BeiGene had another quarter of strong financial results. Supported by tremendous global growth in revenue, the company has now ascended into the top 15 of global oncology innovators based on total oncology sales. BeiGene also continues to make significant improvement in operating leverage as it progresses to sustainable profitability.

BeiGene strengthened its hematology leadership with BRUKINSA, now the BTK inhibitor with the broadest label in the class, as it advances its innovative pipeline of therapies for hematologic malignancies. With TEVIMBRA now approved for use in the U.S. and Europe, BeiGene looks forward to rapidly advancing its deep pipeline of solid tumor therapies to match its leadership in hematology and continue to solidify its reputation as a global oncology innovator.

Key highlights for the first quarter of 2024

• Total revenues of $751.7 million in the first quarter, including product revenue of $746.9 million, an 82% increase from the prior-year period;

• BRUKINSA revenue of $488.5 million, driven by growth in the U.S. and Europe of 153% and 243%, respectively, from the prior-year period; with recent fifth FDA approval, BRUKINSA now has the broadest label in the BTKi class;

• Rapidly advancing late-stage hematology pipeline; sonrotoclax in development both as a monotherapy and in combination with backbone therapy BRUKINSA; pivotal program initiated for BTK CDAC;

• Progressing potentially differentiated solid tumor programs with ADC, degrader platforms and targeted therapies in priority cancer types; and

• Significantly improved operating leverage and progress on path to sustainable profitability.

Financials

For the full year 2023, BeiGene reported annual revenue of $2.46 billion, a 67% increase from the prior year. However, the company incurred a net loss of $881.7 million, primarily due to continued investment in research and development as well as commercial expansion. Operating cash flow for the year was negative $1.16 billion, and free cash flow was negative $1.74 billion, reflecting the company's significant investment in its pipeline and operations.

In the first quarter of 2024, total revenues increased 67.9% year-over-year to $751.7 million, driven by an 82% increase in product revenue to $746.9 million. This was primarily due to continued growth in sales of BRUKINSA globally, with significant increases in the U.S. and Europe markets. BRUKINSA revenue reached $488.5 million in Q1 2024, up 131.1% from the prior-year period.

The rapid growth of BRUKINSA, which now has the broadest label in the BTK inhibitor class, has been a key driver of BeiGene's success. The medicine was recently approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma, marking its fifth indication in B-cell malignancies in the U.S. This expanded label, combined with continued market share gains, has fueled BRUKINSA's impressive performance.

Beyond BRUKINSA, BeiGene's other internally developed medicines, tislelizumab and pamiparib, also contributed to the strong product revenue growth. Tislelizumab revenue in China reached $145.2 million in Q1 2024, up 26.4% year-over-year, driven by broader reimbursement and hospital listings. The company's in-licensed products from Amgen, including XGEVA, BLINCYTO and KYPROLIS, also saw solid growth in China.

Business Overview

On the pipeline front, BeiGene continues to make significant progress. The company is rapidly advancing its late-stage hematology pipeline, with sonrotoclax in development both as a monotherapy and in combination with BRUKINSA. Additionally, the company has initiated a pivotal program for a novel BTK CDAC compound. In solid tumors, BeiGene is progressing potentially differentiated programs utilizing antibody-drug conjugate (ADC), protein degrader, and targeted therapy platforms.

Liquidity

BeiGene's financial position remains strong, with $2.8 billion in cash, cash equivalents and restricted cash as of March 31, 2024. However, the company's operating cash flow and free cash flow remain negative, reflecting the significant investments being made in R&D and commercial expansion.

Outlook

Looking ahead, BeiGene expects to continue its strong revenue growth trajectory, driven by the continued success of BRUKINSA and its other marketed products. The company is also focused on advancing its robust pipeline of innovative oncology therapies, which should support long-term growth. However, the company will likely continue to report net losses in the near-term as it invests heavily in R&D and commercialization.

Conclusion

Overall, BeiGene is solidifying its position as a global oncology leader, with a diversified portfolio of approved medicines and a deep pipeline of promising drug candidates. The company's strong commercial execution, coupled with its innovative R&D efforts, position it well to drive long-term value for shareholders.