Third quarter: 1 July – 30 September 2021

• Net sales amounted to SEK 1.1 million (0.0).
• The operating result totalled SEK -50.0 million (-50.0).
• The result for the period amounted to SEK -49.1 million (-48.7).
• Earnings per share before and after dilution amounted to SEK -1.68 (-1.80).
• Cash flow from operating activities totalled SEK -63.0 million (-46.7).

Period: 1 January – 30 September 2021

• Net sales amounted to SEK 5.4 million (0.2).
• The operating result totalled SEK -181.9 million (-164.5).
• The result for the period amounted to SEK -180.3 million (-162.1).
• Earnings per share before and after dilution amounted to SEK -6.46 (-6.55).
• Cash flow from operating activities totalled SEK -164.2 million (-160.6).
• As of 30 September 2021, the Company had access to cash and cash equivalents of SEK 21.6 million (10.1), short-term investments including short-term components of other securities held as non-current assets of SEK 207.5 million (296.7) and long-term listed corporate bonds of SEK 215.4 million (24.4), totalling SEK 444.5 million (331.3) in available funds.

Significant events
in the third quarter of 2021

• No significant events took place during the quarter.

after the end of the period

• Q-linea’s partner Thermo Fisher Scientific announced the launch of ASTar for the European market.
• The Company signed the first commercial evaluation contract for ASTar with a Swedish regional hospital.
• The Company has commenced the reproducibility phase of the clinical study for ASTar market approval in the US.

Comments by the CEO
The third quarter was dominated by preparations ahead of a major launch of ASTar and ongoing US clinical studies.

ASTar launched in Europe
The commercial evaluation conducted by our partner Thermo Fisher Scientific will form the basis for a major launch of ASTar during the autumn. The start of the next step of the launch for the European market was announced by Thermo Fisher Scientific in a press release on 7 October, and it naturally feels incredibly gratifying to now be able to take the next commercial step with ASTar.

The launch of ASTar is taking place in several stages, the first of which occurred during the summer when selected European customers evaluated the ASTar system to ensure that it delivers a first-rate performance. During the quarter, we received extremely positive feedback from these first commercial users which inspires a great deal of enthusiasm. The aim of our first commercial systems is for customers to see that ASTar provides added value, which is what will drive future sales.

We have also devoted a considerable amount of time and energy to improving the system. Even though ASTar has the market’s broadest panel of antibiotics, we have worked hard to broaden it even further during the year. This work continues to progress at a good pace. We want ASTar users to always be able to make decisions based on ASTar. We also want this to be possible in the shortest time possible, and we are therefore working to speed up the time for susceptibility determination and have extremely strong data that we expect will further strengthen the product in the future.

Now that the pandemic has loosened its grip, the Company has returned to a more normal situation. We have worked long-term to scale up the production of instruments and consumables. To date, we have noted a certain impact of the components shortage that has affected many manufacturing companies but have managed to come up with solutions so far and are maintaining a watchful eye on how the situation is progressing. If the components shortage were to be long term, it has the potential to affect production in the coming years.

Blood culture technology heading for production
When it comes to our portable blood culture technology, we took further development steps and commenced planning to enter the production transfer stage during the quarter. Our market studies in Europe and the US have provided us with valuable insight into how we should adjust the prototype, and we have now begun the process of determining specifications to bring the product into production. If everything proceeds according to plan, we will be able to initiate pivotal studies at the end of next year.

Study and planning progressing as planned
The analytic part of our US ASTar study commenced back in the second quarter at Q-linea, and shortly after the end of the third quarter we were able to announce that the reproducibility study had been started and that we are now preparing for the prospective part of the study that will be conducted at three US hospitals. Our intention is to conclude the prospective part of the study this year to then be able to submit a 510(k) application for market approval in 2022.

In terms of the health economics studies, we plan to commence two studies in 2022, one in northern Europe and one in southern Europe, since susceptibility differs to such a great extent between the regions. We expect that the study in southern Europe will commence at the start of 2022 and will be highly useful for the commercialisation of ASTar. The interest among the hospitals to participate in the studies has been substantial, and we are considering increasing the number of participants in the study, which could shorten the length of time it takes to complete.

The future is looking bright
I am highly confident for the future and what we together with our partner Thermo Fisher Scientific can accomplish for the coming year. The margins will naturally be negative to begin with, but this will change as volumes increase, and we anticipate extremely positive developments in the long term. Q-linea targets an enormous market with substantial requirements and has the opportunity to establish a leading position in the next few years. In summary, I am proud of what we achieved during the quarter and know that the journey ahead of us will remain interesting and intense.

Uppsala, November 3, 2021, Jonas Jarvius, President

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, 4 November, at 1:00 to 2:00 p.m. (CET). President Jonas Jarvius and CFO Anders Lundin will present Q-linea, comment on the interim report for the January to September 2021 period and respond to questions.

Webcast: https://tv.streamfabriken.com/q-linea-q3-2021

Telephone numbers for the teleconference:
SE: +46 856 642 692
UK: +44 333 300 9267
US: +1 631 913 1422 (PIN US:10379906#)