Scinopharm Taiwan, Ltd. · TWSE:1789
Scinopharm Taiwan — JPM Healthcare Conference 2018
38 slides from Scinopharm Taiwan's conference presentation, Jan 8, 2018
Slide 1: ScinoPharm Management Presentation
1789 TT ScinoPharm Management Presentation 2018/01/08 1
Slide 2: Disclaimer
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.
Slide 3: Table of Content
Confidential Table of Content Overview of ScinoPharm ScinoPharm’s Strategies and Opportunities Operating Results & Business Updates 3 3
Slide 4: Overview of ScinoPharm
_ — Overview of ScinoPharm
Slide 5: ScinoPharm at a Glance
ScinoPharm at a Glance ScinoPharm specializes in high potency (steroid/cytotoxic) APIs provider and injectable formulation developer, serving customers worldwide Facility & organization established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai, Ch
Slide 6: Specialty Pharmaceutical Company with Two Businesses
Specialty Pharmaceutical Company with Two Businesses Partner’s Third Injectable Party’s API Plant Plant API + ANDA NCE Generic CRO+CMO In-house Injectable Plant 6 28
Slide 7: Driving Long Term Growth by Dual Profits
Driving Long Term Growth by Dual Profits Self-Developed Contract Products Services Target difficult-to-make Provide CRO/CMO for APIs (peptide)API in our portfolio Offer integrated service from Tap into formulation business related to our API API to formulation for niche core competencies inj
Slide 8: World Class Facilities
World Class Facilities Taiwan China 6.6 hectares of land, 330K sq.ft. facilities with 6.7 hectares of land with > 250M3 reactor volume >200M3 reactor volume 3 of 7 production lines equipped with high 5 of 16 production lines equipped with high potency capabilities for cytotoxics potency capa
Slide 9: Strong Generics Product Portfolio
Confidential Strong Generics Product Portfolio 36 unlaunched 40 35 launched 30 25 23 20 13 15 10 7 7 6 13 4 2 2 2 3 5 6 6 3 4 2 2 3 1 1 0 Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic) 9 11
Slide 10: 2017 Sales Distribution
Confidential 2017 Sales Distribution by Region by Business 10 by Indications 10
Slide 11: ScinoPharm - Oncology API Leader
Confidential ScinoPharm - Oncology API Leader Stand-Alone API Companies ScinoPharm 32 21 Shilpa 12 11 3 Polymed 10 2 3 MacChem Products 6 5 2 # Oncology DMF Overlap with SPT Laurus Labs 8 7 16 # Non-overlapping Oncology DMF # Other DMFs Sichuan Xieli 1 2 1 Chemwerth 3 5 34 Apicore 5 8 27 0 10 20 30
Slide 12: ScinoPharm's Strategies and Opportunities
ScinoPharm’s Strategies and Opportunities 12
Slide 13: Focused To Achieve Our Goals
Focused To Achieve Our Goals 1.Deploying the network of development, production and distribution of injectables − Develop dossiers per our difficult-to-make APIs (complicated synthesis & analytical methods) plus specialized injection devices − Build partnerships and to achieve critical mass workforc
Slide 14: Transforming Our Business
Confidential Transforming Our Business Expanding into formulation business, synergizing with our API business, to maximize ROI Positioning as a Transforming into a Gateway into China full-scope pharma Tightening cost control, and process optimization with providing Supply-Chain company by executing
Slide 15: Keys to Generic Formulation Business
Keys to Generic Formulation Business Opportunity Strategy Tactics Already the leader in Developing dossiers per our Expanding formulation providing oncology APIs to difficult-to-make APIs to increase portfolio regulated markets worldwide value proposition in the supply Establishing on-site
Slide 16: Strategic Alliance Highlights
Strategic Alliance Highlights * Already launched Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013* 1st co-developed formulation product launch Oncology 1st US ANDA filing, triggering US FDA inspection in Changshu, Sagent Myeloid Leukemia US 2
Slide 17: In-House Injectable Plant Progress
In-House Injectable Plant Progress Taiwan-based facility will accommodate R&D, Quality Control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage. Planned kick-off registration batch production by early 2018. Expected submission of 1st in-house ANDA in late 2
Slide 18: U7 +/
4 U7 +/ 18
Slide 19: Aseptic Fill & Finish Service
Confidential Aseptic Fill & Finish Service Vial Product Line 19
Slide 20: Progress of Injectable Business
Confidential Progress of Injectable Business Product Oncology Injectable Fondaparinux Others (10 drugs) Partner Co-development with US-self development+local Self development and Sagent marketer partnership CN-collaboration with Lee’s Pharma Formulation Kindos Pharmaceuticals, CMO CMO + In-house pro
Slide 21: CRO Phase III Product Portfolio
Confidential CRO Phase III Product Portfolio NDA Filing Indication Region Remarks Year (E) Intermediate project made both in Changshu & Type I,II 2018 US/ EU Taiwan sites. Expected revenue of several million Diabetes USD per year after launch API project made in Changshu site. CFDA granted Advanced
Slide 22: Emerging and Japan Market Development
Confidential Emerging and Japan Market Development China Accelerate progress to create positive cash flow Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, anti-hypertension, and diabetes Seek generic APIs/intermediates with large demand to increase prod
Slide 23: Capturing Chinese Growth on Multiple Fronts
Confidential Capturing Chinese Growth on Multiple Fronts MNCs and emerging virtual-model players create a sizable demand in high-quality and compliant API contract manufacturing in China Existing review and approval mechanisms significantly raise the entry barrier and cost structure in the Chine
Slide 24: Selected List of CRAM Projects at Changshu
Confidential Selected List of CRAM Projects at Changshu Project Customer Product Indication/stage Product Type Remarks/ Market Type Passed Mexican authority Top 10 global pharma CMO Approved antidepressant drug in US GMP Intermediate (APIF) GMP inspection Top 5 global pharma CMO Approved African sle
Slide 25: Maintain Market Share of Existing APIs
Maintain Market Share of Existing APIs - 2017 Major Products account for 50 % of total sales # of US DMF/EDMF & API Product Indication MKT share* other filings Irinotecan HCI Antineoplastic 37% 64 Exemestane Antineoplastic 25% 46 Paclitaxel Antineoplastic 21% 60 Gemcitabine Antineoplastic 17% 76 Doc
Slide 26: Operating Results & Business Updates
Operating Results & Business Updates 26
Slide 27: P&L - Consolidated
P&L - Consolidated 1Q~3Q,’17 1Q~3Q,’16 In NT$ million, except for EPS YoY (Reviewed) (Reviewed) Operating Revenue 2,621 3,028 -13% Gross Profit 1,203 1,362 -12% Gross margin 46% 45% Operating Expenses (744) (704) -6% Operating Income 459 658 -30% Operating margin 17% 22% Other Rev.(Exp.) (61) (60) -
Slide 28: Balance Sheet- Consolidated
Balance Sheet- Consolidated 2017/09/30 2016/09/30 In NT$ million (Reviewed) (Reviewed) Cash and Cash Equivalents 3,950 31% 3,137 25% Accounts Receivable 470 4% 614 5% Inventories 1,830 14% 2,018 16% Long-Term Investments 391 3% 364 3% Property, plant and equipment 5,122 40% 5,248 42% Other Current/N
Slide 29: Cash Flows- Consolidated
Cash Flows- Consolidated 1Q~3Q 2017 1Q~3Q 2016 In NT$ million (Reviewed) (Reviewed) Cash and cash equivalents at beginning of period 3,707 2,336 Cash flows from operating activities 789 1,130 CAPEX (383) (420) Short-term borrowings (405) (747) Long-term borrowings 570 812 Cash Dividends (228) (219)
Slide 30: Historical Performance
Historical Performance Unit: millions of NT$ 5,088 4,572 5,000 3,953 4,098 3,955 4,031 3,145 3,887 4,000 3,145 2,621 3,000 2,000 872 1,041 1,000 1,040 1,170 961 1,273 635 659 362 484 0 484 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Q1-Q3 30 12
Slide 31: Recent Financials
Recent Financials In NT$ Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M Shareholders’ equity 9,643 M 9,380 M 9,857 M 10,228 M Sales 5,088 M 4,098 M 3,955 M 4,031 M Net profit after tax 1,273 M 484 M 635 M 659 M Earnings per share 1.88 0.69 0.87 0.87 Cash dividends 1.2 0.2
Slide 32: Injectable Products Allied with Baxter
Injectable Products Allied with Baxter ScinoPharm and Baxter Healthcare establish worldwide partnerships to co- develop and commercialize five niche generic injectable products at the initial stage ScinoPharm develops all APIs and injectable formulations. Baxter leads regulatory submissions in t
Slide 33: Collaboration Framework
Collaboration Framework Initial product portfolio including the generic injectables for breast cancer, lung cancer, multiple myeloma and antinauseant. Targeting US/EU markets first and expect to expand to other territories This exclusive partnership will utilize each other's strengths and expert
Slide 34: Responsibilities by ScinoPharm and Baxter
Responsibilities by ScinoPharm and Baxter API Development API Production ScinoPharm Formulation Development ScinoPharm FDF Manufacturing Baxter CMO Sales & Marketing Baxter 34 28
Slide 35: Benefits of the Collaboration
Benefits of the Collaboration Aggressively expanding our “Double A” strategy (API+ANDA) for in-house developed/produced APIs and formulations. Providing an outlet for our injectable plant capacity A win-win solution and collaboration. ScinoPharm provides comprehensive APIs and formulation portfo
Slide 36: 2018 Product Launch Plan
2018 Product Launch Plan Brand Regional Type Product Region Indication WW Sales Marketer Sales Generic Benign Prostatic Boehringer Tamsulosin HCl CN US$97m US$1,652.8m API Hyperplasia (BPH) Ingelheim Reversal of Conscious Generic Flumazenil JP Sedation and General Roche N/A US$76.1m API Anesthesia G
Slide 37: Pipeline Outlook Timeline
Pipeline Outlook Timeline 3 generic APIs launched 5-7 generic APIs launched 3 in-house drug ANDAs filed 2 co-developed China ANDAs 1st BD & 1st self-developed US ANDA launched 2 APIs by CRAM customers launched 4 NDAs filed by CRAM customers 2018 2019 2020 2021 5-7 generic APIs launch
Slide 38: Brand Quality with Asian Advantages
Confidential Brand Quality with Asian Advantages www.scinopharm.com 1789 TT 38 38