Xvivo Perfusion Ab · OMXSTO:XVIVO
Xvivo Perfusion Ab — Q1 2025 Earnings Presentation
27 slides from Xvivo Perfusion Ab's earnings presentation, Apr 24, 2025
Slide 1: Interim report Q1 2025
Interim report Q1 2025 Earnings call, April 24, 2025
Slide 2: Today's presenters
Today’s presenters Christoffer Kristoffer Rosenblad Nordström CEO CFO DOC ID: Year-End Report 2024
Slide 3: Q1 Financials – at a glance
Q1 Financials – at a glance Organic growth Net Sales Thoracic Net sales SEK 219 Million Net Sales SEK 141 million +16% Gross margin Products 82% Sales growth Organic Abdominal Net sales growth 14% Net Sales SEK 57 million Gross margin Products 63% +28% - Acquired growth 2% - Currency effect 2% - Tot
Slide 4: Q1 Highlights
Q1 Highlights Alex Moroianu Heart transplant recipient, AU DOC ID: Interim report Q1
Slide 5: Regulatory & Clinical updates
Regulatory & Clinical updates DOC ID: Interim report Q1
Slide 6: PRESERVE Heart Trial
PRESERVE Heart Trial A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors 20 US Transplant programs* What’s next? • 1 year patient follow-up period, followed by FDA regulatory review 13 Months enrollment completed
Slide 7: DeLIVER Trial
DeLIVER Trial A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE with eXVIVO LIVER Perfusion 20 US Transplant • IDE for protocol evaluating dual hypothermic oxygenated perfusion (DHOPE) with XVIVO Liver programs Assist approved by FDA in Febru
Slide 8: Gearing up for full market launch in Canada with MDSAP approval
Gearing up for full market launch in Canada with MDSAP approval Portfolio • Full lung portfolio already approved for number of years • Q1 approval of Kidney Assist Transport and Liver Assist • XVIVO Heart Assist Transport approval subject to European CE-mark Market Dynamics • Healthcare system compa
Slide 9: Regulatory approval status in core markets
Regulatory approval status in core markets PMA approval for STEEN Solution STEEN Solution, XPS & STEEN Solution, XPS & & XPS / PERFADEX 510(k) cleared PERFADEX CE marked PERFADEX approved by the TGA Kidney Assist Transport Kidney Assist Transport Kidney Assist Transport 510(k) cleared CE marked appr
Slide 10: Clinical Trial Status & Tentative Timeline
Clinical Trial Status & Tentative Timeline REVIEW & PRECLINICAL CLINICAL MARKET APPROVAL FOLLOW-UP • Patient enrolment completed May 2023 • 204 patients included across 15 centres 12-month 12 month patient Commercial launch across 8 countries patient follow-up completed target Q2 2025* • Results wer
Slide 11: ISHLT 2025
ISHLT 2025 XVIVO highlights at the upcoming ISHLT in Boston April 27-30: • 12-month data from the European heart preservation trial NIHP 2019 presented by Prof. Rega • Normothermic Ex-Vivo Lung Perfusion Long- Term Outcomes: The NOVEL Trial presented by Dr. Sanchez • Two industry symposia • April 27
Slide 12: Business operations update
Business operations update XVIVO Perfusion AB | Entreprenörsstråket 10 | SE-431 53 Mölndal | Sweden Tel +46 31 788 21 50 | xvivogroup.com XVIVO trademarks, names and logos are registered trademarks of XVIVO Perfusion AB. DOC ID: Interim report Q1 © 2023 XVIVO Perfusion AB. All rights reserved.
Slide 13: Q1 Business operations update
Q1 Business operations update Political landscape Organization • Closely following geopolitical • Continuously strengthening organization developments and changing trade policies • Investment in new facility/academy in Denver, CO XVIVO production • Investments in Operations for improved • USA: Lung
Slide 14: Q1 Business operations update
Q1 Business operations update Thoracic Abdominal • Record quarter for heart in ANZ through • Liver growth continues to be strong in special access scheme Europe based on robust clinical evidence • Launch preparations in Europe for Heart • Strong growth for KAT in both US and – XVIVO team fully staff
Slide 15: Q1 Business operations update
Q1 Business operations update Services • Strategic importance for the US heart launch • Initiated strategic review of XVIVO Services in order to determine future direction and investments • Strategically important for the US heart launch
Slide 16: Financial Performance Q1
Financial Performance Q1 DOC ID: Interim report Q1
Slide 17: Net sales and key ratios Q1
Organic sales Net sales and key ratios Q1 growth R12 33% Jan-Mar Jan-Mar Full Year SEK Million 2025 2024 2024 Net sales 218 186 822 Sales growth, % 16 % 32 % 38 % Whereof organic growth, % 14 % 32 % 39 % Gross profit 160 135 616 Gross margin, % 73 % 73 % 75 % EBIT (adj) 30 20 95 EBIT, % (adj) 14 % 1
Slide 18: Thoracic – Q1 Highlights
Organic sales Thoracic – Q1 Highlights growth R12 39% 14% Net sales by Net sales by Net sales by organ Net Sales region product category SEK 142 million (121) 6% 2% Organic growth 27% 16 % (33) 38% Gross margin 7% 60% 66% 82 % (81) 94% Lung Heart Americas Machine perfusion APAC Static preservation E
Slide 19: Abdominal – Q1 Highlights
Organic sales Abdominal – Q1 Highlights growth R12 31% Net sales by Net Sales Net sales by organ region SEK 57 million (44) 13% Organic growth 25% 2% 28 % (45) Gross margin 63 % (68) 75% 85% Liver Kidney Americas APAC EMEA Liver Sales Kidney Sales 43million (33) 14million (11) DOC ID: Interim report
Slide 20: Services – Q1 Highlights
Organic sales Services –Q1 Highlights growth R12 0% Net Sales Net sales by service SEK 20 million (21) 2025 focus: 14% Organ Recovery • Strategic overview Organic growth • Optimize geographical footprint -19 % (11) Acquired growth 2025 focus: 13 % (-) 86% Digital Services • Continued business integr
Slide 21: EBITDA
EBITDA Q1 2025 EBITDA (adj), by quarter EBITDA (adj), R12 months Comments SEKm SEKm • R12 Trend continues to improve as Q1 EBITDA 30% 250 30% (adj) strenghted YoY 70 225 25% 25% • SEK/USD ratio will impact EBITDA negatively 60 200 188 due to large portion of sales in the US. As for 183 51 52 175 ref
Slide 22: Cashflow and financial position
Cashflow and financial position Cash flow from Cashflow from Q1 Cashflow operating activities (R12) investing activities • Cash flow from operating R12 SEKm Q1 Q1 YTD activities SEK -15 million (2) 150 • Investments SEK -59 million (-42) +97m SEKm 2025 2024 2024 125 Total cashflow 111 -59 -42 -244 •
Slide 23: Outlook
Outlook Alex Moroianu Heart transplant recipient, AU
Slide 24: Outlook 2025
Outlook 2025 • Continued high interest in EVLP globally • Leverage enthusiasm for hypothermic oxygenated perfusion (HOPE) across organs: Liver, Kidney, Heart • Expected to meet critical milestones related to product commercialization and market expansion: • European approval and launch of XVIVO Hear
Slide 25: Long term outlook
Long term outlook • The demand for transplants are x 10 of today’s supply • Sales value of machine perfusion vs cold static storage is ~x 10 • Machine perfusion and service models have proven to increase the number of organs used for transplantation • XVIVO has unique, innovative and world leading p
Slide 26: Nobody should die waiting for a new organ
Nobody should die waiting for a new organ Fredrica Höglund Liver transplant recipient, Sweden DOC ID: Interim report Q1
Slide 27: Financial calendar & contacts
Financial calendar & contacts Financial reports 2025 Investor Relations Interim report April - June 2025: July 11, 2025 Christoffer Rosenblad, CEO Telephone: +46 735 19 21 59 Interim report July – September 2025: October 23, 2025 E-mail: christoffer.rosenblad@xvivogroup.com Year-end report 2025: Jan