UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2023
Commission File Number: 001-40552
(Translation of registrant’s name into English)
Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Nyxoah SA
On August 8, 2023, Nyxoah SA (the “Company”) issued a press release announcing its financial and operating results for the second quarter and first half of 2023. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Additionally, on August 8, 2023, the Company announced its unaudited first half-year results for 2023, which are further described in an H1 2023 report.
The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
The information in the attached Exhibit 99.2 shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-261233 and 333-269410) and Form F-3 (Registration Number 333-268955) of the Company (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibits
99.1 | ||
99.2 | ||
101.INS | XBRL Instance Document. | |
101.SCH | XBRL Taxonomy Extension Schema Document. | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |
101.IAB | XBRL Taxonomy Extension Labels Linkbase Document. | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document |
Exhibit 99.1
REGULATED INFORMATION
Nyxoah Reports Second Quarter and First Half 2023 Financial and Operating
Results
Mont-Saint-Guibert, Belgium – August 8, 2023 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the second quarter and first half of 2023.
Recent Financial and Operating Highlights
● | Presented 12-month efficacy data1 on the first 34 DREAM patients and safety data on all DREAM patients at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success. |
● | Filed the second module in the modular PMA submission. |
● | Accelerated US pre-commercialization efforts, focused on market access and commercial leadership. |
● | Continued to enroll the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC) patients. Implant completion is expected in 2024. |
● | Reported second-quarter sales of €1.1 million and ended the quarter with 42 active German accounts. |
● | Ended the quarter with a cash position of €84.5 million, providing an anticipated cash runway into late 2024. |
“Being less than nine months away from the DREAM study readout, our attention continues to be on patient follow up. We are highly encouraged by both the efficacy and safety data presented at SLEEP 2023. Our modular PMA filing is well underway, with the second module submitted during the quarter,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are building strong commercial expertise in the competitive German market. Our direct-to-consumer advertising, helpline and referral networks have increased HGNS penetration and give us confidence on entering new markets.”
1 | For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up. |
1
REGULATED INFORMATION
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
| | For the three | | For the six | | ||||||||
| | 2023 | | 2022 | | 2023 | | 2022 | | ||||
Revenue |
| € | 1,107 |
| € | 936 |
| € | 1,548 |
| € | 1,595 |
|
Cost of goods sold | | | (419) | | | (334) | | | (594) | | | (623) | |
Gross profit | | € | 688 | | € | 602 | | € | 954 | | € | 972 | |
Research and Development Expense | | | (6,605) | | | (3,470) | | | (12,762) | | | (7,065) | |
Selling, General and Administrative Expense | | | (6,185) | | | (4,536) | | | (11,736) | | | (8,729) | |
Other income/(expense) | | | 219 | | | 14 | | | 265 | | | 150 | |
Operating loss for the period | | € | (11,883) | | € | (7,390) | | € | (23,279) | | € | (14,672) | |
Financial income | | | 789 | | | 4,669 | | | 1,414 | | | 6,246 | |
Financial expense | | | (775) | | | (2,162) | | | (1,732) | | | (2,950) | |
Loss for the period before taxes | | € | (11,869) | | € | (4,883) | | € | (23,597) | | € | (11,376) | |
Income taxes | | | ( 928) | | | ( 107) | | | (1,110) | | | ( 315) | |
Loss for the period | | € | (12,797) | | € | (4,990) | | € | (24,707) | | € | (11,691) | |
| | | | | | | | | | | | | |
Loss attributable to equity holders | | € | (12,797) | | € | (4,990) | | € | (24,707) | | € | (11,691) | |
Other comprehensive loss | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss (net of tax) | | | | | | | | | | | | | |
Currency translation differences | | | (50) | | | (12) | | | (78) | | | (114) | |
Total comprehensive loss for the year, net of tax | | € | (12,847) | | € | (5,002) | | € | (24,785) | | € | (11,805) | |
Loss attributable to equity holders | | € | (12,847) | | € | (5,002) | | € | (24,785) | | € | (11,805) | |
| | | | | | | | | | | | | |
Basic Loss Per Share (in EUR) | | € | (0.447) | | € | (0.193) | | € | (0.907) | | € | (0.453) | |
Diluted Loss Per Share (in EUR) | | € | (0.447) | | € | (0.193) | | € | (0.907) | | € | (0.453) | |
2
REGULATED INFORMATION
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
| | As at | | ||||
| | June 30 | | December 31 | | ||
ASSETS |
| |
|
| |
|
|
Non-current assets | | |
| | |
| |
Property, plant and equipment | | | 2,813 | | | 2,460 | |
Intangible assets | | | 44,488 | | | 39,972 | |
Right of use assets | | | 3,571 | | | 3,159 | |
Deferred tax asset | | | 48 | | | 47 | |
Other long-term receivables | | | 165 | | | 173 | |
| | € | 51,085 | | € | 45,811 | |
Current assets | | |
| | |
| |
Inventory | | | 1,146 | | | 882 | |
Trade receivables | | | 1,820 | | | 1,463 | |
Other receivables | | | 2,262 | | | 1,775 | |
Other current assets | | | 1,576 | | | 1,284 | |
Financial assets | | | 67,919 | | | 76,968 | |
Cash and cash equivalents | | | 16,604 | | | 17,888 | |
| | € | 91,327 | | € | 100,260 | |
Total assets | | € | 142,412 | | € | 146,071 | |
| | | | | | | |
EQUITY AND LIABILITIES | | |
| | |
| |
Capital and reserves | | |
| | |
| |
Capital | | | 4,924 | | | 4,440 | |
Share premium | | | 246,070 | | | 228,275 | |
Share based payment reserve | | | 7,005 | | | 5,645 | |
Other comprehensive income | | | 98 | | | 176 | |
Retained loss | | | (142,522) | | | (118,212) | |
Total equity attributable to shareholders | | € | 115,575 | | € | 120,324 | |
| | | | | | | |
LIABILITIES | | |
| | |
| |
Non-current liabilities | | |
| | |
| |
Financial debt | | | 8,433 | | | 8,189 | |
Lease liability | | | 2,991 | | | 2,586 | |
Pension liability | | | 50 | | | − | |
Provisions | | | 127 | | | 59 | |
Deferred tax liability | | | − | | | − | |
| | € | 11,601 | | € | 10,834 | |
Current liabilities | | |
| | |
| |
Financial debt | | | 559 | | | 388 | |
Lease liability | | | 751 | | | 719 | |
Trade payables | | | 4 690 | | | 4,985 | |
Current tax liability | | | 4 475 | | | 3,654 | |
Other payables | | | 4 761 | | | 5,167 | |
| | € | 15,236 | | € | 14,913 | |
Total liabilities | | € | 26,837 | | € | 25,747 | |
Total equity and liabilities | | € | 142,412 | | € | 146,071 | |
3
REGULATED INFORMATION
Revenue
Revenue was €1.1 million for the second quarter ending June 30, 2023, compared to €0.9 million for second quarter ending June 30, 2022.
Cost of Goods Sold
Cost of goods sold was €0.4 million for the three months ending June 30, 2023, representing a gross profit of €0.7 million, or gross margin of 62.2%. This compares to total cost of goods sold of €0.3 million in the second quarter ending June 30, 2022, for a gross profit of €0.6 million, or gross margin of 64.3%.
Research and Development Expenses
Research and development expenses were €6.6 million for the three months ending June 30, 2023, versus €3.5 million for the prior year period, driven by an acceleration in clinical activities, notably the start of the ACCCESS study.
Selling, General and Administrative Expenses
Selling, general and administrative expenses rose to €6.2 million for the second quarter of 2023, up from €4.5 million in the second quarter of 2022. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah’s corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.
4
REGULATED INFORMATION
Operating Loss
Total operating loss for the second quarter 2023 was €11.9 million versus €7.4 million in the second quarter of 2022. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.
Cash Position
As of June 30, 2023, cash and financial assets totaled €84.5 million, compared to €94.9 million on December 31, 2022. Total cash burn was approximately €4.8 million per month during the second quarter of 2023.
First Half 2023 Report
Nyxoah’s financial report for the first half 2023, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Nyxoah will conduct a conference call open to the public today at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah’s Q2 2023 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: Nyxoah’s Q2 2023 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.
The archived webcast will be available for replay shortly after the close of the call.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC)
5
REGULATED INFORMATION
patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
6
REGULATED INFORMATION
Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313
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Exhibit 99.2
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 2023
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.
Enrollment in the DREAM trial is now complete, and 115 patients have undergone a Genio® implantation procedure. The company presented 12-month efficacy data on the first 34 DREAM patients and safety data, as of March 14, 2023, on all DREAM patients demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success. For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up. The Company anticipates having 12-month clinical data in the first half of 2024 and has submitted the first and second modules in the modular PMA.
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.
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
2
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 first patients had undergone a Genio(R) implantation procedure.
B.EUROPEAN COMMERCIALIZATION
During the first six months of 2023, Nyxoah recognized total revenue of €1.5 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, 2023, the Company has activated 42 Tier 1 sites across Germany, up from 12 as of December 31, 2021.
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 and Austria, and the Company expects to expand into other European countries.
2.FINANCIAL HIGHLIGHTS
Revenue was €1.5 million for the six months ending June 30, 2023, compared to €1.6 million for the six months ending June 30, 2022 with strong acceleration in Q2 2023.
3
Cost of goods sold was €0.6 million for the six months ending June 30, 2023, compared to €0.6 million cost for the six months ending June 30, 2022.
Selling, general and administrative expenses increased by €3.0 million or 34 % from €8.7 million for the six months ended June 30, 2022 to €11.7 million for the six months ended June 30, 2023, mainly due to an increase of costs to support the commercialization of Genio® system in Europe, scale up of the Company and also due to a start of new ERP system implementation.
Before capitalization of €5.0 million for the six months ended June 30, 2023 and €7.8 million for the six months ended June 30, 2022, research and development expenses increased by €3.0 million or 20 %, from €14.8 million for the six months ended June 30, 2022, to €17.8 million for the six months ended June 30, 2023, due to the combined effect of higher clinical, R&D activities and manufacturing expenses and also due to a start of new ERP system implementation. This increase is mainly in staff, consulting costs and in manufacturing and outsourced development to support those activities, these increases were offset by a decrease of €1.7 million in clinical study activities due to completion of Dream Study.
Nyxoah realised a net financial loss of €0.3 million for the six months ending June 30, 2023 primarily driven by the exchange rate depreciation of dollar versus euro. This compares to a net positive financial result of €3.3 million for the six months ended June 30, 2022, during which dollar appreciated versus euro.
Nyxoah realized a net loss of €24.7 million for the six months ended June 30, 2023, compared to a net loss of €11.7 million for the six months ended June 30, 2022
Cash and cash equivalents
On June 30, 2023, cash and cash equivalents and financial assets totalled €84.5 million, compared to €94.9 million on December 31, 2022. The decrease in cash and cash equivalents resulted mainly from net cash used in operating activities of €22.5 million and net cash from investing activities of €3.9 million and offset by net cash flows from financial activities of €17.8 million due to capital increase. See note 13.
3.2023 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 will focus on patient follow-up in the DREAM IDE trial resulting in reaching primary endpoints, continue to enrol the ACCCESS IDE study for CCC patients and begin preparations to enter the US market with regulatory, manufacturing and market access readiness.
4.RISK FACTORS
We refer to the description of risk factors in the Company’s 2022 annual report, pp. 60-83. 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 2022 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, 2023 –
INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(unaudited)
(in thousands)
As at | ||||||||
June 30 | December 31 | |||||||
| Notes |
| 2023 |
| 2022 | |||
ASSETS | ||||||||
Non-current assets |
|
|
|
|
|
| ||
Property, plant and equipment |
| 7 |
| |
| | ||
Intangible assets |
| 8 |
| |
| | ||
Right of use assets |
| 9 |
| |
| | ||
Deferred tax asset |
| 19 |
| |
| | ||
Other long-term receivables |
|
|
| |
| | ||
|
|
| € | |
| € | | |
Current assets |
|
|
|
| ||||
Inventory |
| 10 |
| |
| | ||
Trade receivables |
| 11 |
| |
| | ||
Other receivables |
| 11 |
| |
| | ||
Other current assets |
| 12 |
| |
| | ||
Financial assets |
| 14 |
| |
| | ||
Cash and cash equivalents |
| 13 |
| |
| | ||
|
|
| € | |
| € | | |
Total assets |
|
|
| € | |
| € | |
|
|
|
|
| ||||
EQUITY AND LIABILITIES |
|
|
|
|
| |||
Capital and reserves |
|
|
|
|
| |||
Capital |
| 15 |
| |
| | ||
Share premium |
| 15 |
| |
| | ||
Share based payment reserve |
| 16 |
| |
| | ||
Other comprehensive income |
| 15 |
| |
| | ||
Retained loss |
|
|
| ( |
| ( | ||
Total equity attributable to shareholders |
|
|
| € | |
| € | |
|
|
|
|
| ||||
LIABILITIES |
|
|
|
|
| |||
Non-current liabilities |
|
|
|
|
| |||
Financial debt |
| 17 |
| |
| | ||
Lease liability |
| 9 |
| |
| | ||
Pension liability |
|
|
| |
| | ||
Provisions |
|
|
| |
| | ||
Deferred tax liability |
|
|
| |
| | ||
|
|
| € | |
| € | | |
Current liabilities |
|
|
|
|
| |||
Financial debt |
| 17 |
| |
| | ||
Lease liability |
| 9 |
| |
| | ||
Trade payables |
| 18 |
| |
| | ||
Current tax liability |
| 19 |
| |
| | ||
Other payables |
| 20 |
| |
| | ||
|
|
| € | |
| € | | |
Total liabilities |
|
|
| € | |
| € | |
Total equity and liabilities |
|
|
| € | |
| € | |
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, 2023 -
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS
(unaudited)
(in thousands)
| For the three months |
| For the six months ended | |||||||||||
ended June 30 | June 30 | |||||||||||||
| Notes | 2023 |
| 2022 |
| 2023 |
| 2022 | ||||||
Revenue | 22 | | | | | |||||||||
Cost of goods sold |
| 22 | ( |
| ( |
| ( |
| ( | |||||
Gross profit |
|
| € | | € | | € | | € | | ||||
Research and Development Expense |
| 22 |
| ( |
| ( |
| ( |
| ( | ||||
Selling, General and Administrative Expense |
| 22 |
| ( |
| ( |
| ( |
| ( | ||||
Other income/(expense) |
|
|
| |
| |
| |
| | ||||
Operating loss for the period |
|
| € | ( | € | ( | € | ( | € | ( | ||||
Financial income |
| 24 |
| |
| |
| |
| | ||||
Financial expense |
| 25 |
| ( |
| ( |
| ( |
| ( | ||||
Loss for the period before taxes |
|
| € | ( | € | ( | € | ( | € | ( | ||||
Income taxes |
| 19 |
| ( |
| ( |
| ( |
| ( | ||||
Loss for the period |
|
| € | ( | € | ( | € | ( | € | ( | ||||
|
|
|
|
|
| |||||||||
Loss attributable to equity holders |
|
| € | ( | € | ( | € | ( | € | ( | ||||
Other comprehensive loss |
|
|
|
|
|
| ||||||||
Items that may be subsequently reclassified to profit or loss (net of tax) |
|
|
|
|
|
| ||||||||
Currency translation differences |
|
|
| ( |
| ( |
| ( |
| ( | ||||
Total comprehensive loss for the year, net of tax |
|
| € | ( | € | ( | € | ( | € | ( | ||||
Loss attributable to equity holders |
|
| € | ( | € | ( | € | ( | € | ( | ||||
|
|
|
|
|
| |||||||||
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 2023 -
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, 2023 |
| € | |
| € |
| € | |
| € | |
| € | ( |
| € | | |
Loss for the period |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Other comprehensive loss for the period |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Total comprehensive loss for the period |
| — |
| — |
| — | € | ( | € | ( | € | ( | ||||||
Equity-settled share-based payments |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Granted during the period |
| — |
| — |
|
| — |
| — |
| | |||||||
Forfeited during the period |
| — |
| — |
| ( |
| — |
| |
| — | ||||||
Transaction cost | — | ( | — | — | — | ( | ||||||||||||
Issuance of shares for cash |
| |
|
| — |
| — |
| — |
| ||||||||
Total transactions with owners of the company recognized directly in equity |
| |
| |
| |
| — |
| |
| | ||||||
Balance at June 30, 2023 | € | | € | | € | | € | | € | ( | € |
Attributable to owners of the parent | ||||||||||||||||||
Share | ||||||||||||||||||
based | Other | |||||||||||||||||
Common | Share | payment | comprehensive | Retained | ||||||||||||||
| shares |
| premium |
| reserve |
| income |
| loss |
| Total | |||||||
Balance at January 1, 2022 | € | | € | | € | | € | | € | ( | € | | ||||||
Loss for the period |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Other comprehensive income for the period |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Total comprehensive loss for the period |
| — |
| — |
| — | € | ( | € | ( | € | ( | ||||||
Equity-settled share-based payments |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Granted during the period | — | — | | — | — | | ||||||||||||
Exercised during the period |
| |
| |
| ( |
| — |
| |
| | ||||||
Issuance of shares for cash | | — | — | — | — | | ||||||||||||
Total transactions with owners of the company recognized directly in equity |
| |
| |
| |
| — |
| |
| | ||||||
Balance at June 30, 2022 | € | | € | | € | | € | | € | ( | € | |
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, 2023 –
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
| For the six months ended | |||||||
June 30 | ||||||||
| Notes |
| 2023 |
| 2022 | |||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Loss before tax for the year |
|
| € | ( | € | ( | ||
Adjustments for |
|
|
|
| ||||
Finance income |
|
|
| ( |
| ( | ||
Finance expenses |
|
|
| |
| | ||
Depreciation and impairment of property, plant and equipment and right-of-use assets |
| 7, 9 |
| |
| | ||
Amortization of intangible assets |
| 8 |
| |
| | ||
Share-based payment transaction expense |
| 16 |
| |
| | ||
Increase/(Decrease) in provisions |
|
|
| |
| | ||
Other non-cash items |
|
|
| ( |
| | ||
Cash generated before changes in working capital |
|
| € | ( | € | ( | ||
Changes in working capital |
|
|
|
| ||||
Decrease/(Increase) in inventory |
| 10 |
| ( |
| ( | ||
(Increase)/Decrease in trade and other receivables |
| 11 |
| ( |
| | ||
Increase/(Decrease) in trade and other payables |
| 18, 20 |
| ( |
| | ||
Cash generated from changes in operations |
|
| € | ( | € | ( | ||
Income tax paid |
|
|
| ( |
| ( | ||
Net cash from / (used in) operating activities |
|
| € | ( | € | ( | ||
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
| ||||
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 |
|
| |
| | |||
Net cash from / (used in) investing activities |
|
| € | | € | ( | ||
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
| ||||
Payment of principal portion of lease liabilities |
| 9 |
| ( |
| ( | ||
Repayment of other loan |
|
|
| ( |
| ( | ||
Interests paid |
|
|
| ( |
| ( | ||
Repayment of recoverable cash advance |
| 15 |
| |
| | ||
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 three 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).
The interim condensed consolidated financial statements of Nyxoah SA and its subsidiaries (collectively, the Group) as of June 30, 2023 and for the three and six months ended June 30, 2023, have been authorized for issue on August 8, 2023 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, 2022.
Except for the application of standards, interpretations and amendments being mandatory as of January 1, 2023, 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, 2022.
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).
10
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, 2022.
Going concern principle
The Unaudited Interim Condensed Consolidated Financial Statements have been prepared on a going concern basis. As at June 30, 2023, the Company had cash and cash equivalents of €
New and amended standards and interpretations applicable
Effective for the annual periods beginning on January 1, 2023
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 2023, but do not have an impact on the interim condensed consolidated financial statements of the Company:
₋ | IFRS 17 Insurance Contracts (applicable for annual periods beginning on or after January 1, 2023) |
₋ | Amendments to IFRS 17 Insurance contracts: Initial Application of IFRS 17 and IFRS 9 – Comparative Information (applicable for annual periods beginning on or after January 1, 2023) |
₋ | Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of Accounting Policies (applicable for annual periods beginning on or after January 1, 2023) |
₋ | Amendments to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates (applicable for annual periods beginning on or after January 1, 2023) |
₋ | Amendments to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction (applicable for annual periods beginning on or after January 1, 2023) |
₋ | Amendments to IAS 12 Income taxes: International Tax Reform – Pillar Two Model Rules (effective immediately – disclosures are required for annual periods beginning on or after 1 January 2023) |
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 2022 year-end consolidated financial statements for further details about the main critical accounting estimates and assumptions.
11
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 options and foreign currency forwards are measured at fair value through profit and loss. Fair value is determined by the financial institution and is based on foreign currency forwards 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) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
Financial Assets |
|
|
|
|
|
|
|
|
Other long-term receivables (level 3) |
| |
| |
| |
| |
Trade and other receivables (level 3) |
| |
| |
| |
| |
Foreign currency forwards (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) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
Financial liabilities |
|
|
|
|
|
|
|
|
Financial debt (level 3) |
| |
| |
| |
| |
Foreign currency option (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
The Company also owns
In May 2020, the Company incorporated Nyxoah Inc, an US-based company located in Delaware with a share capital of USD
12
7.Property, Plant and Equipment
The total acquisitions for the six months ended June 30, 2023 amount to €
The depreciation charge amounts to €
8.Intangible assets
Development | Patents and | |||||
(in EUR 000) |
| cost |
| licenses |
| Total |
Cost |
|
|
|
|
|
|
Opening value at January 1, 2022 |
| |
| |
| |
Additions |
| |
| |
| |
Cost at June 30, 2022 |
| |
| |
| |
Opening value at January 1, 2023 |
| |
| |
| |
Additions |
| |
| |
| |
Cost at June 30, 2023 |
| |
| |
| |
Amortization |
|
|
|
|
|
|
Opening amortization at January 1, 2022 |
| ( |
| ( |
| ( |
Amortization |
| ( |
| ( |
| ( |
Amortization at June 30, 2022 |
| ( |
| ( |
| ( |
Opening amortization at January 1, 2023 |
| ( |
| ( |
| ( |
Amortization |
| ( |
| ( |
| ( |
Amortization at June 30, 2023 |
| ( |
| ( |
| ( |
Net book value at June 30, 2022 |
| |
| |
| |
Net book value at June 30, 2023 |
| |
| |
| |
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 2023 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, 2023, the Company entered into new lease agreements for €
10.Inventory
As at | ||||
June 30, | December 31, | |||
(in EUR 000) |
| 2023 |
| 2022 |
Raw materials | | | ||
Work in progress |
| |
| |
Finished goods |
| |
| |
Total Inventory |
| |
| |
13
The increase in inventory is due to increasing activities to prepare for the commercialization and further scale-up of the company in 2023. For the period ended June 30, 2023 and the year ended December 31, 2022 the Company did not recognize any expenses for inventory write-offs since the inventory level is expected to be sold in the foreseeable future.
11.Trade and Other receivables
As at | ||||
June 30, | December 31, | |||
(in EUR 000) |
| 2023 |
| 2022 |
Trade receivables |
| |
| |
R&D incentive receivable (Australia) |
| |
| |
VAT receivable |
| |
| |
Current tax receivable |
| |
| |
Foreign currency swaps |
| |
| |
Other |
| |
| |
Total trade and other receivables |
| |
| |
The increase of €
The Company may 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, 2022 and June 30, 2023, there were
R&D incentive receivables relates to incentives received in Australia as 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 Israel and in Belgium.
Other mainly relates advance payments and withholding tax to be received related to Belgian R&D employees.
12.Other current assets
The increase of €
13.Cash and cash equivalents
As at | ||||
June 30, | December 31, | |||
(in EUR 000) |
| 2023 |
| 2022 |
Short term deposit |
| |
| |
Current accounts |
| |
| |
Total cash and cash equivalents |
| |
| |
Cash and cash equivalents remain relatively stable totalling €
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.
14
In 2023, the Company entered into USD term deposits and US Treasury bills for a total amount $US
As per June 30, 2023, the current financial assets consists of $US
The total amount of term deposits as per June 30, 2023, amounts to €
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, 2023, the share capital of the Company amounts to €
Evolution of the share capital and share premium over the six months ended June 30, 2023 and 2022:
| Common |
| Total of |
| Par value |
| Share |
| Share | |
(Number of shares except otherwise stated) | shares | shares | (EUR) | capital | premium | |||||
January 1, 2022 |
| |
| |
| |
| |
| |
February 10, 2022 - Exercise warrants |
| |
| |
| |
| |
| |
June 8, 2022 - Capital increase in cash |
| |
| |
| |
| |
| |
June 30, 2022 |
| |
| |
| |
| |
| |
September 30, 2022 - Exercise warrants |
| |
| |
| |
| |
| |
December 31, 2022 |
| |
| |
| |
| |
| |
March 29, 2023 - Capital increase in cash |
| |
| |
| |
| |
| |
March 30, 2023 - Capital increase in cash |
| |
| |
| |
| |
| |
April 13, 2023 - Capital increase in cash |
| |
| |
| |
| |
| |
June 30, 2023 | | | | | |
On March 29, 2023, the Company issued
On March 30, 2023, the Company raised €
On April 13, 2023, the Company issued
15
on December 22, 2022 at an issue price equal to the market price on the Nasdaq Global Market at the time of the sale. The proceeds will be used for general corporate purposes.
As part of above capital increases, the Company incurred direct-attributable transaction costs of €
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, 2023 and 2022 is detailed in the table below:
Post- | ||||||
Currency | employment | |||||
translation | benefit | |||||
(in EUR 000) |
| reserve |
| obligations |
| Total |
Opening value at January 1, 2022 |
| |
| ( |
| |
Currency translation differences |
| ( |
| |
| ( |
Total other comprehensive income at June 30, 2022 |
| |
| ( |
| |
Opening value at January 1, 2023 |
| |
| |
| |
Currency translation differences |
| ( |
| |
| ( |
Total other comprehensive income at June 30, 2023 |
| |
| |
| |
16.Share-Based compensation
Equity-settled share-based payment transactions
As of June 30, 2023, 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.
Number of shares (after share split) warrants give right to across all plans |
| 2023 |
| 2022 |
Outstanding at January 1 |
| |
| |
Granted |
| |
| |
Forfeited/Cancelled |
| ( |
| ( |
Exercised |
| |
| ( |
Outstanding as at June 30 |
| |
| |
Exercisable as at June 30 |
| |
| |
16
The followings warrants from the 2021 warrant plan have been granted in 2023:
-March 24, 2023:
-April 12, 2023:
-June 14, 2023:
On June 14, 2023,
The following tables provide the input to the Black-Scholes model for warrants granted in 2018, 2020, 2021, 2022 and 2023 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 |
| |
| |
| |
| |
| |
17
Plan 2021 | Plan 2022 | ||||
(grant June 14 | (grant June 14 | ||||
| 2023) |
| 2023) |
| |
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
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 €
18
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) | 2023 | 2022 | ||
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 |
| |
| |
Financial debt related to recoverable cash advances
Recoverable cash advances received
As at June 30, 2023, the details of recoverable cash advances received can be summarized as follows:
| Contractual |
| Advances |
| Amounts | |
(in EUR 000) | advances | received | reimbursed | |||
Sleep apnea device (6472) |
| |
| |
| |
First articles (6839) |
| |
| |
| |
Clinical trial (6840) |
| |
| |
| |
Activation chip improvements (7388) |
| |
| |
| |
Total |
| |
| |
| |
During the six months ended June 30, 2023 and the six months ended June 30, 2022 , 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) | 2023 | 2022 | ||
Contract 6472 |
| |
| |
Contract 6839 |
| |
| |
Contract 6840 |
| |
| |
Contract 7388 |
| |
| |
Total recoverable cash advances |
| |
| |
Non-current |
| |
| |
Current |
| |
| |
Total recoverable cash advances |
| |
| |
19
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) |
| 2023 |
| 2022 |
As at January 1 |
| |
| |
Advances reimbursed (excluding interests) |
| |
| |
Initial measurement and re-measurement |
| ( |
| ( |
Discounting impact |
| |
| |
As at June 30 |
| |
| |
18.Trade payables
As at | ||||
| June 30, |
| December 31, | |
(in EUR 000) | 2023 | 2022 | ||
Payables |
| |
| |
Invoices to be received |
| |
| |
Total Trade payables |
| |
| |
The decrease in total trade payables of €
19.Income taxes and deferred taxes
For the three months ended | For the six months ended | |||||||
| June 30 |
| June 30 | |||||
(in EUR 000) |
| 2023 |
| 2022 | 2023 |
| 2022 | |
Current tax income/(expense) |
| ( | ( | ( |
| ( | ||
Deferred tax income/(expense) |
| ( | | |
| | ||
Total Income Tax Income/(Expense) |
| ( | ( | ( |
| ( |
The current tax expense mainly relates to (i) income tax paid or payable by certain of the Company’s subsidiaries for an amount of €
As of January 1, 2022, new tax regulations are in place in the US. In order to fully comply with internal revenue requirements, R&D expenses can no longer be deducted when incurred but instead they will be capitalized only for tax purposes and they will be amortized over a 5 year period.The current tax liability amount to €
20
20.Other payables
| As at | |||
June 30, | December 31, | |||
(in EUR 000) |
| 2023 |
| 2022 |
Holiday pay accrual | | | ||
Salary |
| |
| |
Accrued expenses |
| |
| |
Foreign currency option - current |
| |
| |
Other |
| |
| |
Total other payables |
| |
| |
The decrease 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
The Company has entered into several foreign currency swaps and foreign currency forwards for which the notional amounts are detailed in the table below:
As at | ||||
| June 30, |
| December 31, | |
(in EUR 000) | 2023 | 2022 | ||
Foreign currency swaps EUR - NIS (in EUR) |
| |
| |
Foreign currency swaps EUR - NIS (in NIS) |
| |
| |
Foreign currency forwards EUR - NIS (in EUR) |
| |
| |
Foreign currency forwards EUR - NIS (in NIS) | | | ||
Foreign currency swaps EUR - AUD (in EUR) | | | ||
Foreign currency swaps EUR - AUD (in AUD) | | | ||
Foreign currency swaps USD - EUR (in USD) | | | ||
Foreign currency swaps USD - EUR (in EUR) |
| |
| |
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, 2023 | ||||||||
(in EUR 000) |
| Level I |
| Level II |
| Level III |
| Total |
Financial liabilities |
|
|
|
|
|
|
|
|
Foreign currency swaps |
| |
| |
| |
| |
Foreign currency forwards |
| |
| |
| |
| |
The fair value is determined by the financial institution and is based on foreign currency swaps rates, foreign currency forward rates and the maturity of the instrument. All foreign currency swaps and forwards are classified as current as their maturity date is within the next twelve months.
21
The change in the balance of the financial assets is detailed as follows:
(in EUR 000) |
| 2023 |
| 2022 |
Financial asset | ||||
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) |
| 2023 |
| 2022 |
Financial liability | ||||
Opening value at January 1 |
| |
| |
Fair value adjustments |
| |
| |
Exchange rate difference |
| |
| |
Closing value at June 30 |
| |
| |
22.Results of operation
Revenue and cost of goods sold
In the six months ended June 30, 2023, 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.
For the six month period ended June 30, 2023 the sales (based on country of customer) were generated in Germany (€
For the three month period ended June 30, 2023 the sales (based on country of customer) were generated in Germany (€
Cost of goods sold for the three and six months ended June 30, 2023 and 2022:
| For the three months ended | For the six months ended | ||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
Purchases of goods and services |
| | | |
| | ||
Inventory movement |
| | ( | ( |
| ( | ||
Total cost of goods sold |
| | | |
| |
22
Operating expenses
The tables below detail the operating expenses for the six months ended June 30, 2023 and 2022:
Operating | ||||||
expense for the | ||||||
(in EUR 000) |
| Total cost |
| Capitalized |
| period |
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income and expenses |
| ( |
| |
| ( |
For the six months ended June 30, 2023 |
| |
| ( |
| |
|
|
| Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income and expenses |
| ( |
| |
| ( |
For the six months ended June 30, 2022 |
| |
| ( |
| |
The tables below detail the operating expenses for the three months ended June 30, 2023 and 2022:
|
|
| Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income and expenses |
| ( |
| |
| ( |
For the three months ended June 30, 2023 |
| |
| ( |
| |
|
|
| Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income and expenses |
| ( |
| |
| ( |
For the three months ended June 30, 2022 |
| |
| ( |
| |
Research and Development expenses
| For the three months ended | For the six months ended | ||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
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 |
| | | |
| |
23
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) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
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 €
24
Other operating income / ( expenses)
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
Recoverable cash advances |
|
|
|
| ||||
Initial measurement and re-measurement |
| | | |
| | ||
R&D incentives (Australia) |
| | | |
| | ||
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 €
The other operating income contains the R&D Incentive (Australia) that relates to an incentive to be received on development expenses incurred by the subsidiary in Australia. The R&D incentive for the period of six months ended June 30, 2023 includes a correction for 2022.
23.Employee benefits
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 | 2022 |
| 2023 |
| 2022 | |
Salaries |
| | | |
| | ||
Social charges |
| | | |
| | ||
Fringe benefits |
| | | |
| | ||
Defined contribution plan |
| | | |
| | ||
Holiday pay |
| | ( | |
| | ||
Share-based payment |
| | | |
| | ||
Other |
| | | |
| | ||
Total employee benefits |
| | | |
| |
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 | 2022 |
| 2023 |
| 2022 | |
Selling, general and administrative expenses |
| | | |
| | ||
Research & Development expenses |
| | | |
| | ||
Total employee benefits |
| | | |
| |
24.Financial income
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 |
| 2022 |
| 2023 |
| 2022 |
Interests |
| | | |
| | ||
Exchange differences |
| | | |
| | ||
Other |
| ( | ( | |
| | ||
Total financial income |
| | | |
| |
For the six month period ended June 30, 2023, the total interest income amounted to €
25
For the six month period ended June 30, 2022, exchange gains amount €
25.Financial expense
For the three months ended | For the six months ended | |||||||
June 30 | June 30 | |||||||
(in EUR 000) |
| 2023 |
| 2022 | 2023 |
| 2022 | |
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.
For the six month period ended June 30, 2023, exchange losses amount to €
The Company holds its USD cash balances and term deposits as they expect to incur cash-outflows in the US relating to both clinical costs (DREAM and ACCESS) and to the commercial launch of the Genio® system.
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.
EPS for June 2023 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 | |||||||
2023 |
| 2022 |
| 2023 |
| 2022 | ||
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 |
| | | |
| |
26
Basic and Diluted EPS for the three and six month period ended June 30, 2023 and 2022 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 | |||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | |
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 €
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) |
| 2023 |
| 2022 | 2023 |
| 2022 | |
Short-term remuneration & compensation |
| | | |
| | ||
Share based payment |
| | | |
| | ||
Total |
| | | |
| |
Transactions with Non-Executive Directors and Shareholders:
For the six months ended June 30, | For the six months ended June 30, | |||||||||||
2023 | 2022 | |||||||||||
R&D | Consulting | Board | R&D | Consulting | Board | |||||||
(in EUR 000) |
| Collaboration |
| services |
| Remuneration |
| Collaboration |
| services |
| Remuneration |
Cochlear |
| |
| — |
| — |
| |
| — |
| — |
MINV SA |
| — |
| — |
| — |
| — |
| |
| — |
Ray Cohen |
| — |
| — |
| — |
| — |
| — |
| |
Donald Deyo |
| — |
| — |
| — |
| — |
| — |
| |
Robert Taub |
| — |
| — |
| |
| — |
| — |
| |
Kevin Rakin |
| — |
| — |
| |
| — |
| — |
| |
Pierre Gianello |
| — |
| — |
| |
| — |
| — |
| |
Jan Janssen |
| — |
| — |
| — |
| — |
| — |
| |
Jurgen Hambrecht |
| — |
| — |
| |
| — |
| — |
| |
Rita Mills |
| — |
| — |
| |
| — |
| — |
| |
Giny Kirby | — | — | | — | — | | ||||||
Wildman Ventures LLC | — | — | | — | — | — | ||||||
Total |
| |
| — |
| |
| |
| |
| |
Amounts outstanding at period-end |
| — |
| — |
| |
| |
| |
| |
27
| For the three months ended June 30, 2023 |
| For the three months ended June 30, 2022 | |||||||||
(in EUR 000) | R&D |
| Consulting |
| Board |
| R&D |
| Consulting |
| Board | |
| Collaboration |
| services |
| Remuneration |
| Collaboration |
| services |
| Remuneration | |
Cochlear |
| |
| — |
| — |
| |
| — |
| — |
Ray Cohen |
| — |
| — |
| — |
| — |
| — |
| |
Donald Deyo |
| — |
| — |
| — |
| — |
| — |
| |
Robert Taub |
| — |
| — |
| |
| — |
| — |
| |
Kevin Rakin |
| — |
| — |
| |
| — |
| — |
| |
Pierre Gianello |
| — |
| — |
| |
| — |
| — |
| |
Jan Janssen |
| — |
| — |
| — |
| — |
| — |
| ( |
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 €
29.Events after the Balance-Sheet Date
The Company has acquired all shares of Nyxoah GmbH, a German company, on July 26, 2023. Nyxoah was incorporated on May 11, 2023. Except for the minimum capital of €
Upon closing of the acquisition, the Company has paid a consideration of €
28
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 8, 2023.
On behalf of the board of directors
Robert Taub, Chairman |
| Olivier Taelman, CEO |
29