BeiGene Reports Third Quarter 2019 Financial Results

BeiGene Reports Third Quarter 2019 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, November 12, 2019 (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 third quarter and first nine months of 2019.

"We recently announced a transformative collaboration with Amgen that we expect to close in early 2020, at which point we'll begin executing on the commercialization and development plans for Amgen's three commercial-stage drugs and 20 drug candidates in China. We believe that this collaboration fortifies our position as the commercialization and development partner of choice in China because of our people, our global reach, and our relentless commitment to patients, to compliance and to quality," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "During this past quarter we continued momentum for our planned upcoming product launches in the U.S. and China. As we look ahead to key catalysts over the rest of the year and into 2020, we're on track for readouts from up to 10 ongoing Phase 3 or potentially registration-enabling studies in addition to the planned commercial launches."

Recent Business Highlights and Upcoming Milestones

Zanubrutinib, an investigational small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects

Expected Milestones for Zanubrutinib

Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc R on macrophages

Expected Milestones for Tislelizumab

Pamiparib, an investigational small molecule PARP inhibitor

Expected Milestones for Pamiparib

Lifirafenib (BGB-283), an investigational RAF dimer inhibitor

BGB-A1217, an investigational TIGIT monoclonal antibody

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

Expected Milestone for BGB-11417

Manufacturing Facilities

Commercial Operations

Corporate Developments

Third Quarter 2019 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.28 billion as of September 30, 2019, compared to $1.56 billion as of June 30, 2019 and $1.81 billion as of December 31, 2018.

Revenue for the quarter ended September 30, 2019 was $50.14 million, compared to $54.20 million in the same period in 2018. The decrease is primarily attributable to the termination of the Celgene collaboration agreement for tislelizumab in the second quarter of 2019, and as a result, the cessation of any related collaboration revenue.

Expenses for the quarter ended September 30, 2019 were $362.41 million, compared to $205.30 million in the same period in 2018.

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

(Amounts in thousands of U.S. Dollars)

[1] The bank loan is attributable to (i) BeiGene Guangzhou Biologics Manufacturing Co., Ltd., which totaled $81.15 million as of September 30, 2019, and (ii) a long-term loan from Industrial Bank Co., Ltd. to BeiGene Shanghai.

[2] The shareholder loan is attributable to a RMB900 million convertible note obtained in 2017 from our joint venture partner for the construction and operation of our manufacturing facilities in Guangzhou.

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)

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 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. BeiGene markets ABRAXANE (nanoparticle albumin-bound paclitaxel), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Corporationi.

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 BeiGene's collaboration with Amgen; the conduct of late-stage clinical trials and expected data readouts; the planned 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; 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, 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.