2018 annual results presentation - innovent bio · 2019. 4. 1. · events and financial trends that...

March 2019

2018 Annual Results Presentation

1Copyright© 2019 Innovent Biologics

This presentation includes forward-looking statements. All statements contained in this presentation other than statements of historical facts, including statements regarding future

results of operations and financial position of Innovent Biologics (“Innovent” “we,” “us” or “our”), our business strategy and plans, the clinical development of our product candidates

and our objectives for future operations, are forward-looking statements. The words “anticipate,” believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “will” and similar

expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future

events and financial trends that we believe may affect our financial condition, results of operations, business strategy, clinical development, short-term and long-term business

operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, we operate in a very

competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all

factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking

statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this presentation may not occur and actual results could

differ materially and adversely from those anticipated or implied in the forward-looking statements.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance,

achievements or events and circumstances reflected in the forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the

date of this presentation to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking

statements as representing our views as of any date subsequent to the date of this presentation.

This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry.

This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Neither we nor any other person makes any

representation as to the accuracy or completeness of such data or undertakes any obligation to update such data after the date of this presentation. In addition, projections,

assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and

risk.

This presentation may not be all inclusive and may not contain all of the information that you may consider material. Neither Innovent nor any of its affiliates, shareholders,

directors, officers, employees, agents and advisors makes any expressed or implied representation or warranty as to the completeness, fairness, reasonableness of the information

contained herein, and none of them shall accept any responsibility or liability for any loss or damage, whether or not arising from any error or omission in compiling such information

or as a result of any party's reliance or use of such information. By attending or receiving this presentation you acknowledge that you will be solely responsible for your own

assessment of our business, the market and our market position and that you will conduct your own analysis and be solely responsible for forming your own view of the potential

future performance of our business.

This presentation is intended solely for investors that are qualified institutional buyers or institutional accredited investors solely for the purposes of familiarizing such investors with

Innovent and determining whether such investors might have an interest in a securities offering contemplated by Innovent . Any such offering of securities will only be made

pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act of 1933, as amended, or by means of a registration

statement (including a prospectus) filed with the SEC, after such registration statement becomes effective. No such registration statement has been filed, or become effective, as of

the date of this presentation. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in

any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Disclaimer


Our Mission, Vision and Development Strategy

Company Mission

Company Vision

Company Strategy

To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people

To be the premier biopharmaceutical company in China

Robust and high quality pipeline Global standard cGMP biologics manufacturing

facility in China


Our History

2011.8 Innovent was

established

2012 First IND

application to the

NMPA

2013 Strategic

alliance with

Adimab

2014 First IND

application

was approved

Manufacturing

facility was

built

2015

Strategic

partnership with

Eli Lilly

Passed audit on

GMP system

and production

facility


2016 IBI-301,IBI-303, IBI-305

entered Phase III clinical

trials

Passed GMP audits on

drug products system

2017

2018 Listed on HKEX

NDA for IBI-303, biosimilar to

adalimumab

Tyvyt granted marketing

approval by the NMPA

Strategic partnership with Incyte

Strategic alliance

with Hanmi

PD-1 monoclonal

antibody IBI-308

entered Phase III

clinical trials 2019

NDA for IBI-305,

biosimilar to

bevacizumab

IND approval for

IBI-318 bispecific

Cover Story of sintilimab

(Tyvyt ) by The Lancet

Haematology

®

®


Major Accomplishments Since 2018

1 As of Mar. 11, 2019

Clinical

Advancement

Pipeline Expansion

through Partnership

Corporate

Milestone

6Entered a strategic partnership with IncyteStrategic collaboration with Incyte for pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib

(PI3Kδ inhibitor)

8Organization grows toApproximately 1200 employees1

9IPO on the Main Board of HKEXSuccessfully listed on the Main Board of HKEX (with stock code: 01801.HK) on October 31, 2018

7Continuous expansion of the manufacturing facilitiesConstruction of the 6x3000L M1b facility has been completed, and its validation is in progress

1First NDA ApprovalTyvyt (sintilimab injection) was granted marketing approval by the NMPA on Dec 24, 2018

2Three NDA Applications submitted to the NMPANDA application for sintilimab (Apr 2018), adalimumab biosimilar (Nov 2018) and bevacizumab biosimilar (Jan 2019)

3One Phase III trial completed patient enrollmentComplete patient enrollment for IBI-301 (rituximab biosimilar)

4Nine trials completed first patient doseSintilimab (6 trials); IBI-188; IBI-101; IBI-310

5Nine IND approvalsIBI-101 China & US IND; IBI-188 China & US IND; IBI-310 China IND; IBI-307 China IND; IBI-310 China IND; IBI-338

China IND; IBI-318 China IND

®


As of March 11, 2019 Status (China)

IND

Candidate/

Reference Drug Target(s) Therapeutic Area: Disease Indications Commercial Rights Pre-clinical (Filed) (Accepted) Phase1 Phase 2 Phase 3 NDA Launched

sintilimab (IBI-308) PD-1

Oncology: r/r Hodgkin’s lymphoma, 1L and 2Lmelanoma, refractory gastrointestinal cancers, 2L NSCLC, 2L esophageal cancer, 1L and 2L squamous NSCLC, 1L non-squamous NSCLC, r/r NK/T-cell lymphoma, 2L ESCC, 1L gastric cancer, solid tumors, and esophageal carcinoma

Worldwide2

IBI-303 (adalimumab

biosimilar)TNF-alpha

Autoimmune: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis,ankylosing spondylitis, Crohn’sdisease, ulcerative colitis and psoriasis Worldwide2

IBI-305 (bevacizumab

biosimilar)VEGF-A Oncology: r/r NSCLC and metastatic CRC Worldwide2

IBI-301 (rituximab

biosimilar)CD20

Oncology: non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis Worldwide2

IBI-377 (Itacitinib) JAK1 Graft versus host disease (phase 3 in the US) Mainland China, HK, Taiwan

IBI-376 (Parsaclisib) PI3Kδ NHL (phase 2 in the US) Mainland China, HK, Taiwan

IBI-375 (Pemiga) tinib FGFR1/2/3 Cholanglocarcizoma, urothelial cancer (phase 2 in the US) Mainland China, HK, Taiwan

IBI-306 PCSK9Metabolic: homozygous familial hyperlipidemia; statin intolerant high CV risk

patientsMainland China, HK, Taiwan

IBI-3101 CTLA-4 Oncology: melanoma and renal cell carcinoma Worldwide

IBI-101 OX40 Oncology: advanced solid tumors, hepatitis B Worldwide

IBI-188 CD47 Oncology: B-cell lymphoma, ovarian cancer, colorectal cancer Worldwide

IBI-318PD-1/

undisclosed targetOncology: advanced tumors (undisclosed target) Mainland China, HK, Macau3

IBI-302 VEGF/Complement proteins Ophthalmology: wet AMD Worldwide

IBI-307 RANKLMetabolic: osteoporosis and lytic bone lesions associated with cancer

metastasisWorldwide

IBI-110 LAG-3 Oncology: NSCLC, melanoma, mBrCA, advanced tumors Worldwide

IBI-939 TIGIT Oncology: advanced solid tumors Worldwide

IBI-319PD-1/

undisclosed targetOncology: advanced tumors (undisclosed target) Mainland China, HK, Macau3

IBI-322 PD-L1/CD47 Oncology: PDL1/CD47 coexpressing tumors, M1 macrophage signature tumors Worldwide

IBI-315 PD-1/HER2 Oncology: Her2 + cancers, mBrCA, gastric cancer, NSCLC worldwide

IBI-323 LAG-3/PD-L1 Oncology: PDL1+ tumors with “hot tumor” phenotype Worldwide

Clinical advancement since IPO1 We are developing IBI-310 as an innovative drug candidate in accordance with NMPA regulations because ipilimumab has not been approved for marketing in China even though it has the

same amino acid sequence as ipilimumab ; 2 We and Eli Lilly will co-promote sintilimab (IBI-308) and rituximab (IBI-301) in Mainland China, Hong Kong and Macau; 3 Eli Lilly may opt in to

co-commercialize IBI-318 and IBI-319 with us in Mainland China, Hong Kong and Macau

IND approved: Dec 2016

IND approved: Sep 2017

IND approved: Jun 2018

NDA filed in Jan 2019

NDA filed in Nov 2018

NDA to be filed in Q4 2019

IND approved: Feb 2018

IND approved: Jun 2018

IND approved: Feb 2019

IND approved: Aug 2018

Biologics Small molecules

NDA approved Dec 24, 2018

Robust Pipeline across Biologics and Small Molecules


Sintilimab Injection - Tyvyt® (信迪利单抗注射液– 达伯舒®)

Tyvyt (sintilimab injection) has

been granted marketing approval

by the NMPA on December 24, 2018

®


Clinical Highlight of Sintilimab (Tyvyt®)

Cover Story of Sintilimab (Tyvyt®) by The Lancet Haematology

Significant unmet medical need for patients with

classical Hodgkin’s lymphoma in China

Registration trial in 96 patients with relapsed or

refractory classical Hodgkin’s lymphoma

Well tolerated with no non-PD-1 class toxicities

80.4% ORR, 34% CR

Lancet Coverage

Clinical Highlight

More than 1,000 patients were on sintilimab and its

safety profile very similar to globally approved anti-

PD-1 products

Sintilimab showed higher PD-1 occupancy in cancer

patients, suggesting potential better clinical efficacy

More than 20 trials including 7 registration studies

are under way


Clinical Development Programs for Sintilimab

As of March 11, 2019Status

Indication1, 2, 3Mono-/Combo-Therapy (Other

Components)

Phase 1

Phase 2 Phase 3

NDA

Filed

NDA

Approved1a 1b

China

r/r Classical Hodgkin’s Lymphoma Mono

2L Squamous NSCLC Mono

1L Non-squamous NSCLC Combo (pemetrexed and platinum)

1L Squamous NSCLC Combo (gemcitabine and platinum)

1L Non-squamous NSCLC Combo (pemetrexed and cisplatin)

EGFR+ TKI Failure NCSLC Combo (IBI-305)

1L Hepatocellular Carcinoma Combo (IBI-305)

1L Gastric Cancer Combo (capecitabine and oxaliplatin)

1L Esophageal Carcinoma Combo (paclixel and cisplatin)

2L ESCC Mono

r/r NK/T-cell Lymphoma Mono

2L NSCLC Mono

1L/2L Melanoma Mono

Refractory Gastrointestinal Cancer Mono

2L Neuroendocrine Tumor Mono

1L Squamous NSCLC Combo (gemcitabine and cisplatin)

1L Gastric Cancer Combo (capecitabine and oxaliplatin)

Refractory Solid Tumors Mono

U.S.

Solid Tumors Mono

Late Stage Endometrial Carcinoma Mono

Notes1 Abbreviations: r/r = relapsed, refractory; 2L = second-line; 1L = first-line; NK/T-cell lymphoma = natural killer/T-cell lymphoma; ESCC = esophageal squamous cell carcinoma; NSCLC = non-small cell lung

cancer; EGFR = epidermal growth factor receptor; TKI = tyrosine kinase inhibitor.2 Symbols: = completed; = in progress = to be initiated within next quarter.3 Some indications may not require every clinical trial indicated on his chart to completed prior to the filing of an NDA.

Advancement since IPO


Commercialization of Sintilimab (Tyvyt®)

Right Team and Strategy

1 As of Mar. 11, 2019

Experienced Team Strategy

Led by former vice president and head of one of

Roche’s two oncology business units in China with

expertise in the fields of lung cancer, gastrointestinal

cancers, and hematology

Key commercial leadership members have

significant commercial experience in the

pharmaceutical industry

Currently, 350-member 1 commercialization team

was built for sintilimab in China

Focus on the rapid delivery of sintilimab to

markets

Strengthen competitive share of voice in

promotion and medical services

Build extensive hands-on experience at launch

Leveraging Eli Lilly’s in-depth knowledge of

commercialization in China

Sintilimab launched sales on March 9, 2019


Commercialization of Sintilimab (Tyvyt®)

Marketing Readiness

Research Fund Program Media Channel Launch Activities

To enhance HCP hands-on experiences

To fill data gap of sintilimab in different disease areas

Press conference for sintilimabcommercial launch

Engage KOLs after the approval from the NMPA (National Medical Products Administration)


Pre-clinical IND Phase1 Phase 2 Phase 3 NDA Launched

Other Major Clinical Advancements

Continuous Pipeline Enhancement throughout Stage of Development

IBI-101 (OX40) Received IND Approval in Dec 2018

IBI-318 (PD-1 /

undisclosed target)Received IND Approval in Feb 2019

IBI-101 (OX40) First Patient Dosed in Feb 2019

IBI-188 (CD47) First Patient Dosed in Jan 2019

IBI-303 (Adalimumab) Filed NDA in Nov 2018

IBI-305 (Bevacizumab) Filed NDA in Jan 2019

Ch

ina

U.S

.

Filed NDA First Patient Dosed Received IND Approval


State-of-the-art Manufacturing Facilities Designed to, Built to and Operating at International Standards

Innovent’s manufacturing facilities are

designed for FDA, EMA and NMPA

standards, and support the full

process from DS to DP. DS, DP and

GMP were successfully audited.

Undergone ordinary course,

comprehensive annual audits of

production facility to evaluate

compliance with industry GMP and

quality compliance standards.

Manufacturing team with extensive

experience at multi-national

pharmaceutical companies.

M1b Facility

4 x 15,000 L

Planned

3 x 1,000 L In Operation

6 x 3,000 L (cGMP

validated) Ready in 2019

Total capacity in the future: 81KL

On 29 December 2018, our manufacturing facilities received GMP certification from the NMPA for manufacturing Tyvyt® (sintilimab)


Global Partners

July 2013

Therapeutic

antibody discovery

platform

June 2016

Bispecific

Antibody platform

March 2017

Bispecific

antibody collaboration

November 2018

Combination Therapy

February 2019

Combination Therapy

October 12th 2015

Innovent out licensed Ex-

China right of additional 3 PD-

1 bispecific mAbs to Lilly

In return, Innovent received

milestones >$1 billion

March 20th 2015

Innovent out licensed PD-1 mAb

Ex-China to Lilly

Co-development of 3 mAbs in

China

Upfront payment of $56 mm and

milestone payment >$0.4 bn

Dec 17th 2018

Multi-product strategic collaboration announced between Innovent and

Incyte, a well-recognized global biopharmaceutical company

Innovent strengthened its portfolio by licensing in 3 potentially best-in-

class innovative late clinical-stage product candidates for China

development and commercialization

Transformed Innovent from being a mAb development focused

company to a broader portfolio oncology focused entity

Our Other Global R&D PartnersStrategic Partnership with Renowned MNCs


Pipeline Expansion through Partnership

Product Candidates Licensed from Incyte for China Market

Dec 17th 2018

Strengthened portfolio by licensing in 3 potentially Best-in-Class innovative late clinical-stage candidates, including 2

potentially First-in-Class candidates, for China development and commercialization

Transformed Innovent from being a mAb focused oncology company to a company across biologics and small

molecules

Pemigatinib

(FGFR1/2/3)

Potential First-in-Class, Best-in-Class

in treating oncology patients with

FGFR mutations

Solid tumors for Cholangiocarcinoma

(bile-duct cancer), and Urothelial

Cancer (bladder cancer)

Itacitinib

(JAK1)

Potential First-in-Class, Best-in-Class

in the treatment of GvHDGraft versus Host Disease (GvHD)

Parsaclisib

(PI3Kδ)

Potential Best-in-Class

in treating hematological malignancies Non-Hodgkin’s Lymphoma


Strong Support from Globally Renowned Investors

Ten Cornerstone Investors with an Aggregate Amount of US$245 mm

US$20 mm

~US$20 mm US$25 mm

US$5 mmUS$20 mm

US$15 mmUS$60 mm

US$30 mm US$20 mm

US$30 mm


Corporate Milestones

1 Up to Mar. 14, 2019

2 International Financing Review

Listed on HKEX with stock code: 01801.HK,

raising HK$3.3 billion (US$485 mm) on Oct.

31, 2018

Largest pre-revenue IPO at the time

Stock price increased over 100% since IPO¹

Superior pricing outcome with significant

over-subscription

Awarded by IFR2 as

“Asia-Pacific IPO of

the Year”

Asia-Pacific

IPO of the Year

Awarded by IFR2

Asia as

“Hong Kong

Equity Issue of the

Year”Hong Kong Equity

Issue of the Year


Management with a Proven Track Record of Success

Visionary Founder, CEO and Chairman Supported by Experienced Management Team

Dr. Michael Yu

Founder, CEO & Chairman

Ph.D. in Genetics, Chinese Academy of Sciences

Inventor of Oncorine, Co-inventor of Conbercept and

sintilimab, three Class One novel biologics in China

Inventor of 60+ issued patents & patent applications

Published 50+ SCI scientific articles & book chapters

22 years of industry experience

— 1997 – 2001: Vice President, Calydon

— 2001 – 2005: Principal Scientist and Senior Director, Cell Genesys

— 2005: Vice President of R&D, Applied Genetics

— 2006 – 2010: Director, President, and CEO of Chengdu

Kanghong Biotech

— 2011 to date: Founding President and CEO of Innovent

Management Team

Qinwei Zhou, Ph.D.

Chief Operating Officer

Over 24 years of biotech and biopharma

experience

Former Vice President at Eli Lilly in

charge of bioanalytical science and Vice

President at ImClone

Ronnie Ede

Chief Financial Officer

Former CFO of Mindray Medical

International Ltd. Responsible for

Finance, Investor Relation, North

America Operations, and Internal Audits

Former CFO of Biosensors

International Ltd.

Kerry Blanchard, Ph.D., M.D.

Chief Scientific Officer

Senior Vice President China Drug

Development at Eli Lilly & Company

Responsible for building, training and

developing the drug development and

medical affairs organization and for

delivering Lilly’s internal and external

portfolio for China

Min Liu

Chief Commercial Officer

Former member of Roche Global

Oncology Franchise Leadership Team

Vice President of Business Unit

Oncology 2 at Roche Pharma China, in

charge of leading the marketing & sales

efforts for products in lung cancer,

gastrointestinal cancer, and hematology

Founder, CEO & Chairman


Innovent: A Platform Company

Fully-integrated Platform with World-class Discovery, Development, Manufacturing and Commercialization

Capabilities

IBI-306

IBI-310

IBI-302

IBI-307

IBI-101

IBI-188

IBI-110

IBI-318

IBI-939

IBI-315

IBI-322

IBI-319

IBI-301

IBI-303

IBI-323

IBI-305

IBI-308

IBI-385

IBI-376

IBI-377

Clinical

Development

CMC (Manufacturing & Quality)

Discovery Commercialization


Our Growth Strategies

Our Mission


Maximize the value of our

fully-integrated platform

through a global strategy

of organic growth and

collaboration

Continue to enhance our

fully-integrated platform

Rapidly advance our

clinical programs for

pipeline products

Enhance research and

development capabilities

and commercialize our

lead products

01 02 03 04


Expect 4 products launched

Multiple biologics in late

stage development

Global R&D platform

Higher capacity GMP

manufacturing facility

Strong commercial capability

and capacity

2H 2021

Innovent at a Glance

20 drug candidates:

• Tyvyt launched

• 2 NDA filed (IBI-303 & IBI-305)

• 1 Phase III mAb (IBI-301)

Experienced

management team

Global standard GMP

manufacturing facility

Strategic partnership

with Eli Lilly & IncyteIncorporated

Mar-2019Aug-2011

®


Near Term Catalysts

Next 12 months

Launch and commercialization of sintilimab

IBI-301 (Rituximab biosimilar) to file NDA to the NMPA in Q4 2019

Continuous clinical advancement of a number of drug candidates

The 6*3000L M1b facility will be ready for production

1

2

3

4


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2018 annual results presentation - innovent bio · 2019. 4. 1. · events and financial trends that...

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