How SomnoMed Hit $111.5M Revenue and Plans FDA-Backed Growth in FY26

• FY25 revenue up 21.6% to $111.5 million
• Positive EBITDA of $9.2 million and free cash flow of $0.8 million
• FDA clearance obtained for Rest Assure® compliance monitoring
• Over one million patients treated worldwide milestone achieved
• FY26 guidance – revenue $119–126 million, EBITDA $10–12 million

Record Revenue and Operational Turnaround

SomnoMed Limited has delivered an exceptional financial year, reporting a 21.6% increase in revenue to $111.5 million for FY25, surpassing the $100 million annual revenue threshold for the first time. This growth was accompanied by a return to positive EBITDA of $9.2 million and free cash flow of $0.8 million, signaling a significant operational turnaround from prior losses.

The company attributes this performance to a sustained operational improvement program initiated in FY24, which enhanced production capacity through new equipment investments, process optimizations, and workforce expansion. These efforts effectively eliminated order backlogs and improved turnaround times, enabling SomnoMed to meet growing global demand for its oral appliance therapies.

Innovation and Regulatory Milestones

Innovation remains central to SomnoMed’s strategy. In October 2024, the company secured FDA clearance for Rest Assure®, the first oral appliance featuring built-in compliance monitoring. This breakthrough technology provides clinicians with real-time patient usage data, enhancing treatment management for obstructive sleep apnea (OSA). SomnoMed plans to initiate a US-based clinical trial in FY26 to support a subsequent FDA 510(k) submission for efficacy monitoring, potentially expanding the device’s market reach and clinical validation.

Reaching over one million patients treated globally is a landmark achievement for SomnoMed, underscoring its leadership in oral appliance therapy across more than 20 countries. This milestone reflects strong clinician and patient trust in the company’s products and reinforces its competitive position in the sleep disorder treatment market.

Regional Growth and Market Dynamics

Europe remains SomnoMed’s largest market, generating $61.4 million in revenue, a 17% increase driven by robust demand in France, Germany, Sweden, and new national tender wins in the Nordics and UK. Western European reimbursement frameworks continue to support product adoption.

North America experienced exceptional growth with revenue up 31% to $43 million, benefiting from improved operational efficiencies, disciplined cost control, and heightened public awareness of sleep apnea. The company also noted favorable market tailwinds from increased GLP-1 usage and advertising by new market entrants.

Asia Pacific revenue grew 11% to $7 million, predominantly from Australia, despite some demand moderation following price adjustments. Brand loyalty and medical referral networks remain strong in the region.

Strategic Outlook and Risks

Looking ahead, SomnoMed aims to sustain revenue and margin growth by expanding manufacturing capacity by at least 25% in FY26 to meet rising demand. Continued investment in Rest Assure® development and regulatory approvals is expected to drive future innovation-led growth.

The company provided FY26 guidance projecting revenue between $119 million and $126 million, EBITDA of $10 million to $12 million, and capital expenditure of $6 million to $8 million. These targets reflect confidence in operational scalability and market opportunities.

However, risks remain, including potential manufacturing disruptions, regulatory approval uncertainties, competitive pressures, and currency fluctuations. The company is actively managing these risks through operational controls, regulatory engagement, and financial risk management.

Governance and Leadership

SomnoMed’s Board saw changes with the appointment of two new Non-Executive Directors, Benjamin Gisz and Andrew Price, enhancing governance expertise. The executive leadership team, led by Co-CEOs Karen Borg and Amrita Blickstead and CFO Ye-Fei Guo, continues to drive the company’s strategic agenda.

With a strengthened operational foundation, regulatory milestones, and a clear growth trajectory, SomnoMed is well positioned to deliver long-term shareholder value while advancing treatment solutions for sleep-related disorders worldwide.

Bottom Line?

SomnoMed’s FY25 momentum and FDA-backed innovation set the stage for a pivotal FY26, but execution risks remain under watch.

Questions in the middle?

• Will the upcoming US clinical trial validate Rest Assure® efficacy to secure FDA 510(k) clearance?
• How effectively can SomnoMed scale manufacturing to meet accelerating global demand?
• What impact will evolving reimbursement policies and tariff changes have on future margins?