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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

  • Leverage Tainan/Changshu production advantage with better sales/production coordination to stably supply JP market

  • on-

  • 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

  • 3 new CFDI on-site inspection is scheduled in 2021, w/w 1 was completed in Feb. 2021

  • 5 generic APIs approved in China and Japan to pave the way for both markets

  • CDMO business growth

  • 1 CDMO product (MAA) approved by EMA

  • 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

  • Preparing documentation for submission

  • 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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38
40 Data as of 2021/02/28
35 Pipeline
30 Approved
20
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
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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
14
12
10 7
8 1 SciAnda (Changshu)
6
ScinoPharm Taiwan
6
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

  • Profit-sharing from 3 drug products (in-house development + outsourcing production)

  • ANDA of 1[st] in-house prefilled-syringe product was submitted to FDA in May, 2020 – Response to FDA review

  • Registration batches of Vial Product Line (prefilled-syringed /pen device) and Cartridge Product Line (liquid solution/ lyophilized powder) products were produced

  • Aim to trigger the 1[st] TFDA on-site inspection in Apr. 2021

  • 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

  • Generic drug market share in Japan is increasing, which is in favor of API suppliers

  • 2018:74%2020:79%

  • Become the largest Galantamine HBr generic API supplier in Japan in 2020

  • Indication:Alzheimer’s disease

  • 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

  • Changshu site, in Sep. 2020, completed CFDI’s 1[st] on-site inspection for Sodium Phenylbutyrate, and will enter China local market after approval

  • Customer approval expected in Mar./Apr. and to launch as orphan drug

    • Indication:Urea cycle disorders
  • 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**
  • Target another 2 on-site inspections in 2021

  • Customer’s Fondaparinux Sodium PFS was approved as the 4[th] generic drug supplier and launched in China in Feb. 2021

  • Indication:Anti-thrombotic

  • 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 Pemetrexed
Disodium 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

  • Est. in 1997 in Taiwan (Tainan) with cGMP plants/R&D in Tainan and Changshu and marketing forces in Tainan, Shanghai and Tokyo

  • Specializes in high potency (cytotoxic/steroid) API and injectable R&D and manufacturing with customers worldwide

  • 74 generic APIs in portfolio with 32 referred and approved by ANDA/NDA*

  • 869 active DMFs worldwide with 63 US DMFs

  • 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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