BeiGene's Brukinsa Surpasses AstraZeneca's Calquence in Q4 Sales, Signaling Shift in BTK Inhibitor Market

BeiGene's Brukinsa has overtaken AstraZeneca's Calquence in quarterly sales for the first time, marking a significant shift in the competitive landscape of BTK inhibitor treatments for blood cancers. This development comes as BeiGene continues to expand its global presence and solidify its position in the chronic lymphocytic leukemia (CLL) market.

Brukinsa's Impressive Growth and Market Position

In the fourth quarter of 2023, Brukinsa generated $828 million in sales, doubling its year-over-year performance and surpassing Calquence's $808 million for the same period. BeiGene CEO and co-founder John Oyler described this achievement as a "once-in-a-lifetime opportunity," comparing the company's potential in CLL to legendary biotech success stories like Gilead in HIV and Vertex in cystic fibrosis.

BeiGene reports that Brukinsa now enjoys the highest number of new patient starts in the U.S. across all indications within the BTK inhibitor class. Matt Shaulis, BeiGene's general manager of North America, stated that Brukinsa has captured over 50% of U.S. new patient market share in all lines of CLL treatment.

Competition and Strategic Developments

The BTK inhibitor market has become increasingly competitive, with AstraZeneca and BeiGene vying for leadership based on different metrics. While AstraZeneca claims Calquence maintains a leading share of U.S. new patient starts in front-line CLL, BeiGene's broader market share across all CLL treatment lines suggests a shifting landscape.

To strengthen Calquence's position, AstraZeneca recently proposed a fixed-duration combination treatment, which showed positive results in a phase 3 trial. However, Oyler criticized the data, citing concerns about minimal residual disease outcomes, progression-free survival, and safety profile compared to Brukinsa.

BeiGene is not resting on its laurels, with several strategic initiatives underway:

1. Testing Brukinsa in combination with its BCL-2 inhibitor sonrotoclax for first-line CLL treatment.
2. Developing a BTK protein degrader (BGB-16673) with potential registrational data expected in 2026.
3. Planning a head-to-head phase 3 trial of BGB-16673 against Eli Lilly's Jaypirca in relapsed or refractory CLL.

BeiGene's Global Ambitions and Financial Outlook

As BeiGene seeks to establish itself as a global pharmaceutical player, the company is taking steps to reduce its reliance on the Chinese market. In 2023, the U.S. contributed 51.4% of BeiGene's total annual revenue of $3.8 billion, compared to 37% from China. This marks a significant shift from previous years when China was the primary revenue source.

BeiGene's global expansion efforts include:

• Establishing a U.S. biologics innovation center
• Proposing a name change to BeOne Medicines
• Moving to redomicile in Switzerland

The company expects to break even under GAAP measurements and generate positive cash flow from operations starting in 2025. For 2024, BeiGene projects full-year revenue between $4.9 billion and $5.3 billion, driven by the continued global expansion of Brukinsa.

As BeiGene continues to challenge established players in the pharmaceutical industry, its success with Brukinsa and ambitious pipeline developments suggest a promising future in the treatment of blood cancers and beyond.