About BeiGene BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients

BeiGene Reports First Quarter 2020 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, May 11, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology 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 first quarter of 2020.

"Our recent approval of tislelizumab in China for patients with previously treated locally advanced or metastatic urothelial carcinoma, as well as the positive readouts of two Phase 3 trials of tislelizumab for first-line non-small cell lung cancer at interim analyses, are key milestones for BeiGene as we execute on our goals and work to create impactful medicines that will be accessible to far more cancer patients around the world. With the COVID-19 pandemic continuing to create obstacles globally, our team has been quick to react as we work to minimize the impact and support our patients and physicians on the frontlines. We are managing the challenges to maintain momentum with our broad development program and are contributing to the global effort to fight the pandemic," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "In addition to our launch of tislelizumab in China this quarter, we are on the way to having potentially up to 11 commercial products before the end of next year, and look forward to presenting Phase 3 data on BRUKINSA and tislelizumab at ASCO. We also anticipate several additional Phase 3 or potentially registration-enabling studies reading out in the next 12 months."

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

supportive care. The trial's primary endpoint is the respiratory failure-free survival rate at day 28 in the randomized cohort.

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

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

Expected Milestones for Pamiparib

Lifirafenib, an investigational RAF dimer inhibitor

BGB-A1217, an investigational TIGIT monoclonal antibody

Expected Milestones for BGB-A1217

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

Collaboration Programs

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

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

Manufacturing Facilities

COVID-19 Impact and Response

First Quarter 2020 Financial Results

Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.38 billion as of March 31, 2020, compared to $985.50 million as of December 31, 2019.

Revenue for the three months ended March 31, 2020 was $52.06 million, compared to $77.83 million in the same period of 2019. The decrease in total revenue is primarily attributable to the lack of collaboration revenue after the termination of the Celgene collaboration agreement for tislelizumab and decreased product sales of ABRAXANE, REVLIMID (lenalidomide) and VIDAZA (azacitidine) in China, partially offset by the initial sales of tislelizumab in China and BRUKINSA in the United States.

Expenses for the three months ended March 31, 2020 were $425.82 million, compared to $251.59 million in the same period of 2019.

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

(Amounts in thousands of U.S. Dollars)

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)

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 recent clinical data for BeiGene's product candidates and approvals of its products; the conduct of late-stage clinical trials and expected data readouts; additional planned commercial product launches; the advancement of and anticipated clinical development, regulatory milestones and commercialization of BeiGene's products and drug candidates; the success of launch efforts for tislelizumab and BRUKINSA; BeiGene's efforts to minimize the impact of the COVID-19 pandemic on its operations and to support its patients and physicians on the frontlines; BeiGene's efforts to develop a therapeutic treatment for COVID-19; the impact of the COVID-19 pandemic 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 COVID-19 pandemic 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 annual report on Form 10-K, 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.

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.

XGEVA , KYPROLIS and BLINCYTO are registered trademarks of Amgen.

SYLVANT and QARZIBA are registered trademarks of EUSA Pharma.