Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $163.4 million, with $156.8 million coming from Orlodayo, representing a 45% year-over-year growth in quarterly revenue [20][21] - Non-GAAP operating expenses were $106.4 million, up from $87.4 million in 2024, while non-GAAP operating profit was $57 million, and non-GAAP net income was $32.3 million, resulting in a non-GAAP EPS of $0.15 [21][22] - The company generated $45 million in cash during the quarter and paid down $75 million in principal from its term loan in April and an additional $50 million in July, reducing term debt to $199 million [22] Business Line Data and Key Metrics Changes - Orlodayo had its best quarter since approval, with new patient prescriptions up over 10% compared to Q1 2021 and over 15% compared to Q1 2025, leading to revenue exceeding expectations by over $22 million [14][15] - The gross-to-net improvement was noted to be closer to 15%, with a significant increase in paid shipments contributing to revenue growth [20][98] Market Data and Key Metrics Changes - The U.S. accounted for almost 90% of Orlodayo revenue, with strong demand from Type I and II patients and increasing demand from patients with normal C1 inhibitor [20][18] - The company anticipates continued revenue growth momentum into 2026 and beyond, supported by the expected FDA approval of Orlodayo granules for pediatric use in December [18][19] Company Strategy and Development Direction - The company plans to leverage its commercial capabilities to consolidate rare disease assets and expand its product offerings, aiming for BioCryst 2.0 [10][11] - A definitive agreement was signed to sell the European business, which is expected to strengthen the company's financial position and allow for debt repayment [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching the upper half of the revenue guidance of $580 million to $600 million for the full year, even after the anticipated sale of the European business [15][19] - The management highlighted the importance of real-world evidence in building physician confidence and driving long-term growth [16][18] Other Important Information - The company is on track to generate approximately $700 million in cash by 2027 and plans to actively deploy this capital into value-creating opportunities [22][25] - The transition of leadership to Charlie Guyer as the new CEO was announced, with a focus on executing the company's growth strategy [11][12] Q&A Session Summary Question: What contributed to the 45% year-over-year growth in Orlodayo revenue? - The growth was attributed to a mix of volume increase, better paid rates, and improved efficiency in shipments [28][30] Question: What are the current discontinuation rates? - The one-year discontinuation rate remains solid at 60%, with a slight downward trend in overall discontinuation rates as the patient base grows [32][33] Question: How does Orlodayo's persistency compare to other injectable prophylactic regimens? - Orlodayo's one-year persistence rate is statistically similar to other products, with about 60% for all three compared therapies [39][40] Question: How are recent approvals affecting Orlodayo demand? - There has been a substantial increase in new patient prescriptions, indicating that physicians are not waiting for new products [43][44] Question: What is the current penetration rate into the addressable market? - Approximately 3,000 patients have tried Orlodayo, with about half still on therapy, indicating significant growth potential [51][52] Question: What is the expected impact of the upcoming pediatric PDUFA delay? - The FDA required more time for review, leading to a new PDUFA date of December 12, but the company remains optimistic about approval [45][46] Question: What is the competitive landscape for the pipeline assets? - The company is optimistic about its position in the market, noting that competitors have not made significant progress recently [76][77] Question: How does the company plan to deploy capital moving forward? - The company aims to consolidate rare disease assets and balance its portfolio with later-stage assets, leveraging its strong cash flow [84][86]