Strategic shift towards full commercial focus on the US market now in place
As we sum up 2022, it becomes clear that Acarix has in a short time developed from being an R&D-oriented company to a commercial company with full focus on significant opportunities in the US. In 2022, we laid the foundation for a strong sales development by strengthening the company with important key competencies, initiating sales in the US and securing successful progress in collaborations within the US insurance and healthcare system. We have established a strategically very important collaboration with the American College of Cardiology (ACC) to design clinical recommendations for most effective use of the CADScor®System. We have ongoing dialogues with several regions within the US Department of Veterans Affairs Medical Care (VA) and are working towards making our CADScor System an integrated part of cardiac care throughout the VA nationally and further drive our sales. A Rights Issue was carried out during December/January that provided SEK 32.7 million, before issue-related costs. We continue to work on the long-term financing to meet our communicated targets for the end of 2024.
Extract from CEO Helen Ljungdahl Round’s message to the Year End Report.
Fourth quarter of 2022 compared with the same period 2021
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Revenues during the quarter increased by 78 percent to SEK 1,653k (929), with a gross profit of SEK 1,329k (725) and a gross margin of 80.3 percent (78.1).
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During the fourth quarter 13 (11) CADScor Systems and 2,138 (1,780) disposable patches were sold. A growth of 18% and 20% respectively.
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Operating expenses amounted to SEK 23,942 thousand (16,942).
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Profit before tax amounted to SEK –22,612 thousand (–16,223).
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Net cash flow for the period amounted to SEK -18,361 thousand (-13,070).
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Earnings per share amounted to -0.09 SEK and -0.08 including ongoing rights- and offset issue. (-0.12 and -0.09 including ongoing rights- and offset issue).
Full year 2022 compared with same period 2021
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Revenues during the year increased by 55 percent to SEK 5,822k (3,760) with a gross profit of SEK 4,621k (2,823), corresponding to a gross margin of 79.3% (75%). During the year, a total of 61 (57) CADScor-Systems and 8,650 (6,880) patches were sold.
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Operating costs amounted to SEK 81,095 thousand (54,519).
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Result before tax amounted to SEK –76,895 thousand (–51,731).
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Net cash flow for the period amounted to SEK -5,989 thousand (–48,214).
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Cash position amounted to SEK 11,161 thousand (15,860).
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Earnings per share amounted to -0.31 SEK and -0.29 including ongoing rights- and offset issues. (-0.37 and -0.34 SEK including ongoing rights- and offset issue).
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Number of shares amounts to 251,972,194 (251,972,194).
Events in the fourth quarter, 2022
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On November 16, 2022, the company announced in its quarterly report important strategic step of putting full commercial focus on the US market. The important key building blocks is 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. The company´s early commercial validation of CADScor System in selected European countries has given important insights for the US launch. Until relevant reimbursement coverage is in place in Europe, the company is scaling back the investments in this region. The company’s financial targets for 2024 remain in effect.
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On November 22, 2022, the board announced the decision, subject to approval from an extraordinary general meeting to carry out a new issue of a maximum of 188,979,145 units with preferential rights for the Company’s existing shareholders corresponding to approximately SEK 52.9 million before deduction of costs attributable to the rights issue (the ”Rights Issue”). The subscription price per unit has been set to SEK 0.28, corresponding to SEK 0.28 per newly issued share. The Company has received subscription commitments and entered into guarantee undertakings amounting to a total of SEK 31.7 million, corresponding to 60 percent of the Rights Issue.
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On December 5, 2022, the company announced their participation at the 7th Annual Nordic American Life Science Conference, the most comprehensive Nordic life science innovation gathering in the United States. The Nordic American Life Science Conference took place in New York on 7-8 December 2022 and brought together investors, business development leaders and industry partners who wanted to meet and learn more about the most promising Nordic life science companies and investments.
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On December 14, 2022, the prospectus was published in connection with the company’s rights issue, which was announced on November 22.
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On December 15, 2022, the company announced additional orders for the CADScor®System in Louisiana. These sales are a result of a previously announced collaboration with Bio-Rhythms Inc, targeting an area with the highest prevalence of heart disease in the United States. Louisiana is in the top-5 of US states based on heart disease death rates, due to a high frequency of obesity, diabetes, and kidney disease, all of which are risk factors for heart disease. The number of patients and the need for rapid assessment and exclusion of heart disease is therefore high.
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On December 19, 2022, the company confirmed insurance coverage for the CADScor System by key payors in Texas, considered the largest medical device market in the US. As a result, Acarix received first order of CADScor System from a leading heart center in Texas, with additional orders expected from the region in early 2023.
Events after December 31, 2022
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On January 3, 2023, the company announced final outcome of the rights issue. The final outcome in the Rights Issue showed that 90,334,941 Units, corresponding to approximately 48 percent of the Rights Issue, had been subscribed for by the exercise of unit rights (including subscription undertakings of approximately 4 percent). Additionally, 6,983,825 Units were subscribed for without unit rights, corresponding to approximately 4 percent of the Rights Issue. The remaining 19,640,149 Units, corresponding to approximately 10 percent of the Rights Issue, were subscribed for by the parties who entered into guarantee commitments. Through the Rights Issue, the company received proceeds amounting to approximately SEK 32.7 million before deduction of costs attributable to the Rights Issue.
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On January 11, 2023, The Board of Directors of Acarix AB has resolved on a directed issue of shares to those guarantors in the Rights Issue who have chosen to receive guarantee commission in the form of newly issued shares in the Company. The subscription price in the Remuneration Issue is set at SEK 0.28 per share and payment is made by offsetting the guarantors’ claims on the Company.
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On February 7, 2023, the company announced Acarix´s participation in 2023 BIO CEO & Investor Conference in New York City. The BIO CEO & Investor Conference is recognized as a premier event for C-Suite executive leaders, investors and banking communities, focusing on established as well as emerging companies, publicly traded and select private companies delivering innovation in health care.
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On February 14, 2023, the company announced the appointment of two additional members of the Acarix US Commercial team, covering the states of California, Pennsylvania, and New Jersey. These constitute strategically important states with combined 2.8 million chest pain patients per year. Covering these states with experienced sales professionals is an important step in Acarix expansion in the US market and driving sales of CADScor Systems.
The 2022 annual report is available on the company's website on April 20, 2023
Annual General Meeting 2022 takes place on 11 May 2023
Link to the report : https://www.acarix.com/for-investors/financial-reports-and-calendar