Slides
Page 1
Acarix Q4 2025 Transforming Early Cardiac Diagnostics Aamir Mahmood President & CEO 02/12/26
Page 2
The CADScor®System Transforming Early Cardiac Diagnostics with Rapid Assessment A rapid, point of care diagnostic aid that uses highly sensitive acoustics and advanced computational processing to calculate a patient specific CAD risk score Quickly and easily risk-stratify significant coronary artery disease with 96.2% Negative Predictive Value (NPV)¹ CE-marked and FDA De Novo cleared, designated as a Class II Medical Device with CPT code(s) for reimbursement Based on over 15 years of R&D, covered by 45 patents, clinically studied in over 6,000 patients with over 60,000 assessments to date Headquarters in Sweden | R&D and manufacturing in Denmark | Global Sales Ref: 1. User manual US-FDA v.12.Y, prevalence 10,7%
Page 3
Executive Summary Q4 Highlights Q4 Financials 3
Page 4
Executive Summary 44
Page 5
Continuous Expansion and Progress in Q4 5 Q4 Commercial Performance ● Revenue increased 26% year over year to SEK 2,141 thousand, driven by 87% growth in the U.S. ● CADScor System deliveries grew 64% reflecting accelerating adoption. Financial Performance & Cost Discipline ● Gross margin remained strong at 83%, reflecting the strength of the recurring revenue model. ● Operating costs declined 23%, contributing to a 27% improvement in net loss. U.S. Market Momentum ● Expanded reimbursement coverage with HealthChoice effective October 1 strengthened access across care settings. ● 4 systems were consigned and 19 were sold in the U.S. market, with consignment-led placements supporting utilization growth and long-term recurring revenue. Strategic Progress ● Continued progress on Rural Health opportunities in the U.S. market. ● Ongoing expansion efforts in MENA through a partner-led model.
Page 6
Aamir Mahmood President & CEO 6 The fourth quarter of 2025 concluded a year of strong execution for Acarix, with revenue up 26% year-over-year, driven by 87% U.S. growth. Operating costs declined 23% and net loss improved 27%, reflecting continued progress in scaling the business with financial discipline. The U.S. remained the key growth driver, with 23 CADScor® Systems delivered, up 64% year-over-year, and patch sales increasing 73%. New reimbursement coverage from HealthChoice in Oklahoma further validates the CADScor® System’s clinical and economic value and expands clinician access across care settings. Acarix continued to build a scalable commercial model by expanding consigned system placements to lower adoption barriers and drive recurring patch revenue. Gross margin remained strong at 83% for the quarter and 85% for the full year, underscoring the strength of the recurring revenue model. Internationally, initial distributor sales in the MENA region confirmed the effectiveness of a partner-led expansion strategy. While reimbursement developments in Germany highlight ongoing data requirements in some markets, Acarix enters 2026 focused on increasing U.S. utilization, expanding through partnerships, and building a sustainable cardiovascular diagnostics business.
Page 7
Q4 Highlights 7
Page 8
Acarix Secures HealthChoice Reimbursement, Advancing CADScor® Access ● HealthChoice implemented reimbursement for the CADScor® System effective October 1, 2025, expanding access across physician offices and outpatient/ED settings. ● Coverage extends access to more than 150,000 members, strengthening Acarix’s U.S. reimbursement footprint. ● Reimbursement momentum supports increased system utilization and recurring patch revenue. 8 We enter 2026 with a clear strategic focus: to convert growing reimbursement and system placements in the U.S. into higher utilization and recurring revenue, to expand internationally through disciplined partnerships, and to continue building a sustainable, scalable cardiovascular diagnostics company. Aamir Mahmood, President & CEO
Page 9
CADScor® System Receives EU MDR Certification ● EU MDR Certification Achieved for the CADScor® System, confirming CE marking in accordance with Regulation (EU) 2017/745 and demonstrating compliance with applicable EU safety, quality, and clinical performance requirements. ● Strengthens European Commercial Foundation, enabling continued and expanded market access and supporting accelerated adoption across key EU markets. ● Strategic Growth Catalyst, reinforcing Acarix’s regulatory execution capabilities and advancing the long-term pathway toward global scale, including U.S. expansion. 9 This certification is more than a regulatory milestone, it’s a strategic inflection point for Acarix…and it supports our push to bring a faster, non-invasive approach to ruling out significant coronary artery disease to more clinicians and patients, including in the United States Aamir Mahmood, President & CEO
Page 10
Creating a Scalable Pathway for Reimbursement ● Secured a second fixed-rate reimbursement of $300 per CADScor® test, expanding coverage across both physician office and emergency department settings. ● Three of the five largest U.S. payors removed the “experimental” label and eliminated prior authorization requirements – a major milestone toward routine adoption. ● HealthChoice implemented CADScor® reimbursement coverage on October 1, 2025, extending access to 500,000+ covered lives, 12,000+PCPs, 69,000+ specialists, and 3,000+ facilities across Oklahoma, Texas, Ohio, and Louisiana. ● These developments strengthen payer confidence and position Acarix for accelerated clinical utilization and long-term reimbursement scalability. 10 Aetna FederalCigna Connect
Page 11
0716T Private Clinic Reimbursement *Reimbursements listed in USD. Based on 2025 EOB’s Commercial, GA, LA, IL, AZ Avg payment $289 Cigna, Cigna Connect Avg payment $302 Federal Avg payment $403 Incl. Commercial & MA Avg payment $350 Avg payment $750 Avg payment $300 Average Reimbursement $387 As of August 2025, Cigna, Humana and United Healthcare NO LONGER consider the CADScor® System to be investigational and NO LONGER require pre-authorization Avg payment $274 Avg payment $294 Avg payment $627 11
Page 12
Q4 Financials 12
Page 13
Revenue in the quarter increased 26% year-over-year, driven primarily by 87% growth in the U.S., while operating costs declined by 23% and net loss improved by 27%. These results reflect a company that is steadily scaling its commercial footprint while maintaining financial discipline. Q4 2025 Financial Highlights Aamir Mahmood U.S. Patch Sales 73% YoY Quarterly Operating Costs 23% YoY Quarterly 13 CADScor Systems Delivered 64% YoY Quarterly
Page 14
U.S. CADScor® System Installations Driving Recurring Patch Sales U.S. CADScor System Installations U.S. Acoustic Patch Sales 14
Page 15
U.S. CADScor System Installations* 15 Broadening Market Adoption: Growth led by continued expansion in Primary Care and Cardiology, with increasing adoption in Concierge Medicine and early traction in ER/Urgent Care. Expanding U.S. Clinical Adoption Across Key Disciplines *Numbers are accumulated
Page 16
1,700 2,141 +26% ● Total revenue amounted to SEK 2,141 thousand (1,700), an increase of 26% Q4 Global Revenue Revenue Q4 2024 Q4 2025 16
Page 17
14 23 +64% ● A total of 23 systems were sold and consigned during the period. Of these, 4 systems were consigned in the US market. Q4 Global CADScor Units Installed CADScor Units Q4 2024 Q4 2025 17
Page 18
88% 83% -5 point ● Gross margin was 83%, compared to 88% in Q4 2024, reflecting a greater mix of distributor-led sales as part of our international growth strategy. Q4 Global Gross Margin Gross Margin Q4 2024 Q4 2025 18
Page 19
73 126 +73% ● In the U.S., patch sales amounted 126 boxes (73), an increase of 73% compared to the same quarter in 2024. Q4 U.S. Patch Sales U.S. Patch Sales (boxes) Q4 2024 Q4 2025 19
Page 20
17,812 13,728 -23% ● Operating costs totaled SEK 13,728 thousand, down 23% from SEK 17,812 thousand in Q4 2024, reflecting continued cost-saving initiatives and stronger operational efficiency. Continued Cost Saving Initiatives OPEX Reduction kSEK Q4 2024 Q4 2025 20
Page 21
-16,020 -11,673 -27% ● Net loss improved 27% to SEK –11,673 thousand, compared to SEK –16,020 thousand in Q4 2024, reflecting disciplined execution. Q4 Net Loss Net Loss kSEK Q4 2024 Q4 2025 21
Page 22
-5,546 -3,508 -37% Monthly Burn Rate Monthly Burn Rate kSEK Q4 2024 Q4 2025 22
Page 23
Key Go-Forward Objectives 23 ● Clinical Trials: ○ Systematic review of clinical trials has been published. ■ Requirement for CMS CPT 1 transition. ○ US Performance Trial: Targeting the addition of one new center by Q3 2026. ■ Requirement for CMS CPT 1 transition. ○ UC Davis Study: Continued enrollment to 100 patients. An abstract has been abstract accepted by ACC for presentation, March 2026, New Orleans. ● Continue evaluations for opening new OUS Markets via Distribution Partners
Page 24
Strategic Distribution Partnership Opens Saudi Arabia Market 24 ● New Distribution Agreement Signed in Kingdom of Saudi Arabia, with a local partner responsible for regulatory approval of the CADScor® System. ● Commercial commitment following regulatory approval, with forecasted product orders of approximately SEK 9.8 million within the first 6 months after approval. ● Strategic Market Expansion, entering a high-priority cardiovascular market with strong national focus on prevention, early diagnosis, and healthcare efficiency, further strengthening Acarix’s international footprint. “This partnership reflects confidence in CADScor’s clinical and economic value and supports our strategy to expand access to efficient, non-invasive cardiovascular diagnostics in strategically important global markets.” Aamir Mahmood, President & CEO
Page 25
Clinical Validation, Testimonial ● A clinician’s perspective on using the the CADScor® System as an additional data point when evaluating stable, symptomatic patients. CADScor serves as a valuable additional data point for evaluating stable symptomatic patients—particularly when traditional testing appears reassuring, yet clinical suspicion remains. In my case, it helped drive timely escalation to definitive testing and appropriate treatment. Internal Medicine Physician, Alabama 25
Page 26
Thank You! Transforming Early Cardiac Diagnostics 26