Investor Presentaiton

Made public by

sourced by PitchSend

35 of 39

Creator

PitchSend logo
PitchSend

Category

Pending

Published

Unknown

Slides

Transcriptions

#1-001 1789 TT ScinoPharm Taiwan, Ltd. Fourth Quarter 2017 Investor Meeting February 23, 2018 GO ScinoPharm#22 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. ScinoPharm#33 Table of Content ■ Company Overview and Key Priorities ■ Operating Results Business Highlights and Company Outlook ScinoPharm#44 001 Company Overview and Key Priorities ScinoPharm#55 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 portfolio with 25 APIs launched; 56 US DMFs filed (767 DMFS WW), 33 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 NDAs launched and 4 in phase III ■Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australia TGA, Japan PMDA, Korea KFDA, Mexico COFEPRIS and Germany regulatory Authority ScinoPharm#66 Driving Long Term Growth by Dual Profits Self-Developed Products ✓ Target difficult-to-make (peptide)API in our portfolio ✓ Tap into drug product related to our API core competencies ✓ Target 505(b)(2) and Paragraph IV drug product via strategic alliances Contract Services ✓ Provide CRO/CMO for APIs ✓ Offer integrated service from API to formulation for niche injectables ✓ Provide biologics fill & finish CMO services ScinoPharm#7World Class Facilities Taiwan ■API Plant . 5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroid Provides comprehensive contract research & manufacturing services for brand drug companies ■Injectable Plant • Vial and cartridge production lines for oncological and peptide products To meet US, EU, Japan GMP standards with adopting state-of-the-art isolator technology and single use technology for product contact path GB-3806A China ■API Plant • • 3 of 7 production lines equipped with high potency capabilities for cytotoxic US FDA approved cGMP facility for intermediates & high potency API Full scope capabilities in the development and production of APIs on small to large scales for generic & CRAM markets Strategic partnerships with China clients with downstream formulations and mutually. target for global and China markets Swan 7 神隆弱(常)有限公司 ScinoPharm#88 We Value Our R&D ■R&D investments remain stable R&D Investment (mn $NT) ■Strong focus on R&D with +125 experts (Ph.D:27) -R&D (% TO sales) 330 10% 9% 9% 320 R&D Staffs 8% 8% Employees 310 7% 7% 300 6% 290 16% 280 84% 5% 4% 3% 270 2% 260 1% 250 0% 2015 2016 2017 ScinoPharm#99 40 40 Strong API Portfolio for Generic Product 35 30 23 225 20 15 10 5 0 13 36 Oncology CNS 13 7 7 6 2 2 6 6 4 2 Cardiovascular Infectious unlaunched ■launched 3 3 4 3 Genitourinary Respiratory 22 Ophthalmology Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic) Other ScinoPharm#1010 ScinoPharm - Oncology API Leader Stand-Alone API Companies 21 ScinoPharm Shilpa Polymed MacChem Products Laurus Labs Sichuan Xieli Chemwerth Apicore 11 16 # Oncology DMF Overlap with SPT # Non-overlapping Oncology DMF # Other DMFS 34 8 27 0 10 20 30 40 50 60 21 28 14 13 ScinoPharm Teva 18 Dr. Reddy's Cipla 17 Sun 17 12 Hisun 19 Qilu 838 Hengrui 33 11 0 Source: US FDA DMF Q2 2017 database Large Generic Pharmaceutical Companies 176 128 164 50 100 150 264 ■ # Oncology DMF Overlap with SPT # Non-overlapping Oncology DMF # Other DMFS 200 250 ScinoPharm 300#11Drug Product Pipeline-Focus on Complex Generics 11 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 API and Formulation Anti nauseant Lyo Difficult to make API and Formulation Antineoplastic Lyo,Vial Antineoplastic Lyo Antineoplastic Lyo Antineoplastic Lyo,Vial Difficult to make API Difficult to make API, Complex Route of Delivery and Formulation Difficult to make API Difficult to make API Antineoplastic Lyo,Vial Difficult to make API and Formulation Antineoplastic Vial Existing API Antineoplastic Vial Existing API Antineoplastic Vial Existing API ScinoPharm#1212 Potential Headwinds & Tailwinds Headwind Tailwind Generic business continues facing negative pricing environment Increased consolidation among the US distribution supply chains More and faster ANDA approvals leading to quicker price erosion ■Fewer small molecule blockbuster drugs invented ■Impact of patent linkage and patent term extension in Taiwan ■ Pipeline of complex generics benefits from a faster approval cycle and higher margins ■ CRAMS grow faster than the pharma ■ Pharmerging markets are expected to grow due to increasing geriatric population and healthcare expenditure ScinoPharm#1313 Focused Execution into 2018 UP 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 by improving operating efficiency, RD productivity and portfolio optimization - Comply with the modern strict environmental laws in China Near term CRO projects pose to propel the company to next level - Focus on targeted therapies and orphan drugs /first in class or best in class - Provide integrated service from API to formulation for niche injectable Continuous process optimization on our existing APIs Maintain market share and profits of our major products ScinoPharm#1414 001 Operating Results ScinoPharm#1515 Quarterly P&L - Consolidated In NT$ million, except for EPS Revenue Cost of Goods Sold Gross Profit Q4 2017 (Unaudited) 895 100% Q3 2017 (Reviewed) Q4 2016 QoQ (Audited) YOY 849 100% 5% 1,002 100% -11% (548) -61% (441) -52% -24% (559) -56% 2% 347 39% 407 48% -15% 444 44% -22% Operating Expense (247) -28% (256) -30% 3% (234) -23% -6% Operating Income 100 11% 152 18% -34% 210 21% -53% Non-operating Income, Net (23) -3% (25) -3% 10% 3 0% -928% Income before Tax 77 9% 127 15% -39% 213 21% -64% Net Income 61 7% 107 13% -43% 147 15% -59% EPS (NT$) 0.08 0.14 0.19 *Weighted average outstanding shares were 790.739m units in 4Q 17. ScinoPharm#16Profit & Loss - Consolidated Revenue In NT$ million, except for EPS FY 2017 (Unaudited) 3,516 100% FY 2016 (Audited) YOY Cost of Goods Sold (1,966) -56% 4,031 100% (2,225) -55% -13% (note) 12% Gross Profit 1,550 44% 1,806 45% -14% Operating Expense (991) -28% (938) -23% -6% Operating Income 559 16% 868 22% -36% Non-operating Income, Net (84) -2% (58) -1% -45% Income before Tax 475 14% 811 20% -41% Net Income 422 12% 659 16% -36% EPS (NT$) 0.53 0.83 EBITDA 986 28% 1,294 32% -24% * Total outstanding shares were 790.739m units at 12/31/2017. 16 Note: 2016 vs 2017: 5.96% NTD appreciation against USD YoY ScinoPharm#17Profit & Loss (ScinoPharm stand-alone) In NT$ million, except for EPS FY 2017 (Unaudited) FY 2016 (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 Income 801 23% 1,066 27% -25% Non-operating Income, Net (313) -9% (244) -6% -28% Income before Tax 489 14% 822 21% -41% Net Income 422 12% 659 17% -36% EPS (NT$) 0.53 0.83 EBITDA 823 24% 1,178 30% -30% * Total outstanding shares were 790.739m units at 12/31/2017. 17 Note: 2016 vs 2017: 5.96% NTD appreciation against USD YoY ScinoPharm#1818 Sales by Business FY2017 BD & CRO FY2016 Others CMO 8% 5% BD & 18% CMO CRO Others 2% 12% <1% Generic ΑΡΙ 86% Generic API 69% ScinoPharm#1919 Sales by Indications FY2017 Others FY2016 Infectious 12% Others 12% CNS 12% 12% Oncology CNS 66% 10% Oncology 76% ScinoPharm#2020 Sales by Region FY2017 FY2016 JP China ROW 9% 3% 7% AU+NZ India CN 2% Others 11% 7% JP 4% 8% EU 29% India 10% US+CAN EU 49% 20% US+CAN 41% ScinoPharm#21Balance Sheet- Consolidated 2017/12/31 2016/12/31 (In NT$ million) (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/Non-Current Assets 1,068 9% 1,035 8% Total Assets 12,701 100% 12,783 100% Current Liabilities 1,115 9% 1,692 13% Long-Term & Other Liabilities 1,169 9% 863 7% Total Liabilities 2,284 18% 2,555 20% Total Shareholders' Equities 10,417 82% 10,228 80% Key Indices A/R Turnover (Days) 65.6 71.6 Inventory Turnover (Days) 434.5 405.6 Current Ratio (x) 5.8 3.9 ROE (%) 4.1 6.6 21 24 ScinoPharm#22Cash Flows- Consolidated (In NT$ million) FY 2017 (Unaudited) FY 2016 (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 Actavities (314) (138) Short-term loans (584) (720) Long-term loans 518 803 Cash dividends (228) (219) Net Change in Cash 204 1,371 Beginning Balance 3,707 2,336 Ending Balance 3,911 3,707 22 22 Free Cash Flow 570 1,218 ScinoPharm#2323 001 Business Highlights and Company Outlook ScinoPharm#24Focusing on Weathering Near-Term Headwinds While Positioning for Long-Term Growth 2017 Challenging generic market conditions, leading to price erosion and volume decline Gained some, lost some in CRAM business China site still faced a financial loss Focused on cost reductions and portfolio optimization 2018 Industry headwinds expected to continue Sales from CRAM projects are expected to boost Speed up momentum of downstream integration strategy by establishing alliance with partner Aggressively expand formulation products Further cost reductions and portfolio optimization Accelerate progress to create positive cash flow for Changshu site 2019 and beyond Market conditions expected to improve Continue investment in growth opportunities Maintain high level of quality and compliance Strong pipeline to drive growth from: - CRAM business - Drug products business 24 24 ScinoPharm#25Building Capability to Deliver Injectable Growth ■ Developing dossiers per our high-entry-barrier APIs to increase value proposition in the supply chain ■ Building a pipeline of complex and difficult to make generic injectable products ■ Significant investment in injectable R&D in the next few years ■ Quality driven, diversified manufacturing operations ■ Promoting our formulations via strategic alliance, especially in China and US ■ Acquiring critical resources via M&A Expected > 15 drug product launched in the next 5 years Introducing 3 to 4 drug products per year in our pipeline 25 25 ScinoPharm#262018 In-House Injectable Plant Progress First Half Second Half ✓ Complete equipment/ sterility verification and CGMP system deployment for both vial and cartridge production lines ✓ Complete registration batch production for liquid solution/lyophized powder/prefilled-syringe and pen decvece ✓ Kick-off registration batch production for other products and offering CMO services for both brand and proprietary drugs ✓ Expected submission of 1st in-house produced ANDA ✓ Taiwan FDA on-site inspection 26 26 ScinoPharm#27Strategic 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 Sagent Oncology Injectable Myeloid Leukemia US 2018 1st US ANDA filing, triggering US FDA inspection in Changshu, China site Foresee Leuprolide Prostate cancer US 2019 505(b)(2) NDA CRAM + Equity Coland Bortezomib Multiple China 2020 Myeloma 1st co-developed drug in China to trigger CFDA inspection in Changshu site Fondaparinux Anti-thrombotic China 2022 Lee's Co-development collaboration Pharma Travoprost Glaucoma China 2022 &Bimatoprost Nanjing King Friend Stress agent for Regadenoson China 2021 heart scan US partner Project A Non-small cell lung cancer US 2018 US & China partners Project B Imaging agent US 2021 Co-developed formulation in China US NDA 505(b)(2) / The estimated launch year is subject to litigation results ANDA with Paragraph IV filing/ The estimated launch year is subject to litigation results Baxter ☐ 5 niche injectables Anti-cancer & antinauseant US/EU 2020& continuing thereafter Baxter has the right to add up to 15 additional injectable products for collaboration Indian Int'l partner Fondaparinux Anti-thrombotic US/EU 2018 1st self-developed US ANDA submitted. Executive right for marketing & sales 27 SeinoPharm#2828 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 designated as a qualified infectious disease product (QIDP)and enjoys a five-year extension of any non-patent exclusivity period More indications on the way for Baxdela™ include Serious Community-Acquired Bacterial Pneumonia (CABP) in Phase III and Complicated Urinary Tract Infections (CUTI) in Phase I ■ Four CRO projects in Phase III trials are expected to file NDAs in 2018/2019 and if successful could result in the drugs being launched in 2019/2020 with incremental sales ScinoPharm#29CRO Phase III Products Portfolio 29 NDA Filing Year (E) Indication Region Type I,II 2018 Diabetes 2018 Advanced Hepatocellular Carcinoma, Myelofibrosis, Autoimmune disease 2018 Prostate Cancer Familial Adenomatous 2019 Polysis Remarks Intermediate project made both in US/EU Changshu & Taiwan sites. Expected revenue of several million USD per year after launch CN API project made in Changshu site. CFDA granted accelerated review under its category 1.1 innovative drug. Anticipated launch in 2019 with demand in tons Started process validation. Anticipated US EU launch in 2019 and revenue of several million USD per year API project made both in Taiwan & US/EU Changshu sites. Anticipated launch in 2020 with demand in tons to tens tons ScinoPharm#3030 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 ■Full Market Authorization Holder (MAH) rolled out creating a sizable demand in high-quality CDMO services. ■Reduction of application backlog and review timeline acceleration for NDA and China+US dual-track drug filing ScinoPharm#3131 ScinoPharm Changeshu - Capturing Chinese Growth on Multiple Fronts Position as a gateway into China providing supply- chain to MNCs Adopt dual-track drug filing process in China and the US Seek generic APIs or intermediates with large demand to increase production utilization Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, anti-hypertension, and diabetes Tighten cost control and process optimization with enhanced management As the back up site for generic API after the Implementation of patent term extension ScinoPharm#32Maintain Market Share of Existing APIs - 2017 Major Products account for 50% of total sales API Product # of US DMF/EDMF & other filings Indication MKT share* Irinotecan HCI Antineoplastic 37% 64 Exemestane Antineoplastic 25% 46 Paclitaxel Antineoplastic 21% 60 60 Gemcitabine Antineoplastic 17% 76 Docetaxel Antineoplastic 15% 72 Anhydrous 32 32 *Source: IMS data from Newport ScinoPharm#332018 Product Launch Plan 33 Type Product Region Indication Brand Regional Marketer Sales WW Sales Generic API Tamsulosin HCI ☐ CN Benign Prostatic Hyperplasia (BPH) Boehringer Ingelheim US$97MM US$1,652.8MM Reversal of Conscious Generic API Flumazenil JP Sedation and General Anesthesia Roche US$13.5MM US$76.1MM Generic ΑΡΙ Capecitabine JP Antineoplastic Roche US$122MM US$834.7MM Generic Drug Oncology Injectable US Myeloid Leukemia MDS US$175.9MM US$284.4MM Generic Fondaparinux US Anti-thrombotic Mylan US$75.1MM US$194.9MM Drug Source: IMS Data (2016Q3-2017Q2) ScinoPharm#34Pipeline Outlook Timeline ✓ 3 generic APIs launched ✓ 3 in-house drug ANDAs filed ✓ 1st BD & 1st self-developed US ANDA launched ✓ 3 NDAs filed by CRAM customers ✓ 5-7 generic APIs launched ✓ 2 co-developed China ANDAS ✓ 3 APIs by CRAM customers launched 34 =4 2018 2019 2020 2021 ✓ 5-7 generic APIs launched ✓ 1 BD US ANDA launched ✓ 3 APIs by CRAM customers launched ✓ US FDA inspection at Injectable plant ✓ CFDA inspection at Changshu site ✓ 6-8 generic APIs launched ✓ 3 BD & 1 self-developed ANDA launched ✓ 5 APIs by CRAM customers launched ScinoPharm#35Four Key Pillars to Achieve Strategic Roadmap BUILD strong pipelines of complex drug products / APIs and expand geographic presence CONTINUE 1 to drive transformation and operational excellence through leadership, people and culture 2 FOSTER partnership and collaboration to 3 increase value and capture untapped opportunity FOCUS long term value creation for our shareholders 4 35 ScinoPharm#3636 0 Brand Quality with Asian Advantages www.scinopharm.com 1789 TT ScinoPharm

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Q4 & FY22 - Investor Presentation image

Q4 & FY22 - Investor Presentation

Financial Services

FY23 Results - Investor Presentation image

FY23 Results - Investor Presentation

Financial Services

Ferocious - Plant Growth Optimizer image

Ferocious - Plant Growth Optimizer

Agriculture

Market Outlook and Operational Insights image

Market Outlook and Operational Insights

Metals and Mining

2023 Investor Presentation image

2023 Investor Presentation

Financial

Leveraging EdTech Across 3 Verticals image

Leveraging EdTech Across 3 Verticals

Technology

Axis 2.0 Digital Banking image

Axis 2.0 Digital Banking

Sustainability & Digital Solutions

Capital One’s acquisition of Discover image

Capital One’s acquisition of Discover

Mergers and Acquisitions