2019 interim results presentation - innovent...

August 2019

2019 Interim 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

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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 History

2011.8 Innovent was

established

2012 First IND filed

with 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

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

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

entered Phase III clinical

trials

Passed GMP audits on

drug products system

2017

2018 Listed on HKEX

Filed NDA for IBI-303 (biosimilar

to adalimumab) with NMPA

Tyvyt granted with 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

Cover Story of sintilimab

(Tyvyt ) by The Lancet

Haematology

Flied NDA for IBI-305

(biosimilar to bevacizumab)

Filed NDA for IBI-301

(biosimilar to rituximab)

Strategic partnership with

Eli Lilly for diabetes

Inaugural Issue of The

Lancet Rheumatology of

IBI-303 (biosimilar to

adalimumab)

®

®


Major Accomplishments in 2019

CommercializationClinicalAdvancement

Corporate MilestonePipeline Expansionthrough Partnership

1st LAUNCH AND

COMMERCIALIZATIONTyvyt ® (sintilimab injection) was launched sales on Mar 9, 2019,and achieved RMB 331.6 M sales in 1H 2019. That remarks the company has grown to the commercial phaseof the business cycle and has unleashed the full power of our fully-integrated multi-functionplatform for the discovery, development, manufacture and commercialization of innovativedrugs in a variety of therapeutic areas.

2 NDA SUBMITTED

NDA for IBI-305 (biosimilar to bevacizumab) in Jan 2019 and IBI-301 (biosimilar to rituximab) in Jun 2019

EXPANSION OF

MANUFACTURING FACILITIESSecond manufacturing facility M1b, housing 6x3000L stainless steel bioreactors, have completed GMP commissioning and validation

STRATEGIC PARTNERSHIP

WITH Eli Lilly and CompanyStrategic collaboration with Lillyfor mid-stage potentially global best-in-class diabetes molecule product candidate, OXM3

STRATEGIC PARTNERSHIP

WITH IncyteStrategic collaboration with Incyte(entered in December 2018) for three late-stage first in China, potentially global best-in-class small molecule product candidates, IBI-375(pemigatinib, a novel FGFR inhibitor), IBI-376 (parsaclisib, a novel PI3Kδ inhibitor), IBI-377 (itacitinib, a novel JAK1 inhibitor)

5 IND APPROVED

sintilimab (IBI308F101) China;IBI-318 China; IBI-110 China & US; IBI-315 China

10 TRIALS COMPLETED

FIRST PATIENT DOSINGsintilimab (4 trials); IBI-302 (bispecific Fc fusion protein);IBI-318 (bispecific antibody);IBI-188 (China & US); IBI-101; IBI-306

ORGANIZATION GROWTH

Reached approximately 1,500 employees1

8 REGISTRATION TRIALS ON GOING

3 PHASE III TRIALS COMPLETED

PATIENTS ENROLLMENTIncluding 2L Squamous NSCLC;1L Squamous NSCLC;1L Non-squamous NSCLC of sintilimab

1. As of June 30, 2019


Clinical advancement since 2019

(1) We and Eli Lilly will co-promote sintilimab (IBI-308) and rituximab (IBI-301) in China

Status (China)

IND

Candidate/

Reference Drug Target(s) Therapeutic Area: Disease Indications Commercial Rights Pre-clinical (Filed) (Accepted)

Phase IPhase II Phase III 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

Worldwide1

IBI-303 (adalimumab

biosimilar)TNF-alpha

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

IBI-305 (bevacizumab

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

IBI-301 (rituximab

biosimilar)CD20

Oncology: non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis Worldwide1

IBI-377 (itacitinib) JAK1 Graft versus host disease (phase 3 in the US) China

IBI-375 (pemigatinib) FGFR1/2/3

Cholangiocarcinoma, urothelial cancer (phase 3 in the US) China

IBI-376 (parsaclisib) PI3Kδ NHL (phase 2 in the US) China

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

patientsChina

IBI-362 OXM3 Metabolic: diabetes China

IBI-310 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-318 PD-1/PD-L1 Oncology: advanced tumors (undisclosed target) China

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

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

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

IBI-326 BCMA-CART Oncology: Relapsed/Refractory Multiple Myeloma Worldwide

IBI-319PD-1/

undisclosed targetOncology: advanced tumors (undisclosed target) China

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

IBI-939 TIGIT Oncology: advanced solid tumors worldwide

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

IND approved: Dec 2016

IND approved: Sep 2017

IND approved: Jun 2019

NDA filed: Jan 2019

NDA filed: Nov 2018

NDA filed: Jun 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

Clinical progress in the U.S.

IND approved: July 2019


Clinical Highlights of Sintilimab (Tyvyt®) andIBI-303 (Adalimumab Biosimilar)

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

Published at Inaugural Issue of The Lancet Rheumatology

Equivalence trial between IBI-303 and adalimumab

The first China based Phase III report of biosimilar appears in the first-tier medical journal

Registration trial in 96 patients with relapsed or refractory classical Hodgkin’s lymphoma

80.4% ORR, 34% CR


Agenda

1 Commercialization of Sintilimab - Tyvyt®

2 Manufacturing Facility

3 Global Partnership

4 Organization


Commercialization of Sintilimab Injection - Tyvyt®

SALES LAUNCHEDTyvyt® (sintilimab injection)

RMB331.6 MSales reached

1H 2019

March 9, 2019


Stronger Brand to Generate Greater Demands

Commercial Strategy

BROADEN MARKET

PENETRATION & INCREASE

ACCESSIBILITY

• Broaden coverage to lower-tier cities

• Expand DTP and hospital formulary accessibility

• Implement patient benefit program tofurther relievepatients’ financialburden

STRENGTHEN SHARE OF

VOICE

• Further expand sales force

• Launch marketing campaigns for Tyvyt® and Bevacizumab biosimilar launch to strengthen brand loyalty

• Improve positive clinical experiences

BUILD RECOGNITION & LEADERSHIP

• Listed into CSCO 2019 treatment guideline

• Support clinical studies: WJP/CSCO research funds

• Work with KOLs and medical society to generate data through IIS & RS studies

• Play leading role in supporting the market education cross major disease areas


Build a Strong Competitive and ProfessionalSales Force with Scale by End of 2019

30ProvincesCoverage

~300Cities

Coverage

~1,500Target Hospital

~400DTP/Pharmacies

~800Commercial Team

Size


Clinical Development Programs for Sintilimab

Status

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

Components)

Phase I

Phase II Phase III

NDA

Filed

NDA

ApprovedIa Ib

China

r/r Classical Hodgkin’s Lymphoma Mono

2L Classical Hodgkin’s Lymphoma Combo (ICE)

2L Squamous NSCLC Mono

1L Squamous NSCLC Combo (gemcitabine and platinum)

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

EGFR + TKI Failure NSCLC 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; = completed patient enrollment; = in progress; = to be initiated within next quarter.3 Some indications may not require every clinical trial indicated on this chart to completed prior to the filing of an NDA.





4 Organization

Agenda


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

M1b Facility: GMP commissioning and validation completed

4 x 15,000 L Planned

5 x 1,000 L In Operation6 x 3,000 L (cGMP validated) Ready in 2019

Total capacity in the future: 83KL

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

Innovent’s manufacturing facilities

are designed complied with 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.





4 Organization

Agenda


Global Partners

July 2013

• Therapeutic antibody

discovery platform

November 2018

• Combination therapy

June 2016

• Bispecific antibody

platform

February 2019

• Combination therapyMarch 2017

• Bispecific antibody collaboration

December 17th , 2018

• Multi-product strategic collaboration

with Incyte

• Licensed in 3 potentially best-in-class

clinical-stage product candidates

for China development and

commercialization

• Transformed Innovent from a mAb

development focused company to a

broader portfolio oncology

focused entity

August 22th, 2019

• Licensed in Lilly’s mid-stage potentially global best-in-class diabetes productcandidate for China development and commercialization

October 12th, 2015

• Licensed out ex-China right of additional 3 PD-1 bispecific mAbs to Lilly

• Potential milestones >$1 billion

March 20th, 2015

• Licensed out PD-1 mAb ex-China to Lilly

• Co-development of 3 mAbs in China

• Received upfront payment of $56 M and potential milestones >$0.4 Bn

July 2019

• Combination therapy


OXM3Licensed in a mid-stage potentially global best-in-class diabetes

molecule product candidate for China development and

commercialization

Expanded efforts in metabolic diseases into the diabetes area

Deeper Collaboration with Lilly

3 PD-1 bispecific mAbsLicensed out ex-China right of additional 3 PD-1 bispecific

mAbs to Lilly

May receive milestones >$1 billion

3 mAbs , including PD-1 mAbLicensed out PD-1 mAb ex-China to Lilly, Co-development of 3

mAbs in China

Received upfront payment of $56 mm and may receive milestones >$0.4 bn


RATIONALE

Strengthen our metabolic portfolio with a first in China, potentially global best-in-class molecule that will be a strong entry point for Innovent to enter into diabetes, an attractive fast growing therapeutic area

Licensed-in Lilly’s Mid-stage Diabetes Molecule OXM3

PRODUCT

• OXM3 is an engineered analog of Oxyntomodulin, a naturally occurring 37-amino acid peptide hormone

• OXM3 is a dual-agonist that targets both the GLP-1 receptor and the Glucagon receptor• OXM3 is a weekly administered injectable that is expected to offer strong glucose lowering

and Best-in-Class weight loss – addressing an unmet need for a large portion of type 2 diabetes patients

TERMS

• Receives development and commercialization rights to Lilly’s mid-phase diabetes product, OXM3

• Lilly retains ex-China rights• OXM3 is currently in active development by Lilly as a Phase II ready asset• Financial terms have not been disclosed





4 Organization

Agenda


Organization Growth

1. As of June 30, 2019

COMMERCIALIZATION TEAM R&D TEAMCMC MANUFACTURING & QUALITY

TEAMGENERAL AND ADMINISTRATIVE

TEAM

1,500Organization Growth to Approximately 1,500 Employees1

450 530 400 120


Awards

Industry-wide Recognition

LACP 2018

Vision Awards

- Gold Award

2018

Annual

Achievement

Award

10th

Anniversary

CHIC

IPO of the Year

2019 Gelonghui

Best Listed

Companies

Award


2019 Outlook

1 2

3 4

2019

SALES GROWTH

Anticipate to continue the

strong sales momentum for

the remainder of 2019

PRODUCT LAUNCH PREPARATION

• Actively engage with the NMPA for the NDAs approval process for IBI-303, IBI-305 & IBI-301

• Commercial preparation for products launch

CLINICAL ADVANCEMENT

Continuous clinical advancement including 8 pivotal registration trials, late stage clinical trials and a number of drug candidates

MANUFACTURING

Planning to further expand manufacturing

facilities to provide sufficient capacity

commensurate with our growing and

maturing drug pipeline


• Tyvyt® launched sales

• 3 NDAs filed (IBI-303, IBI-305 & IBI-301)and under review by the NMPA withpriority review status

• Extending product portfolio to diabetesarea through licensing in Eli Lilly’s OXM3

• M1b：6*3000L bridging

• 4 commercialized products

• 5 products entering late stage development

• Global R&D platform

2

VISION

5-year Plan with Measurable Goals

• >8 commercialized products

• Multiple products entering late clinical stage

• Larger GMP manufacturing capacity

3

20252021

2019

2019 interim results presentation - innovent...

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