Full Press Release Details
BeiGene Reports Fourth Quarter and Full Year 2018 Financial Results
Company to Host Annual Results Conference Call Today at 6:00 p.m. EST and Investor Event in Hong Kong on February 28th at 2:30 p.m. HKT
CAMBRIDGE, Mass. and BEIJING, China, February 27, 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 fourth quarter and full year of 2018.
"Building on a strong foundation, in 2018 we took BeiGene to new heights with our first three new drug applications accepted and currently under priority review in China for zanubrutinib and tislelizumab," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "In the United States, we received Breakthrough Therapy designation for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma. We have become a global leader in China-inclusive global clinical development, supported by our internal clinical team of more than 800 people and a commitment to high quality standards."
Oyler continued, "In 2019, we plan to continue to grow our commercial business, paving the way for our planned commercial launches in China this year and for our first new drug application in the United States planned for this year or in early 2020."
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 for Zanubrutinib in 2019
Tislelizumab (BGB-A317), an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc R on macrophages
Expected Milestones for Tislelizumab in 2019
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
Expected Milestones for Pamiparib in 2019
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
BGB-A425, an investigational TIM-3 antibody
Expected Milestone for Manufacturing in 2019
Commercial Operations
Corporate Developments
Fourth Quarter and Full Year 2018 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.81 billion as of December 31, 2018, compared to $2.10 billion as of September 30, 2018 and $837.52 million as of December 31, 2017.
total cost related to the acquisition of our Changping facility.
Revenue for the fourth quarter and year ended December 31, 2018 was $58.67 million and $198.22 million, respectively, compared to $18.17 million and $238.39 million in the same periods in 2017. The increase in the quarter-over-quarter period is attributable to increased product revenue in China and collaboration revenue under our license and collaboration agreements with Celgene. The decrease in the year-over-year period is due to the upfront payment recognized in 2017 under our collaboration agreement with Celgene for tislelizumab.
Expenses for the fourth quarter and year ended December 31, 2018 were $339.48 million and $903.99 million, respectively, compared to $121.97 million and $336.84 million in the same periods in 2017.
Conference Call and Investor Event
The Company will hold a live webcast and conference call of fourth quarter and full year 2018 financial results, and business updates and expected upcoming milestones, at 6:00 p.m. EST on February 27 (7:00 a.m. HKT on February 28.) The conference call will be conducted in English, and can be accessed by dialing +1 (844) 461-9930 or +1 (478) 219-0535 in the U.S.; +852 3011-4522 in Hong Kong; or +86 400-682-8609 in mainland China. Please dial in five minutes prior to the start time and provide the passcode 8889396.
In addition, the Company will host an investor and analyst event in Hong Kong from 2:30 p.m. to 4:00 p.m. HKT on February 28 (Thursday, February 28, at 1:30 a.m. EST). This event will be conducted primarily in Mandarin Chinese.
Both events will have live webcast and can be accessed by visiting the investor relations section of the BeiGene website at http://ir.beigene.com and/or http://hkexir.beigene.com. The replay of both events will be available on the BeiGene website approximately two hours following completion of the events and will be archived for three weeks.
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
| As of | ||||||
| December 31, | December 31, | |||||
| 2018 | 2017 | |||||
| Assets: | ||||||
| Cash, cash equivalents, restricted cash and short-term investments | $ | 1,809,222 | $ 837,516 | |||
| Accounts receivable | 41,056 | 29,428 | ||||
| Unbilled receivables | 8,612 | - | ||||
| Working capital | 1,697,390 | 763,509 | ||||
| Property and equipment, net | 157,061 | 62,568 | ||||
| Total assets | 2,249,684 | 1,046,479 | ||||
| Liabilities and equity: | ||||||
| Accounts payable | 113,283 | 69,779 | ||||
| Accrued expenses and other payables | 100,414 | 49,598 | ||||
| Bank loan [1] | 49,512 | 18,444 | ||||
| Shareholder loan [2] | 148,888 | 146,271 | ||||
| Total liabilities | 496,037 | 362,248 | ||||
| Noncontrolling interest | 14,445 | 14,422 | ||||
| Total equity | $ | 1,753,647 | $ 684,231 |
[1] The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd, totaled $40.79 million as of December 31, 2018 and the current portion of long-term debt for a term note secured by our Suzhou manufacturing facility.
[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)
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| (unaudited) | (audited) | ||||||||||||||
| Revenue: | |||||||||||||||
| Product revenue, net | $ | 37,762 | $ | 15,606 | $ | 130,885 | $ | 24,428 | |||||||
| Collaboration revenue | 20,908 | 2,568 | 67,335 | 213,959 | |||||||||||
| Total revenues | 58,670 | 18,174 | 198,220 | 238,387 | |||||||||||
| Expenses: | |||||||||||||||
| Cost of sales - products | (9,193 | ) | (3,030 | ) | (28,705 | ) | (4,974 | ) | |||||||
| Research and development [1] | (257,464 | ) | (91,340 | ) | (679,005 | ) | (269,018 | ) | |||||||
| Selling, general and administrative | (72,490 | ) | (27,415 | ) | (195,385 | ) | (62,602 | ) | |||||||
| Amortization of intangible assets | (331 | ) | (187 | ) | (894 | ) | (250 | ) | |||||||
| Total expenses | (339,478 | ) | (121,972 | ) | (903,989 | ) | (336,844 | ) | |||||||
| Loss from operations | (280,808 | ) | (103,798 | ) | (705,769 | ) | (98,457 | ) | |||||||
| Interest income (expense), net | 5,950 | (527 | ) | 13,947 | (4,108 | ) | |||||||||
| Other (expense) income, net | (396 | ) | 9,960 | 1,993 | 11,501 | ||||||||||
| Loss before income taxes | (275,254 | ) | (94,365 | ) | (689,829 | ) | (91,064 | ) | |||||||
| Income tax benefit (expense) | 8,544 | (4,915 | ) | 15,796 | (2,235 | ) | |||||||||
| Net loss | (266,710 | ) | (99,280 | ) | (674,033 | ) | (93,299 | ) | |||||||
| Less: Net income (loss) attributable to noncontrolling interest | 1,545 | 43 | (264 | ) | (194 | ) | |||||||||
| Net loss attributable to BeiGene, Ltd. | $ | (268,255 | ) | $ | (99,323 | ) | $ | (673,769 | ) | $ | (93,105 | ) | |||
| Net loss per share attributable to BeiGene, Ltd., basic and diluted | $ | (0.35 | ) | $ | (0.17 | ) | $ | (0.93 | ) | $ | (0.17 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 771,982,215 | 590,234,853 | 720,753,819 | 543,185,460 | |||||||||||
| Net loss per ADS attributable to BeiGene, Ltd., basic and diluted | $ | (4.52 | ) | $ | (2.19 | ) | $ | (12.15 | ) | $ | (2.23 | ) | |||
| Weighted-average ADSs outstanding, basic and diluted | 59,383,247 | 45,402,681 | 55,442,601 | 41,783,497 |
[1] Research and development expense for the fourth quarter and year ended December 31, 2018 includes expenses related to in-process research and development collaborations totaling $79 million and $89 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 2,200 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
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 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 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.
| Investor Contact | Media Contact | ||
| Craig West | Liza Heapes | ||
| +1 857-302-5189 | + 1 857-302-5663 | ||
| ir@beigene.com | media@beigene.com | ||
| i ABRAXANE , REVLIMID , and VIDAZA are registered trademarks of Celgene Corporation. |