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SPT — Investor Presentation 2020
Dec 1, 2020
51922_rns_2020-12-01_582d56d9-1328-44bd-af5c-1cac223113af.pdf
Investor Presentation
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1789 TT
ScinoPharm
December 1, 2020
Disclaimer
This material has been prepared by ScinoPharm Taiwan, Ltd. (“ScinoPharm”).
Any opinions expressed in this material are subject to change without notice as a result of using different assumptions. ScinoPharm is under no obligation to update or keep current the information contained herein. The information contained in this presentation is ScinoPharm’s confidential information.
Any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it is prohibited and may be unlawful.
No representation or warranty , express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company as to , the accuracy or completeness of this material and any liability therefore is hereby expressly disclaimed.
Statements made in this material include forward-looking statements, which include, without limitation, statements about the issues, plans and expectations of ScinoPharm. Without limiting the foregoing, statements including the words “believes”, “anticipates”, “plans”, “expects” and similar expressions are also forward-looking statements. Forward-looking statements reflect, among other things, management’s plans and objectives for future operations, current views with respect to future events and future economic performances and projections of various financial items. These forward-looking statements involve known and unknown risks , uncertainties and other factors which may cause actual results to differ materially from those implied by such forward-looking statements.
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Table of Content
Business Overview
Business Update
2020 Product Approval Plan
Operating Results
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Business Overview
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ScinoPharm at a Glance
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Est. in 1997 in Taiwan (Tainan) with cGMP plants/R&D in Tainan and Changshu and marketing forces in Tainan, Shanghai and Tokyo
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Listed on TWSE in 2011 with market cap of c. USD 806 million as of 2020/09/30. Major shareholders include Uni-President Group, National Development Fund and Taiwan Sugar Corporation
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Specializes in high potency (cytotoxic/steroid) API and injectable R&D and manufacturing with customers worldwide
73 generic APIs in portfolio with 32 referred and approved by ANDA/NDA. 856 active DMFs worldwide with 62 US DMFs Certified by key international regulators - US FDA, EMA, EDQM, Australian TGA, Japanese PMDA, Korea KFDA, Mexico COFEPRIS and German Authority*
*** Data as of 2020/09/30**
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Progress of Three Key Businesses
3Q 2020 revenue of NTD 2,209 million, up 7% YoY, with net profit of NTD 274 million, up 63% YoY, and EPS NTD 0.35
Generic API
Drug Product
CDMO
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Strengthen sales &
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production coordination • Maximize production advantage in two sites
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Develop economy scale
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of core products
3 outsourcing drug product launched
Submitted 1st ANDA of in-house prefilledsyringe product to FDA in May
One CDMO product (MAA) approved by EMA
Two CDMO products submitted to EMA and FDA by customers
Leverage US/EU experiences to expand Japan & China markets
Completed registration batches of 1st pen device and liquid solution in March and July
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Integrate Production Resources in Two Sites
External Market
- Adjust for market segmentation and supply chain change in the post-pandemic period
Changshu to focus on FDA/CFDI dual filing customers for API business under MAH regulation
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CFDI completed on-site inspection of Changshu site in September
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Internal Resources
Allocate resources based on product features and two sites’ advantage
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Business Update
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Business Strategies
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Advancing to
Injectables
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Optimize
Existing Generic
API Portfolio
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Expand CDMO
Business
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Actively Develop Japan, China and Emerging Markets
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Advancing to Injectables
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Oral Solids
Extended Release
Oral Solids
Immediate Release
APIs
Dermatological
Semi-Solids
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Peptides
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Sterile
Injectables
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Pen Injectors
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Otics & Opthalmics Respiratory Devices
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Higher entry barriers due to more tech, IP and regulatory requirements
lead to more value
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In-House Injectables Portfolio 12 drug products under development
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5 3
2 2
Data as of 2020/09/30
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Existing Generic API Portfolio
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37
40
Pipeline
35 Approved
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19
25
20
12
15
10 18 7 6 6
5 4 2 3 2 2 2 2 1
5 2 4 3 2 1 1 2 2 1
0
Data as of 2020/09/30
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CDMO Business
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12
10
10
8
6
7
8
1
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SciAnda (Changshu)
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ScinoPharm Taiwan
4 7 7
6
4
2
0
Phase 1 Phase 2 Phase 3 Commercial
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Data as of 2020/09/30
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2020 Product Approval Plan
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2020 Product Approval Plan (I)
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| Type | Product | Region | Indication | Brand Marketer |
|---|---|---|---|---|
| Generic API | Capecitabine | CN( ) | Various cancers | Roche |
| Generic API | Dantrolene Sodium |
CN( ) | Skeletal Muscle Relaxant |
Par Sterile Products |
| Generic API | Tamsulosin HCl | CN( ) | Benign prostatic hyperplasia (BPH) |
Sanofi Aventis |
| Generic API | Irinotecan HCl | CN | Colorectal cancer | Pfizer |
| Generic API | Fondaparinux Sodium |
CN | Anti-thrombotic | Mylan |
| Generic API | Anastrozole | CN | Breast cancer | ANI Pharmaceuticals |
| Generic API | Sodium Phenylbutyrate |
CN | Urea cycle disorders | Horizon Therapeutics |
| Generic API | Azilsartan | CN | Hypertension | Arbor Pharmaceuticals |
:Approved
Data as of 2020/09/30
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2020 Product Approval Plan (II)
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| Type | Product | Region | Indication | Brand Marketer |
|---|---|---|---|---|
| Generic API | Galantamine HBr | JP( ) | Alzheimer’s disease | Janssen |
| Generic API | Topiramate | JP | Anti-convulsant | Janssen |
| Generic API | Topiramate | EU | Weight management | Vivus |
(*)Generic API |
Pemetrexed Disodium 7H2O CEP |
EU | Non-small cell lung cancer | Eli Lilly |
| Generic API | Fulvestrant | US | Breast cancer | AstraZeneca |
| CDMO API | Donafenib | CN | Cancer | Suzhou Zelgen |
| CDMO API | Quofenix | EU( ) | Anti-biotic | Menarini |
:Approved
*: Collaborative project with partner for drug product development
Data as of 2020/09/30
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Operating Results
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Consolidated Income Statement
| In NTD Million, except for EPS |
3Q 2020 (Reviewed) |
3Q 2020 (Reviewed) |
YoY | 3Q 2019 (Reviewed) |
3Q 2019 (Reviewed) |
|---|---|---|---|---|---|
| Revenue | 2,209 | 100% | 7% | 2,073 | 100% |
| Gross Profit | 1,058 | 48% | 18% | 896 | 43% |
| Operating Profit | 354 | 16% | 69% | 210 | 10% |
| Net Profit before Tax | 346 | 16% | 67% | 208 | 10% |
| Net Profit after Tax | 274 | 12% | 63% | 168 | 8% |
| EPS (NTD) | 0.35 | - | - | 0.21 | - |
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3Q 2020 Sales Distribution
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China
Drug India Others
CDMO
Product 3%
13% 7%
23%
5%
US+Canada
Japan
20%
16%
Generic
EU
API
41%
72%
Others
by Business CNS 7% by Region
28%
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by Indication
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Sales Distribution – YoY
B Business Unit: USD y Generic API CDMO Drug Product 3Q 2020 Sales 53.4M 17.2M 3.5M YoY -2.2% 56.2% 192.4%
B Business y
B Indication y
Oncology CNS Others 3Q 2020 Sales 47.9M 20.9M 5.3M YoY 4.2% 57.9% -29.9%
By Region
US & EU Japan India China Others Canada 3Q 2020 Sales 30.4M 14.5M 12.1M 9.8M 2.1M 5.2M YoY 42.4% 9.3% -12.4% -2.2% 22.8% -21.5%
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Consolidated Balance Sheet
| In NTD Million | 2020/9/30 (Reviewed) |
2020/9/30 (Reviewed) |
2019/9/30 (Reviewed) |
2019/9/30 (Reviewed) |
|---|---|---|---|---|
| Cash and Cash Equivalents | 3,759 | 31% | 3,143 | 27% |
| Accounts Receivable | 468 | 4% | 439 | 4% |
| Inventories | 1,350 | 11% | 1,238 | 10% |
| Property, Plant & Equipment | 4,211 | 35% | 4,501 | 39% |
| Other Current/Non-Current Assets | 2,212 | 19% | 2,401 | 20% |
| Total Assets | 12,000 | 100% | 11,722 | 100% |
| Financial Debt | 244 | 2% | 271 | 2% |
| Other Current Liabilities | 638 | 6% | 472 | 4% |
| Other Non-Current Liabilities | 633 | 5% | 669 | 6% |
| Total Liabilities | 1,515 | 13% | 1,412 | 12% |
| Total Shareholders' Equities | 10,485 | 87% | 10,310 | 88% |
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Consolidated Cash Flow Statement
| In NTD million | 3Q 2020 (Reviewed) |
3Q 2019 (Reviewed) |
|---|---|---|
| From Operating Activities | 616 | 636 |
| From Investing Activities | 51 | (160) |
| From Financing Activities | (210) | (1,545) |
| Effect of foreign exchange rate changes | (3) | 9 |
| Net Change in Cash | 454 | (1,060) |
| Beginning Balance | 3,305 | 4,203 |
| Ending Balance | 3,759 | 3,143 |
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Q & A
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Brand Quality with Asian Advantages
www.scinopharm.com
1789 TT
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