FDA decision sets up for growth in U.S. FDA clearance for expanded U.S. menu combined with encouraging progress across Europe and focus organisation, positions Q-linea for growth during the second half of the year.
The quarter April - June 2026
• Contracted ASTar end of period 24 instruments (12).
• Annualized consumable sales per contracted instruments past 12-months SEK 266 thousand (278).
• Net sales amounted to SEK 1.5 million (1.1).
• Operating result (EBIT) of SEK -31.3 million (-47.3).
• Result after tax amounted to SEK -29.9 million (-48.2).
• Earnings per share before and after dilution amounted to SEK -1.58 (-9.13).
• Earnings per share, adjusted, before and after dilution amounted to SEK -1.58 (-2.54).
• Cash flow from operating activities totaled SEK -30.1 million (-36.4).
The period January - June 2026
• Net sales amounted to SEK 3.5 million (4.8).
• Operating result (EBIT) of SEK -66.3 million (-91.9).
• Result after tax of SEK -63.5 (-93.4) million.
• Earnings per share before and after dilution amounted to SEK -3.35 (-24.76).
• Earnings per share, adjusted, before and after dilution amounted to SEK -3.35 (-4.93).
• Cash flow from operating activities totaled SEK -60.2 million (-85.4).
• Net cash position at end of period SEK 186.8 million (82.7).
Significant events during the quarter
• Three new contracts signed in Italy.
• FDA clearance of expanded ASTar® blood testing menu for the U.S market.
• At the Annual General meeting on May 27, Johan Bygge (chairman), Erika Kjellberg Eriksson, Mario Gualano (vice chairman), Sebastian Backlund and Jonas Jarvius were re-elected as well as new election of Kari Krogstad and Öystein Engebretsen. Karin Fischer declined re-election. The registered accounting firm Öhrlings PricewaterhouseCoopers AB, was re-elected. It was resolved to establishment a long-term share savings program (LTIP 2026).
• The company engaged Annika Blondeau Henriksson as interim CFO.
COMMENTS BY THE CEO
Foundations for scale
The second quarter of 2026 saw important progress to our goals. While reported sales and new contract figures for the period remain modest, they do not fully reflect the progress we see across our key markets. As is typical for a novel product, there is a lag between customer commitment, contract execution, installation and revenue generation, something we also have experienced. This is sometimes frustrating, especially knowing that many of the patients would have benefited from the use of ASTar. However, encouragingly enough the quantity, intensity and momentum in our customer dialogues have all continued in the right direction.
A defining milestone for the quarter was the FDA approval in April of our expanded U.S. menu. This represents a step-change in our value proposition. With this approval, ASTar now offers the broadest and deepest antibiotic testing menu on the market-approximately twice the range of the nearest alternative-while maintaining clear advantages in workflow and automation. Importantly, the approval includes the Predetermined Change Control Protocol, a unique capability that enables us to automatically update clinical breakpoints for customers, removing a significant operational burden from laboratories and further differentiating ASTar as the most user-efficient system available.
Following the FDA approval, we have seen a marked increase in commercial activity across the U.S. Multiple customers have now formally communicated their intention to proceed with ASTar installations, and we are actively advancing these through contracting. While these commitments are not yet reflected in reported revenues, they represent high-conviction opportunities.
At the same time, we are taking deliberate steps to shorten sales cycles and improve scalability. We have introduced a "Verify and Adopt" program, facilitating data sharing by existing customers with prospective sites. This aim to reduce duplication of effort, accelerate decision-making, and is now being used for active projects.
A new ASTar entered routine clinical use in the southeastern U.S. during the quarter, providing a reference site in an important region. We completed successful evaluations in Texas and the Midwest, with expected contract conversions during Q3. Our U.S. team is now focused on closing the next wave of customer agreements following the expanded menu approval, including several multi-instrument opportunities, as well as progressing contracting discussions for first installations with a major national reference laboratory network.
In EMEA, we shipped a total of five instruments to customers during Q2 2026. Italy remains the leading market, with three instruments shipped during the quarter. Encouragingly, contracting cycle times in Italy have reduced significantly, reflecting increased familiarity with ASTar and growing clinical acceptance. We expect timelines from shipment to clinical go-lives to continue to shorten. Across the broader region, we are seeing a steadily expanding pipeline of projects in both established markets and in new territories, supported by increasing engagement from our distribution partners.
We have also taken important steps to accelerate our international expansion. During the quarter, we signed four new distribution agreements across Southern Europe, Africa, and Asia, with several additional partnerships in advanced stages of negotiation. Notably, all new partners bring active customer projects into the relationship, providing a clear pathway to near-term installations. We anticipate our first placements in Asia during the second half of the year.
Consumable revenues were comparable to Q1 2026, reflecting the timing of installations and customer activation. As more systems transition into routine we expect a stronger increase in consumables demand during the second half of 2026, driven in particular by U.S customers activating the expanded ASTar menu. The planned launch of our RUO Isolate product later this year is expected to provide an additional driver of volume growth.
The competitive landscape continues to evolve favorably, and we believe the environment will lead to further consolidation over time as customers select a limited number of leading technologies. Based on customer feedback and ongoing competitive evaluations, we remain confident in the ASTar position as the leading platform globally.
Internally, we completed the consolidation of our Sweden-based operations into a single site in Uppsala, bringing R&D and production together. This will enhance collaboration, improve efficiency, and reduce our cost base. We continue to maintain strong cost discipline. We maintain our outlook for the remainder of the year below 11 MSEK per month.
Our priorities are clear: convert our growing pipeline of customer commitments into contracts, accelerate installations, and drive increasing utilization across the installed base. Our progress during Q2 reinforces our confidence that the foundations are in place to support scale up through the second half of the year.
Stuart Gander CEO | Uppsala, Sweden
Presentation
A telephone conference with CEO Stuart Gander and Interim CFO Annika Blondeau Henriksson will be held on July 10, 2026 at 1:00-2:00 p.m. CEST.
Investors analysts and the media are invited.
To participate, please register via Q2 report-2026/register
There will be an opportunity to ask questions in writing at the webcast. If you would like to ask questions verbally, please register at the following link: Q2 report-2026/dial in
About Q-linea
Q-linea is an innovative infection diagnostics company dedicated to saving lives and reducing healthcare costs by developing and delivering solutions for the rapid diagnosis and treatment of infectious diseases. The company's core focus is on rapid Antibiotic Susceptibility Testing (rAST), a critical step in the treatment of sepsis and other severe infections.
Q-linea's flagship technology, ASTar®, is a fully automated instrument designed to deliver rapid phenotypic AST results directly from positive blood cultures in approximately six hours. By significantly reducing the time to answer compared to traditional methods, Q-linea enables physicians to prescribe the optimal antibiotic treatment sooner, improving patient outcomes and actively combating the global threat of antimicrobial resistance (AMR). Founded in 2008 and headquartered in Uppsala, Sweden, Q-linea is listed on Nasdaq Stockholm.
This information is information that Q-linea is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-07-10 07:30 CEST.
