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Company to Host Annual Results Conference Call Today at
and Investor Event in
“Building on a strong foundation, in 2018 we took
Oyler continued, “In 2019, we plan to continue to grow our commercial business, paving the way for our planned commercial launches in
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
- Received Breakthrough Therapy designation from the
U.S. Food and Drug Administration( FDA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy;
- Granted priority review by the
Center for Drug Evaluation(CDE) of the China National Medical Products Administration(NMPA, formerly known as CFDA) to new drug applications (NDAs) for the treatment of patients with relapsed or refractory (R/R) MCL and with R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);
- Presented full results of the pivotal Phase 2 trial in Chinese patients with R/R MCL in an oral presentation at the 60th
American Society of Hematology(ASH) Annual Meeting;
- Presented updated data from a global Phase 1 trial in patients with MCL at the ASH Annual Meeting;
- Completed enrollment of a significantly expanded cohort 2, of 110 previously untreated patients with 17p deletion in the Phase 3 trial in first-line CLL/SLL; and
- Initiated a global Phase 2 trial in patients with R/R marginal zone lymphoma (MZL).
Expected Milestones for Zanubrutinib in 2019
- Receive approvals in
Chinafor the treatment of patients with R/R MCL and R/R CLL/SLL;
- Submit an initial NDA for zanubrutinib in the U.S. in 2019 or early 2020;
- Announce top-line results from the pivotal Phase 2 trial in Chinese patients with Waldenström macroglobulinemia (WM) and submit an NDA in
- Announce top-line results from the Phase 3 trial comparing zanubrutinib to ibrutinib in patients with WM; and
- Present updated data from the global Phase 1 trial in WM and MCL; pivotal data from the China Phase 2 trials in R/R MCL and CLL/SLL; Phase 1 obinutuzumab combination data in CLL/SLL; data from the MYD88WT cohort of the Phase 3 WM trial; updated data from the Phase 1 obinutuzumab combination trial in non-Hodgkin’s lymphoma (
NHL); and updated data from the global Phase 1 trial in CLL/SLL.
Tislelizumab (BGB-A317), an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages
- Granted priority review by the CDE of NMPA to our NDA for the treatment of patients with R/R classical Hodgkin’s lymphoma (cHL);
- Presented data from the pivotal Phase 2 trial of tislelizumab in Chinese patients with R/R cHL in an oral session at the ASH Annual Meeting;
- Presented updated data from Phase 1 trial expansion cohorts in patients with urothelial carcinoma, esophageal, gastric, hepatocellular, and non-small cell lung cancers at the
European Society for Medical Oncology Immuno-Oncology(ESMO-IO) congress;
- Presented Phase 2 clinical results in esophageal squamous cell carcinoma (ESCC) and gastric cancer (GC) at the
American Society of Clinical Oncology Gastrointestinal Cancers Symposium(ASCO-GI);
- Completed enrollment of the global Phase 2 trial in second- or third-line patients with hepatocellular carcinoma (HCC); and
- Initiated the following clinical trials:
-- A global Phase 3 trial of tislelizumab in combination with chemotherapy in patients with front-line advanced gastric or gastroesophageal junction adenocarcinoma; and
-- A global Phase 3 trial of tislelizumab in combination with chemotherapy in patients with front-line, locally advanced recurrent or metastatic ESCC.
Expected Milestones for Tislelizumab in 2019
- Receive NDA approval in
Chinafor treatment of patients with R/R cHL;
- Announce top-line results from the pivotal Phase 2 trial in Chinese and Korean patients with PD-L1 positive urothelial bladder cancer (UBC) and submit an NDA in
- Announce top-line results from the global Phase 2 trial in second- or third-line patients with HCC and have regulatory discussions;
- Present updated
Chinapivotal Phase 2 data in R/R cHL; updated Phase 2 chemotherapy combination data; and Phase 1 data from Chinatrials;
- Complete or close to completing enrollment in all four ongoing Phase 3 trials in lung and liver cancers; and
- Initiate additional pivotal solid tumor trials.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
- Presented preliminary Phase 1/2 trial data of pamiparib in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or R/R glioblastoma in an oral presentation at the 23rd Annual Scientific Meeting and Education Day of the
Society for Neuro-Oncology(SNO); and
- Initiated a global Phase 2 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination deficiency (HRD).
Expected Milestones for Pamiparib in 2019
- Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in late 2019 or early 2020; and
- Present data in patients with ovarian cancer from the global Phase 1 trial and updated Phase 1 combination data.
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
- Expanded Phase 1 combination trial with tislelizumab in
Chinaand Australiato a total of five advanced solid tumors including non-small cell lung cancer, renal cell carcinoma, ovarian cancer, HCC, and GC.
BGB-A425, an investigational TIM-3 antibody
- Initiated a global Phase 1 trial in combination with tislelizumab.
- Substantially completed physical construction of the commercial-scale biologics manufacturing facility in
Guangzhou, China, with four 2,000 liter KUBio bioreactors installed.
Expected Milestone for Manufacturing in 2019
- Complete Phase 1 construction of the
Guangzhoumanufacturing facility, with expanded capacity to follow, to support the manufacturing of tislelizumab and other potential drug candidates in the pipeline.
$37.76 millionand $130.89 millionin product revenue in the fourth quarter and year ended December 31, 2018, respectively, from sales in Chinaof ABRAXANE®, REVLIMID® and VIDAZA®, which represents a 142% increase and a 436% increase, respectively, compared to the same periods in 2017 (2017 revenue was from the last four months of the year after the Celgenetransaction closed on August 31, 2017); and
- In support of the planned commercial launch of zanubrutinib in
the United States, the Company made key hires in sales and marketing, market access, commercial operations, and business analytics. In China, the Company more than quadrupled the size of its commercial team since September 2017.
- Announced license and collaboration agreements with
Zymeworks Inc., under which BeiGeneacquired exclusive development and commercial rights in Asia-Pacificfor Zymeworks’ HER2-targeted therapeutic candidates ZW25 and ZW49, and a research and license agreement under which BeiGeneacquired rights to internally develop and commercialize globally up to three other bispecific antibodies using Zymeworks’ Azymetric™ and EFECT™ platforms; and
- Appointed Dr.
Yong (Ben) Benas Chief Medical Officer, Immuno-Oncology. Dr. Ben has extensive experience in immuno-oncology and early- to late-stage drug development, with multiple successful NDAs and biologics license applications (BLAs), including most recently the approval of PD-L1 immunotherapy IMFINZI® (durvalumab) for the treatment of certain patients with locally advanced or metastatic urothelial cancer. Prior to joining BeiGene, he served most recently as chief medical officer of BioAtla, and previously worked at other pharmaceutical companies, including AstraZeneca, Millennium Pharmaceuticals, and Pfizer.
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
- The decrease of
$291.85 millionin the fourth quarter of 2018 was primarily due to $193.89 millionof cash used in operating activities, a $60 millionupfront payment made to Zymeworksunder our collaboration agreement, $23.25 millionfor investments in property, plant and equipment, and the payment of the remaining $30.35 millionacquisition cost for our research, development, and office facility in Changping, Beijing, China.
- The increase of
$971.71 millionfrom the prior year period was primarily due to net proceeds received from our global follow-on offering and initial listing on the Hong Kong Stock Exchangeof $869.71 millionin August 2018and net proceeds from our follow-on offering on the NASDAQ of $757.59 millionin January 2018. These net proceeds were partially offset by $547.72 millionof cash used in operating activities, $70 million in upfront payments related to the Zymeworksand Mirati collaboration agreements, investments in property, plant and equipment totaling $70.28 millionand primarily attributable to the build-out of our Guangzhoubiologics manufacturing facility, and $38.30 million of total cost related to the acquisition of our Changping facility.
Revenue for the fourth quarter and year ended December 31, 2018 was
- Product revenue from sales of ABRAXANE®, REVLIMID® and VIDAZA® in
Chinatotaled $37.76 millionand $130.89 millionfor the fourth quarter and year ended December 31, 2018, respectively, compared to $15.61 million and $24.43 millionfor the same periods in 2017 (2017 revenue was from the last four months of the year after the Celgenetransaction closed on August 31, 2017).
- Collaboration revenue totaled
$20.91 millionand $67.34 millionfor the fourth quarter and year ended December 31, 2018, respectively, compared to $2.57 millionand $213.96 millionfor the same periods in 2017.
Expenses for the fourth quarter and year ended
- Cost of sales for the fourth quarter and year ended
December 31, 2018were $9.19 millionand $28.71 million, respectively, compared to $3.03 millionand $4.97 millionin the same periods in 2017 (the full year period in 2017 included only the last four months of the year after the Celgenedeal closed on August 31, 2017). Cost of sales related to the cost of acquiring ABRAXANE®, REVLIMID® and VIDAZA® for distribution in China.
- R&D Expenses for the fourth quarter and year ended
December 31, 2018were $257.46 millionand $679.01 million, respectively, compared to $91.34 millionand $269.02 millionin the same periods in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply, as well as increases in spending related to our preclinical-stage programs. Also contributing to the fourth quarter and year-over-year increases were expenses for in-process research and development collaborations, which totaled $79 millionin the fourth quarter of 2018 (including $60 millionrelated to the Zymeworkscollaboration and $19 millionrelated to the termination of the Merck pamiparib collaboration) and $89 million(inclusive of the $10 millionrelated to the Mirati collaboration) for the year ended December 31, 2018. We did not have any in-process research and development expense from collaborations in the fourth quarter or year ended December 31, 2017. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $16.09 million and $54.38 millionfor the fourth quarter and year ended December 31, 2018, respectively, compared to $10.95 millionand $30.61 millionfor the same periods in 2017, due to increased headcount and a higher share price.
- SG&A Expenses for the fourth quarter and year ended
December 31, 2018 were $72.49 million and $195.39 million, respectively, compared to $27.42 millionand $62.60 millionin the same periods in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in Chinaand the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $9.87 million and $32.74 millionfor the fourth quarter and year ended December 31, 2018, respectively, compared to $5.51 millionand $12.25 millionfor the same periods in 2017, due to increased headcount and a higher share price.
- Net Loss for the fourth quarter and year ended
December 31, 2018was $268.26 million and $673.77 million, or $0.35and $0.93per share, or $4.52and $12.15per American Depositary Share (ADS), respectively, compared to $99.32 millionand $93.11 million, or $0.17and $0.17per share, or $2.19and $2.23per ADS, respectively, in the same periods in 2017.
Conference Call and Investor Event
The Company will hold a live webcast and conference call of fourth quarter and full year 2018 financial results, and business updates and expected upcoming milestones, at
In addition, the Company will host an investor and analyst event in
Both events will have live webcast and can be accessed by visiting the investor relations section of the
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
|December 31,||December 31,|
|Cash, cash equivalents, restricted cash and short-term investments||$||1,809,222||$||837,516|
|Property and equipment, net||157,061||62,568|
|Liabilities and equity:|
|Accrued expenses and other payables||100,414||49,598|
|Bank loan ||49,512||18,444|
|Shareholder loan ||148,888||146,271|
 The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by
 The shareholder loan is attributable to a
Condensed Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)
|Three Months Ended
|Twelve Months Ended
|Product revenue, net||$||37,762||$||15,606||$||130,885||$||24,428|
|Cost of sales – products||(9,193)||(3,030)||(28,705)||(4,974)|
|Research and development ||(257,464)||(91,340)||(679,005)||(269,018)|
|Selling, general and administrative||(72,490)||(27,415)||(195,385)||(62,602)|
|Amortization of intangible assets||(331)||(187)||(894)||(250)|
|Loss from operations||(280,808)||(103,798)||(705,769)||(98,457)|
|Interest income (expense), net||5,950||(527)||13,947||(4,108)|
|Other (expense) income, net||(396)||9,960||1,993||11,501|
|Loss before income taxes||(275,254)||(94,365)||(689,829)||(91,064)|
|Income tax benefit (expense)||8,544||(4,915)||15,796||(2,235)|
|Less: Net income (loss) attributable to noncontrolling interest||1,545||43||(264)||(194)|
|Net loss attributable to BeiGene, Ltd.||$||(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|
 Research and development expense for the fourth quarter and year ended
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
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