About BeiGene BeiGene is a global, commercial-stage research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,500 employees in the United States,

BeiGene Reports Fourth Quarter and Full Year 2019 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, March 2, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today reported recent business highlights, anticipated upcoming milestones, and financial results for the fourth quarter and full year of 2019.

"Having co-founded BeiGene in 2010 with Dr. Xiaodong Wang, this anniversary year promises to continue the momentum and trajectory from our recent catalysts, including the read-outs of two Phase 3 trials, approvals for BRUKINSA and tislelizumab in the United States and China, respectively, and closing on our collaboration with Amgen, which is already off to a productive start as we advance the commercialization and development plans for Amgen's three commercial-stage drugs and 20 drug candidates," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "In the next two years, we expect to launch up to eight products and see continued robust clinical progress with the potential readout of more than 10 Phase 3 or potentially registration-enabling studies. Our earlier stage pipeline is also advancing with several internally developed or in-licensed drug candidates entering the clinic or reporting proof of concept data."

"Despite challenges to our business in China caused by the coronavirus outbreak (COVID-19), our team has continued to advance our programs and serve our patients. BeiGene took immediate safety measures to protect our staff in Wuhan and elsewhere and our employees are safe. In addition, we were one of the first companies to source and deliver donated safety equipment to major hospitals in the area. While we expect our broad business operations in China to be impacted by COVID-19, we continue to execute towards our tislelizumab launch goal in the first quarter this year," said Dr. Xiaobin Wu, General Manager of China and President of BeiGene.

Recent Business Highlights and Upcoming Milestones

Commercial Operations

BRUKINSA (zanubrutinib), a small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects; approved in the United States

Expected Milestones for Zanubrutinib

Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc R on macrophages; approved in China

Expected Milestones for Tislelizumab

with chemotherapy in second-line patients with advanced ESCC in early 2020 and announce top-line results in 2020 or early 2021.

Pamiparib, an investigational selective small molecule inhibitor of PARP1 and PARP2

Expected Milestones for Pamiparib

Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Expected Milestones for Sitravatinib

ZW25, a novel investigational Azymetric bispecific antibody currently in Phase 2 clinical development with Zymeworks, Inc.

Expected Milestones for ZW25

Lifirafenib, an investigational RAF dimer inhibitor

Expected Milestones for Lifirafenib

BGB-A1217, an investigational TIGIT monoclonal antibody

Expected Milestones for BGB-A1217

BGB-A445, an investigational non-ligand competing anti OX40 agonistic monoclonal antibody

BGB-3245, an investigational B-RAF inhibitor with activity against mutant monomeric and dimeric forms of B-RAF in pre-clinical studies. BGB-3245 is being developed by MapKure, which BeiGene jointly owns with SpringWorks Therapeutics

BGB-11417, an investigational small molecule Bcl-2 inhibitor

Expected Milestones for BGB-11417

Manufacturing Facilities

Corporate Developments

Expected COVID-19 Impact

Fourth Quarter and Full Year 2019 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $985.50 million as of December 31, 2019, compared to $1.28 billion as of September 30, 2019 and $1.81 billion as of December 31, 2018. Cash and cash equivalents as of December 31, 2019 does not include $2.8 billion of cash received from the sale of ADSs to Amgen in connection with the closing of the Amgen collaboration on January 2, 2020.

Revenue for the fourth quarter and year ended December 31, 2019 was $56.89 million and $428.21 million, respectively, compared to $58.67 million and $198.22 million in the same periods in 2018. The slight decrease in total revenue in the quarter compared to the prior year is attributable to the lack of collaboration revenue after the termination of the Celgene collaboration agreement for tislelizumab, offset in part by increased product sales of ABRAXANE, REVLIMID, and VIDAZA in China and the initial sales of BRUKINSA in the United States. The increase in the year-over-year period is primarily due to the $150 million payment in connection with the termination of the tislelizumab collaboration agreement with Celgene Corp., a Bristol-Myers Squibb company (BMS), as well as increased product sales.

Expenses for the fourth quarter and year ended December 31, 2019 were $444.93 million and $1.39 billion, respectively, compared to $339.48 million and $903.99 million in the same periods in 2018.

Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)

(Amounts in thousands of U.S. Dollars)

[1] Cash, cash equivalents, restricted cash and short-term investments as of December 31, 2019 does not include $2.8 billion of cash received from the sale of ADSs to Amgen in connection with the closing of the Amgen collaboration on January 2, 2020.

Condensed Consolidated Statements of Operations (U.S. GAAP)

(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)

[1] Research and development expense for the fourth quarter and year ended December 31, 2019 includes expenses related to in-process research and development collaborations totaling $20 million and $50 million, respectively.

BeiGene is a global, commercial-stage research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,500 employees in the United States, China, Australia, and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA (zanubrutinib) and in China, the Company has received approval to market its anti-PD-1 antibody tislelizumab and markets ABRAXANE (nanoparticle albumin-bound paclitaxel), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Logistics S rl, a Bristol-Myers Squibb companyi, and plans to market XGEVA (denosumab) under a collaboration with Amgenii. For more information please visit www.beigene.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the encouraging clinical data for BeiGene's product candidates and product revenue for its products; the conduct of late-stage clinical trials and expected data readouts; the potential commercial launches of BeiGene's product candidates; the advancement of and anticipated clinical development, regulatory milestones and commercialization of BeiGene's products and drug candidates; the impact of the coronavirus on the Company's clinical development, commercial and other operations; and BeiGene's plans and the expected milestones under the caption "Recent Business Highlights and Upcoming Milestones". Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene's limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the coronavirus on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

i ABRAXANE is a registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company; REVLIMID and VIDAZA are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb company.

ii XGEVA is a registered trademark of Amgen.