10-KPeriod: FY2021

BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2021

Filed February 28, 2022For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (ONC) is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines for cancer treatment. The company's core internally developed products are BRUKINSA® (zanubrutinib), a BTK inhibitor for blood cancers, and tislelizumab, an anti-PD-1 antibody immunotherapy for various cancers. The company also has the PARP inhibitor pamiparib. Significant progress has been made in global approvals and commercialization for BRUKINSA®, including in the US, EU, and China, with ongoing trials expanding its indications. Tislelizumab has secured approvals in China for multiple indications, with a US Biologics License Application (BLA) review underway. The company has a robust pipeline with over 30 medicines and drug candidates in development, supported by a global clinical development team of over 2,200 people and a growing internal manufacturing capability. Strategic collaborations with Amgen and Novartis are key to its development and commercialization strategy, providing significant upfront payments and potential milestone revenue.

Financial Highlights

55 data points
Beta

Revenue

$1.18B

86.0% Gross Margin

Net Income

-$1.46B

-123.9% Net Margin

EPS (Diluted)

$-1.21

Total Assets

$8.54B

Cash & Equivalents

$4.38B

Free Cash Flow

-$1.56B

Financial Statements
Beta
Revenue$1.18B
Cost of Revenue$164.91M
Gross Profit$1.01B
R&D Expenses$1.46B
SG&A Expenses$990.12M
Operating Expenses$2.45B
Operating Income-$1.44B
Interest Expense$29.26M
Net Income-$1.46B
EPS (Basic)$-1.21
EPS (Diluted)$-1.21
Shares Outstanding (Basic)1.21B
Shares Outstanding (Diluted)1.21B

Key Highlights

  • 1BeiGene has three internally discovered and approved medicines: BRUKINSA® (zanubrutinib), tislelizumab, and pamiparib, with global approvals for BRUKINSA® in multiple markets and expanding indications.
  • 2The company has a substantial global clinical development program with over 90 ongoing or planned clinical trials across more than 30 medicines and drug candidates, including over 30 pivotal trials.
  • 3Significant strategic collaborations are in place, notably with Novartis for tislelizumab and ociperlimab, generating substantial upfront payments and potential future milestone and royalty revenues.
  • 4BeiGene is expanding its manufacturing capabilities with state-of-the-art facilities in China and plans for a new U.S. facility in New Jersey.
  • 5Product revenue for the year ended December 31, 2021, increased significantly to $634.0 million, driven by strong sales growth for BRUKINSA® and tislelizumab.
  • 6Collaboration revenue was $542.3 million for the year ended December 31, 2021, primarily from the Novartis collaboration, highlighting the value of its pipeline assets.
  • 7Despite increased revenues, the company reported a net loss attributable to BeiGene, Ltd. of $1.4 billion for the year ended December 31, 2021, reflecting substantial investments in R&D and commercialization.

Frequently Asked Questions

BeiGene has three internally discovered approved medicines: BRUKINSA® (zanubrutinib), an orally active Bruton's Tyrosine Kinase (BTK) inhibitor; tislelizumab, an anti-PD-1 antibody; and pamiparib, a PARP1/2 inhibitor. The company also in-licenses and commercializes 13 other approved medicines in China. Its pipeline includes numerous investigational oncology medicines and drug candidates, with a strong focus on blood cancers and solid tumors, including TIGIT, BCL2, and OX40 inhibitors.

For the year ended December 31, 2021, BeiGene reported total revenues of $1.18 billion, a significant increase from $308.9 million in 2020. This growth was primarily driven by product sales, which more than doubled to $634.0 million, and the recognition of $542.3 million in collaboration revenue from the Novartis agreements. Despite the revenue growth, the company incurred a net loss of $1.41 billion for the year, reflecting substantial investments in research and development and expanding commercial operations.

BeiGene has established significant collaborations with major biopharmaceutical companies. Key partnerships include an agreement with Novartis for the global development and commercialization of tislelizumab and an option agreement for ociperlimab, as well as collaborations with Amgen for the commercialization of Amgen's oncology products in China and co-development of pipeline products. These collaborations provide BeiGene with upfront payments, potential milestone payments, royalties, and access to valuable development and commercialization expertise.

BeiGene's strategy involves leveraging its global clinical development and commercial capabilities to bring its innovative medicines to patients worldwide. This includes building a strong presence in key markets like the United States and China, expanding its sales and marketing infrastructure, and pursuing regulatory approvals in additional geographies. The company also focuses on securing favorable reimbursement and market access, particularly by securing inclusion in national reimbursement drug lists, such as China's NRDL, which has been a significant driver for its product sales.