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SPT — Investor Presentation 2021
Mar 24, 2021
51922_rns_2021-03-24_b015e417-ae80-4d11-bc76-04e15b6cc4d7.pdf
Investor Presentation
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1789 TT
ScinoPharm
March 24, 2021
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 and Outlook
Financial Performance
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Business Overview
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Flexibility to Stabilize Operations and Grow Healthy
Stable market demand after outbreak of covid-19 pandemic, but adjusted production/shipping schedule to accommodate raw material supply change due to disruption on global logistics
2020 revenue achieved NTD 3,083 million, up 6.6% yoy, with NPAT NTD 282 million, up 30.2% yoy, and NPAT margin 9.2%
Adjusted financial assets/liabilities to strengthen capital structure and cash reserve
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Extend Generic API Core Business to New Markets
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Leverage Tainan/Changshu production advantage with better sales/production coordination to stably supply JP market
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on-
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Changshu site, in Sep. 2020, completed CFDI’s 1[st ] site inspection for Sodium Phenylbutyrate, which is expected to launch by Chinese customer in 2021
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3 new CFDI on-site inspection is scheduled in 2021, w/w 1 was completed in Feb. 2021
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5 generic APIs approved in China and Japan to pave the way for both markets
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CDMO business growth
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1 CDMO product (MAA) approved by EMA
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2 CDMO products submitted to EMA and FDA by customers
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Injectables for Long-term Development
3 drug products (in-house development + outsourcing production) continue generating revenue with multiple drug products development in progress
1[st] ANDA of in-house peptides prefilled-syringe product submitted to FDA in May, 2020 – Response to FDA review in progress
Registration batches of Vial Product Line (prefilledsyringed /pen device) and Cartridge Product Line (liquid solution/ lyophilized powder) were completed
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Preparing documentation for submission
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Aim to trigger the 1[st] TFDA on-site inspection
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Enrich Generic API Portfolio for Future Business Opportunity
74 generic APIs in portfolio with 32 referred and approved by ANDA/NDA
- 869 active DMFs worldwide with 63 US DMFs
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Business Update and Outlook
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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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Optimize
Existing
Generic API
Portfolio
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1. Existing Generic API Portfolio
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40 Data as of 2021/02/28
35 Pipeline
30 Approved
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12
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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
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2. 2020 A roved Generic APIs pp
| Product | Region | Indication | Brand Marketer |
|---|---|---|---|
| Capecitabine | CN | Various cancers | Roche |
| Dantrolene Sodium | CN | Skeletal Muscle Relaxant | Par Sterile Products |
| Tamsulosin HCl | CN | Benign prostatic hyperplasia | Sanofi Aventis |
| Galantamine HBr | JP | Alzheimer’s disease | Janssen |
| Topiramate | JP | Anti-convulsant | Janssen |
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Expand
CDMO
Business
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1. CDMO Business
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Data as of 2021/02/28
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10 7
8 1 SciAnda (Changshu)
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ScinoPharm Taiwan
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4 7 7
6
4
2
0
Phase 1 Phase 2 Phase 3 Commercial
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Data as of 2021/02/28
2. 2020 A roved CDMO Product pp
| Product | Region | Indication | Brand Marketer |
|---|---|---|---|
| Quofenix | EU | Anti-biotic | Menarini |
3. Two CDMO products submitted to EMA and FDA by customers
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Advancing
to
Injectables
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Peptides
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Sterile Injectables
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Pen Injectors
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Profit-sharing from 3 drug products (in-house development + outsourcing production)
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ANDA of 1[st] in-house prefilled-syringe product was submitted to FDA in May, 2020 – Response to FDA review
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Registration batches of Vial Product Line (prefilled-syringed /pen device) and Cartridge Product Line (liquid solution/ lyophilized powder) products were produced
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Aim to trigger the 1[st] TFDA on-site inspection in Apr. 2021
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Target to submit the 2[nd] in-house produced ANDA and 1[st] NDA (505(b)(2)) in 2021
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Actively Develop Japan, China and Emerging Markets
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Japan Market
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Generic drug market share in Japan is increasing, which is in favor of API suppliers
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2018:74% 2020:79%
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Become the largest Galantamine HBr generic API supplier in Japan in 2020
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Indication:Alzheimer’s disease
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Japan market size:c. USD 200 million
Leverage Japan’s late patent expiration and our new injectables capacity to explore opportunities for generic APIs + CDMO projects
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China Market
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Changshu site, in Sep. 2020, completed CFDI’s 1[st] on-site inspection for Sodium Phenylbutyrate, and will enter China local market after approval
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Customer approval expected in Mar./Apr. and to launch as orphan drug
- Indication:Urea cycle disorders
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Changshu site, in Feb. 2021, completed CFDI’s on-site inspection for NCE - Donafenib
Customer approval expected in May, 2021 and to launch afterwards
- **Indication:Advanced liver cancer first-line treatment**
- **1[st] year sales projected by research report:c. RMB 220 million**
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Target another 2 on-site inspections in 2021
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Customer’s Fondaparinux Sodium PFS was approved as the 4[th] generic drug supplier and launched in China in Feb. 2021
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Indication:Anti-thrombotic
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Market Size:c. RMB 200 million
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2021 API Product Approval Plan (I)
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| Type | Product | Region | Indication | Brand Marketer |
|---|---|---|---|---|
| Generic API | Fondaparinux Sodium |
CN( ) | Anti-thrombotic | Mylan |
| Generic API | Irinotecan HCl | CN | Colorectal cancer | Pfizer |
| 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 |
| Generic API | Letrozole | CN | Breast cancer | Novartis |
| Generic API | Bimatoprost | CN | Glaucoma | Allergan |
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Data as of 2021/02/28
:Approved
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2021 API Product Approval Plan (II)
| Type | Product | Region | Indication | Brand Marketer |
|---|---|---|---|---|
| Generic API | Regadenoaon | US | MPI | Astellas |
| Generic API | *PemetrexedDisodium 7H2O CEP |
EU | Non-small cell lung cancer |
Eli Lilly |
| Generic API | Topiramate | EU | Weight management | Vivus |
| CDMO API | Donafenib | CN | Cancer | Suzhou Zelgen |
| CDMO API | Leuprolide Mesylate | US/EU | Cancer | Foresee |
| CDMO API | Eflornithine | US/EU | FAP | CPP |
*: Collaborative project with partner for drug product development
Data as of 2021/02/28
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Financial Performance
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Consolidated Income Statement
| In NTD Million, except for EPS |
2020 (Audited) |
2020 (Audited) |
YoY | 2019 (Audited) |
2019 (Audited) |
|---|---|---|---|---|---|
| Revenue | 3,083 | 100% | 7% | 2,893 | 100% |
| Gross Profit | 1,317 | 43% | 12% | 1,176 | 41% |
| Operating Profit | 376 | 12% | 41% | 267 | 9% |
| Net Profit before Tax | 359 | 12% | 35% | 265 | 9% |
| Net Profit after Tax | 282 | 9% | 30% | 217 | 8% |
| EPS (NTD) | 0.36 | - | - | 0.27 | - |
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2020 Sales Distribution
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Drug
Product India China Others
7% 11% 3% 9%
CDMO
24%
US+Canada
Generic 19%
Japan
API
19%
69%
EU
39%
by Business CNS Others
by Region
29% 13%
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by Indication
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Sales Distribution – YoY
B Business Unit: USD y Generic API CDMO Drug Product 2020 Sales 71.8M 25.2M 7.5M YoY 2.1% 78.7% -18.8% B Indication y Oncology CNS Others 2020 Sales 60.5M 30.1M 13.9M YoY -2.3% 54.6% 13.6%
By Region US & EU Japan India China Others Canada 2020 Sales 40.4M 20.4M 19.5M 12.1M 3.1M 9.0M YoY 41.5% 10.9% 4.0% -4.4% -22.8% -20.4%
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Consolidated Balance Sheet
| In NTD Million | 2020/12/31 (Audited) |
2020/12/31 (Audited) |
2019/12/31 (Audited) |
2019/12/31 (Audited) |
|---|---|---|---|---|
| Cash and Cash Equivalents | 4,055 | 34% | 3,305 | 28% |
| Accounts Receivable | 387 | 3% | 590 | 5% |
| Inventories | 1,246 | 11% | 1,124 | 10% |
| Property, Plant & Equipment | 4,211 | 36% | 4,434 | 38% |
| Other Current/Non-Current Assets | 1,948 | 16% | 2,222 | 19% |
| Total Assets | 11,847 | 100% | 11,675 | 100% |
| Financial Debt | 9 | 0% | 234 | 2% |
| Other Current Liabilities | 677 | 6% | 508 | 4% |
| Other Non-Current Liabilities | 631 | 5% | 673 | 6% |
| Total Liabilities | 1,317 | 11% | 1,415 | 12% |
| Total Shareholders' Equities | 10,530 | 89% | 10,260 | 88% |
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Consolidated Cash Flow Statement
| In NTD million | 2020 (Audited) |
2019 (Audited) |
|---|---|---|
| From Operating Activities | 946 | 789 |
| From Investing Activities | 242 | (98) |
| From Financing Activities | (445) | (1,572) |
| Effect of foreign exchange rate changes | 7 | (17) |
| Net Change in Cash | 750 | (898) |
| Beginning Balance | 3,305 | 4,203 |
| Ending Balance | 4,055 | 3,305 |
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Q & A
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Brand Quality with Asian Advantages
www.scinopharm.com
1789 TT
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Appendix: 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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Specializes in high potency (cytotoxic/steroid) API and injectable R&D and manufacturing with customers worldwide
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74 generic APIs in portfolio with 32 referred and approved by ANDA/NDA*
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869 active DMFs worldwide with 63 US DMFs
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150+ contract projects with 7 approved/launched (5 NCEs) and 8 in phase 3 for NDA/MAA filing in 1-3 years*
Certified by key international regulators - US FDA, EMA, EDQM, Australian TGA, Japanese PMDA, Korea KFDA, Mexico COFEPRIS and German Authority
- Data as of 2021/02/28
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