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CAMBRIDGE, Mass. and BEIJING, China, May 09, 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 first quarter of 2019.
“We made good progress in each of our business areas, including strong commercial performance in the first quarter of 2019, as we prepare for our planned launches in China and first new drug application in the United States. Our team is continuing to expand across the globe, with new trials, new indications, and importantly, new hope for patients with cancer who may not have had access or options for treating their disease,” said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.
Recent Business Highlights and Upcoming Milestones
Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects
Expected Milestones in 2019
Tislelizumab (BGB-A317), an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages
Expected Milestones in 2019
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
Expected Milestones in 2019
Lifirafenib (BGB-283), an investigational RAF dimer inhibitor
First Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $1.64 billion as of March 31, 2019, compared to $1.81 billion as of December 31, 2018.
Revenue for the first quarter ended March 31, 2019 was $77.83 million, compared to $32.54 million in the same period in 2018. The increase is attributable to increased product revenue in China and collaboration revenue under our license and collaboration agreements with Celgene.
Expenses for the first quarter ended March 31, 2019 were $251.59 million, compared to $143.35 million in the same period in 2018.
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
|March 31,||December 31,|
|Cash, cash equivalents, restricted cash, and short-term investments||$||1,637,550||$||1,809,222|
|Property and equipment, net||197,806||157,061|
|Liabilities and equity:|
|Accrued expenses and other payables||90,737||100,414|
|Bank loan ||86,420||49,512|
|Shareholder loan ||155,174||148,888|
 The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd., which totaled $77.48 million as of March 31, 2019, and the current portion of long-term debt for a term note secured by our Suzhou manufacturing facility.
 The shareholder loan is attributable to a RMB900 million convertible note obtained in 2017 by BeiGene Biologics from our joint venture partner for the construction and operation of our manufacturing facilities in Guangzhou.
Condensed Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)
|Three Months Ended|
|Product revenue, net||$||57,421||$||23,250|
|Cost of sales - products||(15,261||)||(4,550||)|
|Research and development||(178,351||)||(109,700||)|
|Selling, general and administrative||(57,645||)||(28,915||)|
|Amortization of intangible assets||(331||)||(188||)|
|Loss from operations||(173,755||)||(110,809||)|
|Interest income, net||4,477||1,552|
|Other income, net||1,728||729|
|Loss before income taxes||(167,550||)||(108,528||)|
|Income tax (expense) benefit||(519||)||3,412|
|Less: Net loss attributable to noncontrolling interest||(429||)||(520||)|
|Net loss attributable to BeiGene, Ltd.||$||(167,640||)||$||(104,596||)|
|Net loss per share attributable to BeiGene, Ltd., basic and diluted||$||(0.22||)||$||(0.16||)|
|Weighted-average shares outstanding, basic and diluted||774,750,255||670,510,605|
|Net loss per ADS attributable to BeiGene, Ltd., basic and diluted||$||(2.81||)||$||(2.03||)|
|Weighted-average ADSs outstanding, basic and diluted||59,596,173||51,577,739|
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of approximately 2,400 employees in China, the United States, 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) in China under a license from Celgene Corporation.i
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 advancement of and anticipated clinical development, regulatory milestones and commercialization of its 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 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.
Investor Contact Media Contact
Craig West Liza Heapes
+1 857-302-5189 +1 857-302-5663
i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation
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