ScinoPharm Feb. 2019 1 Disclaimer This material has been prepared - - PowerPoint PPT Presentation

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ScinoPharm Feb. 2019 1 Disclaimer This material has been prepared - - PowerPoint PPT Presentation

1789 TT ScinoPharm Feb. 2019 1 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.


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ScinoPharm

1789 TT

  • Feb. 2019
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Disclaimer

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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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Confidential

Table of Content

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Overview

Strategies

  • Optimize Existing Generic API Portfolio
  • Value up into Injectables
  • Expand CDMO Business
  • Actively Develop Japan and Emerging Markets

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Overview

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ScinoPharm at a Glance

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 Est. in 1997 and HQ in Taiwan (Tainan) with cGMP plants/R&D in Taiwan and

China (Changshu) and marketing forces in Taiwan and China (Shanghai)

 Specializing in high potency (steroid/cytotoxic) APIs and injectable

formulation, serving customers worldwide

 70 generic APIs in portfolio with 29 APIs approved

60 active US DMFs (805 DMFs WW) with 31 of them oncology APIs

 100+ contract projects with 6 launched (4 NCEs) and 7 in phase 3 for NDA

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

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World Class Facilities

China

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Taiwan

 API Plant

  • 6 of 16 production lines equipped with high potency

capabilities for cytotoxic/steroid

  • Provides comprehensive CRAM services for brand

drug companies

 Injectable Plant

  • Vial and cartridge production lines for oncological

and peptide products

  • To meet US, EU, Japan GMP standards by adopting

state-of-the-art isolator technology and single use technology for product contact path

 API Plant

  • 3 of 7 production lines equipped with high potency

capabilities for cytotoxic

  • US FDA approved cGMP facility for intermediates &

high potency API

  • Strong R&D capabilities of APIs on small to large

scales for generic & CRAM markets

  • Strategic partnerships with China clients for

formulations targeting global/China markets

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Confidential

2018 Sales Distribution

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US+CAN 42% EU 34% JP 8% India 10% China 1% Ohters 5%

by Region

Generic API 65% CRO 19% CMO 15% BD & Others 1% Oncology 56% CNS 14% Infectious 15% Others 15%

by Business by Indication

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Confidential

Regulatory Inspections (API)

US FDA inspection (6)

  • 2001/10; 2005/08; 2008/10; 2012/03; 2015/03; 2017/02

Europe EMA inspection (2)

  • 2013/01; 2014/03

Japan PMDA inspection (30)

  • On-site inspection (2) on 2008/05 and 2017/11
  • Desk inspection (28)

EDQM Inspection (1)

  • 2016/10

Taiwan DOH / TFDA inspection (22)

  • 2002/01; 2003/01; 2003/06; 2004/04; 2005/11; 2007/12; 2008/02; 2008/10; 2009/02; 2010/04; 2010/11; 2011/09;

2012/01; 2012/03; 2012/12; 2013/04; 2013/10; 2014/01; 2015/05; 2016/02; 2016/03;2016/06; 2017/01

German authority HSSEN (1)

  • 2016/11

Korea KFDA inspection (5)

  • 2008/08; 2011/02; 2015/09
  • Desk inspection (2)

Mexico COFEPRIS inspection (4)

  • 2010/10; 2013/05; 2016/01; 2017/09

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Strategies

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Strategies

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Actively Develop Japan and Emerging Markets Optimize Existing Generic API Portfolio Value up into Injectables Expand CDMO Business

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Strategy - Optimize Existing Generics API Portfolio

11 5 10 15 20 25 30 35

20 7 4 2 1 3 4 15 6 2 4 1 1

Approved Pipeline 35 13 6 6 2 3 5

Note: Others (Women's Health, Respiratory, Gastrointestinal, Immunology and Metabolic)

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Strategy - Value Up into Injectables

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 Leverage leading position in oncology APIs to expand formulation portfolio  Target complex products with high entry barriers or high unit-pricing  Develop dossiers based on API expertise, including ANDA filing

 Apply ANDA with in-house APIs via P4 or 505(b)(2) fast track  3 US ANDA filings (via Injectable CMO) with 2 approvals (Decitabine and

Fondaparinux Sodium)

 Submission of 1st in-house ANDA in late 2019

 15 projects with multiple partners in China and US/EU  Offer CMO services for proprietary and generic drugs

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Confidential

In-House Injectable Portfolio

Vial Product Line

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3 6 2 2

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Confidential

Strategy - Expand CDMO Business

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15 1 2 3 4 5 6 7 8 9

Phase 1 Phase 2 Phase 3 Commercial

6 4 6 6 3 5 1 SciAnda (Changshu) ScinoPharm Taiwan

9 9 7 6

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Confidential

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Strategy - Develop Japan and Emerging Markets

China

Focus on mid- to late-phase CRO projects Seek generic APIs/intermediates with large demand

Japan

20 generic customers with 7 from top 10 drug firms Direct business with local generic customers Support Japanese and foreign pharmaceutical companies for market expansion Develop CRAM projects and leverage new capabilities of injectables

South America & Russia

Focus on oncology API/injectable market development

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Brand Quality with Asian Advantages

www.scinopharm.com

Confidential

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