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Q-Linea

Quarterly Report Nov 2, 2023

3100_10-q_2023-11-02_fbceac3d-83c3-4373-9855-b99554f76a23.pdf

Quarterly Report

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Interim report 1 January–30 September 2023

Dialogue with the FDA intensifies

Third quarter: 1 July–30 September 2023

  • Net sales amounted to SEK 3.0 million (2.9).
  • The operating result totalled SEK -48.2 million (-58.5).
  • The result for the period amounted to SEK -48.6 million (-59.0).
  • Earnings per share before and after dilution amounted to SEK -0.56 (-2.02).
  • Cash flow from operating activities totalled SEK -54.5 million (-53.7).

Period: 1 January–30 September 2023

  • Net sales amounted to SEK 4.4 million (12.8).
  • The operating result totalled SEK -175.1 million (-202.7).
  • The result for the period amounted to SEK -175.1 million (-205.0).
  • Earnings per share before and after dilution amounted to SEK -3.59 (-7.02).
  • Cash flow from operating activities totalled SEK -180.3 million (-171.2).
  • As of 30 September 2023, the Company had a total of SEK 134.9 million (72.9) in available funds and shortterm investments with terms of less than three months.

Significant events

In the third quarter of 2023

  • Q-linea AB held an extraordinary general meeting at which the Board's proposal regarding a new share issue with preferential rights for existing shareholders was approved. Prospectus was published as well as the outcome the rights issue, which raised approximately SEK 263 million for Q-linea AB before transaction costs. The number of shares and votes increased by a total of 87,628,425.
  • The Company strengthened its commercial teams in Europe and the US through the appointment of Franco Pellegrini as Sales Director for Southern Europe and Jim Kathrein as VP US Commercial Operations.
  • Q-linea AB completed its 510(k) application for US market approval.
  • Q-linea AB received two orders for ASTar instruments and consumables from Eurobio Scientific in France.
  • Jonas Jarvius announced that he plans to step down as CEO before summer 2024. Three of the largest shareholders in Q-linea (69% of shares) informed the Board that they intend to support the nomination of Jonas Jarvius as a new director in 2024.

After the end of the period

• The Company presented the results of the first commercial evaluation of ASTar in the UK at the IBMS congress in Birmingham and strengthened its presence in Finland and the Baltics through a contract with Labema Oy.

We are approaching the US market

During the third quarter of the year, we carried out several activities to prepare for the market. At the time of writing, I have just returned home from an intense period of travel to prepare Q-linea for a US launch. This included activities to secure logistics chains, deciding on the location of our US head office and compiling candidates for early access. As soon as ASTar is approved, we want to allow hospitals and hospital chains to test the system. We now have a good list of early access customers that we plan to go ahead with as part of our pre-launch activities.

During the quarter, I also met with several major potential strategic partners. In short, the dialogue concerning potential future partnerships is going well. Our focus is on the US market, but major strategic partnerships could also include other regions.

The positive results of a commercial evaluation of ASTar in the UK were presented at the IBMS congress in Birmingham after the end of the quarter. The study investigated ASTar's performance in a real environment and showed that ASTar not only supported optimisation of treatment for most patients, but also prevented a major outbreak of multidrug-resistant bacteria at the hospital. It is very encouraging to see this type of result, which shows that ASTar performs as expected in a real environment – especially considering that many hospitals have been under significant pressure during and after the pandemic and need tools and systems that provide patient value. It is my firm conviction that rapid susceptibility testing will eventually be implemented in all hospitals that carry out blood culture analyses.

During the quarter, we received two orders for ASTar in France from our French partner Eurobio Scientific. Eurobio Scientific is in active discussions with several potential customers in France and therefore decided in September to purchase a second instrument to support these activities, which bodes well for 2024. France has a widespread problem with antibiotic resistance, and we have immense confidence in Eurobio Scientific, which has a motivated team and a large installed base of more than 500

diagnostic instruments at its customers' laboratories.

Per the FDA's recommendation, we completed our 510(k) application for US market approval during the quarter, adding the results from supplementary analytical and clinical studies. The continuous dialogue that we have had with the FDA was likely helped by ASTar's designation as a breakthrough device. The dialogue intensified during the quarter and our assessment is that the process is moving in a positive direction, but it is difficult to estimate how long it will take.

As we await US market approval, we are working on strengthening our commercial presence in the US, and in the beginning of the quarter we hired a Chief Commercial Officer, Jim Kathrein, to lead the local organisation and build up our commercial team in the US. We also carried out similar measures for the commercial team in Europe through the appointment of Franco Pellegrini as Sales Director for Southern Europe. Franco most recently worked at Thermo Fisher Scientific. It is incredibly gratifying to see that people in such senior roles want to come to Qlinea to work with ASTar. They are joining us because they see that ASTar can drastically change treatment and results for critically ill patients.

As I announced previously, in 2024 I will be stepping down as CEO to take over as CEO for a US-based life sciences company. It has truly been a privilege to work for Q-linea for over 15 years and I am pleased and honoured that the major owners would like me to continue to contribute to Q-linea's development as a director. I am proud over what we have accomplished so far. We have built a strong commercial foundation and I hope to see ASTar in the US market before I leave. I look forward to seeing all of the good things Q-linea will accomplish for patients with serious infections and would like to take the opportunity to thank you for your confidence in the new share issue that raised SEK 263 million before issue costs.

Overall, the commercial initiative is proceeding according to plan. We dedicated 2023 to preparing for the market, with work and studies that laid the foundation for next year. We still believe that we will see commercial orders during the fourth quarter and expect a distinctly positive sales trend in 2024.

Uppsala, 1 November 2023, Jonas Jarvius, President

The expanded testing for the clinical study in the US has been completed for the gram-negative product and work on the gram-positive product is intensifying

Developments in the third quarter of 2023

Q-linea focuses on supplying the market with automated systems for rapid antibiotic susceptibility testing of bacteria that cause infectious diseases, primarily sepsis.

ASTar is sold to hospital microbiology laboratories and is a fully automated instrument for measuring bacteria's antibiotic susceptibility using the consumables developed by the Company. The aim of the instrument is to be able to deliver patient-specific treatment prescriptions for the choice of antibiotics more than 24 hours faster than today's traditional technologies.

Consumables

Development of the Company's upcoming product for gram-positive bacteria continued during the quarter. The work has largely focused on the last technical choices before locking down the design. The components will largely be identical with those of the gram-negative product, which will enable greater synergies in production and storage. Certain reagents and formulations, however, will be unique for the new product. As previously announced, production will be based on the Company's own process and production line for dispensing, drying and quality control of antibiotics in the AST disc, which is expected to lead to significant cost savings.

During the quarter, the implementation of a new process for faster joining of the AST disc proceeded according to plan and performed as expected.

Instruments

During the quarter, the Company built up an inventory of instruments to be ready for delivery in the European market. An improved and streamlined process for deploying and releasing instruments introduced earlier in the year made this work easier.

In parallel with this, the Company began work on upcoming software updates that are planned for next year, which aim to ensure compatibility with new hardware components and to simplify or reduce the need for service measures for the instrument.

Regulatory studies for the US market

In mid-July, the Company could submit the results for a supplementary study in support of the 510(k) application for US market approval of the ASTar platform. The supplement includes data from analytical and clinical studies carried out at two US hospitals as well as Q-linea's microbiology laboratory in Uppsala during the quarter. The testing was completed according to plan during the first half of the year and compilation of the data was finished in the third quarter. The Company also carried out an ongoing dialogue with the FDA during the third quarter and received follow-up questions about the new data that had come in, which according to the Company's interpretation means that the review process is continuing as expected. However, as previously communicated, it is difficult to assess the time it will take from submission to market approval in the US. The FDA could have additional questions, and the processing time is difficult to estimate.

During the quarter, the Company also continued with preparations ahead of the planned regulatory study in the US for the upcoming product for Gram-positive bacteria. Contact was made with the intended reference laboratory and other parties who will be involved in carrying out the study.

Development of new products

The development of Podler, Q-linea's portable blood culture technology, continued to be given lower priority during the third quarter in order to focus on work with the ASTar platform. Discussions with possible partners for Podler resumed during the quarter.

Financial performance in brief

Comments on the report

Figures in parentheses refer to the outcome for the corresponding period in the preceding year with respect to earnings and cash flow and to the closing balance in the preceding financial year with respect to the balance sheet. Unless otherwise stated, the amounts are presented in thousands of kronor (SEK thousand). All amounts presented have been rounded, which may mean that certain totals do not tally.

Future financing

Q-linea's product, ASTar, has been approved for sales in Europe. However, the Company is yet to generate any positive cash flow. Therefore, the Company is continually engaged in pursuing other financing options. This process includes holding discussions with potential partners for the licensing of distribution and sales rights, negotiations with new and existing investors, financiers and lenders.

At 30 September 2023, Q-linea had available cash and cash equivalents of SEK 135 million as well as an unutilised loan facility of SEK 41.5 million from the Company's principal owner Nexttobe. The Board considers the available cash and cash equivalents, short term investments, the total unutilised portion of the loan facility and an adjusted business plan sufficient to cover the liquidity needed for the Company to conduct its planned operations for the next 12 months.

Income, expenses and earnings

Net sales for the third quarter amounted to SEK 2,998 thousand (2,868), an increase of SEK 130 thousand compared with the year-earlier period. Net sales for the January–September period totalled SEK 4,378 thousand (12,788), down SEK 8,410 thousand. Sales comprised ASTar instruments and associated consumables.

Other operating income amounted to SEK 1,484 thousand (618) for the third quarter and SEK 2,041 thousand (1,295) for the January–September period, and pertained primarily to sales of customer-specific prototypes to external customers.

The change in inventories of products in progress, semifinished goods and finished goods amounted to SEK - 2,646 thousand (-2,742) for the third quarter and SEK 162 thousand (-19,250) for the January–September period.

Costs for raw materials and consumables and goods for resale totalled SEK -693 thousand (-4,150) for the third quarter and SEK -4,402 thousand (-10,525) for the

January–September period.

During the launch period for ASTar, the Company's margins will be negative. As volumes increase and the production mix shifts toward a higher share of consumables, the margins will improve. The efficiency-enhancement projects under way in the manufacturing division will also contribute to improved margins.

Other external costs totalled SEK -9,841 thousand (-19,525) for the third quarter, down SEK 9,684 thousand. Costs for the January–September period totalled SEK - 51,019 thousand (-64,394), down SEK 13,375 thousand. The changes were mainly attributable to a decrease in the number of consultants during the quarter and the period.

Personnel costs amounted to SEK -34,463 thousand (-31,344) for the third quarter, up SEK 3,119 thousand compared with the corresponding quarter in the preceding year. Personnel costs for the January to September period totalled SEK -111,910 thousand (-110,503), up SEK 1,407 thousand. With regard to personnel costs for the third quarter, a total of SEK 6.4 million in restructuring costs for the communicated cost-saving programme was reversed.

Depreciation, amortisation and impairment of tangible and intangible assets totalled SEK -4,423 thousand (- 3,973) for the third quarter and SEK -13,131 thousand (- 11,306) for the January–September period. This cost increase was attributable to the Company's investments in production improvements and ASTar instruments used in clinical studies, which are now being depreciated.

Other operating expenses amounted to SEK -669 thousand (-268) for the third quarter and SEK -1,224 thousand (-782) for the January–September period, and mainly pertained to exchange-rate losses.

The operating result amounted to SEK -48,253 thousand (-58,515) for the third quarter and SEK -175,103 thousand (-202,677) for the January–September period. The earnings improvement of SEK 27,574 thousand was primarily attributable to the reduction of inventory and consultant costs.

The result from financial items totalled SEK -395 thousand (-534) for the third quarter and SEK -5 thousand (- 2,325) for the January–September period.

The reported tax for the third quarter and for the January–September period amounted to SEK 0 thousand (0).

The result totalled SEK -48,648 thousand (-59,049) for the third quarter and SEK -175,108 thousand (- 205,002) for the January–September period.

Financial position

Cash and cash equivalents at the end of the third quarter totalled SEK 54,945 thousand (72,878). During the third quarter, the Company invested SEK 80,000 thousand (0) in a short-term fixed-interest investment.

Financial assets totalled SEK 4,145 thousand (3,047) on the balance sheet date, an increase of SEK 1,098 thousand compared with the end of 2022. The change is attributable to the revaluation of participations in associated companies.

The Company's financial assets primarily comprise participations in EMPE Diagnostics AB amounting to SEK 4,095 thousand (2,997) at the end of the quarter. Q-linea AB's holding comprises 23,400 shares, corresponding to 4.97% of the capital and votes.

At the end of the quarter, equity amounted to SEK 244,076 thousand (163,190), the equity/assets ratio to 86% (71) and the debt/equity ratio to -55% (-45).

Cash flow and investments

Cash flow from operating activities totalled SEK -54,452 thousand (-53,705) for the third quarter and SEK -180,331 thousand (-171,171) for the January–September period. The decline was attributable to the working capital trend.

Cash flow from investing activities amounted to SEK - 79,525 thousand (64,644) for the third quarter and SEK - 85,030 thousand (189,866) for the January–September period, of which investments in tangible assets totalled SEK 475 thousand (-869) for the third quarter and SEK - 5,505 thousand (-13,940) for the January–September period.

The Company invested SEK 80,000 thousand (0) in shortterm investments during the third quarter. During the January–September period, the Company invested SEK 80,000 thousand (70,000) in short-term investments, of which SEK 0 thousand (70,000) was invested in interestbearing funds and SEK 80,000 thousand (0) in a deposit account at Nordea Bank with a fixed interest rate.

In addition, the Company divested short-term investments totalling SEK 0 thousand (65,491) in the third quarter. Of the amount for the quarter, short-term fixed-income funds comprised SEK 0 thousand (65,491). The Company divested short-term investments totalling SEK 0 thousand (266,776) in the January–September period.

The Company divested financial assets valued at SEK 0 thousand (12,022) in the quarter, and SEK 0 thousand (19,030) in the January–September period.

Cash flow from financing activities totalled SEK 163,900 thousand (-1,650) for the third quarter and SEK 247,306 thousand (-4,929) for the January–September period. SEK 87,000 thousand (0) of the loan from the Company's principal owner Nexttobe was repaid in full in the third

quarter and SEK 87,000 thousand (0) in the January–September period. The remaining amount primarily pertains to the repayment of lease liabilities.

Financing

As of 30 September 2023, the Company had access to cash and cash equivalents of SEK 54,645 thousand (72,878), short-term fixed-interest investments of SEK 80,000 thousand (0) and an unutilised loan facility of SEK 41,547 thousand (0) from the Company's principal owner, Nexttobe, for a total of SEK 176,192 thousand (72,878).

During the quarter, the Company carried out a rights issue (3:1) that raised SEK 263 million for the Company before issue costs. The number of shares increased by 87,628,425 in connection with the issue at a price of SEK 3 per share issued. As a result of the issue, Nexttobe's shareholding increased to 53.5%, meaning that Q-linea AB is a Nexttobe subsidiary.

Other information

Nomination Committee

Q-linea's Nomination Committee ahead of the 2024 Annual General Meeting has been appointed and comprises: Öystein Engebretsen, Chairman of the Nomination Committee (Investment AB Öresund), Erika Kjellberg Eriksson, Chairperson of Q-linea AB (Nexttobe AB) and Ulf Landegren (Landegren Gene Technology AB).

Employees

Calculated on the basis of full-time equivalents, Q-linea had 122 (156) employees at the end of the third quarter, 49 (69) of whom were women. The number of consultants at the end of the third quarter was 2 (18), 0 (4) of whom were women.

Information about risks and uncertainties

Q-linea's management makes assumptions, assessments and estimates that impact the contents of the Company's financial statements. As stated in the Company's accounting policies, actual outcomes may differ from these assessments and estimates.

The goal of the Company's risk management is to identify, measure, control and limit the risks associated with its operations. Risks can be divided into financial risks and operational and business environment risks. Q-linea's operational and business environment risks mainly comprise risks related to research and development, production risks, clinical trials, market risks, risks associated with product approval and the dependence on key individuals. A detailed description of the Company's risk exposure and risk management is presented in the 2022 Annual Report.

Definition of performance measures

In this financial report, Q-linea presents certain alternative performance measures that are not defined in accordance with IFRS. These performance measures are generic and are often used for the purpose of analysing and comparing different companies. Accordingly, the Company believes that these alternative performance measures serve as an important supplement to enable readers to conduct a quick overview and assessment of Q-linea's financial situation.

These alternative performance measures are not to be considered independent and are not deemed to replace the performance measures calculated in accordance with IFRS. Moreover, such performance measures, as defined by Q-linea, are not to be compared with other performance measures with similar names used by other companies. This is because the above performance measures have not always been defined in the same way and because other companies may not calculate them in the same way as Q-linea.

The performance measures "Net sales", "Result for the period", "Earnings per share" and "Cash flow from operating activities" are defined in accordance with IFRS.

Performance measure Definition Purpose
EBITDA Operating result before depreciation/amortisation and
impairment.
This performance measure provides an overall view
of profit for the operating activities.
Operating result
(EBIT)
Result before financial items according to the income
statement.
This earnings measurement is used for external
comparisons.
Equity/assets
ratio, %
Equity in relation to total assets. This performance measure shows the amount of the
balance sheet that has been financed by equity and is
used to measure the Company's financial position.
Debt/equity ratio Net debt divided by recognised equity according to the
balance sheet. Net debt is defined as total borrowing
(comprising the items short-term borrowing and long
term borrowing in the balance sheet, including
borrowing from related parties/Group companies and
provisions), less cash and cash equivalents and short
and long-term investments.
This performance measure is a measure of capital
strength and is used to determine the relationship
between liabilities and equity. In the case of positive
equity, a negative debt/equity ratio means that
available cash and cash equivalents and short-term
investments exceed total borrowing.
Equity per share
before and after
dilution
Equity attributable to the Company's shareholders in
relation to the number of shares outstanding,
excluding treasury shares, at the end of the period.
This performance measure shows the amount of the
Company's equity that can be attributed to a share.

Reconciliation of alternative performance measures

The following is a reconciliation of certain alternative performance measures showing the various performance measure components that make up the alternative performance measures. Treasury shares refers to the Company's own holding to ensure the delivery of performance shares. In the event that share options are exercised, shares will be primarily allotted from treasury shares and secondarily through a new issue.

The Company's holding of treasury shares has been excluded from the calculation of per-share performance measures.

EBITDA

SEK thousand 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Operating result (EBIT) -48,253 -58,515 -175,103 -202,677 -262,247
Depreciation, amortisation and impair
ment
4,423 3,973 13,131 11,306 15,286
EBITDA -43,830 -54,542 -161,972 -191,370 -246,961

Equity/assets ratio

SEK thousand (unless otherwise stated) 30 Sep 2023 30 Sep 2022 31 Dec 2022
Total assets 285,239 290,548 229,916
Equity 244,076 223,988 163,190
Equity/assets ratio (%) 86% 77% 71%

Debt/equity ratio

SEK thousand (unless otherwise stated) 30 Sep 2023 30 Sep 2022 31 Dec 2022
Current liabilities to credit institutions - - -
Current liabilities to owners - - -
Total borrowing (a) 0 0 0
- Less cash and cash equivalents (b) -54,945 -28,855 -72,878
- Less short-term investments (c) -80,000 -63,502 -
- Less long-term investments (d) - -60,398 -
Net debt (e=a+b+c+d) -134,945 -152,755 -72,878
Equity (f) 244,076 223,988 163,190
Debt/equity ratio (e/f) (%) -55% -68% -45%

Equity per share

SEK thousand (unless otherwise stated) 30 Sep 2023 30 Sep 2022 31 Dec 2022
Equity (a) 244,076 223,988 163,190
Total number of shares outstanding (b) 117,166,372 29,537,947 29,537,947
- Less holding of treasury shares (c) -328,472 -328,472 -328,472
Equity per share (a/(b-c)), SEK 2.09 7.67 5.59

Performance measures and other information

SEK thousand (unless otherwise stated) 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Earnings
Net sales 2,998 2,868 4,378 12,788 12,788
EBITDA -43,830 -54,542 -161,972 -191,370 -246,961
Operating result (EBIT) -48,253 -58,515 -175,103 -202,677 -262,247
Result for the period -48,648 -59,049 -175,108 -205,002 -268,694
Per share
Equity per share, SEK 2.09 7.67 2.09 7.67 5.59
Earnings per share before and after dilution, SEK -0.56 -2.02 -3.59 -7.02 -9.20
Total number of shares outstanding 117,166,372 29,537,947 117,166,372 29,537,947 29,537,947
- of which, treasury shares 328,472 328,472 328,472 328,472 328,472
Number of shares outstanding excl. treasury shares 116,837,900 29,209,475 116,837,900 29,209,475 29,209,475
Total average number of shares 87,639,403 29,537,947 49,117,925 29,537,947 29,537,947
- of which, average number of treasury shares 328,472 328,472 328,472 328,472 328,472
Average number of shares excl. treasury shares 87,310,931 29,209,475 48,789,453 29,209,475 29,209,475
Cash flow
Cash flow from operating activities -54,452 -53,705 -180,331 -171,171 -250,863
Cash flow from investing activities -79,525 64,644 -85,030 189,866 315,254
Cash flow from financing activities 163,900 -1,650 247,307 -4,929 -6,604
SEK thousand (unless otherwise
stated)
30 Sep 2023 30 Sep 2022 31 Dec 2022
Financial position
Total assets 285,188 290,548 229,916
Cash and cash equivalents 54,945 28,855 72,878
Short-term and long-term investments 80,000 123,900 -
Equity 244,076 223,988 163,190
Equity/assets ratio, % 86 77 71
Debt/equity ratio, % neg neg neg

The Board of Directors and the President hereby certify that this interim report provides a fair and true overview of the Company's operations, financial position and earnings and describes the material risks and uncertainties facing the Company.

Uppsala, 1 November 2023

Jonas Jarvius
President
Erika Kjellberg Eriksson
Chairperson
Mats Nilsson Mario Gualano Nina Korfu-Pedersen
Director Director Director
Karin Fischer Finn Sander Albrechtsen Hans Johansson
Director Director Director

This report has been reviewed by the auditor of the Company. 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.

Upcoming reporting dates

15 February 2024 Year-end report January to December 2023
12 April 2024 2023 Annual Report
3 May 2024 Interim report, Q1 January to March 2024
11 June 2024 2024 Annual General Meeting
11 July 2024 Interim report, Q2 January to June 2024
31 October 2024 Interim report, Q3 January to September 2024

About the Company

Q-linea AB (publ)

Corporate Registration Number: 556729–0217
Registered office: Uppsala
Contact: Dag Hammarskjölds väg 52 A,
SE-752 37 Uppsala, Sweden
Tel: +46 18 444 3610
www.qlinea.com
E-mail: [email protected]

For questions about the report, contact:

Jonas Jarvius, President Tel: +46 70 323 7760 E-mail: [email protected]
Christer Samuelsson, CFO & IR Tel: +46 70 600 1520 E-mail: [email protected]

This information is information that Q-linea AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Market Act. The information was submitted for publication, through the agency of the contact persons set out above, on 2 November 2023 at 7:30 a.m. CET.

Presentation

Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 2 November, at 1:00 to 2:00 p.m. (CET). President Jonas Jarvius and CFO Christer Samuelsson will present Q-linea, comment on the interim report for the January to September 2023 period and respond to questions.

To participate via webcast, please visit the following link: https://ir.financialhearings.com/q-linea-q3-2023 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=5002045

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.

Consolidated statement of profit and loss

Amounts in SEK thousand Note 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Net sales 2 2,998 2,868 4,378 12,788 12,788
Other operating income 1,484 618 2,041 1,295 1,817
Changes in inventories of products in progress,
semi-finished goods and finished goods
-2,646 -2,742 162 -19,250 -17,017
Raw materials and consumables, and goods for re -693 -4,150 -4,402 -10,525 -17,151
Other external costs -9,841 -19,525 -51,019 -64,394 -80,695
Personnel costs 4 -34,463 -31,344 -111,910 -110,503 -145,639
Depreciation/amortisation of tangible and intangi
-4,423 -3,973 -13,131 -11,306 -15,286
Other operating expenses -669 -268 -1,224 -782 -1,064
Operating result -48,253 -58,515 -175,103 -202,677 -262,247
Financial income 261 540 1,359 1,778
Financial expenses -656 -1,074 -1,364 -4,103 -8,621
Result from financial items -395 -534 -5 -2,325 -6,447
Result before tax -48,648 -59,049 -175,108 -205,002 -268,694
Income tax - - - -
Result for the period -48,648 -59,049 -175,108 -205,002 -268,694
Result attributable to:
Parent Company shareholders 7 -48,648 -59,049 -175,108 -205,002 -268,694
Non-controlling interests - - - -
Earnings per share before and after dilution -0.56 -2.02 -3.59 -7.02

Consolidated statement of comprehensive income

Amounts in SEK thousand 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Result for the period -48,648 -59,049 -175,108 -205,002 -268,694
Other comprehensive income, net after tax - 498 - -3,162 1,138
Items that may be subsequently reversed in
profit or loss
- - - - -
Change in fair value of financial instruments - - - - -
Translation differences -115 - 12 - -4
Total comprehensive income -48,763 -58,551 -175,096 -208,164 -267,559
Comprehensive income attributable to:
Parent Company shareholders
-48,763 -58,551 -175,096 -208,164 -267,559
Non-controlling interests - - - - -

Consolidated statement of financial position

Amounts in SEK thousand Note 30 Sep 2023 30 Sep 2022 31 Dec 2022
ASSETS
Non-current assets
Tangible assets 33,934 35,269 36,362
Right-of-use assets 23,295 23,446 21,957
Goodwill 4,889 4,889 4,889
Other intangible assets 148 273 235
Financial assets 6 4,145 63,446 3,047
Total non-current assets 66,409 127,323 66,489
Current assets
Inventories 5 43,351 22,292 42,281
Accounts receivable 1,233 1,541 -
Other receivables 36,684 44,960 45,798
Prepaid expenses and accrued income 2,566 2,077 2,469
Short-term investments 6 80,000 63,502 -
Cash and cash equivalents 54,945 28,855 72,878
Total current assets 218,779 163,226 163,426
TOTAL ASSETS 285,188 290,548 229,916

Consolidated statement of financial position

Amounts in SEK thousand Note 30 Sep 2023 30 Sep 2022 31 Dec 2022
EQUITY AND LIABILITIES
Equity attributable to Parent Company share
holders
Share capital 5,858 1,477 1,477
Reserves 19 -4,300 -4
Other contributed capital 1,483,364 1,234,972 1,234,972
Retained earnings, including result for the year -1,245,165 -1,008,161 -1,073,255
Total equity attributable to Parent Company
shareholders
244,076 223,988 163,190
Equity attributable to non-controlling interests - - -
Total equity 244,076 223,988 163,190
Liabilities
Non-current liabilities
Non-current lease liabilities 14,769 16,405 14,813
Total non-current liabilities 14,769 16,405 14,813
Current liabilities
Loan from principal owner 3 - - -
Accounts payable 5,241 9,017 21,555
Current lease liabilities 7,557 5,963 6,117
Current tax liabilities - - -
Other liabilities 5,464 11,469 11,613
Accrued expenses and deferred income 8,080 23,707 12,629
Total current liabilities 26,343 50,156 51,914
Total liabilities 41,112 66,560 66,726
TOTAL EQUITY AND LIABILITIES 285,188 290,548 229,916

Consolidated statement of changes in equity

Equity attributable to Parent Company shareholders 1)
Amounts in SEK thousand Note Share capital Other contrib
uted capital
Reserves Retained earnings,
including result for
the year
Total equity
Opening balance, 1 Jan 2022 1,477 1,234,972 -1,138 -804,857 430,454
Result for the period - - - -205,002 -205,002
Other comprehensive income - - -3,162 - -3,162
Comprehensive income for the pe
riod
0 0 -3,162 -205,002 -208,164
Share-based remuneration pro 4 - - - 1,698 1,698
grammes
Transactions with shareholders
0 0 0 1,698 1,698
Closing balance, 30 Sep 2022 1,477 1,234,972 -4,300 23,337,947 223,988
Opening balance, 1 Jan 2022 1,477 1,234,972 -1,138 -804,858 430,454
Result for the period - - - -268,694 -268,694
Other comprehensive income - - 1,134 - 1,134
Comprehensive income for the pe
riod
0 0 1,134 -268,694 -267,560
Share-based remuneration pro 4 - - - 295 295
grammes
Transactions with shareholders
0 0 0 295 295
Closing balance, 31 Dec 2022 1,477 1,234,972 -4 -1,073,255 163,190
Opening balance, 1 Jan 2023 1,477 1,234,972 -4 -1,073,255 163,190
Result for the period - - - -175,107 -175,107
Other comprehensive income 15 7 22
Comprehensive income for the pe
riod
- - 15 -175,100 -175,085
New share issue 4,381 258,504
Issue costs - -10,111 - - -
Share-based remuneration pro 4 - - - 3,198 3,198
grammes
Transactions with shareholders
4,381 248,393 - 3,198 255,972
Closing balance, 30 Sep 2023 5,858 1,483,365 12 -1,245,158 244,077

Equity attributable to Parent Company shareholders 1)

1) There are no non-controlling interests.

Consolidated statement of cash flows

Amounts in SEK thousand Note 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Cash flow from operating activities
Operating result -48,253 -58,515 -175,103 -202,677 -262,247
Adjustments for non-cash items 11,479 4,456 16,269 13,284 15,261
Interest received 11 594 11 1,653 2,599
Interest paid -642 -1,014 -1,371 -3,276 -8,825
Tax paid
Cash flow from operating activities before changes
in working capital -37,405 -54,480 -160,193 -191,015 -253,212
Changes in working capital
Change in inventories 5 2,227 -3,591 -1,070 6,354 -13,635
Change in accounts receivable -614 -473 -1,233 1,941 3,481
Change in other current receivables -1,030 4,704 9,265 3,393 2,147
Change in other current liabilities -12,613 -686 -10,796 7,243 -3,096
Change in accounts payable -5,017 821 -16,302 913 13,451
Changes in working capital -17,047 774 -20,137 19,844 2,349
Cash flow from operating activities -54,452 -53,705 -180,331 -171,171 -250,863
Cash flow from investing activities
Investments in tangible assets 475 -869 -5,030 -13,940 -17,249
Short-term investments -80,000 - -80,000 -70,000 -70,000
Divestment of short-term investments - 65,491 - 266,776 331,958
Investments in financial assets 6 - -12,000 - -12,000 -12,000
Divestment of financial assets 6 - 12,022 - 19,030 82,545
Cash flow from investing activities -79,525 64,644 -85,030 189,866 315,254
Cash flow from financing activities
New share issue 262,885 - 262,885 - -
Issue costs -10,111 - -10,111
Loans raised from principal owner 3 - - 87,000 - -
Repayment of lease liabilities -1,874 -1,650 -5,468 -4,850 -6,525
Repayment of loans -87,000 - -87,000 -79 -79
Cash flow from financing activities 163,900 -1,650 247,306 -4,929 -6,604
Cash flow for the period 29,923 9,288 -18,055 13,766 57,787
Cash and cash equivalents at the beginning of the
period 25,032 19,567 72,878 15,089 15,089
Exchange rate difference in cash and cash equiva
lents
-9 - 122 - 2
Cash and cash equivalents at the end of the pe
riod 54,945 28,855 54,945 28,855 72,878

Parent Company income statement

Amounts in SEK thousand Note 2023 2022 2023 2022 2022
Jul–Sep Jul–Sep Jan–Sep Jan–Sep Jan–Dec
Net sales 2 2,998 2,868 4,378 9,335 12,788
Other operating income 1,484 618 2,041 450 1,817
Changes in inventories of products in progress,
semi-finished goods and finished goods
-2,646 -2,742 162 -21,455 -17,017
Raw materials and consumables, and goods for
resale
-693 -4,150 -4,402 -12,908 -17,151
Other external costs -10,761 -21,367 -55,741 -90,765 -87,815
Personnel costs 4 -30,842 -31,344 -107,909 -110,512 -145,639
Depreciation/amortisation of tangible and in
tangible assets -2,781 -2,539 -8,378 -7,311 -9,693
Other operating expenses -668 -268 -1,223 -383 -1,064
Operating result -43,910 -58,923 -171,072 -233,550 -263,774
Revenue from holdings of listed corporate
bonds that are non-current assets - 118 - 1,668 1,348
Other interest income and similar profit items 261 422 1,359 2,580 826
Interest expenses and similar loss items -436 -866 -710 -2,887 -7,903
Result from financial items -175 -326 649 1,361 -5,729
Result before tax -44,085 -59,249 -170,424 -232,189 -269,503
Tax on result for the period - - - - -
Result for the period -44,085 -59,249 -170,424 -232,189 -269,503

Parent Company statement of comprehensive income

Amounts in SEK thousand Note 2023 2022 2023 2022 2022
Jul–Sep Jul–Sep Jan–Sep Jan–Sep Jan–Dec
Result for the period -44,085 -59,249 -170,424 -232,189 -269,503
Other comprehensive income, net after tax
Items that may be subsequently reversed in
profit or loss
- - - - -
Changes in fair value of financial instruments - 498 - -354 1,138
Total comprehensive income -44,085 -58,751 -170,424 -232,543 -268,365

Parent Company balance sheet

Amounts in SEK thousand Note 30 Sep 2023 30 Sep 2022 31 Dec 2022
ASSETS
Non-current assets
Intangible assets
Licences - 42 24
Technology and customer relationships 148 232 211
Goodwill 1,901 2,988 2,716
Total intangible assets 2,049 3,261 2,950
Tangible assets
Equipment, tools, fixtures and fittings 33,934 35,269 36,362
Total tangible assets 33,934 35,269 36,362
Financial assets
Participations in Group companies 6,352 - 264
Other securities held as non-current assets 6 4,095 63,396 2,997
Other non-current receivables 50 50 50
Total financial assets 10,498 63,446 3,312
Total non-current assets 46,480 101,976 42,624
Current assets
Inventories 5 43,351 22,292 42,281
Current receivables
Accounts receivable 985 1,541 -
Other receivables 36,165 44,960 45,798
Prepaid expenses and accrued income 4,038 3,658 4,065
Total current receivables 41,188 50,158 49,863
Short-term investments 80,000 63,502 -
Cash and bank balances 53,989 28,855 72,617
Total current assets 218,528 164,807 164,762
TOTAL ASSETS 265,008 266,782 207,386

Parent Company balance sheet

Amounts in SEK thousand
30 Sep 2023 30 Sep 2022 31 Dec 2022
EQUITY AND LIABILITIES
Restricted equity
Share capital 5,858 1,477 1,477
Total restricted equity 5,858 1,477 1,477
Unrestricted equity
Share premium reserve 1,483,364 1,234,972 1,234,972
Fair value reserve - -4,300 -
Retained earnings -1,071,622 -803,913 -805,316
Result for the period -170,424 -205,646 -269,503
Total unrestricted equity 241,319 221,113 160,153
Total equity 247,177 222,590 161,630
Liabilities
Current liabilities
Loan from principal owner 3 - - -
Accounts payable 4,996 9,017 21,515
Current tax liabilities - - -
Other liabilities 5,247 11,469 11,613
Accrued expenses and deferred income 7,588 23,707 12,629
Total current liabilities 17,831 44,192 45,757
Total liabilities 17,831 44,192 45,757
TOTAL LIABILITIES AND EQUITY 265,008 266,782 207,386

Parent Company statement of changes in equity

Restricted Unrestricted
Amounts in SEK thousand Note Share
capital
Share
premium
reserve
Fair
value
reserve
Retained
earnings
Result for
the period
Total eq
uity
Opening balance, 1 Jan 2022 1,477 1,234,972
72
-1,138 -573,423 -232,189 429,699
Result for the period - - - - -205,646 -205,646
Comprehensive income
Other comprehensive income
- - -3,162 - - -3,162
Appropriation of profits in accordance with
AGM decision:
- - - -232,189 232,189 0
- Carried forward to unrestricted equity - - - - - 0
Total comprehensive income 0 0 -3,162 -232,189 26,543 -208,808
Transactions with shareholders
Share-based remuneration programmes 4 - - - 1,698 - 1,698
Transactions with shareholders - - - 1,698 - 1,698
Closing balance, 30 Sep 2022 1,477 1,234,972
2
-4,300 -803,913 -205,646 222,590
0312-31
Opening balance, 1 Jan 2022 1,477 1,234,972 -1,138 -573,423 -232,188 429,699
Comprehensive income 2
Result for the period - - - - -269,503 -269,503
Other comprehensive income - - 1,138 - - 1,138
Appropriation of profits in accordance with
AGM decision:
- Carried forward to unrestricted equity - - - -232,188 232,188 0
Total comprehensive income 0 0 -1,138 -232,188 -37,315 -268,365
Transactions with shareholders
Share-based remuneration programmes 4 - - - 295 - 295
Transactions with shareholders 0 0 0 295 0 295
Closing balance, 31 Dec 2022 1,477 1,234,972
2
0 -805,316 -269,503 161,630
Opening balance, 1 Jan 2023 1,477 1,234,972 0 -805,316 -269,503 161,630
Comprehensive income
Result for the period - - - - -170,424 -170,424
Appropriation of profits in accordance with - - - -269,503 269,503 0
AGM decision:
- Carried forward to unrestricted equity
- - - - - 0
Total comprehensive income 0 0 0 -269,503 99,080 -170,424
Transactions with shareholders
New share issue 4,381 258,504 - - - 262,885
Issue costs - -10,111 - - - -10,111
Share-based remuneration programmes 4 - - - 3,198 - 3,198
Transactions with shareholders 4,381 248,393 - 3,198 - 255,972
Closing balance, 30 Sep 2023 5,858 1,483,364 0 -1,071,622 -170,424 247,177

4

Accounting policies and notes

Note 1 Accounting policies

Q-linea has prepared consolidated financial statements in accordance with the IFRS issued by the International Accounting Standards Board (IASB) as adopted by the EU.

The accounting policies applied in this interim report are the same as the policies applied and described in the 2022 Annual Report. Nor have the significant estimates and judgements described in the aforementioned Annual Report changed significantly during the period.

Parent Company accounting policies

The Parent Company's financial statements have been prepared in accordance with the Swedish Annual Accounts Act (1995:1554) and the Swedish Financial Reporting Board's recommendation RFR 2, Accounting for Legal Entities. RFR 2 means that IFRS is applied with certain limitations.

Note 2 Specification of net sales

Net sales comprise sales of ASTar instruments and associated consumables, and are distributed by geographic markets as follows:

SEK thousand 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Sweden - - 60 - -
UK 141 2,868 1,462 12,788 12,788
France 2,857 - 2,857 - -
Total net sales by geographic market 2,998 2,868 4,379 12,788 12,788

Note 3 Related-party transactions

Related parties are defined as owners with a significant or controlling influence, senior executives in the Company, meaning directors and members of the management team, and their close family members. In addition to the groups mentioned, Q-linea AB's subsidiaries Q-linea Inc. and Q-linea S.r.l. are also related parties.

Disclosures concerning transactions between the Company and other related parties are presented below. Related-party transactions are performed on an arm's length basis.

The previous loan from the Company's principal owner was set off against shares in the recent rights issue. As of 30 September, Qlinea AB therefore had no loans from the Company's principal owner Nexttobe AB.

Note 4 Share-based remuneration programmes

The Board resolved to not introduce the employee share option programme that was resolved on at the general meeting on 13 June (LTIP 2023/26). The primary reason is that the rights issue carried out after the general meeting entailed a significant dilution of the programme, which was then deemed unable to fulfil its purpose of rewarding and retaining key individuals in the Company.

Note 5 Inventories

At the end of the third quarter of 2023, the Company had an inventory value of SEK 43,351 thousand (42,281).

SEK thousand (unless
otherwise stated)
30 Sep 2023 30 Sep 2022 31 Dec 2022
Raw materials and consuma
bles
8,255 5,554 8,180
Goods for resale 26,190 11,222 29,450
Products in progress 422 1,077 510
Semi-finished goods 5,867 3,967 3,317
Finished goods 2,616 472 824
Total inventories 43,351 22,292 42,281

Note 6 Financial instruments

Cash and cash equivalents not used in daily operations are invested in low-risk listed corporate bonds as well as in fixed-income funds that invest in low-risk interest-bearing securities and other interest-rate instruments.

Since most of the securities in these fixed-income funds have a remaining term of more than three months, they have been recognised as short-term investments rather than cash and cash equivalents. The fixed-income funds are measured at fair value. Changes in fair value are recognised in profit or loss. They are traded in an active market with quoted market prices comprising their fair value. The Company had no holdings in fixed-income funds at 30 September 2023.

The corporate bonds in which Q-linea invests some of its positive cash flow are also traded in an active market with quoted market prices, which comprise their fair value, which is also the amount at which they are measured. Changes in the bonds' fair value are recognised in other comprehensive income. The Company had no holdings in bonds at 30 September 2023.

During the third quarter, Q-linea invested SEK 80,000 thousand (0) in a short-term fixed-interest deposit account. On 30 September, accrued interest amounted to SEK 250 thousand.

Other securities held as non-current assets primarily comprise participations in EMPE Diagnostics AB amounting to SEK 4,095 thousand (2,997) at the end of the quarter. Q-linea AB's holding comprises 23,400 shares, corresponding to 4.97% of the capital and votes.

Note 7 Earnings per share

Earnings per share are calculated by dividing the result for the period by a weighted average of the number of ordinary shares outstanding, excluding holdings of treasury shares, during the period:

SEK thousand (unless otherwise stated) 2023
Jul–Sep
2022
Jul–Sep
2023
Jan–Sep
2022
Jan–Sep
2022
Jan–Dec
Result for the period -48,648 -59,049 -175,108 -205,002 -268,694
Weighted average number of shares outstanding 23,337,947 29,537,947 49,117,925 29,537,947 29,537,947
- Less average holding of treasury shares -328,472 -328,472 -328,472 -328,472 -328,472
Earnings per share before and after dilution -0.56 -2.02 -3.59 -7.02 -9.20

(SEK)

Note 8 Risk management

The Company is exposed to various types of risks during the course of its operations. By creating an awareness of the risks associated with the operations, such risks can be limited, controlled and managed while allowing business opportunities to be utilised in order to increase the Company's earnings.

At the end of third quarter, the Company had a credit reserve of SEK 0 thousand (461). Material risks associated with Q-linea's operations are presented in the Annual Report for the 1 January to 31 December 2022 financial year.

Note 9 Future financing

Q-linea's product, ASTar, has been approved for sales in Europe. However, the Company is yet to generate any positive cash flow. Therefore, the Company is continually engaged in pursuing other financing options. This process includes holding discussions with potential partners for the licensing of distribution and sales rights, negotiations with new and existing investors, financiers and lenders.

At 30 September 2023, Q-linea had available cash and cash equivalents of SEK 135 million as well as an unutilised loan facility of SEK 41.5 million from the Company's principal owner Nexttobe. The Board considers the available cash and cash equivalents, short term investments, the total unutilised portion of the loan facility and an adjusted business plan sufficient to cover the liquidity needed for the Company to conduct its planned operations for the next 12 months.

Note 10 Significant events after the end of the period

The Company presented the results of the first commercial evaluation of ASTar in the UK at the IBMS congress in Birmingham.

Q-linea strengthened its presence in Finland and the Baltics through a contract with Labema Oy.

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