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Q-Linea
Quarterly Report • Nov 5, 2024
3100_10-q_2024-11-05_7265aeec-00f4-4293-9480-f1f41456beda.pdf
Quarterly Report
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Q3
Growing pipeline in the US
Third quarter: 1 July – 30 September 2024
- Net sales amounted to SEK 0.6 million (3.0).
- The operating result totalled SEK -41.1 million (-48.2).
- The result for the period amounted to SEK -42.4 million (-48.6).
- Earnings per share before and after dilution amounted to SEK -0.36 (-0.56) SEK.
- Cash flow from operating activities totalled SEK -50.0 million (-54.5).
Period: 1 January – 30 September 2024
- Net sales amounted to SEK 2.2 million (4.4).
- The operating result totalled SEK -162.4 million (-175.1).
- The result for the period amounted to SEK -164.0 million (-175.1).
- Earnings per share before and after dilution amounted to SEK -1.4 (-3.59).
- Cash flow from operating activities totalled SEK -142.1 million (-180.3).
- As of 30 September 2024, the Company had a total of SEK 7.5 million (81.9) in available funds. In addition, the Company has an unutilized loan facility of SEK 23 million (41.5) from the principal owner Nexttobe.
Significant events
In the third quarter of 2023
- The Company participates in its first public tender in Belgium.
- Two American hospitals presented ASTar-data in line with good results shown in several European studies.
- CMS grants New Technology Add-on Payment (NTAP) for ASTar with a reimbursement of USD 97.50 per eligeble patient.
- Q-linea expands its operation to Romania and the Middle East through two new distribution agreements.
After the of the period
- Q-linea announces changes in executive leadership team and expands US commercial team.
- Large US reference laboratory completes ASTar evaluation successfully.
- Two UK commercial evaluations successfully completed.
- The Company receives a formal request for a contract from a prominent hospital in Milano and participates in a multi-site public tender in Italy.
- First clinical evaluation of ASTar begins at a National Cancer Institute-designated (NCI) cancer center.
- Q-linea resolves to carry out a rights issue of approximately SEK 225 million and enters into an agreement for a bridge loan facility of approximately SEK 40 million.
Growing pipeline in the US
ASTar® awarded NTAP funding
\$97.50 in reimbursement for Medicare and Medicaid patients
Unique reimbursement from Medicare for ASTar analyses! Q-linea is the only company to receive NTAP reimbursement from Medicare for rapid resistance testing. We estimate that this will accelerate the use of ASTar in the U.S.
More than 66 million people in the United States are covered by the Medicare health insurance. It is partly publicly funded, partly paid by the patient.
In August, the U.S. Centers for Medicare and Medicaid Services (CMS) announced that ASTar System had been awarded NTAP funding. NTAP is an abbreviation of New Technology Add-on Payment. It is a way to make it easier for hospitals to introduce new technologies into clinical routines. ASTar qualified by meeting criteria around significant clinical improvement, novelty and cost.
The funding is valid for three years, from October 2024 to September 2027. Patient cases involving the use of ASTar and eligible for reimbursement will be identified using a unique NTAP code. The additional reimbursement to the hospital will be \$97.50 per eligible Medicare patient.
Growing pipeline in the US
Even before the FDA approval in April, we started a number of ASTar evaluations and it is gratifying to see the results. In August, clinical data was presented for the first time by a U.S. university hospital at the annual meeting of the Southwestern Association of Clinical Microbiology. The performance and results were as expected and in line with what had previously been shown in several European studies. At a webinar in September, Penn State Hersey Medical Center and George Washington University presented additional interim data from their respective studies, corroborating the August presentation.
This US-specific clinical data is an additional factor driving the growing pipeline of customers seeking to evaluate the ASTar platform. Our US team has been focused on the top 200 – 300 hospitals and labs in the US, and now have a sizeable pipeline of customers lined up for evaluations through the autumn and winter. Several of these are at or nearing completion and are entering
commercial contracting. I hope to be able to announce our first US commercial placements during Q4 2024.
Market expansion
We continue the geographical expansion with a focus on countries and regions that are actively working to address the challenge of antibiotic resistance. Romania is one of the countries with the highest number of infections with antibiotic-resistant bacteria in the EU. With the help of financial support, the country has drawn up a national action plan for optimising the use of antibiotics. We have found a very knowledgeable and experienced partner in S.C. Mecro System S.R.L. to bring ASTar into the country.
After evaluation of several potential partners for expansion in the Middle East, we are very pleased to have entered into an exclusive agreement with the medical technology company AMICO Group. The company is active in 12 countries in the Middle East and North Africa and employs more than 1,300 people. Q-linea will benefit from their extensive experience in clinical microbiology.
In our other core EMEA markets, projects continue to move through the pipeline. Our partner in the UK, Pro-Lab, has completed two successful evaluations with others ongoing. We anticipate that these will convert to commercial systems, along with similar projects in Benelux and Italy which should yield contracts in Q4.
Organization and cost savings
The previously communicated cost savings program is now clearly visible in the results for the third quarter. In addition to the total cost savings of approximately SEK 50 million on an annual basis, there has also been a shift of resources and focus from development and clinical studies to sales and market support activities. We will continue to maintain good cost control and to balance the increased need for in-market resources with savings in other areas.
As Thomas Fritz and Tiziana Di Martino prepare to leave the management team, having both been instrumental in establishing ASTar on the market, Franco Pellegrini, who led our launch in the Italian market, will take on the overall leadership of the EMEA commercial and clinical teams. We have also strengthened our US commercial team to meet the demands of a fast-expanding pipeline.
Financing
We are entering a critical phase of Q-linea's journey, having positioned ourselves assertively during 2024 for accelerated commercial growth. The communicated Rights Issue will provide us with funding for a pivotal upcoming period when we expect to see a steady pace of commercial contracts and revenue generation.
Uppsala, den 4 November 2024, Stuart Gander, koncernchef
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 first product, ASTar, has been approved for sales in Europe and in the US market 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.
The available cash and cash equivalents as of 30 September amount to SEK 7.5 million. In addition, there is an unutilized part of a loan facility from the Company´s principal owner Nexttobe of SEK 23 million.
The Board considers the available cash and cash equivalents, the unutilised portion of the loan facility and the 80 percent underwritten, ongoing rights issue, sufficient to cover the Company's requirements to carry out the activities planned for the next 12 months.
Income, expenses and earnings
Net sales in the third quarter amounted to SEK 569 thousand (2,998), a decrease of SEK 2,429 thousand compared to the corresponding period in the preceding year. Net sales for the January-September period totalled SEK 2,204 thousand (4,378), a decrease of SEK 2,174 thousand. Sales comprised ASTar instruments and consumables.
Other operating income amounted to SEK 281 thousand (1,484) for the third quarter and SEK 2,179 thousand (2, 041) for the January to September period, and refers primarily to sales of customer-specific prototypes and services.
The change in inventories of products in progress, semifinished goods and finished goods amounted to SEK -
2,207 thousand (-2,646) for the third quarter and SEK - 3,114 thousand (162) for the January to September period. A negative value indicates a cost.
Costs for raw materials and consumables and goods for resale totalled SEK 1,126 thousand (-693) for the third quarter and SEK -2,759 thousand (-4,402) for the January to September period.
Other external costs totalled SEK -11,391 thousand (- 9,841) for the quarter, up SEK 1,550 thousand. Costs for the January – September period totalled SEK -40,866 thousand (-51,019), down SEK 10,153 thousand. The changes during the quarter were largely attributable to a decrease in the number of consultants during both the quarter and the period.
Personnel costs amounted to SEK -24,689 thousand (- 34,463) for the quarter, down SEK 9,774 thousand. Personnel costs for the January-September period amounted to SEK -105,274 thousand (-111,910), down SEK 6,636 thousand. The decrease is attributable to the reorganization completed in 2024 where restructuring costs totalling SEK 8,426 thousand was taken in the third quarter. Cost for the Company´s employee share option program amounted to 0 (0) for the quarter, including social security contributions and to SEK 0 thousand (3,902) for the January-September period.
Costs for depreciation, amortisation and impairment of tangible and intangible assets totalled SEK -4,153 thousand (-4 423) for the quarter and SEK -13,420 thousand (- 13,131) for the January-September period.
Other operating expenses amounted to SEK -686 thousand (-669) for the quarter and SEK -1,342 thousand (- 1,224) for the January-September period and pertained largely to exchange-rate losses.
The operating result SEK -41,150 thousand (-48,253) for the quarter and SEK -162,392 thousand (-175,103) for the January-September period. The improvement is primarily attributable to lower costs for personnel and consultants.
The result from financial items totalled SEK -1,217 thousand (-395) for the quarter and SEK -1,683 thousand (-5) for the January-September period. Increased cost explained by higher loans from the principal owner Nexttobe.
The reported tax for the quarter and for the January-September period amounted to SEK 0 thousand (0).
The result totalled SEK -42,366 (-48,648) for the third quarter and SEK -164,075 thousand (-175,108) for the January-September period.
Financial position
Cash and cash equivalents at the end of the quarter totalled SEK 7,451 thousand (81 895).
Financial assets totalled SEK 4,196 thousand (4,146) on the balance sheet date.
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 25,665 thousand (189,636), the equity/assets ratio to 19% (82) and the debt/equity ratio to 277% (-neg.).
Cash flow and investments
Cash flow from operating activities totalled SEK -50,039 thousand (-54,452) for the third quarter and SEK -142,127 thousand (-180,331) for the January-September period. The improvement was primarily attributable to the development of working capital, but also to lower overheads.
Cash flow from investing activities amounted to SEK 1,558 thousand (-79,525) for the third quarter and SEK - 4,961 thousand (-85,030) for the January- September period, of which investments in tangible assets totalled SEK 1,558 thousand (475) for the third quarter and SEK -4,909 thousand (-5,030) for the January-September period.
The Company invested SEK 0 thousand (80,000) in financial assets in the third quarter and in the January-September period.
Cash flow from financing activities totalled SEK 35,245 thousand (163,900) for the third quarter and SEK 72,754 thousand (247,306) for the January-September period. SEK 37,000 thousand (0) of the loan from the Company´s principal owner Nexttobe was utilized in the third quarter and SEK 78,500 thousand (87,000) in the period.
Remaining amount refers to repayment of lease liabilities.
Parent Company
The Parent Company's net sales for the January – September period amounted to SEK 13,934 thousand (4,378), and the result before tax totalled SEK -135,184 thousand (-170,424). As of 30 September 2024, the Parent Company's cash and cash equivalents totalled SEK 4,840 thousand (79,712).
Other information
Nomination Committee
Q-linea´s Nomination Committee ahead of the 2025 Annual General meeting has been appointed and comprises: Öystein Engebretsen, Chairman of the Nomination Committee (Investment AB Öresund), Erika Kjellberg Eriksson, Chairperson of Q-linea AB (Nexttobe AB) and Ulf Landegren (Landegren Gene Technology AB).
Employees
Q-linea had 97 (122) employees at the end of the third quarter, 39 (49) of whom were women. The number of consultants on the same date was three (three), one (0) of whom was a 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 related parties/Group companies and provisions), less cash and cash equivalents and short and long-term investments. |
This performance measure is a measure of capital strength and is used to determine the relationship between liabilities and equity. In the case of positive equity, a negative debt/equity ratio means that available cash and cash equivalents and short-term investments exceed total borrowing. |
| Equity per share before and after dilution |
Equity attributable to the Company's shareholders in relation to the number of shares outstanding, excluding treasury shares, at the end of the period. |
This performance measure shows the amount of the Company's equity that can be attributed to a share. |
Reconciliation of alternative performance measures
The following is a reconciliation of certain alternative performance measures showing the various performance measure components that make up the alternative performance measures. Treasury shares refers to the Company's own holding to ensure the delivery of performance shares. In the event that share options are exercised, shares will be primarily allotted from treasury shares and secondarily through a new issue.
The Company's holding of treasury shares has been excluded from the calculation of per-share performance measures.
EBITDA
| SEK thousand | 2024 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|
| Operating result (EBIT) | -41,150 | -48,253 | -162,392 | -175,103 | -230,587 |
| Depreciation, amortisation and impairment |
4,153 | 4,423 | 13,420 | 13,131 | 17,521 |
| EBITDA | -36,997 | -43,830 | -148,972 | -161,972 | -213,066 |
Equity/assets ratio
| SEK thousand (unless otherwise stated) | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 |
|---|---|---|---|
| Total assets | 138,563 | 285,239 | 231,976 |
| Equity | 25,665 | 244,076 | 189,636 |
| Soliditet (%) | 19% | 86% | 82% |
Debt/equity ratio
| SEK thousand (unless otherwise stated) | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 |
|---|---|---|---|
| Current liabilities to credit institutions | - | - | - |
| Current liabilities to owners | 78,500 | - | - |
| Total borrowing (a) | 78,500 | 0 | 0 |
| - Less cash and cash equivalents (b) | -7,451 | -54,945 | -81,895 |
| - Less short-term investments (c) | - | -80,000 | - |
| - Less long-term investments (d) | - | - | - |
| Net debt (e=a+b+c+d) | 71,049 | -134,945 | -81,895 |
| Equity (f) | 25,665 | 244,076 | 189,636 |
| Debt/equity ratio (e/f) (%) | 277% | -55% | -43% |
Equity per share
| SEK thousand (unless otherwise stated) | 2024-09-30 | 2023-09-30 | 2023-12-31 |
|---|---|---|---|
| Equity (a) | 25,665 | 244,076 | 189,636 |
| Total number of shares outstanding (b) | 117,166,372 | 117,166,372 | 117,166,372 |
| - Less holding of treasury shares (c) | -328,472 | -328,472 | -328,472 |
| Equity per share (a/(b-c)), SEK | 0.22 | 2.09 | 1.62 |
Performance measures and other information
| SEK thousand (unless otherwise stated) | 2024 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|
| Earnings | |||||
| Net sales | 569 | 2,998 | 2,204 | 4,378 | 4,440 |
| EBITDA | -36,997 | -43,830 | -148,972 | -161,972 | -213,066 |
| Operating result (EBIT) | -41,150 | -48,253 | -162,392 | -175,103 | -230,587 |
| Result for the period | -42,366 | -48,648 | -164,075 | -175,108 | -229,366 |
| Per share | |||||
| Equity per share, SEK | 0.22 | 2.09 | 0.22 | 2.09 | 1.62 |
| Earnings per share before and after dilution, SEK | -0.36 | -0.56 | -1.40 | -3.59 | -3.48 |
| Total number of shares outstanding | 117,166,372 | 117,166,372 | 117,166,372 | 117,166,372 | 117,166,372 |
| - of which, treasury shares | 328,472 | 328,472 | 328,472 | 328,472 | 328,472 |
| Number of shares outstanding excl. treasury shares | 116,837,900 | 116,837,900 | 116,837,900 | 116,837,900 | 116,837,900 |
| Total average number of shares | 117,166,372 | 87,639,403 | 117,166,372 | 49,117,925 | 66,269,862 |
| - of which, average number of treasury shares | 328,472 | 328,472 | 328,472 | 328,472 | 328,472 |
| Average number of shares excl. treasury shares | 116,837,900 | 87,310,931 | 116,837,900 | 48,789,453 | 65,941,390 |
| Cash flow | |||||
| Cash flow from operating activities | -50,039 | -54,452 | -142,127 | -180,331 | -228,522 |
| Cash flow from investing activities | 1,558 | -79,525 | -4,961 | -85,030 | -7,766 |
| Cash flow from financing activities | 35,245 | 163,900 | 72,754 | 247,307 | 245,408 |
| SEK thousand (unless otherwise stated) |
30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 |
|---|---|---|---|
| Financial position | |||
| Total assets | 138,563 | 285,188 | 231,976 |
| Cash and cash equivalents | 7,451 | 54,945 | 81,895 |
| Short-term and long-term investments | - | 80,000 | - |
| Equity | 25,665 | 244,076 | 189,636 |
| Equity/assets ratio, % | 19 | 86 | 82 |
| Debt/equity ratio, % | 277 | neg | neg |
The Board of Directors and the President hereby certify that this interim report provides a fair and true overview of the Company's operations, financial position and earnings and describes the material risks and uncertainties facing the Company.
Uppsala 4 November 2024
| Stuart Gander | Erika Kjellberg Eriksson | Anders Ljunggren |
|---|---|---|
| CEO | Chairperson | Managing Director |
| Hans Johansson | Mario Gualano | Karin Fischer |
| Director | Director | Director |
| Finn Sander Albrechtsen Director |
Jonas Jarvius Director |
This report has been reviewed by the auditor of the Company. The report has been prepared in a Swedish original and an English translation. In the event of any discrepancies between the two, the Swedish version is to apply.
Upcoming reporting events
| 13 February 2025 | Year-end report | January to December 2024 |
|---|---|---|
| 11 April 2025 | 2024 Annual Report | |
| 2 May 2025 | Interim report, Q1 | January to March 2025 |
| 22 May 2025 | 2025 Annual General Meeting | |
| 10 July 2025 | Interim report, Q2 | January to June 2025 |
| 30 October 2025 | Interim report, Q3 | January to September 2025 |
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: 070 - 600 1520 | E-mail: [email protected] |
This information is information that Q-linea AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Market Act. The information was submitted for publication, through the agency of the contact persons set out above, on 5 November 2024 at 7:30 a.m. CET.
Presentation
Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 5 November 2024 kl. 13:00 – 14:00 (CET). CEO Stuart Gander and CFO Christer Samuelsson will present Q-linea, comment on the interim report for the January to September 2024 period and respond to questions.
To participate via webcast, please visit the following link: https://ir.financialhearings.com/q-linea-q3-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=50048764
You will receive a telephone number and a meeting ID to log into the conference call after registering. There will be an opportunity to ask questions verbally during the conference call.
Consolidated statement of profit and loss
| Amounts in SEK thousand | Note | 2024 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|---|
| Net sales | 2 | 569 | 2,998 | 2,204 | 4,378 | 4,440 |
| Other operating income | 281 | 1,484 | 2,179 | 2,041 | 2,183 | |
| Changes in inventories of products in progress, semi-finished goods and finished goods |
-2,207 | -2,646 | -3,114 | 162 | 2,341 | |
| Raw materials and consumables, and goods for resale |
1,126 | -693 | -2,759 | -4,402 | -5,786 | |
| Other external costs | -11,391 | -9,841 | -40,866 | -51,019 | -64,083 | |
| Personnel costs | 4 | -24,689 | -34,463 | -105,274 | -111,910 | -150,643 |
| Depreciation/amortisation of tangible and intangible assets |
-4,153 | -4,423 | -13,420 | -13,131 | -17,521 | |
| Other operating expenses | -686 | -669 | -1,342 | -1,224 | -1,519 | |
| Operating result | -41,150 | -48,253 | -162,392 | -175,103 | -230,587 | |
| Financial income | 4 | 261 | 6 | 1,359 | 2,790 | |
| Financial expenses | -1,221 | -656 | -1,689 | -1,364 | -1,569 | |
| Result from financial items | -1,217 | -395 | -1,683 | -5 | 1,221 | |
| Result before tax | -42,366 | -48,648 | -164,075 | -175,108 | -229,366 | |
| Income tax | - | - | - | - | - | |
| Result for the period | -42,366 | -48,648 | -164,075 | -175,108 | -229,366 | |
| Result attributable to: | ||||||
| Parent Company shareholders | 7 | -42,366 | -48,648 | -164,075 | -175,108 | -229,366 |
| Non-controlling interests | - | - | - | - | - | |
| Earnings per share before and after dilution | -0.36 | -0.56 | -1.40 | -3.59 | -3.48 |
Consolidated statement of comprehensive income
| Amounts in SEK thousand | 2024 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|
| Result for the period | -42,366 | -48,648 | -164,075 | -175,108 | -229,366 |
| Items that may be subsequently reversed in profit or loss |
- | - | - | - | - |
| Change in fair value of financial instruments | - | - | - | - | - |
| Translation differences | -1,359 | -115 | -1,417 | 12 | -160 |
| Total comprehensive income | -43,725 | -48,763 | -165,493 | -175,096 | -229,526 |
| Comprehensive income attributable to: | |||||
| Parent Company shareholders | -43,725 | -48,763 | -165,493 | -175,096 | -229,526 |
| Non-controlling interests | - | - | - | - | - |
Consolidated statement of financial position
| Amounts in SEK thousand | Note | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Tangible assets | 31,176 | 33,934 | 34,060 | |
| Right-of-use assets | 14,812 | 23,295 | 21,528 | |
| Goodwill | 4,889 | 4,889 | 4,889 | |
| Other intangible assets | 63 | 148 | 126 | |
| Financial assets | 6 | 4,196 | 4,145 | 4,146 |
| Total non-current assets | 55,137 | 66,409 | 64,749 | |
| Current assets | ||||
| Inventories | 5 | 39,619 | 43,351 | 46,527 |
| Accounts receivable | 271 | 1,233 | 60 | |
| Other receivables | 34,169 | 36,684 | 35,711 | |
| Prepaid expenses and accrued income | 1,917 | 2,566 | 3,034 | |
| Short-term investments | 6 | - | 80,000 | - |
| Cash and cash equivalents | 7,451 | 54,945 | 81,895 | |
| Total current assets | 83,426 | 218,779 | 167,227 | |
| TOTAL ASSETS | 138,563 | 285,188 | 231,976 |
Consolidated statement of financial position
| Amounts in SEK thousand | Note | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 |
|---|---|---|---|---|
| EQUITY AND LIABILITIES | ||||
| Equity attributable to Parent Company share holders |
||||
| Share capital | 5,858 | 5,858 | 5,858 | |
| Reserves | 1,483,364 | 19 | -745 | |
| Other contributed capital | -1,417 | 1,483,364 | 1,483,364 | |
| Retained earnings, including result for the year |
-1,462,141 | -1,245,165 | -1,298,842 | |
| Total equity attributable to Parent Company shareholders |
25,665 | 244,076 | 189,636 | |
| Equity attributable to non-controlling interest | - | - | - | |
| Total equity | 25,665 | 244,076 | 189,636 | |
| Liabilities | ||||
| Non-current liabilities | ||||
| Non-current lease liabilities | 7,100 | 14,769 | 12,905 | |
| Total non-current liabilities | 7,100 | 14,769 | 12,905 | |
| Kortfristiga skulder | ||||
| Loan from principal owner | 3 | 78,500 | - | - |
| Accounts payable | 2,134 | 5,241 | 5,305 | |
| Current lease liabilities | 6,738 | 7,557 | 7,659 | |
| Current tax liabilities | - | - | - | |
| Other liabilities | 2,772 | 5,464 | 6,805 | |
| Accrued expenses and deferred income | 15,655 | 8,080 | 9,665 | |
| Total current liabilities | 105,798 | 26,343 | 29,435 | |
| Total liabilities | 112,898 | 41,112 | 42,340 | |
| TOTAL EQUITY AND LIABILITIES | 138,563 | 285,188 | 231,976 |
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 2023 | 1,477 | 1,234,972 | -4 | -1,073,255 | 163,190 | |||
| Result for the period | - | - | - | -175,107 | -175,107 | |||
| Other comprehensive income | - | - | 15 | 7 | 22 | |||
| Comprehensive income for the period |
- | - | 15 | -175,100 | -175,085 | |||
| New share issue | 4,381 | 258,504 | - | - | 262,885 | |||
| Issue cost | - | -10,111 | - | - | -10,111 | |||
| Share-based remuneration pro grammes |
4 | - | - | - | 3,198 | 3,198 | ||
| Transactions with shareholders | 4,381 | 248,393 | - | 3,198 | 255,972 | |||
| Closing balance, 30 Sep 2023 | 5,858 | 1,483,365 | 12 | -1,245,158 | 244,077 | |||
| 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 | - | - | - | -164,075 | -164,075 | |||
| Other comprehensive income | - | - | -672 | 776 | 104 | |||
| Comprehensive income for the period |
0 | 0 | -672 | -163,299 | -163,971 | |||
| Share-based remuneration programmes |
4 | - | - | - | - | 0 | ||
| Transactions with shareholders | ||||||||
| Closing balance, 30 Jun 2024 | 5,858 | 1,483,364 | -1,417 | -1,462,141 | 25,665 | |||
1) There are no non-controlling interests.
Consolidated statement of cash flows
| Amounts in SEK thousand | Note | 2024 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|---|
| Cash flow from operating activities | ||||||
| Operating result | -41,150 | -48,253 | -162,392 | -175,103 | -230,587 | |
| Adjustments for non-cash items | 4,549 | 11,479 | 13,962 | 16,269 | 20,879 | |
| Interest received | 4 | 11 | 7 | 11 | 1,691 | |
| Interest paid | -1,209 | -642 | -1,628 | -1,371 | -1,562 | |
| Tax paid | - | - | - | - | - | |
| Cash flow from operating activities before changes in working capital |
-37,805 | -37,405 | -150,052 | -160,193 | -209,580 | |
| Changes in working capital | ||||||
| Change in inventories | 5 | 720 | 2,227 | 6,894 | -1,070 | -4,265 |
| Change in accounts receivable | -99 | -614 | -215 | -1,233 | -61 | |
| Change in other current receivables | 386 | -1,030 | 2,627 | 9,265 | 9,485 | |
| Change in other current liabilities | -9,138 | -12,613 | 1,802 | -10,796 | -7,874 | |
| Change in accounts payable | -4,102 | -5,017 | -3,183 | -16,302 | -16,227 | |
| Changes in working capital | -12,233 | -17,047 | 7,925 | -20,137 | -18,941 | |
| Cash flow from operating activities | -50,039 | -54,452 | -142,127 | -180,331 | -228,521 | |
| Cash flow from investing activities | ||||||
| Investments in tangible assets | 1,558 | 475 | -4,909 | -5,030 | -8,342 | |
| Sale of tangible assets | - | - | - | - | 575 | |
| Short-term investments | - | -80,000 | - | -80,000 | -80,000 | |
| Divestment of short-term investments | - | - | - | - | 80,000 | |
| Investments in financial assets | 6 | - | - | -52 | - | - |
| Divestment of financial assets | 6 | - | - | - | - | |
| Cash flow from investing activities | 1,558 | -79,525 | -4,961 | -85,030 | -7,766 | |
| Cash flow from financing activities | ||||||
| New share issue | - | 262,885 | - | 262,885 | 262,885 | |
| Issuer cost | - | -10,111 | - | -10,111 | -10,111 | |
| Loans raised from principal owner | 3 | 37,000 | - | 78,500 | 87,000 | 87,000 |
| Repayment of lease liabilities | -1,755 | -1,874 | -5,746 | -5,468 | -7,367 | |
| Repayment of loans | -87,000 | -87,000 | -87,000 | |||
| Cash flow from financing activities | 35,245 | 163,900 | 72,754 | 247,306 | 245,407 | |
| Cash flow for the period | -13,235 | 29,923 | -74,334 | -18,055 | 9,120 | |
| Cash and cash equivalents at the beginning of the | ||||||
| period Exchange rate difference in cash and cash equiva |
20,858 | 25,032 | 81,895 | 72,878 | 72,878 | |
| lents | -172 | -9 | -110 | 122 | -103 | |
| Cash and cash equivalents at the end of the pe |
Parent Company income statement
| Amounts in SEK thousand | Note | 2024 | 2023 | 2024 | 2023 | 2023 |
|---|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan - Dec | ||
| Net sales, external | 2 | 498 | 2,998 | 1,988 | 4,378 | 7,391 |
| Net sales, internal | 2,935 | - | 11,946 | - | - | |
| Other operating income | 281 | 1,484 | 2,179 | 2,041 | 2,183 | |
| Changes in inventories of products in progress, semi-finished goods and finished goods |
-2,854 | -2,646 | -11,010 | 162 | -480 | |
| Raw materials and consumables, and goods for | 1,126 | -693 | -2,753 | -4,402 | -5,786 | |
| resale Other external costs |
-10,679 | -10,761 | -41,336 | -55,741 | -70,191 | |
| Personnel costs | 4 | -18,215 | -30,842 | -86,013 | -107,909 | -142,352 |
| Depreciation/amortisation of tangible and | ||||||
| intangible assets | -2,599 | -2,781 | -7,895 | -8,378 | -11,093 | |
| Other operating expenses | -613 | -668 | -1,237 | -1,223 | -1,516 | |
| Operating result | -30,119 | -43,910 | -134,132 | -171,072 | -221,844 | |
| Revenue from holdings of listed corporate bonds that are non-current assets |
- | - | - | - | - | |
| Other interest income and similar profit items | 197 | 261 | 275 | 1 359 | 2 790 | |
| Interest expenses and similar loss items | -1,071 | -436 | -1,327 | -710 | -710 | |
| Result from financial items | -874 | -175 | -1,052 | 649 | 2,080 | |
| Result before tax | -30,993 | -44,085 | -135,184 | -170,424 | -219,764 | |
| Tax on result for the period | - | - | - | - | ||
| Result for the period | -30,993 | -44,085 | -135,184 | -170,424 | -219,764 |
Parent Company statement of comprehensive income
| Amounts in SEK thousand | Note | 2024 | 2023 | 2024 | 2023 | 2023 |
|---|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan - Dec | ||
| Result for the period | -30,993 | -44,085 | -135,184 | -170,424 | -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 | - | - | - | - | - | |
| Total comprehensive income | -30,993 | -44,085 | -135,184 | -170,424 | -219,764 |
Parent Company balance sheet
| Amounts in SEK thousand | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 | |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | ||||
| Licences | - | - | - | |
| Technology and customer relationships | 63 | 148 | 126 | |
| Goodwill | 815 | 1,901 | 1,630 | |
| Total intangible assets | 878 | 2,049 | 1,756 | |
| Tangible assets | ||||
| Equipment, tools, fixtures and fittings | 24,821 | 33,934 | 31,838 | |
| Total tangible assets | 24,821 | 33,934 | 31,838 | |
| Financial assets | ||||
| Participations in Group companies | 3 | 109,539 | 6,352 | 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 | 113,685 | 10,498 | 17,112 | |
| Total non-current assets | 139,384 | 46,480 | 50,706 | |
| Current assets | ||||
| Inventories | 5 | 37,209 | 43,351 | 46,225 |
| Current receivables | ||||
| Accounts receivable | 185 | 985 | 1,558 | |
| Accounts receivable in Group companies | 2,280 | - | - | |
| Other receivables | 33,510 | 36,165 | 35,367 | |
| Other receivables in Group companies | 8,480 | - | - | |
| Prepaid expenses and accrued income | 2,928 | 4,038 | 4,299 | |
| Total current receivables | 47,383 | 41,188 | 41,224 | |
| Short-term investments | - | 80,000 | - | |
| Cash and bank balances | 4,840 | 53,989 | 79,712 | |
| Total current assets | 89,432 | 218,528 | 167,161 | |
| TOTAL ASSETS | 228,816 | 265,008 | 217,867 |
Parent Company balance sheet
| Amounts in SEK thousand | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 | |
|---|---|---|---|---|
| EQUITY AND LIABILITIES | ||||
| Restricted equity | ||||
| Share capital | 5,858 | 5,858 | 5,858 | |
| Revaluation reserve | 70,000 | - | - | |
| Total restricted equity | 75,858 | 5,858 | 5,858 | |
| Unrestricted equity | ||||
| Share premium reserve | 1,483,364 | 1,483,364 | 1,483,364 | |
| Fair value reserve | - | - | - | |
| Retained earnings | -1,291,386 | -1,071,622 | -1,071,622 | |
| Result for the period | -135,184 | -170,424 | -219,764 | |
| Total unrestricted equity | 56,795 | 241,319 | 191,979 | |
| Total equity | 132,653 | 247,177 | 197,837 | |
| Liabilities | ||||
| Current liabilities | ||||
| Loan from principal owner | 3 | 78,500 | - | - |
| Accounts payable | 1,994 | 4,996 | 4,762 | |
| Accounts payable in Group companies | 240 | - | - | |
| Current tax liabilities | - | - | - | |
| Other liabilities | 2,466 | 5,247 | 6,356 | |
| Liabilities to Group companies | 25 | - | - | |
| Accrued expenses and deferred income | 12,939 | 7,588 | 8,912 | |
| Total current liabilities | 96,163 | 17,831 | 20,030 | |
| Total liabilities | 96,163 | 17,831 | 20,030 | |
| TOTAL LIABILITIES AND EQUITY | 228,816 | 265,008 | 217,867 |
Parent Company statement of changes in equity
| Restricted equity | |||||||
|---|---|---|---|---|---|---|---|
| Share | |||||||
| Share | Revaluation | premium | Retained | Result for | |||
| Amounts in SEK thousand | Note | capital | reserve | reserve | earnings | the period | Total equity |
| Opening balance, 1 Jan 2023 | 1,477 | 0 | 1,234,972 | -805,316 | -269,503 | 161,630 | |
| Result for the period Comprehensive income |
- | - | - | - | -170,424 | -170,424 | |
| Appropriation of profits in accordance with | - | - | - | -269,503 | 269,503 | 0 | |
| AGM decision: - Carried forward to unrestricted equity |
- | - | - | 0 | |||
| Total comprehensive income | 0 | 0 | 0 | -269,503 | 99,080 | -170,424 | |
| Transactions with shareholders | |||||||
| New share issue | 4,381 | 258,504 | - | - | - | 262,885 | |
| Issue costs | - | -10,111 | - | - | - | -10,111 | |
| Share-based remuneration programmes | 4 | - | - | 3,198 | - | 3,198 | |
| Transactions with shareholders | 4,381 | 248,393 | - | 3,198 | - | 255,972 | |
| Closing balance, 30 Sep 2023 | 5,858 | 1,483,364 | 0 | -1,071,622 | -170,424 | 247,177 | |
| 0312-31 Opening balance, 1 Jan 2023 |
1,477 | 0 | 1,234,972 | -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 | 0 | 1,483,364 | -1,071,622 | -219,764 | 197,837 | |
| Opening balance, 1 Jan 2024 | 5,858 | 0 | 1,483,364 | -1,071,622 | -219,764 | 197,837 | |
| Comprehensive income | |||||||
| Result for the period | - | - | - | - | -135,184 | -135,184 | |
| Other comprehensive income | - | - | - | - | - | 0 | |
| Revaluation of participations in subsidiaries | - | 70,000 | - | - | - | 70,000 | |
| Appropriation of profits in accordance with AGM decision: |
|||||||
| - Carried forward to unrestricted equity | - | - | - | -219,764 | 219,764 | 0 | |
| Total comprehensive income | - | 70,000 | - | -219,764 | 84,580 | -65,184 | |
| Transactions with shareholders | |||||||
| Share-based remuneration programmes | 4 | - | - | - | - | - | - |
| Transactions with shareholders | - | - | - | - | - | - | |
| Closing balance, 30 Sep 2024 | 5,858 | 70,000 | 1,483,364 | -1,291,386 | -135,184 | 132,653 |
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:
| SEK thousand | 2024 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|
| Sweden | - | - | - | 60 | 60 |
| Italy | 71 | - | 216 | - | - |
| UK | 402 | 141 | 462 | 1,462 | 1,522 |
| France | - | 2,857 | 95 | 2,857 | 2,857 |
| Finland | 96 | - | 1,431 | - | - |
| Total net sales by geographic market | 569 | 2,998 | 2,204 | 4,379 | 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. In addition to the groups mentioned above, Qlinea AB's subsidiaries Q-linea Inc., Q-linea S.r.l. and NexttoQ AB are also related parties.
Disclosures concerning transactions between the Company and other related parties are presented below. Transactions with related parties are made om market-based terms.
During the third quarter, the Parent Company paid a capital contribution of EUR 200 thousand (190) to Q-linea S.r.l, which was reported in the Parent Company at SEK 2,272 thousand (2,272) and to Q-linea Inc a capital contribution of USD 700 (100) thousand, which in the Parent Company was reported at SEK 7,351 thousand (1,104).
Of the loan facility resolved at the 2024 Annual General Meeting from the Company's principal owner Nexttobe, Qlinea AB has as of September 30 utilized SEK 78.5 million out of a total of SEK 101.5 million. In total, therefore, SEK 23 million remains in unutilized loan facility from the Company's principal owner Nexttobe. The entire loan facility runs until 30 June 2026 at the latest. Q-linea and its main owner Nexttobe are considered to be related parties, which means that the rules in Chapter 1 of the Swedish Companies Act. 16a on related party transactions have been taken into account.
Not 4 Aktierelaterade ersättningsprogram
Det personaloptionsprogram som beslutades vid bolagsstämman den 28 juni 2024 (LTIP 2024/27) är per den 4 november det enda programmet som är utestående. Programmet har tilldelats under oktober månad i enlighet med beslutet på bolagsstämman men har inte haft någon finansiell påverkan på resultatet i kvartal 3.
Note 5 Inventories
At the end of the third quarter 2024, the Company had an inventory value of SEK 40,393 thousand (46,527).
| SEK thousand | 30 Sep 2024 | 30 Sep 2023 | 31 Dec 2023 |
|---|---|---|---|
| Raw materials and consumables | 7,021 | 8,255 | 8,531 |
| Goods for resale | 21,413 | 26,190 | 27,648 |
| Products in progress | 2,992 | 422 | 5,856 |
| Semi-finished goods | 6,304 | 5,867 | 2,361 |
| Finished goods | 1,889 | 2,616 | 2,131 |
| Total inventories | 39,619 | 43,351 | 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.
The Company had no holdings in fixed-income funds at 30 September 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 Jul-Sep |
2023 Jul-Sep |
2024 Jan-Sep |
2023 Jan-Sep |
2023 Jan-Dec |
|---|---|---|---|---|---|
| Result for the period | -42,366 | -48,648 | -164,075 | -175,108 | -229,366 |
| Weighted average number of shares outstanding | 117,166,372 | 87,639,403 | 117,166,372 | 49,117,925 | 66,269,862 |
| - Less average holding of treasury shares | -328,472 | -328,472 | -328,472 | -328,472 | -328,472 |
| Earnings per share before and after dilution (SEK) |
-0.36 | -0.56 | -1.40 | -3.59 | -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 first product, ASTar, has been approved for sales in Europe and in the US market 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.
The available cash and cash equivalents as of 30 September amount to SEK 7.5 million. In addition, there is an unutilized part of a loan facility from the Company´s principal owner Nexttobe of SEK 23 million.
The Board considers the available cash and cash equivalents, the unutilised portion of the loan facility and the 80 percent underwritten, ongoing rights issue, sufficient to cover the Company's requirements to carry out the activities planned for the next 12 months..
Note 10 Significant events after the end of the period
Q-linea announces changes in executive leadership team and expands US commercital team.
US reference laboratory completes ASTar evaluation.
Two UK commercial evaluations successfully completed.
The Company receives a formal request for a contract from a prominent hospital in Milano and participates in a multi-site public tender in Italy.
First clinical evaluation of ASTar begins at a National Cancer Institute-designated (NCI) cancer center.
Q-linea resolves to carry out a rights issue of approximately SEK 225 million and enters into an agreement for a bridge loan facility of approximately SEK 40 million.