BeOne Medicines (ONC) is Wednesday's IBD Stock Of The Day. Shares of the IBD 50 biotech stock are breaking out after a record-breaking quarter for the company's blockbuster drug, Brukinsa.
Brukinsa treats a handful of blood cancers by blocking a protein called BTK. BTK is involved in the development and function of some white blood cells. But those cell can become too active, causing cancer. By latching onto BTK, Brukinsa prevents the cancerous cells from spreading.
The drug rivals Imbruvica from Johnson & Johnson (JNJ) and AbbVie (ABBV) as well as Calquence from AstraZeneca (AZN). During the third quarter, Brukinsa generated $1.04 billion in sales, up 51% vs. a year earlier.
RBC Capital Markets analyst Leonid Timashev called it "another solid quarter."
"We believe ONC remains well positioned to be a leader in (hematology oncology), with upside optionality on their solid tumor pipeline," he said in a Nov. 6 report.
The New BeiGene
BeOne Medicines changed its name last year from BeiGene and switched its Nasdaq ticker from BGNE to ONC.
In a release explaining the decision, the company said it wants to reflect that cancer, the leading cause of death worldwide, isn't a one-person or even a one-company problem.
"No person, family, scientist, clinician, hospital, policymaker, company or country can or should face this devastating disease alone," Chief Executive John Oyler said in a November 2024 statement. "We all must work together to win, which is why we are committed to playing a critical role and unifying the global community in the fight against cancer."
BeOne is notching incredible growth as it takes on AbbVie, AstraZeneca and J&J.
During the same three-month period in which Brukinsa sales topped $1 billion for the first time, AstraZeneca's Calquence brought in $916 million, growing just 13%.
J&J, which sells Imbruvica outside the U.S., reported $695 million in sales, down 8%. AbbVie reported $706 million in global sales of Imbruvica, down 15%. AbbVie commercializes the drug in the U.S. and shares profits on international sales.
"ONC attributes their success to rapid and increased adoption by patients and physicians across the U.S. despite launching later than competitors," Leerink Partners analyst Andrew Berens said in a report. "Additionally, ONC positions Brukinsa as the best-in-class BTK inhibitor with the broadest label and efficacy, regardless of risk status."
Fixed-Dose Combination
Importantly, BeOne announced the inclusion of a fixed-dose regimen using Brukinsa with venetoclax, the generic name for AbbVie and Roche's (RHHBY) Venclexta, in the National Comprehensive Cancer Network guidelines for patients with previously untreated chronic lymphocytic leukemia. The decision is based on a study called SEQUOIA.
AstraZeneca ran a similar study and is also hoping to win approval for its own fixed-dose combo of Calquence and venetoclax. Fixed-dose regimens don't need to be personalized based on a patient's weight. The AstraZeneca decision is expected in the first half of 2026.
"The inclusion was deemed a Category 2A endorsement, which will allow payers to reimburse for the off-label usage, but the company cannot directly promote the indications," Berens said.
He rates BeOne Medicines stock an outperform with a 356 price target.
Across all products, BeOne Medicines reported $1.4 billion in sales, up 40% year over year. That narrowly topped estimates for $1.37 billion. The company also sells a handful of other cancer drugs and is partnered with Amgen (AMGN) on several other products.
The company raised the lower end of its full-year outlook and now calls for $5.1 billion to $5.3 billion in sales.
BeOne Medicines Breaks Out
On Wednesday, BeOne stock rose sharply, breaking out of a flat base with a buy point at 355.30, according to MarketSurge chart analysis. Shares are now solidly trading in the chase zone, which runs up to 373.07. ONC stock is at its highest level since late 2021.
The relative strength line is trading near a 52-week high on the weekly chart. On the daily chart, the biotech stock is trading above its 50-day and 200-day moving averages. Shares have nearly doubled in 2025, climbing 98% as of Wednesday afternoon.
Shares have a strong IBD Digital Composite Rating of 97. This means BeOne Medicines ranks in the top 3% of all stocks in terms of fundamental and technical measures. Shares have a slightly lower, but still strong, Relative Strength Rating of 92, reflecting their strong 12-month performance.
BeOne Medicines lands on the IBD 50 list of elite growth stocks and, on Tuesday, featured as one of the IBD 50 Growth Stocks To Watch. On Wednesday, ONC stock was added to Leaderboard.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
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