Document
false0001651308 0001651308 2019-08-08 2019-08-08



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): August 8, 2019

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 August 8, 2019, BeiGene, Ltd. (the "Company") announced its financial results for the three and six months ended June 30, 2019. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01. Regulation FD Disclosure
On August 8, 2019, the Company posted an investor presentation to its website at http://ir.beigene.com. A copy of the investor presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein. The information in Item 7.01 of this Current Report on Form 8-K, including the presentation, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing or this Current Report.
Item 8.01. Other Events.
In its press release dated August 8, 2019, the Company also provided an update on second quarter 2019 and recent business highlights and expected milestones for the remainder of 2019 and 2020. 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
 
Description
99.1
 
Press release issued by BeiGene, Ltd. on August 8, 2019
 
 
 
99.2
 
BeiGene Ltd. Investor Presentation dated August 8, 2019
 
 
 
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: August 8, 2019
By: 
/s/ Scott A. Samuels        
 
Name:
Scott A. Samuels
 
Title:
Senior Vice President, General Counsel




Exhibit
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Exhibit 99.1

BeiGene Reports Second Quarter 2019 Financial Results
CAMBRIDGE, Mass. and BEIJING, China, August 8, 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 second quarter and first half of 2019.
“This quarter, our team continued to deliver across all functions, with the completion of enrollment in five Phase 3 or pivotal trials and the initiation of three new Phase 3 trials in oncology indications where we expect to have a profound impact on people fighting both hematologic and solid tumors. We believe that we are well-positioned to continue running our late-stage trials, including those for tislelizumab, for which we re-acquired full global rights from Celgene in advance of the closing of its pending acquisition by Bristol-Myers Squibb,” said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. “We are progressing well with our U.S. and China product launch preparations, including our commercial and manufacturing build-outs, and we expect the remainder of 2019 and 2020 to be transformative for BeiGene, with readouts from up to 10 ongoing Phase 3 or potentially registration-enabling studies in addition to planned commercial launches of two of our internally developed products.”
Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects
Completed enrollment in the global Phase 3 SEQUOIA trial (NCT03336333) comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naive (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);
Achieved first patient dosing in a Phase 1b trial (NCT02914938) conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;
Presented data at the 15th International Conference on Malignant Lymphoma (ICML), including:
Clinical data from the pivotal Phase 2 trial (NCT03206918) in China in patients with relapsed/refractory (R/R) CLL or SLL;
Updated data from the pivotal Phase 2 trial (NCT03206970) in China in patients with R/R mantle cell lymphoma (MCL);
Updated data from the global Phase 1/2 trial (NCT02343120) in patients with different subtypes of B-cell malignancies, including MCL;
Updated data from the Phase 1b combination trial (NCT02569476) with GAZYVA® (obinutuzumab) in patients with R/R or TN CLL or SLL, and patients with R/R follicular lymphoma (FL).
Presented data at the 24th Congress of European Hematology Association (EHA), including:
Clinical data from the nonrandomized cohort in patients with MYD88wt Waldenström’s Macroglobulinemia (WM) from the Phase 3 ASPEN trial (NCT03053440). The randomized cohort of the study, in patients with MYD88mut WM, is ongoing;
Updated results from the ongoing Phase 1 trial (NCT02343120) of patients with WM;
Pooled safety data from six ongoing monotherapy studies in patients with B-cell malignancies; and
Published in Blood, the Journal of the American Society of Hematology, an article on the Phase 1 trial of zanubrutinib in R/R B-cell malignancies, including CLL/SLL.
Expected Milestones for Zanubrutinib
Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020. The Company expects manufacturing inspections to occur after the completion of the technical reviews. In addition, non-clinical and chemistry, manufacturing and controls (CMC) supplemental information was requested and has been provided;



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Exhibit 99.1

File an initial New Drug Application (NDA) in the U.S. in 2019 or early 2020;
File a supplemental new drug application (sNDA) in China for WM in 2019;
Announce top-line results from the Phase 3 ASPEN trial comparing zanubrutinib to ibrutinib in patients with WM in 2019;
Announce top-line interim analysis from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with TN CLL or SLL as early as 2020; and
Initiate a global Phase 3 clinical trial (NCT04002297) comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated MCL who are ineligible for stem cell transplant in 2019.
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages
Filed an sNDA in China for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC); the sNDA has been granted priority review status from the China National Medical Products Administration (NMPA);
Regained full global rights from Celgene in advance of its pending acquisition by Bristol-Myers Squibb, and received a payment of $150 million in connection with the termination;
Completed enrollment in the Phase 3 trials in China of tislelizumab combined with chemotherapy in the front-line setting for patients with advanced squamous (NCT03594747) and non-squamous (NCT03663205) non-small cell lung cancer (NSCLC);
Initiated the following trials:
A Phase 3 randomized trial (NCT04005716) in China of platinum plus etoposide with or without tislelizumab in patients with untreated extensive-stage small cell lung cancer (SCLC);
A Phase 3 randomized trial (NCT03967977) in China of tislelizumab in combination with chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic UC; and
A Phase 3 randomized trial (NCT03957590) in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized esophageal squamous cell carcinoma (ESCC).
Presented updated clinical results from the pivotal Phase 2 trial (NCT03209973) in China in patients with R/R classical Hodgkin lymphoma (cHL) at EHA; and
Presented preliminary Phase 2 results from the Phase 1/2 trial (NCT03924986) in China in patients with nasopharyngeal cancer (NPC) at ASCO.
Expected Milestones for Tislelizumab
Receive NDA approval in China for treatment of patients with R/R cHL in 2019;
Announce top-line results from the global Phase 2 trial (NCT03419897) in second- or third-line patients with hepatocellular carcinoma (HCC) in 2019 or early 2020 and have regulatory discussions;
Announce top-line results from the Phase 3 trial (NCT03594747) in first-line squamous NSCLC in China in 2019 or 2020;
Announce top-line results from the Phase 3 trial (NCT03663205) in first-line non-squamous NSCLC in China in 2020; and
Complete enrollment in the global first-line Phase 3 trial (NCT03412773) in HCC in 2019 and the global portion of the second-line Phase 3 trial (NCT03358875) in NSCLC in 2019 or early 2020.
Pamiparib, an investigational small molecule PARP inhibitor
Completed enrollment in the Phase 3 randomized trial in China (NCT03519230) of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer;



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Exhibit 99.1

Completed enrollment in the pivotal Phase 2 trial in China (NCT03333915) in third-line and above patients with ovarian cancer with germ-line BRCA mutation; and
Published in The Lancet Oncology an article on the Phase 1A/B trial of pamiparib in combination with tislelizumab in patients with advanced solid tumors.
Expected Milestones for Pamiparib
Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in 2020; and
Announce top-line results from the Phase 3 trial in China of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer in 2020.
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
Initiated a Phase 1/2 trial (NCT03941873) in China of sitravatinib in combination with tislelizumab in patients with unresectable locally advanced or metastatic HCC or gastroesophageal junction cancer.
BGB-A1217, an investigational TIGIT monoclonal antibody discovered by BeiGene scientists
Expected Milestones for BGB-A1217
Initiate patient enrollment in a Phase 1a/1b trial in China and Australia investigating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors in 2019.
Manufacturing Facilities
Completed equipment installation and systems qualification of the Company’s biologics manufacturing facility in Guangzhou, China. We expect manufacturing and validation of tislelizumab drug substance to begin later this year.
Commercial Product Portfolio
Generated $58.14 million in product revenue in the three months ended June 30, 2019, from sales in China of ABRAXANE®, REVLIMID® and VIDAZA®, which represents an 85.0% increase compared to the same period in 2018; and
Announced that the China National Medical Products Administration (NMPA, formerly known as CFDA) accepted the supplemental import drug application for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in combination with gemcitabine, as a potential first-line treatment of patients with metastatic adenocarcinoma of the pancreas (mPC).
Corporate Developments
Received approval from the Stock Exchange of Hong Kong Limited (HKEX) to transition into a general listing under Rule 8.05(3) by meeting its specified revenue and market capitalization thresholds. As a result of the approval, the “B” marker was removed from the Company’s stock symbol in the HKEX, and the Company’s ordinary shares may become eligible for listing in the Hang Seng indices;
Along with SpringWorks Therapeutics, announced the formation of MapKure, LLC to develop BGB-3245, an investigational, selective next-generation RAF kinase inhibitor discovered by BeiGene scientists;
Appointed Qingyi “Anita” Wu as Chief Commercial Officer, Greater China. Prior to joining BeiGene, Anita served as General Manager of the Specialty Care business unit at Sanofi China; and
Appointed Yan “Lily” Liu as Vice President, Head of Marketing, Greater China. Lily was most recently Vice President, Head of the Specialty Care business unit at Takeda China.



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Exhibit 99.1

Second Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.56 billion as of June 30, 2019, compared to $1.64 billion as of March 31, 2019 and $1.81 billion as of December 31, 2018.
The decrease of $76.07 million in the second quarter of 2019 was primarily due to $46.10 million of cash used in operating activities, $21.45 million for investments in property, plant and equipment, and $20 million for an upfront payment related to the BioAtla collaboration agreement.
Revenue for the quarter ended June 30, 2019 was $243.35 million, compared to $52.80 million in the same period in 2018. The increase is primarily attributable to the $150 million payment received in connection with the termination of the tislelizumab collaboration agreement with Celgene, the recognition of previously deferred revenue from the collaboration as well as increased product revenue from sales of the in-licensed products from Celgene in China.
Product revenue from sales of ABRAXANE®, REVLIMID® and VIDAZA® in China totaled $58.14 million for the second quarter ended June 30, 2019, compared to $31.43 million for the same period in 2018.
Collaboration revenue totaled $185.20 million for the second quarter ended June 30, 2019, compared to $21.38 million for the same period in 2018. The increase is due primarily to the $150 million payment in connection with the termination of our tislelizumab collaboration agreement with Celgene, as well as the recognition of previously deferred revenue from the collaboration.
Expenses for the second quarter ended June 30, 2016 were $329.18 million, compared to $215.85 million in the same period in 2018.
Cost of sales for the second quarter ended June 30, 2019 were $17.84 million, compared to $6.26 million in the same period in 2018. Cost of sales related to the cost of acquiring ABRAXANE®, REVLIMID® and VIDAZA® for distribution in China.
R&D Expenses for the second quarter ended June 30, 2019 were $228.76 million, compared to $164.25 million in the same period in 2018. 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, and manufacturing costs related to pre-commercial activities and supply. Additionally, we expensed $20.0 million for the upfront payment related to the BioAtla collaboration agreement. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $18.15 million for the second quarter ended June 30, 2019, compared to $10.72 million for the same period in 2018, due to increased headcount.
SG&A Expenses for the second quarter ended June 30, 2019 were $82.25 million, compared to $45.16 million in the same period in 2018. 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 China and 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 $14.45 million for the second quarter ended June 30, 2019, compared to $7.92 million for the same period in 2018, due to increased headcount.
Net Loss for the second quarter ended June 30, 2019 was $85.57 million, or $0.11 per share, or $1.43 per American Depositary Share (ADS), compared to $156.89 million, or $0.22 per share, or $2.92 per ADS in the same period in 2018.



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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
 
June 30,
 
December 31, 
 
2019
    
2018
 
(unaudited)

 
(audited)
Assets:
 
 
 
Cash, cash equivalents, restricted cash and short-term investments
$
1,561,479

 
$
1,809,222

Accounts receivable
58,108

 
41,056

Working capital
1,484,001

 
1,697,390

Property and equipment, net
212,672

 
157,061

Total assets
2,150,318

 
2,249,684

Liabilities and equity:
 
 
 
Accounts payable
148,536

 
113,283

Accrued expenses and other payables
103,061

 
100,414

Bank loan [1]
93,229

 
49,512

Shareholder loan [2]
154,321

 
148,888

Total liabilities
579,054

 
496,037

Noncontrolling interest
17,387

 
14,445

Total equity
$
1,571,264

 
$
1,753,647

[1] The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd., which totaled $84.49 million as of June 30, 2019, 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.



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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
June 30,
 
Six Months Ended
June 30,
 
2019
 
2018
 
2019
 
2018
 
(unaudited)
Revenue:
 
 
 
 
 
 
 
Product revenue, net
$
58,142

 
$
31,426

 
$
115,563

 
$
54,676

Collaboration revenue
185,204

 
21,378

 
205,616

 
30,672

Total revenues
243,346

 
52,804

 
321,179

 
85,348

Expenses:
 
 
 
 
 
 
 
Cost of sales - products
(17,839
)
 
(6,256
)
 
(33,100
)
 
(10,806
)
Research and development
(228,760
)
 
(164,251
)
 
(407,111
)
 
(273,951
)
Selling, general and administrative
(82,248
)
 
(45,160
)
 
(139,893
)
 
(74,075
)
Amortization of intangible assets
(332
)
 
(187
)
 
(663
)
 
(375
)
Total expenses
(329,179
)
 
(215,854
)
 
(580,767
)
 
(359,207
)
Loss from operations
(85,833
)
 
(163,050
)
 
(259,588
)
 
(273,859
)
Interest income, net
2,886

 
1,892

 
7,363

 
3,444

Other (expense) income, net
(878
)
 
75

 
850

 
804

Loss before income taxes
(83,825
)
 
(161,083
)
 
(251,375
)
 
(269,611
)
Income tax (expense) benefit
(2,129
)
 
3,368

 
(2,648
)
 
6,780

Net loss
(85,954
)
 
(157,715
)
 
(254,023
)
 
(262,831
)
Less: Net loss attributable to noncontrolling interest
(384
)
 
(828
)
 
(813
)
 
(1,348
)
Net loss attributable to BeiGene, Ltd.
$
(85,570
)
 
$
(156,887
)
 
$
(253,210
)
 
$
(261,483
)
 
 
 
 
 
 
 
 
Net loss per share attributable to BeiGene, Ltd., basic and diluted
$
(0.11
)
 
$
(0.22
)
 
$
(0.33
)
 
$
(0.38
)
Weighted-average shares outstanding, basic and diluted
777,509,102

 
698,506,891

 
776,137,299

 
684,586,086

 
 
 
 
 
 
 
 
Net loss per ADS attributable to BeiGene, Ltd., basic and diluted
$
(1.43
)
 
$
(2.92
)
 
$
(4.24
)
 
$
(4.97
)
Weighted-average ADSs outstanding, basic and diluted
59,808,392

 
53,731,299

 
59,702,869

 
52,660,468





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Exhibit 99.1

About BeiGene
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,700 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 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 the encouraging clinical data for BeiGene’s product candidates and product revenue for its products; the conduct of late-stage clinical trials and expected data readouts; the potential 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.
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.



bgneinvestordeck20190808
Corporate Presentation August 8, 2019


 
• Certain statements contained in this presentation and in the accompanying oral presentation, other than Disclosures statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include those regarding investigational drug candidates and clinical trials and the status and related results thereto, as well as those regarding continuing and further development and commercialization efforts and transactions with third parties. Such statements, based as they are on the current analysis and expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BeiGene’s control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical industries, changes in the global and regional regulatory environments in the jurisdictions in which BeiGene does business, market volatility, fluctuations in costs and changes to the competitive environment. Consequently, actual future results may differ materially from the anticipated results expressed in the forward- looking statements. In the case of forward-looking statements regarding investigational drug candidates and continuing further development efforts, specific risks which could cause actual results to differ materially from BeiGene’s current analysis and expectations include: failure to demonstrate the safety, tolerability and efficacy of our drug candidates, final and quality controlled verification of data and the related analyses, the expense and uncertainty of obtaining regulatory approval, including from the FDA, NMPA (formerly CFDA/CDA) and EMA, the possibility of having to conduct additional clinical trials and BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services. Further, even if regulatory approval is obtained, pharmaceutical products1 are generally subject to stringent on-going governmental regulation, challenges in gaining market acceptance and competition. These statements are also subject to a number of material risks and uncertainties that are described in BeiGene’s filings with the Securities and Exchange Commission (SEC). The reader should not place undue reliance on any forward-looking statements included in this presentation or in the accompanying oral presentation. These statements speak only as of the date made, and BeiGene is under no obligation and disavows any obligation to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. • Some of the clinical data in this presentation relating to BeiGene’s investigational drug candidates is from early phase, single-arm trials. When such data or data from later stage trials are presented in relation to other investigational or marketed drug products, the presentation and discussion are not based on head-to-head trials between BeiGene’s investigational drug candidates and other products. BeiGene is still conducting clinical trials and, as additional patients are enrolled and evaluated, data on BeiGene’s investigational drug candidates may change. • This presentation and the accompanying oral presentation contains data and information obtained from third- party studies and internal company analysis of such data and information. BeiGene has not independently verified the data and information obtained from these sources. Forward-looking information obtained from these sources is subject to the same qualifications noted above. 2


 
BeiGene At-A-Glance Fully-integrated global biotech 2,700+ employees Key catalysts in 2019 / 20 company with internal 10 offices on 4 continents including expected product capabilities in research, clinical Trials in 34 countries and approvals and up to 10 development, commercialization regions Phase 3 or potentially and manufacturing • ~300 research registration-enabling trial • 1000+ global clinical readouts could further • 600+ commercial transform the company Broad product portfolio and pipeline • Three wholly owned late-stage candidates including two currently under regulatory review • 26 Phase 3 or potentially registration-enabling trials ongoing, 60+ studies in total • Balanced portfolio of 13 clinical or commercial stage assets including 6 internally developed and 7 in-licensed • Growing commercial business, from $15.6M in 4Q:17 to $58.1M in 2Q:19 since transition to BeiGene 3


 
Our Strategies -- Building a Leading Global Innovative Biotech Company From China With the utmost commitment to patients, quality, and science Realize two large near-term commercial opportunities • Global opportunity for potentially best-in-class BTK inhibitor zanubrutinib • Opportunity for differentiated anti-PD-1 antibody tislelizumab in China and beyond Strengthen key strategic capabilities • Global clinical development • Commercial platform Capture opportunities created by regulatory reforms in China • Accelerate global development through China-inclusive global trials • Continue to expand our portfolio by leveraging our strong clinical capabilities Pursue a new global model for growth by leveraging China’s reimbursement expansion • Expanded commercial base in China lowers per-patient R&D investment and allows greater access • Uniquely positioned due to strong China presence and global development 4


 
Our Leadership Team Attracting global talent to build a world-class team John V. Oyler Xiaodong Wang, Ph.D. Founder, CEO, and Chairman Founder and Chairman SAB BioDuro, Galenea, Telephia, NIBS: National Institute of Biological Sciences in Genta, McKinsey & Company Beijing, UT Southwestern Medical Center, Howard Hughes Medical Institute, National Academy of Sciences Xiaobin Wu, Ph.D. Howard Liang, Ph.D. Eric Hedrick, M.D. GM of China, President CFO and Chief Strategy Officer Chief Advisor Pfizer Leerink Genentech Wyeth Abbott Pharmacyclics Bayer Epizyme Lai Wang, Ph.D. Jane Huang, M.D. Yong Ben, M.D. Wendy Yan SVP, Head of Global Research, Chief Medical Officer, Chief Medical Officer, SVP, Global Head of Clinical Operation & Biometrics Hematology Immuno-Oncology Regulatory Affairs and APAC Clinical Development Genentech BioAtla Bayer UT Southwestern Medical Acerta AstraZeneca AstraZeneca Center Anita Wu Lily Liu Josh Neiman Chief Commercial Officer, Greater China VP, Head of Marketing, Head of U.S. Commercial Sanofi Greater China Flatiron Health AstraZeneca Takeda Onyx Pharmaceuticals Pfizer Pfizer Genentech Scott Samuels, Esq. Todd Yancey, M.D. Guillaume Vignon, SVP, General Counsel SVP, Global Medical Affairs & New Ph.D. ARIAD Market Development SVP, Business Mintz Levin BioMarin, Medivation Development Clovis Oncology, Onyx Merck 5


 
BeiGene Product Portfolio and Pipeline Global Three marketed products in China, three late-stage assets, seven early-stage clinical assets China DOSE ESC. DOSE EXPANSION PIVOTAL COMMERCIAL ASSETS PROGRAMS FILED PH1a PH1b PH2* PH2** PH3 RIGHTS R/R MCL, R/R CLL/SLL (NDAs accepted) R/R WM zanubrutinib monotherapy WM, 1L CLL/SLL, R/R CLL/SLL Global (BTK) R/R MZL + GAZYVA® (CD20) R/R FL R/R cHL, 2L+ UC (NDAs accepted) 2L NSCLC, 1L HCC, 2L ESCC monotherapy 2L/3L HCC tislelizumab R/R NK/T-cell lymphoma Global (PD-1) 1L Sq. NSCLC, 1L Non-Sq. NSCLC, 1L NPC, 1L SCLC + chemo 1L GC, 1L ESCC + pamiparib (PARP) Solid tumors + zanubrutinib (BTK) B-cell malignancies 1L platinum-sensitive GC maintenance 2L platinum-sensitive OC maintenance Internally Internally Developed monotherapy pamiparib 3L gBRCA+ OC Global (PARP) Solid tumors + TMZ (chemo) Solid tumors + RT/TMZ (RT/chemo) Glioblastoma B-Raf- or K-RAS/N-RAS-mutated solid tumors lifirafenib (RAF Dimer) monotherapy Global B-Raf- or K-RAS/N-RAS-mutated solid tumors BGB-A333 (PD-L1) monotherapy & + tislelizumab Solid tumors Global BGB-A425 (TIM-3) monotherapy & + tislelizumab Solid tumors Global REVLIMID® (IMiD) R/R MM (marketed), NDMM (marketed), R/R NHL (Ph3) China ABRAXANE® (albumin-bound paclitaxel) Breast cancer (marketed), Metastatic pancreatic cancer (filed) China VIDAZA® (hypomethylating agent) MDS, AML with 20-30% bone marrow blasts, CMML (marketed) China sitravatinib (multi-kinase inhibitor)1 NSCLC, RCC, OC, Melanoma, HCC/GEJ Asia ex-Japan, NZ, AU ZW25 (bispecific HER2 antibody)2 Planned (in Ph2 ex-China by Zymeworks) Asia ex-Japan, NZ, AU 2 Collaborations ZW49 (bispecific anti-HER2 ADC) Planned (in Ph1 ex-China by Zymeworks) Asia ex-Japan, NZ, AU avadomide (CC-122, CELMoD) Planned (in Ph1b ex-China by Celgene) China *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. **Confirmatory clinical trials post approval are required for accelerated approvals. ***REVLIMID® approved as a combination therapy with dexamethasone. 1.Collaboration with Mirati Therapeutics, Inc; APAC study; 2. Collaboration with Zymeworks 6


 
Two Late-Stage Assets Represent Significant Commercial Opportunities zanubrutinib tislelizumab Potentially Best-in-Class BTK Inhibitor PD-1 Inhibitor Targeting Asia-Prevalent Tumors ▪ 2018 Global: $4.2 Bn ▪ 2018 Global^: $15.5 Bn CLASS REVENUE & FORECAST** ▪ 2025E Global: $13.8 Bn ▪ 2025E Global^: $57.4 Bn ▪ 2025E China: $1.3 Bn ▪ 2025E China^: $12.1 Bn KEY TARGET Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenstrom’s Lung, liver, gastric, and esophageal cancers, classical INDICATIONS Macroglobulinemia, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma Hodgkin’s lymphoma, urothelial carcinoma, nasopharyngeal 70-patient China pivotal 104-patient China pivotal 86-patient R/R MCL1 73-patient WM2 91-patient R/R CLL/SLL3 Ph2 R/R cHL4 Ph2 2L+ UC5 CLINICAL DATA* ▪ 84% ORR ▪ 92% ORR, 82% MRR ▪ 85% ORR ▪ 87% ORR ▪ 23% ORR ▪ 59% CR ▪ 41% VGPR ▪ 5% CR ▪ 63% CR ▪ 8% CR ▪ NDAs for R/R MCL and R/R CLL/SLL accepted by NMPA ▪ NDAs for cHL and UC in China accepted by NMPA FILING PROGRESS ▪ Priority review status granted to NDAs in R/R MCL and R/R CLL/SLL ▪ Priority review granted by NMPA ▪ Fast Track in WM and Breakthrough Therapy in MCL by U.S. FDA 1. ICML 2019 Song et. al.; 2. EHA 2019 Trotman et. al.; 3. ICML 2019 Xu et. al.; 4. EHA 2019 Song et. al. 5. China pivotal Phase 2 trial, BeiGene press release May 30, 2019. *All data are from independent review committee (IRC) assessment. **Frost&Sullivan analysis; RMB:USD conversion: 6.5:1. ^For PD-1 & PD-L1 class; BTK: Bruton’s Tyrosine Kinase; cHL: Classical Hodgkin’s Lymphoma; CLL/SLL: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; CR: Complete Response; FL: Follicular Lymphoma; f/u: Median follow up time; MCL: Mantle Cell Lymphoma; MZL: Marginal Zone Lymphoma; MRR: Major Response Rate; NDA: New Drug Application; NMPA: National Medical Products Administration; ORR: Overall Response Rate; PD-1: Programmed Cell Death-1; R/R: Relapsed/Refractory; UC: Urothelial Carcinoma; VGPR: Very Good Partial Response; WM: Waldenstrom’s Macroglobulinemia; R/R: Relapsed / Refractory. 7


 
Zanubrutinib Broad Clinical Development Program Eight ongoing potentially registration-enabling studies Filed, In NDA review Pivotal Phase 2 (n=86) in R/R MCL Phase 3 (n=500) in 1L MCL Phase 1 cohort (n=45) in MCL zanu monotherapy, PE: ORR R+zanu vs. R+chemo, PE: PFS zanu monotherapy, PE: Safety RP2D MCL Enrollment Complete Initiated: Mar 2017, Enrollment complete: Sep 2017 Initiated: TBD Initiated: Aug 2014 Enrolling Phase 3 (n=229) in WM (ASPEN) Pivotal Phase 2 (n=44) in R/R WM Phase 1 (n=73) in WM WM zanu vs. ibrutinib, PE: VGPR/CR, zanu monotherapy, PE: MRR zanu monotherapy, PE: Safety, RP2D Planned Initiated: Jan 2017, Enrollment complete: Jul 2018 Initiated: Aug 2017, Enrollment complete: May 2018 Initiated: Aug 2014, Enrollment complete: July 2018 Filed or potentially registrational Pivotal Phase 2 (n=91) in R/R CLL/SLL Phase 31 (n=550) in 1L CLL/SLL (SEQUOIA) Phase 3 (n=400) in R/R CLL/SLL (ALPINE) zanu monotherapy, PE: ORR zanu vs. BR, PE: PFS, zanu vs. ibrutinib, PE: ORR Initiated: Mar 2017, Enrollment complete: Dec 2017 Initiated: Nov 2017, Enrollment complete^: Aug 2019 Initiated: Nov 2018 China CLL/ SLL Global Phase 1 cohort (n=69) in CLL/SLL zanu monotherapy, PE: Safety RP2D Initiated: Aug 2014 Pivotal phase 2 (n=210) in R/R FL Phase 22 (n=65) in R/R MZL FL Obinutuzumab ± zanu, PE: ORR MZL zanu monotherapy, PE: ORR Phase 1b: zanu + ME-401, in B-cell malignancies Initiated: Nov 2017 Initiated: Feb 2019 Phase 2: zanu / venetoclax / Phase 1b/2: zanu + tislelizumab, Phase 1b: zanu + obinutuzumab, Phase 2: Monotherapy, R/R Non- obinutuzumab in 1L CLL GCB DLBCL B-cell malignancies R/R CLL (MSKCC study) CLL DLBCL Phase 2: zanu / venetoclax / Phase 1b: zanu + Revlimid, R/R Phase 1b: zanu + R-chemo, 1L and obinutuzumab in 1L CLL DLBCL 2L DLBCL Combination (GCLLSG study) ^Time of the announcement of the enrollment completion; 1L: First Line; CLL/SLL: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; CR: Complete Response; DLBCL: Diffuse Large B-Cell Lymphoma; FL: Follicular Lymphoma; GCB: Germinal Center B-cell-like; MCL: Mantle Cell Lymphoma; MRR: Major Response Rate; MZL: Marginal Zone Lymphoma; NHL: Non-Hodgkin’s Lymphoma; ORR: Overall Response Rate; PCNSL: Primary Central Nervous System Lymphoma; PE: Primary endpoint; PFS: Progression-Free Survival; RP2D: Recommended Phase 2 Dose; R/R: Relapsed / Refractory; RT: Richter’s Transformation; VGPR: Very Good Partial Response; WM: Waldenstrom’s Macroglobulinemia. 1. Cohort 2 of 17p del patients completed enrollment. 2. global trial and potentially registration-enabling in certain countries. 8


 
Tislelizumab Broad Late-stage Development Program Fifteen ongoing potentially registration-enabling studies Phase 3 (n=360) in 1L Stage IIIB or IV squamous NSCLC Filed, In NDA review Phase 3 (n=800) in 2L NSCLC tislelizumab+ paclitaxel and carboplatin combo or nab-paclitaxel and carboplatin tislelizumab vs. docetaxel, PE: OS combo vs. paclitaxel and carboplatin combo, PE: PFS Enrollment Complete Initiated: Nov 2017 Initiated: Aug 2018, Enrollment complete^: Aug 2019 Lung Phase 3 (n=364) in 1L SCLC Enrolling Phase 3 (n=320) in 1L Stage IIIB or IV non-squamous NSCLC Tislelizumab+ chemo (Carboplatin /Cisplatin, Etoposide) vs. placebo + chemo, PE: tislelizumab+ chemo (platinum-pemetrexed) vs. chemo, PE: PFS PFS, OS Planned Initiated: Jul 2018, Enrollment complete^: Aug 2019 Initiated: July 2019 Filed or Phase 3 (n=640) in 1L HCC Phase 2 (n=225) in 2L/3L HCC potentially registrational HCC tislelizumab vs. sorafenib, PE: OS tislelizumab monotherapy, PE: ORR by IRC Initiated: Jan 2018 Initiated: Apr 2018, Enrollment complete^: Feb 2019 China Phase 3 (n=480) in 1L advanced ESCC Phase 3 (n=450) in 2L ESCC tislelizumab or placebo + platinum- and fluoropyrimidine-based chemo, Co-PE: tislelizumab vs. single-agent chemo (paclitaxel, docetaxel, or irinotecan), PE: OS PFS and OS Global Initiated: Jan 2018 Initiated: Dec 2018 ESCC Phase 3 (n=720) in 1L advanced GC Phase 3 (n=316) in localized ESCC tislelizumab or placebo + platinum- and fluoropyrimidine-based tislelizumab + chemoradiotherapy vs chemoradiotherapy, PE: OS GC chemo, Co-PE: PFS and OS Initiated: May 2019 Initiated: Dec 2018 Phase 3 (n=420) in 1L UC Pivotal phase 2 (n=110) in 2L UC tislelizumab + chemo (cisplatin + carboplatin + gemcitabine) vs placebo + chemo tislelizumab monotherapy, PE: ORR, Initiated: Jul 2017, UC PE: OS Enrollment complete: Aug 2018, NDA accepted May 2019 Initiated: May 2019 Pivotal phase 2 (n=70) in R/R cHL Phase 2 (n=90) in 1L R/R Mature T- and NK- Neoplasms R/R NK/T-cell tislelizumab monotherapy, PE: ORR tislelizumab monotherapy, PE: ORR cHL lymphomas Initiated: Apr 2017, Enrollment complete: Nov 2017, NDA accepted in Aug 2018 Initiated: Apr 2018 MSI-H or Pivotal phase 2 (n=60) in MSI-H or dMMR solid tumors Phase 3 (n=256) in 1L tislelizumab + chemo (gemcitabine plus dMMR tislelizumab monotherapy, PE: ORR NPC cisplatin) vs. placebo + chemo PE: PFS solid Initiated: Sep 2018 Initiated: Apr 2019 tumors ^Time of the announcement of the enrollment completion; *Tislelizumab dosage 200mg every three weeks, Q3W. Global Ph2 in R/R/ NK/T-cell lymphoma and Ph2 trial in MSI-H or dMMR solid tumors in China are potentially registrational-enabling trials. 1/2L: First/Second Line; cCRT: concurrent chemoradiotherapy; cHL: Classical Hodgkin’s Lymphoma; ESCC: Esophageal Squamous-Cell Carcinoma; GC: Gastric Cancer; HCC: Hepatocellular Carcinoma; IRC: Independent Review Committee; ITT: Intent-to-treat; MSI-H or dMMR: Microsatellite Instability High or Deficient Mismatch Repair; NDA: New Drug Application; NK: Natural Killer; NSCLC: Non-Small Cell Lung Cancer; ORR: Overall response rate; OS: Overall survival; PE: Primary Endpoint; PFS: Progression-free survival; R/R: Relapsed / Refractory; UC: Urothelial Carcinoma; 9


 
Other Clinical-Stage Drug Candidates and Internal Combinations Global China ROBUST PIPELINE BEYOND BTK AND PD-1 DOSE ESC. DOSE EXPANSION INDICATIONS pamiparib • Late stage studies in ovarian cancer in China PH1a PH1b PH2* (PARP1&2 Inhibitor) • Combination studies with temozolomide HCC or GEJ tislelizumab + sitravatinib** 1 sitravatinib • Combination with tislelizumab initiated (Multi-Kinase • In-licensed from Mirati, rights in Asia ex-Japan, AU, NZ Inhibitor) NSCLC, RCC, OC, tislelizumab + sitravatinib** • Clinical activity observed in RAS-mutated cancers including NSCLC and melanoma lifirafenib endometrial cancer (Raf Dimer Inhibitor) • Global clinical trial collaboration with SpringWorks for combination with Solid tumors lifirafenib + PD-0325901 (MEK MEK inhibitor inhibitor, SpringWorks) ZW252 • In-licensed from Zymeworks, rights in Asia ex-Japan, AU, NZ (Bispecific HER2 • Designed to provide dual HER2 signaling blockade by binding to epitopes B-cell Planned: zanubrutinib + ME401 Antibody) for Herceptin and Perjeta malignancies (PI3K delta inhibitor, MEI Pharma) • In-licensed from Zymeworks, rights in Asia ex-Japan, AU, NZ ZW492 • Designed to bind two non-overlapping epitopes of HER2 to maximize tislelizumab + (Bispecific HER2 ADC) internalization and delivery of payload Solid tumors BGB-A333 (PD-L1) BGB-A333 • Ph1 trial testing the monotherapy and the combination with tislelizumab tislelizumab + (PD-L1 Antibody) Solid tumors BGB-A425 (TIM-3) BGB-A425 • Ph1 testing the combination with tislelizumab B-cell tislelizumab + (TIM-3 Antibody) malignancies zanubrutinib avadomide • In-licensed from Celgene, rights in China Solid tumors tislelizumab + (CELMoD [CC-122]) pamiparib *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or 3 clinical trials; confirmatory clinical trials post-approval are required for accelerated approvals. **Clinical trials in Asia Pacific regions; 1.Collaboration with Mirati Therapeutics, Inc., 2. Collaboration with Zymeworks; GEJ: gastroesophageal junction cancer. 10


 
Leverage China to Pursue Global Excellence BeiGene Is Becoming a Leader in China-Inclusive Global Clinical-Development • In-house research capability with a team of approximately 300; all three late-stage clinical assets were discovered by BeiGene scientists with potentially differentiating profiles • Additional new targets and potentially first-in-class candidates in earlier stages of development • Clinical team of over 1,000, with over 50% in China and remainder in US, EU, AU; Largest oncology-focused clinical development team in China • Initiated 6 China-inclusive global pivotal studies; 26 pivotal trials or potentially registration-enabling trials ongoing Countries with BeiGene clinical trial sites • 60+ ongoing or planned clinical trials in China and globally with 7,000+ patients and healthy subjects enrolled • Regulatory interactions and monitoring from 20+ countries Source: BeiGene Corporate Presentation – BioCentury China Healthcare Summit 13/14 Nov. 2018 11


 
Building Oncology-Focused Commercial Footprint in China and Establishing a Presence in the U.S. Marketed product growth and commercial team expansion in China; Building a 100-200-person hematology commercial team in the U.S. A growing 600+ top innovative oncology commercial Marketed Brand Revenue team targeting to cover 800 – 1,000 hospitals in Since Transition to BeiGene China1 1000 900 800 $57.4Mn $58.1Mn 700 600 $38.4Mn $37.8Mn 500 $31.4Mn 400 $23.3Mn 300 $15.6Mn 200 100 0 4 Q1 7 1 Q1 8 2 Q1 8 3 Q1 8 4 Q1 8 1 Q1 9 2 Q1 9 4Q17 1Q18 2Q18 3Q18 4Q18 Xiaobin Wu, Ph.D. Anita Wu Lily Liu Josh Neiman GM of China, President Chief Commercial VP, Head of Marketing, Head, U.S. Commercial Pfizer Officer, Greater China Greater China Flatiron Wyeth Sanofi Takeda Onyx Pharmaceuticals Bayer AstraZeneca Pfizer Genentech 1 As of December 31, 2018 12


 
Developing Strong Manufacturing Capabilities • Manufacturing collaborations with BIOLOGICS MULTI-FUNCTIONAL leading high-quality manufacturers MANUFACTURING in biologics and small molecules MANUFACTURING • BI collaboration established in FACILITY IN FACILITY IN 2013; cell line and CMC process SUZHOU, CHINA for tislelizumab developed by BI GUANGZHOU (UNDER • Commercial scale 2,000L at BI’s CONSTRUCTION) Shanghai expandable facility • Aligned with the design criteria of EXPERIENCED • Joint venture with Guangzhou Development District US, EU and China • Investment of $300+ million -- mostly from external • Total area of 9,000 square meters HIGH-QUALITY funding but BeiGene retains majority equity ownership • Commercial-scale small molecule MANUFACTURING • 100,000 square meter manufacturing site; 24,000-liter drug products facility, ~100M pills PARTNERS commercial-scale biologics manufacturing facility annual capacity • First phase of the manufacturing plant to be completed • Pilot-scale biologic facility at in 2019 500L scale William Novotny, Advisor, Zhengming Du, Ph.D. Head Jonathan Liu, Ph.D. Michael Garvey Technical Operations of Chemistry Manufacturing SVP, Bio-Manufacturing VP, Head of Guangzhou BMS, VP and Global Lead in & Control (CMC) J&J, Head of China Biologics Manufacturing Supply Chain Roche China, Head of Pharmaceutical Samsung Biologics, Merck, AVP in Global Supply Process and Synthesis, Development and VP of Manufacturing Chain Management and Deputy Head of CMC Manufacturing Sciences Product Operations 13


 
China Is Becoming an Important Clinical Science Center, Representing a Historic Opportunity BeiGene is well-positioned within this ecosystem • NMPA reforms have removed delays, allowing China NMPA reforms expand to participate in early drug development and to China’s role in global contribute significantly to global pivotal trials World-Class Clinical development • NMPA joined ICH in June 2017, setting international quality standards for China trials Development Team Positions BeiGene Well to Capture This Opportunity Bottlenecks today • Limited CRO capability • Highly limited talent pool in China • Data and trials management challenges • Single biggest time and expense for drug 1,000+ member clinical team development is trial enrollment Effectively operating in • Adding China significantly accelerates enrollment of All data and clinical practices are designed to meet global ICH standards China can significantly global trials • China alone had 4.3 million new cancer patients in Early mover in simultaneous China- enhance global 2015, as large as the U.S. and EU combined global pivotal trial paradigm and has development • Greater willingness to join clinical trials initiated six dual-purpose trials • Having access to a large pool of patients can also reduce the average upfront cost in drug development 14


 
Commercial Transformation in China Facilitates Access Expanding national reimbursement, at reasonable prices Median Monthly cost of oncology drugs included in NRDL through price negotiation monthly cost $4,000 ZELBORAF No generic NEXAVAR competition at $3,500 AVASTIN IMBRUVICA the time of NRDL inclusion REVLIMID ERBITUX STIVARGA With generic $3,000 VELCADE competition or in VOTRIENT the same class XALKORI at the time of ZYTIGA $2,500 TAGRISSO NRDL inclusion $1,996 MABTHERA NINLARO $2,000 VIDAZA AITAN INLYTA $2,141 Monthly USD Cost/ Monthly FUKEWEI TYKERB TASIGNA $1,500 HERCEPTIN SUTENT IRESSA AFINITOR GIOTRIF $1,000 AIYANG $947 TARCEVA ZYKADIA CONMANA FASLODEX $500 SANDOSTATIN-LAR $0 2016 2017 2018 NRDL = National Reimbursement Drug List; USD / RMB := 6.9:1. 15


 
China Enables a Model to Succeed in an Evolving Global Environment BeiGene is uniquely positioned to leverage the large commercial base Dramatic changes to biopharma industry occurring – China increasingly key focal point for future Being able to effectively operate in clinical development in China attracts other U.S. biotech companies to partner with BeiGene, as part of their global development strategy China enables an alternative model for growth, which is no longer reliant on U.S. pricing The large commercial base in China allows more affordable pricing which in turn can be leveraged to provide greater access to high quality drugs globally BeiGene will pursue true global model without sacrificing quality, innovation, or science 16


 
Established Collaborations Leverage China Capabilities and Expand Portfolio ▪ Obtained Celgene’s commercial operations and ▪ Global collaboration for co- license to three marketed products in development, manufacturing and China commercialization of conditionally active anti-CTLA-4 antibody BA3071 ▪ In June 2019, BeiGene regained full global rights Agreement: Apr. 2019 CTLA-4 inhibitor Agreement: July 2017 of tislelizumab in advance of the pending tislelizumab and Celgene acquisition of Celgene / BMS and received $150M ▪ to commercial assets in China from Celgene Global R&D collaboration utilize Ambrx’s Expanded Genetic Code Agreement: Mar. 2019 technology ▪ In-licensed sitravatinib in Asia (ex-JP) and AU/NZ ▪ Global clinical collaboration to evaluate in RAS-mutant advanced solid Agreement: Jan. 2018 ▪ Encouraging results -- 16 PRs and CRs (9 tumors in combination with BeiGene’s sitravatinib confirmed) in 56 patients -- reported by Mirati in an Agreements: Sept. 2018, Jun. 2019 RAF dimer inhibitor lifirafenib (multi-kinase inhibitor including ongoing Ph2 trial in combination with nivolumab in MEK inhibitor PD-0325901 and TAM receptors (TYRO3, Axl, NSCLC patients who have progressed on BGB-3245 ▪ MapKure established to develop MER), split receptors (VEGFR2, checkpoint inhibitor therapy1 (MEK inhibitor synergistic with RAF BGB-3245 RAF Kinase Inhibitor KIT) and RET) inhibition in RAS-mutant solid tumors) ▪ Global clinical collaboration to ▪ In-licensed ZW25 and ZW49 in Asia (ex- evaluate safety and efficacy in B-cell JP) and AU/NZ; global research and license malignancies in combination with Agreement: Nov. 2018 agreement for AzymetricTM and EFECTTM zanubrutinib ZW25 HER2-targeted bispecific platforms ▪ MEI will amend its ongoing Phase 1b antibody and ZW49 bispecific Agreement: Oct. 2018 antibody drug conjugate (ADC); ▪ Areas of high interest (breast and gastric cancers) ME-401 trial to include evaluation of ME-401 and TM TM zanubrutinib combination therapy in Azymetric and EFECT ▪ Access to bispecific antibody discovery platform (oral phosphatidylinositol 3- platforms kinase , PI3K, delta inhibitor) patients with B-cell malignancies 17 1. ESMO 2018 Ticiana et al. 17


 
Financial Summary Selected Financials Three Months Ended Six Months Ended Amounts in thousands of U.S. dollars, except for shares, American June 30, 2019 June 30, 2018 June 30, 2019 June 30, 2018 Depositary Shares (ADSs), per share and per ADS data) (unaudited) (unaudited) (unaudited) (unaudited) Total Revenue $ 243,346 $ 52,804 $ 321,179 $ 85,348 Product revenue, net 58,142 31,426 115,563 54,676 Collaboration revenue 185,204 21,378 205,616 30,672 Total Expenses (329,179) (215,854) (580,767) (359,207) Cost of sales – products (17,839) (6,256) (33,100) (10,806) Research and development (228,760) (164,251) (407,111) (273,951) Selling, general and administrative (82,248) (45,160) (139,893) (74,075) Net loss attributable to BeiGene, Ltd. $ (85,570) $ (156,887) $ (253,210) $ (261,483) Weighted-average ADSs outstanding, basic and diluted 59,808,392 53,731,299 59,702,869 52,660,468 Net loss per ADS attributable to BeiGene, Ltd, basic and diluted $ (1.43) $ (2.92) $ (4.24) $ (4.97) Cash, cash equivalents, restricted cash and short-term investments $ 1,561,479 $ 1,401,219 $ 1,561,479 $ 1,401,219 Cash used in operations excluding business development $46,101* $218,076* * Includes $150,000 from Celgene in connection with termination of tislelizumab collaboration 18


 
Upcoming Milestones and Catalysts Zanubrutinib (BTK Inhibitor) Timing Approval ▪ Approval in China for MCL and CLL ▪ 1H20 Submission ▪ File sNDA for WM in China ▪ 2019 Submission ▪ NDA filing in the U.S. ▪ 2019 or early 2020 Data ▪ Top-line Phase 3 data of zanubrutinib vs. ibrutinib in WM, ASPEN ▪ 2019 Data ▪ Potential top-line data in Phase 3 of zanubrutinib vs. bendamustine rituximab (BR) in 1L CLL, SEQUOIA ▪ As early as 2020 Data ▪ Updated Phase 1 obinutuzumab combination data in NHL, updated CLL data from global Phase1 trial ▪ 2019 Initiate ▪ Initiate global Phase 3 comparing zanubrutinib + rituximab vs. bendamustine + rituximab in TN MCL ▪ 2019 Tislelizumab (PD-1 Antibody) Approval ▪ Approval in China for cHL ▪ 2019 Data + ▪ Global top-line Phase 2 data in HCC and regulatory filing discussions ▪ 2019 or early 2020 Data ▪ Top-line Phase 3 data from China study in 1L Sq NSCLC ▪ 2019 or 2020 Data ▪ Top-line Phase 3 data from China study in 1L Non-Sq NSCLC ▪ 2020 Data ▪ China pivotal Phase 2 data in UC ▪ 2019 Data ▪ Chemotherapy combination data in esophageal and lung cancers from China Ph.2 trials; HCC cohort data from China Ph.1 ▪ 2019 or early 2020 Enrollment ▪ Complete enrollment in Phase 3 global study in 1L HCC vs. sorafenib ▪ 2019 Enrollment ▪ Complete enrollment in global portion of Phase 3 study in 2/3L Non-Sq NSCLC vs. docetaxel ▪ 2019 or early 2020 Initiate ▪ Initiate Phase 1/1b in China and Australia of A1217 (TIGIT) with tislelizumab in patients with advanced solid tumors ▪ 2019 Pamiparib (PARP inhibitor) Data ▪ Top-line data from China pivotal Phase 2 in 3L+ ovarian cancer ▪ 2020 Data ▪ Top-line data from China Phase 3 comparing pamiparib vs. placebo as maintenance in platinum-sensitive OC ▪ 2020 Data ▪ Ovarian expansion cohort data including (including QD cohort) from global Ph.1 trial presented at a medical conference ▪ 2019 Data ▪ Updated Ph.1 combination data with chemotherapy in solid tumors, and chemotherapy with or without radiation in GBM presented at ▪ 2019 medical conferences Early-stage Assets Initiate ▪ Advance at least one additional preclinical compound from internal pipeline into clinic ▪ 2019 19


 
Review of Product Candidates


 
• Optimized pharmacologic properties relative to ibrutinib: superior bioavailability and higher selectivity OVERVIEW Overview of • Development hypothesis: more complete target inhibition, deeper Zanubrutinib responses, and favorable safety profile (BGB-3111) • More than 1,4501 patients enrolled across trials, including combinations Potentially best-in-class • Clinical experience to date supports best-in-class hypothesis BTK inhibitor • Strong suggestion of deeper responses in WM and MCL CLINICAL • Favorable response rate, depth, and durability in CLL/SLL DATA • High overall and complete response rates in FL with obinutuzumab combination • Low rate of toxicity/tolerability-related discontinuation • Fast Track in WM and Breakthrough Therapy in MCL designations by FDA • Global registrational trials: WM (H2H vs. ibrutinib, enrollment completed), 1L DEVELOPMENT CLL/SLL (vs. BR), R/R CLL/SLL (vs. ibrutinib), FL (potential for global first-in- PLAN class BTK approval in FL); and R/R MZL (global pivotal phase 2 trial) • China registration trials: accelerated approval trials for MCL (filed), CLL/SLL (filed), and WM (enrollment completed) • Submitted NDAs in China for MCL and CLL/SLL (acceptance announced on August 26, 2018 and October 24, 2018; priority review granted to NDA in MCL announced on November 15, 2018, in CLL/SLL in January 14, 2019) MILESTONES AND • Presented MYD88WT cohort from Ph3 WM trial and update Phase 1 WM data at STATUS EHA • Presented updated Ph2 data in MCL at 15-ICML • Presented updated Ph2 data in CLL at 15-ICML 1 As of August 7, 2019. 21


 
Zanubrutinib Clinical Program Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) FILED PH1a PH1b PH2* PH2** PH3 R/R CLL/SLL (NDA Accepted) R/R MCL (NDA accepted) WM: zanubrutinib vs. ibrutinib, ASPEN TN CLL/SLL: zanubrutinib vs. BR, SEQUOIA zanubrutinib R/R CLL/SLL: zanubrutinib vs. ibrutinib, ALPINE (BGB-3111, BTK) Planned: 1L MCL: zanubrutinib + R vs. BR R/R MZL4 R/R WM R/R DLBCL B-cell malignancies R/R FL: zanubrutinib + GAZYVA® vs. GAZYVA® + GAZYVA® (CD20) B-cell malignancies + GAZYVA® + venetoclax (CD20 TN CLL/SLL + BCL2) + tislelizumab (PD-1) Hematological tumors + ME-401 (PI3K delta) R/R CLL/SLL or B-cell malignancies More than 1,450 patients3 treated with zanubrutinib across program, including combination trials. 1. Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. 2. Confirmatory clinical trials post approval are required for accelerated approvals. 3. as of August 7, 2019. 4. global study and potentially registration-enabling in certain countries; DLBCL: Diffuse Large B-cell Lymphoma 22


 
Zanubrutinib – Pharmacokinetics Profile zanubrutinib ibrutinib acalabrutinib Data from separate Ph1/2 trials^ 700 700 700 Ph3 Dose: Approved Doses: Ph3 Dose: • 160mg BID • 420mg QD for CLL/WM • 100mg BID 600 600 600 • 560mg QD for MCL/MZL 500 500 500 400 400 400 300 300 300 200 200 Adapted from 200 Adapted from Advani et al., JCO, 2013 Byrd et al., NEJM, 2016 100 100 100 Plasma Concentration (ng/mL) Concentration Plasma 0 0 0 0 6 12 18 24 0 6 12 18 24 0 6 12 18 24 Time post-dose (hours) Time post-dose (hours) 40mg QD 80mg QD Time post-dose (hours) 160mg QD 320mg QD 560mg QD 100mg QD • Cmax and AUC of zanubrutinib at 80mg QD appear to be similar to those of ibrutinib at 560mg • Free drug exposure of zanubrutinib at 40mg QD appears to be comparable to that of ibrutinib at 560mg • Distinct profile compared to acalabrutinib which has a short half-life (1 hour)2 and lower in vitro BTK inhibition IC501-4 • In vitro BTK inhibition IC50 relative to ibrutinib: 1.11 (zanubrutinib) and 3.42–7.23 (acalabrutinib) ^Cross-trial comparison Source: 1. Tam et al., ASH, 2015; 2. Byrd et al., NEJM, 2016; 3. Lannutti et al., AACR, 2015, 4. BeiGene data 23


 
Zanubrutinib Efficacy in WM Favorable response depth and durability Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response in zanubrutinib WM Overall TN RR Evaluable for 73 24 49 efficacy, n 95% CI Median Follow-up 23.9 mo 12.3 mo 24.8 mo Mod. 6th IWWM Response Criteria (IgM decreases only, and not extramedullary disease) Median Prior Lines 0 2 (1-8) of Therapy ORR 92% 96% 90% MRR 82% 87% 78% No. of patients at risk CR/VGPR1 42% 29% 49% PR 40% 58% 31% 1 One R/R patient achieved a CR, TN: treatment naïve; RR: relapsed refractory; Data cutoff 16 September 2018. Source: Trotman et al. EHA 2019 24


 
Ibrutinib Efficacy in WM Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response in WM ibrutinib Enrolled, n 63 100 free Median Time-on-Treatment 19.1 months - 90 80 Modified 3rd IWWM 70 Response Criteria (IgM only) 60 50 Median Prior Lines of Tx 2 (1-9) 40 Survival (%) 30 20 ORR, n (%) 57 (90%) 10 Probability Progression of Probability 0 MRR 46 (73%) VGPR 10 (16%) 0 3 6 9 12 15 18 21 24 27 30 No. of Subjects at Risk Month Median IgM Reduction (g/L) 35.2 to 8.8 (75%) 63 62 59 55 50 50 45 37 24 17 8 Median Hb Change (g/dl) 10.5 to 13.8 Source: Treon et al., NEJM, 2015 25


 
Zanubrutinib MYD88WT Data from Phase 3 Cohort 2 and Phase 1 Suggest Activity in Difficult-to-Treat WM Patients Best response, Phase 3 cohort 21 Phase 12 n (%) (n=26) (n=8) EHA 2019 ORR 21 (80.8) 7(87.5) MRR 14 (53.8) 5(62.5) CR / VGPR 6 (23.1)a,b 2(25.0) PR 8 (30.8) 3(37.5) MR 7 (26.9) 2(25.0) SD 4 (15.4) 1(12.5) PD 1 (3.8) 0 Study follow-up time, median (range) Months 12.2 (2.3 - 21.7) 24.3 (4.1-45.7)* Phase 1 safety summary for full WM n=77 cohort. Patients with an event n (%): Patients with ≥1 AE grade ≥3 40 (51.9); Patients with ≥1 serious AE 361 (46.8); AE leading to treatment discontinuation 82 (10.4); Fatal AE 5c (6.5). 1Includes serious AEs possibly related to zanubrutinib (n=6): hemothorax+pleural effusion+anemia (n=1), atrial fibrillation (n=1), colitis (n=1), febrile neutropenia (n=1), pneumonia (n=1), and cellulitis (n=1); septic arthritis relatedness was unknown. 2Abdominal sepsis (fatal), septic arthritis (fatal), worsening bronchiectasis (fatal), gastric adenocarcinoma (fatal), prostate adenocarcinoma, metastatic neuroendocrine carcinoma, acute myeloid leukemia, and breast cancer (each n=1). aOne patient achieved IgM complete response (normalized IgM and negative immunofixation since Cycle 11, with bulky extramedullary disease improving). bIncluding the patient who had CXCR4 frameshift mutation. 1 Dimopoulos et. al. EHA 2019, Data cut: Feb 28, 2019, Safety summary below; 2 Tam et al, EHA 2019; * Follow up for full WM cohort. 26


 
Zanubrutinib Efficacy in CLL/SLL Frequent and durable responses Overall Response Rate (ORR) Progression Free Survival (PFS) zanubrutinib TN CLL R/R CLL Total CLL n 16 50 66 free Median follow- - 7.6 14.0 10.5 up (mo) Best Response ORR 16 (100%) 46 (92%) 62 (94%) CR 1 (6%) 1 (2%) 2 (3%) Survival (%) Survival PR 13 (81%) 41 (82%) 54 (82%) PR-L 2 (13%) 4 (8%) 6 (9%) SD 0 3 (6%) 3 (5%) of ProgressionProbability Non-evaluable* 0 1 (2%) 1 (2%) No. of Subjects at Risk Month 66 66 62 53 45 37 27 25 19 11 9 6 4 *Discontinuation prior to first assessment Source: Seymour et al. 14-ICML 2017 (abstract 237) poster 27


 
Ibrutinib Efficacy in CLL/SLL Overall Response Rate (Relapsed / Refractory) Progression Free Survival (Relapsed / Refractory) n 85 free - Median FU (mo) 20.9 Best Response ORR 75 (88%) CR 2 (2%) PR 58 (68%) Survival PR-L 15 (18%) SD NR PD NR Probability Progression of Probability Overall Response Rate (Treatment-Naïve) Progression Free Survival (Treatment-Naïve) n 136 free Median FU (mo) 18.4 - Best Response ORR 117 (86%) CR 5 (4%) PR 107 (79%) PR-L 5 (4%) Survival (%) SD NR PD NR Probability Progression of Probability Source: For TN, Burger, et al New Engl J Med 2015. For R/R, Byrd, et al New Engl J Med 2013 28


 
Ibrutinib Discontinuation for toxicity or progression in CLL/SLL Treatment-Naïve (n=80) Relapsed/Refractory (n=536) Total (n=616) Median Follow-Up 14.5 months Total Treatment Discontinuation 19 (24%) 231 (43%) 250 (41%) Toxicity/Tolerability 12 (15%) 117 (22%) 129 (21%) CLL/SLL Progression 3 (4%) 49 (9%) 52 (8%) Transformation (RT or HD) 0 (0%) 10 (2%) 10 (2%) Death Unrelated to Treatment 1 (1%) 28 (5%) 29 (5%) Physician or Patient Decision 2 (2%) 15 (3%) 17 (3%) Transplant 0 (0%) 8 (1.5%) 8 (1%) Financial Concerns 0 (0%) 1 (0.2%) 1 (0.2%) Secondary Malignancy 1 (1%) 2 (0.5%) 3 (0.5%) Source: Mato ASH 2016 Note: at med follow-up 24.5 mos, 22% discontinuation rate with acalabrutinib in R/R CLL; 9% AE-related, 8% PD-related. Byrd ASH 2017. 29


 
Zanubrutinib Discontinuation for toxicity or progression in CLL/SLL is uncommon Treatment-Naïve (n=18) Relapsed/Refractory (n=51) Total (n=69) Median Follow-Up 10.3 months Total Treatment D/C 0 (0%) 2 (4%) 2 (3%) Toxicity/Tolerability 0 (0%) 1 (2%) 1 (1%) CLL/SLL Progression 0 (0%) 0 (0%) 0 (0%) Transformation (RT or HD) 0 (0%) 1 (2%) 1 (1%) Source: Seymour, ICML 2017 30


 
Zanubrutinib Safety and tolerability summary; Over 600-patient experience Adverse Events of Interest for BTK Inhibitors in Patients Treated with Zanubrutinib Zanubrutinib Zanubrutinib AE of Interest (All Causes)1 (Including Patients AE of Interest (All Causes)2 (Single Agent Only) Enrolled in Combo Studies) Patient Number N=641 Patient Number N=682 Mean Exposure Time 7.7 mo Median Exposure Time 13.4 mo Atrial Fibrillation 1.7% Atrial Fibrillation (Gr ≥3) 1.9% (0.6%) Major Hemorrhage 1.9% Major Hemorrhage* 2.5% (2.1%) Diarrhea (Gr ≥3) 19.4% (0.9%) • Very low rates of headache and hypertension (6.7% and 6.3%) • Concomitant use of anti-coagulants was allowed in these zanubrutinib trials • Low rate of treatment discontinuation for drug-related adverse events Major hemorrhage includes serious or grade ≥3 bleeding of any site, or central nervous system bleeding of any grade. Source: pooled safety analysis of ongoing zanubrutinib clinical trials; 1 Seymour, ICML 2017; 2 Tam et, al., EHA 2019 (Data cut-off dates: BGB-3111-207: Sept 2018; BGB-3111 AU-003, -1002, -205 and 210: Dec 2018; BGB-3111-206: Feb 2019) 31


 
Zanubrutinib Responses Across Additional B-Cell Malignancies MZL MCL MCL FL FL DLBCL China CSCO Source ASH 20171 ICML 20193 pivotal data ASH 20171 ASH 20171 20184 ASH20182 n 9 48 85 17 26 26 Follow-up 7.0 mo 16.7 mo 35.9 wk 7.8 mo 9.5 mo 4.2 mo (med) Prior Lines 2 (1-8) 1 (1-4) 2 (1-4) 2 (1-8) 3 (1-9) 2 (1-10) (med) ORR 78% 85% 84% 41% 42% 31% CR 0 29%* 59%** 18% 8% 15% VGPR -- -- -- -- -- -- PR/PR-L 78% 56% 25% 24% 35% 15% MR -- -- -- -- -- -- • Despite relatively early follow-up, responses were observed in multiple B-cell malignancies • Consistency across tumor types suggests that zanubrutinib is a highly active BTK inhibitor * CT response assessment; ** PET-CT response assessment. Source: 1. Tam et. al., ASH 2017; 2. Song et al., ICML 2019; 3. Tam et al., ICML 2019; 4. Song et. al., CSCO 2018 32


 
Zanubrutinib Plus Obinutuzumab Combination in Follicular Lymphoma Data from separate trials Zanubrutinib + FL Zanubrutinib Ibrutinib Obinutuzumab Idelalisib Obinutuzumab Source ICML 20191 ASH 20172 ASH 20163 JCO 20134 NEJM 20145 n 36 17 110 34 72 prior alkylator and CD20, prior alkylator and CD20, median 2 prior lines of mixed rituximab-sensitive alkylator and rituximab- Population mixed rituximab-sensitive last response <12 therapy, range 1-8 and -refractory refractory relapse and -refractory months Follow-up (med) 20.1 mo 7.8 mo 27.7 mo 33.7 mo NR ORR 72% 41% 21% 50% 54% CR 39% 18% 11% 18%6 6% • Overall response rate and complete responses to date compare favorably to those achieved with respective single-agents and recently approved therapies Notes: data on slide are cross-trial comparison; Source: 1. Tam et al., ICML 2019; 2. Tam et al., ASH (abstract 152), 2017; 3. Gopal, et al ASH 2016; 4. Salles, et al J Clin Oncol 2013; 5. Gopal, et al N Engl J Med 2014; 6. 18% represents complete response rate in the 40 indolent lymphoma patient population that include 34 FL patients. 33


 
Ongoing Global Phase 3 Studies ASPEN Zanubrutinib vs. Ibrutinib in WM Cohort 1: R/R or TN* WM with MYD88L265P mutation Arm A *TN must be unsuitable for standard chemoimmunotherapy Zanubrutinib 160 mg BID until PD MYD88MUT WM patients R (N=201, 164 R/R) 1:1 Arm B Ibrutinib 420mg QD until PD Primary endpoint: CR or VGPR in R/R and all enrolled patients Cohort 2: WM with wild type MYD88 Arm C MYD88WT WM patients Zanubrutinib (N = 26) 160 mg BID until PD WM=Waldenstrom’s macroglobulinemia, BID=twice daily, CR=complete response, MUT=mutation, PD=progressive disease, QD=once daily, R=randomization, R/R=relapsed/refractory, TN=treatment naïve, VGPR=very good partial response, WT=wild type. This study is registered at ClinicalTrials.gov (NCT03053440) 34


 
Ongoing Global Phase 3 Studies SEQUOIA and ALPINE Zanubrutinib vs. BR in 1L CLL/SLL Phase 3 Zanubrutinib Vs Ibrutinib in R/R CLL/SLL Cohort 1: Non–17p del TN CLL Arm A Must be not suitable for FCR Zanubrutinib Relapsed/Refractory CLL/SLL 160 mg BID until PD Arm A Previously (received ≥ 1 prior treatments) untreated R Zanubrutinib CLL patients 1:1 160mg BID (N=420) (n = 200) Arm B R/R CLL/SLL ≥ 1 prior Bendamustine Primary endpoint: PFS treatment R + Rituximab (BR) 1:1 × 6 cycles (N=400) Arm B Ibrutinib 420mg QD Cohort 2: 17p del TN CLL (n = 200) Previously untreated Arm C Primary Endpoint: ORR (non-inferiority and superiority) 17p del CLL patients Zanubrutinib (N=110) 160 mg BID until PD 1L=first-line treatment, BID=twice daily, CLL=chronic lymphocytic leukemia, del=deleted, FCR=fludarabine, cyclophosphamide, and rituximab, ORR=overall response rate, PD=progressive disease, PFS=progression-free survival, QD=once daily, R=randomized, SLL=small lymphocytic lymphoma, TN=treatment naïve. These studies are registered at ClinicalTrials.gov (NCT03734016) and (NCT03336333). 35


 
Ongoing Pivotal Study Phase 2 Zanubrutinib + Obinutuzumab vs Obinutuzumab in R/R FL Relapsed/Refractory FL (received ≥2 prior treatments*) Arm A Zanubrutinib 160 QD + Obinutuzumab X 6 cycles then q 8 wks until PD Grade 1, 2, or 3a FL (n = 140) patients R 2:1 (N=210) Arm B Obinutuzumab X 6 cycles then q 8 wks until PD (n = 70) Primary Endpoint: ORR CLL/SLL=chronic lymphocytic leukemia/small lymphocytic lymphoma, FL=follicular lymphoma, ORR=overall response rate, PD=progressive disease, PFS=progression-free survival, QD=once daily, R=randomization. *Must have received prior treatment with rituximab and an alkylator; relapsed <12 months from end of last treatment OR refractory to last treatment. This study is registered at ClinicalTrials.gov (NCT03332017). 36


 
Zanubrutinib Potentially Addresses Areas of Need for Patients Treated with BTK Inhibitors Efficacy • Complete and sustained target inhibition may result in better response quality • We are testing this hypothesis in Phase 3 head-to-head trials against ibrutinib in WM and CLL Tolerability • In “real-world” ibrutinib use in CLL, not only acute/ serious toxicities (atrial fibrillation, serious bleeding), but cumulative tolerability issues (myalgia, arthralgia, hypertension) are frequently treatment-limiting • Zanubrutinib to date has been associated with low rates of toxicity-related discontinuations and cumulative “off-target” toxicities1 Drug-Drug Interactions • Based on drug interaction studies, co-administration with strong CYP3A inhibitors is permitted • Includes important agents in management of leukemia/ lymphoma patients, such as azole anti-fungals • Co-administration of proton pump inhibitor (PPIs) or other Acid-Reducing Agents (ARA) does not affect zanubrutinib exposure based on PK models • Patients have been allowed to receive anticoagulants and and aspirin on zanubrutinib single arm trials 1. Tam et. al. EHA 2019 37


 
• Tislelizumab is a PD-1 checkpoint inhibitor with distinct molecular structure and an engineered Fc region; believed to minimize potentially negative interactions with other immune cells1 Overview of • Pivotal data in lead indication: 87% ORR (63% CR) in R/R cHL • Broad development in Asia-prevalent cancers Tislelizumab • 14 ongoing and soon-to-start Ph. 3 or potentially registration-enabling trials: 4 in lung OVERVIEW cancer, 2 in liver cancer, 3 in esophageal cancer, 1 in gastric cancer, 2 in bladder (BGB-A317) cancer, 1 in nasopharyngeal cancer, and 1 in MSI-H or dMMR solid tumors Broad integrated global and • Aimed to support broad label and label-based reimbursement China development program • Strong manufacturing capabilities with emphasis on quality • Manufacturing process and initial capacity developed by Boehringer Ingelheim • BeiGene’s state-of-the-art 24,000L facility in Guangzhou expected to become operational in 2019 CLINICAL • Clinical experience in more than 2,950 patients2 enrolled over 3 years has DATA demonstrated encouraging clinical activity and generally well-tolerated safety profile • Broad development program designed to capture worldwide commercial opportunities • Two China accelerated approval trials : cHL (priority) and urothelial cancer (priority) DEVELOPMENT • Initiated global Ph2 trials in NK/T cell lymphomas and 2L/3L HCC, China pivotal Ph2 in MSI-H or dMMR solid tumors, 5 global Ph3 trials in 1L GC, 1L and 2L ESCC, 1L HCC PLAN and 2L NSCLC; 6 Ph3 trials in 1L non-sq and sq NSCLC, 1L SCLC, 1L UC, localized ESCC and 1L NPC in China • Combinations ongoing with BeiGene’s PARP, BTK, PD-L1 and TIM3 inhibitors • Additional Ph3 trials planned • Submitted first NDA in China for cHL (priority review granted November 15, 2018) and sNDA for UC (priority review announced July 8, 2019) MILESTONES AND • Presented data on long term exposure and structure/mechanism at AACR 2019 STATUS • Presented data on use in NPC at ASCO 2019 • Presented China cHL pivotal trial data at EHA 2019 Source: 1. Dahan et al., Cancer Cell, 2015; Arlauckas et al., Sci. Transl. Med., 2017; 2. as of June 20, 2019 38


 
Tislelizumab Clinical Program Broad development for Asia-prevalent cancers Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) TUMOR FILED PH1a PH1b PH2* PH2** PH3 R/R cHL (NDA accepted) Heme R/R NK/T-cell lymphoma 2L+ UC (NDA accepted) Bladder 1L UC 2L NSCLC 1L non-squamous NSCLC Lung 1L squamous NSCLC 1L SCLC tislelizumab 1L HCC (PD-1) Liver 2L/3L HCC2 2L ESCC Esophageal 1L ESCC Localized ESCC Gastric 1L GC 1L NPC MSI-H or dMMR solid tumors Solid tumors + pamiparib (PARP) Solid tumors + zanubrutinib(BTK) Hematologic tumors + sitravatinib(multi-kinase) NSCLC, RCC, OC, melanoma^ + sitravatinib(multi-kinase) HCC, GC^ + A333(PD-L1) Solid tumors + A425(TIM3) Solid tumors • More than 2,950 patients1 enrolled over 3 years across tislelizumab program, including combination trials • Broad development global program with additional Ph3/potential registration-enabling trials planned in lung, gastric, liver, and esophageal cancers *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or 3 clinical trials. **Confirmatory clinical trials post-approval are required for accelerated approvals. ^Trials conducted in the APAC region. 1. as of June 2019. 2. global study and potentially registration-enabling in certain countries 39


 
Tislelizumab’s Lack of FcγR Binding Is Designed to Prevent Macrophage-Mediated T-Cell Clearance We believe the different FcγR design may have meaningful differences in the clinic Antibody-Dependent Cellular Phagocytosis Tislelizumab Differential Preclinical Efficacy in in vivo Mouse Tumor Model Based on FcγR Binding 1600 Vehicle T cell Nivolumab Macrophage Pembrolizumab TislelizumabBGB-A317 10mg/kg10mg/kg  1400 Nivo surrogate Fc RI SEM) Nivolumab 10mg/kg - ± + 3 1200 Pembrolizumab 10mg/kg 1000 Dosed Weekly 800 *P<0.05 600 Tislelizumab has Minimal FcγRI Binding Thus Abrogating ADCP Activity 400 200 FcRI Tislelizumab 0 - + MeanTumor Volume (mm 6 11 16 21 26 Treatment Days + • Tislelizumab was specifically engineered to minimize binding to FcγR on macrophages, thereby CD8 T cell Macrophage abrogating antibody-dependent cellular phagocytosis (ADCP), a potential mechanism of T-cell clearance CD4+ T cell Monocyte MDSC • Hypothesis supported by literature: Dahan et al. reported that FcγR engagement compromises the Dendritic cell anti-tumor activity of anti-PD-1 Abs; Arlauckas et al. showed in a mouse model that anti-PD-1 Abs could be transferred from PD-1+ T cells to macrophages in FcγR-dependent manner FcγRI=Fc gamma receptor-1, MDSC=myeloid-derived suppressor cell; Source: Dahan et al., Cancer Cell, 2015; Arlauckas et al., Sci. Transl. Med., 2017 40


 
Tislelizumab China cHL Pivotal Trial Data Deep and frequent responses observed in both transplant-ineligible patients and patients who failed transplant Baseline Characteristics Total (N=70) Age (years), median (range) 32.5 (18, 69) Age group <65 / 65-74 years, n (%) 66 (94.3) / 4 (5.7) 40 (57.1) / 30 IRC Dataset cHL Sex, male / female, n (%) (42.9) Enrolled Patients N=70 Time since first diagnosis of cHL (months), median (range) 25.33 (4.6, 262.3) Stage IV at study entry, n (%) 42 (60.0) Median Follow-up 13.9 months Bulky disease*, n (%) 8 (11.4) Bone marrow involvement, n (%) 22 (31.4) Prior Lines, Median (range) 3 (2-11) B-symptom(s), n (%) 26 (37.1) Ineligible for prior ASCT†, n (%) ORR 87.1% Failure to achieve an objective response to salvage 53 (75.7) chemotherapy CR 62.9% Inadequate stem cell collection or unable to collect stem cells 2 (2.9) PR 24.3% Co-morbidities 2 (2.9) Prior lines of systemic therapy, median (range) 3 (2-11) Type of prior therapy, n (%) Chemotherapy 70 (100.0) Radiotherapy 21 (30.0) ASCT 13 (18.6) Immunotherapy‡ 15 (21.4) Brentuximab vedotin 4 (5.7) -- Majority of transplant-ineligible patients had failed to respond to salvage chemotherapy Source: Song et al., EHA 2019. *Mediastinal mass ratio of 0.33 or size of any single node/nodal mass ≥10 cm in diameter; ‡All received ≥2 prior regimens. 41


 
Summary of Tislelizumab Adverse Events cHL pivotal trial Summary of Treatment-Emergent TEAEs in ≥10% of Patients and Grade ≥3 TEAEs in ≥2 Adverse Events Patients Regardless of Causality Event, n (%) N=70 Pyrexia Grade ≥3 TEAE 21 (30) Hypothyroidism Serious TEAE 12* (17.1) Weight increased TEAE leading to treatment discontinuation 4† (5.7) Upper respiratory tract infection TEAE leading to death 0 (0.0) Cough Immune-related (ir) TEAEs (by aggregate category) Pruritus ≥1 irTEAE 27 (36.8) White blood cell count decreased Thyroid disorder 16 (22.9) Gr 1-2 Gr ≥3 Alanine aminotransferase increased Pneumonitis 5 (7.1) Neutrophil count decreased Skin adverse reactions 6 (8.6) Myositis/rhabdomyolysis/cardiomyopathy‡ 1 (1.4) Rash Nephritis and renal dysfunction 1 (1.4) Diarrhea Other immune-related reactions (lipase Anemia 1 (1.4) increased Pneumonitis Source: Song et al., EHA 2019 0% 10% 20% 30% 40% 50% 60% Data cut: Nov 26, 2018; TEAE, treatment-emergent adverse events by individual preferred term. *SAEs in 11 of the 12 patients determined to be possibly related to tislelizumab Patients (%) †Pneumonitis (n=2), focal segmental glomerulosclerosis (n=1), organizing pneumonia (n=1) ‡Blood creatine phosphokinase increased 42


 
Tislelizumab China UC Pivotal Trial Data Activity in previously treated patients UC Enrolled Patients/evaluable N=113/104 Median Follow-up 8 months ORR 23.1% CR 7.7% PR 15.4% • IRC assessed • Frequency and severity of adverse events were generally consistent with the previously reported Phase 1/2 safety and tolerability data for tislelizumab, or, in the case of certain immune-related adverse events, consistent with previous reports of other PD-1 antibodies. Full results of the study are planned to be presented at an upcoming medical conference. Source: BeiGene press release May 30, 2019 43


 
Tislelizumab Response Data in Disease-Specific Cohorts Gastric Esophageal Head & Neck Ovarian Hepatocellular Urothelial MSI-H / Tumor Type NSCLC NPC Cancer Cancer SCC Cancer Carcinoma Cancer dMMR ESMO-IO Source ESMO-IO 20181 ESMO-IO 20181 ESMO 20172 ESMO 20173 ESMO-IO 20181 ESMO-IO 20181 CSCO 20185 ASCO 20196 20184 Median Treatment 104 days 71 days 4.1 mo 2.2 mo 7.5 mo -- -- -- -- Duration (30-339) (29-540) (0.7-26.3) (0.69-11.1) (2.1-15.8) Median Follow-up 4.9 mo 5.2 mo 10.8 mo 11.2 mo 4.4 mo 11.7 mo -- -- -- Time (0.9-25.4) (0.2-22.7) (0.7-31.6) (0.5-25.9) (0.1-10.7) (4.9-15.7) Median Duration of 18.7 mo 8.5 mo NR -- -- 15.7 mo NR -- 8.3 mo Response (6.2-18.7) Evaluable Patients N=54 N=54 N=17 N=50 N=49 N=17 N=46 N=14 N=21 CR (Confirmed) -- 1 -- -- -- 1 -- -- -- PR 7 5 3 2 6 4 6 4 9 SD 9 14 6 20 19 3 23 4 9 Patients Remaining 3 3 3 6 5 2 7 9 9 on Treatment* • Objective responses observed with limited follow-up in multiple disease-specific cohorts. NR = Not reached Sources:1. Ph1A/1B data as of August 31, 2018, presented at the ESMO Immuno-Oncology 2018 Congress (Sanjeev et al); 2. Ph1 data as of June 8, 2017, presented at the ESMO 2017 Congress (Horvath et al, Abstract 389P); 3. Ph1 data as of June 8, 2017, presented at the ESMO 2017 Congress (Meniawy et al, Abstract 388P); 4. Ph1/2 data as of August 31, 2018, presented at the ESMO Immuno-Oncology 2018 Congress (Shahneen et al); 5. Ph1 data as of May 11, 2018, presented at CSCO 2018; 6. Ph1/2 as of December 1, 2018, presented at ASCO 2019 (Wang et al); * At time of data cutoff. 44


 
Tislelizumab Phase 1 Common AEs in ≥ 10% of Patients Phase 1a Phase 1b Total System Organ Class Preferred Term N=116 N=335 N=451 n (%) n (%) n (%) Patients with at least one TEAE 114 (25.3) 322 (71.4) 436 (96.7) Fatigue 47 (10.4) 78 (17.3) 125 (27.7) Nausea 41 (9.1) 68 (15.1) 109 (24.2) Decreased appetite 19 (4.2) 71 (15.7) 90 (20.0) Diarrhea 32 (7.1) 49 (10.9) 81 (18.0) Constipation 26 (5.8) 50 (11.1) 76 (16.9) Abdominal pain 26 (5.8) 38 (8.4) 64 (14.2) Vomiting 20 (4.4) 43 (9.5) 63 (14.0) Back pain 22 (4.9) 40 (8.9) 62 (13.7) Cough 15 (3.3) 45 (10.0) 60 (13.3) Rash 23 (5.1) 37 (8.2) 60 (13.3) Dyspnea 12 (2.7) 33 (7.3) 45 (10.0) All grades, regardless of causality; Data cut-off 27 April 2018; 6 months after Last Patient Enrolled; Source: BGB-A317 IB v6.0 Of the 451 total patients in the Safety Population for Study BGB A317_001, 203 (45.0%) experienced at least 1 Grade 3 or higher TEAE. The most commonly occurring Grade 3 or higher TEAEs (≥ 2%; 9 or more patients overall incidence) were pneumonia (22 patients, 4.9%), anemia (18 patients, 3.2%), and hypokalemia (9 patients, 2.0%). 45


 
Tislelizumab Chemotherapy Combination Data in Lung Cancers Non-Sq Sq Sq SCLC Tislelizumab + Tislelizumab + Tislelizumab + Tislelizumab + Total Responses pemetrexed + paclitaxel + gemcitabine + etoposide + (N=54) platinum (n=16) platinum (n=15) platinum (n=6) platinum (n=17) BOR, n (%) CR 0 0 0 0 0 PR 5 (31.3) 12 (80.0) 4 (66.7) 8 (47.1) 29 (53.7) UPR 4 (25.0) 0 0 6 (35.5) 10 (18.5) SD 5 (31.3) 2 (13.3) 1 (16.7) 1 (5.9) 9 (16.7) PD 2 (12.5) 0 0 1 (5.9) 3 (5.6) Missing 0 1 (6.7) 1 (16.7) 1 (5.9) 3 (5.6) ORR % 56.3 80.0 66.7 82.3 72.2 ORR confirmed % 31.3 80.0 66.7 47.1 53.7 Abbreviations: BOR, best overall response; CR, complete response; Sq, squamous; PD, progressive disease; PR, partial response; SCLC, small cell lung cancer; SD, stable disease; UPR, unconfirmed partial response. Source: CSCO 2018 Wang et al Abstract 450 AEs were considered manageable and reversible, with chemotherapy dose modifications or tislelizumab dose holds, except for one fatal event of myocarditis/myositis (onset of AEs on Day 10 and died on Day 19 of treatment administration). Five patients (9.3%) experienced at least one grade ≥3 AE (polymyositis, dyspnea, rhabdomyolysis, myocarditis/myositis, and myasthenia gravis) that were considered to be possibly related to tislelizumab. Immune-related AEs (irAEs) occurred in 13 patients (24%) and included hypothyroidism (n=3), decreased tri-iodothyronine (n=2), hyperthyroidism (n=2), pneumonitis (n=2), pyrexia (n=2), and rash (n=2). 46


 
• Highly selective PARP1 and PARP2 inhibitor with potential brain OVERVIEW Overview of penetration and strong PARP trapping activity in preclinical studies Pamiparib • Ph1/2 data demonstrated pamiparib was generally well-tolerated with (BGB-290) CLINICAL promising anti-tumor activity in ovarian cancer Selective Inhibitor of DATA • Low incidence of hematological toxicities (e.g. thrombocytopenia), no PARP1 and PARP2 liver toxicity • Two ongoing global Ph1b/2 trials with chemotherapy: combination with radiation therapy and temozolomide (TMZ) in glioblastoma or combination with TMZ in advanced solid tumors • Enrollment complete in China pivotal Ph2 trial in patients with gBRCA+ ovarian cancer DEVELOPMENT • Enrollment complete in Ph3 trial in China as maintenance therapy in PLAN patients with platinum-sensitive recurrent ovarian cancer • Enrolling patients for a global Ph3 trial in gastric cancer as maintenance therapy • Internal combination with tislelizumab: preliminary anti-tumor activity observed in multiple solid tumors • Presented updated Ph1 data in ovarian cancer at AACR 2018 MILESTONES AND • Presented updated Ph1/2 combination data in solid tumours at ESMO STATUS 2018 • Presented updated Ph1/2 combination data in GBM at SNO 2018 47


 
Pamiparib Clinical Program Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) PH1a PH1b PH2* PH2** PH3 3L gBRCA+ OC 2L plat-sensitive OC maintenance pamiparib (BGB-290, PARP) 1L plat-sensitive GC maintenance Solid tumors + TMZ (Chemo) Solid tumors + RT/TMZ (RT/Chemo) Solid tumors + tislelizumab (PD-1) Solid tumors • Two ongoing global Ph1b/2 trials with chemotherapy: combination with radiation therapy and temozolomide (TMZ) in glioblastoma or combination with TMZ in advanced solid tumors • Internal combination with tislelizumab: preliminary anti-tumor activity observed in multiple solid tumors *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or 3 clinical trials. **Confirmatory clinical trials post-approval are required for accelerated approvals. 48


 
Pamiparib100 Monotherapy Phase 1/2 Data 80 Promising activity and generally well-tolerated 60 Best Change from Baseline in Target Lesions in Epithelial 40 Summary of Adverse Events from Across the Ph1/2 Trial 100 Ovarian Cancer and Other Associated Tumors BRCA+ 2080 Ph1 Ph1 Total BRCA-WT BRCA Unknown (n=45) (n=23) (N=68) 600 Platinum Resistant Patient Reporting ≥1 TEAE 45 (100%) 22 (95.7%) 67 (98.5%) 40 ++ + + Platinum Sensitive (20) + Ongoing Patients 20 ++ Patients Reporting ≥1 Treatment-Related TEAE 34 (75.6%) 19 (82.6%) 53 (77.9%) + (40)0 Patients Reporting ≥1 Serious TEAE 25 (55.6%) 6 (26.1%) 31 (45.6%) ++ + + + (20) ++ Best Response in Target (%) Lesionsin ResponseBest (60) + Patients who Experienced ≥1 DLT 4 (8.9%) NA 4 (5.9%) + (40) + (80) + TEAEs Leading to Discontinuation 4 (8.9%) 0 4 (5.9%) Best Response in Target (%) Lesionsin ResponseBest (60) + + + (100)(80) TRAEs Occurring in ≥10% of All Patients (N=68) Grade 1 or 2 Grade ≥3 Total + + + (100) Nausea 36 (52.9%) 2 (2.9%) 38 (55.9%) (120) P1: Ph1; P2: Ph2. + + (120) Vomiting 13 (9.1%) 1 (1.5%) 14 (20.6%) 5mg 5mg 10 mg 10 mg 80 mg 10 mg 10 mg 80 mg 20 mg 80 mg 80 mg 80 mg 40 mg 20 mg 20 mg 40 mg 80 2.5 mg 2.5 5mg 5mg 120mg 120mg 10 mg 10 mg 80 mg 10 mg 10 mg 80 mg 20 mg 80 mg 80 mg 80 mg 40 mg 20 mg 20 mg 40 mg 80 2.5 mg 2.5 120mg 120mg 60 mg-P1 60 mg-P2 60 mg-P1 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P1 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P1 60 mg-P2 60 60 mg-P2 60 Diarrhea 12 (17.6%) 2 (2.9%) 14 (20.6%) 60 mg-P2 60 mg-P1 60 mg-P2 60 mg-P1 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P1 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P2 60 mg-P1 60 mg-P2 60 Best Overall Response, n (%) Total (N=39) Fatigue 25 (36.8%) 2 (2.9%) 27 (39.7%) Overall Response rate per RECIST v1.1 (CR+PR) 13 (33.3%) Anemia 10 (14.7%) 7 (10.3%) 17 (25.0%) Complete Response (CR) 3 (7.7%) Neutropenia/Neutrophil Count Decrease 2 (92.9%) 6 (8.8%) 8 (11.8%) Partial Response (PR) 10 (25.6%) Stable Disease (SD) 21 (53.8%) Decreased Appetite 10 (14.7%) 0 10 (14.7%) Clinical Benefit Rate (CR+PR+SD with ≥24 Weeks Duration) 18 (46.2%) All date are presented as n (%). Overall response rates by BRCA status were 43.5% (n=10/23; BRCA+), 15.4% Abbreviations: DLT: dose-limiting toxicity; NA: not applicable; TEAE: treatment-emergent (n=2/13; BRCA-WT), and 33.3% (n=1/3; BRCA unknown) adverse event; TRAE: treatment-related adverse event. Source: Ph1/2 data as of June 1, 2017, presented at the ESMO 2017 meeting (Lickliter et al) 49


 
Tislelizumab/Pamiparib Combination Escalation Data Generally well-tolerated with preliminary anti-tumor activity in multiple tumor types • Ovarian or fallopian tube cancer patients (n=29) had best responses of CR (1), PR (2 confirmed, 5 unconfirmed), and SD (7). Breast cancer patients (n=2) had 1 confirmed PR. A. Change in Tumor Volume by Baseline Tumor Type Pancreatic cancer patients (n=3) had best responses of PR (1 unconfirmed) and SD (2). Uterine cancer patient (n=1) had an unconfirmed PR. SD was observed in 1 of 3 patients with prostate cancer and the 1 patient with bile duct cancer. Additional tumor types enrolled included bladder, cervical, lung, and peripheral nerve sheath cancer (n=1 each) • Grade 3-4 AEs related to tislelizumab in >1 :1 bile duct, 1 peripheral nerve sheath tumor patients were AI hepatitis/hepatitis (12%) and ALT inc. (5%); related to pamiparib in >1 patients were anemia (14%), and ALT inc., AST inc., fatigue, and nausea (5% each) • Liver-related AEs regardless of causality occurred in 12 patients (gr. 3-4 in 8 patients: 5 hepatitis, 3 including ALT and/or AST); all Best Overall Responses Included 1 CR, 3 reversible with/without corticosteroids Confirmed PRs and 7 Unconfirmed PRs • Treatment-related hepatic AEs have been reported in 1 of 300 patients treated with tislelizumab monotherapy and 0 of 65 patients treated with pamiparib monotherapy in separate ongoing trials Source: Dose escalation data as of March 31, 2017, presented at ASCO 2017 (Friedlander et al) 50


 
Thank you 51