Vivesto Ab · OMXSTO:VIVE
Vivesto Ab — Oasmia Pharmaceutical — Investor Presentation (February 2016)
28 slides from Vivesto Ab's investor presentation, Feb 26, 2016
Slide 1: Corporate Presentation – Winter 2016
Oasmia Pharmaceutical AB (NASDAQ: OASM) Corporate Presentation – Winter 2016
Slide 2: Forward Looking Statement
Forward Looking Statement IMPORTANT NOTICE: This document (or any part of it) is not to be reproduced, distributed, passed on, or the contents otherwise divulged, direct ly or indirectly, in or into the United States of America, Canada, Republic of Ireland, Switzerland, South Africa, Japan, Hong Kon
Slide 3: Corporate Overview
Corporate Overview 2 ◼ Oasmia Pharmaceutical AB (NASDAQ OMX: OASM) is a Swedish pharmaceutical company focused on innovative treatments within human and animal oncology. ◼ The product and product candidates utilize a proprietary, nanoparticle formulation technology that is designed to facilitate the
Slide 4: Technology Platform
Technology Platform 3 ◼ Based on novel Vitamin A derivate - proprietary technology based on in - house research and development ◼ Validated in clinical and toxicological studies ◼ Several clear advantages compared to existing therapies • Improves solubility and facilitates administration • Improves
Slide 5: Advantages vs. Existing Therapies
Advantages with a lower ratio (carrier vs API) • Enables higher doses • Shortens infusion time • No need for pre - medication • Lower toxicity • Lower production cost Advantages vs. Existing Therapies 4 CARRIER PRODUCT (API) RATIO (CARRIER vs API) HYPERSENSITIVITY XR - 17 Apealea/Paclical ( paclitax
Slide 6: Potential API Candidates
Water insoluble compounds Water soluble compounds Dual encapsulation compounds ▪ Taxanes • Cabazitaxel • Docetaxel • Ixabepilone ▪ Etoposide ▪ Retinoids • Fenretinide • Etretinate • Tazarotene – Bexarotene / Adapalene ▪ Immunosuppressants • Cyclosporine • Sirolimus • Tacrolimus • Everolimus ▪ Anthra
Slide 7: The Global Oncology Market
0% 25% 50% 75% 100% Oncology therapeutics market Cytostatic market The Global Oncology Market 6 ◼ Five major products dominate the generic cytostatic market: • Paclitaxel ( Taxol ) • Docetaxel ( Taxotere ) • Abraxane • Doxorubicin ( Doxil / Caelyx ) • Carboplatin ◼ Before becoming generic, Taxol pea
Slide 8: Robust Product Pipeline
Robust Product Pipeline 7 HUMAN HEALTH Candidate Indication Pre - clinical Phase I Phase II Phase III Reg / Approval Geography Rights Apealea/Paclical ( paclitaxel ) Ovarian cancer Global (ex - RUS/CIS) Ovarian cancer Approved RUS/CIS Metastatic breast cancer On - going Global Metastatic breast canc
Slide 9: Apealea/Paclical – Competitors
Apealea /Paclical – Competitors 8 ◼ Taxol and Abraxane currently generate in excess of $1.7 Billion in annual sales combined Product Apealea/Paclical Taxol Abraxane Cynviloq Company Oasmia NASDAQ:OASM) Generic Celgene Corporation (NASDAQ:CELG) Sorrento Therapeutics (NASDAQ:SRNE) Infusion solution Mi
Slide 10: Docecal – Competitors
Docecal – Competitors 9 ◼ Taxotere generated $2.8 Billion in annual revenue for Sanofi in 2010 Product Docecal Taxotere Company Oasmia Sanofi - Aventis (now generic) Particle size 20 nm No particles Excipient XR - 17 Polysorbate 80, ethanol Dose 80 - 110 mg/m 2 75 - 100 mg/m 2 Ratio 2.25 : 1.0 26.0
Slide 11: Apealea/Paclical: Phase III Study
Indication : Epithelial ovarian cancer (orphan designation granted in US and EU) Phase: Phase III finished ( collecting complementary Overall survival data) Type of study: Open , randomized , comparative (Taxol) Dose: 250mg/m 2 (Apealea /Paclical ); 175mg/m 2 (Taxol) Cycles: 6 (3 - week cycles ); 1h
Slide 12: Non-Inferiority Established
Non - Inferiority Established 11 ◼ Patients treated with Apealea /Paclical tended to have longer progression free survival as compared to those patients receiving TAXOL® ◼ Patients with more frequent CT (every 3rd month during follow - up) also showed an advantage for Apealea /Paclical Median PFS =
Slide 13: Risk Benefit Profile of Apealea/Paclical
Risk Benefit Profile of Apealea /Paclical ◼ The infusion time is 1 hour ◼ Number of patients with hyperensitivity reactions is the same with Apealea /Paclical without pre - medication as with Taxol with pre - medication with corticosteroids and antihistamines ◼ There are more cases of myelosuppressi
Slide 14: Apealea/Paclical vs. Abraxane – Pharmacokinetic Study
Apealea /Paclical vs. Abraxane – Pharmacokinetic Study ◼ Cross - over, 2 cycles , 3 weeks between treatments • Patients randomized to a sequence o Apealea /Paclical + Abraxane or Abraxane + Apealea /Paclical • Infusion period: 1 h • Dose 260 mg/m2 • 28 patients received both treatments • Primary obj
Slide 15: Plasma concentrations of paclitaxel: Apealea/Paclical vs Abraxane
Plasma concentrations of paclitaxel following 1h - infusion of Apealea /Paclical or Abraxane (260 mg/m2), cross - over study 14 Time, h 0 2 4 6 8 10 12 Mean (±SD) Total Plasma Paclitaxel Concentration, ng/mL 0 2000 4000 6000 8000 10000 12000 14000 Paclical, n= 28 Abraxane, n= 28 Time, h 0 2 4 6 8 10
Slide 16: Plasma concentrations of paclitaxel: Apealea/Paclical vs Taxol
Plasma concentrations of paclitaxel following 3h - infusion of Apealea /Paclical or Taxol (175 mg/m2), cross - over study 15 Source: Company data OAS - 09APPK ”Pharmacokinetic comparison between Paclical and Abraxane” 0 20 40 60 80 100 120 0 10 20 30 Time (h) Paclitaxel (ng/mL) Apealea/Paclical Mean
Slide 17: Apealea/Paclical Regulatory Timelines
Apealea /Paclical Regulatory Timelines 16 ◼ In April 2015, Apealea /Paclical received market authorization in the Russian Federation and will be marketed by Pharmasyntez ◼ As a reformulation of paclitaxel, Apealea /Paclical will be approved via the 505(b)(2) regulatory pathway in the US H2 - 2014 H1
Slide 18: Animal Health Market – Overview & Trends
Animal Health Market – Overview & Trends 17 ◼ Oasmia estimate: total market for Paccal Vet in the US, EU and Japan approx. 900,000 dogs per annum. Assuming 100,000 dogs treated in year 5 (at a price of $3,500 - 4,000), this presents an attractive opportunity Source: Oncology insight, Vetnosis , Febr
Slide 19: Paccal Vet-CA1 and Doxophos Vet
Paccal Vet - CA1 and Doxophos Vet 18 PACCAL VET - CA1 DOXOPHOS VET API: Paclitaxel Doxorubicin Phase: Launched (mammary/squamous cell); Clinical Phase III (mast cell tumours) Clinical Phase 2 study on - going MUMS: Yes Yes Indications : Mammary carcinoma, squamous cell carcinoma, mast cell tumours L
Slide 20: Investment Highlights
Investment Highlights 19 XR - 17, a Novel , Broadly Applicable Technology • Nanotechnology platform used to improve drug (API) solubility; patent protection filed to 2028 and onwards • Applicable across wide variety of APIs; can be combined with novel compounds and generic drugs • Nanoparticle drug
Slide 21: Milestones
Milestones 20 August 2015 Release of top line clinical data of Apealea/Paclical vs Abraxane October 2015 Listing on the NASDAQ NYC October 2015 Initiating Docecal ® Phase I clinical studies October 2015 Launch US Animal Oncology Platform and start implementing new strategy November 2015 Launch of Ap
Slide 22: Capitalization Table
Capitalization Table 21 * Trades as American Depository Receipt (1 ADR = 3 ordinary shares) Oasmia is listed on NASDAQ Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Capital Markets (OA SM .US ) Shares Total Potential ADR Shares Outstanding* 35,180,881 Restrict
Slide 23: Financial Snapshot
Stock Symbol: OASM (NASDAQ) Price (ADR): $3.82* (2/01/16) 52 Week Range: $2.88 – $4.49 Avg. Daily Volume (90 day): 7,763 Shares Outstanding: 34,958,581 (ADR) = 104,875,744 SO Market Cap: $133.5* Float: 16.6 Million* Financial Snapshot 22 Price & volume quotes from Yahoo! Finance and other reliable s
Slide 24: Ownership Structure
Ownership S tructure 23 Ownership S tructure The 10 major shareholders as of Dec 31, 2015 Shares of votes and capital (%) Alceco International S.A. 33.3 Nexttobe AB 18.6 Bank of New York 4.9 Försäkringsaktiebolaget Avanza Pension 4.2 JP Morgan Clearing Corp 3.0 JP Morgan Bank Luxembourg 2.5 Liv & Pe
Slide 25: Extensive IP Portfolio
Extensive IP Portfolio 24 ◼ A robust intellectual property portfolio of issued, pending, and published patents provides extensive protection for both Apealea/Paclical as well as XR - 17 across the seven major markets (US, Germany, Italy, France, Spain, UK and Japan) as well as a number of emerging m
Slide 26: Apealea/Paclical: Commercial
Apealea/Paclical: Commercial 25 ◼ Apealea/Paclical can be launched with a targeted sales force in North America. • Focus on key specialty distributors and gaining formulary acceptance at major cancer centers . • Initially target ovarian cancer with an intent to expand the label into additional indic
Slide 27: Management – Selective
Management – Selective 26 ◼ Julian Aleksov – Executive Chairman of the Board • Executive Chairman of Oasmia and one of the founders of the company • Extensive experience in coordination of research projects and strategic development of global intangible assets • Economist ◼ Anders Lundin – Chief Fin
Slide 28: Oasmia Pharmaceutical AB – Winter 2016
Oasmia Pharmaceutical AB (NASDAQ: OASM) Corporate Presentation – Winter 2016 Corporate Address : Vallongatan 1, Uppsala 752 28 Sweden Corporate Website: www.oasmia.com Media and Investor Relations: IRTH Communications Robert Haag, Managing Director 1 - 866 - 976 - 4784 OASM@irthcommunications.com
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