On Monday, BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) released results from an interim analysis of the ongoing APeX-P trial.

The study centered on an oral granule formulation of once-daily Orladeyo (berotralstat) in pediatric patients. The patients have hereditary angioedema (HAE) aged 2 to 12 years.

• ORLADEYO was safe and well tolerated in APeX-P, with no new safety signals identified. Adverse events (AEs) were similar across all ages and weights.
• ORLADEYO resulted in early and sustained reductions in monthly attack rates. After one month of taking ORLADEYO, the median and mean monthly attack rates dropped to 0 and 0.5, respectively. The median monthly attack rate remained at 0 through month 12, and the mean monthly attack rate at month 12 was 0.3.

The company also announced new real-world evidence with Orladeyo showing statistically significant HAE attack rate reductions experienced by patients with HAE with C1-INH deficiency (HAE Type I/II) and normal C1-INH levels and function (HAE-nl-C1-INH).

The company plans to submit an FDA marketing application this year.

Concurrently, BioCryst reported fourth-quarter sales of $131.53 million, up 41% year over year, beating the consensus of $130.15 million.

The company reported an adjusted loss of 13 cents per share, missing the consensus loss of 6 cents per share.

Orladeyo net revenue increased 36.6% to $124.2 million and 34% to $437.7 million.

BioCryst expects 2025 sales of $560 million—$575 million, compared to the prior guidance of $540 million—$560 million and the consensus of $545.31 million.

The company increased its 2025 outlook for Orladeyo revenue to between $535 million and $550 million, from $515 million to $535 million.

The company expects to approach quarterly positive EPS and cash flow in the second half of 2025 and to be profitable on an EPS basis, with positive cash flow, for the full year 2026.

Price Action: BCRX stock is down 11.4% at $8.16 at last check Monday.

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