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SPT Investor Presentation 2021

Nov 10, 2021

51922_rns_2021-11-10_b5b2666a-dcc0-4b1e-912d-b1aa13394e03.pdf

Investor Presentation

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1789 TT

ScinoPharm

November 10, 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 Update

Financial Performance

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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 coordinationThe impact of Covid-19 pandemic and dual control of energy consumption in China are still manageableGeneric API Portfolio

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38
40 Data as of 2021/09/30
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 2021/09/30

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Expand
CDMO
Business
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CDMO Business

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10 9 9 9
1
8
4 4 6
6
1
SciAnda (Changshu)
ScinoPharm Taiwan
8
4
5 5 5
2
0
Phase 1 Phase 2 Phase 3 Commercial
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Data as of 2021/09/30

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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 2021/09/30

Donafenib:

  • Approved and launched in China in June, 2021 (Indication: Advanced liver cancer)

  • Summited to NMPA in Oct. 2021 (Indication: RAIR-DTC)

  • Camcevi:

  • Approved by FDA in June, 2021; MAA review in progress

  • Replied Canada Healthcare in Sep. 2021

  • Eflornithine:

  • Submitted to FDA and EMA by customer

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Advancing
to
Injectables
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Peptides Sterile Injectables Pen Injectors
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  • Registration batches of Vial line (prefilled-syringed /pen device) and Cartridge line (liquid solution/ lyophilized powder) products were completed

  • ANDA of 1[st] in-house prefilled-syringe product was submitted to FDA in May, 2020 - Responded to FDA CRL in Sep. 2021

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

  • Registration batches of 2[nd] prefilled-syringed product in progress

  • Target to summit the ANDA of 1[st] in-house lyophilized powder product to FDA in year-end of 2021

  • Completed the 1[st] TFDA on-site inspection in April, 2021 - Replied TFDA in Q3, 2021, and TFDA’s review in progress

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Actively Develop
Japan, China and
Emerging Markets
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Japan Market

Completed the establishment of Japan branch in Q3, 2021 to cultivate Japan market

  • 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 inspection in Changshu site

Inspection Product Approval Indication Market
2020.09 Sodium
Phenylbutyrate
2021.05 Urea cycle
disorders
Urea cycle disorders
2021.02 Donafenib 2021.06 Advanced liver
cancer first-line
treatment
1st year sales projected
by research report:
c. RMB 220 million
2021.06 Bimatoprost Expected by
2021 year-end
Glaucoma c. RMB 1 billion
  • Clinic trial of customer’s Sodium Phenylbutyrate for new indication in progress

  • Customer’s Donafenib summited to NMPA in Oct. 2021 for new indication - RAIR-DTC

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Financial Performance

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Consolidated Income Statement

In NTD Million,
except for EPS
3Q 2021
(Reviewed)
3Q 2021
(Reviewed)
YoY 3Q 2020
(Reviewed)
3Q 2020
(Reviewed)
Revenue 2,043 100% -8% **2,209 ** 100%
Gross Profit 945 46% -11% 1,058 48%
Operating Profit 227 11% -36% 354 16%
Net Profit before Tax 235 11% -32% 346 16%
Net Profit after Tax 190 9% -31% 274 12%
EPS (NTD) 0.24 - - 0.35 -

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3Q 2021 Sales Distribution

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CDMO Drug China Others
Product India 7% 8%
14%
10% 7%
US+Canada
Japan
Generic 25%
29%
EU
API
24%
76%
by Business CNS Others
by Region
24% 7%
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by Indication

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Sales Distribution – YoY

By Business Unit: USD Generic API CDMO Drug Product 3Q 2021 Sales 55.2M 10.4M 7.3M YoY 3.4% -39.4% 105.3%

By Indication

Oncology CNS Others 3Q 2021 Sales 50.6M 17.6M 4.7M YoY 5.6% -16.0% -10.4%

By Region US & Canada EU Japan India China Others 3Q 2021 Sales 18.4M 17.6M 20.8M 5.3M 4.8M 6.0M YoY 27.1% -42.1% 71.7% -46.7% 125.7% 17.0%

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Consolidated Balance Sheet

In NTD Million 2021/9/30
(Reviewed)
2021/9/30
(Reviewed)
2020/9/30
(Reviewed)
2020/9/30
(Reviewed)
Cash and Cash Equivalents 3,732 33% 3,759 31%
Accounts Receivable 284 2% 468 4%
Inventories 1,373 12% 1,350 11%
Property, Plant & Equipment 4,066 36% 4,211 35%
Other Current/Non-Current Assets 1,994 17% 2,212 19%
Total Assets 11,449 100% 12,000 100%
Financial Debt 0 0% 244 2%
Other Current Liabilities 503 4% 638 6%
Other Non-Current Liabilities 624 6% 633 5%
Total Liabilities 1,127 10% 1,515 13%
Total Shareholders' Equities 10,322 90% 10,485 87%

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Consolidated Cash Flow Statement

In NTD million 3Q 2021
(Reviewed)
3Q 2020
(Reviewed)
From Operating Activities 331 616
From Investing Activities (238) 51
From Financing Activities (411) (210)
Effect of foreign exchange rate changes (5) (3)
Net Change in Cash (323) 454
Beginning Balance 4,055 3,305
Ending Balance 3,732 3,759

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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*

  • 875 active DMFs worldwide with 64 US DMFs*

  • 150+ contract projects with 9 approved/launched (7 NCEs) and 6 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 2021/09/30

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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