Correction to press release: Acarix AB (publ) publishes

Press release
Malmö, Sweden, February 17, 2022

Correction to the press release: Acarix AB (publ) publishes its 2021 year-end report

The press release published today at 08:00 CET does not have include the quarterly report. the quarterly report is included in the press release below, which otherwise matches the previously issued press release.

For more information contact:
Christian Lindholm, CFO, phone +46 705 118333, email Christian.lindholm@acarix.com

The information was provided, through the contact person above, for publication at the time indicated by the company’s news distributor, GlobeNewswire.

About Acarix:
Acarix is ​​a Swedish medical device company innovating solutions for rapid elimination of coronary heart disease (CAD) based on AI. The CE-cleared and FDA-cleared DeNovo Acarix CADScor® System is for patients with CAD-suspect chest pain and designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures. The CADScor®System calculates a patient-specific CAD score non-invasively in less than 10 minutes and can help exclude more than a third of patients with at least 96% certainty (in a population with a CAD prevalence of around 10 %). Acarix is ​​listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX). Redeye AB (+46 (0)8 121 576 90, Certifiedadviser@redeye.se) is Acarix Certified Advisor. For more information, visit www.acarix.com.

Press release
Malmö, Sweden, February 17, 2022

Preparing the ground for accelerated expansion in the United States

During the fourth quarter, we presented operational and financial objectives based on our three-year plan. Our goal is to increase sales to over SEK 200 million and secure a gross margin of at least 80% by 2024. This corresponds to an established base of 3,000 CADScor® systems by the end of 2024, with a focus on the United States.

I am extremely proud to be able to take Acarix to the next level, based in the United States and close to customers in our most important market. With the investment capital from the share issue in December and our excellent teams in Sweden, Denmark, Germany and the United States, we now have everything in place to drive our growth and deliver on our strategic plan.

Excerpt from the CEO Chubby Helen Ljungdahl‘s message to the year-end report.

Fourth quarter 2021 compared to the same period 2020

  • During the fourth quarter, 11 (22) CADScor® systems and 1,780 (1,420) disposable patches were sold.
  • Revenues were SEK 929,000 (966), with a gross profit of SEK 725,000 (713) and a gross margin of 78% (74).
  • Operating expenses amounted to SEK 16,942 thousand (12,100).
  • Profit before tax amounted to –16,223 thousand SEK (–11,411).
  • Cash flow from operating activities amounted to SEK –13,128 thousand (–12,546). The net cash flow for the period amounts to -13,070 thousand SEK (12,034).
  • Earnings per share amounted to –0.12 SEK (–0.08). Earnings per share, including the pending new share issue and the issue of remuneration, amount to –0.09 SEK.

Financial year 2021 compared to the same period 2020

  • During the year, a total of 57 (51) CADScor® systems and 6,880 (3,540) disposable patches were sold and generated total revenue of SEK 3,760,000 (2,170). Gross profit amounted to SEK 2,823,000 (1,594), corresponding to a gross margin of 75% (73).
  • Operating expenses amounted to SEK 54,519 thousand (43,025).
  • Profit before tax amounted to –51,731 thousand SEK (–41,496).
  • Cash flow from operating activities amounted to SEK –48,007 thousand (–36,686).
  • Cash and cash equivalents amounted to SEK 15,680 thousand (64,113).
  • Earnings per share amounted to –0.37 SEK (–0.51). Earnings per share, including the outstanding new share issue and the compensation issue, amount to SEK –0.34.

Events of the fourth quarter of 2021

  • On October 27, the company announced that the American Medical Association (AMA) Editorial Board had approved the CPT® Category III (CPT III) Code Application for the Acarix CADScor® System. The application was actively endorsed by the American College of Cardiology (ACC) and accepted by WADA without comment. CPT III redemption codes are assigned to emerging technologies, services and procedures. In accordance with the CPT III process, the new code for the CADScor® system will be published by the Center for Medicare and Medicaid services (CMS) on January 1, 2022 and available to U.S. payers and providers by July 1, 2022. process, no amount of specific payment is attached to the code and Acarix will now work with selected payers to agree the level of coverage and payment. Once a code is in effect, healthcare providers will be able to submit claims through their standard billing processes.
  • On November 5, the company announced plans to conduct a fully subscribed rights issue of approximately SEK 79.3 million to enable expansion into the US market. On the same day, the board of directors called an extraordinary general meeting to approve the capital increase on November 23, 2021.
  • On November 8, the company announced its funding and operating targets for 2024 – to have sales above SEK 200 million and a gross margin of at least 80%. This corresponds to an established base of 3,000 CADScor® systems by the end of 2024, with a focus on the US market.
  • On November 9, the company announced that it had signed a commercial access agreement with Proximo Medical LLC. The agreement will enable rapid business expansion in the United States through the sales force that covers strategic states in the United States. The deal is part of a sales strategy for the US market.
  • On December 20, the company announced the final result of the rights issue of up to 105,784,077 shares with preferential rights for the existing shareholders of the Company, which was decided by the additional general meeting of November 2021. A total of 82,638,585 shares were subscribed in the rights issue, which corresponds to approximately 78%. The remaining 23,145,492 shares, or approximately 21.9% of the rights issued, were subscribed through guarantee commitments.
  • On December 29, the company announced a directed issuance of shares to guarantors who elected to receive a guarantee fee in the form of newly issued shares in a completed rights issue. The subscription price under the indemnification issue is set at SEK 0.75 per share and payment is made by offsetting the claims of the guarantors.

Events after December 31, 2021

  • On January 10, the company announced the appointment of US-based Helen Ljungdahl Round as CEO effective immediately. Helen was appointed President of Acarix USA Inc. and will continue to be based in the United States in her capacity as the new CEO of Acarix Group. Helen has over 25 years of leadership experience in strategy, product innovation, business management, marketing and sales in the pharmaceutical and medical technology industry. Helen has held numerous management and executive positions with Merck & Co, Inc, working in North America, EU, Middle East/Africa, Latin America and Asia. Her career also includes roles as CEO of AMNICELL, a New York-based biotech start-up, and Senior Vice President of Global Marketing and Business Development for GN Hearing Denmark.
  • On February 9, the company announced the expansion of its portfolio and submitted a breakthrough designation application for its innovative heart failure diagnostic technology to the Food and Drug Administration (FDA) in the United States. “I am very proud of this submission to the FDA, and we believe the Seismo system has the potential to dramatically improve the early diagnosis of heart failure. The Seismo system provides rapid AI-based access to information from diagnosis, which can help better guide optimal patient care and improve clinical outcomes more quickly.We expect a response from the FDA in April,” said Helen Ljungdahl Round, CEO.

For more information contact:
Helen Ljungdahl Round, CEO, phone +1 267 809 1225, email helen.round@acarix.com
Christian Lindholm, CFO, phone +46 705 118333, email Christian.lindholm@acarix.com

The information was provided, through the contact person above, for publication at the time indicated by the company’s news distributor, GlobeNewswire.

About Acarix:
Acarix is ​​a Swedish medical device company innovating solutions for rapid elimination of coronary heart disease (CAD) based on AI. The CE-cleared and FDA-cleared DeNovo Acarix CADScor® System is for patients with CAD-suspect chest pain and designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures. The CADScor®System calculates a patient-specific CAD score non-invasively in less than 10 minutes and can help exclude more than a third of patients with at least 96% certainty (in a population with a CAD prevalence of around 10 %). Acarix is ​​listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX). Redeye AB (+46 (0)8 121 576 90, Certifiedadviser@redeye.se) is Acarix Certified Advisor. For more information, visit www.acarix.com.

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