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Q-Linea

Interim / Quarterly Report May 31, 2024

3100_10-q_2024-05-31_045169f6-7abe-46ef-b39d-4bc60bd54a68.pdf

Interim / Quarterly Report

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Interim report 1 January–31 March 2024

ASTar approved for the American market

First quarter: 1 January–31 March 2024

  • Net sales amounted to SEK 1.5 million (0).
  • The operating result totalled SEK -56.0 million (-62.2).
  • The result for the period amounted to SEK -56.0 million (-61.4).
  • Earnings per share before and after dilution amounted to SEK -0.5 (-2.1).
  • Cash flow from operating activities totalled SEK -47.9 million (-72.4).
  • As of 31 March 2024, the Company had a total of SEK 29.4 million (20.6) in available funds.

Significant events

In the first quarter of 2024

  • The Company was awarded a public tender for rapid AST instruments and consumables issued by Fondazione PTV in Italy.
  • Q-linea successfully finished the clinical trials required to add the drug Meropenem-Vaborbactam to its existing ASTar panel.
  • The Company announced that Stuart Gander would take over as CEO of Q-linea and that Anders Ljunggren would take office as Managing Director of Q-linea AB in Sweden on 1 March 2024.
  • Q-linea initiated a cost-saving programme with anticipated savings of SEK 50 million annually.
  • The Company received its first order from its distribution partner in Finland and the Baltic states, and signed an agreement with a logistics partner for the US market.
  • Q-linea created a separate subsidiary for Podler.
  • Q-linea participates in tender for nine rapid AST instruments in Tuscany, Italy.
  • Strong ASTar results presented at AMCLI in Italy. The use of ASTar led to modifications of the antibiotic treatment in up to 45 percent of septic patients and enabled adequate treatment 20 – 34 hours earlier than the current standard of care.

After the end of the period

  • Q-linea receives US FDA 510(k) clearance for the ASTar® System on 26 April.
  • The Company signs evaluation contract with reference laboratory network in the US.
  • Q-linea applies for a NTAP code for the US market.
  • The company sends out a notice for the 2024 Annual General Meeting, which will be held on June 28.
  • Q-linea announced that the technology behind Podler has been valued at SEK 70 million. The valuation is based on a report carried out by an external analysis company.
  • The company is offered an increased and extended loan facility from its main owner Nexttobe. Total facility, when utilized, amounts to SEK 101,500,000.

ASTar approved for the American market

I am pleased to share an update on Q-linea's progress for the first quarter of 2024, a transformative period filled with major milestones. As we move forward with the commercialisation of our rapid AST platform ASTar, the momentum is truly inspiring.

FDA approval for ASTar opens the US market

The most significant news this quarter is the FDA's 510(k) approval for ASTar, officially opening the US market for ASTar. This achievement is a testament to the hard work and dedication of our team. With this approval, we're initially targeting around 1,600 large microbiology labs across the US, many of which are part of integrated delivery networks (IDNs) and large reference lab networks. This is a market that has been primed for adoption of rapid AST, and we are excited to be at the forefront.

Strong customer interest and early commercial activities

We are happy with the enthusiastic response from our pre-market discussions and early access programs (EAP) in the US. Since receiving FDA approval, our team has begun commercial evaluations with customers eager to install ASTar in their labs. The positive feedback from sites that have trialed ASTar has been instrumental in shaping our go-to-market strategy, and we expect a steady stream of evaluations and installations over the coming months.

Global expansion and growing interest

Our reach is not limited to the US. At the ESCMID conference in Barcelona, the largest microbiology conference globally, rapid AST emerged as a key theme, with extensive interest from physicians and lab managers. Q-linea's partners presented compelling evidence of the clinical and economic benefits of rapid AST, further reinforcing the value proposition of ASTar. It was particularly encouraging to see interest from beyond Europe and the US,

demonstrating that the need for rapid AST solutions to combat sepsis is truly global.

Building on European success

Following our first commercial installation in Italy at Tor Vergata Hospital, we continue to see growth in our European pipeline. Several tenders in Southern Europe are approaching final stages, and we are witnessing increased interest in second-wave markets across Northern Europe. While strained healthcare budgets remain a challenge, the potential savings from rapid AST are shifting perspectives and will drive increased adoption going forward.

Organisational transformation and cost optimisation

Our transformation agenda is well underway. We have completed a comprehensive organisational restructuring, reducing development costs by approximately 50 percent and overhead by 25 percent. This restructuring allows us to reallocate resources to our commercial organisation, strengthening our in-field capabilities without increasing overall spending. By making targeted appointments in our commercial organisation and realigning our focus, we are realising cost savings that will benefit the company throughout 2024 and beyond.

Innovation and continued product development

The Q-linea team is energised by the growing commercial pull and remains committed to innovation. We are expanding our menu with additional drug and bug combinations, ensuring that ASTar maintains its leading position. This includes rounding out our US-approved menu and incorporating the latest generation of antimicrobials. Our customers are keen to see new capabilities from ASTar based on its superior workflow, usability, and clinical accuracy. We are pacing our resources to meet these expectations with a carefully planned cadence of product launches in the coming years.

Financing

In support of the efforts outlined above, we have agreed to an extension of our loan facility with Nexttobe, our largest shareholder. This will provide SEK 60 million in addition to the SEK 41.5 million previously committed of which will further reinforce our commercial activities.

In closing, I would like to thank the entire Q-linea team for their dedication and creativity. We have much to accomplish and I am confident that with the strong foundation we have built, the innovative spirit of our team, and the growing demand for rapid AST, Q-linea is positioned for continued success in 2024 and beyond. I look forward to updating you on our progress.

Uppsala, 30 May 2024, Stuart Gander, CEO

FDA approval and launch in the US

Product development in the first quarter of 2024

During the quarter, the company was able to add the drug Meropenem-Vaborbactam to the CE-marked kit product for gram-negative bacteria. The clinical trials could be coordinated with the company's trials in the US, which enabled an efficient use of resources. Meropenem-Vaborbactam is a combination drug of a carbapenem and a beta-lactam inhibitor with increased activity against gram-negative organisms. The expanded panel is now available in Europe.

The work to reduce production costs and increase the production capacity of the consumables has continued. During the quarter, the new equipment for dispensing and quality control of antibiotics in the disc underwent the final phase of process validation at one of the company's subcontractors. This means a significantly higher capacity and degree of automation than before and will thus reduce production costs and at the same time enable higher production volumes.

The development of the company's upcoming kit product for gram-positive bacteria has also continued during the quarter.

Regulatory approval for the US market

As previously communicated, the ASTar system (ASTar Instrument and ASTar BC G-Kit) has now received 510(k) market approval in the US.

Communication with the FDA intensified in late 2023 and continued into the first quarter of 2024 as the review process entered its final stages and remaining the issues became increasingly specific and detailed. During the review process, the company worked to quickly and accurately provide the information requested by the FDA in order to speed up the process as much as possible. The market approval was received at the end of April and was announced at the opening of the ESCMID conference in Barcelona. FDA clearance enables the launch of the ASTar platform to hospitals and laboratories in the US.

The market approval in the US has made it possible for the company to apply for a unique so-called NTAP code (New Technology Add-on Payment) for the US market. If the application is granted, hospitals will receive additional reimbursement in addition to the regular Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount when an ASTar test is run. ASTar's classification as a "Breakthrough Device" means that several of the criteria considered in the review are automatically met. A product's NTAP designation lasts for a maximum of three years for a specific indication.

The company plans to gradually improve the US version of the gram-negative product, primarily by improving the machine learning algorithms used to calculate the analysis results.

Development of new products

As previously announced, Podler, Q-linea's portable blood culture technology, has been spun off into a separate company to give Q-linea the opportunity to focus on building value with the ASTar platform. At the same time, the change makes it easier for Podler to be further developed independently from Q-linea's main business in order to maximize the value of Podler.

European market

During the quarter, Q-linea won a public tender for rapid resistance determination at the Tor Vergata University Hospital in Rome, Italy. The procurement has a validity period of five years and a total value of EUR 600,000. Several companies were involved in the procurement and ASTar was selected based on the highest score between technical criteria and pricing. The market is beginning to realize the value of rapid resistance testing and Q-linea expects to see more procurements across Europe shortly. During the quarter, Q-linea participated in another public procurement in Italy; proof that the market for rapid resistance determination is now gaining momentum and growing.

US market

The FDA approval means that Q-linea can now conduct commercial evaluations. Already at the beginning of the quarter, Q-linea installed ASTar as a research system at two very reputable sites – and received a lot of positive feedback – but with the market approval, commercial installations can now be made. There is great interest in evaluating rapid resistance determination, both from prominent laboratories and clinical experts across the United States.

In May, for example, an evaluation agreement was signed with a large reference laboratory network and the company has also initiated an additional evaluation at a major US healthcare centre. The pace of new evaluations is expected to increase now that FDA clearance has enabled the full range of commercial discussion with customers.

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.

Future financing

Q-linea's product, ASTar, has been approved for sales in Europe and in the US following the FDA's approval of ASTar on 26 April. The Company has yet to generate any positive cash flow and is thus continually engaged in pursuing other financing options. This process includes holding discussions with potential partners for the licensing of distribution and sales rights, and negotiations with new and existing investors, financiers and lenders. Additionally, the Company announced a cost-saving programme on 30 January, which has now been implemented and is expected to reduce the Company's overheads by approximately SEK 50 million on a yearly basis, with full effect starting in the third quarter.

At 31 March 2024, Q-linea had available cash and cash equivalents of SEK 29.4 million as well as the unutilised portion of the loan facility offered by the Company's principal owner, Nexttobe, amounting to SEK 41.5 million.

On May 29, the Company announced that the main owner Nexttobe has offered Q-linea an extended loan facility of SEK 60,000,000. Together with the remaining, existing loan facility of SEK 41,500,000, the total loan can then amount to a maximum of SEK 101,500,000 at full utilization and is valid until 30 June 2026 at the latest. The extended loan facility shall be approved at the Annual General Meeting since the transaction is classified as a related party transaction. So far, the Company has utilized SEK 15,000,000.

The available cash and cash equivalents and the total unutilised portion of the loan facility as per 31 March together with the increased and extended 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 ongoing work on possible financing alternatives, the Board of Directors assesses that the prospects are good for financing Q-linea's operations. If the work with the financing is not successful to the extent needed, this may affect the group's ability to implement the current business plan and also constitute a significant factor of uncertainty regarding the group's continued operations.

Income, expenses and earnings

Net sales in the first quarter amounted to SEK 1,476 thousand (22), an increase of SEK 1,454 thousand compared with the corresponding period in the preceding year. Sales comprised ASTar instruments and consumables. Other operating income for the first quarter amounted to SEK 1,436 thousand (24) and pertained to sales of other products and services.

The change in inventory of products in progress, semi-finished goods and finished goods amounted to SEK -1,578 thousand (3,955) for the quarter. Costs for raw materials and consumables and goods for resale for the quarter totalled SEK 366 thousand (1,366).

Other external costs totalled SEK 15,568 thousand (19,476) for the quarter, down SEK 3,908 thousand. The change for the quarter was largely attributable to a yearon-year decrease in the number of consultants.

Personnel costs amounted to SEK 36,325 thousand (41,025) for the quarter. The decrease of SEK 4,700 thousand compared with the corresponding quarter in the preceding year was attributable to the reorganisation completed in 2023. Costs for the Company's employee share option programme for the quarter amounted to SEK 0 (544) thousand including social security contributions.

Costs for depreciation, amortisation and impairment of tangible and intangible assets amounted to SEK 4,807 thousand (4,199) for the quarter. This cost increase was 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 178 thousand (180) for the quarter and pertained largely to exchange-rate losses.

The operating result totalled SEK -55,909 thousand (- 62,244) for the quarter. The earnings improvement of SEK 6,335 thousand was attributable to reduced overheads.

The result from financial items totalled SEK -67 thousand (828) 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 -55,976 thousand (-61,416).

Financial position

Cash and cash equivalents at the end of the quarter totalled SEK 29,369 thousand (81,895). 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 4,199 thousand (4,146) on the balance sheet date, an increase of SEK 53 thousand compared with 2023.

Q-linea's financial assets primarily comprise participations in EMPE Diagnostics AB amounting to SEK 4,095 thousand (4,095) 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 133,832 thousand (189,636), the equity/assets ratio to 77% (82) and the debt/equity ratio to -22% (-43).

Cash flow and investments

Cash flow from operating activities totalled SEK -47,970 thousand (-72,369) for the first quarter. The improvement was primarily attributable to the development of working capital, but also to lower overheads.

Cash flow from investing activities for the first quarter amounted to SEK -2,499 thousand (-3,137), of which investments in tangible assets totalled SEK -2,447 thousand (-3,137) for the first quarter.

Q-linea invested SEK -53 thousand (0) and divested SEK 0 thousand (0) in financial assets in the first quarter.

Cash flow from financing activities totalled SEK -2,171 thousand (23,188) for the first quarter. Repayments of lease liabilities amounted to SEK -2,171 thousand (- 1,812). SEK 0 thousand (25,000) of the loan from the Company's principal owner Nexttobe was utilised in the first quarter.

Parent Company

The Parent Company's net sales for the year amounted to

SEK 5,373 thousand (22), and the loss before tax totalled SEK -48,482 thousand (-61,561). As of 31 March 2024, the Parent Company's cash and cash equivalents totalled SEK 26,489 thousand (79,712).

Other information

Employees

Calculated on the basis of full-time equivalents, Q-linea had 126 (149) employees at the end of the first quarter, 52 (65) of whom were women. The number of consultants on the same date was three (ten), one (four) of whom was woman.

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 38–87 of the 2023 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

SEK thousand 2024 2023 2023
Jan–Mar Jan–Mar Jan–Dec
Operating result (EBIT) -55,909 -62,244 -230,587
Depreciation, amortisation and im
pairment
4,807 4,199 17,521
EBITDA -51,102 -58,045 -213,066

Equity/assets ratio

SEK thousand (unless otherwise
stated)
31 Mar 2024 31 Mar 2023 31 Dec 2023
Total assets 174,079 188,414 231,976
Equity 133,832 102,634 189,636
Equity/assets ratio (%) 77% 54% 82%

Debt/equity ratio

SEK thousand (unless otherwise
stated)
31 Mar 2024 31 Mar 2023 31 Dec 2023
Current liabilities to credit institutions
Current liabilities to owners - 24,753 -
Total borrowing (a) 0 24,753 0
- Less cash and cash equivalents (b) -29,369 -20,559 -81,895
- Less short-term investments (c) - - -
-81,895
- Less long-term investments (d) - - -
Net debt (e=a+b+c+d) -29,369 4,194 -81,895
Equity (f) 133,832 102,634 189,636
Debt/equity ratio (e/f) (%) -22% 4% -43%

Equity per share

SEK thousand (unless otherwise
stated)
31 Mar 2024 31 Mar 2023 31 Dec 2023
Equity (a) 133,832 102,634 189,636
Total number of shares outstanding (b) 117,166,372 29,537,947 117,166,372
- Less holding of treasury shares (c) -328,472 -328,472 -328,472
Equity per share (a/(b-c)), SEK 1.15 3.51 1.62

Performance measures and other information

SEK thousand (unless otherwise stated) 2024 2023 2023
Jan–Mar Jan–Mar Jan–Dec
Earnings
Net sales 1,476 22 4,440
EBITDA -51,102 -58,045 -213,066
Operating result (EBIT) -55,909 -62,244 -230,587
Result for the period -55,976 -61,416 -229,366
Per share
Equity per share, SEK 1.15 3.51 1.62
Earnings per share before and after dilution, SEK -0.48 -2.10 -3.48
Total number of shares outstanding 117,166,372 29,537,947 117,166,372
- of which, treasury shares -328,472 -328,472 -328,472
Number of shares outstanding excl. treasury shares 116,837,900 29,209,475 116,837,900
Total average number of shares 117,166,372 29,537,947 117,166,372
- of which, average number of treasury shares 328,472 328,472 328,472
Average number of shares excl. treasury shares 117,166,372 29,537,947 66,269,862
Cash flow
Cash flow from operating activities -47,970 -72,369 -228,522
Cash flow from investing activities -2,499 -3,137 -7,766
Cash flow from financing activities -2,171 23,188 245,408
SEK thousand (unless otherwise stated) 31 Mar 2024 31 Mar 2023 31 Dec 2023
Financial position
Total assets 174,079 188,414 231,976
Cash and cash equivalents 29,369 20,559 81,895
Short-term and long-term investments - - -
Equity 133,832 102,634 189,636
Equity/assets ratio, % 77 54 82
Debt/equity ratio, % neg 4 neg

The Board of Directors and the CEO 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, 30 May 2024
Stuart Gander Erika Kjellberg Eriksson Anders Ljunggren
CEO Chairperson Managing Director
Mats Nilsson Mario Gualano Nina Korfu-Pedersen
Director Director Director
Karin Fischer Finn Sander Albrechtsen 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

28 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:
Stuart Gander, CEO Tel: +1-857-409-7463 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 31 May 2024 at 7:30 a.m. CEST.

Presentation

Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 31 May 2024, at 1:00 to 2:00 p.m. (CEST). CEO Stuart Gander and CFO Christer Samuelsson will present Q-linea, comment on the interim report for the January to March 2024 period and respond to questions. To participate via webcast, please visit the following link: https://ir.financialhearings.com/q-linea-q1-report-2024

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=50048291

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

2024 2023 2023
Amounts in SEK thousand Note Jan–Mar Jan–Mar Jan–Dec
Net sales 2 1,476 22 4,440
Other operating income 1,436 24 2,183
Changes in inventories of products in progress,
semi-finished goods and finished goods
-1,578 3,955 2,353
Raw materials and consumables, and goods for resale -366 -1,366 -5,786
Other external costs -15,568 -19,476 -64,094
Personnel costs 4 -36,325 -41,025 -150,643
Depreciation/amortisation of tangible and intangible
assets -4,807 -4,199 -17,521
Other operating expenses -178 -180 -1,519
Operating result -55,909 -62,244 -230,587
Financial income 6 1,098 2,790
Financial expenses -73 -270 -1,569
Result from financial items -67 828 1,221
Result before tax -55,976 -61,416 -229,366
Income tax - - -
Result for the period -55,976 -61,416 -229,366
Result attributable to:
Parent Company shareholders -55,976 -61,416 -229,366
Non-controlling interests - - -
Earnings per share before and after dilution 7 -0.48 -2.10 -3.48

Consolidated statement of comprehensive income

Amounts in SEK thousand 2024 2023 2023
Note Jan–Mar Jan–Mar Jan–Dec
Result for the period -55,976 -61,416 -229,366
Other comprehensive income, net after tax - - -
Items that may be subsequently reversed in profit or loss
Change in fair value of financial instruments - 317 -
Translation differences 172 - -160
Total comprehensive income -55,804 -61,099 -229,526
Comprehensive income attributable to:
Parent Company shareholders -55,804 -61,099 -229,526

Consolidated statement of financial position

Amounts in SEK thousand Note 31 Mar 2024 31 Mar 2023 31 Dec 2023
ASSETS
Non-current assets
Tangible assets 34,101 37,173 34,060
Right-of-use assets 17,518 26,035 21,528
Goodwill 4,617 4,889 4,889
Other intangible assets 105 196 126
Financial assets 6 4,199 4,145 4,146
Total non-current assets 60,541 72,437 64,749
Current assets
Inventories 5 43,519 48,190 46,527
Accounts receivable 2,000 28 60
Other receivables 34,488 44,595 35,711
Prepaid expenses and accrued income 4,163 2,605 3,034
Short-term investments - - -
Cash and cash equivalents 29,369 20,559 81,895
Total current assets 113,538 115,978 167,227
TOTAL ASSETS 174,079 188,414 231,976

Consolidated statement of financial position

Amounts in SEK thousand Note 31 Mar 2024 31 Mar 2023 31 Dec 2023
EQUITY AND LIABILITIES
Equity attributable to Parent Company shareholders
Share capital 5,858 1,477 5,858
Reserves 1,483,364 1,234,972 1,483,364
Other contributed capital 145 -4 -745
Retained earnings, including result for the year -1,355,536 -1,133,810 -1,298,842
Total equity attributable to Parent Company share
holders
133,832 102,634 189,636
Equity attributable to non-controlling
interests - - -
Total equity 133,832 102,634 189,636
Liabilities
Non-current liabilities
Non-current lease liabilities 9,612 17,928 12,905
Total non-current liabilities 9,612 17,928 12,905
Current liabilities
Loans from credit institutions - - -
Loan from principal owner 3 - 24,753 -
Accounts payable 5,610 13,829 5,305
Current lease liabilities 6,691 7,074 7,659
Current tax liabilities - - -
Other liabilities 4,046 5,739 6,805
Accrued expenses and deferred income 14,287 16,458 9,665
Total current liabilities 30,635 67,852 29,435
Total liabilities 40,247 85,780 42,340
TOTAL EQUITY AND LIABILITIES 174,079 188,414 231,976

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 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 pe
riod
0 0 0 -61,099 -61,099
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
Opening balance, 1 Jan 2023 1,477 1,234,972 -4 -1,073,255 163,190
Result for the period - - - -229,366 -229,366
Other comprehensive income - - -742 582 -160
Comprehensive income for the pe 0 0 -742 -228,784 -229,526
riod
New share issue
4,381 258,504 - - 262,885
Issue costs - -10,111 - - -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, 31 Dec 2023 5,858 1,483,364 -745 -1,298,842 189,636
Opening balance, 1 Jan 2024 5,858 1,483,364 -745 -1,298,842 189,636
Result for the period - - - -55,976 -55,976
Other comprehensive income - - 891 -719 172
Comprehensive income for the pe
riod
0 0 891 -56,694 -55,804
Share-based remuneration pro 4 - - - - 0
grammes
Transactions with shareholders
0 0 0 0 0
Closing balance, 31 Mar 2024 5,858 1,483,364 145 -1,355,536 133,832

1) There are no non-controlling interests.

Consolidated statement of cash flows

Amounts in SEK thousand 2024 2023 2023
Jan–Mar Jan–Mar Jan–Dec
Cash flow from operating activities
Operating result -55,909 -62,244 -230,587
Adjustments for non-cash items 4,797 4,744 20,879
Interest received 7 - 1,691
Interest paid -38 -230 -1,562
Tax paid - - -
Cash flow from operating activities
before changes in working capital
-51,143 -57,731 -209,580
Changes in working capital
Change in inventories 3,045 -5,909 -4,265
Change in accounts receivable -1,940 -28 -61
Change in other current receivables 103 1,098 9,485
Change in other current liabilities 1,681 -2,072 -7,874
Change in accounts payable 285 -7,726 -16,227
Changes in working capital 3,173 -14,638 -18,941
Cash flow from operating activities -47,970 -72,369 -228,521
Cash flow from investing activities
Investments in tangible assets -2,447 -3,137 -8,342
Short-term investments - - -80,000
Divestment of short-term investments - - 80,000
Investments in financial assets -52 - -
Divestment of financial assets - - -
Cash flow from investing activities -2,499 -3,137 -7,766
Cash flow from financing activities
New share issue - - 262,885
Issue costs - - -10,111
Loans raised from principal owner - 25,000 87,000
Repayment of lease liabilities -2,171 -1,812 -7,367
Repayment of loans - - -87,000
Cash flow from financing activities -2,171 23,188 245,407
Cash flow for the period -52,640 -52,318 9,120
Cash and cash equivalents at the beginning of the period 81,895 72,878 72,878
Exchange rate difference in cash and cash equivalents 114 -1 -103
Cash and cash equivalents at the end of the period 29,369 20,559 81,895

Parent Company income statement

Amounts in SEK thousand Note 2024 2023 2023
Jan–Mar Jan–Mar Jan–Dec
Net sales 2 5,373 22 7,391
Other operating income 879 24 2,183
Changes in inventories of products in progress,
semi-finished goods and finished goods
-4,916 3,955 -480
Raw materials and consumables, and goods for resale -360 -1,366 -5,786
Other external costs -16,056 -21,388 -70,191
Personnel costs 4 -30,599 -41,025 -142,352
Depreciation/amortisation of tangible and intangible
Non-current assets -2,658 -2,637 -11,093
Other operating expenses -164 -180 -1,516
Operating result -48,501 -62,594 -221,844
Revenue from holdings of listed corporate
bonds that are non-current assets
- - -
Other interest income and similar profit items 20 1,098 2,790
Interest expenses and similar loss items -1 -65 -710
Result from financial items 20 1,033 2,080
Result before tax -48,482 -61,561 -219,764
Tax on result for the period - - -
Result for the period -48,482 -61,561 -219,764

Parent Company statement of comprehensive income

Note 2024 2023 2023
Amounts in SEK thousand Jan–Mar Jan–Mar Jan–Dec
Result for the period -48,482 -61,561 -219,764
Other comprehensive income, net after tax
Items that may be subsequently reversed in profit or loss
Changes in fair value of financial instruments - 317 -
Total comprehensive income -48,482 -61,244 -219,764

Parent Company balance sheet

Amounts in SEK thousand
Note 31 Mar 2024 31 Mar 2023 31 Dec 2023
ASSETS
Non-current assets
Intangible assets
Licences - 6 -
Technology and customer relationships 105 190 126
Goodwill 1,358 2,444 1,630
Total intangible assets 1,463 2,640 1,756
Tangible assets
Equipment, tools, fixtures and fittings 29,473 37,173 31,838
Total tangible assets 29,473 37,173 31,838
Financial assets
Participations in Group companies 21,428 376 12,966
Other securities held as non-current assets 6 4,095 4,095 4,095
Other non-current receivables 51 50 51
Total financial assets 25,574 4,521 17,112
Total non-current assets 56,510 44,333 50,706
Current assets
Inventories 5 42,417 48,190 46,225
Current receivables
Accounts receivable 5,164 28 1,558
Other receivables 35,466 44,595 35,367
Prepaid expenses and accrued income 5,407 4,276 4,299
Total current receivables 46,037 48,900 41,224
Cash and bank balances 26,489 20,285 79,712
Total current assets 114,943 117,375 167,161
TOTAL ASSETS 171,453 161,708 217,867

Parent Company balance sheet

Amounts in SEK thousand
31 Mar 2024 31 Mar 2023 31 Dec 2023
EQUITY AND LIABILITIES
Restricted equity
Share capital 5,858 1,477 5,858
Total restricted equity 5,858 1,477 5,858
Unrestricted equity
Share premium reserve 1,483,364 1,234,972 1,483,364
Fair value reserve - - -
Retained earnings -1,291,386 -1,073,959 -1,071,622
Result for the period -48,482 -61,561 -219,764
Total unrestricted equity 143,497 99,453 191,979
Total equity 149,355 100,929 197,837
Liabilities
Current liabilities
Loans from credit institutions - - -
Loan from principal owner - - -
Accounts payable 5,649 13,829 4,762
Current tax liabilities - - -
Other liabilities 3,727 5,739 6,356
Accrued expenses and deferred income 12,722 16,458 8,912
Total current liabilities 22,098 60,779 20,030
Total liabilities 22,098 60,779 20,030
TOTAL LIABILITIES AND EQUITY 171,453 161,708 217,867

Parent Company statement of changes in equity

Restricted
equity
Unrestricted equity
Share Fair Retained Result for Total eq
Amounts in SEK thousand Note Share capital premium value earnings the period uity
reserve reserve
Opening balance, 1 Jan 2023 1,477 1,234,972 0 -805,316 -269,503 161,630
Result for the period
Comprehensive income
Other comprehensive income
-
-
-
-
-
-
-
317
-61,561
-
-61,561
317
Appropriation of profits in accordance with
AGM decision:
- Carried forward to unrestricted equity - - - -269,503 269,503 0
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 0 0 0 544 0 544
Closing balance, 31 March 2023 1,477 1,234,972 0 -1,073,959 -61,561 100,929
0312-31
Opening balance, 1 Jan 2023 1,477 1,234,972 0 -805,316 -269,503 161,630
Comprehensive income
Result for the period - - - - -219,764 -219,764
Other comprehensive income - - - - - 0
Appropriation of profits in accordance with
AGM decision:
- Carried forward to unrestricted equity - - - -269,503 269,503 0
Total comprehensive income 0 0 0 -269,503 49,739 -219,764
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, 31 Dec 2023 5,858 1,483,364 0 -1,071,622 -219,764 197,837
Opening balance, 1 Jan 2024 5,858 1,483,364 0 -1,071,622 -219,764 197,837
Comprehensive income
Result for the period - - - - -48,482 -48,482
Other comprehensive income - - - - - 0
Appropriation of profits in accordance with
AGM decision:
- - - -219,764 219,764 0
- Carried forward to unrestricted equity - - - - - 0
Total comprehensive income 0 0 0 -219,764 171,282 -48,482
Transactions with shareholders
Share-based remuneration programmes 4 - - - - - 0
Transactions with shareholders - - - - - 0
Closing balance, 31 Mar 2024 5,858 1,483,364 0 -1,291,386 -48,482 149,355

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 2023 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:

2024 2023 2023
SEK thousand Jan–Mar Jan–Mar Jan–Dec
Sweden - 22 60
UK 57 - 1,522
France 95 - 2,857
Finland 1,314 - -
Total net sales by geographic market 1,466 22 4,440

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, the parent company made a capital contribution to Q-linea S.r.l. of EUR 200 thousand (10), which was recognised as SEK 2,219 thousand (111) in the Parent Company, and a capital contribution to Q-linea Inc of USD 600 thousand (0), which was recognised as SEK 6,243 thousand (0) in the parent company.

Q-linea AB had a remaining loan facility with its principal owner, Nexttobe, of SEK 41.5 million as of 31 March. The conditions for the loan facility were established at the 2023 Annual General Meeting. Q-linea and its principal owner, Nexttobe, are considered to be related parties, and as a result the rules in Chapter 16a of the Swedish Companies Act on related-party transactions had to be taken into account. It is expected that the portion of the loan facility remaining as of the forthcoming Annual General Meeting will be extended by 12 months.

Note 4 Share-based remuneration programmes

As of 31 March 2024, Q-linea had two employee share option programmes.

The employee share options in the two programmes were allotted free of charge on 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 2024, there were employee share options outstanding as follows:

Programme Date range for possible exercise Number of op
tions outstanding
Total possible
number of
shares
Exercise
price
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 315,850

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 2024, the Company had an inventory value of SEK 43,519 thousand (46,527).

SEK thousand 31 Mar
2024
31 Mar
2023
31 Dec
2023
Raw materials and consumables 8,356 8,968 8,531
Goods for resale 25,497 29,925 27,648
Products in progress 5,152 215 5,856
Semi-finished goods 3,971 6,668 2,361
Finished goods 543 2,415 2,131
Total inventories 43,519 48,190 46,527

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 2024.

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 2024.

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) 2024 2023 2023
Jan–Mar Jan–Mar Jan–Dec
Result for the period -55,976 -61,416 -229,366
Weighted average number of shares outstanding 117,166,372 29,537,947 66,269,862
- Less average holding of treasury shares -328,472 -328,472 -328,472
Earnings per share before and after dilution (SEK) -0.48 -2.10 -3.48

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 2023 financial year.

Note 9 Future financing

Q-linea's product, ASTar, has been approved for sales in Europe and in the US following the FDA's approval of ASTar on 26 April. The Company has yet to generate any positive cash flow and is thus continually engaged in pursuing other financing options. This process includes holding discussions with potential partners for the licensing of distribution and sales rights, and negotiations with new and existing investors, financiers and lenders. Additionally, the Company announced a cost-saving programme on 30 January, which has now been implemented and is expected to reduce the Company's overheads by approximately SEK 50 million on a yearly basis, with full effect starting in the third quarter.

At 31 March 2024, Q-linea had available cash and cash equivalents of SEK 29.4 million as well as the unutilised portion of the loan facility offered by the Company's principal owner, Nexttobe, amounting to SEK 41.5 million.

On May 29, the Company announced that the main owner Nexttobe has offered Q-linea an extended loan facility of SEK 60,000,000. Together with the remaining, existing loan facility of SEK 41,500,000, the total loan can then amount to a maximum of SEK 101,500,000 at full utilisation and is valid until 30 June 2026 at the latest. The extended loan facility shall be approved at the Annual General Meeting since the transaction is classified as a related party transaction. So far the Company has utilized SEK 15,000,000.

The available cash and cash equivalents and the total unutilised portion of the loan facility as per 31 March together with the increased and extended 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 ongoing work on possible financing alternatives, the Board of Directors assesses that the prospects are good for financing Q-linea's operations. If the work with the financing is not successful to the extent needed, this may affect the group's ability to implement the current business plan and also constitute a significant factor of uncertainty regarding the group's continued operations.

Note 10 Significant events after the end of the period

Q-linea receives US FDA 510(k) clearance for the ASTar® System on 26 April.

Q-linea signs evaluation contract with reference laboratory network in the US.

Q-linea applies for a NTAP code for the US market.

The company sends out a notice for the 2024 Annual General Meeting, which will be held on June 28.

Q-linea announced that the technology behind Podler has been valued at SEK 70 million. The valuation is based on a report carried out by an external analysis company.

The company receives an extended loan facility from its main owner Nexttobe. Total facility, when utilized, amounts to SEK 101,500,000.

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