Somnomed Ltd Ord

Well, good morning everyone and welcome to Somnamed's results presentation for the FY26 full year. My name is Jane Lowe and I will be your moderator for today's session. With me today are Karen Borg, who is CEO, and Yifei Guo, who is CFO of Somnamed. They will take us through the results presentation which was lodged with the ASX this morning. A bit of housekeeping before we kick off. Today's webinar is being recorded, including the Q&A, and we will post this on Somnamed's website following the completion of the webinar. We will invite you to ask questions at the end of the presentation, and you can do so either via the online Q&A function or by using the raise your hand function in the Zoom ribbon at the bottom of your screen. If you'd like to ask a question that way, we will take you off mute so that you can use audio for that. For now, though, I'll pass over to Karen to kick off the presentation. Thank you, Karen.

Great. Thanks, Jane. Before we begin, I'd like to draw your attention to the disclaimer on the screen. Today's presentation contains forward-looking statements which involve risks and uncertainties. Actual results may differ from those anticipated and investors should not place undue reliance on these statements. So, now let's have a look at the company highlights. Looking at these dynamics around the Somnamed Business and then we'll look at our financial and operating highlights. Now Somnamed's vision is a world where oral appliance therapy is the standard of care for obstructive sleep apnea treatment or OSA. Our mission is to set the standard for outcomes, innovation and patient experience while helping drive the transformation of sleep medicine worldwide. The market opportunity remains vast. Approximately 1 billion people globally suffer from obstructive sleep apnea, which presents a significant opportunity for market penetration with the appropriate therapy. At the same time, increasing consumer awareness, growth in GLP-1 therapies and rising demand for CPAP alternatives continue to expand the oral appliance therapy market. Importantly, we also operate within a large potential customer market of more than 700,000 dentures across our key regions. While we ultimately service the patient, our customer is the dentist, so every extra dentist we build a relationship with has the potential to support our market penetration. As the global market leader in oral appliances for OSA, we believe Somnamed is well positioned to drive growth. Looking at our financial highlights, FY26 delivered a solid financial result and demonstrated our continued disciplined approach to cost and capital management EBITDA increased 19% to 10.9 million with EBITDA margin improving to 9.6% Revenue increased 3% to 114.5 million with North America leading the results This is in line with preliminary unaudited results provided in the ASX announcement on the 27th of July this year We invested $5.7 million in capital expenditure with more than 50% of capex spend driven by growth initiatives and capacity investment. And we generated positive operating cash flow before leases of $8.3 million and after leases of $5.2 million while maintaining a solid 30 June closing cash position of $17.2 million and $16.8 of net cash. Overall, the business has established a strong foundation from which to advance and deliver on its strategic priorities. Looking at the operational highlights, FY26 was a year of focused execution, strengthening the foundation of our strategic priorities. During FY26 and into FY27, our leadership team transitioned to a single CEO structure which is a privilege to step into. Greg Knight was appointed as Chief Operating Officer and Nathan Minich joining as Chief Marketing Officer. In late July, Amrita Blixted announced her decision to step down as Co-CEO. The Board and I thank Amrita for her leadership and service to Somnamed over the last six years, initially as Non-Executive Director and later as Co-CEO. It was a real pleasure working with Amrita as Co-CEO. The partnership we built was instrumental in the company's turnaround and in shaping a strong platform for Somnamed's future. I sincerely wish her well and all that lies ahead. We delivered a number of production improvements. Manufacturing capacity expanded by over 20% in FY26 and by over 40% across two years. Manufacturing production times improved by more than 50% across two years. We advanced the controlled market release of Virtus, our purpose-built solution for OSA patients with coexisting sleep bruxism. Virtus uniquely addresses their dental needs and is engineered to withstand the intense clenching and grinding forces that typically damage standard oral appliance therapy appliances, a meaningful opportunity given that more than half of all OSA patients experience bruxism. For dentists and patients, versus filled a critical gap in care by providing a durable solution where traditional oat appliances often fail. I will now hand over to you, Faye, to take you through the financial results in more detail.

Thank you, Karen. FY26 represented a year of solid performance for Somnamed. The first half revenue was up 13% or 8% in constant currency with this outcome driven by growth in both North America and Europe. In a tale of two halves, the second half revenue was down by 7%, or less than 1% in constant currency, impacted by a change in European market dynamics and the significant appreciation of the Australian dollar against our key currencies. EBITDA increased 19% to $10.9 million, and the EBITDA margin improved from 8.2% to 9.6%, reflecting higher revenue, improved gross margin and disciplined operating cost management. Operating cash flow after lease payments increased 8% to $5.2 million compared with $4.8 million in the prior year owing to both revenue growth and cost management. Turning now to regional performance, Europe, our largest and most mature region, contributed $61.9 million in revenue for the full year, up a reported 1%, but down 1% on a constant currency basis. While first half growth was strong, second half sales were impacted by structural shifts in key European markets, slowing the pace at which patients were able to access oral appliance therapies. These included changes to clinical eligibility and public payer reimbursement criteria, plus a shift in patient referral pathways. In response to these challenges, the company has restructured its European commercial, administrative and operational leadership to strengthen customer focus and is reviewing its commercial and product strategies to respond to the changing environment. North America is our primary growth region. and continued to perform strongly, contributing $45.8 million in FY26 revenue, up 6% on a reported basis and 11% on a constant currency basis. APAC, our first commercial region, contributed $6.8 million of revenue for FY26, down 3% on a reported basis and 2% on a constant currency basis. Cost of living pressures impacted patient demand across these largely non-reimbursed markets. While regional dynamics varied throughout FY26, all markets remained strategically important and continued to provide attractive long-term opportunities. Turning to the P&L statement with a few notable call-outs, operating expenses were tightly managed with year-on-year total op-ex growth of less than 3%. The other line within the EBITDA section increased primarily due to higher share-based payment expenses which were non-cash in nature and margins improved across all key metrics despite European market dynamics and the foreign exchange headwinds. Turning to the balance sheet, cash and cash equivalents ended the year at $17.2 million broadly unchanged from the prior year, with net cash increasing from $16.5 million to $16.8 million. Trade receivables reduced materially during the period, reflecting improved collections performance and working capital management. The balance sheet remains strong and provides flexibility to support future investments and growth. The business delivered operating cash flow before lease payments of $8.3 million and after lease payments of $5.2 million. One-off expenses were slightly higher at $0.9 million up from $0.5 million in the prior year as a result of cashed settlement of prior year and current year one-off cost provisions. Capital expenditure totalled $5.7 million consisting primarily of investment in manufacturing infrastructure and research and development activities. free cash flow was negative $0.6 million reflecting these planned growth investments. The sale of 2.86 million shares through the Employee Share Trust delivered net proceeds of $2 million during the year to the business. An important note here on foreign exchange adjustments which reflects the appreciation of the Australian dollar against key currencies primarily the USD and the Euro in FY26 and in particular in half too. Approximately 95% of the company's revenues are derived in non-AUD currencies. Overall, we continue to balance growth investments with disciplined cash management. I will now hand back to Karen to take you through our strategy and outlook.

Thank you Faye. Now let's have a look at the strategy and outlook section. The sleep apnea market continues to evolve. Up to 50% of CPAP patients discontinue therapy, creating a significant opportunity for oral appliance alternatives. At the same time, we're seeing growth in lower-cost oat products and clinical differentiation challenges, GLP-1s and other emerging pharmaceutical instruments driving patient growth. Newer, high-cost invasive neurostimulation procedures and directed consumer models that remain emerging but nascent. Now while these trends are reshaping the marketplace, they also contribute to greater awareness of sleep health and reinforce the attractiveness of Oral Pines Therapy within the broader treatment pathway. Our strategy is focused on moving from the financial and operational turnaround delivered through FY26 and into the next phase of growth and profitability. From FY24 to FY26, we established the foundation for that next phase. Financially, we cleared the company's legacy of higher costing debt and delivered positive operating cash flow. We made deliberate investments in talent to support execution. And operationally, we increased manufacturing capacity and improved turnaround times for our customers and patients. So now looking ahead to FY30, our objectives include returning to double-digit revenue growth, progressively expanding EBITDA margins through scale and efficiency gains and remaining focused on organic growth while considering small-scale acquisition opportunities where appropriate. Looking at our product portfolio, it's been clearly designed to reflect the different reimbursement and market requirements that exist globally. Flix and Fusion are established platforms reimbursed across key European markets. In North America, Herbst Advanced Elite is our Medicare reimbursed platform. And now Virtus represents our next generation of oat innovation with the controlled market release underway. Each of these products allows Somnamed to effectively address differing regional reimbursement and market requirements to ensure that our therapies reach as many patients and customers as possible. Our commercial priorities are focused on the most tangible growth opportunities in each region. In North America, our major growth-driving region, we are focused on product innovation, targeting the most accessible CMS reimbursement codes, and on developing customer-specific engagement strategies. As noted earlier, Europe, our most mature region, delivered a strong first half before encountering reimbursement and referral park pressures in the second half. We have responded by reshaping commercial and operational leadership, sharpening product strategies and advancing a key reimbursement application. Within Asia Pacific, our first commercial region, we are continuing engagement with a GLP-1 manufacturer and investigating product line extensions suited to the non-reimbursed environment. And looking beyond, Our longer-term growth vision is underpinned by three key themes. Firstly, we're focused on capturing the growing patient pool, GLP weight loss drugs, connective care, home diagnostics and CPAP failures. These are all expanding the number of patients who may benefit from oral appliance therapy. This shift is creating a larger cohort actively seeking alternative treatment options. Accelerating new products aligned to market needs across our established portfolio, versus and future connected care opportunities. And thirdly, expanding the number of referring and treating clinicians through stronger clinician connectivity, engagement, and an expanded reimbursement framework. We will be detailing a broader strategic roadmap at the upcoming Annual General Meeting. So looking now towards FY27, our focus is on delivering growth while continuing to invest in the business. As we announced on the 27th of July this year, the company is targeting high single-digit revenue growth in FY27 while maintaining EBITDA margins consistent with FY26. I know we promised a more definitive guide as I look at these results, but in hindsight it's too early in the new financial year, and there are still some key assumptions and sensitivities that we need to establish further, such as seeing the growth continue in North America and seeing Europe stabilise, executing a successful global role and adoption of Virtus in the second half of FY27, ensuring that we're maintaining stable EBITDA margins while continuing to invest to support future growth, and of course monitoring for significant FX movements as we saw in the second half of FY26. So it would be more appropriate for Somnamed to provide our guidance ranges alongside the AGM in November. And a quick word on investor engagement. We've listened closely to market feedback and it's clear that you want more regular engagement with Somnamed across the year. In response, we have plans to increase our cadence of ASX updates as we do have some important news flow coming, and to introduce new FY27 initiatives that provide greater access to management. We look forward to sharing more shortly. With that, I'd like to hand back to Jane and ask her to open up the floor for Q&A. Thanks, Jane.

Thank you, Karen, and thanks to you also, Yifei. So that concludes the formal presentation. And we'll now open up the floor for questions. As mentioned, participants are invited to ask questions by either typing them into the Q&A function in the ribbon at the bottom of your screen or by raising your hand, at which point I can enable your mic. We do have a couple of questions in the queue already, so we'll go to those. So the first one, what initiatives does Somnomet have in mind to address the European reimbursement changes? and pace at which patients can access oral appliance therapy?

Well, great question. So I think we'll start off just as I already touched on in the presentation. So we already have a significant reimbursement submission underway in one of our largest markets, in fact, in probably our highest growth market. which is which I'm at this point not disclosing my apologies because as you think you might all be aware we obviously are the only oral class manufacturer that reports so at this point we're trying to manage that obviously as it is commercially and somewhat sensitive but we we definitely are already as I said we have our submission underway there The second thing is obviously there's been some changes to reimbursement pathways in other parts of Europe. We're currently investigating those to see how we might best ensure that our strategies for engagement in those markets now take into account some of those changes. And then I think the other question was around the pace at which patients can access OIT. Yeah so look I mean I think that the reality is that it's a real challenge for patients depending on the jurisdictions as to how fast they can get access to this therapy and to be honest at times it's not even the patient's it's not necessarily the clinician's fault or the system's fault it's purely because it really is a therapy that the patient has to actively pursue to some extent themselves. So we're working on ways that we can facilitate access for patients so we can make sure that the awareness is made more broadly visible to them and also what pathways they need to see. Certainly in reimbursed environments, obviously it's very critical for patients to maintain a close relationship between their sleep clinician who's the diagnosing clinician and also with the dentist with whom they have to make the appointment. and in some instances we actually facilitate those appointments for patients directly. So we are doing various things to help them along the way so to speak.

Thanks Karen. What has the feedback been on Virtus during its controlled market release in late FY26?

It's quite early, so we have actually, we didn't launch in every single location globally at the same time simply because obviously there are different regulatory pathways into these regions so each of those have to be observed and so as a result and also as you can imagine it takes a bit of time before the patient then receives the product and early stage feedback without sort of I'd say six weeks into patients having them I guess in their mouth so to speak at night time is very positive and certainly you know patients who for many years have had huge challenges finding a product that allows them to both treat their sleep apnea and their bruxing has been very, very positive. I can only say to you that some people, they really do have very, very strong forces every night in their mouth due to bruxism. So you need a very strong product indeed. And more importantly, their clinicians have said, and I can say anecdotally, one clinician actually said to me that their patient was literally going through products a new product every six months. And they've had this product now and it looks like they may not be coming back every six months. So I think the early stage feedback is positive. But nevertheless, I am cautious. I'm a great believer in test before you launch to ensure that you really understand all aspects of how products will interact with clinicians and with patients. So we are still going to gather some more feedback before we commercialize.

and just a reminder if you'd like to ask a question you can do so using that Q&A function in the ribbon at the bottom of your screen or by raising your hand as it stands at the moment we're at the last couple of questions in the queue so jump in now if you'd like to ask one and the last two that we have are fairly similar so I'll wrap them up into one which is what's happened with Rest Assure and do we have a likely date for FDA approvals So what's the current timetable?

Sure. So, I mean, I think, first of all, we did actually receive FDA approval for the compliance component of Rest Assure. And so we have been looking now, obviously, at the second section, which is around the AHI. We did receive feedback from the FDA on their requirements for the AHI to be approved. And we're currently working through how that might best be done. We have looked very carefully in the last few weeks, certainly now that my leadership team has transitioned and I'm now in the role, to sort of really work out what is the best way to optimize connected care. There are now, of course, there are a couple of products in the market, particularly in North America. And so for us, let's really understand how we might best deliver connected care to the market and ultimately ensure that we get a fast and highly accretive result for entering into this category. So that will be something that we look to obviously share with our investors, ideally around the same time as the AGM, because we do want to then share our strategy for going forward, which will include, of course, rest assured.

Thank you. We have had another question come into the queue. Could you please elaborate on which areas of the business you wish to reinvest in through FY27 as per the guidance of flat EBITDA margins?

So I'm going to assume that this is a question around OPEX and CAPEX rather than just CAPEX. So I think more broadly, I would say that we are very much focused on looking at how to ensure that we capture, as we always have, What is the growing patient pool? And that's really how we might, should we say, enable and accelerate connected care. So that is one big area of investment. The second is really how do we expand our product pipeline? So we really obviously have one product out there. We're looking to obviously now accelerate that pathway. So that's another area of investment. And clearly, obviously, the rollout of Virtus is obviously part and parcel of that. I think the big opportunity, and you can hopefully see that from the narrative that we shared with you today, is not just saying that we obviously need to talk to dentists, but we need to recognize that that is a huge opportunity that we need to really crack. And we have some, I think, pretty good ideas in terms of how we know dentists very well, and obviously we have been talking to dentists now for nearly 20 years. So we do have some ideas to probably what will resonate most with them. But expanding that pool of customers is going to be really, I think, one of the big areas for us of focus. So I think probably if you're looking at total available market, lots of people with sleep apnea, but lots of dentists who we want to then enroll in the sleep apnea treatment area. And I think we have some ideas as to how we can make them very, very enticing for them very soon. So that's That's kind of the three areas, so hopefully that helps.

Thank you. Okay, final call for questions. I know it's a very busy day in the markets today with lots of people reporting, so we have kept people's attention for a good deal of time. Okay, I think we're at the end of our question queue, Karen, and if so, with that, I might just hand back to you, Karen, for any closing comments.

Great. Thanks again, Jane. So look, I think, first of all, thank you to everybody who's participated in this call. This is obviously now a new leadership team. And so we're looking at the business and working out what is really, really important and ultimately how we can do our best to ensure that you as our investors and those that have been supporting our company for a long time can ensure that you feel that we really are getting you the best results possible. I would like to send a big thank you to Amrita who I think might be listening to this call so a shout out to her. I'd also like to thank of course our employees around the world who every day do so much to ensure that ultimately people's treatment and more importantly their sleep is improved through the application obviously of oral appliance therapy. I'm excited about the future and there's a lot to do. So I look forward to your ongoing support and of course I wish you a great day. Thank you.

Thank you Karen. Thank you Yifei. I'll add my thanks to everyone else who joined us today. We look forward to keeping you across on the meds progress and with that I'll invite you all now to disconnect. Have a good day. Thanks.