First quarter: 1 January – 31 March 2022

• Net sales amounted to SEK 5.8 million (0.0).
• The operating result totalled SEK -71.8 million (-63.8).
• The result for the period amounted to SEK -71.9 million (-63.2).
• Earnings per share before and after dilution amounted to SEK -2.46 (-2.34).
• Cash flow from operating activities totalled SEK -51.7 million (-56.1).
• As of 31 March 2022, the Company had SEK 290.2 million (347.8) in available funds.

Significant events
In the first quarter of 2022

• Excellent clinical results from major commercial evaluation.

after the end of the period

• The Company announced that ASTar had received a breakthrough device designation from the US Food and Drug Administration (FDA).

Comments by the CEO
One of the early important milestones of the quarter was our first commercial sale to a hospital in England. The customer decided to purchase an ASTar system after the evaluation showed that patients benefited from rapid antibiotic susceptibility testing and ASTar’s unique advantages.

We are very pleased about the considerable interest we see from potential customers. After many years of hard work, it’s fantastic to finally see ASTar being launched and to receive such a positive response. However, we see that the sales cycles are long and comparable with other players in the market. At present, we estimate that the sale process of ASTar will take about 9 months and we will of course together with our partners investigate the possibilities of shortening these.

We also see that there are currently more customers who simultaneously, and in a short time, have shown interest in evaluating ASTar prior to their purchase, and that the capacity to perform commercial evaluations at our partner is a limiting factor. Seeing the great interest from potential customers is incredibly encouraging and we are now working closely with Thermo Fisher Scientific to adapt the resources to the required needs.

There are also some remaining negative effects of the corona pandemic, but this is improving daily, and we believe that it generally has a very small impact on sales.

Based on the above, we estimate that sales of ASTar systems for 2022 will amount to approximately 20 ASTar.

Another important news item from the quarter was ASTar’s designation as a breakthrough device by the FDA. This designation is given to products that are deemed to provide a more efficient treatment for serious illnesses where no comparable alternative is available in the market. The aim of the designation is to accelerate the regulatory review of new medical devices and provide patients with faster access to new treatment alternatives. Receiving breakthrough device designation from the FDA is itself a milestone, but we also see this prioritised regulatory review as an opportunity to bring ASTar to the US market more quickly. We are following our plan and intend to submit our 510(k) application in the spring.

Q-linea participated in ECCMID in Lisbon in April, hosting its own booth. ECCMID is the world’s largest infectious diseases conference, with over 10,000 participants. Q-linea demonstrated ASTar along with Podler and our new loading station for easy and cost-effective analysis of isolate samples in ASTar. We also demonstrated our upcoming panel for analysing Gram-positive bacteria and, as with our Gram-negative panel, we received a great deal of positive feedback about the breadth of the panel.

We are very pleased with all the feedback we have received on ASTar from potential customers. Podler generated considerable interest and received numerous comments and was considered a huge step for blood cultures. “Why hasn’t anyone done this before?” was a frequent comment.

Thermo Fisher Scientific experienced a similarly high level of interest when presenting ASTar and a great deal of demand for demonstrations. It is clear that we have reached all of the goals we set ahead of the conference, and it will be exciting to see how we and Thermo Fisher Scientific can follow up with interested potential customers during the coming months. We also received a great deal of interest in commercialising Podler from several parties.

All in all, the future looks bright given the significant customer interest we have attracted and I look forward to increased capacity to carry out evaluations and commercial sales at our partner. We are confident that ASTar will contribute to improved patient outcomes for as many patients as possible around the world.

Uppsala, 4 May 2022, Jonas Jarvius, President

This report has not 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, 5 May, at 1:00 to 2:00 p.m. (CEST). President Jonas Jarvius and CFO Anders Lundin will present Q-linea, comment on the interim report for the January to March 2022 period and respond to questions.

Webcast: https://tv.streamfabriken.com/q-linea-q1-2022

Telephone numbers for the teleconference:
SE: +46 850 558 352
UK: +44 333 300 9260
US: +1 +1 646 722 4956