Exhibit 99.2
INTERIM FINANCIAL REPORT
FIRST HALF 2024
TABLE OF CONTENTS
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Notes to the unaudited condensed interim consolidated financial information | 10 | |
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1
INTERIM FINANCIAL REPORT
FIRST HALF 2024
1.BUSINESS UPDATE
A. CLINICAL UPDATE
DREAM US: IDE PIVOTAL STUDY
Nyxoah initiated its pivotal DREAM IDE trial in the United States in December 2020 to support an application seeking FDA marketing authorization and, ultimately, reimbursement in the U.S. for bilateral hypoglossal nerve stimulation for the treatment of moderate-to-severe obstructive sleep apnea (“OSA”). The DREAM trial is a multicenter, prospective, open-label trial in which patients who undergo implantation of the Genio® system will be followed for five years post-implantation to assess the safety and efficacy of the Genio® system in patients with moderate-to-severe OSA.
The trial was initially expected to enroll 134 patients who will undergo the implantation procedure with 12-month effectiveness and safety primary endpoints across 18 centers in the United States and six international sites. In April 2022, the FDA approved the Company’s request to reduce the trial’s sample size to 115 patients from 134 after reviewing data from the BETTER SLEEP trial (see below).
The primary safety endpoint is incidence of device-related severe adverse events ("SAEs") at 12-months post implantation. The co-primary effectiveness endpoints are the percentage of responders with at least a 50% reduction on the apnea-hypopnea index ("AHI") with hypopneas associated with a 4% oxyhemoglobin desaturation and a remaining AHI with hypopneas associated with a 4% oxyhemoglobin desaturation less than 20, and a 25% reduction on the oxygen desaturation index ("ODI") between baseline and 12-month visits. Patients with moderate to severe OSA (AHI score between 15 and 65) and aged between 22 and 75 years are eligible for enrolment if they failed, did not tolerate or refused positive airway pressure ("PAP") treatment. Patients with a body mass index above 32 kg/m2, a complete concentric collapse ("CCC") observed during a drug induced sleep endoscopy and combined central and mixed AHI above 25% at baseline polysomnography are to be excluded.
On March 19th, 2024, the Company reported the DREAM study met its primary endpoints on an intent-to-treat (ITT) basis, with an Apnea-Hypopnea Index (AHI) responder rate of 63.5% (p=0.002) and an Oxygen Desaturation Index (ODI) responder rate of 71.3% (p<0.001). Additionally, the study demonstrated a median 12-month AHI reduction of 70.8%. There were 11 serious adverse events, or SAEs, in ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related and there were three explants. The Company has filed the fourth and final module of the modular premarket approval (PMA) application at the end of the second quarter 2024.
BETTER SLEEP: ACHIEVED PRIMARY ENDPOINT IN BOTH CCC AND NON-CCC PATIENT COHORTS
In March 2022, the Company attended the World Sleep Congress in Rome, Italy, and presented data generated from its BETTER SLEEP trial, a multicenter, prospective, open-label, two-group clinical trial, designed to assess the long-term safety and performance of the Genio® system for the treatment of adult OSA patients with and without CCC of the soft palate over a period of 36 months post-implantation. The BETTER SLEEP trial included a subgroup of CCC patients, which is a patient population that is contraindicated for unilateral hypoglossal nerve stimulation.
In the BETTER SLEEP trial, 42 patients were implanted with the Genio® system, 18 of whom presented with CCC (or 42.9% of the total implanted population) at eight research centers in Australia. The primary safety endpoint was the incidence of device-related SAEs six months post-implantation. The primary performance endpoint was achieving at least a 4-point reduction in the apnea-hypopnea index (4% oxygen desaturation, or AHI4) from baseline at six months for the entire patient cohort. Patients with moderate to severe AHI scores (15 < AHI < 65) and aged between 21 and 75 years were eligible for enrollment if they failed, refused or did not tolerate PAP treatment. Patients with a body mass index above 32 kg/m2 were excluded.
2
Three patients in the non-CCC arm and three patients in the CCC arm did not complete their six-month polysomnography, and as a result, the analysis was calculated based on 36 patients (21 non-CCC and 15 CCC). Of these 36 patients, there were 23 responders (64)%, including nine of the 15 CCC patients (60)% and 14 of the 21 non-CCC patients (67)%, at six months. The overall reduction was statistically significant with an 11-point reduction (p<0.001), with statistically significant reductions of 10 points (p=0.001) in the CCC cohort and 11 points (p<0.001) in the non-CCC cohort. In addition, mean AHI4 reduction exceeded 70% among responders in both CCC and non-CCC cohorts. These results are subject to final review and validation.
With respect to the primary safety endpoint, preliminary unadjudicated safety data showed four SAEs in three patients during the six-month post-implantation period. Of those, two SAEs in one patient were reported as device related, one SAE in one patient was reported as procedure and device related, and one SAE in one patient was reported as unrelated to procedure or device. Final review and adjudication of SAEs and adverse events ("AEs") have not yet been completed by an independent clinical events committee and as a result the characterization of SAEs or AEs could be subject to change.
While additional data, including responder rates, remains subject to ongoing review and continues to be analyzed, the Company observed in the per protocol group a 70% responder rate in the non-CCC patient subgroup based on the Sher criteria. The per protocol group consisted of 35 patients and excluded five patients from the mITT analysis population: two of these patients were lost to follow-up, one patient did not comply with the study protocol, and two patients were removed from the study by the investigator, one for hostility towards staff and one having returned to continuous positive airway pressure, therapy.
The Company expects to announce additional data with respect to the trial as further analyses are conducted and seeks to publish the full data set from the trial in a peer-reviewed publication. There will be no additional enrollment in the BETTER SLEEP trial. However, the Company will continue to monitor patients in the evaluable patient population and plan to continue evaluating over the course of three years following implantation.
The data generated from this study were used to expand the Company’s CE mark for the Genio® system to treat patients demonstrating CCC at the soft palate level, and the first commercial Genio® implants occurred in CCC patients in Germany during the first quarter of 2022.
ACCCESS U.S. IDE STUDY SEEKING APPROVAL TO TREAT CCC PATIENTS
In the United States, supported by the BETTER SLEEP study data, the FDA in September 2021 granted Breakthrough Device Designation for the Genio® system in order to shorten the approval path to treat CCC patients. Following a series of sprint discussions with the FDA regarding the design of a trial called ACCCESS to assess the safety and efficacy of the Genio® system on CCC patients, the FDA approved the Company’s IDE application in July 2022.
In this study, Nyxoah will implant up to 106 patients across up to 40 implant sites with co-primary efficacy endpoints of AHI responder rate, per the Sher criteria, and ODI responder rate, both assessed at 12 months post-implant. The clinical sites are being activated and the study is enrolling.
B.EUROPEAN COMMERCIALIZATION
During the first six months of 2024, Nyxoah recognized total revenue of €2.0 million, primarily in Germany. After securing DRG reimbursement in Germany during the first quarter of 2021, Nyxoah built and expanded its German commercial organization to a total of 14 full time employees.
Nyxoah’s commercial strategy is focused on creating a Center of Excellence ecosystem, with a high level of clinical expertise between implanting ENT surgeons and sleep physicians who are able to provide more treatment options to their large patient pools. As of June 30, 2024, the Company has activated 51 Tier 1 sites across Germany.
The Company has also focused on entering new European markets. The Company has secured DRG reimbursement in Switzerland, state reimbursement in Austria, and is awaiting reimbursement decisions in several other countries. Nyxoah has also generated revenue in Switzerland, Austria, Spain and Italy and the Company expects to expand into other European countries.
3
2.FINANCIAL HIGHLIGHTS
Revenue was €2.0 million for the six months ending June 30, 2024, compared to €1.5 million for the six months ending June 30, 2023.
Cost of goods sold was €0.7 million for the six months ending June 30, 2024, compared to €0.6 million cost for the six months ending June 30, 2023.
Selling, general and administrative expenses increased by €0.6 million or 5.3 % from €11.7 million for the six months ended June 30, 2023 to €12.4 million for the six months ended June 30, 2024, mainly due to an increase of costs to support the commercialization of Genio® system in Europe and scale up of the Company.
Before capitalization of €3.3 million for the six months ended June 30, 2024 and €5.0 million for the six months ended June 30, 2023, research and development expenses increased by €202,000 or 1.1 %, from €17.8 million for the six months ended June 30, 2023, to €18.0 million for the six months ended June 30, 2024, due to a combined effect of the higher R&D activities and clinical expenses, this increase was offset by a decrease in manufacturing expenses due to an increase in inventory value.
Nyxoah realized a net positive financial result of €1.0 million for the six months ending June 30, 2024 primarily driven by the exchange rate depreciation of dollar versus euro. This compares to a net negative financial result of €318,000 for the six months ended June 30, 2023.
Nyxoah realized a net loss of €25.0 million for the six months ended June 30, 2024, compared to a net loss of €24.7 million for the six months ended June 30, 2023.
Cash and cash equivalents
On June 30, 2024, cash and cash equivalents and financial assets totaled €77.8 million, compared to €57.7 million on December 31, 2023. The increase in cash and cash equivalents resulted from net cash from financial activities of €45.0 million mainly due to capital increase and offset by net cash flows used in operating activities amounted to €23.6 million and in investing activities amounted to € 15.6 million.
3.2024 OUTLOOK
The Company expects to continue ramping up sales in Germany as well as in other European countries where we are already present.
In the US, the Company has filed the fourth and final module of its modular PMA submission end of second quarter 2024 and anticipates FDA approval as early as late 2024. Meanwhile, the Company prepares to enter the US market with regulatory, manufacturing, commercial, and market access readiness and continues to enrol in the ACCCESS study.
To meet the Company’s capital needs, the Company raised €48.5 million in capital through the issuance of new shares in May and June 2024 (see note 15.1). Additionally, on July 3, 2024, the Company has signed a €37.5 million loan facility agreement with the European Investment Bank (“EIB”) (see note 29) subject to certain conditions from which a first tranche of €10 million was drawn after the reporting date. The recent capital raise and loan facility agreement extends the Company’s financial runway, providing sufficient funds to support operations until the beginning of 2026. This cash runway considers the second tranche of the EIB facility and excludes any additional capital raise activity the company could consider. Please refer to the Going concern note of the Financial Statements.
4.RISK FACTORS
We refer to the description of risk factors in the Company’s 2023 annual report, pp. 65-86. In summary, the principal risks and uncertainties faced by us relate to our financial situation and need for additional capital, clinical development of our product candidates, commercialization and reimbursement of our product candidates, our dependence on third parties and on key personnel, the markets and countries in which we operate, the manufacturing of our product candidates, legal and regulatory compliance matters, our intellectual property, our organization and operations.
4
5.FORWARD-LOOKING STATEMENTS
This interim management report contains forward-looking statements. All statements other than present and historical facts and conditions contained in this report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Nyxoah’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including Nyxoah’s expectations regarding the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements; Nyxoah’s reliance on collaborations with third parties; estimating the commercial potential of Nyxoah’s product candidates; Nyxoah’s ability to obtain and maintain protection of intellectual property for its technologies; Nyxoah’s limited operating history; and Nyxoah’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Nyxoah’s 2023 annual report. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Nyxoah expressly disclaims any obligation to update any such forward-looking statements in this document, to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by applicable law or regulation.
5
NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED JUNE 30, 2024 –
INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(unaudited)
(in thousands)
As at | ||||||||
June 30 | December 31 | |||||||
| Notes |
| 2024 |
| 2023 | |||
ASSETS | ||||||||
Non-current assets |
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Property, plant and equipment |
| 7 |
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Intangible assets |
| 8 |
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Right of use assets |
| 9 |
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Deferred tax asset |
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Other long-term receivables |
| 10 |
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| € | |
| € | | |
Current assets |
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Inventory |
| 11 |
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Trade receivables |
| 12 |
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Other receivables |
| 12 |
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Other current assets |
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Financial assets |
| 14 |
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Cash and cash equivalents |
| 13 |
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| € | |
| € | | |
Total assets |
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| € | |
| € | |
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EQUITY AND LIABILITIES |
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Capital and reserves |
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Capital |
| 15 |
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Share premium |
| 15 |
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Share based payment reserve |
| 16 |
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Other comprehensive income |
| 15 |
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Retained loss |
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| ( |
| ( | ||
Total equity attributable to shareholders |
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| € | |
| € | |
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LIABILITIES |
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Non-current liabilities |
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Financial debt |
| 17 |
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Lease liability |
| 9 |
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Pension liability |
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Provisions |
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Deferred tax liability |
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| € | |
| € | | |
Current liabilities |
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Financial debt |
| 17 |
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Lease liability |
| 9 |
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Trade payables |
| 18 |
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Current tax liability |
| 19 |
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Other payables |
| 20 |
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| € | |
| € | | |
Total liabilities |
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| € | |
| € | |
Total equity and liabilities |
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| € | |
| € | |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
6
NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED JUNE 30, 2024 -
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS
(unaudited)
(in thousands)
| For the three months |
| For the six months | |||||||||||
ended June 30 | ended June 30 | |||||||||||||
| Notes | 2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
Revenue | 22 | | | | | |||||||||
Cost of goods sold |
| 22 | ( |
| ( |
| ( |
| ( | |||||
Gross profit |
|
| € | | € | | € | | € | | ||||
Research and Development Expense |
| 22 |
| ( |
| ( |
| ( |
| ( | ||||
Selling, General and Administrative Expense |
| 22 |
| ( |
| ( |
| ( |
| ( | ||||
Other income/(expense) |
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| |
| |
| |
| | ||||
Operating loss for the period |
|
| € | ( | € | ( | € | ( | € | ( | ||||
Financial income |
| 24 |
| |
| |
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Financial expense |
| 25 |
| ( |
| ( |
| ( |
| ( | ||||
Loss for the period before taxes |
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| € | ( | € | ( | € | ( | € | ( | ||||
Income taxes |
| 19 |
| ( |
| ( |
| ( |
| ( | ||||
Loss for the period |
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| € | ( | € | ( | € | ( | € | ( | ||||
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Loss attributable to equity holders |
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| € | ( | € | ( | € | ( | € | ( | ||||
Other comprehensive loss |
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Items that may be subsequently reclassified to profit or loss (net of tax) |
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Currency translation differences |
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| ( |
| ( |
| ( |
| ( | ||||
Total comprehensive loss for the year, net of tax |
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| € | ( | € | ( | € | ( | € | ( | ||||
Loss attributable to equity holders |
|
| € | ( | € | ( | € | ( | € | ( | ||||
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Basic Loss Per Share (in EUR) |
| 26 | € | ( | € | ( | € | ( | € | ( | ||||
Diluted Loss Per Share (in EUR) |
| 26 | € | ( | € | ( | € | ( | € | ( | ||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements
7
NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED, JUNE 30 2024 -
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
(in thousands)
Attributable to owners of the parent | ||||||||||||||||||
Share | ||||||||||||||||||
based | Other | |||||||||||||||||
Common | Share | payment | comprehensive | Retained | ||||||||||||||
| shares |
| premium |
| reserve |
| income |
| loss |
| Total | |||||||
Balance at January 1, 2024 |
| € | |
| € | |
| € | |
| € | |
| € | ( |
| € | |
Loss for the period |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Other comprehensive loss for the period |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Total comprehensive loss for the period |
| — |
| — |
| — | € | ( | € | ( | € | ( | ||||||
Equity-settled share-based payments |
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Granted during the period |
| — |
| — |
| |
| — |
| — |
| | ||||||
Expired during the period |
| — |
| — |
| ( |
| — |
| |
| — | ||||||
Exercised during the period | | | ( | — | | | ||||||||||||
Issuance of shares for cash | | | — | — | — | | ||||||||||||
Transaction cost |
| — |
| ( |
| — |
| — |
| — |
| ( | ||||||
Total transactions with owners of the company recognized directly in equity |
| |
| |
| |
| — |
| |
| | ||||||
Balance at June 30, 2024 | € | | € | | € | | € | | € | ( | € | | ||||||
Attributable to owners of the parent | ||||||||||||||||||
Share | ||||||||||||||||||
based | Other | |||||||||||||||||
Common | Share | payment | comprehensive | Retained | ||||||||||||||
| shares |
| premium |
| reserve |
| income |
| loss |
| Total | |||||||
Balance at January 1, 2023 | € | | € | | € | | € | | € | ( | € | | ||||||
Loss for the period |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Other comprehensive loss for the period |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Total comprehensive loss for the period |
| — |
| — |
| — | € | ( | € | ( | € | ( | ||||||
Equity-settled share-based payments |
|
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| ||||||||
Granted during the period | — | — | | — | — | | ||||||||||||
Expired during the period |
| — |
| — |
| ( |
| — |
| |
| — | ||||||
Issuance of shares for cash | | | — | — | — | | ||||||||||||
Transaction costs | — | ( | — | — | — | ( | ||||||||||||
Total transactions with owners of the company recognized directly in equity |
| |
| |
| |
| — |
| |
| | ||||||
Balance at June 30, 2023 | € | | € | | € | | € | | € | ( | € | | ||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
8
NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED JUNE 30, 2024 –
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
| For the six months ended | |||||||
June 30 | ||||||||
| Notes |
| 2024 |
| 2023 | |||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Loss before tax for the year |
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| € | ( | € | ( | ||
Adjustments for |
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Finance income |
|
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| ( |
| ( | ||
Finance expenses |
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| |
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Depreciation and impairment of property, plant and equipment and right-of-use assets |
| 7, 9 |
| |
| | ||
Amortization of intangible assets |
| 8 |
| |
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Share-based payment transaction expense |
| 16 |
| |
| | ||
Increase in provisions |
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Other non-cash items |
|
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| ( |
| ( | ||
Cash generated before changes in working capital |
|
| € | ( | € | ( | ||
Changes in working capital |
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(Increase) in inventory |
| 11 |
| ( |
| ( | ||
(Increase) in trade and other receivables |
| 12 |
| ( |
| ( | ||
Increase/(Decrease) in trade and other payables |
| 18, 20 |
| |
| ( | ||
Cash generated from changes in operations |
|
| € | ( | € | ( | ||
Income tax paid |
|
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| ( |
| ( | ||
Net cash from / (used in) operating activities |
|
| € | ( | € | ( | ||
CASH FLOWS FROM INVESTING ACTIVITIES |
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Purchases of property, plant and equipment |
| 7 |
| ( |
| ( | ||
Capitalization of intangible assets |
| 8 |
| ( |
| ( | ||
Purchase of financial assets - current | 14 | ( | ( | |||||
Proceeds from sale of financial assets - current | 14 | | | |||||
Interest income on financial assets |
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Net cash from / (used in) investing activities |
|
| € | ( | € | | ||
CASH FLOWS FROM FINANCING ACTIVITIES |
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Payment of principal portion of lease liabilities |
| 9 |
| ( |
| ( | ||
Repayment of other loan |
|
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| ( |
| ( | ||
Interests paid |
|
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| ( |
| ( | ||
Proceeds from issuance of shares, net of transaction costs |
| 15 |
| |
| | ||
Other financial costs |
|
|
| ( |
| ( | ||
Net cash from / (used in) financing activities |
|
| € | | € | | ||
Movement in cash and cash equivalents |
|
| € | | € | ( | ||
Effect of exchange rates on cash and cash equivalents |
|
| |
| ( | |||
Cash and cash equivalents at January 1 |
| 13 | € | | € | | ||
Cash and cash equivalents at June 30 |
| 13 | € | | € | | ||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
9
NYXOAH SA
NOTES TO THE UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL INFORMATION
1.General information
Nyxoah SA (the “Company”) is a public listed company with limited liability (naamloze vennootschap/société anonyme) incorporated and operating under the laws of Belgium and is domiciled in Belgium. The Company is registered with the legal entities register (Brabant Walloon) under enterprise number 0817.149.675. The Company’s registered office is in Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium.
The Company is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea, or OSA. Our lead solution is the Genio® system, a CE-Marked, patient-centric, minimally invasive, next generation hypoglossal neurostimulations therapy for OSA. OSA is the world’s most common sleep disordered breathing condition and is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.
The Genio® system is the first neurostimulation system for the treatment of OSA to include a battery-free and leadless neurostimulator capable of delivering bilateral hypoglossal nerve stimulation to keep the upper airway open. The product is intended to be used as a second-line therapy to treat moderate to severe OSA patients who have either not tolerated, failed or refused conventional therapy, including Continuous Positive Airway Pressure, or CPAP, which, despite its proven efficacy, is associated with many limitations, meaning compliance is a serious challenge. In addition, other second-line treatments are more suitable to treat mild to moderate OSA (such as oral devices) or highly invasive. Compared to other hypoglossal nerve stimulation technologies for the treatment of OSA, the Genio® system is a disruptive, differentiating technology that targets a clear unmet medical need thanks to its minimally invasive and quick implantation technique, its external battery and its ability to stimulate the two branches of the hypoglossal nerve.
Obstructive sleep apnea is the world’s most common sleep disordered breathing condition. OSA occurs when the throat and tongue muscles and soft tissues relax and collapse. It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or completely (apnea) blocked, limiting the amount of air that reaches the lungs. During an episode of apnea or hypopnea, the patient’s oxygen level drops, which leads to sleep interruptions.
Nyxoah SA has established four wholly owned subsidiaries: Nyxoah Ltd, a subsidiary of the Company since October 21, 2009 (located in Israel and incorporated on January 10, 2008 under the name M.L.G. Madaf G. Ltd), Nyxoah Pty Ltd since February 1, 2017 (located in Australia) and Nyxoah Inc. since May 14, 2020 (located in the USA) and Nyxoah GmbH since July 26, 2023 (located in Germany).
The interim condensed consolidated financial statements of Nyxoah SA and its subsidiaries (collectively, the Group) as of June 30, 2024 and for the three and six months ended June 30, 2024, have been authorized for issue on August 6, 2024 by the Board of Directors of the Company.
2.Significant accounting policies
Basis of Preparation of the interim condensed consolidated financial statements
The Company’s interim condensed consolidated financial statements have been prepared in accordance with International Accounting Standard 34 – Interim Financial Reporting (“IFRS”), as issued by the International Accounting Standards Board (IASB). They do not include all the information required for complete annual financial statements and should be read in conjunction with the Company’s last annual consolidated financial statements as at and for the year ended December 31, 2023. In order to be consistent with the current period’s presentation, an immaterial correction has been made to certain comparatives on the face of the consolidated statement of financial position. Accrued expenses of €
Except for the application of standards, interpretations and amendments being mandatory as of January 1, 2024, the accounting policies used for the preparation of the interim condensed consolidated financial statements are consistent with those used for the preparation of the Company’s annual consolidated financial statements as of and for the year ended December 31, 2023.
10
The consolidated financial statements are presented in thousands of Euros (€) and all values are rounded to the nearest thousands, except when otherwise indicated (e.g. € million).
The preparation of the interim condensed consolidated financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgement or complexity, are areas where assumptions and estimates are significant to the consolidated financial statements. The critical accounting estimates used in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements as of and for the year ended December 31, 2023.
Going concern principle
The Company has consistently operated with deficits and sustained negative cash flows since its inception as a result of the significant research and development expenses incurred for the development and regulatory approval of the Genio® device. As of June 30, 2024, the Company’s statement of financial position includes an accumulated loss of million and total assets of €
The Company’s current operating plan indicates that it will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its clinical trials only partially offset by the Company’s revenue generating activities outside the U.S., these were €
To meet the Company’s future working capital needs, management raised €
The Unaudited Interim Condensed Consolidated Financial Statements have therefore been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
New and amended standards and interpretations applicable
Effective for the annual periods beginning on January 1, 2024
The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
Several amendments and interpretations apply for the first time in 2024, but do not have an impact on the interim condensed consolidated financial statements of the Company:
| ₋ | Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments: Disclosures : Supplier Finance Arrangements (applicable for annual periods beginning on or after January 1, 2024) |
| ₋ | Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback (applicable for annual periods beginning on or after January 1, 2024) |
| ₋ | Amendments to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current or Non-current and Non-current Liabilities with Covenants (applicable for annual periods beginning on or after January 1, 2024) |
11
3.Critical accounting estimates and assumptions
The preparation of interim financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that may significantly affect the reported amounts of revenues, expenses, assets and liabilities, and the disclosure of contingent liabilities at the end of the reporting period.
Refer to the disclosure note 5 from the Group’s 2023 year-end consolidated financial statements for further details about the main critical accounting estimates and assumptions.
4.Segment reporting
Based on the organizational structure, as well as the nature of financial information available and reviewed by the Company’s chief operating decision makers to assess performance and make decisions about resource allocations, the Company has concluded that its total operations represent
5.Fair Value
The carrying amount of cash and cash equivalents, trade receivables, other receivables, other current assets and financial assets approximate their value due to their short-term character.
The carrying value of current liabilities approximates their fair value due to the short-term character of these instruments. The fair value of non-current liabilities (financial debt and other non-current liabilities), excluding the derivative financial liabilities, is evaluated based on their interest rates and maturity date. These instruments have fixed interest rates and their fair value measurements are subject to changes in interest rates. The fair value measurement is classified as level 3.
The derivative financial liabilities and assets which consist of foreign currency swaps are measured at fair value through profit and loss. Fair value is determined by the financial institution and is based on foreign currency swap rates and the maturity of the instrument.
Carrying value | Fair value | |||||||
As at | As at | As at | As at | |||||
June 30, | December 31, | June 30, | December 31, | |||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Financial Assets |
|
|
|
|
|
|
|
|
Other long-term receivables (level 3) |
| |
| |
| |
| |
Trade and other receivables (level 3) |
| |
| |
| |
| |
Foreign currency swaps (level 2) |
| |
| |
| |
| |
Other current assets (level 3) |
| |
| |
| |
| |
Cash and cash equivalents (level 1) |
| |
| |
| |
| |
Financial assets (level 1) |
| |
| |
| |
| |
Carrying value | Fair value | |||||||
As at | As at | As at | As at | |||||
June 30, | December 31, | June 30, | December 31, | |||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Financial liabilities |
|
|
|
|
|
|
|
|
Financial debt (level 3) |
| |
| |
| |
| |
Foreign currency swaps (level 2) |
| |
| |
| |
| |
Recoverable cash advances (level 3) |
| |
| |
| |
| |
Trade and other payables (level 1 and 3) |
| |
| |
| |
| |
6.Subsidiaries
For all periods that are mentioned in this report, the Company owns
12
The Company also owns
The Company also owns
The Company also owns
7.Property, Plant and Equipment
The total acquisitions for the six months ended June 30, 2024 amount to €
The cost of property, plant and equipment at June 30, 2024 includes a correction of the tax incentive in Belgium on the investments of 2023 for an amount of €
The depreciation charge amounts to €
8.Intangible assets
Development | Patents and | |||||
(in EUR 000) |
| cost |
| licenses |
| Total |
Cost |
|
|
|
|
|
|
Opening value at January 1, 2023 |
| |
| |
| |
Additions |
| |
| |
| |
Cost at June 30, 2023 |
| |
| |
| |
Opening value at January 1, 2024 |
| |
| |
| |
Additions |
| |
| |
| |
Cost at June 30, 2024 |
| |
| |
| |
Amortization |
|
|
|
|
|
|
Opening amortization at January 1, 2023 |
| ( |
| ( |
| ( |
Amortization |
| ( |
| ( |
| ( |
Amortization at June 30, 2023 |
| ( |
| ( |
| ( |
Opening amortization at January 1, 2024 |
| ( |
| ( |
| ( |
Amortization |
| ( |
| ( |
| ( |
Amortization at June 30, 2024 |
| ( |
| ( |
| ( |
Net book value at June 30, 2023 |
| |
| |
| |
Net book value at June 30, 2024 |
| |
| |
| |
There is only one development project: The Genio® system. The Company started amortizing the first-generation Genio® system in 2021. The amortization amounted to €
The Company continues to incur in 2024 development expenses with regard to the improved second-generation Genio® system and clinical trials to obtain additional regulatory approvals in certain countries or to be able to sell the Genio® System in certain countries. The total capitalized development expenses amounted to €
9.Right of use assets and lease liabilities
For the six months ended June 30, 2024, the Company entered into new lease agreements for €
13
10.Other long-term receivables
The other long-term receivables mainly consist of cash guarantees for an amount of €
The R&D tax incentive recorded as of June 30, 2024, pertains to investments made in 2022, 2023, and 2024 in both tangible and intangible assets. These incentives are expected to be received 5 years after the investments are made. However, following the Law of May 12, 2024 (Belgian Gazette, May 29, 2024), the Belgian R&D tax credit regime has been amended. As of 2024, the R&D tax incentive will be refunded after 4 years instead of 5 years. The long-term receivable as of June 30, 2024, also includes an adjustment of the R&D tax incentive for investments made in 2023. For further details, refer to note 22.
11.Inventory
As at | ||||
June 30, | December 31, | |||
(in EUR 000) |
| 2024 |
| 2023 |
Raw materials | | | ||
Work in progress |
| |
| |
Finished goods |
| |
| |
Total Inventory |
| |
| |
The increase in inventory is due to increasing activities to prepare for the commercialization in US and further scale-up of the commercialization in EU in 2024.
12.Trade and Other receivables
As at | ||||
June 30, | December 31, | |||
(in EUR 000) |
| 2024 |
| 2023 |
Trade receivables |
| |
| |
R&D incentive receivable (Australia) |
| |
| |
VAT receivable |
| |
| |
Current tax receivable |
| |
| |
Foreign currency swaps |
| |
| |
Other |
| |
| |
Total trade and other receivables |
| |
| |
The decrease of €
The Company can include unbilled receivables in its accounts receivable balance. Generally, these receivables represent earned revenue from products delivered to customers, which will be billed in the next billing cycle. All amounts are considered collectible and billable. As at December 31, 2023 and June 30, 2024, there were
R&D incentive receivables relate to incentives received in Australia as a support to the clinical trials and the development of the Genio® system.
The current tax receivable relates to excess payment of corporate income tax in the United States and in Belgium.
We refer to note 21 for more details on the foreign currency swaps.
14
13.Cash and cash equivalents
As at | ||||
June 30, | December 31, | |||
(in EUR 000) |
| 2024 |
| 2023 |
Short term deposit |
| |
| |
Current accounts |
| |
| |
Total cash and cash equivalents |
| |
| |
Cash and cash equivalents increased to €
14.Financial assets
Current financial assets relate to term accounts with an initial maturity longer than 3 months but less than 12 months measured at amortized costs.
In 2024, the Company entered into USD term deposits and US Treasury bills for a total amount $US
As per June 30, 2024, the current financial assets consists of $US
15.Capital, Share Premium, Reserves
15.1.Capital and share premium
The number of shares and the par value in the paragraph below take into account resolutions adopted by the shareholders’ meeting of February 21, 2020. All existing preferred shares were converted into common shares, and then a share split of
As part of the IPO on September 21, 2020, the Company incurred direct-attributable transaction costs of €
As part of the IPO on July 7, 2021, the Company incurred direct-attributable transaction costs of €
As of June 30, 2024, the share capital of the Company amounts to €
15
Evolution of the share capital and share premium over the six months ended June 30, 2024 and 2023:
| Common |
| Total of |
| Par value |
| Share |
| Share | |
(Number of shares except otherwise stated) | shares | shares | (EUR) | capital | premium | |||||
January 1, 2023 |
| |
| |
| |
| |
| |
March 29, 2023 - Capital increase in cash |
| |
| |
| |
| |
| |
March 30, 2023 - Capital increase in cash |
| |
| |
| |
| |
| |
April 17, 2023 - Capital increase in cash |
| |
| |
| |
| |
| |
June 30, 2023 | | | | | | |||||
July 14, 2023 - Exercise warrants | | | | — | | |||||
August 29, 2023 - Exercise warrants | | | | | | |||||
December 31, 2023 | | | | | | |||||
March 6, 2024 - Exercise warrants | | | | | | |||||
April 17, 2024 - Exercise warrants | | | | | | |||||
May 28, 2024 - Capital increase in cash | | | | | | |||||
June 3, 2024 - Capital increase in cash | | | | | | |||||
June 24, 2024 - Exercise warrants | | | | | | |||||
June 30, 2024 | | | | | |
On March 29, 2023, the Company issued
On March 30, 2023, the Company raised €
On April 17, 2023, the Company issued
As part of above capital increases, the Company incurred direct-attributable transaction costs of €
On July 14, 2023, pursuant to the exercise of warrants, the Company issued
On August 29, 2023, pursuant to the exercise of warrants, the Company issued
On March 6, 2024, pursuant to the exercise of warrants, the Company issued
On April 17, 2024, pursuant to the exercise of warrants, the Company issued
On May 28, 2024, the Company issued
16
On June 3, 2024, the Company issued
The proceeds of the May 28 and June 3, 2024 capital increases will be used for general corporate purposes.
As part of above capital increases, the Company incurred direct-attributable transaction costs of €
On June 24, 2024, pursuant to the exercise of warrants, the Company issued
15.2.Reserves
The reserves include the share-based payment reserve (see note 16), other comprehensive income and the retained loss. Retained loss is comprised of primarily accumulated losses, other comprehensive income is comprised of currency translation reserves and remeasurements of post-employment benefit obligations.
The movement in other comprehensive income for the six months ended June 30, 2024 and 2023 is detailed in the table below:
Post- | ||||||
Currency | employment | |||||
translation | benefit | |||||
(in EUR 000) |
| reserve |
| obligations |
| Total |
Opening value at January 1, 2023 |
| |
| |
| |
Currency translation differences |
| ( |
| — |
| ( |
Total other comprehensive income at June 30, 2023 |
| |
| |
| |
Opening value at January 1, 2024 |
| |
| |
| |
Currency translation differences |
| ( |
| — |
| ( |
Total other comprehensive income at June 30, 2024 |
| |
| |
| |
16.Share-Based compensation
Equity-settled share-based payment transactions
As of June 30, 2024, the Company has five outstanding equity-settled share-based incentive plans, including (i) the 2016 warrants plan (the 2016 Plan), (ii) the 2018 warrants plan (the 2018 Plan), (iii) the 2020 warrants plan (the 2020 Plan), (iv) the 2021 warrants plan (the 2021 plan) and (v) the 2022 warrants plan (the 2022 plan). The Company had an extraordinary shareholders’ meeting on February 21, 2020 where it was decided to achieve a share split in a ratio of
In accordance with the terms of the various plans, all warrants that had not yet vested before, vested on September 7, 2020, i.e. ten business days prior to the closing of the IPO on September 21, 2020.
17
The changes of the year for the equity-settled warrant plans are as follows:
Number of shares (after share split) warrants give right to across all plans |
| 2024 |
| 2023 |
Outstanding at January 1 |
| |
| |
Granted |
| |
| |
Forfeited |
| ( |
| ( |
Exercised |
| ( |
| |
Expired | ( | ( | ||
Outstanding as at June 30 |
| |
| |
Exercisable as at June 30 |
| |
| |
On February 1, 2024 and on April 21, 2024, respectively
18
The following tables provide the input to the Black-Scholes model for warrants granted in 2018, 2020, 2021, 2022, 2023 and 2024 related to the 2016 warrant plan, the 2018 warrant plan, the 2020 warrant plan, the 2021 warrant plan and the 2022 warrant plan. The tables and notes uses as a basis, the number of shares the warrants give right to across all plans.
Plan 2021 | |||||||||||
| Plan 2016 |
| Plan 2018 |
| Plan 2018 |
| Plan 2020 |
| (grant Sept 17 |
| |
(grant 2018) | (grant 2018) | (grant 2020) | (grant 2020) | 2021) |
| ||||||
Return Dividend |
| | % | | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % | | % |
Risk-free interest rate |
| | % | ( | % | ( | % | ( | % | ( | % |
Expected life |
| |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| |
| |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| |
(grant Oct 27 | (grant Feb 21 | (grant Feb 21 | (grant Feb 21 | (grant May 14 | |||||||
| 2021) |
| 2022) |
| 2022) |
| 2022) |
| 2022) |
| |
Return Dividend |
| | % | | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % | | % |
Risk-free interest rate |
| ( | % | | % | | % | | % | | % |
Expected life |
| |
| |
| |
| |
| |
|
Exercise price |
| |
| |
| |
| |
| |
|
Stock price |
| |
| |
| |
| |
| |
|
Fair value |
| |
| |
| |
| |
| |
|
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| |
(grant June 8 | (grant Aug 8 | (grant Aug 8 | (grant March 24 | (grant April 12 |
| ||||||
2022) | 2022) | 2022) | 2023) | 2023) |
| ||||||
Return Dividend |
| | % | | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % | | % | | % |
Expected life |
| |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| |
| |
Plan 2021 | Plan 2022 | Plan 2022 | Plan 2022 | Plan 2022 | |||||||
(grant June 14 | (grant June 14 | (grant Oct 20 | (grant Feb 01 | (grant Apr 21 | |||||||
| 2023) |
| 2023) |
| 2023) |
| 2024) |
| 2024) | ||
Return Dividend | | % | | % | | % | | % | | % | |
Expected volatility | | % | | % | | % | | % | | % | |
Risk-free interest rate |
| | % | | % | | % | | % | | % |
Expected life |
| |
| | |
| |
| |
| |
Exercise price |
| |
| | |
| |
| |
| |
Stock price |
| |
| | |
| |
| |
| |
Fair value |
| |
| | |
| |
| |
|
On March 24, 2023, the Company reduced the exercise price of
19
The fair value of the modified warrants was determined using the same models and principles as described above, with the following model inputs:
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| |
(grant Sept 17 | (grant Oct 27 | (grant Feb 21 | (grant Feb 21 |
| |||||
2021) | 2021) | 2022) | 2022) |
| |||||
Return Dividend |
| | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| | |
Incremental Fair value |
| |
| |
| |
| |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| Plan 2021 |
| |
(grant Feb 21 | (grant May 14 | (grant Aug 8 | (grant Aug 8 |
| |||||
2022) | 2022) | 2022) | 2022) |
| |||||
Return Dividend |
| | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| | |
Incremental Fair value |
| |
| |
| |
| |
The Company has recognized €
17.Financial Debt
Financial debt consists of recoverable cash advances and other loans. Related amounts can be summarized as follows:
| As at | |||
| June 30, |
| December 31, | |
(in EUR 000) | 2024 | 2023 | ||
Recoverable cash advances - Non-current | | | ||
Recoverable cash advances - Current |
| |
| |
Total Recoverable cash advances |
| |
| |
Other loan - Non-current | — |
| — | |
Other loan - Current |
| |
| |
Total Other loan |
| |
| |
Non-current |
| |
| |
Current |
| |
| |
Total Financial Debt |
| |
| |
20
Financial debt related to recoverable cash advances
Recoverable cash advances received
As at June 30, 2024, the details of recoverable cash advances received can be summarized as follows:
Contractual | Advances | Fixed | Variable | |||||
(in EUR 000) |
| advances |
| received |
| reimbursements* |
| reimbursements* |
Sleep apnea device (6472) |
| |
| | | | ||
First articles (6839) |
| |
| | | | ||
Clinical trial (6840) |
| |
| | | | ||
Activation chip improvements (7388) |
| |
| | | | ||
Total |
| |
| | | |
*Excluding interests
During the six months ended June 30, 2024 , the Company made no reimbursements and did not receive any new amounts.
Based on expected timing of sales and after discounting, the financial debt related to the recoverable cash advances is as follows:
As at | ||||
| June 30, |
| December 31, | |
(in EUR 000) | 2024 | 2023 | ||
Contract 6472 |
| |
| |
Contract 6839 |
| |
| |
Contract 6840 |
| |
| |
Contract 7388 |
| |
| |
Total recoverable cash advances |
| |
| |
Non-current |
| |
| |
Current |
| |
| |
Total recoverable cash advances |
| |
| |
The amounts recorded under “Current” caption correspond to the sales-independent amounts (fixed repayment) and sales-dependent reimbursements (variable repayment) estimated to be repaid to the Walloon Region in the next 12-month period. The estimated sales-independent (fixed repayment) as well as sales-dependent reimbursements (variable repayment) beyond 12 months are recorded under “Non-current” liabilities.
Changes in the recoverable cash advances can be summarized as follows:
(in EUR 000) |
| 2024 |
| 2023 |
As at January 1 |
| |
| |
Initial measurement and re-measurement |
| ( |
| ( |
Discounting impact |
| |
| |
As at June 30 |
| |
| |
18.Trade payables
As at | ||||
| June 30, |
| December 31, | |
(in EUR 000) | 2024 | 2023 | ||
Payables |
| |
| |
Invoices to be received |
| |
| |
Total Trade payables |
| |
| |
21
The increase in total trade payables of €
In order to be consistent with the current period’s presentation, in the condensed consolidated financial statement as at March 31, 2024 an immaterial correction has been made to certain comparatives on the face of the consolidated statement of financial position. Accrued expenses of €
19.Income taxes and deferred taxes
For the three months ended | For the six months ended | |||||||
| June 30 |
| June 30 | |||||
(in EUR 000) |
| 2024 |
| 2023 | 2024 |
| 2023 | |
Current tax income/(expense) |
| ( | ( | ( |
| ( | ||
Deferred tax income/(expense) |
| ( | ( | ( |
| | ||
Total Income Tax Income/(Expense) |
| ( | ( | ( |
| ( | ||
The current tax expense mainly relates to (i) an additional accrual of the liability for uncertain tax positions for an amount of €
20.Other payables
| As at | |||
June 30, | December 31, | |||
(in EUR 000) |
| 2024 |
| 2023 |
Holiday pay accrual | | | ||
Salary |
| |
| |
Accrued expenses |
| |
| |
Foreign currency swap - current |
| |
| |
Other |
| |
| |
Total other payables |
| |
| |
The increase of €
In order to be consistent with the current period’s presentation, in the condensed consolidated financial statement as at March 31, 2024 an immaterial correction has been made to certain comparatives on the face of the consolidated statement of financial position. Accrued expenses of €
21.Derivatives
The Company is exposed to currency risk primarily due to the expected future USD, AUD and NIS expenses that will be incurred as part of the ongoing and planned marketing, clinical trials and other related expenses. A financial risk management policy has been approved to i) generate yields on liquidity and ii) reduce the exposure to currency fluctuations with a timeline up to
22
The Company has entered into several foreign currency swaps for which the notional amounts are detailed in the table below:
As at | ||||
| June 30, |
| December 31, | |
(in EUR 000) | 2024 | 2023 | ||
Foreign currency swaps EUR - NIS (in EUR) |
| — |
| |
Foreign currency swaps EUR - NIS (in NIS) |
| — |
| |
Foreign currency swaps NIS - EUR (in EUR) |
| |
| |
Foreign currency swaps NIS - EUR (in NIS) | | | ||
Foreign currency swaps EUR - USD (in EUR) | | | ||
Foreign currency swaps EUR - USD (in USD) | | | ||
The following table shows the carrying amount of derivative financial instruments measured at fair value in the statement of the financial position including their levels in the fair value hierarchy:
As at June 30, 2024 | ||||||||
(in EUR 000) |
| Level I |
| Level II |
| Level III |
| Total |
Financial assets |
|
|
|
|
|
|
|
|
Foreign currency swaps |
| |
| |
| |
| |
Financial liabilities |
|
|
|
|
|
|
| |
Foreign currency swaps |
| |
| |
| |
| |
The fair value is determined by the financial institution and is based on foreign currency swaps rates and the maturity of the instrument. All foreign currency swaps are classified as current as their maturity date is within the next twelve months.
The change in the balance of the financial assets is detailed as follows:
(in EUR 000) |
| 2024 |
| 2023 |
Opening value at January 1 |
| |
| |
Fair value adjustments |
| ( |
| ( |
Closing value at June 30 |
| |
| |
The change in the balance of the financial liabilities is detailed as follows:
(in EUR 000) |
| 2024 |
| 2023 |
Opening value at January 1 |
| |
| |
Fair value adjustments |
| ( |
| |
Closing value at June 30 |
| |
| |
22.Results of operation
Revenue and cost of goods sold
In the six months ended June 30, 2024, the Company generated revenue for the amount of €
Revenue is recognized at a point in time upon satisfaction of the performance obligation, being the moment control over the Genio® system is transferred to the customer, which is in general at delivery at customer site or a predefined location in the country of the customer. For certain customers, control may be transferred upon shipment to the customer in case the incoterms are Ex-Works. The revenue from the Genio® system consists of a kit of products delivered at the same point in time, and as such revenue does not need to be allocated over the different products. The revenue is then recognized at an amount that reflects the consideration to which the Company expects to be entitled in exchange of the Genio® system. In determining the transaction price for the sale of the Genio® system, the Company considers the effects of variable consideration.
23
For the six month period ended June 30, 2024 the sales (based on country of customer) were generated in Germany (€
For the three month period ended June 30, 2024 the sales (based on country of customer) were generated in Germany (€
Cost of goods sold for the three and six months ended June 30, 2024 and 2023:
| For the three months ended | For the six months ended | ||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Purchases of goods and services |
| | | |
| | ||
Inventory movement |
| ( | | ( |
| ( | ||
Total cost of goods sold |
| | | |
| | ||
Operating expenses
The tables below detail the operating expenses for the six months ended June 30, 2024 and 2023:
Operating | ||||||
expense for the | ||||||
(in EUR 000) |
| Total cost |
| Capitalized |
| period |
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| ( |
| ( |
For the six months ended June 30, 2024 |
| |
| ( |
| |
|
|
| Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| |
| ( |
For the six months ended June 30, 2023 |
| |
| ( |
| |
The tables below detail the operating expenses for the three months ended June 30, 2024 and 2023:
|
|
| Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| ( |
| ( |
For the three months ended June 30, 2024 |
| |
| ( |
| |
|
|
| Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| |
| ( |
For the three months ended June 30, 2023 |
| |
| ( |
| |
24
Research and Development expenses
| For the three months ended | For the six months ended | ||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Staff costs |
| | | |
| | ||
Consulting and contractors' fees |
| | | |
| | ||
Q&A regulatory |
| | | |
| | ||
IP costs |
| | | |
| | ||
Depreciation and amortization expense |
| | | |
| | ||
Travel |
| | | |
| | ||
Manufacturing and outsourced development |
| | | |
| | ||
Clinical studies |
| | | |
| | ||
Other expenses |
| | | |
| | ||
IT | | | | | ||||
Capitalized costs |
| ( | ( | ( |
| ( | ||
Total research and development expenses |
| | | |
| | ||
Before capitalization of €
Before capitalization of €
Selling, General and Administrative expenses
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Staff costs |
| | | |
| | ||
Consulting and contractors' fees |
| | | |
| | ||
Legal fees |
| | | |
| | ||
Rent |
| | | |
| | ||
Depreciation and amortization expense |
| | | |
| | ||
IT |
| | | |
| | ||
Travel |
| | | |
| | ||
Insurance fees |
| | | |
| | ||
Other |
| | | |
| | ||
Total selling, general and administrative expenses |
| | | |
| | ||
Selling, general and administrative expenses increased by €
Selling, general and administrative expenses increased by €
25
Other operating income / ( expenses)
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Recoverable cash advances |
|
|
|
| ||||
Initial measurement and re-measurement |
| | | |
| | ||
R&D incentives |
| | | |
| | ||
Capitalization of R&D incentive |
| ( | ( | ( |
| ( | ||
Other income/(expenses) |
| — | ( | — |
| ( | ||
Total Other Operating Income/(Expenses) |
| | | |
| | ||
The Company had other operating income of €
The Company had other operating income of €
For the six month period ended June 30, 2024, the other operating income contains the R&D incentive in Australia and Belgium while for the six month period ended June 30, 2023 the other operating income only contained the R&D incentive in Australia. For the three month period ended June 30, 2024, €
23.Employee benefits
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Salaries |
| | | |
| | ||
Social charges |
| | | |
| | ||
Pension charges | | | | | ||||
Share-based payment |
| | | |
| | ||
Other |
| | | |
| | ||
Total employee benefits |
| | | |
| | ||
In order to be consistent with the current period’s presentation, comparable figures have been represented which involved aggregation of certain line items based on the nature employee benefits.
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Selling, general and administrative expenses |
| | | |
| | ||
Research & Development expenses |
| | | |
| | ||
Total employee benefits |
| | | |
| | ||
26
24.Financial income
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Interests |
| | | |
| | ||
Exchange differences |
| | | |
| | ||
Other |
| | ( | |
| | ||
Total financial income |
| | | |
| | ||
For the six month period ended June 30, 2024, exchange gains amount €
For the six month period ended June 30, 2024, the total interest income amounted to €
25.Financial expense
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Fair value adjustment |
| ( | | |
| | ||
Recoverable cash advances, Accretion of interest |
| | | |
| | ||
Interest and bank charges |
| | | |
| | ||
Interest on lease liabilities |
| | | |
| | ||
Exchange differences |
| | | |
| | ||
Other |
| | ( | |
| | ||
Total Financial expense |
| | | |
| | ||
The fair value adjustment relates to the fair value adjustment on financial instruments. More information can be found in note 21.
The discounting impact of the recoverable cash advances is further detailed in note 17 above.
The exchange losses for an amount of €
26.Loss Per Share (EPS)
The Basic Earnings Per Share and the Diluted Earnings Per Share are calculated by dividing earnings for the year by the weighted average number of shares outstanding during the year. As the Company is incurring net losses, outstanding warrants have no dilutive effect. As such, there is no difference between the Basic and Diluted EPS.
27
EPS for June 2024 has been presented in the income statement taking into account resolutions adopted by the shareholders’ meeting of February 21, 2020. All existing preferred shares were converted into common shares, and then a share split of
| For the three months ended | For the six months ended | ||||||
June 30 | June 30 | |||||||
2024 |
| 2023 |
| 2024 |
| 2023 | ||
As at June 30, after conversion and share split |
|
|
|
| ||||
Outstanding common shares at period-end |
| | | |
| | ||
Weighted average number of common shares outstanding |
| | | |
| | ||
Number of shares resulting of the exercise of outstanding warrants |
| | | |
| | ||
Basic and Diluted EPS for the three and six month period ended June 30, 2024 and 2023 based on weighted average number of shares outstanding after conversion and share split are as follows:
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
Loss of year attributable to equity holders (in EUR) |
| ( | ( | ( |
| ( | ||
Weighted average number of common shares outstanding (in units) |
| | | |
| | ||
Basic earnings per share in EUR (EUR/unit) |
| ( | ( | ( |
| ( | ||
Diluted earnings per share in EUR (EUR/unit) |
| ( | ( | ( |
| ( | ||
27.Other commitments
The Company has granted in 2022 an amount of €
In addition, in March 2024, the Company has started a Partnership agreement with the American Academy of Otolaryngology (AAO) amounting to a yearly fee of $
28.Related Party Transactions
Transactions between the Company and its subsidiaries have been eliminated in consolidation and are not disclosed in the notes. Related party transactions are disclosed below.
Remuneration of Key Management
The remuneration of the senior management consists of the remuneration of the CEO of the Company for the three and six months ended June 30:
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2024 |
| 2023 | 2024 |
| 2023 | |
Short-term remuneration & compensation |
| | | |
| | ||
Share based payment |
| | | |
| | ||
Total |
| | | |
| | ||
28
Transactions with Non-Executive Directors and Shareholders:
For the six months ended | For the six months ended | |||||||||||
June 30, 2024 | June 30, 2023 | |||||||||||
R&D | Consulting | Board | R&D | Consulting | Board | |||||||
(in EUR 000) |
| Collaboration |
| services |
| Remuneration |
| Collaboration |
| services |
| Remuneration |
Cochlear |
| — |
| — |
| — |
| |
| — |
| — |
Robert Taub |
| — |
| — |
| |
| — |
| — |
| |
Kevin Rakin |
| — |
| — |
| |
| — |
| — |
| |
Pierre Gianello |
| — |
| — |
| |
| — |
| — |
| |
Jurgen Hambrecht |
| — |
| — |
| |
| — |
| — |
| |
Rita Mills |
| — |
| — |
| |
| — |
| — |
| |
Giny Kirby | — | — | | — | — | | ||||||
Wildman Ventures LLC | — | — | | — | — | | ||||||
Total |
| — |
| — |
| |
| |
| — |
| |
Amounts outstanding at period-end |
| — |
| — |
| |
| — |
| — |
| |
| For the three months ended |
| For the three months ended | |||||||||
June 30, 2024 | June 30, 2023 | |||||||||||
R&D |
| Consulting |
| Board |
| R&D |
| Consulting |
| Board | ||
(in EUR 000) |
| Collaboration |
| services |
| Remuneration |
| Collaboration |
| services |
| Remuneration |
Cochlear |
| — |
| — |
| — |
| |
| — |
| — |
Robert Taub |
| — |
| — |
| |
| — |
| — |
| |
Kevin Rakin |
| — |
| — |
| |
| — |
| — |
| |
Pierre Gianello |
| — |
| — |
| |
| — |
| — |
| |
Jurgen Hambrecht |
| − |
| — |
| |
| — |
| — |
| |
Rita Mills |
| — |
| — |
| |
| — |
| — |
| |
Giny Kirby | — | — | | — | — | | ||||||
Wildman Ventures LLC | — | — | | — | — | | ||||||
Total |
| — |
| — |
| |
| |
| — |
| |
Amounts outstanding at period-end |
| — |
| — |
| |
| — |
| — |
| |
The Company and Cochlear Limited, or Cochlear, have entered into a collaboration agreement, dated November 2018, under which they agreed to collaborate to further develop and progress commercialization of implantable treatments for sleep disordered breathing conditions. A new Statement of Work was entered into on June 8, 2020. Under this agreement, Cochlear is working with the Company in developing and enhancing the next generation implantable stimulator. This collaboration agreement led to a financial impact of €
On September 28, 2023, the Company announced a partnership with ResMed in Germany to increase OSA awareness and therapy penetration in the German market. The Company and ResMed Germany will establish a continuum of care that will educate and guide OSA patients in the German market from diagnosis through treatment. Together, the companies will work to accelerate patient identification and better support patient set-up on the appropriate therapy.
29.Events after the Balance-Sheet Date
On July 3, 2024, the Company has signed a €
On July 31, 2024, the Board of Directors, within the framework of the authorized capital, issued
29
RESPONSIBILITY STATEMENT
We certify that, to the best of our knowledge,
| a) | the condensed consolidated interim financial statement, prepared in accordance with the applicable standards for financial statements, give a true and fair view of the assets, liabilities, financial position and results of the Company and the undertakings included in the consolidation taken as a whole; and |
| b) | this interim management report provides a true and fair overview of the development, results and the position of the Company and the undertakings included in the consolidation taken as a whole, as well as a description of the principal risks and uncertainties that they face. |
Mont-Saint-Guibert, August 6, 2024.
On behalf of the board of directors
Robert Taub, Chairman |
| Olivier Taelman, CEO |
30