BioCryst reports fourth quarter and full year 2023 financial results and upcoming key milestones

Biocryst Pharmaceuticals Inc today reported financial results for the fourth quarter and full year ended 31 December 2023, and provided a corporate update.

Jon Stonehouse, President and Chief Executive Officer of BioCryst. “The impressive growth we are seeing with Orladeyo has put us in a position to accelerate our path to profitability while continuing to invest in our diverse pipeline of first-in-class or best-in-class molecules that we believe will deliver our next marketed product.”

Program updates and key milestones for Orladeyo (berotralstat)

  • Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks Orladeyo net revenue in the fourth quarter of 2023 was $90.9 million.
  • The total number of U.S. patients on paid or long-term free product reached 1,104 at the end of the fourth quarter (+30 percent y-o-y) with 71.5 percent of those patients on paid product.
  • Net U.S. patient growth totaled 321 in 2023, including new patients still on short-term quick start product at the end of the quarter.
  • The number of new Orladeyo prescribers in the fourth quarter of 2023 (Q4 2023) was the largest number of new prescribers of any quarter in 2023.

Real-world data presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting reinforced prior data showing patients switching to Orladeyo experience sustained attack reduction regardless of baseline attack rate or prior HAE prophylaxis treatment.

Access to Orladeyo continues to expand to more HAE patients around the world. In Q4 2023, Orladeyo was approved in Argentina, launched in Spain, and granted final pricing approval in Austria. In the first quarter of 2024, Orladeyo secured final reimbursement in Italy.

Charlie Gayer, Chief Commercial Officer of BioCryst, said: “As the real-world evidence with Orladeyo consistently underscores, patients are switching to Orladeyo because they can achieve outstanding HAE attack control and tolerability with an oral, once-daily therapy, leading to life-changing results.”

Fourth Quarter 2023 Financial Results

For the three months ended December 31, 2023, total revenues were $93.4 million, compared to $79.5 million in the fourth quarter of 2022. The increase was primarily due to $90.9 million in Orladeyo net revenue in the fourth quarter of 2023, compared to $70.7 million in the fourth quarter of 2022.

Full Year 2023 Financial Results

For the full year ended December 31, 2023, total revenues were $331.4 million, compared to $270.8 million in the full year ended December 31, 2022. The increase was primarily due to $326.0 million of Orladeyo net revenue in 2023, compared to $251.6 million in 2022.

(Source: BioCryst)