10-KPeriod: FY2019

BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2019

Filed March 2, 2020For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (ONC) presented a strong growth trajectory in its March 2, 2020, 10-K filing, driven by significant advancements in its product pipeline and strategic collaborations. The company is focused on developing and commercializing innovative cancer therapeutics, with a growing commercial presence in China and the United States. Key internal developments include the U.S. FDA accelerated approval and launch of BRUKINSA™ (zanubrutinib) for mantle cell lymphoma and the NMPA approval in China for tislelizumab for classical Hodgkin's lymphoma. These approvals, along with a robust pipeline of internally developed and in-licensed assets, position BeiGene for substantial market penetration. The company also highlighted its strategic collaboration with Amgen, which includes the commercialization of Amgen's oncology products in China and joint global development of Amgen's pipeline assets, alongside a significant equity investment by Amgen. BeiGene's operational strategy emphasizes building strong clinical development and commercial capabilities, particularly leveraging the evolving regulatory landscape in China. Despite significant research and development expenses and net losses, the company's substantial cash reserves and strong partnerships indicate a forward-looking approach to growth and innovation in the oncology space.

Financial Highlights

57 data points
Beta

Revenue

$428.21M

83.4% Gross Margin

Net Income

-$950.58M

-222.0% Net Margin

EPS (Diluted)

$-1.22

Total Assets

$1.61B

Cash & Equivalents

$620.77M

Free Cash Flow

-$839.88M

Financial Statements
Beta
Revenue$428.21M
Cost of Revenue$71.19M
Gross Profit$357.02M
R&D Expenses$927.34M
SG&A Expenses$388.25M
Operating Expenses$1.39B
Operating Income-$959.89M
Interest Expense$15.15M
Net Income-$950.58M
EPS (Basic)$-1.22
EPS (Diluted)$-1.22
Shares Outstanding (Basic)780.70M
Shares Outstanding (Diluted)780.70M

Key Highlights

  • 1Secured U.S. FDA accelerated approval and launched BRUKINSA™ (zanubrutinib) for mantle cell lymphoma.
  • 2Received NMPA approval in China for tislelizumab for classical Hodgkin’s Lymphoma (cHL).
  • 3Entered into a significant strategic oncology collaboration with Amgen, including a $2.8 billion equity investment, enhancing global development and China commercialization capabilities.
  • 4Expanded its commercial portfolio with in-licensed drugs from BMS (ABRAXANE, REVLIMID, VIDAZA) and upcoming launches of Amgen and EUSA Pharma products in China.
  • 5Reported substantial increases in total revenues driven by product sales and collaboration revenue, despite significant ongoing investment in research and development.
  • 6Maintains a robust pipeline with multiple internally discovered drug candidates in various stages of clinical development.
  • 7Invested heavily in building internal manufacturing capabilities with state-of-the-art facilities in China to support global product launches.

Frequently Asked Questions

BeiGene's key internally developed drugs are BRUKINSA™ (zanubrutinib), a BTK inhibitor, which received U.S. FDA accelerated approval for mantle cell lymphoma and is awaiting approval in China for other indications. Tislelizumab, an anti-PD-1 antibody, received NMPA approval in China for classical Hodgkin’s Lymphoma and is under review for other indications in China.

The collaboration with Amgen is highly significant as it involves the commercialization of Amgen's oncology products (XGEVA, KYPROLIS, BLINCYTO) in China and a joint global development program for up to 20 of Amgen's pipeline products. Amgen also made a substantial equity investment in BeiGene, acquiring a 20.5% stake, which provides substantial capital and strengthens the strategic partnership.

BeiGene is making substantial investments in R&D to advance its internally developed and in-licensed drug candidates. The company's strategy focuses on leveraging its global clinical development capabilities and China's regulatory reforms to expedite drug development. While these investments have led to net losses, they are crucial for building a robust pipeline and commercializing innovative therapies.

As of December 31, 2019, BeiGene had significant cash, cash equivalents, and short-term investments totaling $985.5 million. The subsequent $2.8 billion investment from Amgen in January 2020 further bolsters its financial position. However, the company continues to incur substantial net losses due to ongoing R&D and commercialization investments. BeiGene anticipates these expenses will increase as its pipeline progresses and new products launch, and it expects to require additional financing in the future.