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Lotus Pharm — Investor Presentation 2021
Sep 15, 2021
51923_rns_2021-09-15_0a493ba1-6ca3-45a5-a806-b280ee2f41f5.pdf
Investor Presentation
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LOTUS PHARMACEUTICALS Investor presentation
1795.TT APRIL 2020
Safe Harbor Statement
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.
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Today’s Agenda
Recent Operational Updates Strategic Tactics Towards 2020
1
2
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RECENT OPERATIONAL HIGHLIGHTS
SUCCESSFUL TRANSITION TO BECOME A GLOBAL CONTENDER
› Strong year delivered with 43% top line growth, driven by successful execution of export portfolio
-
› Buprenorphine/Naloxone sublingual film as 1[st] wave generics in the US
-
› 1[st] 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 signed
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› 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
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› Commitment in investing pipeline and upgrading infrastructure to cultivate sustainable growth
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› 15 R&D projects under development
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› 5-year site master plan initiated
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5
FRUITFUL YEAR IN 2019 WITH REMARKABLE ACHIEVEMENTS
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FINANCIAL RESULTS
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Key Financials
YoY
(in NTD Millions, except EPS) 2018 2019
%
Net Sales 6,429 9,175 43%
Cost of Goods 3,289 4,927
Gross profit 3,139 4,248 35%
% 49% 46%
o t at o
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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Strong revenue growth
Revenue
driven by successful
expansion of export
+43%
portfolio
OP
Income
Improving operating
+148% leverage
EPS
Record high net profits
+552%
achieved!
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Strong revenue growth driven by successful expansion of export portfolio
Record high net profits achieved!
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6
Q1’20 SALES UPDATE
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Q1 Sales Breakdown
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NT$2,183mn
NT$1,964mn
~30% ~20%
+2% if excluding
gSuboxone sales
~80%
~70%
Q1'19 Q1'20
Asian market NCS Other Export gSuboxone
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7
CONTINUE TO CAPITALIZE ON SUCCESSFUL LAUNCHES
Buprenorphine/Naloxone Market Dynamics
Qsymia Launching Progress
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•
Bup/Nal market share has ramped up as expected
25%
25%
20%
20%
15%
15%
10%
10%
5%
0% //
Feb'19 Jan'20 Feb'20 Mar'20 Apr'20
•
Avg. Weekly EUTRx unit of whole market is also
increasing
Unit: mn
+25%
8 5.9
6 4.7
4
2
0
//
Feb'19 Jan'20 Feb'20 Mar'20 Apr'20
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Source: IQVIA; Company data
Qsymia has taken leadership position in prescription number within 6[th] weeks after launch
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Weekly UBIST data, within new generation products
500
400
300
200
100
0
1st W 2nd W 3rd W 4th W 5th W 6th W 7th W 8th W 9th W 10th W
Belviq Saxenda Contrave Qsymia
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Source: UBIST
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8
STRATEGIC TACTICS TOWARDS 2020
WE ARE WELL-POSITIONED TO ACHIEVE SUSTAINABLE GROWTH
| • Revenue +43% • OP income +148% • EPS +552% • Diversified mix – • 65% Asian Market/ 35% Export Portfolio Well-established foundation with successful transition in 2019… |
Strong Global Commercial Networkswith Leaders across the Regions ExperiencedExecutive Teamfrom the Globewith Proven Track Record Established Infrastructure with QualityManufacturing Capabilities for Being aPreferred Partner in All Markets SolidTwo-pronged Expansion StrategyBacked By Well-covered footprints in Asiaas home base Experienced R&D Talents to Pursue Targeted Portfolio on Oral Oncology, Complex Generics, and 505(b)2 to Address Niche Markets 1 2 3 5 6 STRATEGIC TACTICS FOR EXECUTION Diversification of PortfoliowithBrandProducts via Licensing-inPartnership 4 |
• Further diversification • Key launch execution • Pipeline investment • Revenue growth + profitability improvement To fuel future growth in 2020 & beyond |
• Further diversification • Key launch execution • Pipeline investment • Revenue growth + profitability improvement To fuel future growth in 2020 & beyond |
|---|---|---|---|
| • Revenue +43% • OP income +148% • EPS +552% • Diversified mix – • 65% Asian Market/ 35% Export Portfolio |
• Further diversification • Key launch execution • Pipeline investment • Revenue growth + profitability improvement |
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10
WELL-COVERED INFRASTRUCTURE IN APAC REGION TO CAPTURE GROWTH OPPORTUNITIES
Korea
-
Korea Taiwan
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• 12 sales office • 3 sales office • 225 S&M forces covering General • 104 S&M forces covering Medical Hospitals, Hospitals, and Clinics Centers, Hospitals, General Practices, national-wide and Pharmacies national-wide
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• • Full-function RA supports for continuous Global R&D center •
-
market expansion Experienced RA talents for global
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• 2 manufacturing sites strategy implementation • ISO 37001 anti-bribery management • 1 manufacturing sites eligible for system certified global commercial launches India Thailand[(1)]
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• In-house clinical service company • 26 S&M forces covering Hospitals
-
capable of providing contract • Close relationship with GPO and being
-
services globally the privilege and monopoly supplier for
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• 130 experienced specialists to government healthcare sector
-
conduct biostudies, pharmacovigilance, PK & Singapore
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Biostatstics, and Clinical trial services with dedicated facilities • Regional Hub for SEA/distribution markets[(1)] covering Hong Kong,
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Vietnam[(1)] Philippines, Malaysia, Indonesia,
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• Representative office with BD, RA Myanmar, Sri Lanka, and Bangladesh function support Direct markets Distribution markets Clinical service Notes: (1)In the progress to be under Lotus in 2020
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11
STRONG PARTNERSHIP WITH INDUSTRY LEADERS TO EXPAND ADDRESSABLE MARKETS GLOBALLY
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110+ licensing deals are signed to cover more than 130
markets – all Lotus self-developed products
Gefitinib Vinorelbine Ulipristal Temozolomide
Lenalidomide Enzalutamide Sunitinib
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Note: black – direct market; grey & blue – b2b parterships
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Global Partners
NORTH
9
AMERICA
LATAM 27
EU 31
MENA 29
ASIA 4
AFRICA 7
OCEANIA 4
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12
UNPARALLELED R&D CAPABILITIES WITH CONTINUOUS INVESTMENT IN PORTFOLIO
Strategic Focus
-
Strategic focus on oral oncology products for the global (US/EU/Japan) markets , levereging the existing containment (facilities designed for cytotoxic and high potency compount) manufacturing facilities
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Manufacturing technology focuses on high-containment solid oral dosage forms, including softgel capsule capabilities, both in R&D and production
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Focus on the development on fixed dose combination and 505(b)2 produst, mostly full-blown phase III clinical studies
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Talent Pool Ongoing Projects
Largest number of scientists Oncology [10+ ] [on going]
Lenalidomide, Enzalutamide, etc.
among peers: 225 [1]
3+ on going
Complex
Women healthcare, OAB
PhD, 5
3+ on going
505(b)2
Smoking Cessation, diabetes
Bachelor, 73
R&D Investment
Unit: US$mn
40
30
Master, 132
20
10
0
2020 2021 2022 2023 2024
TOTAL GROSS R&D SPEND
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1: As of Jan’20; Number of scientists are inclusive of Lotus and its subsidiaries (Alvogen Korea and NCS)
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13
MAJORE R&D PIPELINE UPDATE
Focus on high value innovation for patients and customers
| KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT | KEY ONCOLOGY PROJECT |
|---|---|---|---|---|---|---|---|---|
| Generic Name | Indication | IQVIA market size ‘19 (US$mn) |
Formulation | BE & CT | Submission | Approval | ||
| 1 | Lenalidomide | Multiple Myeloma | Global: 10,000 | Out-licensing scope continu | Settled in US es to expand |
rkets | GDUFA TAD = Jul’20 |
|
| and launched in selected ma | ||||||||
| 2 | Enzalutamide softgel |
Castration-resistant prostate cancer |
Global: 2,144 | Te | ntative Approval in TW | |||
| 3 | LP173 | Late stage hepatocellular carcinoma, renal cell carcinoma, thyroid carcinoma |
Global: 673 | |||||
| 4 | LP661 | Multiple Myeloma 血癌 |
Global: 1,516 | |||||
| 5 | LP670 | Treatment for advanced or metastatic breast cancer |
Global: 5,458 | |||||
| 6 | LP657 (SoftGel capsules) |
Treatment for acute myeloid leukemia (AML) |
Global: 205 |
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14
MAJORE R&D PIPELINE UPDATE (CONT’D)
Focus on high value innovation for patients and customers
| N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT | N0N-ONCOLOGY PROJECT |
|---|---|---|---|---|---|---|---|
| Generic Name | Indication | IQVIA market size ‘19 (US$mn) |
Formulation | BE & CT | Submission | Approval | |
| 1 | LP117 | Treatment for moderately to severely active rheumatoid arthritis (RA) |
Global: 1,432 | ||||
| 505(b)2 PROJECT | |||||||
| Generic Name | Indication | IQVIA market size ‘19 (US$mn) |
Phase I | Phase III | Submission | Approval | |
| 1 | AK-R216 | Type II diabetes | Global: 432 |
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15
SITE MASTER PLAN & UPGRADE TO ENSURE QUALITY MANUFACTURING
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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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16
MAJOR CATELYSTS TO WATCH IN FY2020
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Expansion of brand
portfolio in Asian markets
GDUFA TAD in Jul’20
for Lenalidomide
Development of ASEAN markets, including
TH, VN, DX market
Qsymia launch
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Solid sales stream backed by successful export portfolio expansion (Bup/Nal + key oncology products) in 2019 will continue to provide stable contribution throughout 2020
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FY2019
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Throughout 2020
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17