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SPT — Investor Presentation 2020
Sep 10, 2020
51922_rns_2020-09-10_c8da3d96-76bf-4081-9a5a-3d241b376252.pdf
Investor Presentation
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1789 TT
ScinoPharm
September 11, 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 1 billion as of 2020/06/30. 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
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Generic API
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CDMO
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Drug Product - Injectables
Certified by key international regulators - US FDA, EMA, EDQM, Australian TGA, Japanese PMDA, Korea KFDA, Mexico COFEPRIS and German Authority
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A. The achievements from three major business are being progressed
1H 2020 revenue NTD 1,451 million with YoY 4%;net profit NTD 197 million with YoY 45% and net margin to be 13.61%
| Business | Generic API | Drug Product | CDMO |
|---|---|---|---|
| Achievements | 1.The market presence of our core products is being enlarged with aggressive sales approach and production advantage utilization 2.With the credentials earned and facility flexibility established, we have branched out into Japan and China markets |
1.Several drug products are in developing upon our capability in API development 2.ANDA of 1st in-house prefilled-syringe product has been submitted to FDA in May 3.Registration batches of Cartridge product and Vial product have been completed in March and under processing respectively |
1.One CDMO product (new drug MAA) has been approved by EMA 2.Two CDMO products have been submitted to EMA and FDA by customers |
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B. The facilities cross-strait are being further integrated to provide flexibility for market dynamic
Keep on enhancing the connection and collaboration between Tainan and Changshu
To response to market dynamic
In the post-pandemic period, given the possible change in market segmentation and supply, we focus on fulfilling customers’ demand for FDA/CFDA dual filing and thus expanding API business under MAH regulation
To utilize the two facilities
The resource allocation is being made under consideration of product attributes and two sites’ production advantages C. DMFs are being accumulated for business potential 73 generic APIs in portfolio with 31 referred and approved by ANDA/NDA. 853 active DMFs worldwide with 63 US DMFs
Data as of 2020/06/30
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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
Expected TFDA on-site inspection in 2H 2020
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2 2
Data as of 2020/06/30
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Data as of 2020/06/30
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Optimize Existing Generic API Portfolio
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40 37
Pipeline
35 Approved
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20
25
20
12
15
10 17 7 6 6
5 4 2 3 2 2 2 2 1
5 2 4 3 2 1 2 2
1 1
0
Data as of 2020/06/30
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Expand CDMO Business
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8 6 8
7
8
1
SciAnda (Changshu)
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ScinoPharm Taiwan
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7 7
6
4
2
0
Phase 1 Phase 2 Phase 3 Commercial
Data as of 2020/06/30
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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
*: Added due to earlier than expected approval obtained Data as of 2020/06/30
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2020 Product Approval Plan (II)
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| Type | Product | Region | Indication | Brand Marketer |
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| 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 2020/06/30
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Operating Results
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Consolidated Income Statement
| In NTD Million, except for EPS |
1H 2020 (Reviewed) |
1H 2020 (Reviewed) |
YoY | 1H 2019 (Reviewed) |
1H 2019 (Reviewed) |
|---|---|---|---|---|---|
| Revenue | 1,451 | 100% | 4% | 1,390 | 100% |
| Gross Profit | 682 | 47% | 13% | 604 | 44% |
| Operating Profit | 252 | 17% | 41% | 179 | 13% |
| Net Profit before Tax | 252 | 17% | 51% | 167 | 12% |
| Net Profit after Tax | 197 | 14% | 46% | 136 | 10% |
| EPS (NTD) | 0.25 | - | - | 0.17 | - |
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1H 2020 Sales Distribution
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Drug
CDMO China Others
Product
India
18% 2% 7%
1%
15%
US+Canada
23%
Generic Japan
API 17%
EU
81%
36%
Others
CNS
by Business 6% by Region
23%
Oncology
71%
by Indication
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Sales Distribution – YoY
| **Sales Distribution – YoY ** | **Sales Distribution – YoY ** | **Sales Distribution – YoY ** | **Sales Distribution – YoY ** |
|---|---|---|---|
| By Business Unit: USD |
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| Generic API | CDMO | Drug Product | |
| 1H 2020 Sales | 39.1M | 8.7M | 0.5M |
| YoY | 11.6% | -3.0% | -36.2% |
| By Indication | By Indication | By Indication | By Indication |
|---|---|---|---|
| Oncology | CNS | Others | |
| 1H 2020 Sales | 34.4M | 10.8M | 3.1M |
| YoY | 13.3% | 36.9% | -53.1% |
| By Region | By Region | By Region | By Region | By Region | By Region | By Region |
|---|---|---|---|---|---|---|
| EU | US & Canada |
Japan | India | China | Others | |
| 1H 2020 Sales | 17.4M | 11.2M | 8.1M | 7.4M | 0.9M | 3.3M |
| YoY | 6.6% | 20.1% | -6.2% | 30.5% | -8.9% | -14.4% |
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Consolidated Balance Sheet
| In NTD Million | 2020/6/30 (Reviewed) |
2020/6/30 (Reviewed) |
2019/6/30 (Reviewed) |
2019/6/30 (Reviewed) |
|---|---|---|---|---|
| Cash and Cash Equivalents | 3,803 | 31% | 4,534 | 33% |
| Accounts Receivable | 554 | 5% | 434 | 3% |
| Inventories | 1,299 | 11% | 1,294 | 10% |
| Property, Plant & Equipment | 4,255 | 35% | 4,597 | 34% |
| Other Current/Non-Current Assets | 2,197 | 18% | 2,742 | 20% |
| Total Assets | 12,108 | 100% | 13,601 | 100% |
| Financial Debt | 261 | 2% | 1,368 | 10% |
| Other Current Liabilities | 830 | 7% | 863 | 6% |
| Other Non-Current Liabilities | 636 | 5% | 949 | 7% |
| Total Liabilities | 1,727 | 14% | 3,180 | 23% |
| Total Shareholders' Equities | 10,381 | 86% | 10,421 | 77% |
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Consolidated Cash Flow Statement
| In NTD million | 1H 2020 (Reviewed) |
1H 2019 (Reviewed) |
|---|---|---|
| From Operating Activities | 368 | 444 |
| From Investing Activities | 123 | (54) |
| From Financing Activities | 29 | (68) |
| Effect of foreign exchange rate changes | (22) | 9 |
| Net Change in Cash | 498 | 331 |
| Beginning Balance | 3,305 | 4,203 |
| Ending Balance | 3,803 | 4,534 |
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Q & A
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Brand Quality with Asian Advantages
www.scinopharm.com
1789 TT
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