Q-Linea AB: Interim report 1 January - 31 March 2024

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 of SEK 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 that Anders Ljunggren would take office as Managing Director of Q-linea AB in Sweden on 1 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 to SEK 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 Barcelona, the largest microbiology conference globally, rapid AST emerged as a key theme, with extensive interest from physicians and lab managers. Q-linea's partners presented compelling evidence of the clinical and economic benefits of rapid AST, further reinforcing the value proposition of ASTar. It was particularly encouraging to see interest from beyond Europe and the US, demonstrating that the need for rapid AST solutions to combat sepsis is truly global.

Building on European success
Following our first commercial installation in Italy at Tor Vergata Hospital, we continue to see growth in our European pipeline. Several tenders in Southern Europe are approaching final stages, and we are witnessing increased interest in second-wave markets across Northern Europe. While strained healthcare budgets remain a challenge, the potential savings from rapid AST are shifting perspectives and will drive increased adoption going forward.

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 Nexttobe, our largest shareholder. This will provide SEK 60 million in addition to the SEK 41.5 million previously committed of which will further reinforce our commercial activities.

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, 30 May 2024, Stuart Gander, CEO

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, 31 May 2024, 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 March 2024 period and respond to questions.
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.

For more information, please contact:

Stuart Gander, President & CEO, Q-linea
[e-mail]
[phone]

Christer Samuelsson, CFO /IR, Q-linea AB
[e-mail]
[phone]

About Q-linea

Q-linea's rapid AST system, ASTar®, accelerates and simplifies the time-sensitive workflows faced during the treatment of patients with bloodstream infections and sepsis. Hospitals use ASTar to vastly reduce the time to optimal antimicrobial therapies and ensure that patients receive the correct treatments sooner - when time matters most. We are helping to create sustainable healthcare, now and in the future, and safeguard the effectiveness of antibiotics for generations to come.
Q-linea is headquartered in Uppsala, Sweden and has regional offices in Italy and the USA, with partnerships worldwide.
ASTar Instrument and ASTar BC G- Consumable kit are CE-IVD marked and FDA 510(k) cleared. For more information, please visit www.qlinea.com

This information is information that Q-linea is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-05-31 07:30 CEST.