BGNE-Investor-Deck - Q1 2023 - Clean6.8.23
BGNE-Investor-Deck - Q1 2023 - Clean6.8.23
BGNE-Investor-Deck - Q1 2023 - Clean6.8.23
May 4, 2023
Disclosures
Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date
hereof, may constitute forward-looking statements. Examples of such forward-looking statements include statements regarding BeiGene’s research, discovery, and pre-
clinical and early-stage clinical programs and plans; recent clinical data for BeiGene’s product candidates and approvals of its medicines; the conduct of late-stage clinical
trials and expected data readouts; additional planned commercial product launches; and the advancement of and anticipated clinical development, regulatory milestones
and commercialization of BeiGene’s medicines and drug candidates. 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 technology and medicines; 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 and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical
development, commercial, regulatory and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent
periodic report filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the SEC. All
information in this presentation is as of the date of this presentation, and BeiGene undertakes no duty to update such information unless required by law.
Some of the clinical data in this presentation relating to BeiGene’s investigational drug candidates is from pre-clinical studies or early phase, single-arm clinical 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 unless specified in the trial protocol. BeiGene is still conducting pre-clinical studies and
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 contain 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
$1.3B in annual product revenue
~40 offices, 9,400+ colleagues 3,500+ global commercial team
$3.8B cash balance*
on 5 continents 16 approved products
@BeiGeneGlobal BeiGene 60+ pre-clinical programs, ~50 assets in clinical and ~20 industry
the majority with commercial stages collaborations
first-in-class potential
Numbers as of March 2023
3
Building Strategic and Sustainable Competitive Advantages
Innovation with speed and lower cost to better serve patients around the world
1 2 3 4 5
• 950+ research team with • Cost and time-advantaged • 3,300+ in China including • Cornerstone commercial • 500+ people in 3 mfg.
entrepreneurial culture clin dev medical affairs, medicines with huge sites; In-house capabilities
competitively positioned, global potential, BTKi and bring cost, agility to
• 2,300 clinical development
• Heme, solid tumor and I&I science-based leadership PD-1 internal and external
colleagues
franchise including 60+ programs
preclinical programs, • Global development, • 500+ competitive footprint • Complemented by deep Suzhou
~50% with first-in-class Asia inclusive (45+ in North America & Europe and innovative clinical
Guangzhou
potential geographies) portfolio
• Expanding presence in Hopewell, NJ
• ~50 assets in clin & comm
• Focus on innovative multiple countries/ regions,
stage • Capability to manufacture
modalities in oncology and including underserved
both small molecules and
I&I • 20,000+ subjects enrolled areas
biologics
4
T R A N S L AT I N G S C I E N C E T O I M P R O V E A C C E S S A N D
Trials Span
45
A F F O R D A B I L I T Y B Y C H A L L E N G I N G T H E S TAT U S Q U O
+
Enrollment by Geography
Countries
& Regions 16%
20K
8%
+ 14%
53%
9%
People Enrolled in
110
Clinical Trials
+
China Americas Australia APAC-ex Australia EMEA
5
Positioned to Deliver on Significant Revenue Growth
Key Drivers
Global Product Revenue
U.S. 410,291 • Significant revenue growth driven
BRUKINSA
approval in CLL
by BRUKINSA
Dollars in thousands
6
Differentiated Biological Hypothesis and First-in-Class
Programs Based on Deep Oncology Insights from the Bench
Differentiated
BTK - Higher exposure, better selectivity, targeted inhibition biological hypothesis
Potential first-in-class,
PD-1 - Fc function silenced or first wave
2024+
2021-2023 10 New
Prolific First Decade
Molecules
HPK-1 BTK-Targeted CDAC
in the Clinic
TYK2
2016 - 2020 CEA x 4-1BB bispecific Expected
SMAC mimetic
Annually
TIM-3
2013 - 2015 4+ NMEs in 2023
TIGIT OX40
BRAF PARP* SM and mAb: 20+ New CDAC: Total 7+
BCL-2 PI3Kd
programs programs
BTK* PD-1*
ADC: 10+ TAAs BsAb/TsAb: 10 new
programs
Pro-Cytokine
mRNA Therapy
Cell therapy: CAR-NK
and more
*Approved 2019-2021
SM, Small Molecule; mAb, Monoclonal Antibody; ADC, Antibody Drug Conjugate; TAA, Tumor Associated Antigen; CDAC, Chimeric Degradation Activating 8
Compound (targeted protein degradation); BsAb, Bispecific Antibody; TsAb, Trispecific Antibody; CAR-NK, Chimeric Antigen Receptor-Natural Killer Cell, NME, New Molecular Entity
Oncology Research Expertise With Proven Track Record
of Innovation
Prolific in first decade and expected to be more productive • Low-cost and high-efficiency
in the years ahead
• Quality validated by clinical results 1000
• 60+ preclinical programs, ~50% with first-in-class or best-in- and global partnerships
class potential 900
• Expertise across multiple 800
• A burst of new clinical molecules expected in the next few
scientific disciplines
years, 10+ INDs per year expected starting in 2024 700
# of scientists
Expanding new capabilities and talent base with intent to 600
expand into the US 500
• Invest in new modalities including CDAC, BsAb / TsAb, 400
ADC, NK cell therapies, pro-cytokines
300
• Investing in new capabilities and driving efficiencies through
200
portfolio management
100
Quality validated by clinical results, global approvals, and
major pharma/biotech partnerships that have generated $1.4bn 0
2011 - 2015 2015 - 2019 2021 2022
collaboration fees
9
BRUKINSA Superiority to Ibrutinib Core to Hematology Franchise*
*Superior to ibrutinib in ORR & PFS for R/R CLL in ALPINE trial.
10
ALPINE: BRUKINSA PFS & ORR Superiority to Ibrutinib in R/R
CLL/SLL 2022 ASH Late Breaker & Concurrent NEJM Manuscript
BRUKINSA PFS by IRC Significantly Superior to Ibrutinib BRUKINSA Improved PFS in Patients with del(17p)/TP53mut
Data cutoff: 8 Aug 2022. Brown J et al. NEJM 2022. DOI: 10.1056/NEJMoa2211582
11
BRUKINSA: Establishing Leadership with Best-In-Class BTKi
($MM)
BRUKINSA Global Revenues • BTKi is the cornerstone therapy and the standard
of care for non-Hodgkin’s lymphoma
$250
$211
$200 $176 • The BTKi market was $8.4bn in 2022
$155
$150 $129 • CLL is the largest indication for BTKi, accounting
$104
$100
$88 for 80% of the market
$66
$42
$50
$7 $16 $18 $22 • Given its best-in-class profile, as demonstrated in
$0 head-to-head clinical trials for CLL, BRUKINSA is
Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 well positioned to become the leading BTKi
'20 '20 '20 '21 '21 '21 '21 '22 '22 '22 '22 '23
1 Mechanistically
differentiated, Fc-γ
2 Realizing Impact from
favorable labels and 3 Broad clinical program, including:
• 21 registration-enabling clinical
NRDL coverage in China trials
receptor sparing, and
• Achieved #1 value market
multiple share in China despite late • 12,100+ subjects enrolled in
combinations under to market; future filings in clinical trials in 30+ countries and
study
ROW regions, with 4,000+ from outside
of China
4 Commitment to
quality, global 5 Future global approvals in more
indications, and combinations
Collaboration with
Novartis
manufacturing • 10 approved indications in China: R/R cHL, R/R UC, 1L • Acceleration of global
Sq, 1L non-Sq NSCLC, 2L/3L HCC and 2L/3L NSCLC, development in Novartis
• Built state-of-the-art facility 2L/3L MSI-H or dMMR solid tumors, 2L ESCC, 1L NPC,
in Guangzhou, building 1L G/GEJ territory: North America,
toward 200,000L of Europe, and Japan
• 1 filing in the U.S.: 2L ESCC*, 2 filings in Europe:
biologics capacity NSCLC & ESCC, filings in Australia and UK in NSCLC • Further explore
• Collaboration with one of & 2L ESCC, and 2 in China in 1L ESCC & 1L HCC. combination opportunities
the world’s leading • 11 other pivotal or potentially registration-enabling with Novartis pipeline
biologics manufacturers studies ongoing; compelling breadth of combinations
e.g., ociperlimab, sitravatinib, zanidatamab, etc. • Eligible for up to $1.5 billion
25 global biologics
manufacturing • IO combination trials underway to drive success collaboration revenue from
approvals Novartis
13
*Subject to regulatory inspections which have been delayed due to COVID-19 travel restrictions. cHL = classical Hodgkin’s lymphoma; CR = complete response; dMMR = Deficient Mismatch Repair; ESCC = Esophageal Squamous-Cell Carcinoma; HCC = hepato-
cellular carcinoma; MSI-H = microsatellite instability-high; NRDL = China National Reimbursement Drug List; non-Sq: non-squamous; NPC = Nasopharyngeal carcinoma; NSCLC = non-small cell lung cancer; R/R = relapsed/refractory; UC = urothelial carcinoma
BeiGene’s Internal Discovery Pipeline
Late-Stage P1 P2* P2** P3 Filed Early-Stage P1a P1b P2* P2** P3
Zanubrutinib (BTK inhibitor) Surzebiclimab (BGB-A425, anti-TIM-3)
TN MCL, R/R MZL (+rituximab) Solid tumors (+/- tislelizumab)
R/R FL (+obinutuzumab)
BGB-A445 (anti-OX40)
R/R DLBCL#, Ibrutinib/acalbrutinib intolerant CLL/SLL#1, B-cell malignancies# (mono)
Solid tumors (+tislelizumab)
R/R DLBCL# (+lenalidomide)
Lupus nephritis# (mono) Lifirafenib2 (RAF Dimer)
Tislelizumab (anti-PD-1) [Global ex-Novartis territory†] B-Raf- or K-RAS/N-RAS-mutated solid tumors (+mirdametinib)
1L ESCC (+chemo), 1L HCC (mono) BGB-32453+ (B-Raf inhibitor)
Neo/adjuvant NSCLC#, 1L UBC, 1L SCLC# (+chemo), early ESCC# (+CRT)
Solid tumors
MSI-H/dMMR CRC# (mono),1L ESCC&GC/GEJ, neo ESCC# (+chemo)
1L HCC (+lenvatinib), solid
# tumors# (+fruquintinib, +lenvatinib) BGB-10188 (PI3-Kδ inhibitor)
R/R cHL# (mono) B-cell malignancies; Solid tumors (mono; +tislelizumab; +zanubrutinib)
R/R cHL (mono) BGB-15025 (HPK1 inhibitor)
Pamiparib (PARP 1/2 inhibitor) Advanced solid tumors (+/- tislelizumab)
2L PSOC maintenance (mono)#
BGB-23339 (TYK2 inhibitor)
1L GC maintenance (mono)
Solid tumors (+TMZ (chemo)) Dose escalation in healthy subjects
*Some indications will not require a non-pivotal Phase 2 clinical trial prior to beginning pivotal Phase 2 or 3 clinical trials; **Confirmatory clinical trials post-approval are required for accelerated
approvals; † Novartis owns commercial rights in United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.
^SMAC = second mitochondrial-derived activator of caspase. # single-country trial. 1. BGB-3111-215 trial in previously treated B-cell lymphomas intolerant of prior BTKi treatment. 2. In
collaboration with SpringWorks Therapeutics. 3. Developed by MapKure, LLC, jointly owned by BeiGene and SpringWorks. MapKure and is currently developing BGB-3245 under an exclusive
license from BeiGene.
BCL-2i Program Summary
• BGB-11417 is a BCL2 inhibitor with potential to be best in class given higher potency and increased
selectivity as well as shorter half-life compared to venetoclax that can potentially lead to improved
efficacy and safety.
• Broad development plan initiated in CLL, NHL (including WM, MCL, MZL), AML, MDS
and MM.
• With 400+ patients treated to date in 4 phase 1 studies, no safety concerns.
• Encouraging early efficacy in all indications eg. durable and deep responses seen in CLL at all doses
tested- longer follow up is needed for higher dose. AML patients on BGB-11417 + azacitidine have
high rates of blast clearance with doses as low as 40mg and responses are durable.
• Two trials with registrational intent:
– R/R MCL after failure of BTKi
– R/R CLL after failure of BTKi
• Broad registrational opportunities
15
BGB-16673: BTK Chimeric Degradation Activating Compound
for B-Cell Malignancies Showing Promise in Clinic
Deep, Rapid & Sustainable BTK Degradation Observed
at the First Dose Level in Phase 1 Study (50 mg)
• Targeting BTK via an alternative mechanism
Inhibition (%)
Zanubrutinib
Inhibition (%)
80
%Inhibition
• Good oral bioavailability and long t1/2 40
40
40
0
0
– Complete BTK degradation and clinical response -2 0 2 4
0
-2 0 2 4 -2 0 2 4
observed at the first dose level, 50 mg Log [Drug] (nM) Log [Drug] (nM) Log [Drug] (nM)
16
IMiD: immunomodulatory imide drug
Clinical Pipeline from External Collaboration
Commercial
Program / indication P1a P1b P2* P2** P3 Filed rights Partner
Sitravatiniba (multi-kinase inhibitor) - 2/3L NSCLC (+ tislelizumab) Asia ex-Japan, AU, NZ Mirati
Sitravatiniba - HCC#, GC/GEJC# , 2/3L ESCC# (Mono, + tislelizumab) Asia ex-Japan, AU, NZ Mirati
Zanidatamabb (HER2, bispecific antibody) - 1L HER2+ GEA (+ chemo ± tislelizumab) Asia ex-Japan, AU, NZ Zymeworks
ZW49 (HER2, bispecific ADC) - HER2-expressing cancers Asia ex-Japan, AU, NZ Zymeworks
AMG 199c (MUC17 x CD3) - GC/GEJC, Colorectal, and Pancreatic Cancers China Amgen
ABI-H3733 (HBV core inhibitor) - Chronic Hepatitis B virus Greater China Assembly Bio
a. Mirati is also conducting its own clinical studies with sitravatinib, including the Phase 3 SAPPHIRE trial in non-Sq NSCLC; b. ZW25; c. Half-life extended BiTE® molecule; # single-country trial.
*Some indications will not require a non-pivotal Phase 2 clinical trial prior to beginning pivotal Phase 2 or 3 clinical trials; **Confirmatory clinical trials post-approval are required for accelerated
approvals. 1. This is a Phase 1 trial.
Growing Commercial Portfolio: 16 Approved Assets
Product Lead Indications Mechanism of Action Regulatory Status Our Commercial Rights Partner
China:1L Squamous and Non-Squamous NSCLC, 2/3 L NSCLC, R/R Approved in China Outside North America,
Tislelizumab classical Hodgkin’s lymphoma2, 2/3 L HCC2, R/R PD-L1+ UC2, 2L Anti-PD-1 antibody BLA Accepted in U.S.4 Japan, UK, AU, EU and six
ESCC, MSI-H or dMMR solid tumors2, 1L NPC, 1L G/GEJ MAA accepted in EU4 other European countries
Anti-RANK ligand
Giant cell tumor of bone8, Skeletal Related Events (SREs)7 Approved in China Mainland China
antibody
Anti-CD19 x anti-CD3
R/R Acute lymphocytic leukemia7 bispecific T-cell Approved in China Mainland China
engager (BiTE®)
Idiopathic multicentric Castleman disease IL-6 antagonist Approved in China Greater China
1. Approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 2. Conditionally approved. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical
trials. 3. The approval is applicable to all 27 EU member states, plus Iceland, Lichtenstein and Norway. 4. U.S.: For patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy. EU: For patients with advanced or metastatic ESCC after prior systemic chemotherapy and for
patients with NSCLC including: locally advanced or metastatic NSCLC after prior chemo, in combination with chemotherapy for 1L advanced or metastatic squamous NSCLC, and in combination with chemotherapy for 1L locally advanced or metastatic non-squamous NSCLC with no EGFR or ALK positive mutattions.
BLINCYTO®, KYPROLIS®, and XGEVA® are registered trademarks of Amgen or its subsidiaries.
18
Growing Commercial Portfolio
WITH 16 APPROVED ASSETS
TAFINLAR®
Melanoma and BRAF V600 Mutation NSCLC BRAF inhibitor Approved in China China Broad Markets6
(dabrafenib)
MEKINIST®
Melanoma and BRAF V600 Mutation NSCLC MEK inhibitor Approved in China China Broad Markets6
(trametinib)
VOTRIENT® Advance renal cell carcinoma VEGFR inhibitor Approved in China China Broad Markets6
(pazopanib)
ZYKADIA® ALK + NSCLC ALK inhibitor Approved in China China Broad Markets6
(ceritinib)
5. Following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy. 6. Rights to promote and market in China's broad markets pursuant to a Market Development Agreement with an affiliate of Novartis Pharma AG. 7.
Conditionally approved. Full approval of any particular indication will depend on the results of required post-marketing study(ies) in China
Abbreviations: ALK = anaplastic lymphoma kinase; BLA = Biologics License Application; BRAF = B-rapidly accelerated fibrosarcoma; CLL = chronic lymphocytic leukemia; HCC = hepatocellular carcinoma; MCL = mantle cell lymphoma; MEK =
mitogen-activated protein kinase (MAPK) / Extracellular-signal regulated kinase (ERK); MSI = microsatellite instability-high; mTOR = Mammalian target of rapamycin; MZL = marginal zone lymphoma; NET = Neuroendocrine tumors; NPC =
nasopharyngeal carcinoma; NSCLC = non-small cell lung cancer; R/R = relapsed / refractory; SEGA = subependymal giant cell astrocytomas; SLL = small lymphocytic lymphoma; UC = urothelial carcinoma; VEGFR = vascular endothelial growth
factor receptor; WM = Waldenström’s macroglobulinemia
19
Growing Commercial Revenue Stream
$ in mn
Marketed Product Revenue Q1 2023 Marketed Products Breakdown
(by product revenue)
$1400
$1,255
1200 5%
6%
1000
9% BRUKINSA®
800
$634
Tislelizumab
600
52% Amgen Products
400 $309 BMS Products
$223
200 $131 28% Other
$24
0
20
We Work Collaboratively with Our Partners, Large and Small, Regionally
and Globally, to Provide Innovative Medicines to Patients Faster
Entry into cell therapy with Entry into mRNA Entry into LNP
iPSC-derived NK CAR therapeutics therapeutics
Building State-of-the-Art Manufacturing to Support Global
Growth and Broad Portfolio
• Aligned with the design • Manufacturing • Approved capacity 16,000L • Construction underway on a
criteria of U.S., EU, and China collaborations with U.S. manufacturing site
leading manufacturers • 54,000L completed in 2022 for biologic manufacturing
• Commercial-scale small in biologics and small + 10,000L in Q2 2023 and clinical development –
molecule drug products facility molecules complete by 1H 2024
• Building to 200,000L
• Pilot-scale biologic facility • 1 million+ sq ft of space for
future expansion
BeiGene became the first company to have two sites approved in China for a biologic product (tislelizumab)
22
2023 Milestones and Catalysts
1H 2023 2H 2023
FDA decision on sNDA for
Approval
treatment of CLL/SLL
BRUKINSA®
Approval Approvals in China for TN CLL/SLL and WM
(zanubrutinib,
BTK Inhibitor) Approval Approvals in Canada for CLL/SLL
*U.S. FDA pre-approval manufacturing inspections for tislelizumab biologics license application (BLA) scheduled for completion by end of Q2
2023 Milestones and Catalysts (cont'd)
1H 2023 2H 2023
Initiate global pivotal trial in 1L CLL in
Study progress
BGB-11417 combo with BRUKINSA
(BCL-2)
Data readout Data readouts from ongoing studies
Data readout Readouts for multiple P2 studies, including: 2L ESCC in patients whose tumors
Ociperlimab express PD-(L)1, 1L HCC and 1L NSCLC
(anti-TIGIT Ab)
Study progress Complete enrollment in Ph3 AdvanTIG 302 in 1L NSCLC
BGB-16673 (BTK Degrader) Data readout Initial data readout from Phase I study in B cell malignancies
BGB-A445 (anti-OX40) Data readout Initial data readout for Phase 1 study in solid tumors
BGB-15025 (HPK1 inhibitor) Data readout Initiate dose expansion in combination with tislelizumab in solid tumors
Initiate 15 novel IO combos across 6 trials with tislelizumab including LAG3, OX40,
Additional Early Programs Study progress TIM3, TIGIT, and HPK1, targeting multiple new tumor types including HNSCC, CRC,
UBC, RCC, melanoma
24
Key Takeaways
We fight for life against cancer —internally and with partners— in the
3 unrelenting pursuit for exceptional science, quality, and impact by cost-
effectively driving global operational excellence.
25
Thank you
Appendix slides follow
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (U.S. GAAP)
( A m o u n t s i n t h o u s a n d s o f U . S . d o l l a r s , e xc e p t f o r s h a r e s , A m e r i c a n D e p o s i t a r y S h a r e s ( A D S s ) , p e r s h a r e a n d p e r
ADS data)
Three Months Ended
March 31,
2023 2022 1
(Unaudited)
Revenue:
Product revenue, net $ 410,291 $ 261,573
Collaboration revenue 37,510 45,053
Total revenues 447,801 306,626
Expenses:
Cost of sales - products 81,789 65,237
Research and development 408,584 389,915
Selling, general and administrative 328,499 294,573
Amortization of intangible assets 187 188
Total expenses 819,059 749,913
Loss from operations (371,258) (443,287)
Interest income (expense), net 16,016 10,071
Other (loss) income, net 18,303 11,967
Loss before income taxes (336,939) (421,249)
Income tax expense 11,492 13,949
Net loss (348,431) (435,198)
1.We revised certain prior period financial statements for an error related to the valuation of net deferred tax assets, the impact of which was immaterial to our previously filed financial statements in the
first and second quarters of 2022 (see "Notes to the Condensed Consolidated Financial Statements, Note 1. Description of Business, Basis of Presentation and Consolidation and Significant Accounting 27
Policies" and "Note 2. Revision of Prior Period Financial Statements" included in our Quarterly Report on Form 10-Q for the period ended March 31, 2023 filed with the SEC).
Our Commitment to ESG
28
OUR PROGRESS
BeiGene made substantial progress in 2022 across all five Change Is the Cure focus areas and set a number of new goals.
Continue to seek approvals for our medicines Complete. BRUKINSA approved in 19 new countries 10 new molecules in clinic annually
globally and regions in 2022 beginning in 2024
30