Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
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Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results

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Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
Expect to report DREAM U.S. pivotal study efficacy and safety data by early April
Achieved record quarterly sales of €1.8 million

Mont-Saint-Guibert, Belgium – March 5, 2024 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 fourth quarter and financial year 2023.

Recent Financial and Operating Highlights

  • Filed the third out of four modules in the U.S. modular PMA submission.

  • Achieved quarterly sales of €1.8 million, representing sequential quarterly growth of 87% and increasing 42% year-over-year.

  • Achieved 2023 full year sales of €4.3 million, representing 41% year-over-year growth.

  • Ended the year with 48 active German accounts, up from 38 entering 2023.

  • Total cash position of €57.7 million at the end of 2023.

2024 Strategic Priorities

  • Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April.

  • File the fourth and final module in the modular PMA submission.

  • Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch.

  • Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study.

  • Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe.

“In 2023, we completed enrollment in our DREAM U.S. pivotal study, presented positive early DREAM efficacy and safety data, initiated enrollment in our ACCCESS U.S. pivotal study for complete concentric collapse and raised capital from both existing and new investors. These accomplishments strengthen our confidence for a transformational 2024.” commented Olivier Taelman, Nyxoah Chief Executive Officer. “We are excited to report DREAM data in the coming weeks, finalize the regulatory FDA submission and pave the way for bringing Genio® to patients in the U.S.”

Mr. Taelman continued, “Commercially in Europe, this quarter’s performance was the strongest in Nyxoah’s history driven by a targeted direct-to-consumer (DTC) effort and I applaud our European commercial team for their execution. I look forward to a further increase in therapy penetration from our partnership with ResMed in Germany.”


Fourth Quarter and Full Year 2023 Results

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND YEARS ENDED DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in thousands)

 

For the three months ended December 31, 

 

For the year ended December 31,

 

2023

 

2022

 

2023

 

2022

Revenue

€1,824

 

€1,307

 

€4,348

 

€3,084

Cost of goods sold

(726)

 

(465)

 

(1,656)

 

(1,150)

Gross profit

€1,098

 

€842

 

€2,692

 

€1,934

Research and Development Expense

(7,321)

 

(4,575)

 

(26,651)

 

(15,861)

Selling, General and Administrative Expense

(4,893)

 

(5,363)

 

(21,687)

 

(18,855)

Other income/(expense)

279

 

46

 

544

 

283

Operating loss for the period

€(10,837)

 

€(9,050)

 

€(45,102)

 

€(32,499)

Financial income

582

 

(4,609)

 

4,174

 

6,763

Financial expense

(964)

 

1,153

 

(3,729)

 

(4,320)

Loss for the period before taxes

€(11,219)

 

€(12,506)

 

€(44,657)

 

€(30,056)

Income taxes

326

 

(790)

 

1,445

 

(1,169)

Loss for the period

€(10,893)

 

€(13,296)

 

€(43,212)

 

€(31,225)

 

 

 

 

 

 

 

 

Loss attributable to equity holders

€(10,893)

 

€(13,296)

 

€(43,212)

 

€(31,225)

 

 

 

 

 

 

 

 

Other comprehensive income/(loss)

 

 

 

 

 

 

 

Items that may not be subsequently reclassified to profit or loss (net of tax)

 

 

 

 

 

 

 

Remeasurements of post-employment benefit obligations, net of tax

81

 

70

 

81

 

70

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

 

 

 

 

 

 

 

Currency translation differences

(32)

 

(82)

 

(120)

 

(96)

Total other comprehensive income/(loss)

€(39)

 

€(12)

 

€(39)

 

€(26)

Total comprehensive loss for the year, net of tax

€(10,844)

 

€(13,308)

 

€ (43,251)

 

€ (31,251)

Loss attributable to equity holders

€(10,844)

 

€(13,308)

 

€ (43,251)

 

€ (31,251)

 

 

 

 

 

 

 

 

Basic loss per share (in EUR)

€(379)

 

€(514)

 

€(1,545)

 

€(1,209)

Diluted loss per share (in EUR)

€(379)

 

€(514)

 

€(1,545)

 

€(1,209)

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in thousands)

 

As at December 31

 

2023

 

2022

ASSETS

 

 

 

Non-current assets

 

 

 

Property, plant and equipment

€4,188

 

€2,460

Intangible assets

46,608

 

39,972

Right of use assets

3,788

 

3,159

Deferred tax asset

56

 

47

Other long-term receivables

1,166

 

173

 

€55,806

 

€45,811

Current assets

 

 

 

Inventory

3,315

 

882

Trade receivables

2,758

 

1,463

Other receivables

3,212

 

1,775

Other current assets

1,318

 

1,284

Financial assets

36,138

 

76,968

Cash and cash equivalents

21,610

 

17,888

 

€68,351

 

€100,260

Total assets

€124,157

 

€146,071

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

Capital and reserves

 

 

 

Capital

4,926

 

4,440

Share premium

246,127

 

228,275

Share based payment reserve

7,661

 

5,645

Other comprehensive income

137

 

176

Retained loss

(160,829)

 

(118,212)

Total equity attributable to shareholders

€98,022

 

€120,324

 

 

 

 

LIABILITIES

 

 

 

Non-current liabilities

 

 

 

Financial debt

8,373

 

8,189

Lease liability

3,116

 

2,586

Pension liability

9

 

Provisions

185

 

59

Deferred tax liability

9

 

 

€11,692

 

€10,834

Current liabilities

 

 

 

Financial debt

364

 

388

Lease liability

851

 

719

Trade payables

6,155

 

4,985

Current tax liability

1,988

 

3,654

Other payables

5,085

 

5,167

 

€14,443

 

€14,913

Total liabilities

€26,135

 

€25,747

Total equity and liabilities

€124,157

 

€146,071

Revenue