Sequential Worldwide Revenue Growth
Net revenue of ~€6.4M in Q1 2026 (€6.7M gross before €0.3M deferrals), representing 13% sequential growth vs Q4 2025.
Strong U.S. Commercial Momentum
U.S. net revenue of €4.3M in Q1 2026, ~25% sequential growth vs prior quarter; management delivered on commitment to ~25% sequential U.S. growth and expects Q2 U.S. growth of ~25%–30% sequentially with further acceleration in H2.
Commercial Launch KPIs and Field Expansion
Q1 additions included 62 new surgeons trained (total 207 trained), 34 new accounts activated (total 91 active of >125 targeted), 15 new sales reps (total 40 fully operational), and capacity to cover ~200 high-volume U.S. accounts entering Q2.
Robust Prior-Authorization Funnel
241 new patients submitted under prior authorization and pending at quarter end (versus ~100 at end-Q4), with reported 100% approval rate on reviewed commercial prior authorizations.
Reimbursement Clarity and 100% Approval in WISER
CMS issued AGNS-specific facility C-codes (facility fee parity vs existing codes); physician CPT payment remained at ~$732. WISER pilot (AI-supported prior authorization) delivered 100% approval rate for submitted Medicare patients. Management characterized reimbursement as de-risked for 2026–2027.
International Performance and Market Entries
International revenue was flat vs prior year quarter but overcame typical seasonality vs Q4 2025 driven by deeper penetration in Germany, continued Middle East adoption, and successful UK and Netherlands entries.
Clear Product Roadmap to Improve Margins
Planned Genio 2.2 upgrade (new sleep wearable, upgraded software, low-cost disposable patch + activation chip) targeted for early 2027 to materially improve patient experience and gross margin (step to low-70s expected in 2027, long-term >80%).
Full-Year Guidance
Company guides worldwide net revenue €36M–€40M for FY2026, gross margin 60%–62%, total operating expenses €97M–€99M, and non-GAAP cash operating expenses €88M–€90M; expects U.S. sequential growth and back-half acceleration (Q3/Q4 growth rates guided to rise into 40%–50% range sequentially).
Cash and Financing Visibility
Cash and cash equivalents plus financial assets of €25.9M at March 31, 2026, and expected draw of ~€13.8M from second tranche of EIB loan in 2026 to support runway.
Market Research Supporting Adoption
Survey of >100 U.S. HGNS implanters: 88% of ENTs value multiple AGNS options; all Genio-trained surgeons plan to adopt Genio. Top reasons cited: bilateral stimulation, no implanted battery, and alternative therapy option; 84% collaborate with sleep medicine.