Gradientech: Interim report January–June 2025

Gradientech AB (publ) interim report for Q2 2025 is now available on the company's website www.gradientech.se.

Second quarter 2025

• Net sales amounted to SEK 881 thousand (1,948). Please note that quarterly sales may vary as Gradientech’s sales to distributors vary throughout the year.
• Net profit/loss amounted to SEK -20,272 thousand (-17,906).
• Earnings per share before and after dilution were SEK -0.63 (-0.75).
• Cash flow from operating activities amounted to SEK -21,085 thousand (-14,586).
• Cash and cash equivalents amounted to SEK 40,100 thousand (6,750) as of June 30, 2025.
• Equity amounted to SEK 55,868 thousand (14,893) as of June 30, 2025.
• In the beginning of April Gradientech announced that its new CU product that comes with its already award-winning QuickMIC^® system has received the prestigious Red Dot Design Award: Product Design 2025.
• On 7 April, 2025, the second of two registrations was carried out with the Swedish Companies Registration Office regarding the rights Issue decided by the board on December 17, 2024. After the second registration, the cash flow of which affects the second quarter of 2025, the share capital amounts to SEK 3,233,123.20 and the number of shares to 32,331,232.
• Gradientech announced at the end of April that Prof. Gian Maria Rossolini, Professor of Microbiology and Clinical Microbiology at the University of Florence, joins as a new member of the company’s prominent international Scientific Advisory Board.
• At the AGM on May 21, Veronica Byfield Sköld was elected as new member of Gradientech´s Board of Directors. Laura Chirica did not stand for re-election.
• Gradientech announced at the end of May that their distributor Biomedica installed the QuickMIC^® system for routine use at the Clinical Center University of Sarajevo, one of the largest hospitals in Bosnia and Herzegovina.
• In June Gradientech announced that its distributor a.d.a. SRL, the company´s exclusive distributor at the Italian market was awarded direct tenders at two Italian hospitals.

January-June 2025 period

• Net sales amounted to SEK 1,824 thousand (2,434).
• Net profit/loss amounted to SEK -39,221 thousand (-33,554).
• Earnings per share before and after dilution were SEK -1.26 (-1.43).
• Cash flow from operating activities amounted to SEK -41,000 thousand (-29,399).
• 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 CSLI 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 on 17 December, 2024. The rights issue was fully subscribed, which meant that Gradientech received approximately SEK 60.6 million before deduction of issue costs. Part of the issue was registered on 11 February and affects the first quarter’s cash flow by SEK 31.7 million before deduction of issue costs. The registration increased the number of shares by 1,813,908 shares and the share capital by SEK 181,390.80. The registration meant that the share capital as of 31 March 2025 amounted to a total of SEK 3,068,108.10 and the number of shares to 30,681,081. For the second part registration, see further above under “Second quarter 2025”.
• Gradientech announced at the end of February that a.d.a. SRL, its exclusive distributor for the Italian market, is starting a multicenter study in the Milan area of Italy for the QuickMIC^® system. The multicenter study will be performed at four hospitals in collaboration with the Italian Society for Clinical Microbiology (AMCLI) and aims at developing new recommendations for rapid AST for Italian healthcare.
• Gradientech announced in March that the company will present new study data from clinical, real-world evaluations with its QuickMIC^® system for ultra-rapid antibiotic susceptibility testing (AST) at ESCMID Global 2025 in Vienna, Austria, April 11th-15th.
• During March Gradientech announced that Mark Lischeid was appointed as the company’s new Sales Manager for Central Europe. Mark has extensive knowledge from strategic sales and commercial organisations, with over 25 years of experience in the diagnostic sector.

Significant events after the end of the period

• In the beginning of July, Gradientech announced a significant order from its North American distributor, Hardy Diagnostics. The order making an important milestone in Gradientech´s U.S. market expansion strategy.
• In July Gradientech completed its clinical sample testing in ongoing FDA 510(k) clinical study of the QuickMIC^® system.
• In the beginning of August, Gradientech announced that the company was awarded the Clinical Diagnostics Campaign of the Year at the prestigious Scientists’ Choice Awards® 2025, presented by SelectScience^®.

CEO statement

We are now back in full operation after the summer and look forward to an exciting autumn. Looking back at the spring, I’m pleased to note that we successfully installed several QuickMIC systems in European hospitals, both for routine clinical use and for demo evaluations. We also delivered our first systems to Hardy Diagnostics in the U.S., marking a key milestone in our international expansion.

In parallel, our clinical FDA studies have progressed according to plan, both at U.S. hospital sites and at Gradientech. All patient samples required for the first FDA submission – focused on bacterial isolates as sample type – have now been collected and tested. We are currently compiling the final data and documentation, with the goal of submitting our first FDA application this autumn. At the same time, we are completing the testing for our second clinical study, including a larger number of tests, which targets blood cultures as the sample type.

In June, Hardy Diagnostics showcased the QuickMIC system at the ASM Microbe conference in Los Angeles. The interest among attendees was strong, and Gradientech was also present to share study data accepted for presentation at the conference. Hardy Diagnostics is planning a market launch of QuickMIC for investigational use only in the U.S. this autumn, pending FDA clearance for clinical diagnostic use.

During the spring, our Notified Body completed the final review for CE marking under the new In Vitro Diagnostic Regulation (IVDR). This is a rigorous process designed to ensure that high-risk products meet stringent safety and performance standards. In early summer, we were pleased to receive the recommendation for IVDR certification, and we are now awaiting formal issuance of the certificate. This marks a significant achievement where IVDR certification is to be recognised as the European equivalent of FDA clearance, further strengthening both customer trust and our standing in investor discussions.

Awards and accolades are to be celebrated, and we did so in July when we and our industrial designers attended the Red Dot gala in Essen, Germany. Gradientech’s integrated screen product, QuickMIC^® CU, was awarded a Red Dot Design Award earlier this year, and it was an honour to participate in the ceremony together with over a thousand industrial designers and product developers from all over the world. Our products are now on display at the Red Dot Design Museum in Essen – in good company with other winning entries from this year, such as Ferrari’s F80 sports car, Sony’s Playstation 5 and LG’s transparent Signature TV, to name a few.

Finally, since early summer, we have been working with SEB as our financial advisor to prepare for a major issue this autumn. The aim is to secure the financial foundation needed to carry us beyond FDA clearance, support continued commercial growth and scale our production capacity. 

Sara Thorslund, CEO Gradientech

For further information, please contact:
Sara Thorslund, PhD, CEO         
Tel: +46 736 29 35 80                 

Urban Adolfsson, CFO
Tel: + 46 708 20 72 09

About Gradientech
Gradientech is a leader in ultra-rapid antibiotic susceptibility testing, developing next-generation diagnostics for infectious disease medicine. Our innovative diagnostic solutions aim to save lives, reduce healthcare costs, and combat the spread of antibiotic resistance – one of our greatest global health threats. Gradientech is headquartered in Uppsala, Sweden. Visit www.gradientech.se for more information.