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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
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Supply chain change caused by on-going covid-19 pandemic
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Global logistic striving for recovery
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Customer inventory adjustment
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Taiwan level 3 covid-19 alert in 2Q
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Dynamic production and sales planning to adapt the challenge
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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
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CFDI’s on-site inspection on Changshu site
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Inspection for Donafenib and Bimatoprost completed in 2021 1H
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1 on-site inspections scheduled in 2021 2H
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2 customers launched the products after CFDI approval
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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
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Collaborate with customers to complete CFDI’s on-site inspection for their approvals of product launch in China market
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Operations on track for upside
Develop Injectables for future growth
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Profit-sharing from drug products (in-house development + outsourcing production), and various drug products development in progress
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Following the 1[st] in-house prefilled-syringe product, an in-house liquid solution product was submitted to FDA for ANDA
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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 supply The impact of Covid-19 pandemic Generic API Portfolio
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40 Data as of 2021/06/30
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Pipeline
30 Approved
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25
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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 | *PemetrexedDisodium 7H2O CEP |
EU | Non-small cell lung cancer |
Eli Lilly |
| Generic API | Topiramate | EU | Weight management |
Vivus |
:Approved*:Collaborative project for drug product developmentData as of 2021/06/30 |
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Expand
CDMO
Business
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CDMO Business
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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
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Donafenib (NCE) was approved and launched in China in June, 2021
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Camcevi (NCE) was approved by FDA in June, 2021; MAA review in progress
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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
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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 in progress
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ANDA of 1[st] in-house liquid solution product was submitted to FDA in June, 2021
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Registration batches of Vial line (prefilled-syringed /pen device) and Cartridge line (liquid solution/ lyophilized powder) products were completed
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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
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The impact of Covid-19 pandemic
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The largest generic API supplier for Galantamine HBr and Capecitabine in Japan
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Indication: Alzheimer’s disease / Various cancers
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:
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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
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Customer’s Fondaparinux Sodium PFS launched in Feb. 2021 Indication:Anti-thrombotic
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Market Size:c. RMB 200 million
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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
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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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874 active DMFs worldwide with 64 US DMFs*
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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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