Company Presentation March 2019 - Credit Suisse
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Company Presentation March 2019
Disclaimer
This presentation includes forward-looking statements, beliefs or opinions, including statements with respect to
our business, financial condition, results of operations and plans. These forward-looking statements involve
known and unknown risks and uncertainties, many of which are beyond our control and all of which are based on
our management’s current beliefs and expectations about future events. Forward-looking statements are
sometimes identified by the use of forward-looking terminology such as “believe,” “expects,” “may,” “will,” “could,”
“should,” “shall,” “risk,” “intends,” “estimates,” “aims,” “plans,” “predicts,” “continues,” “assumes,” “positioned” or
“anticipates” or the negative thereof, other variations thereon or comparable terminology or by discussions of
strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all
matters that are not historical facts. Forward-looking statements may and often do differ materially from actual
results. No assurance can be given that such future results will be achieved. Factors that may materially affect
our results include, among other things, the scope, rate and progress of our clinical and preclinical trials and
other research and development activities, anticipating timing of new clinical trials, our plans to commercialize
our product candidates, the timing of, and ability to, obtain and maintain necessary regulatory approvals for our
product candidates and those risks listed in our prospectus filed with the Securities and Exchange Commission
on September 21, 2017 and in our filings with the Securities and Exchange Commission. Such forward-looking
statements contained in this presentation speak only as of the date of this presentation. We expressly disclaim
any obligation or undertaking to update any forward-looking statement contained in this presentation to reflect
any change in our expectations or any change in events, conditions or circumstances on which such statements
are based unless required to do so by applicable law.
You may get copies of our final prospectus and other Securities and Exchange Commission filings for free by
visiting EDGAR on the Securities and Exchange Commission’s website at http://www.sec.gov.
2
Agenda
Zai vision, team and infrastructure overview
Pipeline and progress
Financial and catalysts
3
Biotech Leader in Bringing Innovative Therapies to China
and Worldwide
Zai Lab is an innovative, research based, commercial stage biopharma, based
in US and China, treating patients with unmet medical needs around the globe.
Growth Pillars
7 Late stage programs; Gateway to China for Discovery via internal
3 US FDA approved innovative assets research and pipeline
products; 2 Launches in generation platform
HK; 1 China NDA 4 in-licensing deals last
submission year, 3 involving global co- 1-2 INDs/year in 2020
development
Strategic Enablers
Best China-based clinical Extensive global and
development and 2 Pureplay innovative local industry and
operations team; 20+ commercial platforms regulatory expertise
ongoing and planned
trials
4
Strong, Execution-oriented Leadership Team
Samantha Du
Ph.D.
Founder, Chairman & CEO
Tao Fu Yong-Jiang Hei Harald Reinhart Billy Cho
MBA, MS, CFA M.D., Ph.D. M.D. MBA, MA
President and COO Chief Medical Officer - Chief Medical Officer Chief Financial
Oncology - Autoimmune and Officer
Infectious Diseases
William Liang James Yan Ning Xu Jonathan Wang
M.D. Ph.D. M.D. MBA
Chief Commercial EVP, Head of Pre- EVP Head of Clinical SVP Head of BD
Officer clinical development and Regulatory
and Drug Safety
5
Building a fully-integrated innovative biopharma
leader in China
• >450 employees
• Leading late-stage oncology portfolio
• Best China-based clinical team (~150 FTEs)
San Francisco (US HQ
& R&D)
• Elite innovative oncology sales team (~200 FTEs
and expanding)
Beijing (clinical
& regulatory)
Suzhou
(manufacturing)
Shanghai (HQ &
R&D)
Guangzhou Zai office/footprint
(commercial) HK Zai commercial
(commercial) presence / coverage
6
6
Clinical development and regulatory team with strong
execution capability
Clinical Development & Regulatory Affairs Department
Oncology TA Regulatory Clinical Data
PV Biostatistics CQA
Medical Affairs Operations Management
Physicians / Regulatory Clinical Data
Director PV physician/ Quality
Medical Project management Biostaticians
specialists managers
Directors Directors specialists
RA managers Project CQA
managers Medical specialist
Affairs
Field
monitors MSL
CTAs
7
Ready-Built Commercial Organization
Commercial Organization
BU head BU head Medical Sales
Market access
Infectious Oncology Affairs operation
Pricing/
Key teams Sales Sales MSL Hospital SFE
listing Distributor
management Training,
Reimburse- etc.
Marketing Marketing Medical studies
ment
Proven track record and heritage from top-selling oncology MNCs and brands in China –
Current Zai team launched 8 of the top 10 innovative oncology products in China today 8
Agenda
Zai vision, team and infrastructure overview
Pipeline and progress
Financial and catalysts
9
Broad and Validated Late-stage Innovative Pipeline with Global First-in-Class
and/or Best-in-Class Profile
Phase 3/ Commercial
Program Indication Preclinical Phase 1 Phase 2 Partner
pivotal Territories
Ovarian Cancer (2nd line maintenance) / PK Study China
NDA
Ovarian Cancer (1st line maintenance)
ZL-2306 Small Cell Lung Cancer
(Niraparib) IO Combo in Gastric Cancer2 Greater China
IO Combo in Ovarian Cancer2
IO Combo in NSCLC2
Other1
Glioblastoma (GBM)
Mesothelioma
NSCLC
Optune Greater China
Brain Metastases
(TTFields)
Pancreatic Cancer
Ovarian Cancer
Gastric Cancer
HER2+ breast cancer
Margetuximab
HER2+ gastric cancer2
Ovarian2
Gastric1
Greater China
MGD013 TNBC
NSCLC
HCC
Other2
FPA144 (Bemarituzumab) Gastric Cancer, GEJ Greater China
ZL-2301 (Brivanib) Hepatocellular Carcinoma (HCC)2 Greater China
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
ZL-2401 (Omadacycline) Greater China
Community-Acquired Bacterial Pneumonia (CABP)
ETX2514 A.Baumanii Bacterial Infections Asia Pacific
Oncology Infectious FDA approved HK Commercial
Note: (1) Combo and mono therapy; (2) Combo therapy. 10
LaunchContinuously Enhancing Discovery Efforts with 1-2
INDs per year starting in 2020
Zai Lab’s Current Discovery Pipeline
ZL-1102 Topical Psoriasis
ZL-1201 Hematology & Oncology
ZL-1211 Gastric Cancer
ZL-2103 Autoimmune & Oncology
Multiple undisclosed Oncology
Foundation for Future Discovery Pipeline Generation
Best-in-class Human IgG Transgenic Mice Platform (US site)
Improved diversity/yield through B cell cloning & encapsulation
Versatile platform adaptable for bi-specifics
11Strong Oncology Franchise in 5 Common Cancers
in China with Synergistic Late Stage Assets
Women’s Gastric Brain Lung Liver
Cancer Cancer Cancer Cancer Cancer
Ovarian
Niraparib Brain Met SCLC
Breast
Margetuximab Breast
Bemarituzimab
Brivanib
MGD013 Breast NSCLC
Optune Breast GBM NSCLC
Target Therapy I-O TTFields
12Three FDA Approved Products with Significant China
Market Potential
ZL-2306 (Niraparib) Optune ZL-2401 (Omadacycline)
• Best-in-class PARP franchise • New, breakthrough cancer • The only next generation, once-
treatment modality for multiple daily broad spectrum antibiotic
Positioning/
Strategy tumor types available in oral and
• 1st novel GBM treatment in ~15 IV formulations
years
>1.0m >1.0m 16.5m
China Market
Opportunity
(Annual 54K 45K 2.7m
Incidence
(2)
in 2018E) OC Cur. Add. Market
(1)
GBM Cur. Add. Market ABSSI CABP
• Approved in HK and • Launched in HK (Dec 2018) • Abbreviated clinical trial
launched (Q4 2018) • Pursue clinical trial waver in agreed for China
• NDA accepted by NMPA China • Supported by China national
China
(Dec 2018) • Recommended in China Glioma key grants
Regulatory
Status • Priority Review (Jan 2019) guidelines based on Level 1 • Category 1 drug
• Category 1 drug evidence • Local manufacturing
• Local manufacturing
Source: Cancer Statistics in China, National Bureau of Statistics of China, US Department of Health & Human Services, Respiratory Medicine, Thorac Cancer, and Broker Estimates.
Note: (1) Primarily include ovarian, breast (gBRCA, TNBC), SCLC and Gastric; (2) Primarily include NSCLC, Brain Metastases, Pancreatic and Ovarian Cancer.
13Niraparib has Best-in-class Properties Compared to Olaparib in China
Zejula (ZL-2306) / Niraparib Lynparza / Olaparib
Company
Headquarter China England
Class I Class 5
Drug Category
(Local Innovation) (Import)
Manufacturing Local Import
Efficacy (PFS: BRCA+ / BRCA- in
21 mos / 9.3 mos 19.1 mos / 7.4 mos
second line maintenance)
All-comers (PRIMA data expected end of
1st line maintenance trial design gBRCA only
the year)
Dosing 200mg QD 300mg BID
PK Properties Low DDI/Brain penetration high DDI/no brain penetration
Co-Marketing
Commercialization Local, Direct
w/ Merck
Zai Lab’s NDA accepted by NMPA in Dec ‘18 with priority review
status (one year ahead of schedule) 14Margetuximab Positive Topline Phase 3 (SOPHIA) in
Heavily Pretreated Her2+ Metastatic Breast Cancer
All-comers CD16A 158F allele (85%)
Margetuximab HR=0.76 p=0.033 Margetuximab HR=0.68 p=0.005
+chemo +chemo
vs. vs.
trastuzumab trastuzumab
+chemo +chemo
24% improvement in PFS 32% improvement in PFS
• Initiate discussions with Chinese regulators for mBC based on
SOPHIA
• Initiate gastric PD-1 combination study in 2019
15Significant Unmet Need for HER2+ Cancers in China
Breast cancer Gastric Cancer
272 679
234 +16%
Regional >27x
comparison
25
US China US China
HER2+ % in China 20~25%1 12-13%2
54~68K HER2+ breast 82~88K HER2+ gastric
Patient population
cancer patients cancer patients
Herceptin the main metastatic Herceptin as first line SoC
treatment available
Current treatment No target therapy available
Perjeta and Kadcyla not as SoC for 2nd line in China
approved for metastatic setting
(1) Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive Trastuzumab-Refractory Metastatic Breast Cancer 16
(2) HER2 Status in Gastric and Gastroesophageal Junction. Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study; HER2 status in gastric cancers: a retrospective analysis from four Chinese
representative clinical centers and assessment of its prognostic significanceBroad Strategic Collaboration with MacroGenics Across
Multiple Assets
Zai Lab acquired exclusive development and commercial rights for 3
programs for Greater China
Method of Action Indication Stage
Immune-optimized HER2-positive BC Phase III Positive
Margetuximab anti-HER2 monoclonal
HER2-positive GC Phase II
antibody
First-in-class
Various solid and
bispecific blocking
MGD013 hematologic Phase I
PD-1
malignancies
and LAG-3
TRIDENTTM Multi-specific Undisclosed Pre- clinical
TRIDENTTM molecule
17Optune, a Revolutionary Treatment for GBM and
Other Major Tumor Types
EF-14 ph3 pivotal trial in newly diagnosed GBM
Median OS
Extended by ~5 months
PFS
Improved by 2.7 months
Multiple other solid
tumor expansion
opportunities e.g.
mesothelioma
NCCN guidelines include and recommend Optune in combo with TMZ
in new GBM patients as Category 1 recommendation
References: (1) Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs. maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical
trial. JAMA. 2017; 318(23):2306–2316; (2) Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly
diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1–5, 2017; Washington, DC. Oral presentation LBA AACR CT007 18Large Chinese GBM Patient Pool with Huge Unmet Need
Large patient pool Poor prognosis Limited treatment options
Thousands Five-year survival rate KOL interviews
“Temozolomide is currently
the only approved therapy
>3X for GBM in China – we have
45 37% very limited choice for one of
20% ~5% the most deadly cancers”
13
China US All Cancer Lung GBM
“it’s less exciting in GBM…
Opdivo fails to demonstrate
Incidence in China: “It’s a deadly cancer, 5-yr survival benefits in brain
3.2/100,000 population survival is lower than cancer trial”
metastatic lung cancer”
- KOL
- KOL
Source: Global surveillance of trends in cancer survival 2000–14; KOL interviews, RDPAC, China Glioma Treatment Guideline (2015). 19Agenda
Zai vision, team and infrastructure overview
Pipeline and progress
Financial and catalysts
20Financial Overview
Zai Lab currently has a strong balance sheet and remains committed to capital
efficiency and creation of significant shareholders’ value
Total net proceeds raised since inception $462.6 million
Cash, cash equivalents and short-term investments $263.3 million
As of Dec 31, 2018
Net cash used in operating activities in 2018 $97.5 million
Net cash used in operating activities in 2017 + 2016 $64.5 million
Shares outstanding (basic) 58.0 million
As of Dec 31, 2018
21Continued Momentum: Major 2019 Milestones & Catalysts
Event
• Potential China NDA approval and launch
• China Phase 3 data in 2L Ovarian cancer
ZL-2306
• PRIMA readout
• Initiate trials in other key indications in China
• Potential China GBM NDA approval w/ trial waiver and launch
Optune
• Initiate trials in other key indications in China
• SOPHIA topline data
Margetuximab • Initiate China breast cancer study
• Initiate pivotal trials in gastric cancer
ZL-2401 • Complete registration trial and prepare for NDA submission
ETX2514 • Initiate dosing in Phase 3 global registrational trial
Additional • Continue pursuing transformational BD opportunities
Pipeline • Advance and announce internal candidate(s)
22Zejula & Optune Commercially Launched in Hong Kong,
Paving Way for Mainland China
Hong Kong China
2018: Accelerated Hong Kong launch 2019: Full readiness for China launch
Zejula Oct’18; Optune Dec’18
Core marketing, sales management,
market access, and government affairs
teams in place
Recruiting full team of oncology
specialists
Extensive pre-launch programs including
Mainland-HK scientific exchanges
23Fulfilling our Mission: Deliver Innovative, Transformative
Treatments to Patients in China and the World
Our first Optune patient… …treated 3 months after deal signing
56 years old, male,
GBM patient
Recently married chef
travels between HK &
China
Doctor placed Supported by Zai
• Diagnosed in May’18. Original tumor size array on patient Specialist
3.5cmx4.2cm x2.7cm
• Poor prognosis: IDH-1 wildtype; promoter “To have a committed team of doctors
MGMT methylation. and Zai Lab and Novocure staff to
provide this treatment makes me feel
• Craniotomy for near total excision happier than winning the lottery. I will go
• On adjuvant Temozolomide back to work after the new year holiday”
- HK patient
244560 Jinke Road, Jingchuang Plaza, Building 1 Shanghai, China +86 21 6163 2581 +86 21 6163 2570
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