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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): November 4, 2021

BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)
Cayman Islands
001-37686
98-1209416
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
c/o Mourant Governance Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
(Address of Principal Executive Offices) (Zip Code)
+1 (345) 949-4123
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share BGNE The NASDAQ Global Select Market
Ordinary Shares, par value $0.0001 per share* 06160 The Stock Exchange of Hong Kong Limited
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o



Item 2.02. Results of Operations and Financial Condition.
On November 4, 2021, BeiGene, Ltd. (the “Company”) announced its financial results for the three and nine months ended September 30, 2021. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 8.01. Other Events.
In its press release dated November 4, 2021, the Company also provided an update on the third quarter of 2021 and recent business highlights and expected milestones for the remainder of 2021 and 2022. The information in the press release set forth under the headings “Recent Business Highlights and Upcoming Milestones” and “Forward-Looking Statements” is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
On November 4, 2021, the Company announced clinical results and real world data from its hematology program to be presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, including two oral presentations on the Phase 3 SEQUOIA trial comparing BRUKINSA® (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The ASH meeting will take place on December 11-14, 2021, as a hybrid event in Atlanta, GA and in a virtual format. The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.   Description
99.1
Press Release titled "BeiGene Reports Third Quarter 2021 Financial Results", issued by BeiGene, Ltd. on November 4, 2021.
99.2
Press Release titled "BeiGene to Present Clinical Data on BRUKINSA in Chronic Lymphocytic Leukemia at the 63rd ASH Annual Meeting", issued by BeiGene, Ltd. on November 4, 2021.
104 The cover page from this Current Report on Form 8-K, formatted in Inline XBRL



Exhibit Index
 
Exhibit No.   Description
99.1
99.2
104 The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
 



SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
  BEIGENE, LTD.
     
     
Date: November 4, 2021
By:  /s/ Scott A. Samuels
  Name: Scott A. Samuels
  Title: Senior Vice President, General Counsel


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Exhibit 99.1
BeiGene Reports Third Quarter 2021 Financial Results
Recorded product revenue of $192.5 million for the third quarter, representing a 111% increase from $91.1 million in the prior year period
Received approvals for BRUKINSA® in two new indications in the U.S. and approvals in six other markets
Submitted first biologics license application (BLA) in the U.S. for tislelizumab in collaboration with Novartis for patients with advanced or metastatic esophageal squamous cell carcinoma following prior systemic therapy
CAMBRIDGE, Mass. and BEIJING, China, November 4, 2021 -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today reported recent business highlights, anticipated upcoming milestones, and financial results for the third quarter and nine months ended September 30, 2021.
“We remain focused on translating science into highly impactful medicines and making these medicines more affordable and accessible to many more people with cancer around the world,” said John V. Oyler, Co-Founder, Chairman and Chief Executive Officer of BeiGene. “In the third quarter we had two new indications approved for BRUKINSA in the United States, and recent BRUKINSA approvals in Australia, Singapore, Brazil, Russia, and Chile as well as a positive CHMP opinion for our first BRUKINSA filing in Europe. Tislelizumab’s BLA for esophageal squamous cell carcinoma (ESCC) has been accepted for review by the FDA, which is the first filing for our internally developed anti-PD-1 medicine outside of China and an important achievement in our collaboration with Novartis. This is one of many global tislelizumab studies that comprise a comprehensive PD-1 program that has enrolled over 5,600 patients in more than 30 countries and regions and includes over 1,700 patients from outside of China. We also continued to expand and strengthen our strategic competitive advantages that we feel are critical to transform the industry and bring innovative and accessible medicines to billions more people around the world. These include research, predominantly CRO-free global clinical development, global commercial infrastructure, and internal manufacturing capabilities.”
Recent Business Highlights and Upcoming Milestones
Commercial Operations
Product sales increased 111% in the third quarter of 2021 compared to the prior year period, primarily due to increased sales of our internally developed products and in-licensed products from Amgen;
Global sales of BRUKINSA totaled $65.8 million in the third quarter, representing a 320% increase compared to the prior year period; U.S. sales of BRUKINSA totaled $33.7 million in the third quarter compared to $5.7 million in the comparable prior year period. U.S. sales continued to accelerate in the quarter, driven by continued uptake in mantle cell lymphoma (MCL) and the recent FDA approvals in Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma (MZL). BRUKINSA sales in China totaled $32.1 million in the third quarter, representing growth of 223% compared to the prior year period, driven by a significant increase in all approved indications, including chronic lymphocytic leukemia (CLL);
Sales of tislelizumab in China totaled $77.0 million in the third quarter, representing a 54% increase compared to the prior year period. In the third quarter, new patient demand from broader reimbursement and further expansion of our salesforce and hospital listings continued to drive increased market penetration and market share for tislelizumab;
The commercial organization in China continued to demonstrate its ability to bring new products to market, launching the second product from the Amgen collaboration, BLINCYTO® (blinatumomab), which contributed $5.0 million of sales in the third quarter. Two additional new products are expected to be approved or launched by the end of the year; and
We are preparing for the upcoming National Reimbursement Drug List (NRDL) negotiation in China for our eligible medicines, including tislelizumab in first-line non-squamous non-small cell lung cancer (NSCLC), first-line squamous NSCLC and second- or third-line hepatocellular carcinoma (HCC), BRUKINSA in WM, and pamiparib in germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. The NRDL negotiations are anticipated to be completed in the fourth quarter of 2021.



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Exhibit 99.1
Development Programs
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 U.S., China, Canada, Australia, and other international markets in selected indications and under development for additional approvals globally.
Received FDA approvals in two new indications, including full approval for the treatment of adult patients with WM, and accelerated approval for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen;
Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval for the treatment of adult patients with WM who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy;
Was granted a cohort Temporary Authorization for Use (cATU), an early access program, for patients with WM by the French National Agency for Medicines and Health Products Safety (ANSM);
Received acceptance of the marketing authorization application (MAA) from Swissmedic and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for patients with WM;
Received approval in Australia for the treatment of adult patients with MCL who have received at least one prior therapy and for patients with WM who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy; and
Continued to advance BRUKINSA in new markets. BRUKINSA is now approved in Australia, Russia, Singapore, Brazil, Chile, Israel, and UAE for patients with MCL who have received at least one prior therapy. There currently are more than 20 marketing authorization applications in multiple indications under review around the world.
Expected Milestones for BRUKINSA
Receive EMA approval for treating adult patients with WM who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy in 2021;
Report results from the Phase 3 SEQUOIA trial (NCT03336333) comparing BRUKINSA with bendamustine plus rituximab in patients with treatment-naïve CLL or small lymphocytic lymphoma (SLL); and early results from Arm D in patients with del(17p) in combination with venetoclax in two oral presentations at the 63rd American Society of Hematology (ASH) Annual Meeting taking place December 11-14, 2021;
Continue to discuss Phase 3 clinical trial results in CLL with regulatory agencies in the U.S., Europe, and other countries;
Report additional results from the Phase 3 ALPINE trial (NCT03734016) in 2022; and
Continue to expand BRUKINSA's registration program globally in new geographies and indications, including potential additional approvals in 2021 and the first half of 2022 for certain patients with MCL in APAC, the Middle East and South America.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in China in selected indications and under development for additional approvals globally.
Received acceptance by the FDA of a BLA for tislelizumab in collaboration with Novartis as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022;
Received acceptance by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) of a supplemental BLA (sBLA) in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC);
Received approval from the NMPA in a new indication, for front-line squamous NSCLC with nab-paclitaxel and carboplatin; and


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Exhibit 99.1
Reported data at the European Society for Medical Oncology (ESMO) Congress 2021 including:
RATIONALE 304 (NCT03663205): Tislelizumab plus chemotherapy vs. chemotherapy alone as first-line treatment for non-squamous NSCLC in patients who are smokers vs. non-smokers; and
RATIONALE 307 (NCT03594747): Tislelizumab plus chemotherapy vs. chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients who were smokers vs. non-smokers.
Expected Milestones for Tislelizumab
Receive approvals in China for the four sBLAs currently under review in first-line NPC, second- or third-line NSCLC, second-line ESCC, and second- or third-line MSI-High solid tumors in 2022.
Pamiparib, a selective small molecule inhibitor of PARP1 and PARP2 conditionally approved in China for the treatment of patients with germline BRCA mutation-associated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
Expected Milestones for Pamiparib
Report topline results from the Phase 3 trial (NCT03519230) of pamiparib as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer, in 2021 or the first half of 2022.
Ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody with competent Fc function
Initiated patient enrollment in the Phase 2 AdvanTIG-206 trial (NCT04948697) of ociperlimab in combination with tislelizumab plus Bio-Thera's POBEVCY® (BAT1706), a biosimilar to bevacizumab (Avastin®), as first-line treatment in patients with advanced HCC.
Expected Milestones for ociperlimab
Initiate patient enrollment in the global Phase 2 AdvanTIG-205 trial (NCT05014815) in frontline stage IV NSCLC, in 2021.
BGB-11417, an investigational BCL-2 inhibitor
Initiated patient enrollment in a Phase 1 trial (NCT04973605) in patients with multiple myeloma with t (11;14) translocation, in 2021.
Expected Milestones for BGB-11417
Begin patient enrollment in pivotal trials, in 2022.
Early-Stage Programs
Continued to advance our early-stage clinical pipeline of internally-developed product candidates at dose escalation stage, including BGB-A445 (an investigational non-ligand competing OX40 monoclonal antibody as monotherapy or in combination with tislelizumab in solid tumors), BGB-15025 (an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors), BGB-10188 (an investigational PI3Kδ inhibitor as monotherapy or in combination with BRUKINSA in hematology malignancies, or in combination with tislelizumab in solid tumors);
BGB-16673 (an investigational Chimeric Degradation Activating Compound, or CDAC, targeting BTK) received investigational new drug (IND) clearance and permission to proceed from the FDA. Patient dosing in the first Phase 1 trial (NCT05006716) in patients with B-cell malignancies is expected to begin in 2021; and
BGB-A425 (an investigational TIM3 monoclonal antibody) study advanced to the Phase 2 portion of the Phase 1/2 trial (NCT03744468) in combination with tislelizumab.
Collaboration with Amgen
Secured approval by the Hainan BoAo government for early access to LUMAKRAS® (sotorasib, a KRAS G12C inhibitor) in designated hospitals in the province.



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Exhibit 99.1
Other Collaboration Programs
Announced that the NMPA granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of R/R neuroblastoma with or without residual disease. QARZIBA is a targeted immunotherapy licensed by EUSA Pharma to BeiGene in mainland China;
Received notification by BMS-Celgene of its intent to terminate a license and supply agreement with respect to ABRAXANE® (nanoparticle albumin-bound paclitaxel) in China. BeiGene contests this action, as it believes that the reasons provided by BMS-Celgene are not valid bases for terminating the agreement with respect to ABRAXANE. Arbitration proceedings are ongoing between the parties regarding BMS-Celgene’s failure to ensure the continuity and adequacy of its supply of ABRAXANE under the agreement in accordance with Good Manufacturing Practices (GMP); and
Received results from the Phase 2 trial (NCT04551898) evaluating investigational SARS-CoV-2 neutralizing antibody BGB-DXP593 in patients with mild to moderate COVID-19, licensed from Singlomics outside of China. The trial did not meet the primary efficacy endpoint of viral load change in nasopharyngeal swabs at Day 8. The license rights of the two Singlomics candidates (DXP593 and DXP604) outside of the U.S. and the development rights of the candidates in the U.S. have been returned to Singlomics under a reversion agreement signed by the parties, with BeiGene retaining U.S. commercial rights.
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 Inc. (Mirati), in Asia (excluding Japan), Australia, and New Zealand.
Reported data at the European Society for Medical Oncology (ESMO) Congress 2021:
Sitravatinib + tislelizumab in patients with anti-PD-(L)1 refractory/resistant metastatic NSCLC (NCT03666143); and
Sitravatinib + tislelizumab in patients with metastatic NSCLC (NCT03666143).
Zanidatamab, (ZW25) an investigational bispecific HER2 antibody targeting HER2 in late-stage clinical development with Zymeworks, Inc.
Expected Milestones for Zanidatamab
Initiate a Phase 3 clinical trial in first-line HER2+ gastric cancer, in 2021.
Manufacturing Operations
Continued efforts to secure geographically diverse manufacturing and supply chain redundancy with the previously announced plans to build a new commercial-stage manufacturing and clinical R&D campus at Princeton West Innovation Park in Hopewell, New Jersey. The acquisition of the property is expected to close in 2021;
Continued construction on the new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction will bring over 50,000 square meters and 600M solid preparation capacity and is expected to be completed in 2023. Once completed, the total production capacity is expected to increase BeiGene's small molecule manufacturing capability in China by up to six times the current capacity; and
Two additional 2,000L bioreactors at Boehringer Ingelheim's facility are available to support commercial production of tislelizumab’s expanding indications in China. This is in addition to BeiGene’s state-of-the-art biologics facility in Guangzhou, China, which currently is approved for 8,000 liters of biologics capacity with an additional phase of construction expected to bring total capacity to 64,000 liters, and to be completed by the end of 2022.
COVID-19 Impact and Response
The Company expects that the worldwide health crisis of COVID-19 will continue to have a negative impact on its operations, including commercial sales, regulatory interactions, inspections, filings, and clinical trial recruitment, participation, and data read outs. There remains uncertainty regarding the future impact of the pandemic globally. The Company is striving to minimize delays and disruptions, and continues to execute on its commercial, regulatory, manufacturing, and clinical development goals globally.


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Exhibit 99.1
Corporate Developments
Listing of the Company's ordinary shares on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange is expected to be completed in 2021, subject to market conditions and additional regulatory approvals; and
Received inclusion in several FTSE Russell indices, including: the FTSE Global Equity Index Large Cap; the FTSE All-World (LM); the FTSE All-Cap (LMS); and the FTSE Total-Cap (LMSµ). In addition, BeiGene was included in the FTSE Developed ESG Low Carbon Select Index, and the FTSE Asia ex Japan ESG Low Carbon Select Index, reflecting the Company’s commitment to sustainability.
Third Quarter 2021 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.9 billion as of September 30, 2021, compared to $4.4 billion as of June 30, 2021, and $4.7 billion as of December 31, 2020.
In the three months ended September 30, 2021, cash used in operating activities was $495.7 million, primarily due to our net loss of $413.9 million and a $89.4 million increase in our net operating assets and liabilities, offset by non-cash charges of $7.5 million; capital expenditures were $67.0 million; and cash provided by financing activities was $109.2 million, consisting primarily of $50 million in proceeds from the sale of shares to Amgen, as well as the exercise of employee share options.
Revenue for the three months ended September 30, 2021 was $206.4 million, compared to $91.1 million in the same period of 2020.
Product revenue totaled $192.5 million for the three months ended September 30, 2021, compared to $91.1 million in the same period of 2020, including:
Sales of tislelizumab in China of $77.0 million, compared to $49.9 million in the prior year period;
Sales of BRUKINSA of $65.8 million, compared to $15.7 million in the prior year period;
Sales of XGEVA® (denosumab), the first product transferred to BeiGene from the Amgen collaboration, in China of $15.7 million, compared to $3.1 million in the prior year period. BeiGene commenced sales and marketing in China in July 2020;
Collaboration revenue for the three months ended September 30, 2021 was $14.0 million, resulting from the partial recognition of previously deferred revenue associated with the upfront payment received from Novartis in the first quarter of 2021. There was no collaboration revenue in the prior year period.
Expenses for the three months ended September 30, 2021 were $668.8 million, compared to $531.2 million in the same period of 2020.
Cost of Sales for the three months ended September 30, 2021 were $47.4 million, compared to $21.1 million in the same period of 2020. Cost of sales increased primarily due to increased product sales of tislelizumab, BRUKINSA, and XGEVA.
R&D Expenses for the three months ended September 30, 2021 were $351.9 million, compared to $349.1 million in the same period of 2020. The increase in R&D expenses was primarily attributable to increases in headcount and external costs related to our investment in discovery and development activities, including our continued efforts to internalize research and clinical trial activities, partially offset by decreased spending on clinical trials related to BRUKINSA, as well as decreased expense related to upfront fees related to in-process R&D. Additionally, R&D-related share-based compensation expense was $31.7 million for the three months ended September 30, 2021, compared to $25.4 million for the same period of 2020.
SG&A Expenses for the three months ended September 30, 2021 were $269.2 million, compared to $160.8 million in the same period of 2020. The increase in SG&A expenses was primarily attributable to increased headcount and increased external expenses related to the growth of our global commercial organization, as we continued to build our worldwide footprint. SG&A-related share-based compensation expense was $35.4 million for the three months ended September 30, 2021, compared to $24.9 million for the same period of 2020.
Net Loss for the three months ended September 30, 2021 was $413.9 million, or $0.34 per share, and $4.46 per American Depositary Share (ADS), compared to $425.2 million, or $0.37 per share, and $4.81 per ADS in the same period of 2020.


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Exhibit 99.1
Financial Summary
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
September 30, December 31, 
2021      2020
(unaudited) (audited)
Assets:
Cash, cash equivalents, restricted cash and short-term investments $ 3,923,313  $ 4,658,730 
Accounts receivable, net 129,584  60,403 
Working capital 3,128,400  3,885,491 
Property and equipment, net 450,788  357,686 
Total assets 5,286,334  5,600,757 
Liabilities and equity:
Accounts payable 206,203  231,957 
Accrued expenses and other payables 389,874  346,144 
Deferred revenue 124,898  — 
R&D cost share liability 420,001  502,848 
Debt 643,278  518,652 
Total liabilities 1,929,261  1,731,514 
Total equity $ 3,357,073  $ 3,869,243 



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Exhibit 99.1
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
September 30,
Nine Months Ended
September 30,
2021 2020 2021 2020
(Unaudited) (Unaudited)
Revenue:
Product revenue, net $ 192,461  $ 91,080  $ 437,202  $ 208,774 
Collaboration revenue 13,979  —  525,102  — 
Total revenues 206,440  91,080  962,304  208,774 
Expenses:
Cost of sales - products 47,413  21,123  116,361  49,579 
Research and development [1] 351,937  349,070  1,028,754  939,340 
Selling, general and administrative 269,227  160,837  683,622  391,967 
Amortization of intangible assets 188  187  563  658 
Total expenses 668,765  531,217  1,829,300  1,381,544 
Loss from operations (462,325) (440,137) (866,996) (1,172,770)
Interest (expense) income, net (2,230) (614) (11,275) 7,184 
Other income, net 31,477  5,711  26,487  29,368 
Loss before income taxes (433,078) (435,040) (851,784) (1,136,218)
Income tax benefit (19,223) (8,423) (24,083) (8,344)
Net loss (413,855) (426,617) (827,701) (1,127,874)
Less: Net loss attributable to noncontrolling interest —  (1,393) —  (3,713)
Net loss attributable to BeiGene, Ltd. $ (413,855) $ (425,224) $ (827,701) $ (1,124,161)
Net loss per share attributable to BeiGene, Ltd.:
Basic and diluted $ (0.34) $ (0.37) $ (0.69) $ (1.07)
Weighted-average shares outstanding:
Basic and diluted 1,205,971,284  1,148,973,077  1,196,391,201  1,052,940,583 
Net loss per ADS attributable to BeiGene, Ltd.
Basic and diluted $ (4.46) $ (4.81) $ (8.99) $ (13.88)
Weighted-average ADSs outstanding:
Basic and diluted 92,767,022  88,382,544  92,030,092  80,995,429 

[1] Research and development expense for the three and nine months ended September 30, 2021 includes upfront fees related to in-process research and development of in-licensed assets totaling nil and $53.5 million, respectively, compared to $66.5 million and $109.5 million in the comparable prior year periods.


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Exhibit 99.1
About BeiGene
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,700 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
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 clinical data for BeiGene’s drug candidates and approvals of its medicines; the conduct of late-stage clinical trials and expected data readouts; additional planned product approvals and launches; the advancement of and anticipated clinical development, regulatory milestones and commercialization of BeiGene’s medicines and drug candidates; the success of BeiGene’s commercialization efforts and revenue growth; the expected capacities and completion dates for the Company’s manufacturing facilities under construction; the timeline for the Company to complete its proposed public offering and listing on the STAR Market of the Shanghai Stock Exchange, if at all; the impact of the COVID-19 pandemic on the Company’s clinical development, regulatory, commercial and other operations; BeiGene’s plans and the expected events and milestones under the caption “Recent Business Highlights and Upcoming Milestones”; and BeiGene’s plans, commitments, aspirations and goals under the captions “About BeiGene”. 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 medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial and other operations, 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
Gabrielle Zhou Liza Heapes
+86 10-5895-8058 or +1 857-302-5189 +1 857-302-5663
ir@beigene.com media@beigene.com
XGEVA®, BLINCYTO®, and LUMAKRAS® are registered trademarks of Amgen.
ABRAXANE® is a registered trademark of Abraxis Bioscience LLC, a Bristol Myers Squibb company.


Exhibit 99.2
BeiGene to Present Clinical Data on BRUKINSA in Chronic Lymphocytic Leukemia at the 63rd ASH Annual Meeting

First presentation of SEQUOIA results reports BRUKINSA’s superiority over chemoimmunotherapy in patients with treatment-naïve chronic lymphocytic leukemia

Results from SEQUOIA in frontline CLL and the positive ALPINE trial in the relapsed or refractory setting support BRUKINSA’s potential to improve treatment outcomes for patients with chronic lymphocytic leukemia

Additional data at ASH support BRUKINSA’s therapeutic potential for patients intolerant to other BTK inhibitor treatment

CAMBRIDGE, Mass. & BEIJING—(BUSINESS WIRE)—November 4, 2021—BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced clinical results and real world data from its hematology program to be presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, including two oral presentations on the Phase 3 SEQUOIA trial comparing BRUKINSA® (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The ASH meeting will take place on December 11-14, 2021, as a hybrid event in Atlanta, GA and in a virtual format.

Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene, commented: “Together with ALPINE, the positive SEQUOIA trial provides evidence that BRUKINSA can improve treatment outcomes for patients with CLL. Data at ASH this year reinforce our belief that BRUKINSA’s differentiated design can bring patients clinical benefits, including those who experience treatment discontinuation with other BTK inhibitors. We look forward to sharing more details on our clinical progress in our hematology portfolio with the medical community in Atlanta.”

BRUKINSA Shows Promise in Improving CLL Treatment Outcomes with Positive Results in SEQUOIA (vs. B+R) and ALPINE (vs. Ibrutinib)

Following the positive ALPINE trial of BRUKINSA versus ibrutinib in patients in the relapsed or refractory (R/R) setting in June 2021, BRUKINSA demonstrated superiority over B+R as a first-line treatment for patients with CLL in SEQUOIA, the second positive Phase 3 trial of BRUKINSA in CLL.

Data from the randomized Cohort 1 of SEQUOIA met the primary endpoint at interim analysis, with BRUKINSA achieving a highly statistically significant improvement in progression-free survival (PFS) compared to B+R regimen. Efficacy results were consistent between independent review committee (IRC) and investigator assessments, with a hazard ratio (HR) of 0.42 for both, and were observed across patient characteristics. The data also demonstrated superiority in efficacy measured by overall response rate (ORR) as assessed by both IRC and investigator. Similar to data observed in its broad global clinical program, BRUKINSA was generally well-tolerated in patients with CLL. In particular, low rates of a key safety measurement—atrial fibrillation—were observed in the SEQUOIA trial, consistent with data from ASPEN and ALPINE, the two head-to-head Phase 3 trials of BRUKINSA versus ibrutinib.

In addition, early safety results from the ongoing Cohort 3 (Arm D) evaluating BRUKINSA in combination with Bcl-2 inhibitor venetoclax for CLL patients with del(17p), a high-risk characteristic, suggested a good tolerability profile of the combination.




Exhibit 99.2
Additional Data at ASH Support BRUKINSA’s Potential as an Alternative for Patients Intolerant to Other BTK Inhibitors

To address tolerability issues commonly seen in other BTK inhibitors, BRUKINSA was purposefully designed to optimize selectivity to avoid off-target effects. In the ongoing Phase 2 trial BGB-3111-215 in patients with relapsed or refractory (R/R) B-cell malignancies who were intolerant to prior treatment with other approved BTK inhibitors, continued disease control or improved responses were observed with BRUKINSA treatment. The majority of patients (73%) on BRUKINSA did not experience recurrence of adverse events that led to treatment discontinuation with other BTK inhibitors.

BeiGene Presentations at the 63rd ASH Annual Meeting

Abstract Information Date and Time Presenting Author
Oral Presentations
#396: SEQUOIA: Results of a Phase 3 Randomized Study of Zanubrutinib versus Bendamustine + Rituximab (BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I
Sun, Dec 12
10:45 AM ET
Constantine Tam
#67: Zanubrutinib in Combination with Venetoclax for Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with del(17p): Early Results from Arm D of the SEQUOIA (BGB-3111-304) Trial

642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I
Sat, Dec 11
10:45 AM ET
Alessandra Tedeschi
Poster or Mini Oral Presentations
#1410: Phase 2 Study of Zanubrutinib in BTK Inhibitor-Intolerant Patients (Pts) With Relapsed/Refractory B-cell Malignancies

626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Sat, Dec 11
5:30 PM ET
Mazyar Shadman
#1419: Preliminary Safety and Efficacy Data from Patients (Pts) With Relapsed/Refractory (R/R) B-cell Malignancies Treated with the Novel B-cell Lymphoma 2 (BCL2) Inhibitor BGB-11417 in Monotherapy or in Combination with Zanubrutinib

626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Sat, Dec 11
5:30 PM ET
Constantine Tam
#3540: Preliminary Safety and Efficacy from a Multicenter, Investigator-Initiated Phase II Study in Untreated TP53 Mutant Mantle Cell Lymphoma with Zanubrutinib, Obinutuzumab, and Venetoclax (BOVen)

623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Mon, Dec 13
6:00 PM ET
Anita Kumar
#4078: Real-World Testing Patterns for Risk Assessment and Implications on the Adoption of Novel Therapeutics in Chronic Lymphocytic Leukemia: IGHV Mutation Status, FISH Cytogenetic, and Immunophenotyping

905. Outcomes Research—Lymphoid Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Asher Chanan-Khan
#3046: Real-World Bruton Tyrosine Kinase Inhibitor Treatment Patterns, Compliance, Costs, and Hospitalizations in Patients with Mantle Cell Lymphoma in the United States

905. Outcomes Research—Lymphoid Malignancies: Poster II
Sun, Dec 12
6 PM ET
Bijal Shah


Exhibit 99.2
#4009: Productivity Loss and Indirect Costs Among Non-Hodgkin Lymphoma Patients and Their Caregivers

902. Health Services Research—Lymphoid Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Asher Chanan-Khan
#4077: Impact of Atrial Fibrillation on Cardiovascular and Economic Outcomes in Patients with Chronic Lymphocytic Leukemia

905. Outcomes Research—Lymphoid Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Anjana Mohan
#4079: Real-World Treatment Patterns, Adherence and Healthcare Resource Utilization for Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Among Veterans in the United States
905. Outcomes Research—Lymphoid Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Asher Chanan-Khan
#3048: Real-World Disease Burden, Costs and Resource Utilization of Hospital-Based Care Among Mantle Cell Lymphoma, Waldenström Macroglobulinemia, Marginal Zone Lymphoma and Chronic Lymphocytic Leukemia: Disparities and Risk Factors

905. Outcomes Research—Lymphoid Malignancies: Poster II
Sun, Dec 12
6 PM ET
Asher Chanan-Khan
#1968: Factors Associated with Treatment Among Older Adults Diagnosed with Chronic Lymphocytic Leukemia: An Analysis Using Medicare Claims Data

905. Outcomes Research—Lymphoid Malignancies: Poster I
Sat, Dec 11
5:30 PM ET
Eberechukwu Onukwugha

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in the following indications and regions:

For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;

For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;

For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;

For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);

For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);

For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**;

For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021);

For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021);

For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021);

For the treatment of adult patients with WM (United States, August 2021);


Exhibit 99.2

For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*;

For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021);

For the treatment of MCL in patients who have received at least one prior therapy (Israel, October 2021);

For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021);

For the treatment of adult patients with MCL who have received at least one prior therapy (Australia, October 2021); and

For the treatment of adult patients with MCL who have received at least one previous therapy (Russia, October 2021).

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

To-date, more than 30 marketing authorization applications in multiple indications have been submitted in the United States, China, the European Union, and more than 20 other countries or regions.




Exhibit 99.2
BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, Australia and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

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 clinical benefits of BRUKINSA, BeiGene's plan for the advancement, and anticipated clinical development, regulatory milestones and commercialization of BRUKINSA, and BeiGene’s plans, commitments, aspirations, and goals under the headings “BeiGene Oncology” and “About BeiGene”. 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 medicines and technology; 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 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.


BeiGene Contacts

Investor Contact
Gabrielle Zhou
+86 10-5895-8058 or +1 857-302-5189
ir@beigene.com

Media Contact
Vivian Ni
+1 857-302-7596
media@beigene.com