Bifogade filer
Prenumeration
Beskrivning
Land | Sverige |
---|---|
Lista | Small Cap Stockholm |
Sektor | Hälsovård |
Industri | Medicinteknik |
Strong pipeline growth while the installed base of ASTar increases demand for consumables
The quarter July – September 2025
- Net sales amounted to SEK 3.5 (0.6) million.
- Operating result (EBIT) of SEK -40.7 (-41.1) million.
- Profit after tax amounted to SEK -42.2 (-42.4) million.
- Earnings per share (EPS) before and after dilution amounted to SEK -0.04 (-0.36).
- Cash flow from operating activities totaled SEK -37.0 (-50.0) million.
- Cash flow for the period totaled SEK -40.1 (-13.2) million.
The period January – September 2025
- Net sales amounted to SEK 8.2 (2.2) million.
- Operating result (EBIT) of SEK -132.6 (-162.4) million.
- Profit after tax of SEK -135.6 (-164.1) million.
- EPS before and after dilution amounted to SEK -0.05 (-1.4).
- Cash flow from operating activities totaled SEK -122.3 (-142.1) million.
- Cash flow for the period totaled SEK 17.2 (-74.3) million.
Significant events during the quarter
- New ASTar contracts secured in US and Italy
- First instrument shipment to Saudi Arabia
- Six ASTar ‘go-lives’ for routine use supporting record quarter for consumables demand.
- Contracted with three major pharmaceutical companies to co-develop new drugs for the ASTar platform
- ESTAR tender decision appeal was overturned, reducing likelihood of Q-linea receiving award.
- Accelerate Diagnostics informed customers of discontinuation of Pheno platform, pipeline increase in multiple markets for the Company as a result.
- First conversion of Pheno user to ASTar contracted.
- Fully internalised production of consumables significantly reduces per-unit cost.
- The company has carried out a reverse share split where 1000 shares were merged into 1 new share.
- Rights Issue of SEK 322 million announced for Q4 with, with guarantees and subscription commitments of 85.6%, notice to Extra General Meeting.
Significant events after the end of the period
- Stuart Gander appointed CEO of Q-linea AB.
CEO comment
Strong outlook for ASTar placements
With commercial activity in over 15 countries, our pipeline of ASTar customers continues to expand, with new opportunities in Asia and Latin America joining the growing roster across Europe, the Middle East and US. We enter the fourth quarter with a record strong pipeline in both USA and Europe and look forward to a strong Q4 and 2026. New agreements in the US and Italy, bringing our total contracted fleet of ASTar sites to 17.
Customers currently using the retired Pheno system from Accelerate Diagnostics are seeking alternatives. We are engaging closely with many of these to manage a smooth upgrade to ASTar in their clinical practice. We have already signed Pheno-to-ASTar conversions in the U.
In addition to Pheno conversions, our European business has secured additional placements in Italy and shipped another instrument to the Middle East to support commercial evaluations. Conversations are now ongoing in several new countries in Europe, Asia and Latin America for new customer contracts as well as customer evaluations.
Unfortunately, our previously successful appeal of the ESTAR tender for Tuscany, Italy was overturned, and we now assess that our chances of winning the nine-site deal is low, although no contract has yet been awarded. Despite this disappointment, the pipeline continues to expand with numerous prospects advancing including the aforementioned Pheno customer transitions.
Record consumables demand
The quarter finished strong with a record month in September as consumables pull-through continues to grow on the installed base. Of note, sizeable orders for the US and UK markets reflect key institutions moving to full routine use of rapid AST for their clinical patients.
Pull-through per instrument averaged around 600 tests per ASTar in Q3 2025 and we expect this to trend upward through Q4 2025 and into 2026 toward our 1,000 target.
Customer focused product development
The team has been focused on menu expansion for ASTar with an emphasis on strengthening the US gram-negative panel. We are ready to submit for FDA review of our updated panel during October. In addition, work continues to enable ASTar for non-blood infections (Isolates) and we are already actively exploring this potential with customers.
In parallel, the team has completed all steps needed to produce our consumables at our own factory in Uppsala, Sweden. All ASTar discs will now be filled onsite, reducing costs considerably while increasing quality, control of delivery times and improved inventory management.
Partnerships for innovation
To further strengthen our leadership in rapid AST, Q-linea has signed agreements with two of the leading pharmaceutical companies producing antimicrobial therapies to collaborate on expanding the ASTar menu for new drugs. These partnerships will enable Q-linea to execute more quickly while simultaneously reducing and/or sharing development costs.
This philosophy of shared development effort is also behind our partnership with BlastID, with whom we have published exciting data on the potential for ASTar in a direct-from-whole-blood workflow which can further reduce timetooptimised-therapy for patients.
Drive to breakeven
The number of contracted units as well as our pipeline and recurring revenues continue to grow exponentially, resulting in improved gross margins from increased volumes and further cost savings initiatives as demand hits volume thresholds.
Operational expenses were SEK 12.8 million for Q3 2025 and we anticipate costs during Q4 2025 to be approx. SEK 13 million per month. We have intensified our work to improve productivity in all parts of the operation, and continue to adapt the organization to increased sales and customer focus, which will reduce operational spending by more than 10% during 2026.
We are grateful for the strong support from new and existing shareholders in the announcement rights issue of SEK 322 million. The rights issue will provide the necessary funds to deliver on our ambitious targets and establish us as the market leader within the dynamic sector of rapid AST as now starts to become the new standard of care. A more customer centric and cost-efficient Q-linea is now fully focused on reaching breakeven during 2027.
Uppsala, 19 October 2025, Stuart Gander, CEO
This report has been reviewed by the auditor of the Company. The report has been prepared in a Swedish original and an English translation. In the event of any discrepancies between the two, the Swedish version is to apply.
Presentation
Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 20 July 2025, at 1:00 to 2:00 p.m. (CEST). CEO Stuart Gander and CFO Christer Samuelsson will present Q-linea, comment on the interim report for the January to September 2025 period and respond to questions.
To participate via webcast, please visit the following link: https://q-linea.events.inderes.com/q3-report-2025
There will be an opportunity to ask questions in writing at the webcast.
If you would like to ask questions verbally via conference call, please register at the following link:
https://events.inderes.com/q-linea/q3-report-2025/dial-in
You will receive a telephone number and a meeting ID to log into the conference call after registering. There will be an opportunity to ask questions verbally during the conference call.