IR Press releases 2025-02-20

Gradientech: Year-end report 2024

Gradientech AB (publ) year-end report for 2024 is now available on the company's website www.gradientech.se.

Fourth quarter 2024

  • Net sales amounted to SEK 1,194 thousand (376).
  • Net profit/loss amounted to SEK -16,666 thousand (-17,810).
  • Earnings per share before and after dilution were SEK -0.58 (-1.00).
  • Cash flow from operating activities amounted to SEK -18,740 thousand (-14,637).
  • Cash and cash equivalents amounted to SEK 24,596 thousand (10,811) as of December 31, 2024.
  • Equity amounted to SEK 35,424 thousand (48,451) as of December 31, 2024.
  • In the beginning of October Gradientech announced a new scientific publication of the QuickMIC® system. The article is published in the top-tier Journal of Clinical Microbiology. The article describes data from the performance evaluation of the QuickMIC system shows that QuickMIC is highly accurate compared to the reference testing method for AST. QuickMIC provides 95.6% agreement with the reference MIC values (Minimum Inhibitory Concentration) and over two times higher precision compared to broth microdilution. The mean analysis time was 3h and 13 min.
  • Gradientech announced in early October the exclusive partnership with Hardy Diagnostics for the commercialization of its QuickMIC® system in the United States and Canada. Alongside this partnership, Hardy Diagnostics has decided to invest in Gradientech, becoming one of the company’s largest shareholders. The directed issue of shares was registered with the Swedish Companies Registration Office October 17. As a result of the issue, the Company’s shares increased by 1,796,571 shares to 28,867,173 shares and the share capital with SEK 179,657.10 to a total of SEK 2,886,717.30. Through the Issue, Gradientech received proceeds of approximately SEK 31.4 million before deduction of issue costs.
  • At the end of November Gradientech announced that its distributor a.d.a SRL has installed the QuickMIC-system into clinical routine use at the Molinette Hospital in Turin, Italy. The Molinette Hospital is as part of the Azienda Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, one of the biggest university hospitals in Italy and in Europe, with a mission to provide excellent patient care and conduct top-tier research.

January-December 2024 period

  • Net sales amounted to SEK 4,457 thousand (1,950).
  • Net profit/loss amounted to SEK -63,620 thousand (-63,678).
  • Earnings per share before and after dilution were SEK -2.50 (-3.64).
  • Cash flow from operating activities amounted to SEK -62,044 thousand (-60,538).
  • In January 2024 Gradientech successfully completed its pre-clinical testing of the QuickMIC® system in the US. The pre-clinical testing of the QuickMIC system has included about a hundred clinical patient samples and was performed at two reputable US clinical laboratories.
  • The rights issue, whose subscription period ended on December 6, 2023, was registered together with the shares from the conversion of the convertible instruments issued in July 2023, with the Swedish Companies Registration Office on three occasions: 3 January 2024, 12 February 2024 and 15 February 2024. As a result of the two issues, the number of shares increased by 6,165,503 to a total of 23,960,753 shares and the share capital increased by
    SEK 616,550.30 to a total of SEK 2,396,075.30.
  • Gradientech announced in the beginning of February that six QuickMIC® abstracts will be presented at the 34th European Congress of Clinical Microbiology & Infectious Diseases (ESCMID Global) in Barcelona, Spain 27-30 April 2024.
  • In March 2024 Gradientech announced that its assigned distributor for Sweden, Triolab AB, will start its first commercial evaluation of the QuickMIC® system at the Kalmar County Hospital. Further, Gradientech has started a new prospective and observational QuickMIC® study that will investigate the clinical utility of a new rapid workflow for prediction of optimal antibiotic treatment for patients with urosepsis. The study is conducted in collaboration with Assoc. Prof. Martin Sundqvist at Örebro University Hospital.
  • In April 2024 Gradientech announced that AnnaLotta Schiller Vestergren has been appointed as the company’s Chief Commercial Officer and part of the management team. AnnaLotta has extensive experience with international commercial organisations, with nearly 30 years of leading positions in life science and diagnostics.
  • In May Gradientech reports having received a notification to grant patent rights in China for its cassette, the single-use test device in the QuickMIC® diagnostic system for ultra-rapid antibiotic susceptibility testing (AST).
  • In May Gradientech announced that its distributor Biomedica Medizinprodukte GmbH has installed QuickMIC® at a university hospital in central Eastern Europe, which is now the first customer to implement the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST) in clinical routine.
  • Data from the successfully completed US pre-clinical evaluation of QuickMIC® at Medical College of Wisconsin and University of North Carolina in USA was presented at the ASM Microbe conference in Atlanta, Georgia, June 13th-17th 2024.
  • In July Gradientech announced the continued collaboration with Oxford-based Momentum Bioscience Ltd in the ground-breaking project to demonstrate the potential for a next-generation diagnostic workflow for patients with sepsis, together providing the fastest solution to precise phenotypic AST results directly from blood.
  • The directed issue of shares to a limited number of existing shareholders, in which the subscription period ended on July 4, 2024, was registered with the Swedish Companies Registration Office in July. As a result of the issue, the number of shares increased by 3,109,849 to a total of 27,070,602 shares and the share capital increased by SEK 310,984.90 to a total of SEK 2,707,060.20. Through the Issue, Gradientech received proceeds of approximately SEK 22.1 million before deduction of issue costs.
  • In August Gradientech announced that Dr Nathan A. Ledeboer, specialist within the Froedtert & Medical College of Wisconsin network, joined as new member of the company’s prominent international Scientific Advisory Board.
  • Gradientech received in August a Notice of Allowance in Japan for its QuickMIC® cassette, the single-use test device in the QuickMIC® diagnostic system for ultra-rapid antibiotic susceptibility testing (AST).
  • In September Gradientech announced a new scientific publication of the QuickMIC® system by Dr. Balmis University General Hospital demonstrating an impressive concordance of 99% between QuickMIC and the reference methods in use.
  • In early September, Gradientech started the 510(k) clinical study for the QuickMIC® system. The study, which is conducted at well-renowned hospitals in the US, includes antibiotic susceptibility testing results for gram-negative bacteria, both directly from positive blood cultures as well as from bacterial isolated colonies.

Significant events after the end of the period

  • Gradientech announced in January to have started its third FDA 510(k) clinical study site in the US for the QuickMIC® system to ensure comprehensive clinical data collection for the regulatory FDA submission of the QuickMIC system and its gram-negative panel.
  • In the beginning of February Gradientech announced the outcome of the new issue of shares with preferential rights for existing shareholders, resolved by the Board of Directors on December 17, 2024. The Rights issue was fully subscribed, which means that Gradientech will receive approximately SEK 60.6 million before deduction of issue costs. Through the Rights Issue, the Company’s share capital will increase by SEK 346,405.90 to SEK 3,233,123.20 and the number of shares will increase by 3,464,059 shares to 32,331,232 shares.

CEO statement

I summarise 2024 as the year when the QuickMIC® system was implemented in routine diagnostics in the first European hospitals and when we started clinical studies in reputable American hospitals as a step towards FDA clearance in the USA. I have been part of the company since we started Gradientech in 2009, and it feels fantastic to know that seriously ill patients will benefit from the results of the many years of product and production development behind us. It outweighs the challenges we have worked through and have ahead of us and is the most important driving force for many of us working with innovation in the diagnostics area. The past year has, for example, also resulted in successful production scale-ups and regulatory approvals in the UK and Switzerland.

 

To be able to offer an attractive product solution to hospitals, there is also continuous functional growth of QuickMIC®. During the coming year, we are launching an integrated screen solution for the system so that users save even more valuable bench space in their labs. We are also developing our second antibiotic panel for the European market with a focus on countries with high antibiotic resistance levels in society. I personally think that our preliminary results for the sought-after antibiotic Cefiderocol, which no other automated AST system can offer today, are among the most exciting at the moment.

 

Gradientech’s focus is, of course, on commercial growth. For 2025, the goal is to increase the number of hospitals using QuickMIC® in their routine diagnostics of patient samples, to increase the so-called installed base of instruments which will then drive the sales of tests. Important ongoing activities include further training of more salespeople, service, and application specialists at our various European distributors. In this way, we ensure continued high quality in installation and support for prospective hospital customers.

 

Colleagues and I recently spent a few days in Dallas together with the management and sales team at Hardy Diagnostics, Gradientech’s commercial partner in the US since last fall. Hardy Diagnostics met for its annual sales meeting with its sales representatives from across the US. We met a knowledgeable and very enthusiastic sales team that is ready to take on QuickMIC® and bring it to the US market. As a next step, Hardy Diagnostics personnel will come to us in Uppsala for an extended training with the goal that they will then be able to handle the first installations in the US on their own.

 

I would like to conclude by thanking you for the fully subscribed rights issue that closed on January 31. This means that Gradientech has capital for the full 2025, a year where we look forward to submitting FDA applications after completed US clinical studies, and where we foresee a growing instrument base in Europe and new product launches.

 

Sara Thorslund, CEO Gradientech

Uppsala, February 20, 2025

 

For further information, please contact:

Sara Thorslund, PhD, CEO  
Phone: +46 (0)736 29 35 80  

 

Urban Adolfsson, CFO

Phone: + 46 708 20 72 09

 

About Gradientech

Gradientech is a Swedish company that develops and sells next generation diagnostic solutions in infectious medicine. Our market approved QuickMIC® system, classified as a Breakthrough device by the FDA, makes us a world leader in ultra-rapid antibiotic susceptibility testing, helping patients with bacteraemia and sepsis to quickly receive personalised treatment with the right antibiotic at the right dose. This can save lives, reduce healthcare costs and limit the spread of antibiotic resistance in society – probably one of the greatest global health threats of our time. Gradientech is headquartered in Uppsala, Sweden. For more information, please visit www.gradientech.se

 

 

Documents

Gradientech Interim report Q4 2024