Xvivo Perfusion AB · OMXSTO:XVIVO
Xvivo Perfusion AB — Shareholder Meeting (April 2018)
32 slides from Xvivo Perfusion AB's shareholder meeting presentation, Apr 27, 2018
Slide 1: AGM 2018 – CEO Magnus Nilsson
AGM 2018 – CEO MAGNUS NILSSON “NO ONE SHOULD HAVE TO DIE WAITING FOR A NEW ORGAN” April 27, 2018
Slide 2: Summary of XVIVO Perfusion
SUMMARY OF XVIVO PERFUSION Sales in MSEK High market demand – Currently only 10% of need met* XVIVO has an Unique Patented, Approved and Documented technology for making more organs available XVIVO market leader in Lung Tx & the only supplier with FDA approval for warm perfusion of marginal Lungs ex
Slide 3: A Global Footprint & Management Team
A GLOBAL FOOTPRINT & MANAGEMENT TEAM Denver, USA - XVIVO Perfusion Inc. HQ in Gothenburg, Sweden -XVIVO Perfusion AB CEO Development CFO M&S RA / QA EMEA. Production and R&D facility in Lund, Sweden - XVIVO Perfusion Lund Global sales to all countries where lung transplants are performed - Direct sa
Slide 4: XVIVO Performance: Milestones since listing (Oct 2012)
XVIVO PERFORMANCE: MILE STONES SINCE LISTING (Oct 2012) Sales 54 MSEK; 5 XPS in clinical trial XVIVO technology featured 2012 in media 2013 Built capacity & organization (M&S, R&D,etc.) in Gothenburg and Denver Lu nd: 2014- Reg. Approval of XPS-STEEN Solution: EU, 1st 2015 Aus. & USA FDA expert pan
Slide 5: XVIVO Performance
XVIVO PERFORMANCE: ▪ Sales growth from warm perfusion products, 2011 – 2017 CAGR of +55% ▪ EBITDA grew during high investments in development and M&S ▪ Profitable growth every quarter since 2003 Net Sales in MSEK by product Net Sales, Gross Profit & EBITDA group 2011 - 2017 in MSEK 2013 - 2017 Warm
Slide 6: 20 Years of Innovation
} ( ) YEARS TRANSPLANTATION 20 YEARS OF INNOVATION o~ XVIVO PERFUSION
Slide 7: Company history 1998–2000
Company founded by Dr. Magnus Nilsson. 1998 Research collaboration with Prof. Stig Steen and University Hospital in Lund. Research collaboration with Prof. Shaf 1999 Keshavjee and University Hospital Toronto. First clinical EVLP lung transplant with STEEN 2000 Solution™ performed in Lund by Prof. St
Slide 8: History 2001–2008
2001 PERFADEX® FDA clearance. 2006 STEEN SolutionTM CE marked. First STEEN SolutionTM clinical study 2008 (HELP) initiated in Toronto with Prof. Shaf Keshavjee . Positive results published in New England Journal of Medicine (2011). CEO presentation AGM 2018 8
Slide 9: History 2011–2016
Clinical NOVEL study initiated in 2011 several leading transplantation clinics in US. The first warm perfusion device, XPSTM 2014 and STEEN SolutionTM, approved by the FDA under HDE. XPSTM CE marked. Acquisition of Vivoline. With LS, 2016 enabling Scandinavian EVLP protocol. PrimECC® CE marked. CEO
Slide 10: History 2017
First clinical heart transplant using heart preservation technique developed by XVIVO’s partner Prof. Stig Steen was performed at 2017 University Hospital in Lund by Prof. Johan Nilsson. Clinical trial on PrimECC® at Sahlgrenska University Hospital completed. CEO presentation AGM 2018 10
Slide 11: XVIVO
o~ XVIVO PERFUSION
Slide 12: Highlights 2017
HIGHLIGHTS 2017 ▪ The first clinical heart transplant using the heart preservation technology developed by XVIVO´s partner Professor Stig Steen was performed. ▪ All 220 patients included in the NOVEL study in the US which will form the basis of the company’s PMA application. ▪ PrimECC study on 80 pa
Slide 13: Sales Highlights 2017
SALES HIGHLIGHTS 2017 DOUBLE DIGIT GROWTH FOR NON-DURABLE SALES ▪ Sales: Warm Perfusion Sales from non- durable goods, in SEK millions o Non-durable goods increased by 15%* to 141 (Rolling 12 months) MSEK. o Net sales increased by 7% to 148 MSEK. ▪ 4 new countries with XPS™ or LS™ o Australia o Chin
Slide 14: Profit & Loss
PROFIT & LOSS (SEK Millions) 2017 2016 Net sales 148.3 138.2 Sales non-durable Net sales non-Durable goods 141.0 122.5 +15% Gross profit 113.4 102.2 Gross Margin % 76% 74% Gross Margin non-Durable goods % 78% 80% Customer support Selling expenses excl. items eff. comp% -29% -24% build up Admin. expe
Slide 15: XVIVO
“~~ XVIVO PERFUSION
Slide 16: Highlights 2018 – Q1
HIGHLIGHTS 2018 – Q1 ▪ Net sales exceeded SEK 150 million per rolling 12 months for the first time. ▪ Cash flow from operating activities was SEK 9.2 (-2.0) million. Intangible investments SEK 8.7 (6.0) million. ▪ 2 XPS™ were delivered during the quarter. ▪ XVIVO’s prototype of a heart transplantati
Slide 17: Sales Highlights 2018 – Q1
SALES HIGHLIGHTS 2018 – Q1 ▪ Net Sales grew +18% in local currencies to Warm Perfusion Sales from non- durable goods, in SEK millions 42.5 MSEK. (Rolling 12 months) ▪ Net Sales non-durable goods increased by +17% in local currencies to 37.9 MSEK. ▪ Second strongest quarter in Warm perfusion, after a
Slide 18: Profit & Loss
PROFIT & LOSS 2017 2018 2017 Whole Jan- Mar Jan- Mar (SEK Millions) year Net sales 42.5 37.5 148.3 Sales non-durable Net sales non-Durable goods 37.9 33.6 141.0 +17% local currencies Gross profit 30.1 27.1 113.4 Gross Margin % 71% 72% 76% Gross Margin non-Durable goods % 77% 80% 78% Selling expenses
Slide 19: ISHLT Congress
ISHLT CONGRESS International Society of Heart and Lung Transplantation ▪ The upgraded XPS™ drew much attention and appreciation. ▪ Results were presented from the first transplantation using the new heart preservation technology developed by Professor Steen. ▪ Clinics from all over the world showed
Slide 20: XPS Upgrade Program
XPS UPGRADE PROGRAM ▪ Improved usability – e.g. Barcode scanner o Functions added to simplify the EVLP process and improve ease of use for the surgical team. ▪ Improved output – e.g. Online scale for continuous measuring of the weight of the lung o More parameters to ensure that the surgical team ca
Slide 21: Products & Markets for Future Growth
PRODUCTS & MARKETS FOR FUTURE GROWTH
Slide 22: Transplant Market - Overview
TRANSPLANT MARKET - OVERVIEW Lung Trans- Heart Trans- Liver Trans- plantation plantation plantation Yearly deaths in organ related diseases ~3 millions >7 millions >1 million No. of transplants / year ~5 000 ~6 500 ~26 000 Annual growth (no. of Tx) +7% +4% +4% No. of clinics (EU + USA) ~130 ~230 ~24
Slide 23: Market Potential per Indication
MARKET POTENTIAL PER INDICATION Potential Potential Potential Lung Heart Liver Transplantation Transplantation Transplantation Perfadex®, Heart Solution and STEEN Solution™ Product STEEN Solution™ Heart XPS™ and Liver XPS™ and XPS™ 40% of DBD* 50% of DBD* 80% of DBD* Possible usage of organ 20% of
Slide 24: Development Steps
DEVELOPMENT STEPS Standard Established treatment method at a large number of clinics PERFADEX® treatment Revenue for Lung Tx Clinical Implementing clinical praxis with praxis regards to method STEEN SOLUTION™ and XPS™ Functional Development of effective for Lung Tx adaption treatment concepts Market
Slide 25: XVIVO - Future Growth Opportunities
XVIVO - FUTURE GROWTH OPPORTUNITIES Expansion of Lung transplantation indication, EVLP improvement projects, increase of DCD Heart Transplant project, early clinical phase STEEN Solution™ for Liver Transplant, early clinical phase ITT* - Drug administration to isolated organs (e.g. Cancer) with STEE
Slide 26: Lung Transplantation
LUNG TRANSPLANTATION XPS & STEEN Solution the only FDA (HDE) approved device for warm perfusion of marginal lungs NOVEL study & Post Approval Study (PAS) : √ 110 + 110 patients included Follow-up 1 year – May 2018 √ Study analysis ongoing PMA application submission – May 2018 PAS (Post App
Slide 27: Lung Transplantation: Next steps for EVLP
LUNG TRANSPLANTATION Next steps for lung warm perfusion (EVLP) XVIVO will continue to clinically develop EVLP: o Use of DCD* donors for transplantation – controlled / uncontrolled o Ex Vivo Infection therapy through EVLP e.g. Pneumonia therapy and virus reduction – 17 Hep C infected lungs transplant
Slide 28: XVIVO - Heart Transplantation
XVIVO - HEART TRANSPLANTATION Heart perfusion and preservation solution and device developed by Prof. Steen First clinical HTx with new technology: o First patient transplanted with the new technology (new solution and new machine) o Proof of concept study with 6 patients. o Now approved for air tra
Slide 29: PrimECC – Study Inclusion Finalized
PRIMECC – STUDY INCLUSION FINALIZED PRIMECC® developed to avoid side-effects when priming heart-lung machines: o Patent granted in EU, USA, China & Japan. o CE marked Class III Medical Device. o Inclusion of 40+40 patients completed 2018. o Analysis of key parameters completed Next steps: o Expert r
Slide 30: Summary Other New Indications
SUMMARY OTHER NEW INDICATIONS Liver transplantation: o Results from first clinical study on 20 patients with STEEN Solution shows good clinical results. o Marginal (DCD) Liver study planned to start in Canada in 2 centers - Preparations ongoing. Isolated Tissue Therapy – Cancer o Proof of concept st
Slide 31: Outlook 2018 - Focus Areas
OUTLOOK 2018 - FOCUS AREAS Thoracic Surgery o Lungs - Continue to increase footprint and use of EVLP technology o Lungs - PMA application and submission in May o Lungs - Reinforced clinical development of EVLP o Lungs – Hepatis C infected donors study o Heart - Accelerating Heart transplant project
Slide 32: XVIVO Perfusion
XVIVO PERFUSION Patients die waiting for an organ transplant XVIVO has a Patented, Approved and Documented technology to make more organs available for the benefit of patients XVIVO has the experience, capability, competence and technology to expand into more indications/markets