BioCryst Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net revenue reached $180.3 million for the quarter ended September 30, 2026, representing a 13% year-over-year increase and a 24% increase on a comparable basis excluding European revenue.
• ORLADEYO net revenue was $174.8 million for the quarter.
• GAAP operating profit was $53.3 million, compared to $29.6 million in the third quarter of 2025.
• Non-GAAP operating profit was $86.5 million, compared to $50.8 million in the third quarter of 2025.
• Net income was $37.9 million for the quarter, compared to $12.9 million in the prior year period.
• Non-GAAP net income was $71.1 million, compared to $34.7 million in the prior year period.
• Research and development expenses excluding stock-based compensation were $52.4 million for the quarter.
• Sales and marketing expenses excluding stock-based compensation were $37.7 million, a 15% decrease year-over-year.
• General and administrative expenses excluding stock-based compensation were $21.0 million, a 22% decrease year-over-year.
• The company generated positive cash flow during the quarter, with cash, cash equivalents, restricted cash, and investments totaling $376.4 million as of September 30, 2026.
• Balance sheet data shows a secured term loan of $395.6 million and royalty financing obligations of $421.7 million as of September 30, 2026.

Guidance and Future Outlook:

• Maintained full-year 2026 ORLADEYO revenue guidance of $625 million to $645 million.
• Increased full-year 2026 total revenue guidance to $715 million to $730 million, up from the previous range of $690 million to $715 million.
• Improved full-year 2026 non-GAAP operating expense guidance (excluding stock-based compensation, restructuring, and transaction costs) to $415 million to $425 million, down from the previous range of $420 million to $440 million.
• The increase in total revenue guidance is primarily driven by higher revenues from the licensing of navenibart rights and higher RAPIVAB orders from international partners.
• The decrease in operating expense guidance is primarily driven by continued progress on the Birmingham site closure.
• BCX17725 is on track to report early clinical data by the end of 2026.
• Navenibart pivotal results are expected in the third quarter of 2027.

Business Segments and Product Lines:

• ORLADEYO oral pellets launched in August for patients with hereditary angioedema (HAE) aged 2 to <12 years, with early reimbursement and new prescriptions exceeding expectations.
• Received FDA approval in October for ORLADEYO 150 mg oral pellets for patients aged 12 and older.
• Commenced operations with CareMed as the sole-source specialty pharmacy partner for ORLADEYO shipments in August.
• Navenibart is being studied in the ALPHA-ORBIT pivotal study (fully enrolled) and the ORBIT-EXPANSE long-term extension study.
• BCX17725, an investigational KLK5 inhibitor for Netherton syndrome, is in a Phase 1 trial with Part 4 enrolled.
• Discontinued development of STAR-0310, the atopic dermatitis program acquired from Astria Therapeutics, to focus resources on rare diseases.

Market and Competitive Landscape:

• The company is focused on developing and commercializing medicines for hereditary angioedema and other rare diseases.
• ORLADEYO is the first oral, once-daily plasma kallikrein inhibitor.
• The transition to CareMed aims to leverage the partner's deep rare disease experience and operational scale to drive growth across patient segments and formulations.

Risks and Challenges:

• Birmingham site closure activities are on track to be substantially complete by year-end, with expected cash costs of approximately $10 million and annualized cost savings of $30 million to $35 million once fully realized.
• Restructuring costs in research and development included $6.3 million in cash costs and $9.3 million in non-cash costs for the quarter.
• The company faces risks related to the successful execution of pipeline development, regulatory approvals, and the realization of cost savings from the Birmingham closure.
• Forward-looking statements involve uncertainties regarding future results, including revenue, operating expenses, and cash usage.

Management Commentary and Tone:

• Charlie Gayer, President and CEO, stated the company delivered continued growth of ORLADEYO and strong profitability while broadening the foundation for long-term success.
• Management expressed confidence in the ability to drive sustainable growth and lasting value for patients and shareholders.
• The tone indicates optimism regarding the accessibility of ORLADEYO for more patients through the new pellet formulation and CareMed partnership.

Other Key Points:

• Formed a Scientific Advisory Board in October comprising seven scientific and industry leaders to guide external R&D strategy.
• Sold the European ORLADEYO business to Neopharmed Gentili S.p.A. on October 1, 2025.
• Acquired Astria Therapeutics on January 23, 2026, incurring acquired in-process research and development expenses of $697.8 million for the nine months ended September 30, 2026.
• Conference call and webcast scheduled for 8:30 a.m. ET on November 4, 2026.