バイオクリスト、オルラデヨの需要が好調で収益見通しを3,000万ドル引き上げ

With increasing revenue from what it says could be a billion-dollar drug, a Durham pharmaceutical company is raising its financial projections for the year.

Strong demand for its lead product, Orladeyo, has led BioCryst Pharmaceuticals (Nasdaq: BCRX) to increase its revenue guidance for the second straight quarter. The company now expects revenue from Orladeyo this year to be between $420 million and $435 million, up from previous guidance of $390 million to $400 million.

The company’s initial expectation was at least $380 million in Orladeyo revenue in 2024.

The U.S. Food and Drug Administration in late 2020 approved Orladeyo as a treatment for the prevention of hereditary angioedema — a rare disorder characterized by episodes of severe swelling — for patients 12 and older. The company has seen steady growth in sales since the drug launched.

BioCryst reported revenue from Orladeyo in the second quarter of $108.3 million and about $197.2 million for the first half of the year. This is compared to about $149.4 million during the first half of 2023.

Orladeyo is an oral, once-daily treatment while other approved treatments include injectable therapies.

“Demand remains strong and was the key driver of our 34 percent year-over-year revenue growth,” BioCryst Chief Commercial Officer Charlie Gayer said during an earnings call Monday. “New patient prescriptions for the past three quarters continue to equal the high demand we experienced in the very first three quarters of the launch three years ago. But operational improvements made the immediate difference that drove our performance in the quarter.”

The company believes it is on the path toward a blockbuster drug.

“We’ve been describing a billion dollars in peak global revenue for Orladeyo for a few years now,” Gayer said. “The path to that sustainable peak is increasingly clear.”

As it advances its commercial plans, BioCryst is also developing a pipeline of assets. This includes an effort to expand the use of Orladeyo in pediatric patients as young as 2 years old. BioCryst expects to submit a regulatory filing in 2025 to expand the drug’s label.

BioCryst CEO Jon Stonehouse said the company is on track to advance a program focused on Netherton syndrome, a rare genetic disorder, into the clinic by the end of this year. The company is also planning to begin dosing patients in another program focused on diabetic macular edema next year.

While BioCryst is advancing these and other assets, it has discontinued a different program.

Earlier this year, the company cut a few dozen jobs tied to its research and development organization after disclosing plans to either license out the late-stage development of a clinical program called BCX10013 or discontinue it altogether. On Monday, BioCryst confirmed its plans to discontinue the program’s development.

The company said the drug was safe and well tolerated in clinical studies, however, the level of clinical activity observed in the studies was less than therapies already on the market. Potential BioCryst partners declined to take on the additional investment required to evaluate the asset at higher doses.

BioCryst on Monday reported cash of $338.1 million. The company’s closed Monday up nearly 7 percent to $7.51. The share price was up more than 23 percent on the year.