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Interim report 1 January – 31 March 2021

Interim report 1 January – 31 March 2021

An intensive start to 2021

First quarter: 1 January – 31 March 2021

  • Net sales amounted to SEK 0.0 million (0.2).
  • The operating result totalled SEK -63.8 million (-55.9).
  • The result for the period amounted to SEK -63.2 million (-56.0).
  • Earnings per share before and after dilution amounted to SEK -2.34 (-2.44).
  • Cash flow from operating activities totalled SEK -56.1 million (-59.1).
  • At 31 March 2021, cash and cash equivalents totalled SEK 12.5 million (10.1). Short-term investments in fixed-income funds amounted to SEK 106.1 million (165.7), short-term components of listed corporate bonds to SEK 82.6 million (131.0) and long-term investments in listed corporate bonds to SEK 73.0 million (24.4).

Significant events
in the first quarter of 2021

  • Q-linea received its first order for ASTar® from the Company’s global sales partner Thermo Fisher Scientific, valued at over SEK 8 million. The order included a pre-payment for a binding order for the next six months.
  • The Company contracted Thermo Fisher Scientific as the first site to participate in the Company’s US clinical study for ASTar.
  • Q-linea presented very good interim results from the pivotal European trial for antibiotic susceptibility system ASTar.

after the end of the period

  • Q-linea achieves CE-IVD approval for ASTar with very strong study results and can now commercialize ASTar in Europe together with its partner Thermo Fisher Scientific

Comments by the CEO
An intensive start to 2021
Q-linea achieved a number of important milestones during the quarter: we received our first ASTar order, we presented very good interim results from our pivotal European trial and we contracted Thermo Fisher Scientific as the first site to participate in our US study. The quarter was also dominated by preparations for the European launch.

The first quarter marked a highly intensive phase of launch preparations for us and our global sales partner, Thermo Fisher Scientific. Commercial launch will take place when the clinical study is finalised and ASTar receives CE-IVD approval. We have trained our sales and service personnel and prepared sales materials.

Thermo Fisher Scientific has shown considerable interest in training and preparations among both its sales and service organisations. For everyone at Q-linea, it fills us with enthusiasm to see Thermo Fisher Scientific’s dedication. However, we will truly be put to the test when ASTar reaches the end customer. The positive feedback we have received and the interest shown in our product are an important encouragement that bodes well for the commercial launch and reinforces the positive atmosphere at Q-linea.

Together with Thermo Fisher Scientific, we expect the launch to take place in several stages, with the first half of the year spent essentially handpicking customers to carry out thorough evaluations, enabling us to definitively ensure that the ASTar system delivers a first-rate performance. Only then can we pick up the pace. Both Thermo Fisher Scientific and Q-linea anticipate healthy growth for ASTar and are aiming for a long-term, successful and strong expansion after the initial controlled launch phase.

Thermo Fisher Scientific’s strong belief in the ASTar system was reflected in the order placed by the company in early March, even before the clinical study had been completed. The order for ASTar instruments and consumables was worth over SEK 8 million and included a prepayment for the next six months. As a result of this order, we are now prepared for launch and commercially ready for our first orders from end customers.

In light of this order, we were particularly pleased to receive the very strong interim results from our pivotal European trial. Essential agreement (EA) – giving the same result as the reference method on the concentration of antibiotics that kill or inhibit bacterial growth – exceeded 94% and categorical agreement (CA) – giving the same classification of the bacterium within one of three groups (S.I.R) with respect to susceptibility to antibiotics – exceeded 97%. To achieve CE-IVD approval in Europe, EA and CA must exceed 90%. In addition, reproducibility was very high and exceeded 99%.

The third major development during the quarter was that we contracted Thermo Fisher Scientific as the first site to participate in our US clinical study for ASTar. It feels grati-fying to further strengthen our collaboration in this man-ner. Thermo Fisher Scientific will be the reference site for all samples in the study. Thermo Fisher’s long experience in sensitivity testing provides good conditions for a
successful study.

The study is expected to commence during the second quarter of 2021, starting with the analytical portion of the study, followed by the prospective portion. As in Europe, several hospitals have shown considerable interest in testing ASTar and Q-linea will select at least one more US site for the prospective portion of the study.

Having Thermo Fisher Scientific participate in our US study will be positive in many regards, not least in practical terms, but it will also pave the way for further collaboration in the future. ASTars first application is focused on improving diagnostics for patients with blood stream infections, of which sepsis is the most common. The lessons we have learned during the development and commercialisation of ASTar will be of great benefit as we continue to develop our product portfolio.

We are now closing the books on an intensive quarter and look forward with confidence to a continued intense and interesting 2021.

After the end of the period, we achieved CE-IVD mark of ASTar with very good results, it naturally feels very positive and we are now ready to launch. I hope and believe that Q-linea’s shareholders share our enthusiasm. I hope and believe that Q-linea’s shareholders share our enthusiasm.

Uppsala, 5 May 2021, 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.

Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 6 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 2021 period and respond to questions.


Telephone numbers for the teleconference:
SE: +46 850 558 354
UK: +44 3333 009 265
US: +1 833 823 0586