Nyxoah (NASDAQ:NYXH) reported second-quarter worldwide net revenue of €7.7 million, up 21% sequentially from the first quarter, as its U.S. commercial launch continued to expand. U.S. net revenue reached €5.2 million, a 22% increase from the prior quarter, while international revenue rose 19% sequentially to €2.5 million.
For the first six months of 2026, worldwide revenue totaled €14 million, compared with €2.4 million in the first half of 2025. Chief Financial Officer John Landry said the nearly six-fold increase was driven primarily by the company’s U.S. commercial launch.
U.S. Account Activation and Patient Pipeline Expand
Nyxoah entered the third quarter with 427 patients actively under prior authorization, up 77% from 241 patients entering the second quarter. Taelman said the company has maintained a 100% prior-authorization approval rate for commercial payers, Medicare Advantage and Medicare patients submitted through the WISeR program.
“Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio,” Taelman said, referring to the company’s Genio system for obstructive sleep apnea.
The company began the quarter with 40 fully trained sales representatives covering 200 of the 400 highest-volume U.S. hypoglossal nerve stimulation accounts. Nyxoah plans to add 15 representatives, expanding to 55 territories. Taelman said the company expects to have the new hires onboarded by the end of the third quarter, trained in early fourth quarter and fully deployed entering 2027.
Nyxoah expects its current salesforce capacity to support approximately 225 to 230 active high-volume accounts in the second half of 2026. Rather than pursuing broad account expansion, Taelman said the company’s strategy remains focused on reaching the top 400 high-volume U.S. implanting accounts.
In response to an analyst question, Taelman said the company’s active accounts averaged approximately 15% market share, while its more established accounts were above that level. Its top account had surpassed 44% market share, he said.
Reimbursement Developments
Nyxoah said reimbursement clarity for Genio includes dedicated Medicare C-code C8011, while commercial coverage remains stable through existing CPT codes. Commercial payers represented approximately 85% of the business during the quarter, according to Taelman.
The Centers for Medicare & Medicaid Services has proposed increases to 2027 reimbursement for the procedure. Under the proposal, hospital outpatient reimbursement for Genio under C-code C8011 would rise 12% to $35,414 from $31,526. Reimbursement for ambulatory surgical centers would increase 15% to $31,722 from $27,563.
Nyxoah did not submit an application for a dedicated Category 1 CPT code at the upcoming September CPT Editorial Panel meeting. Instead, the company said it supports the American Academy of Otolaryngology-Head and Neck Surgery’s effort toward a comprehensive coding approach for hypoglossal nerve stimulation. Taelman said a comprehensive coding outcome, if pursued, would first become effective on Jan. 1, 2029.
Financial Results and Outlook
Second-quarter gross margin was 60%, up from 57% in the first quarter. Research and development expense declined to €9.5 million from €10.1 million a year earlier, while selling, general and administrative expense rose to €15.6 million from €10.7 million, largely reflecting the expansion of the U.S. commercial organization.
Operating loss was €20.6 million, compared with €19.9 million in the prior-year quarter. Operating expenses included an approximately €900,000 one-time, non-cash share-based compensation charge related to the repricing of employee equity incentive awards.
Non-GAAP cash operating expenses were €21.8 million, essentially unchanged from €21.7 million in the first quarter, but up from €19.8 million in the second quarter of 2025 due to investment in the U.S. commercial organization.
During the quarter, Nyxoah secured $110 million in financing, consisting of a $95 million equity raise and a $15 million drawdown under the second tranche of its European Investment Bank loan. Cash, cash equivalents and financial assets totaled about €97.8 million as of June 30.
- Full-year 2026 worldwide revenue guidance was maintained at €36 million to €40 million.
- Gross-margin guidance remained 60% to 62%.
- Total operating-expense guidance increased by €1 million to €99 million to €102 million because of the one-time share-based compensation charge.
- Non-GAAP cash operating-expense guidance remained €88 million to €90 million.
Landry said the revenue outlook implies €22 million to €26 million of revenue in the second half of 2026. The company expects U.S. revenue to rise sequentially in both the third and fourth quarters, while international revenue is expected to remain consistent with first-half levels.
Study and International Updates
Taelman said Nyxoah is finalizing 12-month data from its ACCESS study and plans to submit a PMA supplement by the end of the third quarter or, at the latest, early in the fourth quarter. The company expects to present CCC data during the International Sleep Surgery Society Congress after receiving acceptance for a podium presentation. Nyxoah expects an FDA decision on the supplement around the end of the first quarter of 2027, or the beginning of the second quarter at the latest.
International revenue nearly doubled in the first half of 2026 compared with the first half of 2025, according to Taelman. In Germany, Nyxoah said it has achieved stable overall market share of up to 25%, with share above 50% at its top high-volume accounts. The company also cited market share above 50% in its initial U.K. accounts, continued expansion in the Middle East, where it is the sole AGNS provider, and a recent entry into the Netherlands.
Nyxoah said it intends to maintain financial discipline internationally while pursuing growth and break-even operations in those markets, a milestone it said it has already achieved in Germany.
About Nyxoah (NASDAQ:NYXH)
Nyxoah SA, headquartered in Mont-Saint-Guibert, Belgium, is a medical technology company focused on neuromodulation therapies for sleep‐disordered breathing. Established in 2018, the company’s primary offering is the Genio® system, a minimally invasive bilateral hypoglossal nerve stimulator designed to treat moderate to severe obstructive sleep apnea (OSA). By electrically stimulating the genioglossus muscle, the device helps maintain airway patency during sleep, reducing apnea events and improving overall sleep quality.
The Genio system comprises a small, implantable stimulator positioned submentally and an external activation unit worn by the patient.
