CREATING A GLOBAL ONCOLOGY LEADERWINNING STRATEGY 10 • Clear vision and market positioning •...

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CREATING A GLOBAL ONCOLOGY LEADER September 2019

Transcript of CREATING A GLOBAL ONCOLOGY LEADERWINNING STRATEGY 10 • Clear vision and market positioning •...

Page 1: CREATING A GLOBAL ONCOLOGY LEADERWINNING STRATEGY 10 • Clear vision and market positioning • Strong strategy execution through ... Source: SG Cowen. WE STRIVE TO PROVIDE AFFORDABLE

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

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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

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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

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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

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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

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