TAKING CONTROL OF OUR FUTURE
Third quarter: 1 July –
• Net sales amounted to
• The operating result totalled
• The result for the period amounted to
• Earnings per share before and after dilution amounted to
• Cash flow from operating activities totalled
Period: 1 January –
• Net sales amounted to
• The operating result totalled
• The result for the period amounted to
• Earnings per share before and after dilution amounted to
• Cash flow from operating activities totalled
• As of
Significant events
In the third quarter of 2022
• Q-linea received a letter of intent (LOI) from a large market-leading company for the evaluation and potential commercialisation of Podler.
after the end of the period
• Q-linea has reached an agreement with
CEO Comment
After the end of the third quarter, we reached an agreement with
As ASTar gets closer to approval and launch on the US market, Q-linea will take control of marketing and distribution on the important US market. Q-linea intends to approach the markets in
Q-linea and
Of course, it’s Thermo Fisher’s change in strategy is regrettable. At the same time, customer interactions during our period of cooperation mean we have evolved significantly on the commercial front and now have a clear idea of what needs to be done to succeed in the years to come. I look forward to building a company with a clearer focus on selling its own products, which will create significant future value. We have also seen continued strong interest in our products from other major companies in the market and will now be able to fully follow up on these discussions in the best interests of our shareholders.
Despite our confident outlook, this change of strategy together with the Covid-19 pandemic impact on customers’ purchasing decisions in 2022, means we will adjust previous sales estimate of 20 ASTar systems for 2022 to around 10 and will not see this turn around until 2023.
We are seeing many customers request comparative studies between ASTar and other available systems for rapid AST testing. We are in the process of joining several such studies to see how ASTar compares to the competition. Based on the data we’ve seen from individual evaluations, we are very much looking forward to seeing ASTar in large-scale comparisons of performance and workflow.
We see that health economics evidence (HEOR) is important to our European customers. It is therefore very gratifying that all the hospitals in our first major health economics study in
Our discussions with the FDA continued during the quarter, and we are now holding discussions on potential expanded testing. FDA has 90 days to examine our application, but it does not mean that the application is expected to be approved within 90 days. The “clock stops” when the FDA has a question or requests a clarification, which results in an extension of the time until approval. Similar products in the market have often had an approval time of 12 to 18 months. Of course, I hope that our review time will be faster than average since ASTar is classified as a breakthrough device by the FDA. Once we have received US market approval, we believe that clinical adoption in the US will go faster than it has in
Commercial discussions regarding Podler continued during the quarter, and I will of course announce how the discussion progress as soon as possible.
Qlinea is undergoing a major change as we now clearly take control of our own future. This change means that 2023 will be a year of transformation and adjustment to our new situation but based on the reception we’ve seen in
Uppsala,
This report has been reviewed by the Company’s auditors. 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,
Webcast: https://ir.financialhearings.com/q-linea-q3-2022
Telephone numbers for the teleconference:
SE: +46 850 558 352
US: +1 646 722 4903
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