AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Q-Linea

Quarterly Report May 4, 2023

3100_10-q_2023-05-04_571db27f-aaf6-4e66-8e99-4e22ce7d0df3.pdf

Quarterly Report

Open in Viewer

Opens in native device viewer

Interim report 1 January – 31 March 2023

COMMERCIAL EXPANSION CONTINUING ACCORDING TO PLAN

First quarter: 1 January–31 March 2023

  • Net sales amounted to SEK 0 million (5.8).
  • The operating result totalled SEK -62.2 million (-71.5).
  • The result for the period amounted to SEK -61.4 million (-72.8).
  • Earnings per share before and after dilution amounted to SEK -2.10 (-2.49).
  • Cash flow from operating activities totalled SEK -72.4 million (-50.0).
  • As of 31 March 2023, the Company had a total of SEK 20.6 million (72.9) in available funds.

Significant events

In the first quarter of 2023

  • In February, Q-linea AB entered into a distribution partnership for the ASTar® instrument and consumables for the UK market with Pro-Lab Diagnostics as its sole distribution partner. However, Q-linea also has the right to address this market.
  • Q-linea AB received certification under the new and more comprehensive EU In Vitro Diagnostics Regulation (IVDR).
  • The Company announced an updated commercialisation strategy focusing on three key geographies in Europe – the UK, Italy and Benelux – to be implemented through an internal sales force, subsidiaries and partnerships. In the US, Q-linea will initially focus on the East Coast and will be assisted by a subsidiary with a dedicated sales force of 8–12 people. Q-linea's majority owner, Nexttobe, fully supports the strategy and has expanded the current loan facility from SEK 100 million to SEK 200 million.
  • Q-linea AB hired Christer Samuelsson as CFO and IR Director. Christer Samuelsson will take up his post on 1 May 2023, replacing Anders Lundin, who has held the role since 2018.
  • In March, the Company received ethics approval for a university hospital in Belgium to initiate a study that evaluates ASTar's clinical benefit. The aim of the study is to investigate the effect of a shorter time to optimal antibiotic treatment using ASTar.

After the end of the period

  • Q-linea AB received the first two orders for ASTar instruments from Pro-Lab Diagnostics in the UK.
  • The Company entered into a non-exclusive distribution agreement for Poland with Integra Diagnostic Sp.
  • Q-linea AB has initiated a cost-saving program with the purpose of enabling investment in the updated commercialisation strategy. The cost savings are estimated to approx. SEK 45 million on an annual basis.
  • The board of Q-linea AB has decided to change the date of the annual general meeting to June 13, 2023 at 4:00 p.m. The background to the board's decision is the cost-saving process that has been initiated.

COMMERCIAL EXPANSION CONTINUING ACCORDING TO PLAN

Q-linea's journey of transformation continued at a rapid rate during the first quarter of the year. We took important steps in accordance with our new commercialisation strategy, and we are delighted with the strong interest we see in ASTar.

We are focusing on the US, Italy and Benelux through an internal sales force and are expanding our presence in other geographies in Europe in partnership with distributors. We are initially focusing on strategically important markets such as the UK.

We were pleased to enter into a distribution partnership with Pro-Lab Diagnostics for the UK market during the quarter. Moreover, shortly after the end of the quarter we received our first order for two ASTar instruments, which will be used by Pro-Lab at future exhibitions and in future customer evaluations.

Poland is also an attractive geographic region, which had a clear focus on investment in improved infection diagnostics in 2023. Therefore we believe that the distribution agreement that we entered into with Integra Diagnostic Sp. z.o.o. provides us with an excellent opportunity to address the Polish market and meet the needs that have been identified.

We are being selective about the distributors we want to work with in order to ensure that we are given priority in their product range and that they possess strong market knowledge. We will continue to make methodical progress when it comes to finding the best and most costeffective commercialisation solution for each market. We are also continuing our dialogue with major strategic companies in order to evaluate the potential for jointly facilitating the commercialisation of ASTar. In the US, we will initially enter with a dedicated sales force in our subsidiary Q-linea Inc., and until we receive market approval we will be engaged in running clinical

evaluation studies with the aim of being ready when ASTar is approved for sale in the US. We received feedback from the FDA during the quarter, and as a result we initiated additional testing in order to verify the performance improvements that were introduced after the clinical study in the 510(k) application was completed. Our objective is to complete testing during the spring in order to submit additional data before the summer.

Rapid susceptibility testing (rapid AST) is definitely the future, but hospitals, laboratories and payers need solid health economic evidence in order to justify their purchases. During the quarter, we announced that a university hospital in Belgium had received ethics approval to initiate a study that evaluates ASTar's clinical benefit. Demonstrating the clinical benefit is a cornerstone of our clinical strategy and for commercial development. Studies such as this one increase awareness of the advantages of rapid AST in general and ASTar in particular.

Another positive piece of news during the quarter was our certification under the new and more comprehensive EU IVDR. This certification is proof of our consistently high level of quality, and is a condition for CE marking the ASTar BC G- kit. Our goal is to receive CE marking for ASTar BC G- Kit under IVDR before the summer. The ASTar instrument has been CE-marked under IVDR since May 2022.

After the end of the period, we participated in ECCMID, which is one of the largest infection diagnostics conferences in the world. We were extremely well received and had a constructive dialogue with potential future customers. At the same time, we are seeing strong interest from the hospitals that have evaluated ASTar. More tenders are being invited as a response to previous evaluations.

The current financial year will continue to be a year of transformation, and in April we announced that the Company is implementing a comprehensive cost savings programme. Other purpose is to enable greater financial sustainability while simultaneously allowing us to use resources to support our new commercialization strategy. The purpose of the year's activities is to enable an increase in sales in 2024. I look forward to keeping you updated.

Uppsala, 3 May 2023Jonas Jarvius, President

Major focus on the US continues

Developments in the first 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 will be 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

Work to reduce production costs and increase production capacity for consumables continues. This work focuses on addressing cost-driving production steps and bottlenecks in production.

In the case of the AST disc, the work focuses primarily on two areas: the development of new dispensing equipment, and quality control of antibiotics on the disc. The new equipment has a significantly higher capacity and level of automation compared with current equipment, and will thus be able to reduce production costs while enabling higher production volumes. The Company began production validation on the new equipment during the quarter, with good results,

while implementing a faster process for joining AST discs at the same time. The plan is to begin using the equipment in the autumn, and development is proceeding on schedule. Work is also proceeding on the sample preparation cartridge, albeit at a slower pace.

Instruments

The Company continued to develop instrument software with the aim of managing multiple hardware versions in the instrument while also speeding up deployment. New software is being verified that will enable ASTar to manage several different consumables, which is a requirement to handle both gram-negative and gram-positive bacteria simultaneously.

Regulatory studies for the US market

The Company began additional testing at two US hospitals as well as Q-linea's microbiology laboratory in Uppsala during the quarter.

The FDA's recommendation to perform additional testing was prompted by an algorithm update, and its purpose is primarily to verify the resulting performance improvements. The update was performed after training data was expanded after completion of the clinical study in the 510(k) application. The training data is the basis for the machine learning algorithms that ASTar's software uses to calculate results. Similar performance improvements for ASTar have already been implemented and approved for the European market.

The expanded testing has proceeded according to our schedule, and we plan to compile the results in order to submit a supplementary application in June. However, 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. However, we are taking a forward-looking approach and planning performance evaluation studies at several major hospitals in the US that have expressed their interest in testing ASTar before market approval.

Planning of the upcoming clinical performance study with ASTar for gram-positive bacteria also continued during the quarter. Q-linea intends to use the same US supplier it used for the gram-negative study, which will save time and resources.

Development of new products

The development of Podler, Q-linea's portable blood culture technology, was given lower priority during the quarter in order to focus on the clinical studies for ASTar. However, Q-linea has fully functioning prototypes that are ready to move into production transfer when the project continues.

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 the statement of profit and loss and statement of cash flows and to the closing balance in the preceding financial year with respect to the statement of financial position. 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.

All of the figures in the comments below refer to the Group and not the Parent Company unless otherwise stated.

Changes to accounting policies

Q-linea AB founded a subsidiary in the US in November 2022. Q-linea is thus a group of companies, and is submitting consolidated financial statements in accordance with IFRS in this interim report, along with the Parent Company's financial statements. This change has also entailed the restatement of previous periods' financial statements according to IFRS regulations. These changes are explained in Note 2 in both the year-and report and the 2022 Annual Report, and are thus not explained in this report.

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 31 March 2023, Q-linea had available cash and cash equivalents of SEK 20.6 million as well as an unutilised loan facility of SEK 175 million from the Company's principal owner Nexttobe. The available cash and cash equivalents and the total unutilised portion of the loan facility are not deemed sufficient to cover the liquidity needed for the Company to conduct its planned operations for the next 12 months. In light of the work being done to pursue potential financing options and the decided costsaving program, the Board considers Q-linea's prospects to finance its operations to be favourable.

Income, expenses and earnings

Net sales in the first quarter amounted to SEK 22 thousand (5,800), a decrease of SEK 5,778 thousand compared with the corresponding period in the preceding year. Sales comprised ASTar consumables. Other operating income for the first quarter amounted to SEK 24 thousand (641) and pertains primarily to exchange-rate gains.

Changes in inventories of products in progress, semi-finished goods and finished goods amounted to SEK 3,955 thousand (-9,583) for the quarter.

Costs for raw materials and consumables as well as goods for resale for the quarter totalled SEK 1,366 thousand (3,172).

The Company's margins will be negative during the launch period and initial commercial phase for ASTar. As volumes increase and the production mix shifts toward a higher share of consumables, the margins will improve.

Other external costs totalled SEK 19,476 thousand (21,945) for the quarter, a decrease of SEK 2,469 thousand. The changes during the quarter were largely attributable to a decrease in the number of consultants during the quarter.

Personnel costs amounted to SEK 41,025 thousand (39,524) for the quarter, up SEK 1,501 thousand compared with the corresponding quarter in the preceding year. Costs for the Company's employee share option programme for the quarter amounted to SEK 544 (-403) thousand including social security contributions.

Costs for depreciation, amortisation and impairment of tangible and intangible assets amounted to SEK 4,199 thousand (3,517) for the quarter. This cost increase was primarily attributable to Q-linea's investments in production improvements and ASTar instruments used in clinical studies, which are now being depreciated.

Other operating expenses amounted to SEK 180 thousand (163) for the quarter and pertained largely to exchange-rate losses.

The operating result totalled SEK -62,244 thousand (- 71,462) for the quarter. The improvement of SEK 9,218 thousand is primarily attributable to revaluation of inventory and lower costs for consultants.

The result from financial items totalled SEK 828 thousand (-1,303) for the first quarter.

The reported tax in the first quarter amounted to SEK 0 thousand (0).

The result for the first quarter totalled SEK -61,416 thousand (-72,765).

Financial position

Cash and cash equivalents at the end of the quarter totalled SEK 20,559 thousand (72,878). Q-linea has a policy that cash and cash equivalents that are not required for daily operations over the coming 12 months are invested in fixed-income funds and listed corporate bonds.

Q-linea's short-term investments totalled SEK 0 thousand (0) on the balance sheet date.

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

Q-linea'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'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 102,634 thousand (163,190), the equity/assets ratio to 54% (71) and the debt/equity ratio to 4% (-45).

Cash flow and investments

Cash flow from operating activities totalled SEK -72,439 thousand (-49,996) for the first quarter. The change is attributable to working capital development.

Cash flow from investing activities for the first quarter totalled SEK -3,137 thousand (51,894), of which investments in tangible assets totalled SEK 3,137 thousand (5,802) for the first quarter.

Q-linea invested SEK 0 thousand (70,000) and divested SEK 0 thousand (120,688) in short-term investments in the first quarter.

Q-linea invested SEK 0 thousand (0) and divested SEK 0 thousand (7,008) in financial assets in the first quarter.

Cash flow from financing activities totalled SEK 23,188 thousand (-1,602) for the first quarter. Repayments of lease liabilities totalled SEK -1,812 thousand (-1,562) and repayment of loans to credit institutes totalled SEK 0 thousand (40). SEK 25,000 (0) of the loan from the Company's principal owner Nexttobe was utilised in the first quarter.

Financing

To provide the Company with sufficient liquidity to continue operating and developing according to its strategic plan, the Company has initiated a cost saving program. As of 31 March 2023, the Company had access to cash and cash equivalents of SEK 20,559 thousand (72,878). In addition, the Company has an unutilised loan facility amounting to SEK 175 million from the Company's principal owner Nexttobe.

Parent Company

The Parent Company's net sales for the year amounted to SEK 22 thousand (5,800), and the loss before tax totalled SEK -61,561 thousand (-72,985). As of 31 March 2023, the Parent Company's cash and cash equivalents totalled SEK 20,285 thousand (72,617).

Other information

Employees

Calculated on the basis of full-time equivalents, Q-linea had 149 (148) employees at the end of the first quarter, 65 (64) of whom were women. The number of consultants on the same date was 10 (32), 4 (9) of whom were women.

The effect of Covid-19 on operations

Q-linea took action to protect its employees, assume its responsibility in society and at the same time minimise the risk that the pandemic would have a negative impact on the Company's operations. However, in the current climate we have welcomed all of our employees back to the office while continuing to offer a flexible way of working and taking the positive aspects of this approach with us into the future.

It is currently difficult to estimate the future effect on Qlinea's operations given that certain areas are under constant change. We have started to see positive effects as well as a certain degree of uncertainty in the following significant areas, which could be subject to the effects of the pandemic:

  • The timeframe of the planned clinical study, if hospitals are tied up with activities related to SARS-CoV-2 and Covid-19. The possibility to visit hospitals during the study, given that this could be limited during certain periods and in certain regions.
  • Delays in commercialisation if customers are less available and purchasing decisions take more time as a result of the pandemic.
  • Expense levels and financing strategy.

Shortage of components that are necessary for the ASTar instrument, which could also apply for consumables. Last

year, the Company placed orders for key components for ASTar in order to be able to manage deliveries while maintaining a safety stock for future deliveries. Q-linea is monitoring the ongoing situation very closely and will implement further measures as required and keep the markets informed if the assessment of the potential impact changes significantly. It is currently impossible to estimate the ultimate impact on the Company.

The situation in Ukraine

The devastating war in Ukraine is a tragedy, and our thoughts are with all of the people affected. The war's impact on the Company is very difficult to predict, but at present the assessment of management and the Board of Directors is that:

  • The Company's operations are not dependent on Russian or Belarusian suppliers or customers, and the Company has no operations in these countries.
  • Costs for fuel, energy, shipping, raw materials and certain insurance could increase further, which will impact the Company's expense levels, although only to a limited extent.

Q-linea is following the events closely.

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 on pages 37–100 of 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 owners (however, lease liabilities
calculated according to IFRS 16 are not included in net
debt) 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

2023 2022 2022
SEK thousand Jan – Mar Jan – Mar Jan – Dec
Operating result (EBIT) -62,244 -71,462 -262,247
Depreciation, amortisation and im
pairment
4,199 3,517 15,286
EBITDA -58,045 -67,946 -246,961

Equity/assets ratio

SEK thousand (unless otherwise
stated)
31 Mar 2023 31 Mar 2022 31 Dec 2022
Total assets 188,414 416,446 229,916
Equity 102,634 357,365 163,190
Equity/assets ratio (%) 54% 86% 71%

Debt/equity ratio

SEK thousand (unless otherwise
stated)
31 Mar 2023 31 Mar 2022 31 Dec 2022
Current liabilities to credit institutions - 40 -
Current liabilities to owners 24,753 - -
Total borrowing (a) 24,753 40 0
- Less cash and cash equivalents (b) -20,559 -15,386 -72,878
- Less short-term investments (c) - -145,180 -
- Less long-term investments (d) - -129,585 -
Net debt (e=a+b+c+d) 4,195 -290,111 -72,878
Equity (f) 102,634 357,365 163,190
Debt/equity ratio (e/f) (%) 4% -81% -45%

Equity per share

SEK thousand (unless otherwise
stated)
31 Mar 2023 31 Mar 2022 31 Dec 2022
Equity (a) 102,634 357,365 163,190
Total number of shares outstanding (b) 29,537,947 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 3.44 11.97 5.59

Performance measures and other information

SEK thousand (unless otherwise stated) 2023 2022 2022
Jan – Mar Jan – Mar Jan – Dec
Earnings
Net sales 22 5,800 12,788
EBITDA -58,045 -67,946 -246,961
Operating result (EBIT) -62,244 -71,462 -262,247
Result for the period -61,416 -72,765 -268,694
Per share
Equity per share, SEK 3.51 12.23 5.59
Earnings per share before and after dilution, SEK -2.10 -2.49 -9.20
Total number of shares outstanding 29,537,947 29,537,947 29,537,947
- of which, treasury shares 328,472 328,472 328,472
Number of shares outstanding excl. treasury shares 29,209,475 29,209,475 29,209,475
Total average number of shares 29,537,947 29,537,947 29,537,947
- of which, average number of treasury shares 328,472 328,472 328,472
Average number of shares excl. treasury shares 29,209,475 29,209,475 29,209,475
Cash flow
Cash flow from operating activities -72,439 -49,996 -250,863
Cash flow from investing activities -3,137 51,894 315,254
Cash flow from financing activities 23,258 -1,602 -6,604
SEK thousand (unless otherwise stated) 31 Mar 2023 31 Mar 2022 31 Dec 2022
Financial position
Total assets 188,414 416,446 229,916
Cash and cash equivalents 20,559 15,386 72,878
Short-term and long-term investments - 271,717 -
Equity 102,634 357,365 163,190
Equity/assets ratio, % 54 86 71
Debt/equity ratio, % 4 -81 -45

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

Uppsala, 3 May 2023
Jonas Jarvius
President
Erika Kjellberg Eriksson
Chairperson
Mats Nilsson Mario Gualano Nina Korfu-Pedersen
Director Director Director
Marianne Hansson Per-Olof Wallström Hans Johansson
Director Director Director

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.

Upcoming reporting dates

13 June 2023 2023 Annual General Meeting
13 July 2023 Interim report, Q2 January to June 2023
2 November 2023 Interim report, Q3 January to September 2023

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. The information was submitted for publication, through the agency of the contact person set out above, on 4 May 2023 at 7:30 a.m. CEST.

Presentation

Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 4 May 2023 from 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 March 2023 period and respond to questions.

To participate via webcast, please visit the following link:https://ir.financialhearings.com/q-linea-q1-2023 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=200726

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

2023 2022 2022
Amounts in SEK thousand Note Jan – Mar Jan – Mar Jan – Dec
Net sales 2 22 5,800 12,788
Other operating income 24 641 1,817
Changes in inventories of products in progress,
semi-finished goods and finished goods
3,955 -9,583 -17,017
Raw materials and consumables, and goods for resale -1,366 -3,172 -17,151
Other external costs -19,476 -21,945 -80,695
Personnel costs 4 -41,025 -39,524 -145,639
Depreciation/amortisation of tangible and intangible
assets -4,199 -3,517 -15,286
Other operating expenses -180 -163 -1,064
Operating result -62,244 -71,462 -262,247
Financial income 1,098 719 2,174
Financial expenses -270 -2,021 -8,621
Result from financial items 828 -1,303 -6,447
Result before tax -61,416 -72,765 -268,694
Income tax - - -
Result for the period -61,416 -72,765 -268,694
Result attributable to:
Parent Company shareholders -61,416 -72,765 -268,694
Non-controlling interests - - -
Earnings per share before and after dilution 7 -2.10 -2.49 -9.20

Consolidated statement of comprehensive income

Amounts in SEK thousand 2023 2022 2022
Note Jan – Mar Jan – Mar Jan – Dec
Result for the period -61,416 -72,765 -268,694
Other comprehensive income, net after tax - -977 1,138
Items that may be subsequently reversed in profit or loss
Change in fair value of financial instruments 317 - -
Translation differences - - -4
Total comprehensive income -61,099 -73,742 -267,559
Comprehensive income attributable to:
Parent Company shareholders -61,099 -73,742 -267,559
Non-controlling interests - - -

Consolidated statement of financial position

Amounts in SEK thousand Note 31 Mar 2023 31 Mar 2022 31 Dec 2022
ASSETS
Non-current assets
Tangible assets 37,173 31,446 36,362
Right-of-use assets 26,035 18,044 21,957
Goodwill 4,889 4,889 4,889
Other intangible assets 196 351 235
Financial assets 6 4,145 129,585 3,047
Total non-current assets 72,437 184,315 66,489
Current assets
Inventories 5 48,190 21,897 42,281
Accounts receivable 28 758 -
Other receivables 44,595 45,719 45,798
Prepaid expenses and accrued income 2,605 3,192 2,469
Short-term investments 6 - 145,180 -
Cash and cash equivalents 20,559 15,386 72,878
Total current assets 115,978 232,131 163,426
TOTAL ASSETS 188,414 416,446 229,916

Consolidated statement of financial position

Amounts in SEK thousand Note 31 Mar 2023 31 Mar 2022 31 Dec 2022
EQUITY AND LIABILITIES
Equity attributable to Parent Company shareholders
Share capital 1,477 1,477 1,477
Reserves -4 -2,116 -4
Other contributed capital 1,234,972 1,234,972 1,234,972
Retained earnings, including result for the year -1,133,811 -876,968 -1,073,255
Total equity attributable to Parent Company share
holders
102,634 357,365 163,190
Equity attributable to non-controlling
interests - - -
Total equity 102,634 357,365 163,190
Liabilities
Non-current liabilities
Non-current lease liabilities 17,928 11,788 14,813
Total non-current liabilities 17,928 11,788 14,813
Current liabilities
Loans from credit institutions - 40 -
Loan from principal owner 3 24,753 - -
Accounts payable 13,829 10,622 21,555
Current lease liabilities 7,074 5,060 6,117
Current tax liabilities - - -
Other liabilities 5,739 10,308 11,613
Accrued expenses and deferred income 16,458 21,262 12,629
Total current liabilities 67,852 47,292 51,914
Total liabilities 85,780 59,081 66,726
TOTAL EQUITY AND LIABILITIES 188,414 416,446 229,916

Consolidated statement of changes in equity

Equity attributable to Parent Company shareholders 1)
Amounts in SEK thousand Note Share capital Other
contributed
capital
Reserves Retained earnings,
including result for
the year
Total equity
Opening balance, 1 Jan 2022 1,477 1,234,972 -1,138 -804,858 430,454
Result for the period - - - -72,765 -72,765
Other comprehensive income - - -977 - -977
Comprehensive income for the 0 0 -977 -72,765 -73,742
period
Share-based remuneration pro
4 - - - 654 654
grammes
Transactions with shareholders
0 0 0 654 654
Closing balance, 31 March 2022 1,477 1,234,972 -2,116 -876,968 357,365
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 0 0 1,134 -268,694 -267,560
period
Share-based remuneration pro
4 - - - 295 295
grammes
Transactions with shareholders
0 0 0 295 295
Closing balance, 31 December
2022
1,477 1,234,972 -4 -1,073,255 163,190
Opening balance, 1 January 2023 1,477 1,234,972 -4 -1,073,255 163,190
Result for the period - - - -61,416 -61,416
Other comprehensive income - - - 317 317
Comprehensive income for the 0 0 0 -61,099 -61,099
period
Share-based remuneration pro
4 - - - 544 544
grammes
Transactions with shareholders
0 0 0 544 544
Closing balance, 31 March 2023 1,477 1,234,972 -4 -1,133,811 102,634

1) There are no non-controlling interests.

Consolidated statement of cash flows

Amounts in SEK thousand 2023 2022 2022
Jan – Mar Jan – Mar Jan – Dec
Cash flow from operating activities
Operating result -62,244 -71,462 -262,247
Adjustments for non-cash items 4,744 4,381 15,261
Interest received - 649 2,599
Interest paid -230 -720 -8,825
Tax paid - - -
Cash flow from operating activities
before changes in working capital
-57,731 -67,153 -253,212
Changes in working capital
Change in inventories -5,909 6,749 -13,635
Change in accounts receivable -28 2,723 3,481
Change in other current receivables 1,098 1,459 2,147
Change in other current liabilities -2,072 3,707 -3,096
Change in accounts payable -7,726 2,519 13,451
Changes in working capital -14,638 17,157 2,349
Cash flow from operating activities -72,369 -49,996 -250,863
Cash flow from investing activities
Investments in tangible assets -3,137 -5,802 -17,249
Short-term investments - -70,000 -70,000
Divestment of short-term investments - 120,688 331,958
Investments in financial assets - - -12,000
Divestment of financial assets - 7,008 82,545
Cash flow from investing activities -3,137 51,894 315,254
Cash flow from financing activities
Loans raised from principal owner 25,000 - -
Repayment of lease liabilities -1,812 -1,562 -6,525
Repayment of loans - -40 -79
Cash flow from financing activities 23,188 -1,602 -6,604
Cash flow for the period -52,318 296 57,787
Cash and cash equivalents at the beginning of the period 72,878 15,089 15,089
Exchange rate difference in cash and cash equivalents -1 - 2
Cash and cash equivalents at the end of the period 20,559 15,385 72,878

Parent Company income statement

Amounts in SEK thousand Note 2023 2022 2022
Jan – Mar Jan – Mar Jan – Dec
Net sales 2 22 5,800 12,788
Other operating income 24 641 1,817
Changes in inventories of products in progress,
semi-finished goods and finished goods 3,955 -9,583 -17,017
Raw materials and consumables, and goods for resale -1,366 -3,172 -17,151
Other external costs -21,388 -23,601 -87,815
Personnel costs 4 -41,025 -39,524 -145,639
Depreciation/amortisation of tangible and intangible
Non-current assets -2,637 -2,231 -9,693
Other operating expenses -180 -163 -1,064
Operating result -62,594 -71,832 -263,774
Revenue from holdings of listed corporate
bonds that are non-current assets - 367 1,348
Other interest income and similar profit items 1,098 351 826
Interest expenses and similar loss items -65 -1,872 -7,903
Result from financial items 1,033 -1,153 -5,729
Result before tax -61,561 -72,985 -269,503
Tax on result for the period - - -
Result for the period -61,561 -72,985 -269,503

Parent Company statement of comprehensive income

Amounts in SEK thousand Note 2023 2022 2022
Jan – Mar Jan – Mar Jan – Dec
Result for the period -61,561 -72,985 -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 317 -977 1,138
Total comprehensive income -61,244 -73,962 -268,365

Parent Company balance sheet

Amounts in SEK thousand Note 31 Mar 2023 31 Mar 2022 31 Dec 2022
ASSETS
Non-current assets
Intangible assets
Licences 6 77 24
Technology and customer relationships
Goodwill
190
2,444
274
3,531
211
2,716
Total intangible assets 2,640 3,882 2,950
Tangible assets
Equipment, tools, fixtures and fittings 37,173 31,446 36,362
Total tangible assets 37,173 31,446 36,362
Financial assets
Participations in Group companies 376 - 264
Other securities held as non-current assets 6 4,095 129,535 2,997
Other non-current receivables 50 50 50
Total financial assets 4,521 129,585 3,312
Total non-current assets 44,333 164,913 42,624
Current assets
Inventories 5 48,190 21,897 42,281
Current receivables
Accounts receivable 28 758 -
Other receivables 44,595 45,719 45,798
Prepaid expenses and accrued income 4,276 4,771 4,065
Total current receivables 48,900 51,248 49,863
Short-term investments 6 - 145,180 -
Cash and bank balances 20,285 15,386 72,617
Total current assets 117,375 233,710 164,762
TOTAL ASSETS 161,708 398,623 207,386

Parent Company balance sheet

Amounts in SEK thousand
31 Mar 2023 31 Mar 2022 31 Dec 2022
EQUITY AND LIABILITIES
Restricted equity
Share capital 1,477 1,477 1,477
Total restricted equity 1,477 1,477 1,477
Unrestricted equity
Share premium reserve 1,234,972 1,234,972 1,234,972
Fair value reserve - -2,116 -
Retained earnings -1,073,959 -804,957 -805,316
Result for the period -61,561 -72,985 -269,503
Total unrestricted equity 99,453 354,914 160,153
Total equity 100,929 356,391 161,630
Liabilities
Current liabilities
Loans from credit institutions - 40 -
Loan from principal owner 24,753 - -
Accounts payable 13,829 10,622 21,515
Current tax liabilities - - -
Other liabilities 5,739 10,308 11,613
Accrued expenses and deferred income 16,458 21,262 12,629
Total current liabilities 60,779 42,232 45,757
Total liabilities 60,779 42,232 45,757
TOTAL LIABILITIES AND EQUITY 161,708 398,623 207,386

Parent Company statement of changes in equity

Restricted
equity
Unrestricted equity
Amounts in SEK thousand Note Share
capital
Share
premium
reserve
Fair
value
reserve
Retained
earnings
Result for
the period
Total
equity
Opening balance, 1 Jan 2022 1,477 1,234,972 -1,138 -573,423 -232,188 429,699
Result for the period - - - - -72,985 -72,985
Comprehensive income
Other comprehensive income
- - -977 - - -977
Appropriation of profits in accordance with
AGM decision:
- Carried forward to unrestricted equity
- - - -232,188 232,188 0
Total comprehensive income 0 0 -977 -232,188 159,204 -73,962
Transactions with shareholders
Share-based remuneration programmes 4 - - - 654 - 654
Transactions with shareholders 0 0 0 654 0 654
Closing balance, 31 March 2022 1,477 1,234,972 -2,116 -804,957 -72,985 356,391
0312-31
Opening balance, 1 Jan 2022 1,477 1,234,972 -1,138 -573,423 -232,188 429,699
Comprehensive income
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 -269,503
Transactions with shareholders
Share-based remuneration programmes 4 - - - 295 - 295
Transactions with shareholders 0 0 0 295 0 295
Closing balance, 31 December 2022 1,477 1,234,972 0 -805,316 -269,503 161,630
Opening balance, 1 January 2023 1,477 1,234,972 0 -805,316 -269,503 161,630
Comprehensive income
Result for the period - - - - -61,561 -61,561
Other comprehensive income - - - 317 - 317
Appropriation of profits in accordance with - - - -269,503 269,503 -
AGM decision:
- Carried forward to unrestricted equity
- - - - - -
Total comprehensive income 0 0 0 -269,186 207,942 -61,244
Transactions with shareholders
Share-based remuneration programmes 4 - - - 544 - 544
Transactions with shareholders - - - 544 - 544
Closing balance, 31 March 2023 1,477 1,234,972 0 1,073,959 -61,561 100,929

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.

According to RFR 2, a company, as a legal entity, can choose to apply IFRS 9 Financial Instruments, which Q-linea has chosen to do. This primarily means that certain financial instruments, which had previously been measured at cost, will now be measured at fair value.

Note 2 Specification of net sales

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

2023 2022 2022
SEK thousand Jan – Mar Jan – Mar Jan – Dec
Sweden 22 - -
UK - 5,800 12,788
Total net sales by geographic market 22 5,800 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. Disclosures concerning transactions between the Company and other related parties are presented below.

In addition to the groups mentioned above, Q-linea AB's subsidiaries Q-linea Inc. and Q-linea S.r.l. are also related parties. During the first quarter, Q-linea S.r.l.'s parent company made a capital contribution of EUR 10 thousand, which was recognised as SEK 111 thousand in the Parent Company.

In March, Q-linea AB received a loan of SEK 25 million from the Company's principal owner Nexttobe AB. Q-linea and its principal owner Nexttobe are considered to be related parties, and as a result the rules in Chapter 16 a of the Swedish Companies Act concerning related-party transactions must be taken into account when the loan facility is utilised. According to these rules, the approval of the general meeting is required for related-party transactions exceeding SEK 1 million and 1% of the Company's market value at the time of the transaction. The threshold values above are not met because the short-term loan in question is interest-free. However, provided that the general meeting approves, the intention is to apply the same market terms (and term) as for the remaining facility to the loan in question, beginning after the Annual General Meeting.

Note 4 Share-based remuneration programmes

As of 31 March 2023, Q-linea had three employee share option programmes.

The employee share options in the three programmes were allotted free of charge on 30 June 2020, 30 June 2021 and 30 June 2022. The options can be redeemed three years after their respective allotment dates for one share per option provided that certain operational and strategic targets have been met.

As of 31 March 2023, there were employee share options outstanding as follows:

Programme Date range for possible
exercise
Number of
options
outstanding
Total possible
number of
shares
Exercise
price
Employee share option programme
2020/2023
30 June–30 September 2023 293,330 293,330 98.98
Employee share option programme
2021/2024
30 June–30 September 2024 110,670 110,670 191.81
Employee share option programme
2022/2025
30 June–30 September 2025 205,180 205,180 102.82
Total possible number of shares 609,180

In the event that share options are exercised, shares will be primarily allotted from treasury shares and secondarily through a new issue.

Note 5 Inventories

At the end of the first quarter of 2023, the Company had an inventory value of SEK 48,190 thousand (42,281).

SEK thousand 31 Mar
2023
31 Mar
2022
31 Dec
2022
Raw materials and consumables 8,968 2,660 8,180
Goods for resale 29,925 14,001 29,450
Products in progress 215 1,080 510
Semi-finished goods 6,668 2,527 3,317
Finished goods 2,415 1,630 824
Total inventories 48,190 21,897 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 31 March 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 31 March 2023.

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 2022 2022
Jan – Mar Jan – Mar Jan – Dec
Result for the period -61,416 -72,765 -268,694
Weighted average number of shares outstanding 29,537,947 29,537,947 29,537,947
- Less average holding of treasury shares -328,472 -328,472 -328,472
Earnings per share before and after dilution (SEK) -2.10 -2.49 -9.20

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.

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 31 March 2023, Q-linea had available cash and cash equivalents of SEK 20.6 million as well as an unutilised loan facility of SEK 175 million from the Company's principal owner Nexttobe. The available cash and cash equivalents and the total unutilised portion of the loan facility are not deemed sufficient to cover the liquidity needed for the Company to conduct its planned operations for the next 12 months. In light of the work being done to pursue potential financing options and the decided cost-saving program, the Board considers Q-linea's prospects to finance its operations to be favourable.

Note 10 Significant events after the end of the period

Q-linea AB received the first two orders for ASTar instruments from Pro-Lab Diagnostics in the UK.

The Company entered into a non-exclusive distribution agreement for Poland with Integra Diagnostic Sp.

Q-linea AB is today initiating a cost-saving program with the purpose of enabling investment in the updated commercialisation strategy. The cost savings are estimated to approx. SEK 45 million on an annual basis.

The board of Q-linea AB has decided to change the date of the annual general meeting to June 13, 2023 at 4:00 p.m. The background to the board's decision is the cost-saving process that has been initiated.

Talk to a Data Expert

Have a question? We'll get back to you promptly.