SomnoMed Limited (SOM) Earnings Call Transcript

Good morning, everybody, and welcome to the SomnoMed results presentation for FY '25. With us this morning, we have Co-CEOs, Amrita Blickstead and Karen Borg; and CFO, Ye-Fei Guo, who will take us through the presentation that was lodged with the ASX earlier today. Just a bit of housekeeping before we kick off. This webinar is being recorded, including the Q&A, and we will post this on SomnoMed's website following the completion of the webinar. We invite research analysts to ask questions at the end of the presentation. [Operator Instructions] And with that, I will now hand over to Amrita.

Good morning, and welcome to SomnoMed's First Half 2025 Earnings Call. My name is Amrita Blickstead, Co-CEO of SomnoMed, and I'm joined by Karen Borg, my Co-CEO; and Ye-Fei Guo, our CFO. We are excited to present the highlights of our financial and operational performance for the 2025 financial year. Let's begin with the financial highlights. FY '25 represented a transformational and exceptional year for SomnoMed. With strong performance across all key metrics, revenue reached $111.5 million, representing a 22% year-on-year growth and exceeding our guidance of $105 million. EBITDA delivered a remarkable turnaround to $9.2 million, up significantly from $0.6 million in FY '24 and slightly ahead of the upper end of our guidance range. We maintained capital discipline with CapEx of $4 million compared to $5.3 million in the prior year and within our guidance of $3 million to $4 million. Our balance sheet remained robust with cash of $17.3 million at 30 June 2025, up 17% -- up 7% year-on-year. Most importantly, we achieved a fundamental shift in cash generation that demonstrates the underlying strength and scalability of our core business. Even while continuing to invest in manufacturing and Rest Assure, our operating cash flow turned positive at $4.8 million compared to negative $8.9 million in FY '24. This effective execution, combined with disciplined capital allocation, delivered positive free cash flow of $0.8 million versus negative $14.3 million in the prior year. Overall, FY '25 was a standout year, demonstrating the resilience and growth capability of our business model and proving our ability to generate cash even as we continue to invest in the future. Growth this year was particularly strong, reflecting both the operational turnaround and the benefits of backlog clearance alongside robust demand. Our results demonstrate the strength of our core business and scalability of our model. FY '25 was about transformation and turnaround. FY '26 will be about embedding those gains, while making disciplined investments to drive our next phase of growth. This positions us to build on this year's foundation and deliver sustainable value creation over the long-term. Our goal for FY '25 was to focus on execution and delivery to demonstrate the full potential of our business across all markets when we execute effectively. We stabilized our foundations around 4 key pillars and achieved a number of key goals. These included people and culture. We set out to build a high-performing team focused on efficiency and value creation. We hired key new leadership capabilities across R&D, operations, human resources, finance, quality and regulatory from top-tier companies such as Johnson & Johnson, British American Tobacco, Alcon and Sunrise. We also refreshed our Board with Andrew Price as an additional Non-Executive Director, bringing 25 years of experience from ResMed, including as Chief Supply Chain Officer. In regards to our financials, we committed to and delivered earnings growth and positive operating cash flow. This was supported by disciplined cost management, resulting in us also delivering positive free cash flow. Operationally, we focused on manufacturing capacity growth, and we delivered on that. We increased capacity by over 50% from the peak of manufacturing constraints in FY '24. And for our customers, we materially improved turnaround times and reduced backlog to negligible levels, which has enhanced customer service levels. These achievements demonstrate the transformation of our operations. Importantly, we have built a strong foundation for sustainable growth, showing that we can scale effectively, while maintaining cost discipline. I will now hand over to Ye-Fei to go through the financials.

Thank you, Amrita, and good morning, everyone. It is my pleasure to now take you through our FY '25 financial results in more detail. On revenue, FY '25 was a milestone year. We surpassed $100 million in revenue for the first time, a significant achievement for the company. Revenue was up 22% compared to FY '24, supported by rising category awareness and our success in reducing backlog constraints. Following the exceptional year we just had, we expect growth to return to more sustainable levels in FY '26. From an earnings perspective, we delivered a step change in profitability. The EBITDA slightly surpassed the upper end of guidance at $9.2 million. And finally, on cash flow, we generated both positive operating cash flow and positive free cash flow. This demonstrates our core business's ability to scale efficiently, while maintaining strategic investments. Regional performance reflected what was an exceptional year with double-digit growth across Europe, North America and APAC. Europe achieved 17% growth in revenue for the full year. We benefited from strong performance in France and Sweden, clearing our backlog in the first half and secured important tender wins. Together, these factors resulted in a significant uplift across the European region. North America was our standout performer with a strong 31% growth. The region delivered outstanding results supported by faster turnaround times, tighter cost management and successful engagement with both new and existing customers. We also benefited from broader industry tailwinds, including growing GLP-1 usage and increased awareness from new market entrants actively promoting the category. The typical seasonal uplift in patient activity around year-end insurance windows contributed to a record performance in Q2, particularly in December. Finally, APAC delivered 11% growth, with Australia continuing to represent more than 80% of the region. Demand was strong throughout the year, although we did see some moderation in Q4 following a price increase. Brand loyalty and medical referrals remain robust, providing confidence in the sustainability of the region's performance. This next slide presents a summarized view of our FY '25 statement of profit or loss. As already highlighted, revenue reached $111.5 million, an increase of $19.8 million compared to last year. Earnings also showed a dramatic step-up with EBITDA rising to $9.2 million from $0.6 million in the prior year. These results reflect the strong demand environment as well as the operational improvements we've implemented to support the growth, whilst also keeping costs tightly managed and ensuring our investments in operations and personnel stayed on budget. These factors drove significant margin expansion from 1% last year to 8% in FY '25. On financing, we meaningfully reduced interest expenses after repaying our primary debt facility in Q4 FY '24. This repayment has lowered ongoing costs, strengthened the balance sheet and improved the quality of earnings going forward. Looking at gross margin, our MAS business, which stands for Mandibular Advancement Splint, our oral appliance devices, delivered a gross margin of 70%, slightly up on FY '24. At the group level, gross margin was flat at 60%, demonstrating stable unit economics as we scale the business. In the next slide, we have provided investors with additional information on our gross margin breakdown. Our gross margin tells a compelling story about the strength and strategic value of our business model across 2 key pillars. Our MAS business, our core oral appliance devices, including those sold through our managed care sales channels, delivered a 70% gross margin, providing -- proving its position as the profit engine of our operations. What makes our model particularly powerful is our managed care channel. While managed care services carry lower gross margins, reflecting their billing and administrative nature, this represents a strategic margin investment that creates a powerful flywheel effect, driving more device sales and customer retention. These multiyear contracted partnerships provide revenue visibility, while spreading our fixed costs across a larger base, creating operational leverage throughout the group. The result is our 60% blended margin, which combines device sales at 70% with managed care administrative services. This demonstrates the value of our model. We invest the margin to unlock additional high-margin volume -- device volumes and operational efficiencies. This combination strengthens our overall financial performance and supports the sustainability of our growth model. Turning to the balance sheet. We've strengthened our financial position over the year. Cash improved on the back of positive operating cash flow of $4.8 million and free cash flow of $0.8 million, a significant turnaround of plus $13.7 million and plus $15.1 million, respectively, compared to FY '24. Our primary debt facility was fully repaid in Q4 of FY '24 and the residual borrowings on the balance sheet are now immaterial. Lease liabilities increased modestly, reflecting the renewal of existing leases as well as investments in expanding our manufacturing footprint. Overall, the balance sheet is stronger, leaner and better positioned to support continued growth. On cash flow, as we've highlighted earlier, FY '25 was a turnaround year with both operating and free cash flow positive. We continue to invest in our future through increased spend on R&D and expansion of our manufacturing infrastructure. These investments are important for sustained long-term growth and innovation. In Q4 prior year, we fully repaid our primary debt facility. And because of that action, FY '25 was the first year we operated without the burden of that debt, which has significantly reduced our interest expense and strengthened the quality of our earnings. I will now hand over to Karen to go through the operations highlights and outlook.

Thanks, Ye-Fei. I'll go through the operations slides first. One of the most significant achievements in the year was the FDA clearance of Rest Assure in October 2024, endorsing the product's system and compliance delivery. Rest Assure is the first oral appliance of its kind with in-built compliance monitoring supported by its own system. This marks a step change for the category and positions SomnoMed as the only company globally with FDA clearance for such technology. We also executed a successful manufacturing overhaul, leading to significantly improved turnaround times and eliminating the backlog. This means we are in a much stronger position operationally with further capacity expansion of at least 25% already underway for FY '26. Another highlight was reaching the milestone of treating our 1 millionth patient in the second half. No other oral appliance company has achieved this, and it reinforces our position as the global leader in this field. We have been successful with several global tenders and contract renewals, particularly across the Nordic region, the NHS in the U.K. and the largest managed care provider in the United States, expanding patient access to SomnoMed products and therapies. And finally, as Amrita mentioned in the opening slides, FY '25 saw the arrival of a new management team and the renewal of our Board. Together, these operational achievements set a strong foundation for FY '26 and beyond, giving us the scale, capability and leadership to continue delivering growth. Now let's look at Rest Assure. During FY '25, we published the first clinical validation paper confirming that Rest Assure enables monitoring of treatment and compliance data. This delivers a global first by providing real-time AHI efficacy data for patients, clinicians and reimbursers, allowing for alignment to the prevailing sleep apnea therapy of CPAP. This represents an important milestone in building clinical confidence and awareness of the technology. Looking ahead, our focus remains on moving from compliance monitoring into efficacy delivery. To support this, the company continues preparations for a U.S.-based clinical test that will underpin a 510(k) submission to the FDA. Work is now progressing on finalizing trial site selection, and we plan to commence and complete the clinical trial during FY '26. I'll now go through the strategy and outlook for FY '26. Our vision is for a world where oral appliance therapy becomes the standard for treating sleep apnea. Our mission as the global leader in this field is to set the standard for outcomes, innovation and patient experience, driving the transformation of sleep medicine worldwide. There is a significant opportunity for SomnoMed with more than 900 million people globally suffering from obstructive sleep apnea, yet the vast majority remain untreated or undertreated. As the market leader in oral appliances, SomnoMed is uniquely positioned to capture this unmet need. We're also seeing strong market tailwinds. Consumer awareness of sleep apnea is growing. The uptake of GLP-1 drugs is both increasing awareness of the condition and fueling demand for alternatives to CPAP. Together, these trends are accelerating demand for oral appliance therapy and as the market leader, SomnoMed is well placed to lead that shift. And finally, we're advancing the development of Rest Assure, the first technology-enabled oral appliance. This innovation will enhance clinical outcomes and build confidence in adoption among physicians, payers and patients, while also serving as a key growth driver that strengthens our market leadership and positions SomnoMed to capture greater long-term value. FY '25 was a year of transformation and turnaround, restoring operational performance, strengthening our leadership team and culture and returning to earnings growth and positive operating cash flow. With that foundation in place, FY '26 will be focused on embedding the progress made in FY '25 alongside disciplined investment that positions us for the next phase of growth. Financially, our priority is to continue delivering sustainable revenue and margin growth, building on the progress we've made in FY '25. Operationally, we're expanding our existing manufacturing footprint to support increased demand and ensure turnaround times remain strong. On the innovation front, our focus is advancing Rest Assure into its next phase, preparing for the U.S. clinical trial and FDA submission for efficacy monitoring, which we expect to commence and complete during the year. And now, turning to our guidance for FY '26. We expect revenue in the range of $119 million to $126 million, reflecting sustainable growth across our regions. EBITDA is guided at $10 million to $12 million and CapEx is guided in the range of $6 million to $8 million, reflecting spends across Rest Assure, manufacturing site expansion and other, including maintenance CapEx. The CapEx increase reflects planned investment in our manufacturing footprint to support future capacity as well as continued investment in R&D, particularly around Rest Assure. These investments are critical to sustaining our growth, improving efficiency and ensuring we are well positioned for the opportunities ahead. With that, I would like to thank you all for your attention, and we will now open the call for your questions. Thank you.

I think I was just on mute. I will repeat what I -- Karen, if you want to respond to that question? Sorry about that.

No problem. All right. Thank you, Dennis, for that question. There are a few factors that influenced our range. First of all, we are obviously very conscious of the swings that we are seeing in the United States. The market has been going through some shifts, and we are conscious about navigating those particularly in the early stage of the year. We are also -- we still see obviously that we have a strong outlook for how we will be growing the business. Nevertheless, we believe that a range is the best way to represent at this stage how we see the growth of the business for the year ahead.