2020 interim results presentation -...
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0Copyright© 2020 Innovent Biologics
Confidential
To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people
2020 Interim Results Presentation
August 2020
1Copyright© 2020 Innovent Biologics
Disclaimer
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
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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
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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.
2Copyright© 2020 Innovent Biologics
Our Mission, Vision and Development Strategy
To develop and commercialize high
quality biopharmaceuticals that are
affordable to ordinary people
To be a premier biopharmaceutical
company in the world• Robust and high quality pipeline
• Global standard cGMP biologics manufacturing facility in China
COMPANY MISSION COMPANY VISION COMPANY STRATEGY
3Copyright© 2020 Innovent Biologics
Byvasda® (bevacizumab biosimilar) received marketing approval
Expanded Collaboration with Eli Lilly on Tyvyt®
Strategic partnership with Roche
Raised US$303million and US$360million via new shares placements
Removed “B” marker on stock name
Stock Included in HSCI
Our History
To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people
2011.8
2012
2013
2014
2015
2016 2018
20192017
Innovent was established
First IND filed with the NMPA
Strategic alliance with Adimab
First IND application received approval
Built manufacturing facilities
Strategic partnership with Eli Lilly
Passed audit on GMP system and production facilities
IBI-301 (biosimilar to rituximab), IBI-303 (biosimilar to adalimumab), IBI-305 (biosimilar to bevacizumab) entered Phase 3 clinical trials
Passed GMP audit on drug products system
Listed on the Main Board of the HKEX
NDA of IBI-303 filed with the NMPA
Tyvyt® (sintilimab injection) received marketing approval from the NMPA
Strategic partnership with Incyte
Strategic alliance with Hanmi
PD-1 inhibitor sintilimabentered Phase 3 clinical trials
Tyvyt® (sintilimab injection) listed in the NRDL
Granted priority review status for the NDAs of three biosimilars (IBI-301, IBI-303 and IBI-305) by the NMPA
Strategic partnership with Eli Lilly for diabetes
Raised US$304 million via new shares placement
2020
4Copyright© 2020 Innovent Biologics
Major Accomplishments since 2020
SIX COLLABORATIOND WITH WORLD-CLASS PATERNERS, INCLUDING LILLY AND ROCHEExpanded Strategic Collaboration with Lilly on Tyvyt®
• Out-licensed the development and commercialization rights of Tyvyt® outside of China to Lilly
• US$200Mn upfront payment, up to US$825Mn potential milestones and double digit royalties of net sales
Strategic Collaboration with Roche
• Collaboration on the discovery and development of bispecific antibodies and multiple cell therapies
• Move ahead to the core drug discovery stage across technology platforms
Collaboration with U.S. MD Anderson Cancer Center
• To study Tyvyt®(sintilimab injection) in rare cancer types
Partnership with Coherus Biosciences
• License out commercial rights of IBI-305 (bevacizumab biosimilar) to Coherus in the U.S. and Canada
Partnership with Alector
• License in first-in-class anti-SIRP-α antibody for oncology treatment in China
ACHIEVEMENTS IN CAPITAL MARKETS AND COMPANY STRUCTURE
Successful Fundraise via New Shares Placements
• Raised approximately US$303 million through a new shares placement in Feb. 2020
• Raised approximately US$360 million through a new shares placement in Jul. 2020
Included into the Hang Seng Composite Index (HSCI) following “B” Marker Removal
• Removed “B” marker from the stock name in Jun. 2020 after market capitalization/revenue test satisfaction
• Included into HSCI with the change taking effective on 7th Sept. 2020
• Potential to be included in the Stock Connect
Expansion and Retention of Talent Team
• Expanded all-rounded talents team from about 2,000 people at the end of 2019 to over 2,600 people at the
end of June 2020
STRONG SALES GROWTH MOMENTUM AND ENLARGED PRODUCT PORTFOLIO
Continued Strong Sales Growth of Tyvyt ®(Sintilimab Injection)
• Achieved RMB920.9 million sales in 1H 2020 with 177.7% yoy growth, despite the pandemic of COVID-19
• Fully leveraged the unique advantage after included in the NRDL from 1 January 2020
Added Second Commercial Product to the Portfolio
• Byvasda® (IBI-305, bevacizumab biosimilar) was approved in June 2020
Commercial Team and Coverage Expansion
• Expended the experienced selling and marketing team to over 1,100 employees at the end of June 2020
• Expanded the coverage to 3,500 hospitals and 900 DTP/pharmacies across 300 cities at the end of June 2020,
from 2,000 hospitals and 500 DTP/pharmacies at the end of 2019
COMMERCIALIZATION
OTHER CORPORATE MILESTONES
ROBUST PIPELINE OF 23 VALUABLE ASSETS with over 50 trials ongoing
Significant Progress of Tyvyt® on big indications (12 registrational trials completed or ongoing)
• sNDA of 1L nsqNSCLC and 1L sqNSCLC accepted by the NMPA;
• Presented key data of 1L nsqNSCLC at WCLC by oral; presented data of four other trials at ASCO;
Newly Entered Registrational Trial of Four Assets
IBI-310(CTLA-4), IBI-375(pemigatinib, FGFR), IBI-376(Parsaclisib, PI3Kδ),IBI-306(PCSK9)
Fast Progressed Prioritized Assets
• IBI-188(CD47): finished Phase1a dosage escalation in U.S., finalizing Phase1a in China;
• IBI-318(PD1/PD-L1): finished Phase1a dosage escalation in China;
• IBI-939(TIGIT): initiated Phase1 in China
GLOBAL COLLABORATIONS
CLINICAL ADVANCEMENT
5Copyright© 2020 Innovent Biologics
Agenda
1 COMMERCIALIZATION
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
6Copyright© 2020 Innovent Biologics
Commercialization Summary of Tyvyt® (Sintilimab Injection) in 1H 2020Strong Revenue Growth Momentum
Key Achievements in 1H 2020 Strong Revenue Growth Momentum
331.6
684.3
920.9
0
100
200
300
400
500
600
700
800
900
1000
1H19 2H19 1H20
Rmb mn
1H20: 177.7% growth over 1H19; 34.6% growth over 2H19
• Revenue of Rmb920.9mn in 1H 2020, representing 177.7% growth year-over-year
• Fully leveraged the unique advantage as the only PD-1 inhibitor in NRDL:
- Expedited the process of entering hospital channels
- Expanded coverage in both major and lower tier cities
- Growing sales and marketing team
- Comprehensive marketing activities to build up
recognition from doctors and patients
7Copyright© 2020 Innovent Biologics
Launched Second Commercial Product BYVASDA®(Bevacizumab Biosimilar)
BYVASDA ® (Bevacizumab biosimilar):
• NMPA marketing approval date: Jun 19, 2020
• Indications: advanced non-small cell lung cancer and
metastatic colorectal cancer
8Copyright© 2020 Innovent Biologics
• Patient assistant program has benefited 20,000+ patients
allocated in 150 cities and 170 DTP. The program got
successfully closed after one-year-launch after Tyvyt® listed
in the NRDL.
• The poverty-relief program is executed around 14
provinces and has donated 372 vials of Tyvyt®, helping the
much needed patients under poverty-relief program.
• Tyvyt® was featured in CSCO and IASLC Guideline of Lymphoma
and LC areas, and were mentioned in HCC, GI, and so on.
• Cooperation with government office extended oncology
diagnosis and immunotherapy standard and speed up
the penetration of immunotherapy in China.
Accelerated the Penetration of Immunotherapy with Guideline, Co-working with Government Office, and Public-welfare Program
Listed in CSCO and IASLC Guidelines APS benefited 20,000+ patients
NHA IO roadshows in lower-tier market Strengthen company image
9Copyright© 2020 Innovent Biologics
Established Broad and Deep Commercial Footprint throughout China
~30Provinces Coverage
~300Cities Coverage
~3,500 Target Hospital
~900 DTP/Pharmacies
~1,000Commercial Team Size
10Copyright© 2020 Innovent Biologics
Built a Competitive and Professional Commercial Force
SALES SOUTH CHINA
MEDICALAFFAIRS
KEWIN XU
• East 1
• East 2
• Key Account Management
• South
CINDY ZHU
• Medical Science
• Medical Liaison
• Biomarker
• Medical Information
SALES NORTH CHINA
STRATEGIC PLANNING & ACCESS STRATEGY
DONGSHENG LIU
• North
• Beijing
• Key Account Management
• West
RACHEL DENG
• Commercial & Portfolio Strategy
• Access Strategy
• Pricing Strategy
• Market Research
MARKETING
SFE &OPERATION
SPARKLER MAO
• Medical Marketing
• General Oncology 1
• General Oncology 2
• Patient Education
BECKY MA
• Sales Performance
• Sales Incentive
• Territory Deployment
• Operation
AUTO-IMMUNE BU & CHANNEL MANAGEMENT
LI CHEN
• Auto-Immune Sales & Marketing
• Channel Management
• Bidding & Tendering
• Channel Data Management
COMMERCIAL DEVELOPMENT
JIHUA QIN
• Strategic Hospital Collaboration
• Commercial Project Management
• Overseas Market Commercialization Support
• Commercial Model Exploration
COO
MIN LIUChief Commercial Officer,General Manager ofInnovent Shanghai Branch
• Former member of Roche Global Oncology Franchise Leadership Team
• Former Vice President of one of two Oncology Business Units at Roche Pharma China, leading marketing & sales efforts for products in lung, GI, and hematology cancers
11Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
RESEARCH & DEVELOPMENT
12Copyright© 2020 Innovent Biologics
Robust Pipeline Across Novel Therapeutics
Status
Products Target (s) Therapeutic Area Commercial Rights Pre-clinical IND Phase1 Phase 2 Phase 3 NDA Launched
sintilimab (IBI-308) PD-1 Oncology Worldwide
Bevacizumab (IBI-305) VEGF-A Oncology Worldwide
IBI-303 (adalimumab biosimilar) TNF-alpha Autoimmune Worldwide
IBI-301 (rituximab biosimilar) CD20 Oncology Worldwide
IBI-375 (Pemigatinib) FGFR1/2/3 Oncology Mainland China, HK, Taiwan, Macau
IBI-306 PCSK9 Metabolic Mainland China, HK, Taiwan
IBI-310 CTLA-4 Oncology Worldwide
IBI-376 (Parsaclisib) PI3Kδ Oncology Mainland China, HK, Taiwan, Macau
IBI-377 (Itacitinib) JAK1 Oncology: GVHD Mainland China, HK, Taiwan, Macau
IBI-362 OXM3 Metabolic Mainland China, HK, Taiwan, Macau
IBI-188 CD47 Oncology Worldwide
IBI-318 PD-1/PD-L1 Oncology Mainland China, HK, Macau
IBI-101 OX40 Oncology Worldwide
IBI-302 VEGF/Complement proteins Ophthalmology Worldwide
IBI-110 LAG-3 Oncology Worldwide
IBI-315 PD-1/HER2 Oncology Worldwide
IBI-326 BCMA-CART Oncology Worldwide
IBI-939 TIGIT Oncology Worldwide
IBI-322 PD-L1/CD47 Oncology Worldwide
IBI-112 IL-23 p19 Autoimmune Worldwide
IBI-102 GITR Oncology Worldwide
IBI-319 PD-1/undisclosed target Oncology Mainland China, HK, Macau
IBI-323 LAG-3/PD-L1 Oncology Worldwide
Biologics Small molecules Clinical progress in the U.S.
IND approved: Dec 2016
NDA filed : Jun 2019
IND approved: Jul 2019
IND approved : Jan 2020
NDA approved: Jun 19, 2020
NDA filed: Nov 2018
IND approved: Sep 2017
IND accepted : Aug 2020
IND approved: Feb 2018
IND approved: Jun 2018
IND approved: Feb 2019
IND approved: Aug 2018
NDA approved: Dec 24, 2018
IND approved: Nov 2019
IND approved: Nov 2019
IND approved: Nov 2019
IND approved: Jul 2019
IND approved: Apr 2020
IND approved: Sep 2019
IND approved: Jan 2020
IND approved: Jan 2020
*
**
*
*
*
*
First Patient Dosed in 2020NDA Acceptance *
*
*
13Copyright© 2020 Innovent Biologics
Robust R&D Platforms and Oncology Product Candidates
IBI-308 (PD-1)
IBI-301 (CD20)
IBI-305 (VEGF-A)
IBI-310 (CTLA-4)
IBI-102 (GITR)
IBI-188 (CD47)
IBI-101 (OX40)
IBI-110 (LAG-3)
IBI-939 (TIGIT)
IBI-375
(FGFR1/2/3)
IBI-376 (PI3Kδ)
IBI-377 (JAK1)
IBI-318 (PD-1/ PD-L1)
IBI-315(PD-1/HER2)
IBI-322 (PD-L1/ CD47)
IBI-323 (LAG-3/PD-L1)
IBI-319 (PD-1/unspecified)
IBI-326
(fully human BCMA CAR-T)
14Copyright© 2020 Innovent Biologics
Symbols: = completed; = completed patient enrollment; = in progress; = to be initiated within next quarter.
STATUS
INDICATION MONO-/COMBO-THERAPY (OTHER COMPONENTS)PHASE 1
PHASE 2 PHASE 3 NDA FILEDNDA
APPROVED1A 1B
China
r/r Classical Hodgkin’s Lymphoma Mono
1L Non-squamous NSCLC Combo (pemetrexed and cisplatin)
1L Squamous NSCLC Combo (gemcitabine and platinum)
2L Squamous NSCLC Mono
1L Hepatocellular Carcinoma Combo (IBI-305 /biosimilar to bavecizumab)
EGFR+ TKI Failure NCSLC (MRCT) Combo (IBI-305 /biosimilar to bavecizumab)
1L Gastric Cancer Combo (capecitabine and oxaliplatin)
1L Gastric Cancer (CPS ≥10) Combo (Ramucizumab)
1L Esophageal Carcinoma (MRCT) Combo (paclixel and cisplatin/5-FU and cisplatin)
2L Classical Hodgkin’s Lymphoma Combo (ICE)
Melanoma (adjuvant) Combo (IBI-310/CTLA-4 mAb )
2L ESCC Mono
r/r NK/T-cell Lymphoma Mono
3L CRC Combo (IBI-310/CTLA-4 mAb )
Refractory Gastrointestinal Cancer Mono
1L Gastric Cancer Combo (capecitabine and oxaliplatin)
2L NSCLC Mono
1L/2L Melanoma Mono
Clinical Development Programs for Sintilimab27 Studies with 12 Registratinal or Pivotal Trials Ongoing or Completed
sNDAs accepted by the NMPA
15Copyright© 2020 Innovent Biologics
Symbols: = completed; = completed patient enrollment; = in progress; = to be initiated within next quarter.
STATUS
INDICATION MONO-/COMBO-THERAPY (OTHER COMPONENTS)PHASE 1
PHASE 2 PHASE 3 NDA FILEDNDA
APPROVED1A 1B
China
1L Squamous NSCLC Combo (gemcitabine and cisplatin)
2L Neuroendocrine Tumor Mono
Solid Tumors/colorectal cancer Combo (Fruquintinib)
Solid Tumors/cholangiocarcinoma Combo (Surufatinib)
3L colorectal cancer Combo (Chidamide)
2L Hepatocellular Carcinoma Combo (siRNA)
U.S.
1L Esophageal Carcinoma (MRCT) Combo (paclixel and cisplatin/5-FU and cisplatin)
Solid Tumors Mono
Late Stage Endometrial Carcinoma Mono
Clinical Development Programs for Sintilimab
16Copyright© 2020 Innovent Biologics
Key Data of Tyvyt® in 2020
Four Clinical Results at ASCO (2020.06)
Phase 1b study in HCC of Tyvyt® in combination with Byvasda®
Long-term follow-up results in r/r cHL (ORIENT-1)
Two-year follow-up results in NK/T-cell Lymphoma (ORIENT-4)
Phase 2 study in 2L ESCC (ORIENT-2 )
Expected major data release in 2H 2020
Biomarker data of 1L nsqNSCLC at virtual meeting of ESMO;
Phase 3 of 1L sq NSCLC to be announced at virtual meeting of ESMO;
Phase 2 part of the Phase2/3 of 1L HCC (combo with Byvasda®) to be announced at ESMO;
Phase2/3 interim data in 1L HCC (combo with Byvasda®) to be announced at STIC and/or ESMO Asia;
Phase 3 final data of 2L sqNSCLC to be announced at an upcoming conference
1L nsq NSCLC on WCLC (2020.08)
Phase 3 of 1L nsqNSCLC(EGFR and ALK mutation wild)
‒ mPFS of 8.9 months for Tyvyt plus chemotherapy versus mPFS of 5.0 months for chemotherapy. (HR=0.482, P < 0.00001)
‒ No new safety signal
‒ Positive trends in OS
Strong Data Announced in 1L nsqNSCLC; More Upcoming Data for Phase 3 trials in Major Indications
17Copyright© 2020 Innovent Biologics
Entered Pivotal Trial for Four More Assets
Status
Pre-clinicalIND
Phase 1Phase 2(pivotal)
Phase 3 NDA LaunchedFiled Accepted
Entered into Pivotal Phase 2 for 2L mCCA in mainland ChinaChina
Joined Incyte’s global Phase 3 for 1L CCA and plan to dose first patient
1H20
2H20E
*Note: 1) We filed NDA in Taiwan for pemigatinib (IBI-375) for 2L mCCA in 1H 2020.
Status
Pre-clinicalIND
Phase 1Phase 2(pivotal)
Phase 3 NDA LaunchedFiled Accepted
Initiated Pivotal Phase 2 for r/r FL and MZLChina
1H20
IBI-375(FGFR)
IBI-310(CTLA-4)
IBI-376(PI3K)
Status
Pre-clinicalIND
Phase 1 Phase 2 Phase 3 NDA LaunchedFiled Accepted
China1H20 Initiated Phase 3 in combo with Tyvyt® for adjuvant melanoma
IBI-306(PCSK9)
Status
Pre-clinicalIND
Phase 1Phase 2(Pivotal)
Phase 3 NDA LaunchedFiled Accepted
China 2019 Pivotal Phase 2 for HoFH
2019
Mainland China, HK, Taiwan, Macau
Oncology
Oncology
Oncology
Metabolic
Mainland China, HK, Taiwan, Macau
Worldwide
Worldwide
Phase 3 for HeFH
Phase 3 for nFH1H20
* Note: 1)HoFH=homozygous familial hypercholesterolemia; HeFH=heterozygous familial hypercholesterolemia; nFH=non-familial hypercholesterolemia
Target/TA Commercial RightsPartner Trial Region
18Copyright© 2020 Innovent Biologics
Trial Progress of Other Prioritized Assets
Status
Pre-clinicalIND
Phase 1 Phase 2 Phase 3 NDA LaunchedFiled Accepted
Finalizing Phase 1a dosage escalation
China Initiate Pivotal Phase 1b/2 in r/r AML
Initiate Pivotal Phase 1b/3 in MDS
1H20
2H20E
2H20E
U.S.
Status
Pre-clinicalIND
Phase 1 Phase 2 Phase 3 NDA LaunchedFiled Accepted
Completed Phase 1a dosage escalation
Initiate Phase 1b in MDS
1H20
2H20E
*Note: In U.S., we will initiate the Phase 1b trial in MDS with plan for a registrational trial thereafter
Data in 2H
Status
Pre-clinicalIND
Phase 1 Phase 2 Phase 3 NDA LaunchedFiled Accepted
Initiated Phase 1 studyChina
File IND
1H20
2H20EU.S.
IBI-188(CD47)
IBI-318(PD-1/PD-
L1)
IBI-939(TIGIT)
Status
Pre-clinicalIND
Phase 1 Phase 2 Phase 3 NDA LaunchedFiled Accepted
Plan for further development of IBI-318
China 1H20 Finalizing Phase 1a dosage escalation
2H20E
Worldwide
Worldwide
Mainland China, HK, Taiwan, Macau
Target/TA Commercial Rights Trial Region
19Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization
MANUFACTURING FACILITIES
Global Partnerships
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
20Copyright© 2020 Innovent Biologics
State-of-the-art Manufacturing Facilities Designed to, Built to, and Operating at-International Standards
4 x 15,000L
6 x 1,000 L6 x 3,000 L
Total capacity in the future: 84,000 L
M1b Facility
®On 29 December 2018, our manufacturing facilities received cGMP certification from the NMPA for manufacturing TYVYT® (sintilimab)
Facilities were designed to meet FDA, EMA,
PMDA and NMPA standards, and support
the full process from DS to DP. DS, DP and
GMP were successfully audited
Facilities have undergone ordinary course,
comprehensive annual audits to evaluate
compliance with industry cGMP and
quality compliance standards
Manufacturing team has extensive experience
at multi-national bio-pharmaceutical
companies
21Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization
Manufacturing Facilities
GLOBAL PARTNERSHIPS
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
22Copyright© 2020 Innovent Biologics
Striving to Be the Partner of Choice
Strategic Partnerships with Renowned Global Partners
Mar 20th, 2015
• Innovent licensed out PD-1 mAb ex-China to Lilly
• Co-development of 3 mAbs in China
• Upfront payment of $56 M, potential milestone payments > US$0.4 B
Oct 12th, 2015
• Innovent licensed out ex-China rights, and received China rights of additional 3 PD-1 bispecific mAbs to / from Lilly
• Potential milestone payments > $1 B
• Lilly returned the PD-1 ex-China rights in late 2017
Dec 17th, 2018
• Innovent licensed in 3 clinical-stage molecules
• Transformed Innovent from only a focus on mAbsto innovative products regardless of molecule size
• Demonstrated Innovent‘s capability to help global partners bring their innovative therapies into China
Aug 22nd, 2019
• Licensing agreement with Lilly to develop & commercialize a Novel Diabetes Medicine in China
• Potential best-in-class clinical stage product
• Innovent’s therapeutic areas extended to diabetes
Other Global Partnerships
Jul, 2013
• Therapeutic antibody discovery platform
Jun, 2016
• Bispecific Antibody platform
Mar, 2017
• Bispecific antibody collaboration
Nov, 2018 & Oct, 2019
• Clinical collaboration
Jan, 2019
• Clinical collaboration
Jan, 2020
• Clinical collaboration
Aug, 2019
• Clinical collaboration
Jan, 2020
• Partnership on IBI-305 (bevacizumab biosimilar)
Mar, 2020
• anti-SIRP-α antibody collaboration
May, 2020
• US PD-1 Development Rare disease exploration
June 9, 2020
• Strategic Collaboration to Discover and develop multiple cellular therapy and bispecific antibody products in a China first, then global partnering model
Aug 22nd, 2020
• Innovent licensed out PD-1 mAb ex-China rights to Lilly
• Potential total payments to Innovent > $1 b. Upfront payment of $200 mn, potential milestone payments ~ $825mn, and double-digit royalties of net sales
23Copyright© 2020 Innovent Biologics
Further Enhance R&D Capability by Strategic Collaboration with Roche
Innovent: Will access certain Roche technologies in the discovery and development of specific
2:1 T-cell bispecific antibodies (TCB) as well as its universal CAR-T platform
Roche: Will retain an option right to license each product for ex-China development and
commercialization
Significantly enhance our R&D capability in bispecific antibody and cell therapy areas
Aim to enrich the potential FIC candidates of our portfolio beyond 2025
Extend our cross-company collaboration one step ahead to drug discovery stage
Show the recognition of our drug discovery and R&D capabilities by a global top-tier
pharmaceutical company
Access to Roche’s Bispecific Antibody and Universal CART Technologies
Further Enhance our R&D Capability and Enrich FIC Candidates
24Copyright© 2020 Innovent Biologics
Strategic Collaboration Expansion with Lilly on Tyvyt® for Ex-China Market
• Lilly: will receive development and commercialization rights to Tyvyt®
outside of China.
• Innovent: will receive US$200Mn upfront payment, up to US$825Mn
potential milestones and double digit royalties of net sales
Accelerate the introduction of Tyvyt® to the global patients
Opportunity to maximize the commercial value of Tyvyt®
Develop global brand to support future commercial efforts of the Company
Innovent’s first major step in bringing our innovative portfolio to the global market
>US$1Bn Total Deal Value
Maximized Benefits for a Global Tyvyt® Collaboration with Lilly
It is the first time for a China innovative, marketed large molecule medicine out-licensed to a global pharmaceutical company
25Copyright© 2020 Innovent Biologics
Accelerating Innovent’s Global Footprint
Jun 2018:
Established U.S. Subsidiary
Aug 2020:
Established EU Subsidiary
2018 2019 2020
2019:
Initiated Phase 1a study of IBI-188 (CD47 antibody) in U.S.
Feb 2020:
Received IND approval from U.S. FDA for global Phase 3 of Tyvyt® for 1L ESCC
May 2020:
Collaborated with University of Texas MD Anderson Cancer Center to co-develop Tyvyt® in rare cancers in U.S.
1H 2020:
Completed Phase 1a study enrolment of IBI-188 (CD47 antibody) in U.S.
Jan 2020:
Licensed out rights of IBI-305 (bevacizumab biosimilar) in U.S. and Canada to Coherus
Jan 2020:
Received IND approval from U.S. FDA for Phase 1 of IBI-322 (PD-L1/CD47 bispecific antibody)
Aug 2020:
Licensed out development and commercialization rights of Tyvyt® outside of China to Eli Lilly
Supported by appropriate global manufacturing capacity plan
Jan-Feb 2020:
Received orphan drug designations for Tyvyt® in TCL and ESCC from US FDA, and PCTL from EMA
2018:
Initiated Phase 1b study of IBI-308 (PD-1) in U.S. for solid tumors and endometrial cancer
Note: TCL= T-cell lymphoma; PCTL=Peripheral T-cell lymphoma; ESCC= Esophageal squamous cell carcinoma.
26Copyright© 2020 Innovent Biologics
Keep Exploring Global Opportunities for Our Assets
IBI-308 (Sintilimab, PD-1)
• Received IND approval from US FDA for global Phase 3 for 1L EC in 1H 2020
• Entered collaboration with MD Anderson in rare cancers in U.S.
• Licensed out ex-China rights of Tyvyt® to Lilly
• Completed Phase 1a study enrollment in 1H 2020 in U.S.
• To initiate U.S. Phase 1b in 2H with plan for a registrational development thereafter
• Licensed out rights of IBI-305 in U.S. and Canada to Coherus in January 2020
• On going effort to expand cooperation with other parties
• Received IND approval from US FDA in January 2020
• Plan to initiate Phase 1 study for IBI-322 and dose first patient in the U.S. in 2020.
IBI-188 (CD47)
IBI-305 (Bevacizumab)
IBI-322 (PD-L1/CD47)
• Planning for global development
• Plan to file IND to the U.S. FDA in 2H 2020
IBI-939 (TIGIT)
Established subsidiaries in U.S. and Europe with expansion plan
Plan appropriate manufacturing capability to support the international strategy
27Copyright© 2020 Innovent Biologics
Comprehensive Globalization Plan from R&D to Commercial
1
• Robust in-house R&D platform
• Strategic collaboration to further enrich R&D
• Establishing global R&D presence
Innovation focused R&D
3 Gradual approach to build up international commercial capability
• Collaboration with global pharmaceutical partner as the first step
• Expand our local commercial capability gradually in the future
2 Anchor drug candidates with global potential
• Potential FIC or BIC category in global market
• Drugs with meaningful global market potential
• Self develop or co-develop with partners in overseas clinical trial
• Supported by appropriate international manufacturing capacity
28Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization
Manufacturing Facilities
Global Partnerships
ORGANIZATION & FUNDRAISE
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
29Copyright© 2020 Innovent Biologics
Expanded All-Rounded Talent Team
General and Administrative Team
Commercialization Team
R&D Team
CMC Team
1,100+ employees
Fully fledged team in sales, medical affairs, strategy planning and operation functions
750+ employees
500+ employees
~200 employees
~2,600employees
30Copyright© 2020 Innovent Biologics
Executives with a Proven Track Record of Success
Visionary Founder, Chairman and CEO Supported by Experienced Management Team
Dr. MICHAEL YUFounder, Chairman & CEO
• Inventor of Oncorine®, Co-inventor of Conbercept and Tyvyt®, three innovative biologics in China
• Inventor of 60+ issued patents & patent applications
• Authorship of 50+ SCI scientific articles & book chapters
Over 20 YEARS OF INDUSTRY EXPERIENCE
• 1997 – 2001: Vice President, Calydon, USA
• 2001 – 2005: Principal Scientist, Cell Genesys, USA
• 2005: Vice President of R&D, Applied Genetics, USA
• 2006 – 2010: Director, Founding President, and CEO, Chengdu Kanghong Biotech
• 2011 to date: Founding President and CEO, Innovent Biologics
Dr. QINWEI ZHOU
Chief Operating Officer
RONNIE EDE
Chief Financial Officer
MIN LIU
Chief Commercial Officer
VIVIAN ZHANG
Chief People Officer
• Over 20 years of biotech and
biopharma experience
• Former Vice President at Eli Lilly in
charge of bioanalytical science and
Vice President at ImClone
• Former CFO of Mindray Medical
International Ltd. Responsible for
Finance, Investor Relation, North
America Operations, and Internal
Audits
• Former CFO of Biosensors
International Ltd.
• Former member of Roche Global
Oncology Franchise Leadership Team
• Vice President of one of two Oncology
Business Units at Roche Pharma
China, leading marketing & sales
efforts for products in lung, GI, and
hematology cancers
• In charge of the operations of the
CEO‘s office
• Responsible for Human Resources and
Administration, Government Affairs,
Public Relations as well as Legal
31Copyright© 2020 Innovent Biologics
Senior Management Team with a Proven Track Record of Success
Visionary Founder, CEO and Chairman Supported by Experienced Management Team
Dongming WangSVP
Bo YiVP
Amy GuoVP
BlakeSalisburyVP
Lena ZhouVP
Xia QingVP
Kedan LinVP
Quality (QC & QA)
RegulatoryAffairs
International Division
Business Development
Government Affairs
Engineer US branch
Kaisong ZhouVP
Yun KangVP
Jianfeng GaoVP
Hui ZhouVP
Process Development& Analytical Sciences
Manufacturing Quality Assurance
MedicalScience
Stephen Lau
COO
US branch
Junjian LiuVP
Biologics Discovery
Amy QueSVP
Project Management & Strategic Alliances
Wei XuVP
Translational Science
32Copyright© 2020 Innovent Biologics
US$304MFollow-On Offering (October 2019)
Continued interests and confidence of global investors
Track record in value delivering
Capability to exceed market expectations
Removed “B” marker and was included in the Hang Seng Composite indexPotential to be included in the Stock Connect
Strong Support from Globally Renowned Investors
US$5MSeries A
US$30MSeries B
US$115MSeries C
US$262MSeries D
US$485MIPO &
Cornerstone
Oct, 2011 June, 2012 Jan, 2015 Nov, 2016 Jan, 2018 Oct, 2018
US$150MSeries E
US$303MFollow-On Offering (February 2020)
Over US$2.1B in aggregate
The largest IPO fund raise at the time for pre-revenue biopharmaceutical company
Over US$967M follow-on offering
The first and only successful 3 round follow-on offering within 18 months since IPO in the Biotech
Board of HKEX
US$360MFollow-On Offering (July 2020)
33Copyright© 2020 Innovent Biologics
Innovent
• Hang Seng Composite Index (HSCI)• Hang Seng China (Hong Kong-listed) 100 Index• Hang Seng Healthcare Index• Hang Seng Stock Connect Hong Kong Index• Hang Seng Stock Connect Hong Kong MidCap & SmallCap Index• Hang Seng SCHK Mainland China Healthcare Index• Hang Seng SCHK Mainland China Companies Index• Hang Seng Hong Kong-Listed Biotech Index
Remove “B” marker from stock
name as we meet the criterial
of:
• Market Cap
• Revenue
• Non-financial requirements
• Hang Seng SCHK ex-AH Companies Index• Hang Seng SCHK New Economy Index• Hang Seng Large-Mid Cap Momentum 50 Index• Hang Seng Large-Mid Cap Momentum Tilt Index• Hang Seng Large-Mid Cap Value Tilt Index• Hang Seng Defensive Industries Index• Hang Seng Stock Connect Biotech 50 Index• Hang Seng Stock Connect China 500 Index
2020.06: 2020.08: Future
Remove “B” marker from stock name
Included in HSCI and a series of Hang Seng
indices
Potential to be included in the Stock
Connect
Included in a series of Hang Seng indices:
2019:
Included in MSCI China and Hang Seng Hong Kong-Listed Biotech
Index
Included in Various Indices with Improved Capital Markets Recognition
34Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
FINANCIAL REVIEW
Outlook
2
3
4
6
5
7
Research & Development
35Copyright© 2020 Innovent Biologics
Income Statement
IFRS Measure
Revenue
Total revenue for the six months ended 30 June 2020 was RMB984 million, including RMB921 million attributable to sales of TYVYT® (sintilimab injection).
Other income primarily consist of RMB61 million interest income and RMB46 million government grants.
Expenses
R&D expenses was RMB808million. We anticipate gradual increase in pace of R&D spending, mainly to cover the completion of multiple pivotal or registration trials of TYVYT ® (sintilimabinjection) and increased trial needs of other promising late-stage assets and prioritized assets.
S&M expenses increased to RMB447 million, attributable to expansion of the sales team and continuous commercialization efforts to explore potential market for our products.
IFRS loss for the period
IFRS loss for the period was RMB 608.2 million.
Six Months Ended 30 June
RMB'million 2020 2019
Revenue from contracts with customers 984.2 345.5
Cost of sales (184.8) (41.0)
Gross profit (IFRS Measure) 799.4 304.6
Other income 107.4 56.0
Research and development expenses (808.0) (670.7)
Administrative and other expenses (186.8) (78.1)
Selling and marketing expenses (446.6) (266.7)
Royalties and other related payments (134.9) (12.9)
Other gains and losses 97.5 (9.8)
Finance costs (32.6) (36.7)
Income tax expense (3.5) -
Loss for the period(IFRS Measure) (608.2) (714.4)
36Copyright© 2020 Innovent Biologics
Income Statement
Non-IFRS Measure
Adjustment to IFRS measures mainly consists of share-based compensation expenses for the six months ended 30 June 2020.
Six Months Ended 30 June
RMB'million 2020 2019
Revenue from contracts with customers 984.2 345.5
Cost of sales (168.8) (36.1)
Gross profit(IFRS Measure) 815.4 309.4
Other income 107.4 56.0
Research and development expenses (766.2) (659.9)
Administrative and other expenses (111.9) (56.2)
Selling and marketing expenses (424.7) (257.5)
Royalties and other related payments (134.9) (12.9)
Operating profit(Non-IFRS Measure) (514.9) (621.1)
Other gains and losses 97.5 (9.8)
Finance costs (32.6) (36.7)
Income tax expense (3.5) -
Loss for the period(Non-IFRS Measure) (453.5) (667.6)
Adjustments to IFRS measures (154.7) (46.8)
Loss for the period(IFRS Measure) (608.2) (714.4)
37Copyright© 2020 Innovent Biologics
As of
RMB'million 2020.06.30 2019.12.31
Bank balances and cash 4,633.3 4,232.6
Other financial assets-current 1,561.1 462.5
Trade receivables 377.8 247.9
Contract assets 2.3 2.2
Deposits, prepayments and other receivables 120.9 151.6
Inventories 467.1 358.6
Total Current Assets 7,162.5 5,455.4
Property, plant and equipment 1,391.9 1344.8
Right-of-Use assets 82.8 91.5
Intangible assets 35.2 -
Deposits for acquisition of property,plant and equipment 56.4 84.8
Other receivables and tax recoverables 223.5 252.0
Other financial assets 2.0 2.0
Total Non-current Assets 1,791.7 1,775.1
Total Assets 8,954.2 7,230.5
Trade payables (196.1) (84.3)
Other payables and accrued expenses (617.1) (885.0)
Contract liabilities-current (110.2) (41.2)
Borrowings-current (146.0) (17.0)
Lease liabilities (15.5) (15.5)
Total Current Liabilities (1,084.9) (1,043.0)
Contract liabilities (635.6) (582.3)
Government grants (19.8) (16.5)
Borrowings-non-current (793.0) (808.0)
Lease liabilities (16.4) (24.5)
Total Non-current Liabilities (1,464.7) (1,431.4)
Total Liabilities (2,549.6) (2,474.4)
Total Equity (6,404.6) (4,756.1)
Balance Sheet
Cash balance
As of June 30 2020, our total cash increased to RMB6,194 million.
As of July 30 2020, our total cash was approximately US$1.2billion.
38Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
Financial Review
OUTLOOK
2
3
4
6
5
7
Research & Development
39Copyright© 2020 Innovent Biologics
Key Upcoming Milestones and Catalysts2H 2020 to Early 2021
1
• Continue to generate revenue growth of TYVYT® (Sintilimab injection) by leveraging the advantage of NRDL
• Benefit from launch of BYVASDA®(bevacizumab biosimilar)
COMMERICAL SALES GROWTH
4 MAJOR DATA READOUT• Present result of key clinical trials for TYVYT® in 1L sqNSCLC, 1L HCC and 2L sqNSCLC
• Present the U.S. Phase 1a safety data of IBI-188(CD47) in SITC in Nov 2020
• Present the Phase 1 data for IBI-302(VEGF/complement bispecific) in Nov 2020
• Present the Phase 1 and Phase 2 data of IBI-306 (PCSK9) in Aug 2020
3 MAJOR CLINICAL ADVANCEMENT
• Submit sNDA for TYVYT® in 1L HCC and 2L sqNSCLC
• Initiate pivotal Phase 1b/2 for IBI-188(CD47) in r/r AML and pivotal Phase1b/3 in MDS
• Initiate Phase 1b of IBI-188 (CD47) for MDS in the U.S. with plan of registrational trial thereafter
5 CORPORATE DEVELOPMENT
• Potential to be included in the Stock Connect
• Further expand manufacturing facilities and capabilities to support continuous business expansions
Overseas
• Expected Approval of IBI-303(Adalimumab biosimilar) in 3Q20
• Expected Approval of IBI-301(Rituximab biosimilar) in end 2020 or early 2021
2 PRODUCT LAUNCHES
Overseas
40Copyright© 2020 Innovent Biologics
01
2020• 3 commercialized
products
• More products at late stage development
• Increased GMP manufacturing capacity
• Establish Innovent Academy
02
VISION
2030
• More commercialized products, including first-in-class products launched globally
• To be a premier global biopharmaceutical company
Summary: A Long Term Vision
2025
• Expandedcommercialized productsin China
• Multiple products approved in the international market
• Commercial supply from overseas manufacturing site
03
41Copyright© 2020 Innovent Biologics
Innovent: A Leading Platform Company
Fully-integrated, Multi-function Platform with World-class Discovery, Development, Manufacturing and Commercialization Capabilities
Discovery
CMC (Manufacturing & Quality) Clinical Development
Commercialization
42Copyright© 2020 Innovent Biologics