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Form 6-K Nyxoah SA For: Aug 05

August 8, 2022 4:37 PM EDT

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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

 

Form 6-K

 

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 2022

 

Commission File Number: 001-40552

 

NYXOAH SA 

(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 x     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, 2022, Nyxoah SA (the “Company”) announced its unaudited first half-year results for 2022, which are further described in an H1 2022 report.

 

The information in the attached Exhibits 99.1 and 99.2 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.

 

 

 

 

Exhibits

 

99.1 Press Release, dated August 8, 2022

 

99.2 H1 Report 2022

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NYXOAH SA
     
Date: August 8, 2022 By: /s/ Loic Moreau
  Name: Loic Moreau
  Title: Chief Financial Officer

 

 

 

 

 

Exhibit 99.1

 

 

 

REGULATED INFORMATION

 

Nyxoah Reports Second Quarter and First Half 2022 Financial and Operating Results

 

DREAM enrollment complete, 12-month clinical data expected in fall of 2023

 

Mont-Saint-Guibert, Belgium – August 8, 2022, 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 2022.

 

Second Quarter 2022 Financial and Operating Highlights

 

·Completed enrollment in DREAM U.S. pivotal trial; expect 12-month clinical data in the fall of 2023 and regulatory approval in the first half of 2024
·Generated revenue of €935,000 from the commercialization of Genio® in Europe, primarily in Germany, which represents growth of more than five times the amount achieved in the second quarter of 2021
·Activated 11 new implanting sites in Germany during the second quarter, bringing the total to 26 as of June 30, 2022; expecting to have at least 35 active implanting sites by the end of 2022
·Received FDA approval of IDE submission to commence the ACCCESS study to treat complete concentric collapse (CCC) patients in the U.S., with first patient implant expected in the fourth quarter of 2022
·Received FDA this approval of the next generation Genio® 2.1 system for use in the DREAM study and CE mark for use in commercial patients in Europe; this improves patient comfort and compliance with a new smartphone application and upgraded external activation chip, which leverages Nyxoah’s scalable platform to continuously enhance patient comfort and therapy efficacy without requiring a new implant
·Partnered with Acurable to distribute the AcuPebble SA100 wearable home sleep test to OSA patients in Germany; launch is expected in the fourth quarter of 2022
·Included in the newly formed Euronext Tech Leaders Index, which is composed of 100+ innovative and high-growth technology companies with greater than €1 trillion in aggregate market capitalization

 

“We made significant progress on all of our key strategic priorities this quarter, including activating 11 new commercial sites in Germany, completing enrollment in our DREAM trial, and receiving approval for our ACCCESS IDE,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “From a commercial standpoint, our second quarter performance showing 42% quarter-over-quarter growth strengthens our confidence that we will achieve market leadership status in Germany by the end of 2022.”

 

 

 

 

 

REGULATED INFORMATION

 

“As the only commercially available hypoglossal nerve stimulation (HGNS) therapy approved for the treatment of CCC patients, we are encouraged by the first strong results from patients who are six months post-implantation. These results, combined with no longer having to perform a drug-induced sleep endoscopy (DISE) procedure prior to implant, are driving physicians to recommend Genio for their CCC and non-CCC patients,” continued Mr. Taelman.

 

Mr. Taelman concluded, “In the meantime, we have already begun investing in our U.S. market access organization. As for our ACCCESS study, we expect to implant the first patients before year end.”

 

 

 

 

 

REGULATED INFORMATION

 

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS
FOR THE THREE MONTHS AND SIX MONTHS ENDED JUNE 30, 2022 (in thousands)

 

Second Quarter and First Half 2022 Results

 

  For the three months   For the six months ended 
   ended June 30    June 30 
   2022   2021   2022   2021 
Revenue  935   170   1 595   355 
Cost of goods sold  (334)  (63)  (623)  (115)
Gross profit  601   107   972   240 
Research and Development Expense  (3 470)  (2 398)  (7 065)  (5 492)
Selling, General and Administrative Expense  (4 536)  (3 913)  (8 729)  (6 279)
Other income/(expense)  14   (101)  150   (97)
Operating loss for the period  (7 391)  (6 305)  (14 672)  (11 628)
Financial income  4 670   39   6 246   43 
Financial expense  (2 162)  (574)  (2 950)  (899)
Loss for the period before taxes  (4 883)  (6 840)  (11 376)  (12 484)
Income taxes  (107)  (99)  (315)  (124)
Loss for the period  (4 990)  (6 939)  (11 691)  (12 608)
                     
Loss attributable to equity holders  (4 990)  (6 939)  (11 691)  (12 608)
Other comprehensive loss                    
Items that may be subsequently reclassified to profit or loss (net of tax)                    
Currency translation differences  (12)  262   (114)  192 
Total comprehensive loss for the year, net of tax  (5 002)  (6 677)  (11 805)  (12 416)
Loss attributable to equity holders   (5 002)  (6 677)  (11 805)  (12 416)
Basic Loss Per Share (in EUR)  (0,193)  (0,314)  (0,453)  (0,570)
Diluted Loss Per Share (in EUR)  (0,193)  (0,314)  (0,453)  (0,570)

 

 

 

 

 

REGULATED INFORMATION

 

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT JUNE 30, 2022 (in thousands)

 

   As at 
   June 30   December 31 
   2022   2021 
ASSETS          
Non-current assets          
Property, plant and equipment  2 111   2 020 
Intangible assets   32 570    25 322 
Right of use assets   3 410    3 218 
Deferred tax asset   1 429    46 
Other long-term receivables   180    164 
   39 700   30 770 
Current assets          
Inventory   506    346 
Trade receivables   957    226 
Other receivables   1 548    2 286 
Other current assets   852    1 693 
Financial assets   47 717    - 
Cash and cash equivalents   75 602    135 509 
   127 182   140 060 
Total assets  166 882   170 830 
           
EQUITY AND LIABILITIES          
Capital and reserves          
Capital   4 438    4 427 
Share premium   228 158    228 033 
Share based payment reserve   4 411    3 127 
Other comprehensive income   88    202 
Retained loss   (98 850)   (87 167)
Total equity attributable to shareholders  138 245   148 622 
           
LIABILITIES          
Non-current liabilities          
Financial debt   8 089    7 802 
Lease liability   2 859    2 737 
Pension liability   80    80 
Provisions   44    12 
Deferred tax liability   -    5 
   11 072   10 636 
Current liabilities          
Financial debt   661    554 
Lease liability   672    582 
Trade payables   4 301    3 995 
Current tax liability   4 391    2 808 
Other payables   7 540    3 633 
   17 565   11 572 
Total liabilities  28 637   22 208 
Total equity and liabilities  166 882   170 830 

 

 

 

 

 

REGULATED INFORMATION

 

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION - INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
AS AT JUNE 30, 2022 (in thousands)

 

   For the six months ended June30 
   2022   2021 
CASH FLOWS FROM OPERATING ACTIVITIES          
Loss before tax for the year  (11 376)  (12 484)
Adjustments for          
Finance income   (6 246)   (43)
Finance expenses   2 950    899 
Depreciation and impairment of property, plant and equipment and right-of-use assets   536    377 
Amortization of intangible assets   402    428 
Share-based payment transaction expense   1 292    - 
Increase/(Decrease) in provisions   32    - 
Other non-cash items   37    11 
Cash generated before changes in working capital  (12 373)  (10 812)
Changes in working capital          
Decrease/(Increase) in inventory   (160)   (27)
(Increase)/Decrease in trade and other receivables   1 011    (3 463)
Increase/(Decrease) in trade and other payables   2 053    6 061 
Cash generated from changes in operations  (9 469)  (8 241)
Income tax paid   (254)   (111)

Net cash used in operating activities

  (9 723)  (8 352)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchases of property, plant and equipment   (302)   (795)
Capitalization of intangible assets   (7 650)   (3 726)
(Increase)/Decrease in financial assets - current   (44 032)   - 
Net cash used in investing activities  (51 984)  (4 521)
CASH FLOWS FROM FINANCING ACTIVITIES          
Payment of principal portion of lease liabilities   (317)   (236)
Repayment of other loan   (42)   (42)
Interests paid   (134)   (258)
Repayment of recoverable cash advance   -    (105)
Proceeds from issuance of shares, net of transaction costs   136    362 
Other financial costs   (8)   (10)
Net cash generated from financing activities  (365)  (289)
Movement in cash and cash equivalents  (62 072)  (13 162)
Effect of exchange rates on cash and cash equivalents   2 165    33 
Cash and cash equivalents at January 1  135 509   92 300 
Cash and cash equivalents at June 30  75 602   79 171 

 

 

 

 

 

REGULATED INFORMATION

 

Revenue

 

Revenue was €935,000 for the second quarter ending June 30, 2022, compared to €170,000 for the second quarter ending June 30, 2021. Revenue for the first half of 2022 was €1.6 million, compared to €355,000 for the first half of 2021. The increase in revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.

 

Cost of Goods Sold

 

Cost of goods sold was €334,000 for the three months ending June 30, 2022, representing a gross profit of €601,000, or gross margin of 64.3%. This compares to total cost of goods sold of €63,000 in the second quarter of 2021, for a gross profit of €107,000, or gross margin of 62.9%.

 

For the six months ending June 30, 2022, total cost of goods sold was €623,000, representing a gross profit of €972,000, or gross margin of 60.9%. This compares to total cost of goods sold of €115,000 in the first half of 2021, for a gross profit of €240,000, or gross margin of 67.6%.

 

Research and Development Expenses

 

Research and Development expenses were €3.5 million for the three months ending June 30, 2022, versus €2.4 million for the prior year period, reflecting the Company’s investments in the development of next generation versions of the Genio® system as well as ongoing clinical studies, most notably DREAM in the U.S.

 

For the six months ending June 30, 2022, Research and Development expenses were €7.1 million, versus €5.5 million for the first half of 2021.

 

Selling, General and Administrative Expenses

 

Selling, General and Administrative expenses rose to €4.5 million for the second quarter of 2022, up from €3.9 million in the second quarter of 2021. 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.

 

For the six months ending June 30, 2022, Selling, General and Administrative expenses were €8.7 million, up from €6.3 million in the first half of 2021 due to increased commercial efforts in Germany and investments in Nyxoah’s corporate infrastructure.

 

Operating Loss

 

Total operating loss for the second quarter and first half of 2022 was €7.4 million and €14.7 million, respectively, versus €6.3 million and €11.6 million in the second quarter and first half of 2021, respectively. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities. Nyxoah realized a net loss of €5.0 million and €11.8 million for the second quarter and first half of 2022, respectively, compared to a net loss of €6.7 million and €12.4 million for the second quarter and first half of 2021, respectively.

 

 

 

 

 

REGULATED INFORMATION

 

Cash Position

 

As of June 30, 2022, cash and financial assets totaled €123.3 million, compared to €135.5 million on December 31, 2021. Total cash burn was approximately €2.0 million per month during the first half of 2022. Nyxoah expects monthly cash burn to increase in the second half of 2022 to account for the commencement of the ACCCESS IDE trial in the U.S., and the current cash position provides ample liquidity to get to U.S. commercialization in 2024.

 

First Half 2022 Report

 

Nyxoah’s financial report for the first half of 2022, including details of the audited 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 10:30 p.m. CET / 4:30 p.m. ET, which will also be webcast. To participate in the conference call, please access the following link to register for a dial-in number:

 

https://register.vevent.com/register/BIfc3a52c9352e4e42958e9d816245b3b9

 

A question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events. 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) 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/.

 

 

 

 

 

REGULATED INFORMATION

 

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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, 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.

 

Contacts:

 

Nyxoah

Loic Moreau, Chief Financial Officer

[email protected]

+32 473 33 19 80

 

Jeremy Feffer, VP IR and Corporate Communications

[email protected]

+1 917 749 1494

 

 

 

Exhibit 99.2

 

 

 

INTERIM FINANCIAL REPORT

 

FIRST HALF 2022

 

Table of contents

 

Table of contents 1
Interim FINANCIAL report 2
First half 2022 2
1.  Business update 2
2.  FINANCIAL HIGHLIGHTS 3
3.  2022 OUTLOOK 4
4.  RISK FACTORS 4
5.   FORWARD-LOOKING STATEMENTS 4
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2022 – Interim consolidated statement of financial position 5
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2022 - Interim consolidated statements of loss and other comprehensive loss 6
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2022 - Interim consolidated statements of changes in equity 7
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2022 – Interim consolidated statements of cash flows 8
Notes to the unaudited condensed interim consolidated financial information 9
1.  General information 9
2.  Significant accounting policies 9
3.  Critical accounting estimates and assumptions 10
4.  Segment reporting 10
5.  Fair Value 10
6.  Subsidiaries 11
7.  Property, Plant and Equipment 11
8.  Intangible assets 12
9.  Right of use assets and lease liabilities 12
10.  Inventory 12
11.  Trade and Other receivables 13
12.  Other current assets 13
13.  Cash and cash equivalents 13
14.  Financial assets 13
15.  Capital, Share Premium, Reserves 14
16.  Share-Based compensation 15
17.  Financial Debt 16
18.  Trade payables 17
19.  Income taxes and deferred taxes 17
20.  Other payables 18
21.  Derivatives 18
22.  Results of operation 19
23.  Employee benefits 22
24.  Financial income 22
25.  Financial expense 22
26.  Loss Per Share (EPS) 23
27.  Other commitments 23
28.  Related Party Transactions 23
29.  Events after the  Balance-Sheet Date 24
Responsibility statement 25

 

1

 

 

Interim FINANCIAL report

 

First half 2022

 

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. One of the co-primary effectiveness endpoints is 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, together with 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. The Company anticipates having 12-month clinical data in the fall of 2023. No SAEs have been reported to date.

 

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 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.

 

2

 

 

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 first patient is expected to be implanted during the fourth quarter of 2022.

 

B.EUROPEAN COMMERCIALISATION

 

During the first half of 2022, Nyxoah recognized total revenue of €1.6 million, primarily in Germany, representing a substantial increase over the first half of 2021. After securing DRG reimbursement in Germany during the first quarter of 2021, Nyxoah built and expanded its German commercial organization to a total of 13 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, 2022, the Company has activated 26 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, hospital reimbursement in Spain, and is awaiting reimbursement decisions in several other countries, including Belgium, Italy, and the Netherlands. In the first half of 2022, Nyxoah also generated revenue in Finland, Switzerland, and the Netherlands, and the Company expects sales in other European countries in 2022.

 

2.FINANCIAL HIGHLIGHTS

 

Revenue was €1.6 million for the six months ending June 30, 2022, compared to €355,000 for the six months ending June 30, 2021. The increase in revenue was attributable to the Company’s commercialization of the Genio® system mainly in Germany.

 

Cost of goods sold was €0.6 million for the six months ending June 30, 2022, compared to €115,000 cost for the six months ending June 30, 2021. The increase in cost of goods sold was attributable to the sales of the Genio® system in Europe.

 

Selling, general and administrative expenses increased from €6.3 million for the six months ending June 30, 2021 to €8.7 million 2022 for the six months ending June 30, 2022, mainly due to an increase in consulting and contractors’ fees to support the company in legal, finance, tax and IT matters as well as insurances following the listing of the company in the United States.

 

Consulting and contractors’ fees include variable compensations for an amount of €1.9 million for the six months ending June 30, 2021 related to a cash settled share-based payment transaction.

 

3

 

 

Before capitalization of €7.8 million for the six months ending June 30, 2022 and €4.1 million for the six months ending June 30, 2021, research and development expenses increased from €9.6 million for the six months ending June 30, 2021 to €14.8 million for the six months ending June 30, 2022, due to the combined effect of higher clinical, R&D activities and manufacturing expenses. This increase is mainly in staff and consulting costs to support those activities. This was offset by a decrease in patent fees and related expenses due to the payment for in-licensing agreement with Vanderbilt University during the first six months ended June 30, 2021.

 

The financial result for the six months ending June 30, 2022 amount to €3.3million due to the combined effect of €5.7 million exchange gains driven by the revaluation of both the Company’s USD cash balance and USD financial assets, partially offset by fair value adjustments on financial instruments (-€1.9million) and accretion of interests on recoverable cash advances (€-0.5million).

 

Nyxoah realized a net loss of €11.7 million for the six months ending June 30, 2022, compared to a net loss of €12.6 million for the six months ending June 30, 2021.

 

Cash and cash equivalents

 

On June 30, 2022, cash and cash equivalents and financial assets totalled €123.3 million, compared to €135.5 million on December 31, 2021. The decrease in cash and cash equivalents resulted mainly from net cash flows used in operating activities of €9.7 million. See note 13.

 

3.2022 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 expects to complete implants in the DREAM IDE trial and to have first patient implanted in ACCCESS IDE study for CCC patients in US.

 

Nyxoah looks forward to opening its manufacturing facility in Belgium to further scale-up production capacity.

 

Following the capital increase related to the Nasdaq IPO and based on the current objectives of the Company’s business plan, Nyxoah expects that its existing cash and cash equivalents will fund planned operating and capital expense requirements in line with the Company’s strategic priorities (European commercialisation, US market entry, clinical data building, driving innovation/pipeline and scaling-up the organisation).

 

4.RISK FACTORS

 

We refer to the description of risk factors in the Company's 2021 annual report, pp. 65-90. 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.

 

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 2021 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.

 

4

 

 

Nyxoah SA

 

Unaudited condensed consolidated interim financial information as at and
for the six months ended June 30, 2022 –
Interim consolidated statement of financial position

 

(unaudited)

 

(in thousands)

 

       As at 
   Notes   June 30
2022
   December 31
2021
 
ASSETS            
Non-current assets               
Property, plant and equipment   7   2 111   2 020 
Intangible assets   8    32 570    25 322 
Right of use assets   9    3 410    3 218 
Deferred tax asset   19    1 429    46 
Other long-term receivables        180    164 
        39 700   30 770 
Current assets               
Inventory   10    506    346 
Trade receivables   11    957    226 
Other receivables   11    1 548    2 286 
Other current assets   12    852    1 693 
Financial assets   14    47 717    - 
Cash and cash equivalents   13    75 602    135 509 
        127 182   140 060 
Total assets       166 882   170 830 
                
EQUITY AND LIABILITIES               
Capital and reserves               
Capital   15    4 438    4 427 
Share premium   15    228 158    228 033 
Share based payment reserve   16    4 411    3 127 
Other comprehensive income   15    88    202 
Retained loss        (98 850)   (87 167)
Total equity attributable to shareholders       138 245   148 622 
                
LIABILITIES               
Non-current liabilities               
Financial debt   17    8 089    7 802 
Lease liability   9    2 859    2 737 
Pension liability        80    80 
Provisions        44    12 
Deferred tax liability        -    5 
        11 072   10 636 
Current liabilities               
Financial debt   17    661    554 
Lease liability   9    672    582 
Trade payables   18    4 301    3 995 
Current tax liability   19    4 391    2 808 
Other payables   20    7 540    3 633 
        17 565   11 572 
Total liabilities       28 637   22 208 
Total equity and liabilities       166 882   170 830 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

5

 

 

NYXOAH SA

 

Unaudited condensed consolidated interim financial information as at and

for the six months ended June 30, 2022 -
Interim consolidated statements of loss and other comprehensive loss

 

(unaudited)

 

(in thousands)

 

       For the six months ended June 30 
   Notes   2022   2021 
Revenue   22   1 595   355 
Cost of goods sold   22    (623)   (115)
Gross profit       972   240 
Research and Development Expense   22    (7 065)   (5 492)
Selling, General and Administrative Expense   22    (8 729)   (6 279)
Other income/(expense)        150    (97)
Operating loss for the period       (14 672)  (11 628)
Financial income   24    6 246    43 
Financial expense   25    (2 950)   (899)
Loss for the period before taxes       (11 376)  (12 484)
Income taxes   19    (315)   (124)
Loss for the period       (11 691)  (12 608)
                
Loss attributable to equity holders       (11 691)  (12 608)
Other comprehensive loss               
Items that may be subsequently reclassified to profit or loss (net of tax)               
Currency translation differences        (114)   192 
Total comprehensive loss for the year, net of tax       (11 805)  (12 416)
Loss attributable to equity holders       (11 805)  (12 416)
                
Basic Loss Per Share (in EUR)   26   (0.453)  (0.570)
Diluted Loss Per Share (in EUR)   26   (0.453)  (0.570)

 

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, 2022 -
Interim consolidated statements of changes in equity

 

(unaudited)

 

(in thousands)

 

   Attributable to owners of the parent 
   Common
shares
   Share
premium
   Share
based
payment
reserve
   Other
comprehensive
income
   Retained
loss
   Total 
Balance at January 1, 2022  4 427   228 033   3 127   202   (87 167)  148 622 
Loss for the period   -    -    -    -    (11 691)   (11 691)
Other comprehensive loss for the period   -    -    -    (114)   -    (114)
Total comprehensive loss for the period   -    -    -   (114)  (11 691)  (11 805)
Equity-settled share-based payments                              
Granted during the period   -    -    1 292    -    -    1 292 
Exercised during the period   4    125    (8)   -    8    129 
Issuance of shares for cash   7    -    -    -    -    7 
Total transactions with owners of the company recognized directly in equity   11    125    1 284    -    8    1 428 
Balance at June 30, 2022  4 438   228 158   4 411   88   (98 850)  138 245 

   

   Attributable to owners of the parent 
   Common
shares
   Share
premium
   Share
based
payment
reserve
   Other
comprehensive
income
   Retained
loss
   Total 
Balance at January 1, 2021  3 796   150 936   2 650   149   (60 341)  97 190 
Loss for the period   -    -    -    -    (12 608)   (12 608)
Other comprehensive loss for the period   -    -    -    192    -    192 
Total comprehensive loss for the period   -    -    -   192   (12 608)  (12 416)
Equity-settled share-based payments                              
Exercised during the period   12    350    -    -    -    362 
Total transactions with owners of the company recognized directly in equity   12    350    -    -    -    362 
Balance at June 30, 2021  3 808   151 286   2 650   341   (72 949)  85 136 

  

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, 2022 –
Interim consolidated statements of cash flows

 

(unaudited)

 

(in thousands)

 

       For the six months ended June 30 
   Notes   2022   2021 
CASH FLOWS FROM OPERATING ACTIVITIES               
Loss before tax for the year       (11 376)  (12 484)
Adjustments for               
Finance income        (6 246)   (43)
Finance expenses        2 950    899 
Depreciation and impairment of property, plant and equipment and right-of-use assets   7, 9    536    377 
Amortization of intangible assets   8    402    428 
Share-based payment transaction expense   16    1 292    - 
Increase/(Decrease) in provisions        32    - 
Other non-cash items        37    11 
Cash generated before changes in working capital       (12 373)  (10 812)
Changes in working capital               
Decrease/(Increase) in inventory   10    (160)   (27)
(Increase)/Decrease in trade and other receivables   11    1 011    (3 463)
Increase/(Decrease) in trade and other payables   18, 20    2 053    6 061 
Cash generated from changes in operations       (9 469)  (8 241)
Income tax paid        (254)   (111)
Net cash used in operating activities       (9 723)  (8 352)
CASH FLOWS FROM INVESTING ACTIVITIES               
Purchases of property, plant and equipment   7    (302)   (795)
Capitalization of intangible assets   8    (7 650)   (3 726)
(Increase)/Decrease in financial assets - current   14    (44 032)   - 
Net cash used in investing activities       (51 984)  (4 521)
CASH FLOWS FROM FINANCING ACTIVITIES               
Payment of principal portion of lease liabilities   9    (317)   (236)
Repayment of other loan        (42)   (42)
Interests paid        (134)   (258)
Repayment of recoverable cash advance   15    -    (105)
Proceeds from issuance of shares, net of transaction costs   15    136    362 
Other financial costs        (8)   (10)
Net cash generated from financing activities       (365)  (289)
Movement in cash and cash equivalents       (62 072)  (13 162)
Effect of exchange rates on cash and cash equivalents   24    2 165    33 
Cash and cash equivalents at January 1   13   135 509   92 300 
Cash and cash equivalents at June 30   13   75 602   79 171 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

8

 

 

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, 2022 and for the six months ended June 30, 2022 have been authorized for issue on August 8, 2022 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, 2021.

 

Except for the application of standards, interpretations and amendments being mandatory as of January 1, 2022, and the new accounting policies mentioned in the relevant notes 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, 2021.

 

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).

 

Certain reclasses to comparatives have been made to be consistent with current year presentation.

 

9

 

 

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, 2021.

 

An entity shall determine the net defined benefit liability (asset) with sufficient regularity that the amounts recognized in the financial statements do not differ materially from the amounts that would be determined at the end of the reporting period. The current pension obligation results from defined benefit liability does not materially differ on a half-yearly basis therefore the Company has determined to recognize the net defined benefit liability on annual basis being at the end of the reporting period.

 

Going concern principle

 

The Unaudited Interim Condensed Consolidated Financial Statements have been prepared on a going concern basis. As at June 30, 2022, the Company had cash and cash equivalents of €75.6 million. Based on cash flow forecasts for the remaining period of 2022 and 2023, which include significant expenses and cash outflows in relation to – among others – the ongoing clinical trials, the continuation of research and development project, and the scaling up of the Company’s manufacturing facilities. The Company believes that this cash position will be sufficient to meet the Company’s capital requirements and fund its operations for at least 12 months as from the date these financials are authorized for issuance.

 

The Company does not believe that COVID-19 or the Ukraine conflict will have an impact on the Company’s activity. The company does not have business relationships with Russia. There is no direct nor indirect impact of the conflict on the day to day business of the Company.

 

New and amended standards and interpretations applicable

 

Effective for the annual periods beginning on January 1, 2022

 

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 2022, but do not have an impact on the interim condensed consolidated financial statements of the Company:

 

-Amendments to IFRS 3 Business Combinations; IAS 16 Property, Plant and Equipment; IAS 37 Provisions, Contingent Liabilities and Contingent Assets as well as Annual Improvements, effective January 1, 2022

 

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 2021 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 one reportable segment. The chief operating decision maker is the CEO.

 

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.

 

10

 

 

 

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 
(in EUR 000)  As at June 30,
2022
   As at
December 31,
2021
   As at June 30,
2022
   As at
December 31,
2021
 
Financial Assets                    
Other long-term receivables (level 3)   180    164    180    164 
Trade and other receivables (level 3)   2 483    2 512    2 483    2 512 
Foreign currency forwards (level 2)   22    -    22    - 
Other current assets (level 3)   852    1 693    852    1 693 
Cash and cash equivalents (level 1)   75 602    135 509    75 602    135 509 
Financial assets (level 1)   47 717    -    47 717    - 

 

   Carrying value   Fair value 
(in EUR 000)  As at June 30,
2022
   As at
December 31,
2021
   As at June 30,
2022
   As at
December 31,
2021
 
Financial liabilities                    
Financial debt (level 3)   188    229    157    194 
Foreign currency option (level 2)   2 631    654    2 631    654 
Recoverable cash advances (level 3)   8 562    8 127    8 562    8 127 
Trade and other payables (level 1 and 3)   9 210    6 974    9 210    6 974 

 

6.Subsidiaries

 

For all periods that are mentioned in this report, the Company owns 100% of the shares of Nyxoah LTD, an Israeli company located in Tel-Aviv that was incorporated in 2009 and has a share capital of NIS 1.00.

 

The Company also owns 100% of the shares of Nyxoah PTY LTD, an Australian Company located in Collingwood that was incorporated in 2017 and has a share capital of AUD 100.

 

In May 2020, the Company incorporated Nyxoah Inc, an US-based company located in Delaware with a share capital of USD 1.00. The Company owns 100% of the shares of Nyxoah Inc.

 

7.Property, Plant and Equipment

 

The total acquisitions for the six months ended June 30, 2022 amount to €302,000 (2021: €0.8 million) and were mainly related to furniture and office equipment and laboratory equipment.

 

The depreciation charge amounts to €198,000 in 2022 and to €104,000 in 2021 for the six months ended June 30.

 

11

 

 

8.Intangible assets

 

There is only one development project : The Genio® system.

 

(in EUR 000)  Development
cost
   Patents and
licenses
   Total 
Cost               
Opening value at January 1, 2021   15 262    591    15 853 
Additions   3 726    -    3 726 
Exchange difference   166    -    166 
Cost at June 30, 2021   19 154    591    19 745 
Opening value at January 1, 2022   25 610    591    26 201 
Additions   7 650    -    7 650 
Exchange difference   -    -    - 
Cost at June 30, 2022   33 260    591    33 851 
Amortization               
Opening amortization at January 1, 2021   -    -    - 
Amortization   (428)   -    (428)
Exchange difference   (4)   -    (4)
Amortization at June 30, 2021   (432)   -    (432)
Opening amortization at January 1, 2022   (837)   (42)   (879)
Amortization   (381)   (21)   (402)
Exchange difference   -    -    - 
Amortization at June 30, 2022   (1 218)   (63)   (1 281)
Net book value at June 30, 2021   18 722    591    19 313 
Net book value at June 30, 2022   32 042    528    32 570 

 

The Company started amortizing the first-generation Genio® system in 2021. The amortization amounted to €402,000 for the six months ended June 30, 2022 (2021: €428,000) and is included in research and development expense.

 

The Company continues to incur in 2022 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 €7.7 million and €3.7 million for the six months ended June 30, 2022, and 2021, respectively.

 

9.Right of use assets and lease liabilities

 

For the six months ended June 30, 2022, the Company did enter into new lease agreements for €0.6 million (2021: €55,000). The repayments of lease liabilities amounted to €317,000 (2021: €236,000). The depreciations on the right of use assets amounted to €338,000 and €273,000 for the six months ended June 30, 2022, and 2021, respectively.

 

10.Inventory

 

    As at
(in EUR 000)   June 30,
2022
  December 31,
2021
Work in progress   387   83
Finished goods   119   263
Total Inventory   506   346

 

The increase in inventory is due to increasing activities. For the period ended June 30, 2022 and the year ended December 31, 2021 the Company did not recognize any expenses for inventory write-offs since the inventory level as per period end respectively year end is expected to be sold in the foreseeable future.

 

12

 

 

11.Trade and Other receivables

 

   As at 
(in EUR 000)  June 30,
2022
   December 31, 2021 
Trade receivables   957    226 
R&D incentive receivable (Australia)   896    1 616 
VAT receivable   392    524 
Current tax receivable   96    71 
Foreign currency forwards   22    - 
Other   142    75 
Total trade and other receivables   2 505    2 512 

 

The increase of €0.8 million in trade receivables as at June 30, 2022 is due to generated revenue by the Company. As of December 31, 2021 and June 30, 2022, unbilled receivables included in the trade receivables were respectively €0 and €400,000.

 

The Company includes 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.

 

R&D incentive receivables relates to incentives received in Australia as support to the clinical trials and the development of the Genio® system. The decrease of €0.7 million in the R&D incentive receivable (Australia) is due to the fact that the Company received payments relating to the R&D incentives during 2022.

 

The current tax receivable relates to excess payment of corporate income tax in Israel.

 

We refer to note 21 for more details on the foreign currency forwards.

 

12.Other current assets

 

The decrease of €0.8 million in other current assets as at June 30, 2022 is mainly due to the partial decrease in the advance payment of €1.1 million for Directors & Officers insurance following the initial public offering in the United States.

 

13.Cash and cash equivalents

 

   As at 
(in EUR 000)  June 30,
2022
   December 31,
2021
 
Short term deposit   37    38 
Current accounts   75 565    135 471 
Total cash and cash equivalents   75 602    135 509 

 

The decrease of current accounts by €59.9 million is due to an increase in term accounts of €47.7 million recorded as financial assets (we refer to note 14 for more details) and a decrease due to cash used in operations.

 

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. As at June 30, 2022, the Company holds USD term deposits at a well established financial institution for a total amount of 50.0 million USD. The investments in USD term deposits are made with excess cash, to optimize the Company’s return and thus benefit the cash management whereby negative returns on cash balances are decreased.

 

The current financial assets consists of 50.0 million USD, which could generate a foreign currency exchange gain or loss in the financial results in accordance with the fluctuations of the USD/EUR exchange rate as the Company’s functional currency is EUR.

 

The total amount of term deposits as per June 30, 2022, amounts to €47.7 million.

 

13

 

 

15.Capital, Share Premium, Reserves

 

15.1.Capital and share premium

 

Evolution of the share capital and share premium over the six months ended June 30, 2022 and 2021:

 

(Number of shares (1) except otherwise stated)  Common
shares
   Total of
shares
   Par value
(EUR)
   Share
capital
   Share
premium
 
January 1, 2021   22 097 609    22 097 609    0.17    3 796    157 514 
February 22, 2021 - Exercise warrants   10 000    10 000    0.17    2    50 
June 23, 2021 - Exercise warrants   60 000    60 000    0.17    10    300 
June 30, 2021   22 167 609    22 167 609    0.17    3 808    157 864 
July 7, 2021 - IPO   2 835 000    2 835 000    0.17    487    71 355 
July 9, 2021 - IPO   425 250    425 250    0.17    73    10 703 
July 9, 2021 - Exercise warrants   10 000    10 000    0.17    2    118 
September 10, 2021 - Exercise warrants   82 500    82 500    0.17    14    558 
September 30, 2021 - Exercise warrants   27 000    27 000    0.17    5    135 
October 11, 2021 - Exercise warrants   110 000    110 000    0.17    19    755 
November 4, 2021 - Exercise warrants   90 000    90 000    0.17    15    585 
November 25, 2021 - Exercise warrants   25 000    25 000    0.17    4    125 
December 31, 2021   25 772 359    25 772 359    0.17    4 427    242 198 
February 10, 2022 - Exercise warrants   25 000    25 000    0.17    4    125 
June 8, 2022 - Capital increase in cash   38 920    38 920    0.17    7    - 
June 30, 2022   25 836 279    25 836 279    0.17    4 438    242 323 

 

 

1 The numbers for the common shares have been retrospectively adjusted for the stock split.

 

On February 10, 2022, pursuant to the exercise of warrants, the Company issued 25,000 new shares for an aggregate capital increase of €129,000 (including share premium).

 

On June 8, 2022, the Company issued 38,920 new shares for an aggregate capital increase of €7,000 (there was no share premium).

 

15.2.Reserves

 

The reserves included 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, 2022 and 2021 is detailed in the table below:

 

(in EUR 000)  Currency
translation
reserve
   Post-
employment
benefit
obligations
   Total 
Opening value at January 1, 2021   149    -    149 
Currency translation differences   192    -    192 
Remeasurements of post-employment benefit obligations   -    -    - 
Total other comprehensive income at June 30, 2021   341    -    341 
Opening value at January 1, 2022   270    (68)   202 
Currency translation differences   (114)   -    (114)
Remeasurements of post-employment benefit obligations   -    -    - 
Total other comprehensive income at June 30, 2022   156    (68)   88 

 

14

 

 

16.Share-Based compensation

 

Equity-settled share-based payment transactions

 

As of June 30, 2022, the Company had four 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) and (iv) the 2021 warrants plan (the 2021 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 500:1. Per warrant issued before February 21, 2020, 500 common shares will be issuable.

 

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.

 

The changes of the period for the equity-settled warrant plans are as follows:

 

Number of shares (after share split) warrants give right to across all plans   2022    2021 
Outstanding at January 1   993 490    1 007 500 
Granted   461 500    - 
Forfeited/Cancelled   (14 125)   - 
Exercised   (25 000)   (70 000)
Outstanding as at June 30   1 415 865    937 500 
Exercisable as at June 30   779 966    937 500 

 

On February 21, 2022, 219,000 warrants were granted from which 5,000 warrants were not accepted. On May 14, 2022 and June 8, 2022 respectively 72,500 and 175,000 warrants were granted which were all accepted.

 

The following tables provide the input to the Black-Scholes model for warrants granted in 2018, 2019, 2020, 2021 and 2022 related to the 2016 warrant plan, the 2018 warrant plan, the 2020 warrant plan and the 2021 warrant plan. The tables and notes uses as a basis, the number of shares the warrants give right to across all plans.

 

   Plan 2016
(grant 2018)
   Plan 2018
(grant 2018)
   Plan 2013
(grant 2018)
   Plan 2018
(grant 2020)
   Plan 2020
(grant 2020)
 
Return Dividend   0%   0%   0%   0%   0%
Expected volatility   66.92%   56.32%   56.32%   56.32%   56.32%
Risk-free interest rate   0.35%   -0.20%   -0.20%   -0.20%   -0.20%
Expected life   3    3    3    3    3 
Exercise price   5.17    6.52    11.94    11.94    11.94 
Stock price   1.09    10.24    10.20    10.20    10.20 
Fair value   0.10    5.30    3.31    3.31    3.31 

 

   Plan 2021
(grant Sept.
17 2021)
   Plan 2021
(grant Oct.
27 2021)
   Plan 2021
(grant Feb
21 2022)
   Plan 2021
(grant Feb
21 2022)
   Plan 2021
(grant Feb
21 2022)
   Plan 2021
(grant May
14 2022)
   Plan 2021
(grant June
8 2022)
 
Return Dividend   0%   0%   0%   0%   0%   0%   0%
Expected volatility   51.30%   51.50%   49.80%   49.80%   49.80%   49.80%   52.60%
Risk-free interest rate   -0.36%   -0.18%   0.37%   0.37%   0.50%   0.00%   1.60%
Expected life   3    3    3    3    4    3    3 
Exercise price   25.31    25.31    17.76    25.31    17.76    13.82    12.95 
Stock price   25.75    20.50    17.50    17.50    17.50    13.82    13.34 
Fair value   9.22    5.94    6.05    4.15    6.90    4.94    5.21 

 

The Company has recognized €1.3 million share-based payment expense for the six months ended June 30, 2022 (2021: €0)

 

15

 

 

 

17.Financial Debt

 

Financial debt consists of recoverable cash advances and other loans. Related amounts can be summarized as follows:

 

   As at 
(in EUR 000)  June 30,
2022
   December 31,
2021
 
Recoverable cash advances - Non-current   8 005    7 656 
Recoverable cash advances - Current   557    471 
Total Recoverable cash advances   8 562    8 127 
Other loan - Non-current   84    146 
Other loan - Current   104    83 
Total Other loan   188    229 
Non-current   8 089    7 802 
Current   661    554 
Total Financial Debt   8 750    8 356 

 

Financial debt related to recoverable cash advances

 

Recoverable cash advances received

 

As at June 30, 2022, the details of recoverable cash advances received can be summarized as follows:

 

(in EUR 000)  Contractual
advances
   Advances
received
   Amounts
reimbursed
 
Sleep apnea device (6472)   1 600    1 600    450 
First articles (6839)   2 160    2 160    184 
Clinical trial (6840)   2 400    2 400    135 
Activation chip improvements (7388)   1 467    1 467    29 
Total   7 627    7 627    798 

 

During the six months ended June 30, 2022, the Company made reimbursements totaling €0 (2021: €105,000). The Company did not receive any new amounts during the six months ended June 30, 2022.

 

Based on expected timing of sales and after discounting, the financial debt related to the recoverable cash advances is as follows:

 

   As at 
(in EUR 000)  June 30,
2022
   December 31,
2021
 
Contract 6472   1 537    1 452 
Contract 6839   2 452    2 333 
Contract 6840   2 767    2 630 
Contract 7388   1 806    1 712 
Total recoverable cash advances   8 562    8 127 
Non-current   8 005    7 656 
Current   557    471 
Total recoverable cash advances   8 562    8 127 

 

16

 

 

The amounts recorded under “Current” caption correspond to the sales-independent amounts (fixed repayment) estimated to be repaid to the Walloon Region in the next 12-month period. The estimated sales-independent (fixed repayment) beyond 12 months as well as sales-dependent reimbursements (variable repayment) are recorded under “Non-current” liabilities. Changes in the recoverable cash advances can be summarized as follows:

 

(in EUR 000)  2022   2021 
As at January 1   8 127    7 910 
Advances reimbursed (excluding interests)   -    (105)
Initial measurement and re-measurement   (28)   154 
Discounting impact   463    441 
As at June 30   8 562    8 400 

 

 

18.Trade payables

 

    As at
(in EUR 000)   June 30,
2022
  December 31,
2021
Payables   2 576   2 394
Invoices to be received   1 725   1 601
Total Trade payables   4 301   3 995

 

The increase in total trade payables of €0.3 million as at June 30, 2022 is mainly due to the increase in invoices to be received.

 

19.Income taxes and deferred taxes

 

   For the six months ended
June 30
 
(in EUR 000)  2022   2021 
Current tax income/(expense)   (1 636)   (132)
Deferred tax income/(expense)   1 321    8 
Total Income Tax Income/(Expense)   (315)   (124)

 

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. Due to this new regulation, there is an increase in current tax expense and current tax liability by €1.5 million, and also an increase in deferred taxed assets and deferred tax income of €1.3 million. The deferred tax asset is recognized because the Company expects the US subsidiary will be able to recover the deferred tax asset in the foreseeable future.

 

The current tax liability of €4.4 million also relates to a liability for uncertain tax positions for an amount of €2.8 million. The current tax expense for the six month period ended June 30, 2022 amounts to €69,000. This current tax liability was recorded following certain public rulings and guidance recently issued by tax authorities in one of the jurisdictions that the Company operates in.

 

17

 

 

20.Other payables

 

   As at 
(in EUR 000)  June 30,
2022
   December 31,
2021
 
Holiday pay accrual   603    493 
Salary   634    870 
Accrued expenses   3 070    1 485 
Foreign currency option - current   2 631    654 
Other   602    131 
Total other payables   7 540    3 633 

 

The increase of €3.9 million in other payables as of June 30, 2022, compared to December 31, 2021, is mainly due to an increase of €1.6 million in accrued expenses related to an increase in clinical and R&D activities and due to an increase of €2.0 million in the fair value of the foreign currency option. The item Other includes € 449,000 social debts towards the social agency.

 

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 24 months and by means of foreign currency forwards or options.

 

The Company has entered into several foreign currency put and call for which the notional amounts are detailed in the table below:

 

    As at 
(in EUR 000)   June 30,
2022
    December 31,
2021
 
call USD (in USD)   34 350    34 350 
put USD (in USD)   -    (3 000)
call EUR (in EUR)   -    2 500 
put EUR (in EUR)   (30 000)   (30 000)

 

The Company has also entered into several foreign currency forwards for which the notional amounts are detailed in the table below:

 

   As at 
(in EUR 000)  June 30,
2022
   December 31,
2021
 
Foreign currency forwards EUR - AUD (in AUD)   600    - 
Foreign currency forwards EUR - AUD (in EUR)   372    - 
Foreign currency forwards EUR - NIS (in NIS)   10 500    - 
Foreign currency forwards EUR - NIS (in EUR)   2 909    - 

 

18

 

 

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, 2022 
(in EUR 000)  Level I   Level II   Level III   Total 
Financial assets                    
Foreign currency forwards   -    22    -    22 
Financial liabilities                  - 
Foreign currency option   -    2 631    -    2 631 

 

The fair value is determined by the financial institution and is based on foreign currency forwards rates and the maturity of the instrument. All foreign currency put and call options and foreign currency forwards 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)  2022   2021 
Opening value at January 1   -    - 
New contracts   -    - 
Fair value adjustments   22    - 
Closing value at June 30   22    - 

 

The change in the balance of the financial liabilities is detailed as follows:

 

   2022   2021 
Opening value at January 1   654    - 
New contracts   -    - 
Fair value adjustments   1 949    - 
Exchange rate difference   28    - 
Closing value at June 30   2 631    - 

 

22.Results of operation

 

Revenue and cost of goods sold

 

In the six months ended June 30, 2022, the Company generated revenue for the amount of €1.6 million (2021: €355,000). 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, 2022 the sales (based on country of customer) were generated in Germany (€1.6 million) and Finland (€40,000) (2021: Germany: €310,000, Spain: €24,000 and Belgium: €20,000). For the six month period ended June 30, 2022, the Company has two customers with individual sales larger than 10% of the total revenue (2021: three customers).

 

19

 

 

Cost of goods sold for the six months ended June 30, 2022 and 2021:

 

   For the six months ended
June 30
 
(in EUR 000)  2022   2021 
Purchases of goods and services   783    87 
Inventory movement   (160)   28 
Total cost of goods sold   623    115 

 

Operating expenses

 

The tables below detail the operating expenses for the six months ended June 30, 2022 and 2021:

 

(in EUR 000)  Total cost   Capitalized   Operating
expense for the
period
 
Research and development   14 817    (7 752)   7 065 
Selling, general and administrative expenses   8 729    -    8 729 
Other income and expenses   (252)   102    (150)
For the six months ended June 30, 2022   23 294    (7 650)   15 644 

 

(in EUR 000)  Total cost   Capitalized   Operating
expense for the
period
 
Research and development   9 596    (4 104)   5 492 
Selling, general and administrative expenses   6 279    -    6 279 
Other income and expenses   (281)   378    97 
For the six months ended June 30, 2021   15 594    (3 726)   11 868 

 

Research and Development expenses

 

   For the six months ended
June 30
 
(in EUR 000)  2022   2021 
Staff costs   5 090    3 126 
Consulting and contractors' fees   1 304    670 
Q&A regulatory   125    363 
IP costs   222    791 
Depreciation and amortization expense   496    454 
Travel   328    45 
Manufacturing and outsourced development   2 341    1 677 
Clinical studies   4 252    1 708 
Other expenses   659    762 
Capitalized costs   (7 752)   (4 104)
Total research and development expenses   7 065    5 492 

 

Before capitalization of €7.8 million for the six months ended June 30, 2022 and €4.1 million for the six months ended June 30, 2021, research and development expenses increased by €5.2 million or 54 %, from €9.6 million for the six months ended June 30, 2021, to €14.8 million for the six months ended June 30, 2022, due to the combined effect of higher clinical, R&D activities and manufacturing expenses. This increase is mainly in staff and consulting costs to support those activities. This was offset by a decrease in patent fees and related expenses due to the payment for in-licensing agreement with Vanderbilt University during the first six months ended June 30, 2021.

 

20

 

 

Selling, General and Administrative expenses

 

   For the six months ended
June 30
 
(in EUR 000)  2022   2021 
Staff costs   3 329    1 262 
Consulting and contractors' fees   2 104    3 703 
Legal fees   415    132 
Rent   202    125 
Depreciation and amortization expense   440    351 
ICT   253    165 
Travel   547    46 
Insurance fees   835    - 
Other   604    495 
Capitalized costs   -    - 
Total selling, general and administrative expenses   8 729    6 279 

 

Selling, general and administrative expenses increased by €2.5 million or 39 % from €6.3 million for the six months ended June 30, 2021 to €8.7 million for the six months ended June 30, 2022, mainly due to an increase in staff costs to support the Company in its activities. The increase in other is largely due to an increase in insurance fees following the listing of the Company in the United States.

 

Consulting and contractors’ fees includes variable compensations for an amount of €1.9 million for the six months ended in June 30, 2021 related to a cash settled share based payment transaction.

 

Other operating expenses

 

The Company had other operating income of €150,000 for the six months ended June 30, 2022 compared to other operating expenses of €97,000 for the six months ended June 30, 2021.

 

   For the six months ended
June 30
 
(in EUR 000)  2022   2021 
Recoverable cash advances          
Initial measurement and re-measurement   28    (153)
R&D incentives (Australia)   137    435 
Capitalization of R&D incentive   (102)   (378)
Other income/(expenses)   87    (1)
Total Other Operating Income/(Expenses)   150    (97)

 

21

 

 

 

 

23.Employee benefits

 

   For the six months ended June 30 
(in EUR 000)  2022   2021 
Salaries  6 089   3 520 
Social charges   500    332 
Fringe benefits   78    155 
Defined contribution plan   136    172 
Holiday pay   38    98 
Share-based payment   1 292    - 
Other   286    111 
Total employee benefits   8 419    4 388 

 

    For the six months ended June 30 
(in EUR 000)   2022    2021 
Selling, general and administrative expenses   3 329    1 262 
Research & Development expenses   5 090    3 126 
Total employee benefits   8 419    4 388 

 

24.Financial income

 

   For the six months ended June 30 
(in EUR 000)  2022   2021 
Interests   113    1 
Exchange differences   6 090    42 
Other   43    - 
Total financial income   6 246    43 

 

For the six month period ended June 30, 2022, exchange gains amount to €6.1 million, mainly due to the revaluation of both the Company’s USD cash balance and USD financial assets (note 14). For the year ended December 31, 2021, the closing rate of EUR/USD amounted to 1.13260, while as at June 30, 2022, the rate of EUR/USD decreased to 1.03870, resulting in unrealized exchange gains on the USD balances.

 

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.

 

25.Financial expense

 

   For the six months ended June 30 
(in EUR 000)  2022   2021 
Fair value adjustment  1 949   - 
Recoverable cash advances, Accretion of interest   463    441 
Interest and bank charges   103    220 
Interest on lease liabilities   47    44 
Exchange differences   388    189 
Other   -    5 
Total Financial expense   2 950    899 

 

22

 

 

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.

 

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 2022 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 500:1 was approved by the shareholders’ meeting.

 

    2022    2021 
As at June 30, after conversion and share split          
Outstanding common shares at period-end   25 836 279    22 167 609 
Weighted average number of common shares outstanding   25 796 560    22 108 001 
Number of shares resulting of the exercise of outstanding warrants   1 953 125    937 500 

 

Basic and Diluted EPS for the six-month periods ended June 30, 2022 and 2021 based on weighted average number of shares outstanding after conversion and share split are as follows:

 

   For the six months ended June 30, 
   2022   2021 
Loss of year attributable to equity holders (in EUR)   (11 691 000)   (12 608 000)
Weighted average number of common shares outstanding (in units)   25 796 560    22 108 001 
Basic earnings per share in EUR (EUR/unit)   (0.453)   (0.570)
Diluted earnings per share in EUR (EUR/unit)   (0.453)   (0.570)

 

27.Other commitments

 

The Company has granted in October 2020 an amount of €0.5 million towards an institute under the Company’s Sponsored Grant Program. The institute will have to perform over a total period of two years certain clinical and research activities and training and education activities. The future payment commitments amount to €50,000 at June 30, 2022, which will be paid quarterly in instalments over the remaining period if the institute performs its activities. During the period ended June 30, 2022, the Company recognized €78,000 in Therapy Development expenses.

 

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.

 

23

 

 

Remuneration of Key Management

 

The remuneration of the senior management consists of the remuneration of the CEO of the Company for the six months ended June 30:

 

   For the six months ended June 30 
(in EUR 000)  2022   2021 
Short-term remuneration & compensation   271    145 
Share based payment   55    - 
Total   326    145 

 

 

Transactions with Non-Executive Directors and Shareholders:

 

   For the six months ended June 30, 2022   For the six months ended June 30, 2021 
(in EUR 000)  R&D
Collaboration
   Consulting
services
   Board
Remuneration
   R&D
Collaboration
   Consulting
services
   Board
Remuneration
 
Cochlear   1 336    -    -    -    -    - 
MINV SA   -    60    -    -    17    - 
Ray Cohen   -    -    4    -    -    - 
Giny Kirby   -    -    3    -    -    - 
Donald Deyo   -    -    14    -    -    21 
Robert Taub   -    -    42    -    -    41 
Kevin Rakin   -    -    25    -    -    22 
Pierre Gianello   -    -    35    -    -    21 
Jan Janssen   -    -    19    -    -    21 
Jurgen Hambrecht   -    -    24    -    -    22 
Rita Mills   -    -    23    -    -    - 
Total   1 336    60    189    -    17    148 
Amounts outstanding at period-end   559    60    78    -    -    - 

 

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 financial impact of €1.3 million for the six months ended June 30, 2022. No expenses for the six months ended June 30, 2021.

 

The Company also recognized a share-based payment expense of €55,000 for the six months ended June 30, 2022 for non-executive directors.

 

29.Events after the Balance-Sheet Date

 

No events after balance-sheet date took place.

 

24

 

 

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, 2022.

 

On behalf of the board of directors

 

Robert Taub, Chairman  Olivier Taelman, CEO

 

25



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