creating a global oncology leaderwinning strategy 10 • clear vision and market positioning •...
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CREATING A GLOBAL ONCOLOGY LEADERSeptember 2019
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ROBERT WESSMAN
Chairman of the Board
TODAY’S PRESENTERS:
PETAR VASHAROV
Chief Executive Officer
BJARTUR SHEN
Chief Financial Officer
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1 LOTUS TODAY
2 THE PREFERRED PARTNER
3 MARKET DYNAMICS
4 WELL TARGETED PIPELINE4 WELL TARGETED PIPELINE
5 FINANCIAL PROFILE
TODAY’S PRESENTERS:
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ROBERT WESSMANChairman of the Board
4
TODAY’S PRESENTERS
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FROM LOCAL TO GLOBAL REACH
Transformation from a single market player to a full-scale global supplier of oncology drugs
Investing in pipeline, production facility and people
Focusing on oncology and complex generics
Positioning Lotus as a leading pharmaceutical company in the fast growing APAC market
Building a commerical platform in the APAC region A
Note: black – direct market; yellow – Alvogen channels, grey – b2b parterships
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Lotus has transformed from a local company limited to Taiwan to a global specialty pharma player with clear focus on oral oncology and complex generics and 505(b)2 products
Global licensing & Strategic alliance with leading pharma companies, based on strong R&D, strong GMP compliance, & global supply capability
READY for two-pronged expansion strategy: strong footprint in fast growing Asian markets vs global expansion based on robust portfolio focus & B2B networks
Molecule product pipeline
20+Revenues 5 X
B2B markets covered
136
IN ONLY FIVE YEARS… 6
Out-licensing & supply agreements
70+ INNs launched3
INNs contracted6
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First to market with Lenalidomide in Europe
Launched Gefitinib in 20 European markets on patent expiry date
First approval of Vinorelbine soft gel capsules
MAKING A DIFFERENCEFOR PEOPLE WITH CANCER
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STRONG SHAREHOLDER SUPPORTS 8
Lotus Pharmaceutical
Free floatFuji Pharmaceutical Alvogen
62.15%
2.02%
35.83%
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THE PREFERRED PARTNER
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WINNING STRATEGY 10
• Clear vision and market positioning
• Strong strategy execution through a world-class management team
• Unique “winning culture”
• Experienced B2B team building global partnerships
• Aim is to be the Preferred Partner in all key markets
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PETAR VASHAROV
Chief Executive Officer
TODAY’S PRESENTERS
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MARKET DYNAMICS
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ONCOLOGY MARKET IS ONE OF FAST-GROWING THERAPEUTIC AREAS
13
Drug sales as a percentage of the total market
2015
Cancer/Onc/Hem
Infectious disease
Rheumatology
Cardiology
Diabetes/Obesity
HBV/HCV
CNS
Respiratory
Multiple Sclerosis
Epilepsy
GI/Ulcer
Opthalmology
Others
19%
World wide oncology sales: USD95b
2020 Forecast
Cancer/Onc/Hem
Infectious disease
Rheumatology
Cardiology
Diabetes/Obesity
HBV/HCV
CNS
Respiratory
Multiple Sclerosis
Orphan disease
Dermatology
Opthalmology
Others
25%
World wide oncology sales: USD163bSource: SG Cowen
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WE STRIVE TO PROVIDE AFFORDABLE ONCOLOGY CARE WORLDWIDE
14
Source: IQVIA global oncology trends 2019
2008 (481) 2018 (849)
Radiotherapies 0.8% (4) 0.2% (2)
Hormonals 2.5% (12) 1.9% (16)
Cytotoxins 16.8% (81) 7.3% (62)
Targeted small molecules 54.7% (263) 40.3% (342)
Targeted biologics 25.2% (121) 50.3% (427)
The pipeline of late phase oncology molecules, 2008-2018
Lotus’ target markets
The cancer treatment landscape continued to evolve since 2014, and now includes new medicines targeting 23 different cancer types. This is creating a substantial opportunity for global generic companies seeking to expand patient access and lower NHI budgets across the world
Lotus’ R&D engine and specialized manufacturing capabilities allow it to develop and produce a wide range of targeted small molecule treatments. Coupled with the company’s broad commercial reach, this is an ideal candidate to address the expanded oncology opportunity globally
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MARKET TRENDS• Major changes with Chinese FDA have eventually led to rising awareness in data integrity, quality
and the birth of group purchasing policy that created industry consolidation• Japan aims to have 80% generics penetration by 2021• Compliance and innovation encouraged by Korea authorities• Market access remains challenging across the region with fierce local competition• Biosimilars are a significant opportunity
WELL POSITIONED IN A GROWING MARKET 15
5.5
5.9
6.6
7.0
19.0
20.0
109.6
147.4
Thailand
Vietnam
Taiwan
Indonesia
Korea
India
Japan
China
2018E APAC Pharmaceutical Market Size ($bn)‘14-’18 CAGR
12%
1%
8%
5%
10%
4%
14%
5%
Source: IQVIA 2018 Dec
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WELL TARGETED PIPELINE
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FOCUSED ONCOLOGY PORTFOLIO… 17
Focus on high value innovation for patients and customers
To be launched in 2019 - 2025
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
1 Lenalidomide Multiple Myeloma血癌
Global: 10,000
2 Sunitinib GIST; inhibitor腸胃道間質腫瘤
Global ex US: 500
3 Enzalutamidesoftgel
Castration-resistant prostate
cancer去勢抗性的轉移性前
列腺癌
Global: 2,400
4 Methotrexate Chemo 癌症
US: 170
Settled in US and launched in selected marketsOut-licensing scope continues to expand
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…FUELS FUTURE GROWTH 18
Focus on high value innovation for patients and customers
To be launched in 2019 - 2025
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
5 LP173
Late stage hepatocellular
carcinoma, renal cell carcinoma,
thyroid carcinoma
晚期肝細胞癌、晚期腎癌、分化型甲狀腺癌(皆非一線)
Global: 800
6 LP661 Multiple Myeloma血癌
Global: 2,000
7 LP664
Ph+ CML in chronic phase
治療慢性期及費城染色體陽性的慢性骨髓性白血病成年患者
Global: 2,000
8 LP644
Castration-resistant prostate
cancer去勢抗性的轉移性前
列腺癌
Global: 240
200mg
400mg
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NON ONCOLOGY SPECIAL PIPELINE 19
Focus on high value innovation for patients and customers
To be launched in 2019 – 2022
Generic Name Indication IQVIA market size
(US$mn) Formulation BE & CT Submission Approval
1 Ulipristal Women health
女性保健US: FTF
2 LP179Women health
女性保健Global: 300
4 LP654softgel
IPF特發性肺纖維化
Global: 1,000
5 AK-R311 OAB膀胱過動症
Global ex US: 500
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505(b)2 PIPELINE 20
Focus on high value innovation for patients and customers
To be launched in 2019 – 2022
Generic Name Indication IQVIA market size
(US$mn) Phase I Phase III Submission Approval
1 AK-R214 Smoking Cessation Global: 1,000
2 AK-R216 Type II diabetes第二類糖尿病
Global: 320
4 AK-R217 Type II diabetes第二類糖尿病
Global: 650
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MAJOR LAUNCH 2019/2020 – QSYMIA 21
US FDA APPROVED 2nd GENERATION ANTI-OBESITRY DRUG
• Alvogen Korea has obtained marketing approval for Qsymia (phentermine and topiramate extended release) with 4 strengths from South Korea Ministry of Food and Drug Safety (“MDFS”) in partnership with Vivus, NASDAQ listed biopharmaceutical company2
• Qsymia was approved by US FDA in 20123 with clinically proven results for long term weight management with the efficacy of –10.2 kg reduction (–9·8%, –10·4 to –9·3; p<0·0001)4,a
• Target market – traditional anti-obesity product (phenetamine) and 2nd generation anti-obesity products
• Plan of launch: December 2019
1. KRW mn,, Source: IMS 2. Qsymia. Product Information. Ministry of Food and Drug Safety as of 31 Jul 2019, QSYMIA have 4 strengths (3.75/23mg, 7.5/46mg, 11.25/69mg, 15/92mg) 3. Qsymia Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2017. 4. Gadde KM, Allison DB, Ryan DH, et al. Lancet 2011; 377: 1341–52
www.qsymia.com
a. Study design : randomized, double-blind, placebo controlled Study, 56-week phase 3 trial, randomly assigned overweight or obese adults (aged 18–70 years), with a body-mass index of 27–45 kg/m² and two or more comorbidities (hypertension, dyslipidemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss.* Saftey Information: Do not take Qsymia if you are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment; have glaucoma; have thyroid problems (hyperthyroidism); are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. See the end of the Medication Guide for a complete list of ingredients in Qsymia
Market share –68%
Phentermine1 9,162 9,942 9,399 8,830 9,386 10,381
Phendimetrazine1 3,887 4,359 4,092 3,822 3,817 4,303
Liraglutide1 4 281 1,692 5,554 10,547 9,217
0%
25%
50%
75%
100%
1Q 2018 2Q 2018 3Q 2018 4Q 2018 1Q 2019 2Q 1019
Phentermine Liraglutide Phendimentrazine Others
2Q 2019
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INVESTING IN PIPELINE EXECUTION 22
ONCOLOGY IS A CHALLENGING FIELD…Largest number of scientists among peers:
203 (as of 2018)1Development – complicated clinical development, high barrier dosage forms such as softgel capsules, on top of IP hurdles in certain cases
Manufacturing and Supply – state of the art containment system, small volume/high SKU supply chain complexity, and high cost API sourcing
Quality – US FDA, EU EMA, PMDA, TFDA & PIC/S certified, expectingANVISA inspection in the near future
0
100
200
300
400
500
600
700
800
2016 2017 2018 2019 2020
R&D Spend
NT$mn
EXCL. D&A and
impairment
PhD, 11
Bachelor, 86 Master, 107
1: Number of scientists are inclusive of Lotus and its subsidiaries (Alvogen Korea and NCS)
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SITE MASTER PLAN TO UPGRADE FOR SUSTAINABLE GROWTH
23
2019 2020 2021 2022
New warehouse
Area C Upgrade & High Containment
QC Extension/Upgrade
Site Upgrade projects
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BJARTUR SHEN
Chief Financial Officer
TODAY’S PRESENTERS
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2015 – 2019 FROM INTERGRATION TO GROWTH 25
Revenue (US$mn) EBITDA 2018 vs 2019 (US$mn) Net Profit (US$mn)
75
178 190 207 207
0
100
200
300
2014 2015 2016 2017 2018 1H2019
-18
5
-4
2 4
-20
-10
0
10
20
2014 2015 2016 2017 2018 1H2019NT$mn 2,310 5,522 5,902 6,424 6,429 4,076
35
28
14
28
9
14
0
5
10
15
20
25
30
35
40
2018FY
20191H
1H2018
1H2019
2018Avg Q
2019Avg Q
*NTD to USD conversion at NTD31/USD for all years
131
11
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FROM LOCAL TO REGIONAL TO GLOBAL
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
PRE-ALVOGEN 2016 2017 2018 6M2019
Global Export
Domestic
APAC
19.2% US (B/N)5.9% SEA + EU 1.2% China (trazodone)
64.0% Korea1.9% India CRO
26
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THANKYOU