0001857190--12-312022Q3falseNYXOAH SA6-K89877000107750001349200051270002524000585000

Table of Contents

Exhibit 99.2

TABLE OF CONTENTS

Table of contents

   

1

Interim financial report

2

Third quarter 2022

2

1. BUSINESS UPDATE

2

2. FINANCIAL HIGHLIGHTS

3

3. 2022 OUTLOOK

4

4. RISK FACTORS

4

5. FORWARD-LOOKING STATEMENTS

5

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

6

Unaudited condensed consolidated interim financial information as at and for the three and nine months ended September 30, 2022 - Interim consolidated statements of loss and other comprehensive loss

7

Unaudited condensed consolidated interim financial information as at and for the nine months ended 2021, 2022 - Interim consolidated statements of changes in equity

8

Unaudited condensed consolidated interim financial information as at and for the nine months ended September 30, 2022 – Interim consolidated statements of cash flows

9

Notes to the unaudited condensed interim consolidated financial information

10

1. General information

10

2. Significant accounting policies

10

3. Critical accounting estimates and assumptions

11

4. Segment reporting

11

5. Fair Value

12

6. Subsidiaries

12

7. Property, Plant and Equipment

12

8.  Intangible assets

13

9. Right of use assets and lease liabilities

13

10.  Inventory

13

11. Trade and Other receivables

14

12. Other current assets

14

13. Cash and cash equivalents

14

14. Financial assets

14

15. Capital, Share Premium, Reserves

15

16. Share-Based compensation

16

17. Financial Debt

17

18. Trade payables

18

19. Income taxes and deferred taxes

18

20. Other payables

19

21. Derivatives

19

22. Results of operation

20

23. Employee benefits

23

24. Financial income

23

25. Financial expense

24

26. Loss Per Share (EPS)

24

27. Other commitments

25

28. Related Party Transactions

25

29. Events after the Balance-Sheet Date

26

Responsibility statement

27

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INTERIM FINANCIAL REPORT

THIRD QUARTER 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, and 110 patients had undergone a Genio® implantation procedure. The remaining implants are being scheduled, and 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.

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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 initial clinical sites are being activated, and the first patients are expected to be implanted during the fourth quarter of 2022.

B.EUROPEAN COMMERCIALIZATION

During the first nine months of 2022, Nyxoah recognized total revenue of €1.8 million, primarily in Germany, representing a substantial increase over the first nine months 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 15 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 September 30, 2022, the Company has activated 32 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 nine months 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 €1.8 million for the nine months ending September 30, 2022, compared to €557,000 for the nine months ending September 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 €0.7 million for the nine months ending September 30, 2022, compared to €198,000 cost for the nine months ending September 30, 2021. The increase in cost of goods sold was attributable to the sales of the Genio® system in Europe.

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Selling, general and administrative expenses increased by 25% from €10.8 million for the nine months ending September 30, 2021 to €13.5 million for the nine months ending September 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 nine months ending September 30, 2021 related to a cash settled share-based payment transaction.

Before capitalization of €11.9 million for the nine months ending September 30, 2022 and €7.7 million for the nine months ending September 30, 2021, research and development expenses increased 39% from €16.7 million for the nine months ending September 30, 2021 to €23.2 million for the nine months ending September 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 nine months ended September 30, 2021.

Nyxoah realised a net positive financial result of €5.9 million for the nine months ending September 30, 2022 primarily driven by the exchange rate appreciation of dollar versus euro. This compares to a net loss of €1.4 million for the nine months ending September 30, 2021.

Nyxoah realized a net loss of €17.9 million for the nine months ending September 30, 2022, compared to a net loss of €21.3 million for the nine months ending September 30, 2021.

Cash and cash equivalents

On September 30, 2022, cash and cash equivalents and financial assets totalled €115.4 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 €18.5 million and net cash used in investing activities of €31.5 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 the first patients implanted in the 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 commercialization, 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.

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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.

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NYXOAH SA

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2022 –

INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION

(unaudited)

(in thousands)

As at

September 30

December 31

    

Notes

    

2022

    

2021

ASSETS

Non-current assets

 

  

 

  

 

  

Property, plant and equipment

 

7

 

2,216

 

2,020

Intangible assets

 

8

 

36,488

 

25,322

Right of use assets

 

9

 

3,413

 

3,218

Deferred tax asset

 

19

 

2,423

 

46

Other long-term receivables

 

  

 

188

 

164

 

  

 

44,728

 

30,770

Current assets

 

  

 

  

 

  

Inventory

 

10

 

594

 

346

Trade receivables

 

11

 

757

 

226

Other receivables

 

11

 

2,022

 

2,286

Other current assets

 

12

 

587

 

1,693

Financial assets

 

14

 

25,505

 

Cash and cash equivalents

 

13

 

89,877

 

135,509

 

  

 

119,342

 

140,060

Total assets

 

  

 

164,070

 

170,830

 

  

 

  

 

  

EQUITY AND LIABILITIES

 

  

 

  

 

  

Capital and reserves

 

  

 

  

 

  

Capital

 

15

 

4,440

 

4,427

Share premium

 

15

 

228,275

 

228,033

Share based payment reserve

 

16

 

5,225

 

3,127

Other comprehensive income

 

15

 

188

 

202

Retained loss

 

  

 

(105,058)

 

(87,167)

Total equity attributable to shareholders

 

  

 

133,070

 

148,622

 

  

 

  

 

  

LIABILITIES

 

  

 

  

 

  

Non-current liabilities

 

  

 

  

 

  

Financial debt

 

17

 

8,035

 

7,802

Lease liability

 

9

 

2,831

 

2,737

Pension liability

 

  

 

80

 

80

Provisions

 

  

 

47

 

12

Deferred tax liability

 

  

 

 

5

 

  

 

10,993

 

10,636

Current liabilities

 

  

 

  

 

  

Financial debt

 

17

 

656

 

554

Lease liability

 

9

 

722

 

582

Trade payables

 

18

 

5,346

 

3,995

Current tax liability

 

19

 

5,391

 

2,808

Other payables

 

20

 

7,892

 

3,633

 

  

 

20,007

 

11,572

Total liabilities

 

  

 

31,000

 

22,208

Total equity and liabilities

 

  

 

164,070

 

170,830

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

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NYXOAH SA

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 -

INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS

(unaudited)

(in thousands)

    

For the three months

    

For the nine months ended 

ended September 30

September 30

    

Notes

2022

2021

    

2022

    

2021

Revenue

22

182

203

1,777

557

Cost of goods sold

 

22

(63)

 

(82)

 

(685)

 

(198)

Gross profit

 

  

119

121

1,092

359

Research and Development Expense

 

22

 

(4,221)

 

(3,517)

 

(11,286)

 

(9,009)

Selling, General and Administrative Expense

 

22

 

(4,763)

 

(4,496)

 

(13,492)

 

(10,775)

Other income/(expense)

 

  

 

87

 

(178)

 

237

 

(274)

Operating loss for the period

 

  

(8,778)

(8,070)

(23,449)

(19,699)

Financial income

 

24

 

5,127

 

29

 

11,372

 

72

Financial expense

 

25

 

(2,524)

 

(585)

 

(5,473)

 

(1,484)

Loss for the period before taxes

 

  

(6,175)

(8,626)

(17,550)

(21,111)

Income taxes

 

19

 

(65)

 

(136)

 

(379)

 

(260)

Loss for the period

 

  

(6,240)

(8,762)

(17,929)

(21,371)

 

  

 

 

 

  

 

  

Loss attributable to equity holders

 

  

(6,240)

(8,762)

(17,929)

(21,371)

Other comprehensive loss

 

  

 

 

 

  

 

  

Items that may be subsequently reclassified to profit or loss (net of tax)

 

  

 

 

 

  

 

  

Currency translation differences

 

  

 

100

 

(54)

 

(14)

 

138

Total comprehensive loss for the year, net of tax

 

  

(6,140)

(8,816)

(17,943)

(21,233)

Loss attributable to equity holders

 

  

(6,140)

(8,816)

(17,943)

(21,233)

 

  

 

 

 

  

 

  

Basic Loss Per Share (in EUR)

 

26

(0.242)

(0.348)

(0.695)

(0.923)

Diluted Loss Per Share (in EUR)

 

26

(0.242)

(0.348)

(0.695)

(0.923)

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

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NYXOAH SA

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND

FOR THE nine MONTHS ENDED 2021, 2022 -

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, 2022

    

4,427

    

228,033

    

3,127

    

202

    

(87,167)

    

148,622

Loss for the period

 

 

 

 

 

(17,929)

 

(17,929)

Other comprehensive loss for the period

 

 

 

 

(14)

 

 

(14)

Total comprehensive loss for the period

 

 

 

(14)

(17,929)

(17,943)

Equity-settled share-based payments

 

  

 

  

 

  

 

  

 

  

 

  

Granted during the period

 

 

 

2,136

 

 

 

2,136

Exercised during the period

 

6

 

242

 

(38)

 

 

38

 

248

Issuance of shares for cash

 

7

 

 

 

 

 

7

Total transactions with owners of the company recognized directly in equity

 

13

 

242

 

2,098

 

 

38

 

2,391

Balance at September 30, 2022

4,440

228,275

5,225

188

(105,058)

133,070

Attributable to owners of the parent

Share

based

Other

Common

Share

payment

comprehensive

Retained

    

shares

    

premium

    

reserve

    

income

    

loss

    

Total

Balance at January 1, 2021

3,796

150,936

2,650

149

(60,341)

97,190

Loss for the period

 

 

 

 

 

(21,371)

 

(21,371)

Other comprehensive income for the period

 

 

 

 

138

 

 

138

Total comprehensive loss for the period

 

 

 

138

(21,371)

(21,233)

Equity-settled share-based payments

 

  

 

  

 

  

 

  

 

  

 

  

Granted during the period

784

784

Exercised during the period

 

33

 

1,160

 

(165)

 

 

165

 

1,193

Issuance of shares for cash

560

82,058

82,618

Transaction cost

(7,587)

(7,587)

Total transactions with owners of the company recognized directly in equity

 

593

 

75,631

 

619

 

 

165

 

77,008

Balance at September 30, 2021

4,389

226,567

3,269

287

(81,547)

152,965

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

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NYXOAH SA

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2022 –

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

    

For the nine months ended 

September 30

    

Notes

    

2022

    

2021

CASH FLOWS FROM OPERATING ACTIVITIES

Loss before tax for the year

 

  

(17,550)

(21,111)

Adjustments for

 

  

 

  

 

  

Finance income

 

  

 

(11,372)

 

(72)

Finance expenses

 

  

 

5,473

 

1,484

Depreciation and impairment of property, plant and equipment and right-of-use assets

 

7, 9

 

832

 

558

Amortization of intangible assets

 

8

 

607

 

653

Share-based payment transaction expense

 

16

 

2,136

 

784

Increase/(Decrease) in provisions

 

  

 

36

 

4

Other non-cash items

 

  

 

(353)

 

247

Cash generated before changes in working capital

 

  

(20,191)

(17,453)

Changes in working capital

 

  

 

  

 

  

Decrease/(Increase) in inventory

 

10

 

(248)

 

(33)

(Increase)/Decrease in trade and other receivables

 

11

 

1,100

 

(2,876)

Increase/(Decrease) in trade and other payables

 

18, 20

 

1,265

 

2,563

Cash generated from changes in operations

 

  

(18,074)

(17,799)

Income tax paid

 

  

 

(314)

 

(205)

Net cash used in operating activities

 

  

(18,388)

(18,004)

CASH FLOWS FROM INVESTING ACTIVITIES

 

  

 

  

 

  

Purchases of property, plant and equipment

 

7

 

(484)

 

(1,257)

Capitalization of intangible assets

 

8

 

(11,774)

 

(7,219)

Purchase of financial assets - current

14

(44,032)

Proceeds from sale of financial assets - current

14

24,582

Interest income on financial assets

 

 

63

 

Net cash used in investing activities

 

  

(31,645)

(8,476)

CASH FLOWS FROM FINANCING ACTIVITIES

 

  

 

  

 

  

Payment of principal portion of lease liabilities

 

9

 

(497)

 

(358)

Repayment of other loan

 

  

 

(62)

 

(63)

Interests paid

 

  

 

(185)

 

(324)

Repayment of recoverable cash advance

 

15

 

(220)

 

(280)

Proceeds from issuance of shares, net of transaction costs

 

15

 

255

 

76,070

Other financial costs

 

  

 

(55)

 

(7)

Net cash used in financing activities

 

  

(764)

75,038

Movement in cash and cash equivalents

 

  

(50,797)

48,558

Effect of exchange rates on cash and cash equivalents

 

24

 

5,165

 

56

Cash and cash equivalents at January 1

 

13

135,509

92,300

Cash and cash equivalents at September 30

 

13

89,877

140,914

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

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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 September 30, 2022 and for the three and nine months ended September 30, 2022 have been authorized for issue on November 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).

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

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 nine months 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 September 30, 2022, the Company had cash and cash equivalents of €89.9 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.

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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

September 30,

December 31, 

September 30,

December 31, 

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Financial Assets

 

  

 

  

 

  

 

  

Other long-term receivables (level 3)

 

188

 

164

 

188

 

164

Trade and other receivables (level 3)

 

2,713

 

2,512

 

2,713

 

2,512

Foreign currency forwards (level 2)

 

66

 

 

66

 

Other current assets (level 3)

 

587

 

1,693

 

587

 

1,693

Cash and cash equivalents (level 1)

 

89,877

 

135,509

 

89,877

 

135,509

Financial assets (level 1)

 

25,505

 

 

25,505

 

Carrying value

Fair value

As at

As at

As at 

As at

September 30,

December 31, 

September 30,

December 31, 

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Financial liabilities

 

  

 

  

 

  

 

  

Financial debt (level 3)

 

167

 

229

 

138

 

194

Foreign currency option (level 2)

 

3,132

 

654

 

3,132

 

654

Recoverable cash advances (level 3)

 

8,524

 

8,127

 

8,524

 

8,127

Trade and other payables (level 1 and 3)

 

10,106

 

6,974

 

10,106

 

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 nine months ended September 30, 2022 amount to €484,000 (2021: €1.3 million) and were mainly related to furniture and office equipment and laboratory equipment.

The depreciation charge amounts to €296,000 in 2022 and to €145,000 in 2021 for the nine months ended September 30.

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8.Intangible assets

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

Development

Patents and

(in EUR 000)

    

cost

    

licenses

    

Total

Cost

 

  

 

  

 

  

Opening value at January 1, 2021

 

15,262

 

591

 

15,853

Additions

 

7,219

 

 

7,219

Exchange difference

 

 

 

Cost at September 30, 2021

 

22,481

 

591

 

23,072

Opening value at January 1, 2022

 

25,609

 

591

 

26,200

Additions

 

11,774

 

 

11,774

Exchange difference

 

 

 

Cost at September 30, 2022

 

37,383

 

591

 

37,974

Amortization

 

  

 

  

 

  

Opening amortization at January 1, 2021

 

 

 

Amortization

 

(647)

 

(6)

 

(653)

Exchange difference

 

 

 

Amortization at September 30, 2021

 

(647)

 

(6)

 

(653)

Opening amortization at January 1, 2022

 

(837)

 

(42)

 

(879)

Amortization

 

(575)

 

(32)

 

(607)

Exchange difference

 

 

 

Amortization at September 30, 2022

 

(1,412)

 

(74)

 

(1,486)

Net book value at September 30, 2021

 

21,834

 

585

 

22,419

Net book value at September 30, 2022

 

35,971

 

517

 

36,488

The Company started amortizing the first-generation Genio® system in 2021. The amortization amounted to €0.6 million for the nine months ended September 30, 2022 (2021: €0.7 million) 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 €11.8 million and €7.2 million for the nine months ended September 30, 2022, and 2021, respectively.

9.Right of use assets and lease liabilities

For the nine months ended September 30, 2022, the Company did enter into new lease agreements for €0.7 million (2021: €187,000). The repayments of lease liabilities amounted to €497,000 (2021: €358,000). The depreciations on the right of use assets amounted to €0.5 million and €413,000 for the nine months ended September 30, 2022, and 2021, respectively.

10.Inventory

As at

September 30, 

December 31, 

(in EUR 000)

    

2022

    

2021

Work in progress

 

286

 

83

Finished goods

 

308

 

263

Total Inventory

 

594

 

346

The increase in inventory is due to increasing activities. For the period ended September 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.

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11.Trade and Other receivables

As at

September 30, 

December 31, 

(in EUR 000)

    

2022

    

2021

Trade receivables

 

757

 

226

R&D incentive receivable (Australia)

 

935

 

1,616

VAT receivable

 

458

 

524

Current tax receivable

 

132

 

71

Foreign currency swaps

 

66

 

Other

 

431

 

75

Total trade and other receivables

 

2,779

 

2,512

The increase of €0.5 million in trade receivables as at September 30, 2022 is due to generated revenue by the Company.

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. As at December 31, 2021 and September 30, 2022, there were no unbilled receivables included in the trade receivables.

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.

The increase in Others mainly due to increase in prepaid payment to vendors

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

12.Other current assets

The decrease of €1.1 million in other current assets as at September 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

September 30, 

December 31, 

(in EUR 000)

    

2022

    

2021

Short term deposit

 

38

 

38

Current accounts

 

89,839

 

135,471

Total cash and cash equivalents

 

89,877

 

135,509

The decrease of current accounts by €45.6 million is due to an increase in term accounts of €25.5 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. In 2022, the Company entered into USD term deposits at a well established financial institution for a total amount 50.0 million USD. As at August 16, 2022, 25.0 million USD reached maturity and is subsequently held as cash. 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 25.0 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.

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The total amount of term deposits as per September 30, 2022, amounts to €25.5 million.

15.Capital, Share Premium, Reserves

15.1. Capital and share premium

Evolution of the share capital and share premium over the nine months ended September 30, 2022 and 2021:

    

Common

    

Par value 

    

Share 

    

Share

(Number of shares (1) except otherwise stated)

shares

(EUR)

capital

premium

January 1, 2021

 

22,097,609

 

0.17

 

3,796

 

157,514

February 22, 2021 - Exercise warrants

 

10,000

 

0.17

 

2

 

50

June 23, 2021 - Exercise warrants

 

60,000

 

0.17

 

10

 

300

July 7, 2021 - IPO

 

2,835,000

 

0.17

 

487

 

71,355

July 9, 2021 - IPO

 

425,250

 

0.17

 

73

 

10,703

July 9, 2021 - Exercise warrants

 

10,000

 

0.17

 

2

 

118

September 10, 2021 - Exercise warrants

 

82,500

 

0.17

 

14

 

558

September 30, 2021 - Exercise warrants

 

27,000

 

0.17

 

5

 

135

September 30, 2021

 

25,547,359

 

0.17

 

4,389

 

240,733

October 11, 2021 - Exercise warrants

110,000

0.17

19

755

November 4, 2021 - Exercise warrants

 

90,000

 

0.17

 

15

 

585

November 25, 2021 - Exercise warrants

 

25,000

 

0.17

 

4

 

125

December 31, 2021

 

25,772,359

 

0.17

 

4,427

 

242,198

February 10, 2022 - Exercise warrants

 

25,000

 

0.17

 

4

 

125

June 8, 2022 - Capital increase in cash

 

38,920

 

0.17

 

7

 

September 30, 2022 - Exercise warrants

 

10,000

 

0.17

 

2

 

117

September 30, 2022

25,846,279

0.17

4,440

242,440

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).

On September 30, 2022, pursuant to the exercise of warrants, the Company issued 10,000 new shares for an aggregate capital increase of €119,000 (including share premium).

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.

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The movement in other comprehensive income for the nine months ended September 30, 2022 and 2021 is detailed in the table below:

Post-

Currency

employment

translation

benefit

(in EUR 000)

    

reserve

    

obligations

    

Total

Opening value at January 1, 2021

 

149

 

 

149

Currency translation differences

 

138

 

 

138

Total other comprehensive income at September 30, 2021

 

287

 

 

287

Opening value at January 1, 2022

 

270

 

(68)

 

202

Currency translation differences

 

(14)

 

 

(14)

Remeasurements of post-employment benefit obligations

 

 

 

Total other comprehensive income at September 30, 2022

 

256

 

(68)

 

188

16.Share-Based compensation

Equity-settled share-based payment transactions

As of September 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

 

536,500

 

401,240

Forfeited/Cancelled

 

(41,125)

 

Exercised

 

(35,000)

 

(189,500)

Outstanding as at September 30

 

1,453,865

 

1,219,240

Exercisable as at September 30

 

783,995

 

918,310

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. On August 8, 2022, 75,000 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 

    

Plan 2018 

    

Plan 2013

    

Plan 2018 

    

Plan 2020 

 

(grant 2018)

(grant 2018)

(grant 2018)

(grant 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

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Plan 2021

    

Plan 2021

    

Plan 2021

    

Plan 2021

    

Plan 2021

    

(grant Sept 17 

(grant Oct 27

(grant Feb 21

(grant Feb 21

(grant Feb 21

 

 2021)

 

 2021)

 

 2022)

 

 2022)

 

 2022)

 

Return Dividend

 

0

%  

0

%  

0

%  

0

%  

0

%

Expected volatility

 

51.30

%  

51.50

%  

49.80

%  

49.80

%  

49.80

%

Risk-free interest rate

 

(0.36)

%  

(0.18)

%  

0.37

%  

0.37

%  

0.50

%

Expected life

 

3

 

3

 

3

 

3

 

4

 

Exercise price

 

25.31

 

25.31

 

17.76

 

25.31

 

17.76

 

Stock price

 

25.75

 

20.50

 

17.50

 

17.50

 

17.50

 

Fair value

 

9.22

 

5.94

 

6.05

 

4.15

 

6.90

 

    

Plan 2021

    

Plan 2021

    

Plan 2021

    

Plan 2021

 

(grant May 14

(grant June 8

(grant Aug 8

(grant Aug 8

 

 2022)

 2022)

 2022)

 2022)

 

Return Dividend

 

0

%  

0

%  

0

%  

0

%

Expected volatility

 

49.80

%  

52.60

%  

53.71

%  

53.97

%

Risk-free interest rate

 

1.06

%  

1.60

%  

1.39

%  

1.45

%

Expected life

 

3

 

3

 

3

 

4

Exercise price

 

13.82

 

12.95

 

9.66

 

9.66

Stock price

 

13.82

 

13.34

 

9.75

 

9.75

Fair value

 

4.94

 

5.21

 

3.79

 

4.32

The Company has recognized €2.1 million share-based payment expense for the nine months ended September 30, 2022 (2021: €0.8 million).

17.Financial Debt

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

As at

    

September 30, 

    

December 31, 

(in EUR 000)

2022

2021

Recoverable cash advances - Non-current

7,972

7,656

Recoverable cash advances - Current

 

552

 

471

Total Recoverable cash advances

 

8,524

 

8,127

Other loan - Non-current

 

63

 

146

Other loan - Current

 

104

 

83

Total Other loan

 

167

 

229

Non-current

 

8,035

 

7,802

Current

 

656

 

554

Total Financial Debt

 

8,691

 

8,356

Financial debt related to recoverable cash advances

Recoverable cash advances received

As at September 30, 2022, 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)

 

1,600

 

1,600

 

480

First articles (6839)

 

2,160

 

2,160

 

284

Clinical trial (6840)

 

2,400

 

2,400

 

210

Activation chip improvements (7388)

 

1,467

 

1,467

 

44

Total

 

7,627

 

7,627

 

1,018

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During the nine months ended September 30, 2022, the Company made reimbursements totaling €220,000 (2021: €280,000). The Company did not receive any new amounts during the nine months ended September 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

    

September 30, 

    

December 31,

(in EUR 000)

2022

2021

Contract 6472

 

1,536

 

1,452

Contract 6839

 

2,403

 

2,333

Contract 6840

 

2,754

 

2,630

Contract 7388

 

1,831

 

1,712

Total recoverable cash advances

 

8,524

 

8,127

Non-current

 

7,972

 

7,656

Current

 

552

 

471

Total recoverable cash advances

 

8,524

 

8,127

The amounts recorded under “Current” caption correspond to the sales-independent amounts (fixed repayment) as well as 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)

    

2022

    

2021

As at January 1

 

8,127

 

7,910

Advances reimbursed (excluding interests)

 

(220)

 

(280)

Initial measurement and re-measurement

 

(77)

 

254

Discounting impact

 

694

 

661

As at September 30

 

8,524

 

8,545

18.Trade payables

As at

    

September 30, 

    

December 31, 

(in EUR 000)

2022

2021

Payables

 

2,667

 

2,395

Invoices to be received

 

2,679

 

1,600

Total Trade payables

 

5,346

 

3,995

The increase in total trade payables of €1.4 million as at September 30, 2022 is mainly due to the increase in invoices to be received. This increase is due to effect of higher clinical, R&D activities and manufacturing activities.

19.Income taxes and deferred taxes

For the three months ended

For the nine months ended

    

September 30 

    

September 30 

(in EUR 000)

    

2022

    

2021

2022

    

2021

Current tax income/(expense)

 

(944)

(136)

(2,579)

 

(268)

Deferred tax income/(expense)

 

879

2,200

 

8

Total Income Tax Income/(Expense)

 

(65)

(136)

(379)

 

(260)

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 €2.4 million and €2.5 million respectively, and also an increase in deferred tax asset and deferred tax income of €2.4 million and €2.2 million respectively. 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.

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The current tax liability of €5.4 million also relates to a liability for uncertain tax positions for an amount of €2.8 million. 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. The current tax expense related to this current tax liability for the nine months period ended September 30, 2022 amounts to €77,000.

20.Other payables

As at

September 30, 

December 31, 

(in EUR 000)

    

2022

    

2021

Holiday pay accrual

551

493

Salary

 

794

 

870

Accrued expenses

 

3,007

 

1,485

Foreign currency option - current

 

3,132

 

654

Other

 

408

 

131

Total other payables

 

7,892

 

3,633

The increase of €4.3 million in other payables as at September 30, 2022, compared to December 31, 2021, is mainly due to an increase of €2.5 million in the fair value of the foreign currency option and due to an increase of €1.5 million in accrued expenses related to an increase in clinical and R&D activities. The item Other includes € 397,000 social liabilities.

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

    

September 30, 

    

December 31, 

(in EUR 000)

2022

2021

call USD (in USD)

 

22,800

 

34,350

put USD (in USD)

 

 

(3,000)

call EUR (in EUR)

 

 

2,500

put EUR (in EUR)

 

(20,000)

 

(30,000)

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

As at

    

September 30, 

    

December 31, 

(in EUR 000)

2022

2021

Foreign currency swaps EUR - NIS (in EUR)

 

1,230

 

Foreign currency swaps EUR - NIS (in NIS)

 

4,500

 

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 September 30, 2022

(in EUR 000)

    

Level I

    

Level II

    

Level III

    

Total

Financial assets

 

  

 

  

 

  

 

  

Foreign currency forwards

 

 

66

 

 

66

Financial liabilities

 

  

 

  

 

  

 

Foreign currency option

 

 

3,132

 

 

3,132

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The fair value is determined by the financial institution and is based on foreign currency swaps rates and the maturity of the instrument. All foreign currency put and call options and foreign currency swaps are classified as current as their maturity date is within the next twelve months.

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

(in EUR 000)

    

2022

    

2021

Financial asset

Opening value at January 1

 

 

New contracts

 

 

Fair value adjustments

 

66

 

Closing value at September 30

 

66

 

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

    

2022

    

2021

Opening value at January 1

 

654

 

New contracts

 

 

343

Fair value adjustments

 

2,558

 

146

Exchange rate difference

 

(80)

 

Closing value at September 30

 

3,132

 

489

22.Results of operation

Revenue and cost of goods sold

In the nine months ended September 30, 2022, the Company generated revenue for the amount of €1.8 million (2021: €0.6 million). In the three months ended September 30, 2022, the company generated revenue for the amount of €182,000 (2021: €203,000).

In the three months ended September 30, 2022, the Company had experienced a delay in sales due to product availability from component supplier due to over malfunctioning. Those malfunctioning were remediated, and the Company will have sufficient manufacturing capacity to meet all commercial demands.

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 nine month period ended September 30, 2022 the sales (based on country of customer) were generated in Germany (€1.6 million), Switzerland (€167,000) and Finland (€40,000) (2021: Germany: €0.5 million, Spain: €20,000 and Belgium: €40,000). For the nine month period ended September 30, 2022, the Company has two customers with individual sales larger than 10% of the total revenue (2021: three customers).

For the three month period ended September 30, 2022 the sales (based on country of customer) were generated in Germany (€15,000) and Switzerland (€167,000) (2021: Germany: €203,000).

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Cost of goods sold for the three and nine months ended September 30, 2022 and 2021:

For the three months ended

For the nine months ended

September 30 

September 30 

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Purchases of goods and services

 

151

143

933

 

231

Inventory movement

 

(88)

(61)

(248)

 

(33)

Total cost of goods sold

 

63

82

685

 

198

Operating expenses

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

Operating

expense for the

(in EUR 000)

    

Total cost

    

Capitalized

    

period

Research and development

 

23,177

 

(11,891)

 

11,286

Selling, general and administrative expenses

 

13,492

 

 

13,492

Other income and expenses

 

(354)

 

117

 

(237)

For the nine months ended September 30, 2022

 

36,315

 

(11,774)

 

24,541

    

    

    

Operating 

expense for the

(in EUR 000)

Total cost

Capitalized

period

Research and development

 

16,726

 

(7,717)

 

9,009

Selling, general and administrative expenses

 

10,775

 

 

10,775

Other income and expenses

 

(224)

 

498

 

274

For the nine months ended September 30, 2021

 

27,277

 

(7,219)

 

20,058

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

    

    

    

Operating 

expense for the 

(in EUR 000)

Total cost

Capitalized

period

Research and development

 

8,360

 

(4,139)

 

4,221

Selling, general and administrative expenses

 

4,763

 

 

4,763

Other income and expenses

 

(102)

 

15

 

(87)

For the three months ended September 30, 2022

 

13,021

 

(4,124)

 

8,897

    

    

    

Operating 

expense for the 

(in EUR 000)

Total cost

Capitalized

period

Research and development

 

7,131

 

(3,614)

 

3,517

Selling, general and administrative expenses

 

4,496

 

 

4,496

Other income and expenses

 

57

 

121

 

178

For the three months ended September 30, 2021

 

11,684

 

(3,493)

 

8,191

Research and Development expenses

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For the three months ended

For the nine months ended 

September 30 

September 30 

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Staff costs

 

2,592

2,240

7,682

 

5,367

Consulting and contractors' fees

 

802

2,481

2,107

 

3,150

Q&A regulatory

 

77

90

203

 

453

IP costs

 

131

143

353

 

934

Depreciation and amortization expense

 

320

239

816

 

694

Travel

 

327

253

655

 

298

Manufacturing and outsourced development

 

1,424

467

3,765

 

2,143

Clinical studies

 

2,325

1,118

6,577

 

2,826

Other expenses

 

362

100

1,019

 

861

Capitalized costs

 

(4,139)

(3,614)

(11,891)

 

(7,717)

Total research and development expenses

 

4,221

3,517

11,286

 

9,009

Before capitalization of €11.9 million for the nine months ended September 30, 2022 and €7.7 million for the nine months ended September 30, 2021, research and development expenses increased by €6.5 million or 39 %, from €16.7 million for the nine months ended September 30, 2021, to €23.2 million for the nine months ended September 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 nine months ended September 30, 2021.

Before capitalization of €4.1 million for the three months ended September 30, 2022 and €3.6 million for the three months ended September 30, 2021, research and development expenses increased by €1.2 million or 17 %, from €7.1 million for the three months ended September 30, 2021, to €8.4 million for the three months ended September 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.

Selling, General and Administrative expenses

For the three months ended

For the nine months ended 

September 30 

September 30 

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Staff costs

 

2,055

1,336

5,384

 

2,598

Consulting and contractors' fees

 

928

1,485

3,032

 

5,189

Legal fees

 

145

1

560

 

133

Rent

 

245

71

447

 

196

Depreciation and amortization expense

 

179

166

619

 

517

ICT

 

109

83

361

 

249

Travel

 

367

150

914

 

196

Insurance fees

 

404

523

1,239

 

523

Other

 

331

681

936

 

1,174

Total selling, general and administrative expenses

 

4,763

4,496

13,492

 

10,775

Selling, general and administrative expenses increased by €2.7 million or 25 % from €10.8 million for the nine months ended September 30, 2021 to €13.5 million for the nine months ended September 30, 2022, mainly due to an increase in staff costs to support the Company in its activities and an increase in insurance fees following the listing of the Company in the United States. This increase was offset by a decrease of €2.2 million in Consulting and contractors’ fees due to variable compensations for an amount of €1.9 million that were included in the nine months ended September 30, 2021 related to a cash settled share based payment transaction.

Selling, general and administrative expenses increased by €267,000 or 6 % from €4.5 million for the three months ended September 30, 2021 to €4.8 million for the three months ended September 30, 2022, mainly due to an increase in staff costs to support the Company in its activities. This increase was offset by a decrease of €0.6 million in Consulting and contractors’ fees due to one time fee of € 0.4 million included in the three months ended September 30, 2021.

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Other operating expenses

The Company had other operating income of €237,000 for the nine months ended September 30, 2022 compared to other operating expenses of €-274,000 for the nine months ended September 30, 2021.

The Company had other operating income of €87,000 for the three months ended September 30, 2022 compared to other operating expenses of €-178,000 for the three months ended September 30, 2021.

For the three months ended

For the nine months ended

September 30 

September 30 

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Recoverable cash advances

 

  

 

  

Initial measurement and re-measurement

 

50

(100)

77

 

(253)

R&D incentives (Australia)

 

55

136

192

 

572

Capitalization of R&D incentive

 

(15)

(121)

(117)

 

(498)

Other income/(expenses)

 

(3)

(93)

85

 

(95)

Total Other Operating Income/(Expenses)

 

87

(178)

237

 

(274)

23.Employee benefits

For the three months ended

For the nine months ended 

September 30

September 30

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Salaries

 

3,133

2,117

9,221

 

5,638

Social charges

 

242

267

742

 

599

Fringe benefits

 

(33)

66

44

 

221

Defined contribution plan

 

69

90

205

 

262

Holiday pay

 

162

189

200

 

287

Share-based payment

 

845

784

2,137

 

784

Other

 

229

63

517

 

174

Total employee benefits

 

4,647

3,576

13,066

 

7,965

For the three months ended

For the nine months ended 

September 30

September 30

(in EUR 000)

    

2022

2021

    

2022

    

2021

Selling, general and administrative expenses

 

2,055

1,336

5,384

 

2,598

Research & Development expenses

 

2,592

2,240

7,682

 

5,367

Total employee benefits

 

4,647

3,576

13,066

 

7,965

24.Financial income

For the three months ended

For the nine months ended 

September 30

September 30

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Interests

 

79

192

 

1

Exchange differences

 

4,955

15

11,045

 

57

Other

 

92

14

135

 

14

Total financial income

 

5,126

29

11,372

 

72

For the nine month period ended September 30, 2022, exchange gains amount to €11.0 million (three month period ended September 30, 2022 : €5.0 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 September 30, 2022, the rate of EUR/USD decreased to 0.980200, 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.

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For the nine month period ended September 30, 2022, the total interest income amounted to €192,000 (three month period ended September 30, 2022 : €79,000). This interest income relates to the USD term accounts. Other financial income mainly consists of premiums received on foreign currency options.

25.Financial expense

For the three months ended

For the nine months ended 

September 30

September 30

(in EUR 000)

    

2022

    

2021

2022

    

2021

Fair value adjustment

 

609

146

2,558

 

146

Recoverable cash advances, Accretion of interest

 

231

220

694

 

661

Interest and bank charges

 

21

33

124

 

253

Interest on lease liabilities

 

26

22

73

 

67

Exchange differences

 

1,632

134

2,020

 

323

Other

 

4

29

4

 

34

Total Financial expense

 

2,523

584

5,473

 

1,484

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 nine month period ended September 30, 2022, exchange differences consists for €1.8 million out of realized losses on foreign currency options that reached maturity.

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 September 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.

    

For the three months ended

For the nine months ended

September 30

September 30

2022

    

2021

    

2022

    

2021

As at September 30, after conversion and share split

 

  

 

  

Outstanding common shares at period-end

 

25,846,279

25,547,359

25,846,279

 

25,547,359

Weighted average number of common shares outstanding

 

25,836,279

25,197,917

25,809,995

 

23,154,759

Number of shares resulting of the exercise of outstanding warrants

 

1,916,125

2,218,000

1,916,125

 

2,218,000

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

For the three months ended

For the nine months ended 

September 30

September 30

    

2022

    

2021

    

2022

    

2021

Loss of year attributable to equity holders (in EUR)

 

(6,240,000)

(8,762,000)

(17,929,000)

 

(21,371,000)

Weighted average number of common shares outstanding (in units)

 

25,836,279

25,197,917

25,809,995

 

23,154,759

Basic earnings per share in EUR (EUR/unit)

 

(0.242)

(0.348)

(0.695)

 

(0.923)

Diluted earnings per share in EUR (EUR/unit)

 

(0.242)

(0.348)

(0.695)

 

(0.923)

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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. During the period ended September 30, 2022, the Company recognized €79,000 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.

Remuneration of Key Management

The remuneration of the senior management consists of the remuneration of the CEO of the Company for the three and nine months ended September 30:

For the three months ended

For the nine months ended 

September 30

September 30

(in EUR 000)

    

2022

    

2021

    

2022

    

2021

Short-term remuneration & compensation

 

120

332

391

 

477

Share based payment

 

47

13

102

 

13

Total

 

167

345

493

 

490

The Company had the following related party transactions in 2021:

On July 15, 2021, the Board of Directors, based on the recommendation of the remuneration committee, approved an exceptional one-off bonus to Olivier Taelman, CEO, for the success of the Nasdaq IPO, for an amount of €150,000.

On August 27, 2021, the Board of Directors approved a revised remuneration package for Olivier Taelman, CEO, effective as of September 1, 2021.

The Company did not have any related party transactions for the three and nine months period ended September 30, 2022.

Transactions with Non-Executive Directors and Shareholders:

For the nine months ended September 30, 2022

For the nine months ended September 30, 2021

R&D

Consulting

Board

R&D

Consulting

Board

(in EUR 000)

    

Collaboration

    

services

    

Remuneration

    

Collaboration

    

services

    

Remuneration

Cochlear

 

1,749

 

 

 

1,450

 

 

MINV SA

 

 

60

 

 

 

69

 

Ray Cohen

 

 

 

20

 

 

 

Ginny Kirby

 

 

 

15

 

 

 

Donald Deyo

 

 

 

21

 

 

 

43

Robert Taub

 

 

 

61

 

 

 

54

Kevin Rakin

 

 

 

33

 

 

 

31

Pierre Gianello

 

 

 

36

 

 

 

28

Jan Janssen

 

 

 

24

 

 

 

28

Jurgen Hambrecht

 

 

 

38

 

 

 

31

Rita Mills

 

 

 

28

 

 

 

Total

 

1,749

 

60

 

276

 

1,450

 

69

 

215

Amounts outstanding at period-end

 

970

 

60

 

126

 

 

69

 

215

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Table of Contents

    

For the three months ended  September 30, 2022

    

For the three months ended  September 30, 2021

(in EUR 000)

R&D 

    

Consulting 

    

Board 

    

R&D 

    

Consulting 

    

Board 

 

Collaboration

 

services

 

Remuneration

 

Collaboration

 

services

 

Remuneration

Cochlear

 

413

 

 

 

1,450

 

 

MINV SA

 

 

 

 

 

52

 

Ray Cohen

 

 

 

16

 

 

 

Ginny Kirby

 

 

 

12

 

 

 

Donald Deyo

 

 

 

7

 

 

 

22

Robert Taub

 

 

 

19

 

 

 

13

Kevin Rakin

 

 

 

8

 

 

 

9

Pierre Gianello

 

 

 

1

 

 

 

7

Jan Janssen

 

 

 

5

 

 

 

7

Jurgen Hambrecht

 

 

 

14

 

 

 

9

Rita Mills

 

 

 

5

 

 

 

Total

 

413

 

 

87

 

1,450

 

52

 

67

Amounts outstanding at period-end

 

970

 

60

 

126

 

 

69

 

215

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 €1.7 million and €1.5 million for the nine months ended September 30, 2022 and 2021 respectively. For the three months ended September 30, the financial impact of the collaboration with Cochlear was of €413,000 in 2022 and €1.5 million in 2021.

29.Events after the Balance-Sheet Date

No events after balance-sheet date took place.

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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, November 8, 2022.

On behalf of the board of directors

Robert Taub, Chairman

    

Olivier Taelman, CEO

27