ASTar installed at two prominent US hospitals
Fourth quarter: 1 October–31 December 2023
- Net sales amounted to
SEK 0.1 million (0). - The operating result totalled
SEK -55.4 million (-59.6). - The result for the period amounted to
SEK -54.2 million (-63.7). - Earnings per share before and after dilution amounted to
SEK -0.46 (-2.18). - Cash flow from operating activities totalled
SEK -48.2 million (-79.7).
Full year: 1 January–31 December 2023
- Net sales amounted to
SEK 4.4 million (12.8). - The operating result totalled
SEK -230.6 million (-262.2). - The result for the period amounted to
SEK -229.4 million (-268.7). - Earnings per share before and after dilution amounted to
SEK -3.48 (-9.20). - Cash flow from operating activities totalled
SEK -228.5 million (-250.9). - As of
31 December 2023 , the Company had a total ofSEK 81.9 million (72.9) in cash and cash equivalents.
Significant events
In the fourth quarter of 2023
- The Company presented strong ASTar results from the first commercial evaluation at a large biomedical congress, IBMS.
- Q-linea entered into two agreements for distribution of ASTar instrument and consumables in
Finland /the Baltic states and Benelux. - Q-linea installed its first two ASTar systems in the US pending market approval.
After the end of the period
- The Company was awarded a public tender for rapid AST instruments and consumables issued by Fondazione PTV in
Italy . - Q-linea successfully concluded the clinical trials required to add the drug Meropenem-Vaborbactam to its existing ASTar-panel.
- The Company announced that
Stuart Gander will take over as CEO of Q-linea and thatAnders Ljunggren will take office as Managing Director ofQ-linea AB inSweden on1 March 2024 . - Q-linea initiated a cost-saving programme with the aim of focusing on its commercial operations.
- The Company received its first order from its distribution partner in
Finland and the Baltic states and signs agreement with logistic partner for the American market. - Q-linea creates separate subsidiary for Podler.
CEO comment
As we look back on 2023, I am proud to say that after starting the year with no partners, through methodical work we successfully built a strong network in all of our key geographic markets in the EU. By the end of 2023, we were able to add
During the year, several evaluation studies confirmed the value of rapid susceptibility testing and improved diagnostics for patients who have access to the technology. An example from the
The largest comparative study of rapid susceptibility testing was carried out in
After the end of the period, we also showed that ASTar is highly competitive. In our first tender in
We can see that our intensive efforts to conduct customer evaluations for ASTar and rapid susceptibility testing are now starting to pay off, with over 15 tenders in the EU either announced or in preparation. Most of these are planned in
To sum up, we made significant progress during the year, despite the market being significantly impacted by the pandemic. Customers have been forced to delay procurement, but rapid susceptibility testing is now becoming a priority in hospital budgets. We are hopeful that sales will increase in 2024 now that we are seeing the first signs of a positive turnaround in the EU. To further enable increased commercial focus, and as communicated earlier, we are now conducting a large restructuring program that will save some 50 MSEK on an annual basis with full effect second half of 2024.
In the US, our dialogue with the FDA has continued and intensified, and I believe that we will soon secure approval for the US market. As soon as ASTar is approved, we will allow hospitals and hospital chains to test the system, and in December – in preparation for launch in the US – we installed the first two ASTar systems for evaluation at two prominent labs. Discussions regarding possible partnerships for the US market are ongoing and are expected to intensify once approval is received.
We are continuing our efforts to obtain a unique New Technology Add-on Payment (NTAP) code for the US market. Our eligibility to apply for an NTAP is based on our breakthrough designation from the FDA. The aim of NTAP is to give new technologies a faster route to market. If we are successful in obtaining an NTAP code, ASTar customers will be able to receive extra reimbursement on top of the regular lump-sum diagnosis-related group (DRG) reimbursement that the hospital receives, which would be very positive.
As this is my last quarterly report, I would like to take this opportunity to thank all of our employees, directors and owners who have supported me over the years. Together, we have successfully built an outstanding company that will play an important role in improving care for patients with serious infections while contributing to the fight against antibiotic resistance.
It has been a pleasure, and I feel grateful to now be able to hand over the reins to
Uppsala,
This report has not 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,
To participate via webcast, please visit the following link: https://ir.financialhearings.com/q-linea-q4-report-2023 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://conference.financialhearings.com/teleconference/?id=50048290
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.
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