Q-LINEA AB ASTar approved for the American market
First quarter: 1 January–31 March 2024
- Net sales amounted to
SEK 1.5 million (0). - The operating result totalled
SEK -56.0 million (-62.2). - The result for the period amounted to
SEK -56.0 million (-61.4). - Earnings per share before and after dilution amounted to
SEK -0.5 (-2.1). - Cash flow from operating activities totalled
SEK -47.9 million (-72.4). - As of
31 March 2024 , the Company had a total ofSEK 29.4 million (20.6) in available funds.
Significant events
In the first quarter of 2024
- The Company was awarded a public tender for rapid AST instruments and consumables issued by Fondazione PTV in
Italy . - Q-linea successfully finished the clinical trials required to add the drug Meropenem-Vaborbactam to its existing ASTar panel.
- The Company announced that
Stuart Gander would take over as CEO of Q-linea and thatAnders Ljunggren would take office as Managing Director ofQ-linea AB inSweden on1 March 2024 . - Q-linea initiated a cost-saving programme with anticipated savings of
SEK 50 million annually. - The Company received its first order from its distribution partner in
Finland and the Baltic states, and signed an agreement with a logistics partner for the US market. - Q-linea created a separate subsidiary for Podler.
- Q-linea participates in tender for nine rapid AST instruments in
Tuscany, Italy . - Strong ASTar results presented at AMCLI in
Italy . The use of ASTar led to modifications of the antibiotic treatment in up to 45 percent of septic patients and enabled adequate treatment 20 – 34 hours earlier than the current standard of care.
After the end of the period
- Q-linea receives
US FDA 510(k) clearance for the ASTar® System on 26 April. - The Company signs evaluation contract with reference laboratory network in the US.
- Q-linea applies for a NTAP code for the US market.
- The company sends out a notice for the 2024 Annual General Meeting, which will be held on
June 28 . - Q-linea announced that the technology behind Podler has been valued at
SEK 70 million . The valuation is based on a report carried out by an external analysis company. - The company is offered an increased and extended loan facility from its main owner
Nexttobe . Total facility, when utilized, amounts toSEK 101,500,000 .
ASTar approved for the American market
I am pleased to share an update on Q-linea's progress for the first quarter of 2024, a transformative period filled with major milestones. As we move forward with the commercialisation of our rapid AST platform ASTar, the momentum is truly inspiring.
FDA approval for ASTar opens the US market
The most significant news this quarter is the FDA's 510(k) approval for ASTar, officially opening the US market for ASTar. This achievement is a testament to the hard work and dedication of our team. With this approval, we’re initially targeting around 1,600 large microbiology labs across the US, many of which are part of integrated delivery networks (IDNs) and large reference lab networks. This is a market that has been primed for adoption of rapid AST, and we are excited to be at the forefront.
Strong customer interest and early commercial activities
We are happy with the enthusiastic response from our pre-market discussions and early access programs (EAP) in the US. Since receiving FDA approval, our team has begun commercial evaluations with customers eager to install ASTar in their labs. The positive feedback from sites that have trialed ASTar has been instrumental in shaping our go-to-market strategy, and we expect a steady stream of evaluations and installations over the coming months.
Global expansion and growing interest
Our reach is not limited to the US. At the ESCMID conference in
Building on European success
Following our first commercial installation in
Organisational transformation and cost optimisation
Our transformation agenda is well underway. We have completed a comprehensive organisational restructuring, reducing development costs by approximately 50 percent and overhead by 25 percent. This restructuring allows us to reallocate resources to our commercial organisation, strengthening our in-field capabilities without increasing overall spending. By making targeted appointments in our commercial organisation and realigning our focus, we are realising cost savings that will benefit the company throughout 2024 and beyond.
Innovation and continued product development
The Q-linea team is energised by the growing commercial pull and remains committed to innovation. We are expanding our menu with additional drug and bug combinations, ensuring that ASTar maintains its leading position. This includes rounding out our US-approved menu and incorporating the latest generation of antimicrobials. Our customers are keen to see new capabilities from ASTar based on its superior workflow, usability, and clinical accuracy. We are pacing our resources to meet these expectations with a carefully planned cadence of product launches in the coming years.
Financing
In support of the efforts outlined above, we have agreed to an extension of our loan facility with
In closing, I would like to thank the entire Q-linea team for their dedication and creativity. We have much to accomplish and I am confident that with the strong foundation we have built, the innovative spirit of our team, and the growing demand for rapid AST, Q-linea is positioned for continued success in 2024 and beyond. I look forward to updating you on our progress.
Uppsala,
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. This report has not been reviewed by the auditor of the Company.
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-q1-report-2024
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=50048291
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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