Nyxoah מדווחת על תוצאות פיננסיות ותפעוליות ברבעון השני ובמחצית הראשונה של 2026

הביצוע המסחרי בארה"ב מניע את מומנטום ההשקה, מה שהוביל לצמיחה רציפה של 22% בהכנסות בארה"ב ברבעון השני של 2026 לעומת הרבעון הראשון של 2026

מונט-סן-גיבר, בלגיה – 5 באוגוסט 2026, GLOBE NEWSWIRE –

Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המתמקדת בפיתוח פתרונות חדשניים לטיפול בדום נשימה חסימתי בשינה (OSA), דיווחה היום על תוצאות כספיות ותפעוליות לרבעון השני ולמחצית הראשונה של 2026.

REGULATED INFORMATION

Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results

U.S. commercial execution driving continued launch momentum resulting in 22% sequential U.S. revenue growth in Q2 2026 over Q1 2026

Mont-Saint-Guibert, Belgium – August 5, 2026, (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 2026.

Financial and Operating Highlights

• Financials
  • U.S. net revenue forthe second quarter of 2026 was €5.2 million, 22% sequential growth overU.S. net revenue for the first quarter of 2026
  • Global net revenuefor the second quarter of 2026 was €7.7 million, 21% sequential growthover global net revenue for the first quarter of 2026
  • Global net revenuefor the first half of 2026 was €14.0 million, as compared to €2.4 millionfor the first half of 2025
  • Secured $110 millionin aggregate financing during the second quarter of 2026. As of June 30,2026, cash and cash equivalents and financial assets totaled €97.8million
• Leading U.S.commercial indicators
  • 40 active sales reps,focused on covering 200 high volume HGNS accounts
  • 55 new surgeonstrained in Q2, bringing the total to 262 surgeons trained
  • 89 new accountsactivated in Q2, bringing the total to 180 active high-volume accounts
  • 427 patients activelyunder prior authorization entering Q3 2026, a 77% increase over thenumber of patients actively under prior authorization entering Q2 2026
• U.S. reimbursementlandscape
  • 100% approval rate onreviewed prior authorization submissions
  • Clarity for Genio,with Medicare C-code 8011 and existing commercial payers CPT codes
  • CMS proposedreimbursement increases in both hospital outpatient and ambulatorysurgical centers of 12% and 15% respectively for 2027
  • Upcoming CPTeditorial panel meetings to involve AAO-HNS and industry discussingcomprehensive HGNS coding
• Hosted investor day onJuly 8 – Link to the replay
  • Featured independentperspectives from ENT and Sleep physicians, who highlighted Genio'sdifferentiated clinical profile and their intent to expand utilizationacross their patient populations
  • Reimbursement expertgroup confirmed the strength and durability of long-term HGNS coverage,with Genio well positioned across future coding scenarios

“The doubling of active accounts in Q2 and the strong acceleration of our patient pipeline, demonstrate the growing acceptance and excitement around Genio by physicians and patients,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. “With a dedicated Genio C-code for Medicare patients and another quarter of 100% prior-authorization approval for commercial and WISeR patients, we are confident that the current reimbursement landscape supports our accelerating U.S. revenue growth. The recent closing of our $110 million financing provides the capital needed to further invest in Genio’s U.S. commercial organization in the second half of 2026.”

Results for the Three and Six Months Ended June 30, 2026

Revenue

• Net revenue in thesecond quarter of 2026 was €7.7 million, compared to €1.3 million in thesecond quarter of 2025. Net revenue in the first half of 2026 was €14.0million, as compared to €2.4 million for the first half of 2025. Theincreases in net revenue were primarily driven by the continued expansionof U.S. commercialization activities following FDA approval in August2025, as well as growth in international markets.

Cost of Goods Sold

• Cost of goods sold was€3.1 million for the second quarter of 2026, resulting in gross profit of€4.6 million and a gross margin of 60% for the second quarter of 2026,compared to cost of goods sold of €0.5 million in the second quarter of2025, resulting in gross profit of €0.9 million and a gross margin of 63%in the second quarter of 2025. The increase in cost of goods sold wasprimarily driven by an increase in revenue. The decrease in gross marginwas primarily due to a higher mix of U.S. revenue.
• Cost of goods sold inthe first half of 2026 was €5.8 million, as compared to €0.9 million forthe first half of 2025, resulting in gross profit of €8.2 million and agross margin of 59% in the first half of 2026, compared to gross profit of€1.5 million and a gross margin of 63% in the first half of 2025. Thedecrease in gross margin was primarily due to production yield issues inthe first quarter of 2026 and higher mix of U.S. revenue.

Research and Development

• For the second quarterof 2026, research and development expenses were €9.5 million, versus €10.1million for the second quarter of 2025. For the first half of 2026,research and development expenses were €18.3 million, versus €19.0 millionfor the first half of 2025. The decreases in research and developmentexpenses were primarily due to a decrease in product development expenses.

Selling, General and Administrative

• For the second quarterof 2026, selling, general and administrative expenses were €15.6 million,versus €10.7 million for the second quarter of 2025. For the first half of2026, selling, general and administrative expenses were €31.0 million,versus €23.1 million for the first half of 2025. The increases in selling,general and administrative expenses were primarily driven by the continuedbuild-out of the Company’s U.S. commercial organization, including sales,marketing, and market access functions.

Operating Loss

• Total operating lossfor the second quarter of 2026 was €20.6 million, versus €19.9 million inthe second quarter of 2025. Total operating loss for the first half of2026 was €41.1 million, versus €40.5 million in the first half of 2025.The increases in operating loss reflect increased net revenue offset byincreased investments to support the build-out of the Company’s U.S.commercial organization.

Cash Position

Cash and cash equivalents and financial assets totaled €97.8 million at June 30, 2026, compared to €48.0 million at December 31, 2025.

Financial Guidance for the full year 2026

• The Company continuesto expect worldwide net revenue for the full year 2026 to be in the rangeof €36 million to €40 million.
• The Company continuesto expect gross margin for the full year 2026 to be in the range of 60% to62%.
• The Company nowexpects total operating expenses for the full year 2026 to be in the rangeof €99 million to €102 million. This increase of approximately €1 millionis due to the one-time share-based compensation expense of approximately€0.9 million associated with the repricing of employee equity incentivearrangements recorded in the second quarter.
• The Company continuesto expect non-GAAP cash operating expenses for the full year 2026 to be inthe range of €88 million to €90 million. Non-GAAP cash operating expensesreflect expected total operating expenses less non-cash expenses such asdepreciation, amortization, and share-based compensation.

Conference call and webcast presentation

Company management will host a conference call to discuss financial results on Wednesday, August 5, 2026, 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 Earnings Call Webcast. For those not planning to ask a question to management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah's Q2 2026 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.

Non-GAAP financial measures

This press release includes non-GAAP (Generally Accepted Accounting Principles) financial measures, including non-GAAP cash operating expenses. Non-GAAP cash operating expenses are calculated by excluding from GAAP certain operating expense items, including depreciation, amortization, capitalized research and development expenses, impairment losses on intangible assets, and share-based compensation. These non-GAAP financial measures are presented because the Company believes they are useful indicators of its operating performance. Management uses these non-GAAP financial measures as measures of the Company's operating performance and for planning purposes, including the preparation of the Company's annual operating budget and financial projections. The Company believes these measures are useful to investors as supplemental information because they are frequently used by analysts, investors and other interested parties to evaluate companies in its industry. These non-GAAP financial measures should not be considered alternatives to, or superior to, any other performance measure derived in accordance with GAAP. They should not be construed to imply that the Company's future results will be unaffected by unusual or non-recurring items. The Company's definitions of non-GAAP cash operating expenses are not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat 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 in 2024 and receipt of approval from the FDA in August 2025.

For more information, please visit http://www.nyxoah.com.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

Rémi Renard
Head of Investor Relations & Corporate Communication
[email protected]

Attachment

ENGLISH_Nyxoah_Q2 2026 Earnings PR_FINAL

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