Zai Lab Corporate Presentation October 2018 Disclaimer This - - PowerPoint PPT Presentation
Zai Lab Corporate Presentation October 2018 Disclaimer This - - PowerPoint PPT Presentation
Zai Lab Corporate Presentation October 2018 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
1
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
- f, 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
- n the Securities and Exchange Commission’s website at http://www.sec.gov.
2
Leader in bringing innovative therapies to China and worldwide
China-based biopharma Expanding US presence
We are
Developing innovative therapeutics to transform the lives of patients in China and worldwide
Broad pipeline Eight programs in development (six in late-stage) and proven in-house discovery capabilities Oncology, anti-infectives and autoimmune Proven ability to rapidly advance in- licensed assets into clinical development in China
Experienced global leaders with domestic expertise Multi-disciplinary track record Extensive local network and capabilities
We have We are led by
Expanding two leading commercial platforms
3
Focused on bringing innovative therapies to China Becoming a fully integrated, global biopharmaceutical company
Building the leading China-based, fully-integrated, global pharmaceutical company
✓ 8 Assets targeting the largest and fastest growing disease areas ✓ Track record of partnerships ✓ Pioneer innovative drug development pathway in China ✓ Assembling most experienced and productive commercial team for innovative products ✓ Build internal discovery platform ✓ Access external innovations globally ✓ Leverage China resources to develop and commercial products for the world ✓ Expand commercial manufacturing ✓ Grow global and China-focused commercial sales force ✓ Explore inorganic growth opportunities Late-stage assets for Chinese market through licensing Accelerate development; Build leading commercial platform Expand pipeline with in worldwide rights Grow global capabilities and presence
4
Strong, execution-oriented leadership team
Scientific advisory board
Richard Flavell Ph.D., FRS Neal Rosen M.D., Ph.D. Gwen Fyfe M.D. Tao Fu MBA, MS, CFA President and COO Samantha Du Ph.D. Founder, Chairman & CEO Harald Reinhart M.D. Chief Medical Officer - Autoimmune and Infectious Diseases William Liang M.D. Chief Commercial Officer Jonathan Wang MBA SVP Head of BD Ning Xu M.D. EVP Head of Clinical and Regulatory James Yan Ph.D. EVP, Head of Pre-clinical Development and Drug Safety Yong-Jiang Hei M.D., Ph.D. Chief Medical Officer - Oncology Billy Cho MBA, MA Chief Financial Officer
5
China’s Innovative Drug Market Opportunity
Population(1) (mm)
1,380 126 327
Middle Class Population(2) (mm)
109 53 92
% of Total Population
7.9% 42.0% 28.1%
Pharmaceutical Market Size (3)(US$ bn)
115 68 370
Pharmaceutical Market Size CAGR (2014-2018E)
11.3% 0.2%(8) 6.2%
Annual Cancer Incidence(4) (mm)
4.3 1.0 1.7
Antibiotics Global Market Share(5) (volume)
~50% NA NA
Innovative Patented Prescriptive Drugs % of Total Drug Sales(6)
22% N/A 75%
Market Cap of leading innovative biopharma companies(7) (US$ bn)
1 – 7 10 – 40 40 – 250
Note: (1) China population as of 2016 from National Bureau of Statistics of China; US population as of 2016 year end from US Census; Japan’s population is as of 2017 year end from MarketLine report (2) As of 2016 year end for China and US, Global Wealth Report; As of 2017 year end for Japan, government survey (3) Market size as of 2016, Frost and Sullivan report and MarketLine report (4) As of 2015, Cancer Statistics of China 2015 for China, Statista Portal for US, and Ganjoho for Japan (5) Chinese Academy of Sciences; By volume (6) As of 2016, Frost and Sullivan report for China and US (7) Market data as of 31/8/2018, Bloomberg (8) CAGR of 2013 – 2017, MarketLine report
6
Regulatory reform in China driving innovation in drug development
Accelerate the review and approval of urgently needed new drug applications Selected reform initiatives announced by CFDA1 in 2017 and YTD 2018
Note: China Food and Drug Administration (CFDA) has been recently renamed to National Medical Products Administration (NMPA).
China joins ICH – Integration of regulatory system into the international community Encourage China to join early global simultaneous development Conditional Approvals for Urgently Needed Drugs Improve clinical trial infrastructure to encourage innovation Enhance IP and Data protection for innovative drugs
China innovative drug industry could be entering a golden age of innovation and development, shifting from an international manufacturing base to a most promising strategic market and efficient R&D center
7
Oncology
ZL-2306 (Niraparib) FPA144 ZL-2301 ZL-2302
China, HK, and Macau China, HK, Macau and Taiwan China, HK, and Macau Global
Ovarian Cancer (2nd line maintenance) / PK Study Other Gastric Cancer / GEJ Hepatocellular Carcinoma (HCC) Non-Small Cell Lung Cancer (NSCLC) Ovarian Cancer (1st line maintenance) Small Cell Lung Cancer
Program Indication Preclinical Phase 1 Phase 2 Phase 3/ pivotal Commercial rights Partner
Broad China and global product pipeline (Oncology)
Optune
China, HK, and Macau
GBM NSCLC / Brain Metastases / Pancreatic Cancer Mesothelioma / Ovarian Cancer / Gastric Cancer
FDA approved HK approved
8
Infectious Auto-immune
ZL-2401 (Omadacycline)
China, HK, Macau and Taiwan
A.Baumanii Bacterial Infections Community-Acquired Bacterial Pneumonia (CABP)
ETX2514
Asia Pacific
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Internal Discovery
Focused on immunotherapy / targeted therapy / autoimmune
Global
ZL-1102
Psoriasis
Global
Program Indication Preclinical Phase 1 Phase 2 Phase 3/ pivotal Commercial rights Partner
Broad China and global product pipeline (Infectious & Auto-immune)
FDA approved
9
Zai is uniquely positioned to establish Niraparib as the leading PARP franchise in China
✓
ZL-2306 (Niraparib), currently in Phase 3 studies for ovarian (1st and 2nd line maintenance) and SCLC
✓
Commercial launch in Hong Kong expected in 4Q’2018
✓
Building a “pipeline in a product” potentially through monotherapy and/or combination studies for various other cancers to maximize commercial potential
52k
Ovarian1 Breast2 (gBRCA+) SCLC3
41k
Breast2 (Triple negative)
1,006k
Current China patient
- pportunity
Pivotal stage
Total potential China patient
- pportunity
Other solid tumors
Sources: 1. Cancer Statistics in China, 2015, a study published by Wangqing Chen et. al. in “A Cancer Journal for Clinicians” in 2016, and based on historical data from 72 local, population- based cancer registries, representing 6.5% of China’s population. 2. Assumes that 10% and 15% of the total breast cancer patients would be with gBRCA+ mutation and triple negative mutation, respectively. According to the study by Kim and Choi in 2013, the percentage of BRCA 1/2 gene mutation in familial breast cancer and early-onset breast cancer patients ranged from 8.0% to 13.5% and from 8.7% to 11.4%, respectively. 10-20% of breast cancer is Triple-negative, according to the study by Ping-Ping Bao et. al in 2016. 3. American Cancer Society estimated that globally about 80-85% of lung cancers are NSCLC. Calculation is based on 80% for NSCLC and 20% for SCLC patients.
27k 147k 679k
Gastric (stomach) Prostate
60k
Potential addressable China patient population
10
Optune brings another significant near term commercial opportunity
- Innovative treatment approved in US, EU and Japan
- Based on large randomized and controlled clinical studies
- Significant long term survival benefits in first line GBM patients (extended
median OS by 4.9 months vs SoC)
- Positive pivotal trial in mesothelioma and on-going phase 3 trials in Brain
Metastases, NSCLC, Pancreatic Cancer & Ovarian Cancer Optune
- verview
- Large unmet need in GBM with chemotherapy the only approved drug in China
- Treatment already included and recommended in China Glioma Guideline
- Significant number of Chinese patients go to US to seek Optune treatment
- Product is synergistic with Zai’s innovative oncology commercial platform
Strategic rationale for Zai Launch timeline
- Expected launch by end of 2018 in HK
- Potentially allow Chinese mainland patients to get treatment in HK
- Seek for accelerated approval in China
- Japan approved Optune with a clinical trial waiver
- Supported by recognition from Chinese KOLs and the current treatment guideline
11
China has a large GBM patient pool with huge unmet medical needs
Large patient pool
45 13 China US >3X
Thousands
Source: Global surveillance of trends in cancer survival 2000–14; KOL interviews, RDPAC, China Glioma Treatment Guideline (2015)
Poor prognosis
Five-year survival rate
~5% 37% All Cancer Lung 20% GBM
Limited treatment options
KOL interviews
Incidence in China: 3.2/100,000 population “It‘s a deadly cancer, 5-yr survival is lower than metastatic lung cancer”
- KOL
“it’s less exciting in GBM… Opdivo fails to demonstrate survival benefits in brain cancer trial”
- KOL
“Temozolomide is currently the only approved therapy for GBM in China – we have very limited choice for one of the most deadly cancers”
12
Building a leading commercial platform for innovative medicines in China
Oncology leader William Liang as CCO to lead commercialization 20+ years in the pharma industry with expertise in commercial launch, strategy and operations Instrumental in establishing market-leading oncology in China for AstraZeneca, expanded team
from approximately 500 to 2,000 professionals.
Significant experience in building and leading oncology sales with 13 years at Roche
1
An elite sales force with strong local relationships being hired Nimble and science-driven sales and marketing team differentiated from multi-national pharma and
domestic competitors
2
Early KOL engagement Leverage deep relationship with leading China KOLs in clinical development, regulatory interactions with
CFDA and pre-launch activities
3
Advantages of being “local” in regulatory and reimbursement discussions Deep and collaborative relationship with the CFDA Market exclusivity for at least 6 years Advantages in reimbursement and priority in hospital procurement
4
13
Zai Lab: Building a fully-integrated China-based pharmaceutical company
- Pro forma cash balance of approximately $320mm as of June 30,
2018 Strong balance sheet
- Continue aggressive in-licensing of late stage/commercial stage
assets to expand the portfolio Systematic business development effort
- Building out commercial team in preparation for launch of 2306
(niraparib) and Optune in Hong Kong and China Gearing up for commercial success
- Most attractive therapeutic areas in China – Oncology, infectious
diseases and autoimmune Strategic therapeutic focus
- 6 late-stage, de-risked clinically validated assets with 3 US FDA-
approved programs Pipeline of validated assets
- Currently engaged in 8+ partnerships, focused on large unmet
needs in the Chinese / Global population Established partnerships
14