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Jefferies healthcare conference 2019
Luye Pharma Passionate for Life
Bruno Delie Jefferies healthcare conference 2019
Disclaimer
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These presentation materials have been prepared by Luye Pharma Group Limited (the “Company”) and have not been independently verified. No representation or warranty, expressed or implied, is
made and no reliance should be placed on the accuracy, fairness or completeness of the information presented or contained in these presentation materials. The Company will not accept any liability
whatsoever for any loss howsoever arising from any information presented or contained in these presentation materials. The information presented or contained in these presentation materials is current
as of the date hereof, unless indicated otherwise, and is subject to change without notice and its accuracy is not guaranteed. The Company does not provide any undertaking to update any such
information subsequent to the date hereof.
These presentation materials contain certain “forward-looking statements”. These forward-looking statements include but not limited to projections, targets, estimates and business plans that the
Company expects or anticipates will or may occur in the future. Certain statements, such as those include the words or phrases “potential”, “estimates”, “expects”, “anticipates”, “objectives”, “intends”,
“plan s”, “believes”, “will”, “may”, “should”, and similar expressions or variations on such expressions may be considered forward-looking statements. These forward looking statements are made based
on the operating conditions, strategies and other circumstances of the Company and are subject to known and unknown risks and uncertainties that may be general or specific. Readers should note that a
variety of factors, many of which may be beyond the Company’s control, affect the performance, growth trends and actual results of the Company. These factors include, but are not limited to, exchange
rate fluctuations, market shares, peer competition, environmental risks, changes in social, political, legal, financial and regulatory frameworks, international economic and financial market conditions and
other risks and factors beyond the control of the Company.
Due to these factors, the future actual operating results of the Company may differ materially from these forward-looking statements. These and other factors should be considered carefully and readers
should not place undue reliance on any of the Company’s forward -looking statements. The Company declares that, the Company and any associated companies, directors, officers, employees, consultants
or representatives of the Company assume no obligation to update or revise any forward-looking statement that is contained in these presentation materials as a result of new information, future events
or otherwise. None of the Company, or any of its associated companies, directors, officers, employees, consultants or representatives is making any representations concerning the future performance of
the Company, or is responsible for any losses arising from reliance on the forward-looking statements contained in these presentation materials.
These presentation materials are for information purposes only and do not constitute or form part of an offer, solicitation or invitation of any offer to buy or subscribe for any securities of the Company, in
any jurisdiction, nor should it or any part of it form the basis of, or be relied upon in any connection with, any contract, commitment or investment decision whatsoever.
Passionate for Life
30+ products marketed in 50 countries
7 manufacturing sites
3 global R&D centers
Robust pipeline with Oncology and CNS focus
Molecular Diagnostics
Regenerative Medicine
Cellular Immunotherapy Over 50 medical institutions
Approximately 3,000 hospital beds
Luye Life Sciences Group
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Passionate for Life
Founded in 1994
Headquartered in Yantai Shandong,
China
Business presence in Asia, Europe and North
America
15,000+ employees worldwide
Passionate for Life
(02186.HK)
Revenue Breakdown by Therapeutic Area
Passionate for Life 4
Oncology
44.9%
CNS
19.6%
Metabolism
17.6%
Cardiovascular
15.4%
Luye Pharm: Oncology and CNS are the core strategic areas 2019 targeted revenues : USD 890 M . CAGR : +19 %
Lipusu® Ovarian
Cancer
Breast
Cancer
SCLC Seroquel® Schizophrenia
Lipascor® Xuezhikang®
Hypercholesterolemia
TTS in CNS Rivastigmine
Buprenorphine
Fentanyl
Key products by Therapeutic Area
The CNS market is expected to continue and even increase its growth globally, driven in part by patient population growth and greater understanding of mental illness
• In the past year, global CNS pharmaceutical market* achieves +2% growth and realizes
123billion USD sales for the total sales of USA, Europe, and China
• As per Datamonitor forecast, global CNS pharmaceutical market is expected to grow at
+5.9% CAGR for the next five years due to several growth drivers globally, from both
growing patient population and entries of innovative treatments and therapies
Key global market drivers
• High global burden of CNS diseases, and growing patient
populations as developed markets age, and diagnosis and
treatment rates increase
• Novel treatments entering the market, in response to rising
demand and persistent unmet need, and on the back of
advancements in drug discovery techniques
• Greater prevalence of psychiatric disorders, and awareness of
mental health, as well as growing social awareness and
acceptance of patients with mental illness, encouraging diagnosis /
treatment
• Growth in injectable treatments, as importance of adherence to
treatment gains further attention
• In China, increasing healthcare access is also a major factor
• Growth in transdermal drug delivery market (11.6% CAGR to
2025)
Source: IQVIA and Datamonitor * Global CNS pharmaceutical market: the data includes those number of USA, Europe and China
Luye is focused on developing innovative treatments for this growing market
5
2017
110
11
112 USA/Europe
10
2018
China
120 123
2%
Global CNS Pharmaceutical Market*
Unit: Billions of USD
Luye Pharma Products marketed through affiliates and network of distributors and strategic partners
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Boston R&D center
Princeton
London
Miesbach
Basel
Singapore
Yantai
Shanghai
Tokio
Sales Presence
Affiliates/Business office
R&D Center/Manufacturing Facilities
• Business office in Switzerland
and UK
• 2nd largest global player in
Transdermal Patches
EUROPE
NORTH AMERICA
• R&D in Boston
• Business office in Princeton
CHINA
More than 1000 sale representatives and
products sold to over 13 700 hospitals.
2 RnD centers
5 manufacturing sites
ASIA Business offices in Japan and Singapore
Passionate for Life
R&D and innovation capabilities
Luye has established R&D centers in China, the U.S. and Europe Over 600 R&D professionals Over 700 patents on PCR and international Over 30 scientific awards Scientific collaboration focussing on external innovation
R&D Center in China
• Key R&D Capabilities:
Long-acting and Extended
Release Technology
Liposome and Targeted
Drug Delivery
Biological Antibody
Technology
Passionate for Life 7
R&D Center in the U.S.
• Key R&D Capabilities:
International R&D
Collaboration
Exploratory Study for
Innovative Drugs
R&D Center in Europe
• Key R&D Capabilities:
Transdermal Drug
Delivery
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Platforms and Technologies
Liposome and Targeted Drug
Del ivery Long-acting and Extended Release
Technology
Transdermal Drug Del ivery System
New Compounds
Biological Antibody Technology
Passionate for Life
Product No. Indications Progress
PC IND Ph I Ph II Ph III NDA
Oncology
LY01008 Colorectal cancer, NSCLC
LY01005 Prostate cancer, breast cancer
LY01007 Prostate cancer, endometriosis
LY01011 Myeloma and bone metastasis
LY01013 Tumor
LY01610 Rectal cancer, pancreatic cancer
Central Nervous System
LY03011 Mild to moderate dementia
LY03401 Parkinson's disease
LY03004 Schizophrenia and bipolar disorder
LY03005 Moderate to severe depression
LY03003 Parkinson's disease
LY03012 Chronic pain
LY021701 Severe pain
LY021702 Moderate to severe pain
LY03010 Schizophrenia
Ophthalmology LY09004 Age-related macular degeneration
Cardiovascular LY02404 Hypercholesterolemia
Orthopaedics LY06006 Osteoporosis
Gynecology Apleek Female contraception
*Launched in the U.S. and EU
*Launched in the EU market
R&D pipelines of nearly 40 drug candidates in China, including 15 oncology drugs,14 CNS drugs.
R&D Pipelines in China
Passionate for Life 12 NDDS Small molecule innovative Antibody Others
Passionate for Life 10
International R&D Pipelines
Luye Pharma has several investigational products in CNS and Oncology therapeutic areas under clinical trials
Therapeutic Areas Indications Product Countries PC IND Ph I Ph II
Ph III/ Pivotal
Registration
CNS
Schizophrenia and bipolar disorder
Rykindo (LY3004) USA , EU
Mild to moderate dementia
Rivakin (30410) EU
Moderate to severe depression LY03005 USA, JAPAN
Parkinson’s disease
LY03003 / LY3009
USA, EU,JAPAN
Schizophrenia LY03010 USA, EU
Oncology Prostate cancer LY01005 USA
Myeloma & Bone metastasis LY06006/01011 USA
Cardiovascular Hypercholesterolemia Lipascor (LY02405) USA
Gynecology Female Contraception Apleek EU
NDDS Small molecule innovative Antibody Others
Passionate for Life 11
U.S FDA acceptance of NDA filing on May 2019
Limited oral supplementation required during treatment initiation
Rapid onset : Steady state concentrations are reached faster than comparators . Provide ability to quickly stabilize patient
Rapid offset : Faster decrease in plasma concentration than comparators which would lower side effect risk
Passionate for Life 12
Passionate for Life
Global
Manufacturing Global R&D
M&A
JV &
Alliances
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Luye Pharma’s vision is to become one of the key Global Pharmaceutical Company in 2025
Global Market Built up an interational
marketing platform
2019 Set up Luye Pharma Ltd UK Set up S&M field force in GCC Operations
2017 Set-up Luye Pharma European HQ 2013 Set up US Business and R&D
2019
first NDA submission for Rykindo ®
Robust pipeline with 40 products
Focus on CNS and Oncology
2019
Launch overseas production Global supply chain management system
2019
Licensing-in Lurbinectidin Zepsyre® for NSCLC in China
Agreement to promotion Lipascor® in China and international
2018
Acquisition of Seroquel®
2016
Acquisition of Acino’s TDS Business
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