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SPT Investor Presentation 2021

Aug 11, 2021

51922_rns_2021-08-11_3836c467-cf68-4f51-8dda-bd02f1d83caa.pdf

Investor Presentation

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1789 TT

ScinoPharm

August 11, 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

Financial Performance

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Business Overview

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Stable USD Sales Growth amid Covid-19

  • Supply chain change caused by on-going covid-19 pandemic

  • Global logistic striving for recovery

  • Customer inventory adjustment

  • Taiwan level 3 covid-19 alert in 2Q

  • Dynamic production and sales planning to adapt the challenge

  • 2021 1H revenue in USD increased 2.1%, yoy

Due to strong NTD, consolidated revenue was NTD 1,389 million, down 4.3% yoy, with NPAT NTD 181 million, down 8.1% yoy, and NPAT margin 13.0%

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Strengthen Generic API Business Expand China & Japan Market

Leverage Tainan/Changshu production advantage with better sales/production coordination to stably supply Japan & China markets

  • CFDI’s on-site inspection on Changshu site

  • Inspection for Donafenib and Bimatoprost completed in 2021 1H

  • 1 on-site inspections scheduled in 2021 2H

  • 2 customers launched the products after CFDI approval

  • 2 CDMO customers obtained approval for Donafenib and Camcevi in China & USA – shipment accommodating launch time; Eflornithine submitted to FDA and EMA by CDMO customer

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Changshu Milestone for Upside

  • Collaborate with customers to complete CFDI’s on-site inspection for their approvals of product launch in China market

  • Operations on track for upside

Develop Injectables for future growth

  • Profit-sharing from drug products (in-house development + outsourcing production), and various drug products development in progress

  • Following the 1[st] in-house prefilled-syringe product, an in-house liquid solution product was submitted to FDA for ANDA

  • Completed the 1[st] TFDA on-site inspection in April, 2021

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Business Update

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Optimize
Generic API
Portfolio
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Generic API Business Update

Leverage Tainan/Changshu production advantage and strengthen sales/production coordination to stabilize supplyThe impact of Covid-19 pandemicGeneric API Portfolio

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38
40 Data as of 2021/06/30
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 11 2 2 1
0
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Optimize
Generic API
Portfolio
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2021 Generic API Product A roval Plan pp

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
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
:Approved
*:Collaborative project for drug product development
Data as of 2021/06/30

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Expand
CDMO
Business
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CDMO Business

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12
11
12
9
10
6
1
6
8
6
6
8
4
6 6
5
2
0
Phase 1 Phase 2 Phase 3 Commercial
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SciAnda (Changshu)
ScinoPharm Taiwan
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Data as of 2021/06/30

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Expand
CDMO
Business
2021 CDMO API Product Approval Plan 2021 CDMO API Product Approval Plan 2021 CDMO API Product Approval Plan 2021 CDMO API Product Approval Plan 2021 CDMO API Product Approval Plan
Type Product Region Indication Brand Marketer
CDMO API Donafenib CN( ) Cancer Suzhou Zelgen
CDMO API Camcevi US( )
EU
Cancer Foresee
CDMO API Eflornithine US/EU FAP CPP

Data as of 2021/06/30

  • Donafenib (NCE) was approved and launched in China in June, 2021

  • Camcevi (NCE) was approved by FDA in June, 2021; MAA review in progress

  • Eflornithine submitted to FDA and EMA by customer

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Advancing
to
Injectables
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Peptides

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Sterile Injectables 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 in progress

  • ANDA of 1[st] in-house liquid solution product was submitted to FDA in June, 2021

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

  • Completed the 1[st] TFDA on-site inspection in April, 2021, official inspection report received in June and replied in July, TFDA’s review in progress

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Actively Develop
Japan, China and
Emerging Markets
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Japan Market

  • The impact of Covid-19 pandemic

  • The largest generic API supplier for Galantamine HBr and Capecitabine in Japan

  • Indication: Alzheimer’s disease / Various cancers

  • Japan market size c. USD 200 million / over USD 100 million

Leverage Japan’s late patent expiration and our new injectables capacity to explore opportunities for generic APIs + CDMO projects

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Actively Develop
Japan, China and
Emerging Markets
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China Market

  • Customer’s Fondaparinux Sodium PFS launched in Feb. 2021Indication:Anti-thrombotic

  • Market Size:c. RMB 200 million

  • CFDI on-site ins ection in Chan shu site p g

Inspection Product Approval Indication Market Sodium Urea cycle 2020.09 2021.05 Urea cycle disorders Phenylbutyrate disorders Advanced liver 1[st] year sales projected 2021.02 Donafenib 2021.06 cancer firstby research report: line treatment c. RMB 220 million Expect in 2021.06 Bimatoprost year-end Glaucoma c. RMB 1 billion of 2021

  • Changshu site expects to activate one more inspections in 2021

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Financial Performance

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Consolidated Income Statement

In NTD Million,
except for EPS
1H 2021
(Reviewed)
1H 2021
(Reviewed)
YoY 1H 2020
(Reviewed)
1H 2020
(Reviewed)
Revenue 1,389 100% -4% **1,451 ** 100%
Gross Profit 702 51% 3% 682 47%
Operating Profit 221 16% -12% 252 17%
Net Profit before Tax 224 16% -11% 252 17%
Net Profit after Tax 181 13% -8% 197 14%
EPS (NTD) 0.23 - - 0.25 -

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1H 2021 Sales Distribution

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Drug
CDMO India China Others
Product
13% 4% 6% 10%
4%
US+Canada
Generic
Japan 25%
API 30%
EU
83%
25%
Others
by Business CNS
7% by Region
26%
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by Indication

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Sales Distribution – YoY

By Business Unit: USD Generic API CDMO Drug Product 1H 2021 Sales 41.0M 6.3M 2.0M YoY 4.9% -27.6% 276.9%

By Business

By Indication

Oncology CNS Others 1H 2021 Sales 33.0M 12.9M 3.4M YoY -3.9% 19.2% 9.2% By Region US & EU Japan India China Others Canada 1H 2021 Sales 12.1M 12.2M 14.8M 1.9M 3.2M 5.1M YoY -30.5% 9.9% 81.3% -74.4% 253.6% 54.0%

By Region

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Consolidated Balance Sheet

In NTD Million 2021/6/30
(Reviewed)
2021/6/30
(Reviewed)
2020/6/30
(Reviewed)
2020/6/30
(Reviewed)
Cash and Cash Equivalents 4,104 34% 3,803 31%
Accounts Receivable 355 3% 554 5%
Inventories 1,449 12% 1,299 11%
Property, Plant & Equipment 4,100 34% 4,255 35%
Other Current/Non-Current Assets 2,070 17% 2,197 18%
Total Assets 12,078 100% 12,108 100%
Financial Debt 40 0% 261 2%
Other Current Liabilities 1,027 9% 830 7%
Other Non-Current Liabilities 626 5% 636 5%
Total Liabilities 1,693 14% 1,727 14%
Total Shareholders' Equities 10,385 86% 10,381 86%

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Consolidated Cash Flow Statement

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1H 2021 1H 2020
In NTD million
(Reviewed) (Reviewed)
From Operating Activities 180 368
From Investing Activities (152) 123
From Financing Activities 27 29
Effect of foreign exchange rate changes (6) (22)
Net Change in Cash 49 498
Beginning Balance 4,055 3,305
Ending Balance 4,104 3,803
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Q & A

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Appendix Company Overview

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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*

  • 874 active DMFs worldwide with 64 US DMFs*

  • 150+ contract projects with 8 approved/launched (6 NCEs) and 7 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 2021/06/30

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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