Vivesto AB · OMXSTO:VIVE
Vivesto AB — Oasmia — FY2018/2019 Earnings Presentation
33 slides from Vivesto AB's earnings presentation, June 2019
Slide 1: Q4 and Full-Year Presentation
OASMIA Q4 AND FULL-YEAR PRESENTATION JUNE 2019 1
Slide 2: Today's Speakers
TODAY’S SPEAKERS Jörgen Olsson, Sven Rohmann, Gunilla Öhman, Christoffer Saidac Chairman of the Board Acting CEO Member of the Board (Hannes Snellman Member of the Board Attourneys Ltd.) Company Secretary 2
Slide 3: Contents
CONTENTS Ongoing review initiated by the Board Q4 events and FY numbers CEO outlook Executive summary 3
Slide 4: Board's Review
BOARD’S REVIEW Ongoing review initiated by the Board 1. 2. 3. Product and distribution strategy Asset & liability review Related party transactions to ensure future value creation Including intellectual property 4. 5. Review of capital market Resources and measures to transactions, share issues stre
Slide 5: Board's Review – Overall Summary
BOARD’S REVIEW – OVERALL SUMMARY Ongoing review initiated by the Board • Oasmia’s new BoD has worked intensively since the EGM on March 19, 2019 reviewing several issues • Considerably more extensive than expected • It has included a number of external legal experts • Based on this, some pressing de
Slide 6: Oasmia Patents and Related Party Transactions
OASMIA PATENTS AND RELATED PARTY TRANSACTIONS Ongoing review initiated by the Board • Review with the assistance of experts in patent law • Review shows that Oasmia has the rights to the patents protecting its business • However, it remains unexplained why the patent registration never has been publ
Slide 7: Oasmia Patents and Related Party Transactions
OASMIA PATENTS AND RELATED PARTY TRANSACTIONS Ongoing review initiated by the Board • A tax audit conducted 2014-2016 shows many question marks regarding related party transactions. Some questions are still unresolved. • A tax audit initiated in April 2019 points at the same and new related party tr
Slide 8: The AdvaVet Situation
THE ADVAVET SITUATION Ongoing review initiated by the Board • In order to regain full control over Oasmia’s Intellectual Property Rights for veterinary purposes, the Board has decided to put the listing plans on hold for the US subsidiary AdvaVet • A new Board and management will be installed which
Slide 9: Delisting of Oasmia Share in Frankfurt and the US
DELISTING OF OASMIA SHARE IN FRANKFURT AND THE US Ongoing review initiated by the Board • The Board has initiated a review to assess whether liquidity and other potential benefits of the stock exchange outweigh the related costs and administrative burden of compliance. • While final decisions will b
Slide 10: Dispute between MGC, Arwidsro and Oasmia
DISPUTE BETWEEN MGC, ARWIDSRO AND OASMIA Ongoing review initiated by the Board • On November 1, 2018, Oasmia announced that MGC Capital Ltd had exercised approximately 25.8 million warrants for subscription of shares and paid through partial set-off of a claim on Oasmia that MGC had purchased from N
Slide 11: Dispute between MGC, Arwidsro and Oasmia
DISPUTE BETWEEN MGC, ARWIDSRO AND OASMIA Ongoing review initiated by the Board • In June 2019, MGC made a claim for compensation from Oasmia as a result of MGC not being allowed to subscribe for shares with the support of 23.2 million warrants. The claim is set at SEK 80 million and with additional
Slide 12: Other
OTHER Ongoing review initiated by the Board • The AGM will be held on September 26, 2019 • The Board has appointed an independent investigator to assist all shareholders ahead of the AGM • Oasmia has, partly helped by an ongoing tax audit, found many dubious transactions between Oasmia and companies
Slide 13: Contents
CONTENTS Ongoing review initiated by the Board Q4 events and FY numbers CEO outlook Executive summary 13
Slide 14: Q4 Events
Q4 EVENTS Q4 and FY events and report figures • Private placement of approximately MSEK 165 before issue expenses carried out • New Board of Directors elected at Extraordinary General Meeting on March 19 • New Board initiates review of the situation in the company • Management team and organization
Slide 15: Q4 and FY P/L
Q4 AND FY P/L Q4 and FY events and report figures 15
Slide 16: Balance Sheet and Financial Situation
BALANCE SHEET AND FINANCIAL SITUATION Q4 and FY events and report figures 16
Slide 17: Contents
CONTENTS Product pipeline and values of Oasmia Ongoing review initiated by the Board Q4 events and FY numbers CEO outlook Executive summary 17
Slide 18: XR17 Technology Platform
XR17 TECHNOLOGY PLATFORM Product pipeline and values of Oasmia Based on novel vitamin A derivative Clinical studies 100% organic and vegan Toxicological studies Compatible with all world religions Proof by market approval Improved solubility Patented until 2028 + SPC Allows for dual capsulation of E
Slide 19: Technology Platform
TECHNOLOGY PLATFORM Product pipeline and values of Oasmia Active Pharmaceutical Ingredient Micelle consisting of XR17 XR17 molecule (API) and API Pacilitaxel A water-insoluble cytostatic Hydrophilic, polar head Water soluble Needs to be water soluble to Hydrophobic, non polar chain be injected 19
Slide 20: Benefit of Our Technology Platform
BENEFIT OF OUR TECHNOLOGY PLATFORM Product pipeline and values of Oasmia Water soluble Nanomolecular No need for immunosupression Reduced risk of allergic reaction This may make it the perfect partner for Immuno-oncology 20
Slide 21: Apealea Today
APEALEA TODAY Product pipeline and values of Oasmia Indication 2nd line ovarian cancer (orphan indication granted in US) Phase Pivotal study finished, 789 patients Type of Study Open, randomized, comparative trial (Taxol) Dose 250mg/ml (Apalea/Paclical), 175mg/ml (Taxol) Cycles 6 three week cycles;
Slide 22: Apealea Next Steps
APEALEA NEXT STEPS Product pipeline and values of Oasmia Further indications (Breast cancer, NSCLC) Combinations with immuno-oncology products Combinations with cell therapy 22
Slide 23: Apealea Next Steps
APEALEA NEXT STEPS Product pipeline and values of Oasmia Launch plan Europe Q4 2019 Launch in Europe + Nordic countries Q1 2020 Roll-out plan rest of the world including the US Q1 2020 Launches according to market approval 23
Slide 24: Product Pipeline - Human Health
PRODUCT PIPELINE - HUMAN HEALTH Registration/ Product Indication Pre-clinical Phase 1 Phase II Phase III Geography Approval Ovarian cancer Submission USA Ovarian cancer EU/EEA* Apealea/ Paclical Ovarian cancer Russia (paclitaxel) Ovarian cancer Kazakhstan Metastatic Global breast cancer Doxophos All
Slide 25: Global Oncology Market
GLOBAL ONCOLOGY MARKET Product pipeline and values of Oasmia Annual growth rate of Expected to reach cancer drug costs: USD 150 billion by 3.8% 2011 2020 11.5% 2015 Traditionally dominated by chemotherapy Moving towards immuno- oncology 25
Slide 26: Global Oncology Market
GLOBAL ONCOLOGY MARKET Product pipeline and values of Oasmia USD 115 BILLION 100 Other therapies Immuno-oncology and chemotherapy 75 combined compose a majority of the Immuno- global oncology therapeutics market oncology 49% Our XR17 product platform allows us 50 to compete in both theese markets -
Slide 27: Value Propositions in Oncology
VALUE PROPOSITIONS IN ONCOLOGY Product pipeline and values of Oasmia Annual turnover of Taxol USD 1.6 billion before becoming generic Abraxane was patented in 2005 by Abraxis Annual turnover USD 1.2 billion (2017) Abraxis was acquired by Celgene for USD 2.9 billion (2010) 27
Slide 28: Summary - Human Health
SUMMARY- HUMAN HEALTH Product pipeline and values of Oasmia Oasmia transitions into a commercially attractive, fully integrated pharmaceutical company XR17 Platform fully validated and ready to run broader Apealea first oncology product from XR17 ready to launch in Europe Apealea to be positioned as
Slide 29: AdvaVet Inc.
ADVAVET INC. Product pipeline and values of Oasmia Oasmia’s American subsidiary for all veterinary medicine - The S1-Filing for the IPO at the NASDAQ stock exchange is on hold - Board and CEO change imminent Next steps: - Re-install the US conditional approval for high-dose Paccal Vet - Conditional
Slide 30: Product Pipeline - Animal Health
PRODUCT PIPELINE - ANIMAL HEALTH Product pipeline and values of Oasmia Registration/ Product Indication Pre-clinical Phase 1 Phase II Phase III Geography Approval Paccal Vet (paclitaxel) Mastycytoma Planned Global Paccal Vet Mammary (paclitaxel) carcinoma Conditional Re-installation Global Paccal Ve
Slide 31: Contents
CONTENTS Ongoing review initiated by the Board Q4 events and FY numbers CEO outlook Executive summary and investment highlights 31
Slide 32: Executive Summary and Investment Highlights
EXECUTIVE SUMMARY AND INVESTMENT HIGHLIGHTS Ongoing review initiated by the Board – issues, still open Global oncology market estimated to reach USD 150 billion by 2020 Strong technology platform; XR17 a broadly applicable technology Late-stage asset; Apealea (Paclical) approved in EES & Russia Oasm
Slide 33: Thank You
THANK YOU 33