2019 Annual Results Presentation - investor.innoventbio.com
Transcript of 2019 Annual Results Presentation - investor.innoventbio.com
0Copyright© 2020 Innovent Biologics
Confidential
To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people
2019 Annual Results Presentation
March 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
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.
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 the premier biopharmaceutical
company in China
Robust and high quality pipeline
Global standard cGMP biologics
manufacturing facility in China
COMPANY MISSION COMPANY VISION COMPANY STRATEGY
3Copyright© 2020 Innovent Biologics
Our History
To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people
2011.8
2012
2013
2014
2015
2016 2018
20192017
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
Tyvyt® (sintilimab injection) included in the 2019 guidelines of the CSCO for Lymphoid Malignancies and featured as a cover story of The Lancet Haematology
IBI-303 published in the Inaugural Issue of The Lancet Rheumatology
Raised US$304 million via new shares placement
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
4Copyright© 2020 Innovent Biologics
Major Accomplishments since 2019 to March 2020
COMMERCIALIZATION CLINICAL ADVANCEMENT GLOBAL COLLABORATIONS OTHER CORPORATE MILESTONES
EXPANSION OF MANUFACTURING FACILITIES• Second manufacturing facility M1b, housing 6x3,000L stainless steel bioreactors, in operation
• Total production capacity increased to 23,000L, becoming one of largest in China
FUNDRAISE PLACEMENT
• Raised approximately US$304 million through a new shares placement in Oct. 2019
• Raised approximately US$303 million through a new shares placement in Feb. 2020
ORGANIZATION GROWTHExpanded all-rounded talents team to 2,000, international division and the U.S. office in operations
EXPANDED STRATEGIC PARTNERSHIP WITH ELI LILY AND COMPANY
• License in mid-stage potentially global best-in-class diabetes molecule product candidate
• IND application of the molecule accepted by the NMPA
EXPENDED GLOBLE COLABORATION WITH CHI-MEDTo evaluate the combination of sintilimab and Chi-Med’s surufatinib in solid tumours
PARTNERSHIP WITH COHERUS BIOSCIENCESLicense out commercial rights of bevacizumab biosimilar to Coherus in the U.S. and Canada
PARTNERSHIP WITH ALECTORLicense in first-in-class anti-SIRP-α antibody for oncology indications treatment in China
1st LAUNCH WITH STRONG MOMENTUM - TYVYT® (SINTILIMAB INJECTION)
• Achieved above RMB1 billion sales in 2019 since launched in March 2019
• Becoming one of the best-selling drugs ever launched in China
NRDL INCLUSIONBecoming the only PD-1 inhibitor included in the NRDL in November 2019
COMMERCIAL TEAM EXPENSIONExpended the experienced commercial team to about 700 employees in 2019
ROBUST PORTFOLIO WITH 22 VALUABLE ASSETS
• 3 NDAs of biosimilars under review with priority review status by the NMPA
• 14 registrational or pivotal trials ongoing with 4 of sintilimab completed patients enrollment
- 1L Non-squamous NSCLC (met primary endpoint of PFS in interim analyst)
- 1L Squamous NSCLC
- 2L Squamous NSCLC
- 1L Hepatocellular Carcinoma (combo with IBI-305 (biosimilar to bevacizumab))
• 17 clinical stage assets with 50+ studies ongoing both in China and the U.S.
• 9 INDs approval
5Copyright© 2020 Innovent Biologics
Agenda
1 COMMERCIALIZATION OF TYVYT® (SINTILIMAB INJECTION)
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
6Copyright© 2020 Innovent Biologics
Delivered strong sales
results with sound
counter-competitive campaign
STRONG SALES PERFORMANCE
SUCCESSFUL NRDL
Succeeded in NRDL negotiation to
be the ONLY PD-1 inhibitor with
reimbursement
ESTABLISHED BRAND PERCEPTION
Established competitive brand perception
in medical society with high quality KOL
engagement and SOV campaigns
STRENGTHENCOMMERCIAL
CAPABILITY
Built a 700-arm strong full
function commercial team with
competitive skill sets,
execution, and mindset
Commercialization Summary of 2019
7Copyright© 2020 Innovent Biologics
Commercialization of Tyvyt® (Sintilimab Injection) Flawless Execution Led to Solid Results in 2019
SALES LAUNCHEDTyvyt® (sintilimab injection)
March 9, 2019
Sales reached
RMB1,015.9 Million
2019
8Copyright© 2020 Innovent Biologics
Tyvyt® (sintilimab injection) is the ONLY PD-1 inhibitor listed in the NRDL
Demonstrated its clinical value recognition from NHSA and increased affordability and accessibility for patients
Commercialization of Tyvyt® (Sintilimab Injection) Flawless Execution Led to Solid Results in 2019
9Copyright© 2020 Innovent Biologics
Free medical consultation in work with 3rd party to engage KOL at online platform
Promote sintilimab’s international quality to HCP together with Lilly at 3rd part platform (CSCO)
Innoventbio Oncology Form covered the Top KOL in China, including 3 academician
KOL interview after NRDL landing, propagate the affordability to HCP and patients
Established Competitive Brand Perception with High Quality KOL Engagement
InnOncology Online Medical Consultation
NRDL KOL interview Cooperate with Lilly
10Copyright© 2020 Innovent Biologics
Established Broad and Deep Commercial Footprint throughout China
30Provinces Coverage
~300Cities
Coverage
~2,000 Target
Hospital
~500 DTP/
Pharmacies
~700Commercial Team Size
11Copyright© 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
12Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization of Tyvyt® (Sintilimab Injection)
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
RESEARCH & DEVELOPMENT
13Copyright© 2020 Innovent Biologics
Select Robust Pipeline Across Novel Therapeutics
Biologics Small molecules Clinical progress in the U.S.First Patient Dosed in 2019
Status (China)
Products Target (s) Therapeutic Area Commercial Rights Pre-clinicalIND
Phase1 Phase 2 Phase 3 NDA LaunchedFiled Accepted
sintilimab (IBI-308) PD-1 Oncology Worldwide
IBI-303 (adalimumab biosimilar) TNF-alpha Autoimmune Worldwide
IBI-305 (bevacizumab biosimilar) VEGF-A Oncology Worldwide
IBI-301 (rituximab biosimilar) CD20 Oncology Worldwide
IBI-306 PCSK9 Metabolic Mainland China, HK, Taiwan
IBI-310 CTLA-4 Oncology Worldwide
IBI-375 (Pemigatinib) FGFR1/2/3 Oncology Mainland China, HK, Taiwan, Macau
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-101 OX40 Oncology Worldwide
IBI-188 CD47 Oncology Worldwide
IBI-318 PD-1/PD-L1 Oncology Mainland China, HK, Macau
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-322 PD-L1/CD47 Oncology Worldwide
IBI-939 TIGIT Oncology Worldwide
IBI-112 IL-23 p10 Autoimmune Worldwide
IBI-319 PD-1/undisclosed target Oncology Mainland China, HK, Macau
IBI-323 LAG-3/PD-L1 Oncology Worldwide
IND approved: Dec 2016
IND approved: Sep 2017
IND approved: Jun 2019
IND filed: Jan 2020
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
NDA approved: Dec 24, 2018
IND approved: Nov 2019
IND approved: Nov 2019
IND approved: Nov 2019
IND approved: Jul 2019
IND filed: Jan 2020
IND approved: Sep 2019
IND approved: Jan 2020
IND approved: Jan 2020
Jan 2019: First Patient Dosed in
China
March 2019: First Patient Dosed
in the U.S.
NDA Acceptance *
******
*
*
*
*
14Copyright© 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-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)
15Copyright© 2020 Innovent Biologics
Clinical Development Programs for Tyvyt® (Sintilimab Injection) 27 Studies with 12 Registratinal or Pivotal Trials Ongoing or under Planning
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
Met primary endpoint in interim analysis
16Copyright© 2020 Innovent Biologics
Clinical Development Programs for Tyvyt® (Sintilimab Injection) 27 Studies with 12 Registratinal or Pivotal Trials Ongoing or under Planning
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
17Copyright© 2020 Innovent Biologics
Clinical Highlights of Tyvyt® (Sintilimab Injection) andIBI-303 (Biosimilar to Adalimumab)
Cover Story of Tyvyt® (sintilimab)
at The Lancet Haematology
Published at Inaugural Issue of
The Lancet Rheumatology
Pivotal trials in patients with relapsed or refractory classical Hodgkin’s lymphoma
97.9% DCR, 85.4% ORR, 42.7% CR
Equivalence trial between IBI-303 and adalimumab
The first China-based Phase 3 report of biosimilar appears in the first-tier medical journal
18Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization of Tyvyt® (Sintilimab Injection)
MANUFACTURING FACILITIES
Global Partnerships
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
19Copyright© 2020 Innovent Biologics
4 x 15,000 L Planned
5 x 1,000 L In Operation6 x 3,000 L in Operation
TOTAL CAPACITY IN THE FUTURE: 83,000 L
State-of-the-art Manufacturing Facilities Designed, Built and Operated at International Standards with Large Scale
Manufacturing
facilities received
GMP certification
from the NMPA
for manufacturing
Tyvyt® (sintilimab)
in December 2018
Designed for FDA, EMA and NMPA
standards and support the full
process from DS to DP. DS, DP and
GMP successfully passed audit.
Becoming one of the largest in China on scale.
Undergone ordinary course,
comprehensive annual audits of
production facilities to evaluate
compliance with industry GMP and
quality compliance standards.
Manufacturing team with
extensive experience at multi-
national pharmaceutical
companies.
20Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization of Tyvyt® (Sintilimab Injection)
Manufacturing Facilities
GLOBAL PARTNERSHIPS
Organization & Fundraise
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
21Copyright© 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 mAbs to 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
22Copyright© 2020 Innovent Biologics
Expanded Collaboration with Eli Lilly
• Licensed in a mid-stage potentially global best-in-class diabetes
molecule for China development and commercialization
Expanded efforts in metabolic diseases into the diabetes area
• Licensed out ex-China right of additional 3 PD-1 bispecific mAbs to Lilly
May receive milestones >$1 billion
• Licensed out PD-1 mAb ex-China to Lilly, Co-development of
3 mAbs in China
Received upfront payment of $56 million and may receive
milestones >$0.4 bn
OXM3
3 PD-1 bispecific mAbs
3 mAbs , including PD-1 mAb
1
23
23Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization of Tyvyt® (Sintilimab Injection)
Manufacturing Facilities
Global Partnerships
ORGANIZATION & FUNDRAISE
Financial Review
Outlook
2
3
4
6
5
7
Research & Development
24Copyright© 2020 Innovent Biologics
Expanded All-Rounded Talent Team
Commercialization Team R&D Team CMC Team General and Administrative Team
700+ employees 500 employees 100+ employees
~2,000 employees
700 employees
Fully fledged team in sales, medical affairs, strategy planning and operation functions
25Copyright© 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,General Manager of
Innovent Shanghai Branch
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
26Copyright© 2020 Innovent Biologics
Senior Management Team with a Proven Track Record of Success
Visionary Founder, CEO and Chairman Supported by Experienced Management Team
Zane YangSVP
Amy QueSVP
Wei XuSVP
Junjian LiuVP
Wei XuVP
Bo YiVP
Amy GuoVP
BlakeSalisburyVP
Kelly YuVP
Lena ZhouVP
Xia QingVP
Kedan LinVP
General ManagerInnovent Biologics (U.S.), Inc.
Quality (QC & QA) Manufacturing Biologics Discovery Translational Science
Regulatory Affairs
International Division
Business Development
Supply Chain Government Affairs
EngineerInnovent Biologics (U.S.), Inc.
Kaisong ZhouVP
Yun KangVP
Jianfeng GaoVP
Hui ZhouVP
Process Development& Analytical Sciences
Manufacturing Quality Assurance Medical Science
27Copyright© 2020 Innovent Biologics
US$304MFollow-On Offering (October 2019)
Continued interests and confidence of global investors
Track record in delivering
Capability to exceed market expectations
The only Chapter 18A biotech company having completed follow-on in Hong Kong
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$1.7B in aggregate
The largest IPO fund raise at the time for pre-revenue biopharmaceutical company
Over US$600M follow-on offering
The first and only successful follow-on offering in the Biotech Board in the HKEX
28Copyright© 2020 Innovent Biologics
Recognitions by the Investment Communities
Awarded by CHIC (China Healthcare Investment Conference) the “IPO of the year 2018”
ASIA-PACIFIC IPO OF THE YEAR
HONG KONG EQUITY ISSUE OF THE YEAR
A component of the MSCI China
Included in the Hang Seng Hong Kong-Listed Biotech Index
29Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization of Tyvyt® (Sintilimab Injection)
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
FINANCIAL REVIEW
Outlook
2
3
4
6
5
7
Research & Development
30Copyright© 2020 Innovent Biologics
Income Statement
IFRS Measure
Year ended 31 December
RMB'million 2019 2018
Revenue 1,047.5 9.5
Cost of sales (124.9) -
Gross profit (IFRS Measure) 922.6 9.5
Other income 144.1 93.8
Research and development expenses (1,294.7) (1,221.7)
Selling and marketing expenses
-Direct selling and marketing expenses (692.5) (136.0)
-Payments under collaboration arrangements (499.7) -
Administrative expenses (255.3) (220.3)
Other gains and losses 15.1 (4,272.1)
Finance costs (59.5) (69.0)
Listing expenses - (57.2)
Loss for the year (IFRS Measure) (1,719.9) (5,873.0)
Revenue
In 2019, we generated revenue of RMB1,047.5 million,including RMB1,015.9 million driven by product sales of Tyvyt® (sintilimab injection)
Other income consists of government grants and interest income
Expenses
R&D expenses was mainly due to 8 pivotal or registration trials for Tyvyt® (sintilimab injection) to cover all the major indications in China
The increase in S&M expenses was due to the commercial launch of Tyvyt® (sintilimab injection) during the year of 2019
IFRS loss for the year
IFRS loss for the year was RMB1,719.9 million
31Copyright© 2020 Innovent Biologics
Income Statement
Non-IFRS Measure
Year ended 31 December
RMB'million 2019 2018
Revenue 1,047.5 9.5
Cost of sales (113.4) -
Gross profit (IFRS Measure) 934.1 9.5
Other income 144.1 93.8
Research and development expenses (1,260.7) (1,204.3)
Selling and marketing expenses
-Direct selling and marketing expenses (676.2) (130.5)
-Payments under collaboration arrangements (499.7) -
Administrative expenses (169.0) (190.0)
Listing expenses - (57.2)
Operating profit (Non-IFRS Measure) (1,527.4) (1,478.7)
Other gains and losses 15.1 66.0
Finance costs (59.5) (69.0)
Loss for the year (Non-IFRS Measure) (1,571.8) (1,481.7)
Adjustments to IFRS measures (148.1) (4,391.3)
Loss for the year (IFRS Measure) (1,719.9) (5,873.0)
Adjustments to IFRS measures mainly consist of share-based compensation expenses for the year ended 31 December 2019. Loss for the year ended 31 December 2018 included a non-cash, non-recurring fair value changes on preferred shares of RMB 4,338.0 million
32Copyright© 2020 Innovent Biologics
Year ended 31 December
RMB'million 2019 2018 Bank balances and cash 4,232.6 4,525.4
Other financial assets 462.6 -
Trade receivables 247.9 -
Contract assets 2.2 7.5
Other receivables 151.6 73.6
Inventories 358.6 66.1
Income tax recoverables - 13.7
Total Current Assets 5,455.4 4,686.3
Property, plant and equipment 1,344.8 1,078.1
Right-of-use assets 91.5 -
Prepaid lease payments - 52.8
Deposits for acquisition of property,plant and equipment 84.8 45.1
Other receivables and tax recoverables 252.0 250.3
Other financial assets 2.0 -
Total Non-current Assets 1,775.1 1,426.3
Total Assets 7,230.5 6,112.6
Trade payables (84.3) (42.8)
Other payables and accrued expenses (885.0) (600.5)
Contract liabilities (41.7) (17.0)
Borrowings (17.0) (10.0)
Lease liabilities (15.5) -
Total Current Liabilities (1,043.6) (670.3)
Government grants (16.5) (16.0)
Contract liabilities (581.8) (449.9)
Borrowings (808.0) (782.0)
Lease liabilities (24.5) -
Total Non-current Liabilities (1,430.8) (1,247.9)
Total Liabilities (2,474.4) (1,918.2)
Total Equity 4,756.1 4,191.4
Balance Sheet
Cash balance
As of December 31, 2019, our total
cash increased to RMB4,695.2 million
33Copyright© 2020 Innovent Biologics
Agenda
1 Commercialization of Tyvyt® (Sintilimab Injection)
Manufacturing Facilities
Global Partnerships
Organization & Fundraise
Financial Review
OUTLOOK
2
3
4
6
5
7
Research & Development
34Copyright© 2020 Innovent Biologics
Key Upcoming Milestones and Catalysts2020 to Early 2021
SALESGROWTH
• Continue to drive Tyvyt® growth and achieve stronger sales momentum in 2020 and beyond with solid foundation layout during 2019
• Leverage NRDL inclusion to expand patient access to Tyvyt®
• Continue to broaden and deepen sales penetration
• Launch IBI-303 (biosimilar to adalimumab), expect to benefit from early-mover advantage in 2020
• Launch IBI-305 (biosimilar to bevasizumab), expect to benefit from early-mover advantage in 2020
• Prepare commercialization of IBI-301 (biosimilar to rituximab) in 2020
• Receive 3 NDA approvals: for IBI-303 and IBI-305 in 2020, for IBI-301 in late 2020 or early 2021
• Submit 5 NDAs for Tyvyt®: in 1L nsq NSCLC, 1L sq NSCLC, 2L sq NSCLC, 1L HCC, 2L EC
• Complete 2 registrational trials patient enrollment for Tyvyt®: in 1L EC and 1L GC
• Conduct 17+ registrational or pivotal trials, including IBI-188 in China and U.S., IBI-318, IBI-310, IBI-306, IBI-375, IBI-376 in China
• 10+ key study results data readout and to be presented in medical meetings
• Further expand manufacturing facilities and capabilities to commensurate with growing and maturing drug pipeline and support continuous business expansions
• Establish Innovent Academy, pursuing science and innovation, to build a research platform for new drug discovery, innovative technologies and first-in-class drugs and to continuously output innovative products
COMMERCAL LAUNCHES
CLINICAL ADVANCEMENT
CORPORATE DEVELOPMENT
01 02 03 04
35Copyright© 2020 Innovent Biologics
Expected Multiple Studies Advancement with Continuous Execution 2020 to Early 2021
Phase 1
Phase 2
Phase 3
NDA
2728
2313
5
IND
57+
Clinical Trials
Patients in Studies
8000+
Clinical Sites
230+
Launch
4*
* Tyvyt approved in Dec 2018, plus three NDA approvals expected in 2020 or early 2021
301 303 305
Tyvyt® (sintilimab injection)
Biosimilar to Rituximab
Biosimilar to Adalimumab
Biosimilar to Bevacizumab
36Copyright© 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