Slides
Page 1
Q2 2025 Earnings call, July 11, 2025 Interim report
Page 2
DOC ID: Today’s presenters Interim report Q2 Christoffer Rosenblad CEO Kristoffer Nordström CFO
Page 3
DOC ID: Q2 Financials – at a glance Interim report Q2 Thoracic Net Sales SEK 105 million Gross margin 86% Abdominal Net Sales SEK 52 million Gross margin 68% Services Net Sales SEK 21 million Gross margin 34% -19% Net sales +19% Net sales -1% Net Sales Organic growth Net Sales SEK 178 Million EBITDA (adj) 13% (24) Sales growth Organic growth -11% - Acquired growth 2% - Currency effect -6% - Total growth -15%
Page 4
DOC ID: YTD Financials – at a glance Interim report Q2 Thoracic Net Sales SEK 247 million Gross margin 84% Abdominal Net Sales SEK 109 million Gross margin 65% Services Net Sales SEK 41 million Gross margin 36% -3% Net sales +23% Net sales -3% Net Sales Organic growth Net Sales SEK 397 Million EBITDA (adj) 18% (22) Sales growth Organic growth 1% - Acquired growth 2% - Currency effect -3% - Total growth 0%
Page 5
DOC ID: Interim report Q2DOC ID: Q2 highligths Alex Moroianu Heart transplant recipient, AU
Page 6
DOC ID: Market update: Lung US Lower activity than expected Interim report Q2 Slowdown in transplant growth YTD • Flat growth in lung transplants, 5 %, in Q2 vs last year • Cuts in public healthcare funding causes uncertainties and cost pressure • Some centres with temporarily reduced waiting lists • Disproportationate slowdown in EVLP 0 500 1000 1500 2000 2500 3000 3500 4000 0 100 200 300 400 500 600 700 800 900 1000 2020 2021 2022 2023 2024 2025 Annually Quartely Lung Transplants US 2020-2025 Q1 Q2 Q3 Q4 Annually YTD growth: 6 % (10%) Q2 growth: 5 % (5%)
Page 7
DOC ID: Market update: Lung US Leadership in EVLP further strengthened Interim report Q2 Q2: Continued execution on ELVP strategy • Destocking at largest customer • EVLP growth at other customers +21 % • 2 additional XPS sold - Including one newly launched, high-ambition program • Future focus: geografic expansion in the US and OPO’s Aquisition of XPS customers 2025 Q1: 2* Q2: 2 Q3/Q4: *Including a Top 5 lung program 4 new XPS YTD Targeting 3-4 additional lung programs/ OPOs
Page 8
DOC ID: 12-month follow-up results from EU heart trial Convincing 12-month follow-up data from EU heart trial presented at ISHLT in Boston, April 2025 Interim report Q2 Clinical superiority further demonstrated: • 76 % risk reduction in severe PGD – the leading cause of mortality after heart transplantion • The risk reduction translated into an improved survival in the XVIVO Group with 92 percent survival vs 86 in the control arm • Corresponding to additionally six lives saved after usage of XVIVO Heart Assist Transport • Significant interest from participating clinicians at ISHLT
Page 9
Clinical Evidence Liver Assist HOPE: Hypothermic oxygenated perfusion | DHOPE: Dual hypothermic oxygenated perfusion | NMP: Normothermic machine perfusion | COR: Controlled oxygenated rewarming | DCD: Donation after circulatory death | DBD: Donation after brain death | ECD: Extended criteria donor Increased utilization +70% Sequential use of DHOPE-COR-NMP enables safe transplantation of initially declined livers with excellent results Cost-effectiveness -€25,832 Mean reduction in transplant-related costs per patient with DHOPE compared to SCS alone 73% REDUCED RISK OF GRAFT LOSS reduced risk of graft loss up to 5 years post-Tx* 64% REDUCED RISK OF BILIARY COMPLICATIONS reduced risk of Biliary strictures 74% FEWER GRAFT-RELATED COMPLICATIONS reduction of severe liver graft-related complications* * In ECD-DBD DBD DCD ECD-DBD ECD-DCD
Page 10
DOC ID: Regulatory & Clinical updates Interim report Q2DOC ID:
Page 11
DOC ID: Regulatory approval status in core markets Interim report Q2 PMA approval for STEEN Solution & XPS / PERFADEX 510(k) cleared Kidney Assist Transport 510(k) cleared IDE application approved US trial to be started in 2025 STEEN Solution, XPS & PERFADEX CE marked Kidney Assist Transport CE marked Liver Assist CE marked STEEN Solution, XPS & PERFADEX approved by the TGA Kidney Assist Transport approved by the TGA Liver Assist approved by the TGA * Products not approved for commercial sales Patient inclusion in US trial completed 12-month follow-up on-going Patient inclusion in European trial completed Regulatory process on-going Patient inclusion in ANZ trial completed Regulatory process on-going * * * *
Page 12
DOC ID: Clinical Trial Status & Tentative Timeline Interim report Q2 CLINICAL REVIEW & FOLLOW-UP MARKET APPROVAL • Patient enrolment completed May 2023 • 204 patients included across 15 centres across 8 countries • Results were published in The Lancet in August 2924 • Trial included 36 patients from 5 centres • Last patient included in December 2022 • Results published in The Journal of Heart & Lung Transplantation in November 2023 • FDA Breakthrough Device Designation • IDE application for DeLIVER trial approved in February 2025 • Multicentre trial including 215 patients across up to 20 centers Trial initiation planned for Q3 2025 PRECLINICAL 12-month patient follow-up HEART HEART LIVER *Pending regulatory approval Commercial launch target Q3 2025* 12 month patient follow-up completed Commercial launch pending CE-mark. Currently sold under Special access scheme 12 month patient follow-up completed • PRESERVE trial included 141 patients across 20 transplantation centres • 1st patient included in October 2023 • Last patient included in November 2024 13 month patient enrollment HEART 12 month patient follow-up Submission and PMA approval process
Page 13
DOC ID: Financial Performance Q2 Interim report Q2DOC ID:
Page 14
DOC ID: Net sales and key ratios Q2 Interim report Q2 Apr-Jun Apr-Jun YTD YTD SEK Million 2025 2024 2025 2024 Net sales 178 210 396 396 Sales growth, % -15 % 36 % 0 % 34 % Whereof organic growth, % -11 % 35 % 1 % 34 % Gross profit 133 158 293 293 Gross margin, % 74 % 75 % 74 % 74 % EBIT (adj) 7 33 37 53 EBIT, % (adj) 4 % 16 % 9 % 13 % EBITDA (adj) 23 51 69 88 EBITDA (adj), % 13 % 24 % 18 % 22 %
Page 15
DOC ID: Thoracic – Q2 Highlights Interim report Q2 97% 3% Lung Heart Net sales by organ 48% 51% 1% Machine perfusion Static preservation Other Net sales by product category 67% 6% 27% Americas APAC EMEA Net sales by regionNet Sales SEK 105 million (141) Organic growth -19 % (40) Gross margin 86 % (85) Heart Sales 3million (19) Lung Sales 102million (122) Organic sales growth R12 14% Organic sales growth R12 24%
Page 16
DOC ID: Abdominal – Q2 Highlights Interim report Q2 Net Sales SEK 52 million (47) Organic growth 19 % (45) Gross margin 68 % (63) 74% 26% Liver Kidney Net sales by organ 12% 6% 82% Americas APAC EMEA Net sales by region Kidney Sales 14million (14) Liver Sales 38million (33) Organic sales growth R12 25%
Page 17
DOC ID: Services –Q2 Highlights Interim report Q2 Organ Recovery 2025 focus: • Strategic overview • Optimize geographical footprint Digital Services Organic sales growth R12 -6% Net Sales SEK 21 million (23) Organic growth -19 % (11) Acquired growth 13 % (-) Gross margin 34 % (40) 86% 14% Organ Recoveries Digital Services Net sales by service 2025 focus: • Invest in tech scalability • Prepare for product integration
Page 18
DOC ID: EBITDA Q2 2025 Interim report Q2 • R12 Trend weakened due to sales development in Q2 2025 • SEK/USD ratio will impact EBITDA negatively due to large portion of sales in the US. As for reference; A SEK/USD ratio of 9,50 in 2024 would have reduced 2024 EBITDA with approx. 20 MSEK and 1 percent unit. • Ambition is to continue improve EBITDA step by step while continuing investing in commercial organization 37 51 42 52 43 23 0% 5% 10% 15% 20% 25% 30% 35% 40% 0 10 20 30 40 50 60 70 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 SEKm EBITDA (adjusted) EBITDA margin (adjusted) 115 137 151 183 188 160 0% 5% 10% 15% 20% 25% 30% 35% 40% 0 25 50 75 100 125 150 175 200 225 250 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 SEKm EBITDA (adjusted) EBITDA margin (adjusted) EBITDA (adj), R12 monthsEBITDA (adj), by quarter EBITDA (adj) Q2 13% Comments EBITDA (adj) R12 19%
Page 19
DOC ID: Cashflow and financial position Interim report Q2 61 70 68 111 97 79 0 25 50 75 100 125 150 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Cash flow from operating activities (R12) Cashflow from investing activities • Cash flow from operating activities SEK 9 million (25) • Investments SEK -72 million (-48) • Financing activities SEK 82 million (-4) • Total Cash flow SEK 18 million (-27) Q2 Cashflow SEKm Q2 Q2 YTD YTD SEKm 2025 2024 2025 2024 Total cashflow from investments -72 -48 -131 -91 Machine perfusion devices -20 -8 -28 -17 Intangible assets (regulatory approvals) -36 -29 -77 -53 Material assets -16 -11 -26 -21 M&A R12 +79m Cash position June 30, 2025 • SEK 323 million (481) Revolving Credit Facility €20 million • Entered in January 2025. Term: 3 years. • Utilized per June 30, 2025: €8 million (-) The credit facility provides XVIVO with further flexibility for strategic management of growth opportunities, financing working capital and general business purposes. ”
Page 20
Alex Moroianu Heart transplant recipient, AU Outlook
Page 21
DOC ID: Outlook 2025 Interim report Q2 • Continued high interest in EVLP globally • Focus on activation and supporting utilization • Support rapid patient inclusion in the CAP (Continued Access Protocol for heart in the US) • Expected to meet critical milestones related to product commercialization and market expansion: • European approval and launch of XVIVO Heart Assist Transport • Initiation of PMA study for Liver Assist in the US • Prepare for full portfolio commercialization in Canada • Strategic review of Service offering in the US to become the preferred partner
Page 22
DOC ID: 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 products on the market or in R&D pipeline Interim report Q2
Page 23
Nobody should die waiting for a new organ DOC ID: Interim report Q2 Fredrica Höglund Liver transplant recipient, Sweden
Page 24
DOC ID: Financial calendar & contacts Financial reports 2025/2026 Interim report July – September 2025: October 23, 2025 Year-end report 2025: January 27, 2026 Interim report January – March 2026: April 22, 2026 Interim report April – June 2026: July 14, 2026 Investor Relations Christoffer Rosenblad, CEO Telephone: +46 735 19 21 59 E-mail: christoffer.rosenblad@xvivogroup.com Kristoffer Nordström, CFO Telephone: +46 735 19 21 64 E-mail: kristoffer.nordstrom@xvivogroup.com Interim report Q2