Anemia貧血について 貧血 anemia 要旨 貧血とは、「末梢血中のヘモグロビンという鉄を含む成分濃度が基準値以下に 低下した状態」であり、具体的には、血液中の赤血球の数が減少し、酸素を運ぶ
LOTUS PHARMACEUTICAL · market player to a full-scale global supplier of oncology drugs Investing...
Transcript of LOTUS PHARMACEUTICAL · market player to a full-scale global supplier of oncology drugs Investing...
LOTUS PHARMACEUTICAL CREATING A GLOBAL ONCOLOGY LEADER
1795.TT
November 2019
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
3
1 Lotus Today
2 Profitable Growth Strategy
3 2019YTD Results & Highlights
Today to Present:
4 Future Outlook
LOTUS TODAY
4
WELL-ESTABLISHED FOUNDATION FROM REGIONAL PLAYER TO GLOBAL CONTENDER…
5
1966-2014
• A local player servicing
mostly Taiwan domestic
market with “first in Taiwan”
generics
• Established formulation
skills across multiple drug
delivery systems
• Listed on TPEX since 2010
• Reshape portfolio to build key
franchises in APAC direct
markets
• Taiwan manufacturing site
inspected by US FDA, EU
EMA, Japan PMDA and TFDA
PIC/S
• Became a Taiwan Market
Biotechnology and Medical
Care Index stock in July, 2017
• Focused portfolio surrounding
oral oncology, hormonal and
special dosage forms
• Balanced growth from internal
and external opportunities
• Became a TPEX 50 Index
stock in April, 2018
• Relisting to TWSE in December,
2019
LOTUS BEFORE ALVOGEN
2014-2017
POST MERGER INTEGRATION
2018-2025
A STRONG GLOBAL CONTENDER
… WITH NICHE CAPABILITY TO PROVIDE TURNKEY SOLUTION WORLDWIDE
6
Comprehensive global
network offers Lotus and its
partners sustainable growth with
no boundaries
Capability of identifying
products with great market
potentials positions Lotus well as
a preferred partner
7
Transformation from a single market player to a full-scale global supplier of oncology drugs
Investing in pipeline, production facility and people
Building solid commerical platform in APAC regionA
IN ONLY 5 YEARS, WE HAVE DELIVERED…
Molecule product pipeline
20+Revenues
5 XB2B markets covered
130+Out-licensing & supply agreements
80+ INNs launched3
INNs contracted6+
Focusing on oncology and complex genericsz
PROFITABLE GROWTH STRATEGY
8
READY FOR TWO-PRONGED EXPANSION STRATEGY TO ENSURE PROFITABLE GROWTH
9
ASIAN MARKET GLOBAL PORTFOLIO
Solid foundation with stable cash inflow
Long term growth driver with better profits
MAXIMISING COMPANY
VALUE
REGIONALLY, WE WILL CONTINUE TO INVEST IN GROWTH OPPORTUNITIES
10
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 while also an opportunity for
niche player
Thailand
Vietnam
Taiwan
Indonesia
Korea
India
Japan
China
2018E APAC Pharmaceutical Market Size ($bn)‘14-’18 CAGR
12%
1%
8%
5%
10%
4%
14%
5%
Source: IQVIA 2018 Dec
GLOBALLY, ONCOLOGY MARKET IS ONE OF FAST-GROWING THERAPEUTIC AREAS
11
Drug sales as a percentage of the total market
2015
Cancer/Onc/Hem
Infectious disease
Rheumatology
Cardiology
Diabetes/Obesity
HBV/HCV
CNS
Respiratory
Multiple Sclerosis
Epilepsy
GI/Ulcer
Opthalmology
Others
19%
World wide oncology sales: USD95b
2020 Forecast
Cancer/Onc/Hem
Infectious disease
Rheumatology
Cardiology
Diabetes/Obesity
HBV/HCV
CNS
Respiratory
Multiple Sclerosis
Orphan disease
Dermatology
Opthalmology
Others
25%
World wide oncology sales: USD163b
Source: SG Cowen
WE STRIVE TO PROVIDE AFFORDABLE ONCOLOGY CARE WORLDWIDE
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Source: IQVIA global oncology trends 2019
2008 (481) 2018 (849)
Radiotherapies 0.8% (4) 0.2% (2)
Hormonals 2.5% (12) 1.9% (16)
Cytotoxins 16.8% (81) 7.3% (62)
Targeted small molecules 54.7% (263) 40.3% (342)
Targeted biologics 25.2% (121) 50.3% (427)
The pipeline of late phase oncology molecules, 2008-2018
Lotus’
target
markets
The cancer treatment landscape continued to evolve since 2014, and now includes new medicines targeting 23 different cancer types. This is creating
a substantial opportunity for global generic companies seeking to expand patient access and lower NHI budgets across the world
Lotus’ R&D engine and specialized manufacturing capabilities allow it to develop and produce a wide range of targeted small molecule treatments.
Coupled with the company’s broad commercial reach, this is an ideal candidate to address the expanded oncology opportunity globally
FOCUSED ONCOLOGY PORTFOLIO… 13
Focus on high value innovation for patients and customers
To be launched in 2019 - 2025
Generic Name Indication IQVIA market size (US$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
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
Settled in US and
launched in selected marketsOut-licensing scope
continues to expand
Submission in EU and TW
…FUELS FUTURE GROWTH 14
Focus on high value innovation for patients and customers
To be launched in 2019 - 2025
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
6 LP661 Multiple Myeloma血癌
Global: 2,000
7 LP664
Ph+ CML in chronic phase
治療慢性期及費城染色體陽性的慢性骨髓性白血病成年患者
Global: 2,000
8 LP644
Castration-resistant prostate cancer
去勢抗性的轉移性前列腺癌
Global: 240
9 LP654Softgel
IPF特發性肺纖維化
Global: 1,000
• 2+ new projects under development in early stage
NON ONCOLOGY PORTFOLIO 15
Focus on high value innovation for patients and customers
To be launched in 2019 – 2022
Generic Name Indication IQVIA market size
(US$mn) Formulation BE & CT Submission Approval
1 Ulipristal Women health 女性保健
US: FTF
2 LP179 Women health 女性保健
Global: 300
3 AK-R311 OAB膀胱過動症
Global ex US: 500
• 1+ new projects under development in early stage
505(b)2 PIPELINE 16
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-R214Smoking Cessation
戒菸Global: 1,000
2 AK-R216 Type II diabetes第二類糖尿病
Global: 320
3 AK-R217 Type II diabetes第二類糖尿病
Global: 650
MAJOR LAUNCH 2019/2020 – QSYMIA 17
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: End November 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
2019YTD RESULTS & HIGHLIGHTS
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2019YTD OPERATIONAL HIGHLIGHTS 19
Financial Results
Revenue +28%
9M’YoY
w/ gross margin
expanded by 2%
$6,046M
+28%
$864M
+147%
OP Income +147%
9M’YoY
as operating leverage
improves
Commercial Progress
$539M
+9.5x
Net Profits achieved
Record High
w/ EPS of NT$2.17
• 1st to market of 3 leading oncology products
• Lenalidomide in Europe in Feb
• Gefitinib in 20 European markets on patent expiry date
• Vinorelbine soft gel capsules in Europe in Jul
• 1st substantial launch of specialty generic in the US
• Buprenorphine/Naloxone sublingual film, generic of Suboxone
film, as 1st wave generics in Feb
• Strong global collaboration momentum for the export products with
leading partners
• 80+ licensing deals signed
• Strategically partnered with Fuji Pharma
• Excellent outcome from the inspections by 2 authorities and 6
business partners
• Strong supply chain management to maintain ~99% fulfillment of
customer orders
• 1st TWSE alternative listing approved in Nov
FUELED BY A MORE BALANCED PORTFOLIO MIX 20
• Covering Taiwan and Korea domestic
markets
• Proven market presence in TW/KR with
upside potentials from other counties
• Steady cash inflow with sales
contribution ~75% of 9M’19 revenue
• Targeting ASEAN as the next step
• Comprising Global Specialty Generics
and Export Turnkey Solution business
• Initial harvest from gSuboxone and
oncology licensing-out deals
• Rapid growth to contribute ~25% of
9M’19 revenue
• Substantial profitability drivers for long
term success
Global Portfolio
Asian Business
Revenue =
NT$mn5,902 6,424 6,429 6,046
-
20
40
60
80
100
Pre-Alvogen 2016 2017 2018 9M'19
Asian Market Global Portfolio
25%
75%
… AND TURNED INTO SOLID NUMBERS 21
Revenue (NT$mn) Gross and Operating Margin Net Profit (NT$mn)
2,310
5,522 5,902 6,424 6,429 6,046
-
2,000
4,000
6,000
8,000
2014 2015 2016 2017 2018 9M'19
50%58% 56%
48% 49% 51%
-19%
8% 4% 8% 7%14%
-40%
-20%
0%
20%
40%
60%
80%
2014 2015 2016 2017 2018 9M'19
Gross Margin OP Margin -544
161
-111
65124
539
-600
-400
-200
0
200
400
600
2014 2015 2016 2017 2018 9M'19
3.48 3.71
3.50
-
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
4.50
5.00
FY2018 6M'19 9M'19
WITH IMPROVING FINANCIAL STRUCTURE 22
EBITDA (NT$mn) NET DEBT/LTM EBITDA (X)
<3.5x as
committed
*EBITDA =EBIT + Depreciation + Amortization + Non-cash provisions
LTM EBITDA = last 12 months rolling
1,076
1,346
269
449
0
200
400
600
800
1,000
1,200
1,400
1,600
FY2018 9M'2019 2018 AvgQ
2019 AvgQ
FUTURE OUTLOOK
23
NEAR TEAM DELIVERABLES ON TRACK TO FUEL Q4/2020 OUTLOOK
24
Further expand business opportunities with existing portfolio- 20+ contracts under discussion
Efficiently execute new launches from both internal R&D
resources as well as external licensing-in deals - 3+ new launches in Q4
Continuously investing in pipeline to cultivate future growth- 3+ R&D projects in early stage
WE CONTINUE TO BUILD THE LOTUS VALUE PATH 25
ASIAN MARKET GLOBAL PORTFOLIO
Solid foundation with stable cash inflow
Capitalizing well-established
domestic platforms in Korea and
Taiwan .
Exploring more growing
opportunities in other countries
Long term growth driver with better profits
Leveraging competitive portfolio
to enhance profitability profile
Delivering turnkey solution
worldwide with cost-efficient
products
MAXIMISING COMPANY
VALUE
26
APPENDIX
9M’19 I/S 27
Unit: NT$'000 9M'19 % 9M'18 % 9M' YoY Q3'19 % Q2'19 % QoQ
Revenue 6,046,466 100% 4,706,299 100% 28.5% 1,969,931 100% 1,893,864 100% 4.0%
COGS (2,972,709) (2,424,236) (938,727) (930,402)
Gross Profits 3,073,757 51% 2,282,063 48% 34.7% 1,031,204 52% 963,462 51% 7.0%
Total OPEX (2,209,878) 37% (1,931,761) 41% 14.4% (739,546) 38% (837,082) 44% -11.7%
Income from Operations 863,879 14% 350,302 7% 146.6% 291,658 15% 126,380 7% 130.8%
Non-OP Income (Exp)
Others 63,489 4,735 23,026 29,999
Finance Costs (242,795) (222,292) (90,736) (84,752)
Total Non-OP, net (179,306) (217,557) -17.6% (67,710) (54,753) 23.7%
Income Before Tax 684,573 11% 132,745 3% 415.7% 223,948 11% 71,627 4% 212.7%
Income Tax Expenses (145,535) (81,541) (23,930) (19,638)
Net Income (Loss) 539,038 9% 51,204 1% 952.7% 200,018 10% 51,989 3% 284.7%
EPS (NT$) 2.17 0.11 0.82 0.20
B/S AS OF SEP 30TH 2019 28
Unit: NT$'000 Sep-30, 2019 % Jun-30, 2019 %
Current Assets
Cash & Equivalents 1,110,661 6% 1,128,488 6%
A/R 1,070,534 6% 983,950 5%
A/R - Related Party 634,610 4% 603,777 3%
Other Receivables 40,775 0% 3,109 0%
Other Receivables - RP 97,552 1% 68,043 0%
Inventory 2,156,836 12% 2,373,271 13%
Others 939,520 5% 960,022 5%
Current Assets 6,050,487 34% 6,120,660 33%
Non-Current Assets
Investment 469,094 3% 497,257 3%
PP&E 1,786,889 10% 1,987,072 11%
Goodwill 5,898,473 33% 6,014,009 33%
Other Intangible Assets 2,735,730 15% 2,752,802 15%
Others 1,111,814 6% 1,045,146 6%
Total Assets 18,052,487 100% 18,416,946 100%
Unit: NT$'000 Sep-30, 2019 % Jun-30, 2019 %
Current Liability
ST Debts 440,000 2% 310,000 2%
A/P 689,734 4% 831,361 5%
A/P - RP 981,805 5% 1,211,651 7%
Other Payables 303,818 2% 286,602 2%
Other Payables - RP 158,400 1% 282,319 2%
Current portion of LT Debts 208,719 1% 215,933 1%
Others 273,331 2% 393,416 2%
Current Liability 3,055,806 17% 3,531,282 19%
Non-Current Liability
LT Debts 4,031,603 22% 3,050,767 17%
LT Debts - RP 2,326,125 13% 3,157,708 17%
Others 980,092 5% 1,013,404 6%
Total Liability 10,393,626 58% 10,753,161 58%
Equity
Stock 2,431,140 13% 2,431,140 13%
Paid-in Capital 6,588,034 36% 6,588,034 36%
Treasury Shares 0 0%
Accumulated Deficits (712,215) -4% (911,818) -5%
Others (650,106) -4% (445,211) -2%
Shareholders' Equity to Parent 7,656,853 42% 7,662,145 42%
Minority 2,008 0% 1,640 0%
Total Shareholders' Equities 7,658,861 42% 7,663,785 42%
Tatal Liabilities & Equities 18,052,487 100% 18,416,946 100%
TOP15 FOR 9M’2019 29
INN Indication YTD (NT$mn) YoY (%) Remarks
1 Buprenorphine/Naloxone film OUD 戒癮 1,075.0 - 2019 New launch
2 Goserelin (Zoladex) Breast cancer 乳癌 424.2 1%Exclusive marketing alliance with AstraZeneca KR;
launched Oct’16
3 Rosuvastatin/EzetimibeCardiovascular
389.5 -2% Dosage improved to 1/day降血脂與膽固醇
4 Calcium Polystyrene Sulfonate Nephrology 腎臟病 269.4 6%
5 Seroquel (Quetiapine) Schizophrenia 精神分裂症 252.3 14%Exclusive marketing alliance with AstraZeneca KR;
launched Oct’15
6 Sarpogrelate Anticoagulant 抗凝血 219.1 -38%
7 Desogestrel/EE (Mercilon)Oral contraceptive
口服避孕藥210.5 -1%
Acquired from Bayer; launched in May’16; changed
distributor in 2Q’19
8 Anastrozole (Arimidex) Oncology 癌症 159.7 7%Exclusive marketing alliance with AstraZeneca KR;
launched 4Q’16
9 Raloxifene (Evista) Osteoporosis 骨質疏鬆症 151.2 - 2019 new launch
10 Lenalidomide MM 多發性骨髓瘤 150.5 - 2019 New Launch, global export
11 Phentermine Anti-obesity 減肥 149.8 -5%
12 Bicalutamide Prostate cancer 攝護腺癌 148.1 -6%Exclusive marketing alliance with AstraZeneca KR;
launched Oct’16
13 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 108.9 -14%Acquired from Novartis; launched Apr’17; terminated
distributor in Taiwan in 2Q’19
14 Phendimetrazine Anti-obesity 減肥 100.5 -17%
15 Ibandronate D3 Osteoporosis 骨質疏鬆症 100.2 230%