BioCryst Raises 2026 Revenue Outlook on ORLADEYO Growth

BioCryst (BCRX) increased its full-year 2026 total revenue forecast after reporting higher third-quarter ORLADEYO sales and a sharp increase in operating profit. The company now expects total revenue of $715 million to $730 million, up from its August forecast of $690 million to $715 million, while maintaining its ORLADEYO revenue outlook at $625 million to $645 million.

The company also narrowed its forecast for 2026 non-GAAP operating expenses to $415 million to $425 million from $420 million to $440 million. The measure excludes stock-based compensation, restructuring expenses and transaction-related costs.

ORLADEYO sales support higher quarterly profit

Third-quarter ORLADEYO revenue rose to $175 million from $159 million a year earlier on a GAAP basis. Excluding revenue associated with the European ORLADEYO business sold in October 2025, prior-year non-GAAP ORLADEYO revenue was $145 million.

Total revenue increased to $180.3 million from $159.4 million. GAAP operating profit climbed to $53.3 million from $29.6 million, while net income rose to $37.9 million from $12.9 million. Non-GAAP operating profit, which excludes the European business and certain transaction, restructuring and stock-based compensation items, increased to $86.5 million from $50.8 million.

BioCryst said direct ORLADEYO revenue has reached the tier at which no royalties are owed on direct sales above $550 million under its agreements with Royalty Pharma and OMERS. The company expects its overall royalty payments to remain relatively flat until the OMERS royalty reaches its cumulative repayment cap, which is expected in 2029. At that point, BioCryst estimates the total royalty burden will fall by approximately half. Royalties on Japanese sales may still increase.

ORLADEYO, an oral plasma kallikrein inhibitor used to prevent hereditary angioedema attacks, is approved for patients aged 2 and older. Its pediatric pellet formulation was approved in December 2025. At the end of 2025, more than 1,600 U.S. patients were receiving the therapy, including patients in assistance and Quick Start programs, and more than 3,500 had tried it since launch.

Navenibart Phase 3 data targeted for 2027

BioCryst is developing navenibart as a long-acting injectable complement to ORLADEYO within its hereditary angioedema portfolio. The monoclonal antibody, acquired through the January 2026 purchase of Astria Therapeutics, is being studied with dosing every three or six months.

The pivotal Phase 3 program remains on track to report six- and 12-month efficacy data for both dosing schedules in the third quarter of 2027. The program enrolled 157 participants, including adolescents, compared with a target of 135. Earlier interim results cited in the presentation showed mean attack-rate reductions of 90% in 12 patients receiving treatment every three months and 92% in 17 patients receiving treatment every six months, although BioCryst cautioned that results from separate trials cannot be directly compared.

The company estimates that navenibart could address more than 5,000 hereditary angioedema patients who prefer injectable prophylaxis, while ORLADEYO could maintain a base of more than 2,000 patients who prefer oral treatment. These figures are company estimates rather than approved indications or forecasts of actual uptake. Navenibart remains investigational and has not been deemed safe and effective by the FDA.

BioCryst is also advancing BCX17725, a systemic KLK5 inhibitor for Netherton syndrome, a rare genetic disorder with no approved targeted therapies. Initial healthcare claims analysis identified about 1,600 diagnosed U.S. patients, while the company believes improved diagnosis could expand that population beyond 3,000. Parts 1 and 2 of the Phase 1 study in healthy volunteers have been completed, and data from a 12-week, open-label portion involving up to 12 patients with Netherton syndrome are expected by the end of 2026.

Cash position and execution risks

BioCryst ended September with $376 million in cash and investments. It also had a $400 million senior credit facility carrying interest at the secured overnight financing rate plus 4.5%.

The company identified several uncertainties that could affect its outlook, including the transition to a new sole-source specialty pharmacy for ORLADEYO, execution of the pediatric pellet launch and the timing and costs of closing its Birmingham research facility. Clinical studies could take longer than planned or fail to produce positive results, and regulators could require additional studies or delay development and approval timelines. BioCryst also cautioned that expected cost savings, sustained profitability, positive cash flow and projected revenue and expenses may not materialize as anticipated.