug, and compliance retention for the remainder of the year?
A: Charles Gayer, Chief Commercial Officer: We expect consistent demand based on the metrics described. The paid rate is ahead of expectations, and we aim to maintain it at 74.4% for the rest of the year. Compliance is strong, with treatment days in the mid-90s, and we expect this to continue.
Q: Can you talk about the data that gives you confidence in pursuing the KLK5 inhibitor for Netherton syndrome and the cadence of data to expect over the next year?
A: Helen Thackray, Chief R&D Officer: We have all the required data to proceed to first-in-human trials this year, including safety and efficacy data from non-clinical studies. We have seen promising results in animal models, and we expect to have human data by the end of next year.
Q: Can you elaborate on why there was such a big uptick in the paid drug quarter-over-quarter and discuss the resizing of the HAE market?
A: Charles Gayer, Chief Commercial Officer: The uptick in paid drug is due to operational improvements and investments in our team. The resizing of the market reflects the growth in diagnosed and treated HAE patients, partly driven by ORLADEYO's promotion. We now estimate 8,500 treated HAE patients in the US.
Q: Can you discuss the long-term share of oral versus injectable prophylactic options in HAE and the progress in clinician outreach?
A: Charles Gayer, Chief Commercial Officer: We expect ORLADEYO to achieve at least a 20% market share. We continue to see new prescribers, with over 70% of Tier 1 doctors having prescribed ORLADEYO. The introduction of new injectable products and the pediatric indication for ORLADEYO could further drive growth.
Q: Can you provide more clarity on when you could achieve 85% of patients on paid drug?
A: Charles Gayer, Chief Commercial Officer: Achieving 85% paid patients is part of our growth plan to reach $1 billion in peak sales by 2029. We are already at 82% paid for the commercial segment, and we expect to make further progress, particularly with Medicare patients next year.
Q: Can you discuss the market share of ORLADEYO and the increase in the likelihood of prescribing year-over-year?
A: Charles Gayer, Chief Commercial Officer: We are nearing a 20% market share with 2,500 prescriptions at the end of last year. The increase in prescribing likelihood is driven by physicians' confidence in the drug's efficacy and convenience, as seen in their patients' responses.
Q: Can you elaborate on the ex-US versus US split in Q2?
A: Charles Gayer, Chief Commercial Officer: Ex-US sales were $12.4 million, up 51% year-over-year. We see consistent demand and patient retention in ex-US markets, with ORLADEYO becoming the standard of care for prophylaxis in many countries.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
