BioCryst Announces Q2 2024 Financials and Business Update

RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2024 - BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) has announced its financial results for the second quarter ending June 30, 2024, highlighting significant advancements and increased guidance for their flagship product, ORLADEYO.

ORLADEYO® (berotralstat), an oral, once-daily treatment for the prevention of hereditary angioedema (HAE) attacks, reported net revenue of $108.3 million for Q2 2024, a 34% year-over-year increase. This impressive growth was attributed to operational enhancements and a rise in the overall rate of paid patients, which reached 74.4% by the end of 2023. Notably, new patient starts remained consistent with high rates observed in previous quarters, and patient retention was strong, with over 60% of patients continuing therapy for at least a year.

A market research study indicated that 52% of allergist/immunologists are highly likely to prescribe ORLADEYO to more patients, up from 29% in early 2023. With recent approvals in Europe and Latin America, ORLADEYO is now available in over 20 countries. The ex-U.S. revenue for ORLADEYO saw a 51% increase year-over-year, constituting 11% of global net revenues.

BioCryst’s Chief Commercial Officer, Charlie Gayer, emphasized the strong demand and favorable patient outcomes driving the company's revenue growth. Gayer highlighted that the real-world experience of patients aligns with the 91% reduction in attacks observed in long-term clinical trials, positioning ORLADEYO on a clear path towards $1 billion in peak sales.

Looking ahead, BioCryst aims to expand ORLADEYO's label to include children as young as two years old by 2025, making it the first oral prophylactic therapy for this age group with HAE. Additionally, the company has concluded trials for its oral Factor D inhibitor, BCX10013, finding it safe and well tolerated, though the clinical activity was not competitive with existing therapies. Consequently, BioCryst plans to discontinue its development.

The company is progressing with BCX17725, a KLK-5 inhibitor intended for the treatment of Netherton syndrome, a rare genetic disorder affecting the skin, hair, and immune system. This condition can be life-threatening, particularly in infancy. BCX17725 is expected to enter clinical trials by the end of 2024.

Additionally, BioCryst aims to advance avoralstat, a plasma kallikrein inhibitor, into a clinical trial for diabetic macular edema (DME) in 2025. DME, a significant cause of vision loss in diabetes, may be addressed by avoralstat’s unique targeting of the kallikrein-bradykinin system, potentially offering less frequent injections and a reduced burden on patients.

Financially, BioCryst reported total revenues of $109.3 million for Q2 2024, up 32.5% from $82.5 million in Q2 2023. The increase was driven primarily by ORLADEYO's net revenue. R&D expenses decreased by 26.6% to $37.6 million due to reduced spending on BCX10013 and discontinuation of the BCX9930 program, offset by increased investment in BCX17725, avoralstat, and other discovery programs.

Selling, general, and administrative expenses rose by 20% to $61.2 million due to expanded commercial operations and increased resourcing for accounting and IT functions. Despite these increases, total operating expenses fell by 2.5% year-over-year to $100.6 million.

The company achieved a GAAP operating profit of $8.8 million for Q2 2024, compared to a $20.7 million loss in Q2 2023. Adjusted for non-cash stock compensation, the non-GAAP operating profit was $21.9 million. Interest expense decreased by 14.5% year-over-year to $24.7 million.

BioCryst reported a net loss of $12.7 million, or $0.06 per share, for Q2 2024, significantly lower than the $75.3 million loss, or $0.40 per share, in Q2 2023. Excluding one-time events, the non-GAAP net loss for Q2 2023 was $0.24 per share.

As of June 30, 2024, BioCryst held $338.1 million in cash, cash equivalents, restricted cash, and investments. The company used $0.2 million in operating cash for Q2 2024.

Given the strong performance and operational improvements, BioCryst raised its full-year 2024 global net ORLADEYO revenue guidance to between $420 million and $435 million. The company expects full-year operating expenses for 2024 to remain flat compared to 2023, between $365 million and $375 million, excluding non-cash stock compensation and one-time workforce reduction expenses.

BioCryst is confident in achieving a full-year operating profit for 2024, approaching quarterly positive EPS and cash flow in the second half of 2025, and being profitable on an EPS basis with positive cash flow for the full year 2026. The company does not anticipate needing additional funds and does not plan to draw an additional $150 million of debt available from Pharmakon.

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