Releases 06/11/2024 - 18:13

Nyxoah Reports Third Quarter Financial and Operating Results


REGULATED INFORMATION

Nyxoah Reports Third Quarter Financial and Operating Results
FDA approval on track for first quarter 2025, U.S. commercial team build out in progress
Company fully funded with cash until mid 2026

Mont-Saint-Guibert, Belgium November 6, 2024, 10:05pm CET / 4:05pm ET Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (Nyxoah or the Company), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024.

Recent Financial and Operating Highlights

  • Presented compelling DREAM data results at International Surgical Sleep Society in September.
  • Raised 24.6 million through an ATM program from a single U.S. healthcare-dedicated fund providing incremental flexibility as we shift into U.S. commercialization and extending cash runway until mid 2026.
  • Strengthened U.S. organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
  • Reported third quarter sales of 1.3 million, representing 30% growth versus third quarter 2023.
  • Total cash position of 71.0 million at the end of the quarter, 95.6 million proforma including the 24.6 million raised.

Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team, commented Olivier Taelman, Nyxoahs Chief Executive Officer. I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval.


Third Quarter 2024 Results

CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)

 


For the three months ended September 30,

 


For the nine months ended September 30,

 


2024

 


2023

 


2024

 


2023


Revenue 


1,266

 


976

 


3,258

 


2,524


Cost of goods sold 


(482)

 


(336)

 


(1,217)

 


(930)


Gross profit 


784

 


640

 


2,041

 


1,594


Research and Development Expense 


(7,902)

 


(6,568)

 


(22,573)

 


(19,330)


Selling, General and Administrative Expense 


(8,042)

 


(5 058)

 


(20,396)

 


(16,794)


Other income/(expense) 


180

 


 


430

 


265


Operating loss for the period 


(14,980)

 


(10,986)

 


(40,498)

 


(34,265)


Financial income 


1,138

 


2,178

 


4,615

 


3,592


Financial expense 


(3,043)

 


(1,033)

 


(5,480)

 


(2,765)


Loss for the period before taxes 


(16,885)

 


(9,841)

 


(41,363)

 


(33,438)


Income taxes 


(173)

 


2,229

 


(724)

 


1,119


Loss for the period 


(17,058)

 


(7,612)

 


(42,087)

 


(32,319)

 

 

 

 

 

 

 

 


Loss attributable to equity holders 


(17,058)

 


(7,612)

 


(42,087)

 


(32,319)

 

 

 

 

 

 

 

 


Other comprehensive income/(loss) 

 

 

 

 

 

 

 


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

 

 

 

 

 

 

 


Currency translation differences 


(209)

 


(10)

 

(221)

 

(88)


Total comprehensive loss for the year, net of tax 


(17,267)

 


(7,622)

 


(42,308)

 


(32,407)


Loss attributable to equity holders 


(17,267)

 


(7,622)

 


(42,308)

 


(32,407)

 

 

 

 

 

 

 

 


Basic loss per share (in EUR) 


(0.496)

 


(0.266)

 


(1.346)

 


(1.166)


Diluted loss per share (in EUR) 


(0.496)

 


(0.266)

 


(1.346)

 


(1.166)

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)

(in thousands)

 

 

 


As at

 

 

 


September 30,
2024

 


December 31, 2023


ASSETS

 

 

 

 

 


Non-current assets

 

 

 

 

 


Property, plant and equipment

 

 


4,461

 


4,188


Intangible assets

 

 


49,558

 


46,608


Right of use assets

 

 


3,635

 


3,788


Deferred tax asset

 

 


53

 


56


Other long-term receivables

 

 


1,475

 


1,166

 

 

 


59,182

 


55,806


Current assets

 

 

 

 

 


Inventory

 

 


5,272

 


3,315


Trade receivables

 

 


2,504

 


2,758


Other receivables

 

 


2,992

 


3,212


Other current assets

 

 


1,837

 


1,318


Financial assets

 

 


42,299

 


36,138


Cash and cash equivalents

 

 


28,678

 


21,610

 

 

 


83,582

 


68,351


Total assets

 

 


142,764

 


124,157

 

 

 

 

 

 


EQUITY AND LIABILITIES

 

 

 

 

 


Capital and reserves

 

 

 

 

 


Capital

 

 


5,908

 


4,926


Share premium

 

 


290,906

 


246,127


Share based payment reserve

 

 


8,943

 


7,661


Other comprehensive income

 

 


(84)

 


137


Retained loss

 

 


(200,966)

 


(160,829)


Total equity attributable to shareholders

 

 


104,707

 


98,022

 

 

 

 

 

 


LIABILITIES

 

 

 

 

 


Non-current liabilities

 

 

 

 

 


Financial debt

 

 


19,143

 


8,373


Lease liability

 

 


2,636

 


3,116


Pension liability

 

 


47

 


9


Provisions

 

 


398

 


185


Deferred tax liability

 

 


12

 


9

 

 

 


22,236