Key Highlights

• Total net Revenue reached $180.3 million in Q3 2026, with ORLADEYO net revenue contributing $174.8 million of the total.

• Operating profit came in at $53.3 million on a GAAP basis and $86.5 million on a non-GAAP basis for the quarter.

• The FDA approved ORLADEYO 150 mg oral pellets for patients aged 12 and older, expanding the drug's addressable market.

• Full-year 2026 total revenue guidance was increased to $715 million to $730 million, while ORLADEYO revenue guidance was maintained at $625 to $645 million.

BioCryst Pharmaceuticals(NASDAQ:BCRX) reported its third quarter 2026 financial results on November 4, 2026, showing total net revenue of $180.3 million, a 13% year-over-year increase. The Durham, North Carolina-based biopharmaceutical company also posted an operating profit of $53.3 million on a GAAP basis, compared to $29.6 million in the same period a year earlier.

Revenue Performance and ORLADEYO Growth

ORLADEYO, the company's flagship treatment for hereditary angioedema (HAE), generated net revenue of $174.8 million during the quarter. On a comparable basis, excluding European revenue that was divested in October 2025, ORLADEYO revenue grew 24% year-over-year. Revenue growth in the quarter was also supported by the transition to CareMed as the company's sole-source specialty pharmacy partner, with CareMed building an initial inventory of ORLADEYO to support patient demand.

The company launched ORLADEYO oral pellets for pediatric patients aged 2 to under 12 in August, and reported that early reimbursement trends and new prescriptions continued to exceed its expectations. In October, the FDA approved the supplemental New Drug Application for the oral pellet formulation for patients aged 12 and older, giving prescribers additional treatment flexibility.

Profitability and Expense Management

On a non-GAAP basis, operating profit reached $86.5 million in Q3 2026, compared to $50.8 million in the year-ago period. Net Income on a GAAP basis was $37.9 million, up from $12.9 million in Q3 2025, while non-GAAP net income reached $71.1 million versus $34.7 million in the prior-year quarter.

Research and development expenses, excluding stock-based compensation, totaled $52.4 million for the quarter, which included one-time Impairment charges and employee termination costs tied to the closure of the company's Birmingham site. On a non-GAAP basis, R&D expenses were $37.1 million, down from $38.0 million in Q3 2025. Sales and Marketing expenses declined 15% year-over-year on a GAAP basis to $37.7 million, while general and administrative expenses fell 22% to $21.0 million.

The Birmingham site closure activities are on track to be substantially complete by year-end, with the company expecting total cash costs of approximately $10 million and annualized cost savings of approximately $30 million to $35 million once fully realized.

Pipeline Developments and Strategic Moves

BioCryst's pipeline continued to advance during the quarter. The company's navenibart program, a long-acting plasma kallikrein inhibitor, remains on track in its fully enrolled ALPHA-ORBIT pivotal study, with top-line results expected at the six- and twelve-month endpoints in Q3 2027. BCX17725, an investigational KLK5 inhibitor for Netherton syndrome, has enrolled Part 4 of its Phase 1 trial, with initial patient data expected by the end of 2026.

The company also announced the discontinuation of STAR-0310, the atopic dermatitis program acquired through the Astria Therapeutics acquisition, to refocus resources on rare diseases. In October, BioCryst formed a Scientific Advisory Board with seven scientific and industry leaders to guide its external R&D strategy.

Cash, cash equivalents, restricted cash, and investments totaled $376.4 million as of September 30, 2026, supported by positive Cash Flow generation during the quarter.

Looking Ahead

BioCryst maintained its full-year 2026 global net ORLADEYO revenue guidance of $625 million to $645 million and increased its total revenue outlook to $715 million to $730 million. The company also improved its non-GAAP Operating Expense guidance to $415 million to $425 million. With multiple pipeline milestones anticipated in the coming quarters and the expanded ORLADEYO formulation Options now available, the company has outlined a path toward continued revenue growth and profitability improvement heading into 2027.