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BioCryst Pharmaceuticals (NASDAQ:BCRX) shares jumped over 16% in premarket trading after the company presented its first quarter 2025 results on May 5, highlighting exceptional performance of its hereditary angioedema (HAE) treatment ORLADEYO and raising full-year revenue guidance.
Quarterly Performance Highlights
BioCryst reported better-than-expected commercial execution for ORLADEYO in Q1 2025, with approximately 84% paid rate across all patients. The company noted improved revenue capture during reauthorizations, which is expected to benefit results throughout the year.
Based on this strong performance, BioCryst raised its full-year 2025 ORLADEYO revenue guidance to $580-600 million, representing 33-37% growth over 2024. This is a significant increase from the previous guidance of $535-550 million.
As shown in the following chart of ORLADEYO’s revenue growth trajectory:
The company has demonstrated consistent revenue expansion for ORLADEYO since its launch, with annual revenues growing from $123 million in 2021 to a projected $580-600 million in 2025. This represents a compound annual growth rate of 20%, according to company projections.
Financial Analysis & Path to Profitability
BioCryst reported a cash position of $317 million as of March 31, 2025, down from $343 million at the end of 2024. The company also disclosed a senior credit facility of $324 million. In April 2025, BioCryst made a debt payment of $75 million, resulting in a pro forma cash position of $240 million and reduced credit facility of $249 million.
The company’s non-GAAP operating expenses are projected to grow at a controlled rate of approximately 5% annually, compared to the 20% revenue CAGR, creating an expanding profitability gap as illustrated in this projection:
BioCryst outlined an accelerated path to profitability, with full-year operating profit (excluding stock-based compensation) achieved in 2024, positive net income and cash flows expected in 2025/2026, and meaningful sustainable cash generation beginning in 2026.
The company also updated its full-year 2025 guidance for non-GAAP operating expenses to $440-450 million, up from the previous $425-435 million, reflecting increased investment in growth initiatives while maintaining profitability.
Pipeline & Strategic Initiatives
BioCryst’s strategy centers on three overlapping priorities: growing ORLADEYO to $1 billion in peak annual sales, advancing its clinical pipeline with near-term milestones, and achieving financial independence with a clear path to profitability.
A key pipeline initiative is expanding ORLADEYO’s indication to pediatric patients. The company has submitted a New Drug Application (NDA) to the FDA for ORLADEYO in children ages 2 to 11 years, with additional submissions planned for the EU, Japan, and Canada in 2025. This expansion could position ORLADEYO as the market leader for pediatric HAE prophylaxis, addressing approximately 500 patients in the US.
Market research presented by BioCryst shows a strong and increasing preference for oral prophylaxis among HAE patients, with 70% of surveyed patients in 2025 preferring oral administration compared to 51% in 2023.
The company’s pipeline also includes BCX17725, a protein therapeutic for Netherton Syndrome that has received IND clearance from the FDA. This rare genetic skin disorder affects approximately 1,600 diagnosed patients in the US, with potential for the diagnosed population to grow to 3,000-5,000 with greater awareness.
Another promising development is avoralstat for diabetic macular edema (DME), which targets an estimated 1.5 million patients in the US and a projected $4 billion VEGF market by 2028. Preclinical evidence suggests avoralstat may reduce vascular leakage with potential for extended dosing intervals.
Forward-Looking Statements
BioCryst highlighted several key milestones for 2025, including ORLADEYO revenue advancing to a royalty-free tier (above $550 million), the pediatric NDA for ORLADEYO, initial clinical data for BCX17725 and avoralstat, and accelerated full-year profitability.
The company’s Monte Carlo market simulation projects ORLADEYO to maintain approximately 23% market share through 2033, even as new competitive products enter the market. The model estimates the total US prophylaxis patient population will grow from 7,200 in 2024 to 9,300 by 2033.
By 2027, BioCryst projects achieving over $300 million in operating profit (excluding stock-based compensation) and a cash position exceeding $550 million, which includes the impact of the recent debt reduction.
The strong Q1 2025 results and raised guidance appear to have significantly boosted investor confidence, with BioCryst shares rising 16.69% to $10.42 in premarket trading, building on the previous session’s 2.53% gain to $8.93.
Full presentation:
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