Full focus on the US market with strong interest from healthcare providers, reimbursement code in place and collaboration with ACC

Acarix is now taking an important strategic step, putting full commercial focus on the US market. We have the key building blocks in place in the US with our own sales team, FDA clearance, a dedicated reimbursement code and a collaboration with the American College of Cardiology (ACC) to create clinical guidelines. Our early commercial validation of CADScor®System in selected European countries has given us important insights for our US focus. Until we have a relevant reimbursement coverage in place in Europe, we are scaling back our investments in this region, freeing up approximately SEK 25 million in 2023. Our financial targets for 2024 remain in effect.

Extract from CEO Helen Ljungdahl Round’s message to the Interim Report.

Third quarter of 2022 compared with the same period 2021

  • During the third quarter 14 (18) CADScor® Systems and 1,812 (2,319) disposable patches were sold.
  • Revenues amounted to SEK 1,164 thousand (1,231), with a gross profit of SEK 921 thousand (936) and a gross margin of 79,1 percent (76,0).
  • Operating expenses amounted to SEK 21,653 thousand (11,638).
  • Profit before tax amounted to SEK –21,106 thousand (–10,693).
  • Net cash flow for the period amounted to SEK -21,618 thousand (-10,224).
  • Earnings per share amounted to SEK –0,08 (–0.08). No dilution arose.

First nine months 2022 compared with same period 2021

  • During the first nine months a total of 48 (46) CADScor® Systems and 6,252 (5,100) patches were sold and generated totally SEK 4,169 thousand (2,832) in revenue. Gross profit amounted to SEK 3,292 thousand (2,098), corresponding to a gross margin of 79% (74).
  • Operating costs amounted to SEK 57 153 thousand (37,577).
  • Result before tax amounted to SEK –54,372 thousand (–35,508).
  • Net cash flow from operating activities amounted to SEK -56,607 thousand (–34,878).
  • Cash position amounted to SEK 29,408 thousand (28,972).
  • Basic earnings per share amounted to SEK -0,22 (–0.25). No dilution arose.
  • Number of shares amounts to 251,972,194 (141,045,437).

Events in the third quarter, 2022

  • On September 27, Helen Ljungdahl Round, President and CEO at Acarix presented the company´s latest developments within Diagnostics. The presentation is available on the company´s web.
  • On September 26, the company announced that American College of Cardiology (“ACC”) and Acarix have signed a strategic collaboration agreement with the goal to develop a clinical framework for the use of cardiovascular acoustic AI-based technology in the United States, the world’s largest market for cardiovascular care.
    Within the scope of the collaboration, ACC will provide clinical and scientific expertise to Acarix with the intent to assess the utility and role for acoustic AI-based technology in the US and develop a clinical framework for use of CADScor®System in upstream cardiac diagnostics.
    “The agreement with ACC is the most important strategic relationship we have entered so far. Our mission is to make the CADScor®System standard of care to aid rapid chest pain diagnosis and we believe the collaboration with the ACC will help us accelerate the use of our novel technology.” comments Helen Ljungdahl Round, President and CEO of Acarix.
  • On September the 28 the company announced that Patient enrollment is completed in the FILTER-SCAD randomized controlled multi-center trial.
    The FILTER-SCAD study is a randomized controlled clinical trial including more than 2,000 patients with suspected coronary artery disease (CAD). The study has now successfully completed patient enrollment. The one-year follow-up period will assess the impact on cardiac events. Comprehensive study results will be submitted for publication in Q1 2024.

Events after September 30, 2022

  • No events

Link to the report : https://www.acarix.com/for-investors/financial-reports-and-calendar