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FY2019 RESULTS Investor presentation 1795.TT MARCH 2020

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Page 1: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

FY2019 RESULTS

Investor presentation

1795.TTMARCH 2020

Page 2: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

Except for historical information contained herein, the matters set forth in this presentation are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward looking statements are not based on historical facts but rather on management’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward looking statements. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. Investors are cautioned not to place undue reliance on these forward looking statements, which are made as of the date of this presentation and we assume no obligation to update or revise any forward looking statements.

Safe Harbor Statement

Page 3: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

Today’s Agenda

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FY2019 Results

Key Initiatives in FY2020

Key Takeaways

Page 4: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

› Strong year delivered with 43% top line growth, driven by successful execution of export portfolio

› Buprenorphine/Naloxone sublingual film as 1st wave generics in the US

› 1st to market of 3 leading oncology products in EU

› Significant strategic deliverables designed to drive further growth

› Acquisition of ~50 marketed products to further expand in ASEAN markets

› Portfolio diversification with leading brand products throughout APAC region

› Settlement of Lenalidomide in the US to secure 1st wave launch

› 60+ licensing deals signed to grow our export business

› Excellent outcome from the inspections by USFDA with 0 observation, 5 customer audits and 2 HA inspection at Nantou plant

› Commitment in investing pipeline and upgrading infrastructure to cultivate sustainable growth

› 15 R&D projects under development

› 5-year site master plan initiated

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KEY TAKEAWAYS FROM FY2019

Page 5: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

FY2019 RESULTS

Page 6: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

FULL YEAR 2019 FRUITFUL YEAR WITH REMARKABLE ACHIEVEMENTS

Revenue

+43%

OPIncome

+148%

EPS

+552%

FINANCIAL RESULTS

Strong revenue growth driven by successful expansion of export

portfolio

Improving operating leverage

Record high net profits achieved!

Key Financials

(in NTD Millions, except EPS) 2018 2019YoY

%

Net Sales 6,429 9,175 43%

Cost of Goods 3,289 4,927

Gross profit 3,139 4,248 35%

% 49% 46%Amortization

Operating expenses (2,691) (3,135)

Operating Income 449 1,113 148%

% 7% 12%

Earnings before tax & MI 164 876

Net Income 124 678 447%

EPS (TWD) 0.42 2.74 552%

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Page 7: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

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DIVERSIFICATION ACROSS THERAPIES AND MARKETS

2019 Revenue Breakdown by TA

~35%

~65%

Export Portfolio

• gSuboxonecontributed ~30%

• First-wave launches of oncology products also kicked in

Asian Business

The absolute dollar amount remained comparable to last year with more balanced % contribution

2019 Revenue Breakdown by Market

NT$9,175mn

2019

Asian Market Export Portfolio

34%

17%8%

11%

14%

5%

11%

Central Nervous System

Oncology & Immunology

Anti-obesity & lifestyleproducts

Women healthcare

Cardiovascular &Hematology

Nephrology

All Others

Page 8: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

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ENHANCED PRORITABILITY LOWERING LEVERAGE RATIO

EBITDA (NT$mn)

*EBITDA =EBIT + Depreciation + Amortization + Non-cash provisions

NET DEBT/LTM EBITDA (X)

3.37

2.81

-

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

4.50

5.00

FY2018 FY2019

<3.5x as

committed 1,111

2,094

-

500

1,000

1,500

2,000

2,500

FY2018 FY2019

Page 9: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

KEY INITIATIVES IN FY2020

Page 10: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

Efficiently execute new launches as scheduled

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FY2020 STRATEGIC DELIVERABLES

Further strengthen existing portfolio with combined efforts from R&D / BD / RA- Continued market share expansion of Buprenorphine/Naloxone - 2 submissions of biosimilar products in Taiwan to extend the portfolio - GUDFA TAD for Lenalidomide in Jul’20- 23 licensing deals under discussion

Continuously investing in pipeline to cultivate future growth- Further enhancement on oral oncology portfolio - 505(b)2 oncology programs under discussion - Expansion of brand/proprietary products

Page 11: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

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CAPITALIZING ON SUCCESSFUL LAUNCHES

Buprenorphine/Naloxone Market Share Qsymia Launching Progress

Buprenorphine/Naloxone market share has ramped up as expected

Qsymia has taken leadership position in prescription number within 6th weeks after launch

0

100

200

300

400

500

1st W 2nd W 3rd W 4th W 5th W 6th W 7th W 8th W 9th W 10th W

Belviq Saxenda Contrave Qsymia

10%

15%

20%

0%

5%

10%

15%

20%

Feb'19 Jan'20 Feb'20 Mar'20

Source: IQVIA; Company data Source: UBIST

Weekly UBIST data, within new generation products

//

Page 12: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

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R&D PIPELINE EXECUTION

Focus on high value innovation for patients and customers

KEY ONCOLOGY PROJECT

Generic Name Indication IQVIA market size ‘19 (US$mn) Formulation BE & CT Submission Approval

1 Lenalidomide Multiple Myeloma血癌

Global: 10,000

2 Enzalutamidesoftgel

Castration-resistant prostate cancer

去勢抗性的轉移性前列腺癌Global: 2,144

3 LP173(Pazopanib)

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: 673

4 LP661(Pomalidomide)

Multiple Myeloma血癌

Global: 1,516

5 LP670(Palbociclib)

Treatment for advanced or metastatic breast cancer Global: 5,458

6LP657

(SoftGel capsules)(Mido)

Treatment for acute myeloid leukemia (AML) Global: 205

Settled in US and launched in selected marketsOut-licensing scope continues to expand

GDUFATAD = Jul’20

Tentative Approval in TW

Page 13: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

N0N-ONCOLOGY PROJECT

Generic Name Indication IQVIA market size ‘19 (US$mn) Formulation BE & CT Submission Approval

1 LP117(Tofacitinib)

Treatment for moderately to severely active rheumatoid

arthritis (RA)Global: 1,432

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R&D PIPELINE EXECUTION (CONT’D)

Focus on high value innovation for patients and customers

505(b)2 PROJECT

Generic Name Indication IQVIA market size ‘19 (US$mn) Phase I Phase III Submission Approval

1 AK-R216(Vidaqliptin SR)

Type II diabetes第二類糖尿病

Global: 432

Page 14: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

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LOTUS IS WELL-POSITIONED TO BETTER PERFORMAGAINST NEAR TERM HEADWINDS FROM COVID-19

WITH DIVERSIFIED PORTFOLIO AND PLANNED-AHEAD PROCUREMENT POLICY

34%

17%8%

11%

14%

5%

11% Central Nervous System

Oncology & Immunology

Anti-obesity & lifestyleproductsWomen healthcare

Cardiovascular &HematologyNephrology

All Others

2019 Revenue Breakdown by TA

Two-pronged strategy mitigates the impact –• Temporary impact in KR, which is in line with the industry

norm • Expansion of export portfolio provide the diversification of

potential risks

• Not much APIs are directly sourcing from China • Current inventory covers average 4-12 months of demand• Dual sourcing strategy is under implementation

8%

92%

APIs originating outside China

APIs originating in China

Page 15: FY2019 RESULTS · Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or ... › Excellent outcome from the inspections

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MAJOR CATELYSTS TO WATCH IN FY2020

Expansion of brand portfolio in Asian markets

Development of ASEAN markets, including TH, VN, DX market

Qsymia launch

Throughout 2020 FY2019

Solid sales stream backed by successful export portfolio expansion (Bup/Nal + key oncology products) in 2019 will continue to provide stable contribution throughout 2020

GDUFA TAD in Jul’20 for Lenalidomide