BioCryst Pharmaceuticals Soars with Stellar Q1 2025 Results, Raises ORLADEYO Guidance, and Achieves Profitability Ahead of Schedule

May 5, 2025

DENVER, Colo., May 05, 2025 (247marketnews.com)- BioCryst Pharmaceuticals (NASDAQ:BCRX) delivered a blockbuster first quarter of 2025, reporting financial results that surpassed expectations and a robust corporate update that underscores its leadership in rare disease therapeutics. With ORLADEYO (berotralstat) generating $134.2 million in Q1 net revenue, a 51% year-over-year increase, the company raised its full-year 2025 ORLADEYO guidance to $580-$600 million and now anticipates profitability and positive cash flow a year ahead of schedule. Strategic debt reduction, a new drug application (NDA) for pediatric HAE treatment, and an open IND for Netherton syndrome further solidify BioCryst’s growth trajectory, positioning it as a standout in the $150 billion rare disease market.

Jon Stonehouse, BioCryst’s President and CEO, said, “We started 2025 with another quarter of outstanding performance. ORLADEYO revenue growth was driven by moving ORLADEYO patients from free drug to paid at a much faster rate than we expected, resulting in a substantial increase to our annual guidance as we also move closer to peak sales of $1 billion. This increased financial strength accelerates our path to profitability and enables us to start paying down our debt, while continuing to invest in and advance our pipeline.”

ORLADEYO: Driving Revenue Growth

ORLADEYO, an oral, once-daily prophylactic treatment for hereditary angioedema (HAE), continues to dominate BioCryst’s portfolio. Key Q1 2025 highlights include:

  • Revenue Surge: $134.2 million in net revenue, up 51% from $88.9 million in Q1 2024, driven by an 84% paid drug patient rate (up from 73.5% in Q4 2024).
  • Market Penetration: U.S. sales accounted for 89.5% of revenue, with strong global growth in new and existing markets. A company survey showed 70% of U.S. HAE patients prefer oral prophylaxis, up from 50% in 2023.
  • Prescription Strength: Q1 prescriptions exceeded the 2024 quarterly average, reflecting robust demand.

The company raised its full-year 2025 ORLADEYO revenue guidance from $535-$550 million to $580-$600 million, reflecting confidence in sustained patient adoption and global expansion.

Rare Disease Pipeline Advancements

BioCryst is leveraging ORLADEYO’s success to advance its rare disease pipeline:

Pediatric HAE Expansion: An NDA was submitted to the FDA for ORLADEYO oral granules for children aged 2-11 with HAE, potentially the first targeted oral prophylactic for this group. Global filings in Europe, Japan, and Canada are planned for 2025.

Netherton Syndrome: The FDA cleared an IND for BCX17725, a KLK5 inhibitor for Netherton syndrome, a rare genetic disorder causing severe skin barrier issues, infections, and allergies. Phase 1 trials are open in the U.S. and Australia, with initial data expected in 2025. No approved treatments currently target Netherton’s underlying cause, making BCX17725 a high-potential candidate.

Diabetic Macular Edema (DME): Australia authorized a clinical trial for avoralstat, a plasma kallikrein inhibitor delivered suprachoroidally for DME, with initial data expected in 2025. Targeting the kallikrein-bradykinin pathway, avoralstat could reduce injection frequency for DME patients, addressing a $10 billion market need.

Dr. Helen Thackray, BioCryst’s Chief R&D Officer, stated, “Today we are reporting significant milestones for each of the next three programs in our pipeline, demonstrating our focus on advancing medicines with the potential to provide differentiated outcomes for patients of all ages. As we move closer to delivering an urgently needed oral prophylactic therapy to children with HAE, we are simultaneously progressing two clinical-stage programs in Netherton syndrome and DME towards the first patient data later this year.”

Financial Highlights and Debt Reduction

BioCryst’s Q1 2025 financials reflect operational efficiency and strategic financial management:

Total Revenue: $145.5 million, up 56.8% from $92.8 million in Q1 2024, primarily driven by ORLADEYO.

R&D Expenses: Down 19.8% to $37.3 million from $46.5 million, due to the discontinuation of Factor D programs, offset by increased avoralstat and early-phase investments.

SG&A Expenses: Up 38.7% to $82.5 million from $59.5 million, reflecting commercial investments in ORLADEYO’s global expansion.

Operating Income: $21.2 million, compared to a $14.5 million loss in Q1 2024. Non-GAAP operating income (excluding stock-based compensation) was $42.6 million, vs. a $0.8 million loss.

Net Income: $32,000 ($0.00/share), vs. a $35.4 million loss ($0.17/share) in Q1 2024.

Cash Position: $317.3 million in cash, equivalents, and investments at March 31, 2025, with $25.5 million net cash utilization in Q1.

Debt Paydown: In Q2 2025, BioCryst paid down $75 million of Pharmakon debt, saving ~$23.5 million in interest over the loan’s life, reducing Q1 interest expense to $23.5 million (down 4.1% from $24.5 million).

2025 Financial Outlook

BioCryst’s updated 2025 outlook reflects its accelerated path to profitability:

ORLADEYO Revenue: $580-$600 million, up from $535-$550 million.

Operating Expenses: $440-$450 million (excluding non-cash stock compensation), up from $425-$435 million, due to pipeline investments.

Profitability: Net income and positive cash flow expected for full-year 2025, a year ahead of prior 2026 guidance (excluding the $75 million debt prepayment’s cash impact).

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