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.
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 for
the second quarter of 2026 was €5.2 million, 22% sequential growth over
U.S. net revenue for the first quarter of 2026
- Global net revenue for the second quarter of 2026 was €7.7
million, 21% sequential growth over global net revenue for the first
quarter of 2026
- Global net revenue for the first half of 2026 was €14.0 million,
as compared to €2.4 million for the first half of 2025
- Secured $110 million in aggregate financing during the second
quarter of 2026. As of June 30, 2026, cash and cash equivalents and
financial assets totaled €97.8 million
- Leading U.S.
commercial indicators
- 40 active sales reps, focused on covering 200 high volume HGNS
accounts
- 55 new surgeons trained in Q2, bringing the total to 262 surgeons
trained
- 89 new accounts activated in Q2, bringing the total to 180 active
high-volume accounts
- 427 patients actively under prior authorization entering Q3 2026,
a 77% increase over the number of patients actively under prior
authorization entering Q2 2026
- U.S. reimbursement
landscape
- 100% approval rate on reviewed prior authorization submissions
- Clarity for Genio, with Medicare C-code 8011 and existing
commercial payers CPT codes
- CMS proposed reimbursement increases in both hospital outpatient
and ambulatory surgical centers of 12% and 15% respectively for 2027
- Upcoming CPT editorial panel meetings to involve AAO-HNS and
industry discussing comprehensive HGNS coding
- Hosted investor day on
July 8 – Link to the replay
- Featured independent perspectives from ENT and Sleep physicians,
who highlighted Genio's differentiated clinical profile and their intent
to expand utilization across their patient populations
- Reimbursement expert group 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 the
second quarter of 2026 was €7.7 million, compared to €1.3 million in the
second quarter of 2025. Net revenue in the first half of 2026 was €14.0
million, as compared to €2.4 million for the first half of 2025. The
increases in net revenue were primarily driven by the continued expansion
of U.S. commercialization activities following FDA approval in August
2025, 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 of
2025, 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 was
primarily driven by an increase in revenue. The decrease in gross margin
was primarily due to a higher mix of U.S. revenue.
- Cost of goods sold in
the first half of 2026 was €5.8 million, as compared to €0.9 million for
the first half of 2025, resulting in gross profit of €8.2 million and a
gross 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. The
decrease in gross margin was primarily due to production yield issues in
the first quarter of 2026 and higher mix of U.S. revenue.
Research and Development
- For the second quarter
of 2026, research and development expenses were €9.5 million, versus €10.1
million for the second quarter of 2025. For the first half of 2026,
research and development expenses were €18.3 million, versus €19.0 million
for the first half of 2025. The decreases in research and development
expenses were primarily due to a decrease in product development expenses.
Selling, General and Administrative
- For the second quarter
of 2026, selling, general and administrative expenses were €15.6 million,
versus €10.7 million for the second quarter of 2025. For the first half of
2026, 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 continued
build-out of the Company’s U.S. commercial organization, including sales,
marketing, and market access functions.
Operating Loss
- Total operating loss
for the second quarter of 2026 was €20.6 million, versus €19.9 million in
the second quarter of 2025. Total operating loss for the first half of
2026 was €41.1 million, versus €40.5 million in the first half of 2025.
The increases in operating loss reflect increased net revenue offset by
increased 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 continues
to expect worldwide net revenue for the full year 2026 to be in the range
of €36 million to €40 million.
- The Company continues
to expect gross margin for the full year 2026 to be in the range of 60% to
62%.
- The Company now
expects total operating expenses for the full year 2026 to be in the range
of €99 million to €102 million. This increase of approximately €1 million
is due to the one-time share-based compensation expense of approximately
€0.9 million associated with the repricing of employee equity incentive
arrangements recorded in the second quarter.
- The Company continues
to expect non-GAAP cash operating expenses for the full year 2026 to be in
the range of €88 million to €90 million. Non-GAAP cash operating expenses
reflect expected total operating expenses less non-cash expenses such as
depreciation, 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.
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.
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