Scinopharm Taiwan, Ltd. · TWSE:1789
Scinopharm Taiwan — Q4 2017 Earnings Presentation
36 slides from Scinopharm Taiwan's earnings presentation, Feb 23, 2018
Slide 1: Fourth Quarter 2017 Investor Meeting
1789 TT ScinoPharm Taiwan, Ltd. Fourth Quarter 2017 Investor Meeting February 23, 2018
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
Table of Content Company Overview and Key Priorities Operating Results Business Highlights and Company Outlook 3
Slide 4: Company Overview and Key Priorities
Company Overview and Key Priorities 4
Slide 5: ScinoPharm at a Glance
ScinoPharm at a Glance ScinoPharm specializes in high potency (steroid/cytotoxic) APIs and injectable provider, serving customers worldwide Facility & offices established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai 73 generic APIs in current p
Slide 6: Driving Long Term Growth by Dual Profits
Driving Long Term Growth by Dual Profits Self-Developed Contract Products Services Target difficult-to-make (peptide)API in our Provide CRO/CMO for APIs portfolio Offer integrated service Tap into drug product from API to formulation related to our API core for niche injectables competencies
Slide 7: World Class Facilities
World Class Facilities Taiwan China API Plant API Plant • 5 of 16 production lines equipped with high • 3 of 7 production lines equipped with high potency capabilities for cytotoxic/steroid potency capabilities for cytotoxic • Provides comprehensive contract research & • US FDA approved cGMP fac
Slide 8: We Value Our R&D
We Value Our R&D R&D investments remain stable Strong focus on R&D with +125 experts (Ph.D:27) 16% 84% 8
Slide 9: Strong API Portfolio for Generic Product
Strong API Portfolio for Generic Product 40 36 unlaunched 35 launched 30 25 23 20 13 15 10 7 7 6 13 4 5 6 2 2 2 3 6 4 3 1 2 2 3 1 0 Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic) 9
Slide 10: ScinoPharm - Oncology API Leader
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 40 50 60 Larg
Slide 11: Drug Product Pipeline - Focus on Complex Generics
Drug Product Pipeline-Focus on Complex Generics Indication Format Enter Barrier & Advantage Osteoporosis Pen Complex Drug-Device Combination Diabetes Pen Complex Drug-Device Combination Anti-thrombotic Syringe Complex API Multiple Sclerosis Syringe Complex API Antineoplastic Lyo Difficult to make AP
Slide 12: Potential Headwinds & Tailwinds
Potential Headwinds & Tailwinds Headwind Tailwind Generic business continues facing Pipeline of complex generics negative pricing environment benefits from a faster approval Increased consolidation among the cycle and higher margins US distribution supply chains CRAMs grow faster than the
Slide 13: Focused Execution into 2018
Focused Execution into 2018 Expanding into formulation business by synergizing with our APIs - Complete the production of 4 registration batch drug products - Establish partnership for self-developed drug products Strengthening Manufacturing and Quality - Create leaner and flexible cost structures b
Slide 14: Operating Results
Operating Results 2 ee 14 ee ScinoPharm
Slide 15: Quarterly P&L - Consolidated
Quarterly P&L - Consolidated In NT$ million, except for EPS Q4 2017 Q3 2017 Q4 2016 (Unaudited) (Reviewed) QoQ (Audited) YoY Revenue 895 100% 849 100% 5% 1,002 100% -11% Cost of Goods Sold (548) -61% (441) -52% -24% (559) -56% 2% Gross Profit 347 39% 407 48% -15% 444 44% -22% Operating Expense (247)
Slide 16: Profit & Loss - Consolidated
Profit & Loss - Consolidated In NT$ million, except for EPS FY 2017 FY 2016 (Unaudited) (Audited) YoY Revenue 3,516 100% 4,031 100% -13% (note) Cost of Goods Sold (1,966) -56% (2,225) -55% 12% Gross Profit 1,550 44% 1,806 45% -14% Operating Expense (991) -28% (938) -23% -6% Operating Income 559 16%
Slide 17: Profit & Loss (ScinoPharm stand-alone)
Profit & Loss (ScinoPharm stand-alone) In NT$ million, except for EPS FY 2017 FY 2016 (Unaudited) (Audited) YoY Revenue 3,449 100% 3,889 100% -11% (note) Cost of Goods Sold (1,778) -52% (2,041) -52% 13% Gross Profit 1,671 48% 1,848 48% -10% Operating Expense (870) -25% (782) -20% -11% Operating Inco
Slide 18: Sales by Business
Sales by Business FY2017 FY2016 18
Slide 19: Sales by Indications
Sales by Indications FY2017 FY2016 19
Slide 20: Sales by Region
Sales by Region FY2017 FY2016 20
Slide 21: Balance Sheet - Consolidated
Balance Sheet- Consolidated (In NT$ million) 2017/12/31 2016/12/31 (Unaudited) (Audited) Cash and Cash Equivalents 3,911 31% 3,707 29% Accounts Receivable 567 4% 638 5% Inventories 1,675 13% 1,830 14% Long-Term Investments 391 3% 364 3% Property, Plant & Equipment 5,089 40% 5,209 41% Other Current/N
Slide 22: Cash Flows - Consolidated
Cash Flows- Consolidated (In NT$ million) FY 2017 FY 2016 (Unaudited) (Audited) From Operating Actavities 972 1,665 Profit before tax 475 811 Depreciation & Amortization 434 447 Net change in working capital 209 449 From Investing Actavities (437) (202) Capital expenditure (402) (447) From Financing
Slide 23: Business Highlights and Company Outlook
Business Highlights and Company Outlook 23
Slide 24: Focusing on Weathering Near-Term Headwinds While Positioning for Long-Term Growth
Focusing on Weathering Near-Term Headwinds While Positioning for Long-Term Growth 2017 2018 2019 and beyond • Industry headwinds • Market conditions • Challenging generic expected to continue market conditions, expected to improve • Sales from CRAM projects • Continue investment in leading to price
Slide 25: Building Capability to Deliver Injectable Growth
Building Capability to Deliver Injectable Growth Developing dossiers per our high-entry-barrier APIs to increase value proposition in the supply chain Expected > 15 drug product Building a pipeline of complex and difficult to make launched in generic injectable products the next 5 Significant
Slide 26: 2018 In-House Injectable Plant Progress
2018 In-House Injectable Plant Progress First Half Second Half Complete equipment/ Kick-off registration batch sterility verification and production for other cGMP system deployment products and offering CMO for both vial and cartridge services for both brand and production lines proprietary dru
Slide 27: 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 Myeloid 1st US ANDA filing, triggering US FDA inspection Sagent US 2018 Injectable Leukemi
Slide 28: CRAM Business Gaining Momentum
CRAM Business Gaining Momentum CRAM business is on track to regain growth momentum Sales from CMO will be boosted by Melinta's newly launched Baxdela™ , indicated for acute skin infections (ABSSSI), and other shipment by the CRO projects Baxdela™ , expected to become top 5 products in 2018, is
Slide 29: CRO Phase III Products Portfolio
CRO Phase III Products Portfolio NDA Filing Indication Region Remarks Year (E) Intermediate project made both in Type I,II 2018 US/ EU Changshu & Taiwan sites. Expected revenue Diabetes of several million USD per year after launch Advanced API project made in Changshu site. CFDA Hepatocellular grant
Slide 30: China Market Dynamics
China Market Dynamics China has paved the way for integration with global standard and move up to key positions in value chain, requiring dedication to quality and innovation Tightened GMP, Environment/Health/Safety laws and drug license approval process significantly raise the cost structure
Slide 31: ScinoPharm Changshu - Capturing Chinese Growth on Multiple Fronts
ScinoPharm Changeshu - Capturing Chinese Growth on Multiple Fronts Position as a gateway into Adopt dual-track drug filing Seek generic APIs China providing supply- process in China and the US or intermediates with large chain to MNCs demand to increase production utilization Focus on mid- to late-p
Slide 32: 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 33: 2018 Product Launch Plan
2018 Product Launch Plan Brand Regional Type Product Region Indication WW Sales Marketer Sales Generic Tamsulosin Benign Prostatic Boehringer CN US$97MM US$1,652.8MM API HCl Hyperplasia (BPH) Ingelheim Reversal of Conscious Generic Flumazenil JP Sedation and General Roche US$13.5MM US$76.1MM API Ane
Slide 34: 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 3 APIs by CRAM customers launched 3 NDAs filed by CRAM customers 2018 2019 2020 2021 5-7 generic APIs launch
Slide 35: Four Key Pillars to Achieve Strategic Roadmap
Four Key Pillars to Achieve Strategic Roadmap BUILD strong pipelines of complex drug products / APIs and expand geographic presence CONTINUE to drive transformation and operational excellence through leadership, people and culture FOSTER partnership and collaboration to increase value and capture un
Slide 36: Brand Quality with Asian Advantages
Brand Quality with Asian Advantages www.scinopharm.com 1789 TT 36