Will BioCryst's ORLADEYO Hit The $1 Billion Sales Mark?

BioCryst Pharmaceuticals

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(RTTNews) - Shares of BioCryst Pharmaceuticals Inc. (BCRX) are down over 40% from their 52-week high of $11.31, recorded last June, and trade around $6.

This commercial-stage biotechnology company markets ORLADEYO, a plasma kallikrein inhibitor approved for the prophylaxis of hereditary angioedema (HAE) in patients aged 2 years and older, and a non-core product, RAPIVAB (peramivir injection) for the treatment of acute uncomplicated influenza.

ORLADEYO, the first and only approved targeted oral drug for HAE prophylaxis, was approved in the U.S. in December 2020 and is now in its sixth year of launch, supporting a meaningful and established revenue base.

Hereditary angioedema is a rare, inherited, and sometimes life-threatening condition with repeat episodes (attacks) of severe swelling in various parts of the body, including the stomach, limbs, face, and throat. According to the company, ORLADEYO efficacy is consistent with about an 80-90% reduction in attack rate provided by injectable therapies.

Net product sales of ORLADEYO have increased steadily each year, growing from $122.6 million in 2021 to $251.6 million in 2022, $326.0 million in 2023, and reaching $437.6 million in 2024.

For the full year of 2025, the company expects ORLADEYO net revenue of $563?million, excluding European sales. BioCryst sold its European ORLADEYO business to Neopharmed Gentili in October 2025, in a transaction valued at $250?million upfront, with the potential for up to $14?million in milestone payments.

Looking further ahead to the full year 2026, BioCryst expects global ORLADEYO net revenue to range from $625?million to $645?million, with a long-term goal of reaching $1?billion in annual sales by 2029.

The company's non-core marketed product, Peramivir injection, which is approved in the U.S. as RAPIVAB, has received regulatory approvals in Canada (RAPIVAB), Australia (RAPIVAB), Japan (RAPIACTA), Taiwan (RAPIACTA) and Korea (PERAMIFLU).

Peramivir (RAPIVAB, RAPIACTA, PERAMIFLU) is marketed to the company's licensing partners and the U.S. Department of Health and Human Services (HHS), with revenue primarily derived from product sales and royalties.

Including RAPIVAB (peramivir injection), the company expects total revenue to be between $635 million and $660 million for the full year of 2026.

The company's pipeline includes BCX17725, a targeted KLK5 inhibitor for Netherton syndrome, and a non-core investigational product, Avoralstat.

-- BCX17725 is under a 4-part phase 1 study. Parts 1 & 2 of the study involve healthy participants, while Parts 3 & 4 involve Netherton syndrome patients. The company expects initial patient data from this program by the end of the first quarter of 2026.

Netherton syndrome is a severe, rare, genetic disorder with widespread skin involvement and systemic complications. It causes premature separation of skin layers, severe inflammation, and infection risk. There are no approved targeted therapies to treat this disorder.

-- Avoralstat, a plasma kallikrein inhibitor for the treatment of diabetic macular edema, is under a phase 1 study.

In a bid to strengthen its position as a leader in hereditary angioedema (HAE) and enhance the company's long-term growth trajectory, BioCryst acquired Astria Therapeutics, Inc., last October for about $700 million.

The acquisition added Navenibart, a subcutaneously administered drug, which is in a phase 3 trial for hereditary angioedema, dubbed ALPHA-ORBIT. Topline data from this study is expected in early 2027.

Cash Position

Preliminary, unaudited cash, cash equivalents, restricted cash & investments as of December 31, 2025, were $338 million.

BCRX has traded in a range of $6.00 to $11.31 in the last 1 year. The stock closed yesterday's trading at $6.70, up 1.21%.