Xvivo Perfusion AB · OMXSTO:XVIVO
Xvivo Perfusion AB — Shareholder Meeting (April 2019)
22 slides from Xvivo Perfusion AB's shareholder meeting presentation, Apr 25, 2019
Slide 1: AGM 2019 – CEO Magnus Nilsson
AGM 2019 – CEO MAGNUS NILSSON “We believe NO ONE SHOULD HAVE TO DIE WAITING FOR A NEW ORGAN” April 25, 2019
Slide 2: Summary of XVIVO Perfusion
Summary of XVIVO Perfusion SALES IN MSEK High market demand – Currently only10% of need met* XVIVO has an Unique Patented, Approved and Documented technology for making more organs available XVIVO market leader in Lung Tx and the only supplier with FDA approval for warm perfusion of marginal Lungs e
Slide 3: XVIVO performance
XVIVO performance • Sales growth from warm perfusion products, last 12 months +58% • EBITDA positive during high investments in Development and M&S • Profitable growth every quarter since 2003 Warm Perfusion Sales from non-durable 80 goods, in MSEK (rolling 12 months) Net Sales, Gross Profit & EBITD
Slide 4: XVIVO invests for future growth
XVIVO invests for future growth In thousand SEK XVIVO invests in development of IP protected unique products with the vision that nobody should die waiting for an organ. 90 000 80 000 70 000 R&D cost excl. amortization – 2014/2018 CAGR 24% 60 000 Development of the existing product portfolio e.g. ne
Slide 5: A growing & diverse organization
A growing & diverse organization Average number of employees Employees per location Göteborg 41% 35 Denver 39% Lund 20% 29 Employees per function 24 Sales & marketing 37% 18 R&D 36% Finance & administration 15% 15 Operations 12% 13 10 Employees by gender Male 61% Female 39% 2012 2013 2014 2015 2016
Slide 6: Development of EVLP on the total market
Development of EVLP on the total market* EVLP penetration 7% In 2018 an estimated 6 300 lungs were transplanted world wide 6,5% 6% 5,1% Around 400 of those lungs came from EVLP 5% 4,5% 4% EVLP market penetration is estimated to 6,5%, up from 3,2% 3,6% estimated 1,1% in 2012 3% 2,2% 2% 1,1% 1% 0% 201
Slide 7: Highlights 2018
Highlights 2018 • Net Sales grew +27% (+23% in LC*) • Strong growth for non-durable Warm perfusion sales +48% • PMA application for STEEN Solution™ and XPS™ submitted to the FDA • The PrimECC® study shows that the product is safe and displays positive clinical results • United Therapeutics and XVIVO
Slide 8: PERFADEX PLUS launch in 2018
PERFADEX® PLUS launch in 2018 A ready to use Perfadex® with increased patient safety and customer convenience Successfully launched in Europe and USA Well received by customers and clinicians Ready to use and click port – reduced complexity and preparation time while increasing patient safety Patent
Slide 9: 2019 Q1
2019 —- Q1 PERFUSION
Slide 10: Highlights 2019 - Q1
Highlights 2019 - Q1 • Reimbursement for the whole EVLP process approved in 200 Net Non- durable Sales (rolling 12 France 180 months) 160 • Results from first six patients in the heart preservation 140 study were presented during ISHLT showing that the 120 method is safe 100 80 • High interest from
Slide 11: Sales highlights 2019 - Q1
Sales highlights 2019 - Q1 80 Warm Perfusion Sales from non-durable goods, in SEK millions (rolling 12 months) 70 • Net Sales non-durable goods +24% (+13% in LC*) +58% 60 • Warm non-durable growth +52% (+40% in LC*) 50 40 • Warm non-durable growth rolling 12 month + 58% (YoY) 30 20 10 0 2012 2013 20
Slide 12: Profit & loss
Profit & loss 2019 2018 2018 (SEK Millions) Jan-Mar Jan-Mar Full year Net sales 47.6 42.5 187.9 Net sales non-Durable goods 46.8 37.9 172.7 Non-durable Sales +24% Gross profit 36.9 30.1 136.0 Gross Margin % 77% 71% 72% Continued high Gross Gross Margin non-Durable goods % 77% 77% 77% Margin Selling
Slide 13: ISHLT 2019
ISHLT* 2019 Increasing interest for EVLP and the new Heart preservation technology • High and increasing interest for clinical EVLP » Utilization of DCD** & Hep. C donors » Protective ventilation during EVLP » Immunology in EVLP • Excitement for XVIVO´s new heart technology » Prof Stig Steen present
Slide 14: The R&D pipeline - to ensure future growth
THE R&D PIPELINE - TO ENSURE FUTURE GROWTH
Slide 15: Typical development steps – Medical device Class III
Typical development steps – Medical device Class III Standard Established treatment PERFADEX PLUS® method at a large for Lung Tx treatment number of clinics Clinical Implementing clinical praxis with regards practice REVENUE to method STEEN SOLUTION™ and XPS™ for Lung Tx Functional Development of ef
Slide 16: XVIVO enable future growth within lung transplantation
XVIVO enable future growth within lung transplantation XVIVO will continue to clinically develop EVLP: • Expanded use of DCD* lungs for transplantation • Ex vivo infection therapy e.g. Pneumonia therapy and virus reduction • EVLP protocol development • Investigate immunological response during EVLP
Slide 17: XVIVO – The R&D pipeline
XVIVO – The R&D pipeline Priority 1 Priority 2 Heart Transplant PrimECC®, optimized project, optimized priming solution to preservation to prolong reduce known side time outside the body effects Priority 3 Priority 4 STEEN Solution™ ITT* – Perfusion of for Liver and Kidney isolated organs / tissues
Slide 18: XVIVO - Heart transplantation
XVIVO - Heart transplantation Development stage: Early Clinical Phase Heart perfusion and preservation solution and device developed by Prof. Steen Pre-clinical proof of concept studies indicate: » No non-oxygenated time → Better organ quality » Longer preservation time possible (24h in pigs) » Pig
Slide 19: XVIVO - Heart transplantation
XVIVO - Heart transplantation Development stage: Early Clinical Phase Q1 Accomplishments Pre-clinical and technical testing successfully performed XVIVO Perfusion’s heart preservation machine demonstrated → High interest from leading heart transplant surgeons worldwide Next steps Production ramp up
Slide 20: PRIMECC
Development stage: Late Clinical Phase PRIMECC® Serval hundred thousand operations using a heart-lung machine are performed each year. PrimECC® is developed to prime the heart-lung machine before open heart surgery. Accomplishments Ongoing tasks • Patented • Setup of large scale production in eco fr
Slide 21: Outlook 2019 - Focus areas
Outlook 2019 - Focus areas Thoracic Transplantation / Surgery (Primary focus) • Lungs – Further develop the EVLP technology • Heart – Preparation for multicenter study for regulatory approval on all major markets • PrimECC® – Preparation for multicenter study for clinical documentation Abdominal Tra
Slide 22: Thank you!
THANK YOU! ( fe) 2 > 4 PERFUSION