Nyxoah מדווחת על התוצאות הכספיות והתפעוליות לרבעון השני ולמחצית הראשונה של 2024

 

Nyxoah מדווחת על התוצאות הכספיות והתפעוליות לרבעון השני ולמחצית הראשונה של 2024

ההגשה הרגולטורית של ה-FDA הושלמה, אישור בארה"ב יתקבל עד לסוף שנת 2024

השקה מסחרית בארה"ב במימון מלא עם גיוס הון חדש של למעלה מ-85 מיליון אירו

מונט-סנט-גיברט, בלגיה, 6 באוגוסט 2024, (GLOBE NEWSWIRE) :

 

Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה בשינה (OSA), דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השני ולמחצית הראשונה של 2024.

REGULATED INFORMATION

Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results


FDA regulatory submission complete, U.S. approval on track for end of 2024
U.S. commercial launch fully funded with over €85 million in new capital raised

Mont-Saint-Guibert, Belgium – August 6, 2024,  :(GLOBE NEWSWIRE)

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 2024.  

Recent Financial and Operating Highlights

“With the FDA interactive review well advancing, our focus is fully shifted to U.S. commercial readiness. Key commercial leadership is in place, and we are kicking off the recruitment of top sales and marketing talents. We will present the full DREAM U.S. pivotal study data at the ISSS meeting in September, which will further differentiate Genio’s unique, patient centric hypoglossal nerve stimulation solution,” commented Olivier Taelman, Nyxoah Chief Executive officer. “Our recent €85 million in capital raise provides us with a cash runway into mid-2026, fully funding the U.S. launch.”

Second Quarter and First Half 2024 Results

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

 

 

For the three months ended June 30, 

 

For the six months ended June 30, 

 

2024

 

2023

 

2024

 

2023

Revenue 

771

 

1,107

 

1,992

 

1,548

Cost of goods sold 

(281)

 

(419)

 

(735)

 

(594)

Gross profit 

€490

 

€688

 

€1,257

 

€954

Research and Development Expense 

(7,472)

 

(6,605)

 

(14,671)

 

(12,762)

Selling, General and Administrative Expense 

(6,383)

 

(6,185)

 

(12,355)

 

(11,736)

Other income/(expense) 

58

 

219

 

249

 

265

Operating loss for the period 

€(13,307)

 

€(11,883)

 

€(25,520)

 

€(23,279)

Financial income 

2,069

 

789

 

3,477

 

1,414

Financial expense 

(1,445)

 

( 775)

 

(2,436)

 

(1,732)

Loss for the period before taxes 

€(12,683)

 

€(11,869)

 

€(24,479)

 

€(23,597)

Income taxes 

(441)

 

(928)

 

(551)

 

(1,110)

Loss for the period 

€(13,124)

 

€(12,797)

 

€(25,030)

 

€(24,707)

 

 

 

 

 

 

 

 

Loss attributable to equity holders 

€ (13,124)

 

€(12,797)

 

€(25,030)

 

€(24,707)

 

 

 

 

 

 

 

 

Other comprehensive income/(loss) 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Currency translation differences 

(82)

 

(50)

 

(22)

 

(78)

Total comprehensive loss for the year, net of tax 

€(13,206)

 

€(12,847)

 

€(25,052)

 

€(24,785)

Loss attributable to equity holders 

€(13,206)

 

€(12,847)

 

€(25,052)

 

€(24,785)

 

 

 

 

 

 

 

 

Basic loss per share (in EUR) 

€(0.428)

 

€(0.447)

 

€(0.843)

 

€(0.907)

Diluted loss per share (in EUR) 

€(0.428)

 

€(0.447)

 

€(0.843)

 

€(0.907)

                 

 

 

 CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)

 

 

 

As at 

 

 

 

June 30,
2024

 

December 31, 2023

ASSETS

 

 

 

 

 

Non-current assets

 

 

 

 

 

Property, plant and equipment

 

 

4,386

 

4,188

Intangible assets

 

 

49,310

 

46,608

Right of use assets

 

 

3,391

 

3,788

Deferred tax asset

 

 

51

 

56

Other long-term receivables

 

 

1,419

 

1,166

 

 

 

€ 58,557

 

€ 55,806

Current assets

 

 

 

 

 

Inventory

 

 

5,098

 

3,315

Trade receivables

 

 

2,609

 

2,758

Other receivables

 

 

2,885

 

3,212

Other current assets

 

 

1,298

 

1,318

Financial assets

 

 

50,061

 

36,138

Cash and cash equivalents

 

 

27,724

 

21,610

 

 

 

€ 89,675

 

€ 68,351

Total assets

 

 

€ 148,232

 

€ 124,157

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

Capital and reserves

 

 

 

 

 

Capital

 

 

5,905

 

4,926

Share premium

 

 

290,822

 

246,127

Share based payment reserve

 

 

8,841

 

7,661

Other comprehensive income

 

 

115

 

137

Retained loss

 

 

(185,540)

 

(160,829)

Total equity attributable to shareholders

 

 

€ 120,143

 

€ 98,022

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

Financial debt

 

 

8,600

 

8,373

Lease liability

 

 

2,721

 

3,116

Pension liability

 

 

35

 

9

Provisions

 

 

339

 

185

Deferred tax liability

 

 

10

 

9

 

 

 

€11,705

 

€ 11,692

Current liabilities

 

 

 

 

 

Financial debt

 

 

595

 

364

Lease liability

 

 

827

 

851

Trade payables

 

 

9,078

 

8,108

Current tax liability

 

 

2,335

 

1,988

Other payables

 

 

3,549

 

3,132

 

 

 

€ 16,384

 

€ 14,443

Total liabilities

 

 

€ 28,089

 

€ 26,135

Total equity and liabilities

 

 

€ 148,232

 

€ 124,157

Revenue
Revenue was €0.8 million for the second quarter ending June 30, 2024, compared to €1.1 million for the second quarter ending June 30, 2023. 

Cost of Goods Sold

Cost of goods sold was €281,000 for the three months ending June 30, 2024, representing a gross profit of €490,000, or gross margin of 63.6%. This compares to total cost of goods sold of €419,000 in the second quarter of 2023, for a gross profit of €0.7 million, or gross margin of 62.2%. 

Research and Development

For the second quarter ending June 30, 2024, research and development expenses were €7.5 million, versus €6.6 million for the second quarter ending June 30, 2023.

Operating Loss

Total operating loss for the second quarter ending June 30, 2024 was €13.3 million versus €11.9 million in the second quarter ending June 30, 2023. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities. 

Cash Position

As of June 30, 2024, cash and financial assets totaled €77.8 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €4.0 million per month during the second quarter 2024.

Second Quarter and First Half 2024

Nyxoah’s financial report for the second quarter and first half 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation

Company management will host a conference call to discuss financial results on Tuesday, August 6, 2024, beginning at 10:30pm CET / 4:30pm ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link:Nyxoah‘s Q2 2024 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah’s Q2 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

The archived webcast will be available for replay shortly after the close of the call. 

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. 

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please see the Company’s annual report for the financial year 2023 and visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the entry into of the loan facility agreement and the synthetic warrant agreement with the EIB; the use of proceeds from the loan facility agreement; the Genio® system 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; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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.

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