SomnoMed Limited (SOM) Earnings Call Transcript & Summary

Good morning, and welcome to the SomnoMed results presentation for the first half of FY '25. With us this morning, we have our Co-CEOs, Karen Borg and Amrita Blickstead, and we will take you through the presentation that was lodged with the ASX this morning. Just a bit of housekeeping before we kick off. Today's webinar will be recorded, including the Q&A, and we will post this on SomnoMed's website at the conclusion 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 it over to Karen and Amrita.

Thank you. Good morning, and welcome to SomnoMed's First Half 2025 Earnings Call. My name is Karen Borg, Co-CEO of SomnoMed, and I'm joined today by Amrita Blickstead, my Co-CEO. We are excited to present the highlights of our financial and operational performance for the first half ended 31st December 2024 before opening the call for your questions. The first half of FY '25 was very much focused on continuing to build on the foundations that were put in place over the prior 6 months. We are committed to sustainable and profitable long-term growth. Our first half results highlight that we are back on track across the business. We delivered revenue of $53.7 million, up 19% compared to prior FY 2024 first half of $45.1 million. Our EBITDA of $5.8 million was up from the $1.1 million loss in the prior 2024 first half and a cash balance of $18.5 million as at 31st of December 2024, up 14% compared to prior year-end 30th of June 2024. We closed the half year with both positive operating cash flow of $4.1 million and positive free cash flow of $1.3 million, up $8.7 million and $9.3 million versus the prior comparative period, respectively. Our results demonstrate solid growth, disciplined cost management and a stronger balance sheet. It is now 1 year since Amrita and I stepped into the business. At the FY '24 Annual General Meeting, we said it would be a year of resetting the business and getting the foundations right. We focused on addressing the significant financial and operational issues, paying down our primary debt in full, conducting material $5 million cost-out transformation and investing in manufacturing capacity. Building on this strong foundation, our goal for FY '25 is to focus on execution and delivery, demonstrating the full potential of our core business across all markets where we execute effectively. We are really proud of the strides we have made in the last 12 months. We have improved our earnings growth and cash flow, invested in increased manufacturing capacity and vastly improved our key operating metric of customer turnaround time. We have added new capability into critical areas and focused our resources and actions on those parts of the business that will generate the best return while not losing sight of our customers' needs. We are now well on our way to being able to tick off our 3-year priorities of a return to double-digit revenue growth, 10% EBITDA margins and the launch of Rest Assure. With that, I'll hand over to Amrita to go through the financial details.

Thank you, Karen, and good morning, everyone. I'll provide you with a summary and key drivers of our financial performance for the first half of FY '25. We are proud to announce double-digit revenue growth, strong earnings growth and a positive operating and free cash flow. Our results highlight the strong growth driven by effective focus on our core business and disciplined cost management. We delivered revenue of $53.7 million, up 19% compared to prior FY 2024 half 1 of $45.1 million. Our strong growth was driven by improved capacity management and reduced turnaround times. While optimizing these key operational areas, we continue to maintain a rigorous cost discipline. This balanced approach has enabled us to deliver an EBITDA of $5.8 million, up $6.9 million from the $1.1 million loss in the prior FY 2024 half 1 and ahead of our full year FY '24 EBITDA of $0.6 million as well as a positive operating and positive free cash flow, a significant milestone for our business. All our regions experienced double-digit growth. Revenue in Europe grew by 11% to $28 million. This was largely driven by very strong growth in France, Sweden and Germany, markets which reimburse OAT and in jurisdictions where OAT is viewed as first-line therapy. Europe has also been successful with tenders in Scandinavia, winning the national tender in Norway and the city's tender for Helsinki. North America has delivered a record performance with an impressive 32% increase. With turnaround time steadily improving, we have attracted both new customers and welcomed back many of our long-standing customers, reflecting growing confidence in our ability to deliver. APAC was up 16% compared to half 1 FY 2024. Australia continues to dominate APAC with focused commercial programs and leadership driving the strong performance. Pleasingly, our EBITDA for H1 FY '25 was $5.8 million, marking a significant turnaround from the negative $1.1 million in the same period last year. Similarly, our PBT was $1.5 million, reflecting a $7 million increase compared to the previous corresponding period of negative $5.5 million. These positive results further demonstrate our ability to maintain a disciplined cost management approach while achieving double-digit growth across all regions. We are beginning to see the full impact of our FY '24 cost reduction initiatives, evident through our lower expenses and our decision to fully repay our primary debt facility, leading to a lower interest rate payments compared to the prior period. While our gross margin remained steady at 62%, we do expect continued fluctuations as we continue to invest in manufacturing to improve productivity and capacity. As of 31 December 2024, our net cash position improved to $18.5 million, up from $16.2 million on 30 June 2024. This improvement was due to early interventions, leading to substantially lower interest payments following the full repayment of our debt facility with Epsilon and the successful implementation of a $5 million cost reduction initiative in FY '24. These achievements have provided us with the financial flexibility to invest in our growth initiatives while continuing to drive earnings. We are very pleased to report that we have achieved positive operating cash flow of $4.1 million compared to $4.6 million operating cash outflow for the same period last year. Likewise, we also achieved free cash flow positive of $1.3 million, a significant improvement over the $8 million cash outflow in the prior corresponding period. Our strong cash position, combined with the delivery of positive operating cash flow and free cash flow demonstrates the continued strengthening of our balance sheet and provides us with enhanced financial flexibility. We expect to maintain positive operating cash flow for FY '25. Next, we will move on to our operational update. Much of our financial turnaround is as a result of the improved manufacturing capability. This was a priority for Karen and I, once we took the reins in February 2024, and we are proud of the progress we have made in the last 12 months. We have increased capacity by over 40%, and this significant increase has driven backlog levels down to their lowest level since we took over and production turnaround time has been reduced from over 3 weeks to under 10 days. This significant improvement in turnaround time is enabling our regional teams to not only bring in new customers, but also reengage former customers. We are committed to continuing to invest in manufacturing capacity and processes to ensure sustainability of these results. While our investment in manufacturing CapEx is important, securing the right talent is equally critical to our success. Karen and I are leading a business transformation. And as such, we have built our team, we sought professionals who can work swiftly, delve into the details and bring deep expertise in their fields. We needed experts who knew what excellence looks like to help streamline and drive our business forward. To that end, we have recruited 2 key executives from Singapore to strengthen our team. Our new VP of Manufacturing and Operations, Jonathan Vowels, has joined us with over 25 years of experience of British American Tobacco. He is now working closely with our new Chief Product Officer, Keshan Gunasinghe, who brings over 20 years of R&D experience primarily from Johnson & Johnson. We also have a new Chief People Officer, Janice Hiskett-Jones; Chief Financial Officer, Ye-Fei Guo; and Mary Kennell, our Global Director of Quality Assurance and Regulatory Affairs, who each bring a wealth of experience and expertise in their respective fields. We are proud to have built a strong team with key experiences from major organizations such as Johnson & Johnson, Alcon, SunRice, [ BAT and Brookfield ]. We also have 2 new Board members, Andrew Price, who has deep international supply chain, quality and manufacturing experience from ResMed and was a former Chief Supply Chain Officer; as well as Ben Gisz, who is continuing the involvement from TDM. We believe this recruitment across our leadership team and Board is testament to the value proposition of SomnoMed and the runway for the business ahead. With that, I will hand back to Karen to discuss Rest Assure and outlook for the second half of FY '25.

Thanks, Amrita. Rest Assure remains an important part of our strategy and will be a key driver to influence medical guidelines and improve reimbursement. As we mentioned at the AGM, the FDA cleared Rest Assure as the first oral device with built-in compliance monitoring. Our next step is the preparation of a new FDA 510(k) for oral device efficacy for treated AHI centered on a U.S. clinical trial. The submission will center on a clinical trial with selection of sites currently underway and finalized by end FY '25 and the trial commenced in FY '26. As we look ahead to the rest of FY '25, we are confident that we now have the right team, our investment towards sustainable growth is paying off, and we're starting to see the benefits of a faster and more reliable end-to-end customer experience. At the start of FY '25, our goals were to strengthen the business foundations and accelerate the growth potential by resetting the cost base and investing in our manufacturing facility. We soon realized that the initiatives put in place in FY '24 were delivering results faster than we expected, prompting us to upgrade our earnings guidance off the back of greater operational efficiency, particularly in the United States, where we are doing more with less. So in November 2024, we upgraded our revenue guidance to revenue of approximately $105 million and earnings guidance to greater than $7 million with the 2 million additional earnings flowing through from greater volumes. Following strong trading in December and January, we gained greater visibility and provided firmer guardrails around this earnings number and hence, revised our guidance in January to $105 million revenue, $7 million to $9 million EBITDA while retaining the $3 million to $4 million in CapEx. We reaffirm this guidance provided in January. Now that our backlog has nearly cleared, we expect growth to moderate in the remaining FY '25 quarters, and we have factored these dynamics in our guidance. With that, I would like to thank you for your attention. We will now open the call for your questions.

[Operator Instructions] First question is coming from Shane Storey at Wilsons Advisory.

Look, first one is just really on the guidance and trying to understand the, I guess, the pathway between the $7 million and the $9 million EBITDA. Would that be -- would I be right in thinking that the top end really only deliverable in the event that you beat the $105 million revenue? Would that be one way of thinking about it?

Shane, apologies. Can you -- we just -- I don't think Amrita and -- I can hear you, but Amrita and Karen can't hear you. So let me just check. I'll just no, no, that's all right. Just make sure that you -- can you give that another go, Shane?

Sure. I hope it's the same question. The question was with respect to the EBITDA range on the guidance between $7 million and $9 million. I can see that, say, at the low end, that would imply just a lower EBITDA in the second half. So I'm wondering whether the top end of that guidance is really just a function of beating the $105 million revenue top line target. Is that a good way to think about it?

I'm not sure if I quite understand the question, Shane. Do you want to maybe just restate it slightly?

Just the difference between achieving $7 million and $9 million EBITDA, does that just come down simply to beating the $105 million revenue target by $2 million? Just a really simple question.

You mean is the additional EBITDA is coming from the volume?

Yes, just if you outperform on revenue.

To some extent, yes, it is also obviously the continuation of our cost efficiency.

Yes. Well, that's -- the question was just noticing the disparity between, I guess, the first half skew of the EBITDA, you've just booked 5.5 and then you said 7 so it implies about 1.2 for the second half, and that struck me as well. So I was just trying to work out what was going on there.

Yes. I mean it's not a direct relationship between the volume increase and EBITDA. And certainly, obviously, in the first half, we did experience obviously, the additional volumes, which obviously did flow through to the bottom line. But in the second half, there is also the impact of some investments that we've had to make. So it's as I said, the relationship isn't quite as direct as one would like.

That's fine. Second question is really on the trial that you've just described there briefly. Maybe to the extent you can, just maybe a little bit more detail on the design and the endpoints you're anticipating there. I wonder whether that will be sort of parallel arm versus CPAP or just how to think about that study?

Yes. So we're actually still in the process of designing the protocol. So we haven't as yet, I'm not at a stage where I can kind of go into great detail simply because, to be honest, we're still too early on in the development of that. Certainly, we are looking at obviously a larger trial, so the trial that we originally submitted in the first 510(k). So there is obviously, the scale will be different. But in terms of finalizing the actual design of it, that's still a work in progress.

Final question, not so much about the result, but just more about the U.S. environment, particularly in sleep apnea. When we speak to the CPAP companies we cover, we're hearing a lot about resurgence of home sleep testing and some organized -- it seems there's several organized groups there trying to do a better job of home sleep testing. I wondered if you could share a perspective of whether that channel is perhaps more hopeful for oral appliance say, compared to the traditional PSG sleep physician channel, which has sort of dominated that sector for so many years.

Yes. I mean I think it's a good observation. Certainly, HST is definitely getting more and more adoption. I mean, down to a point now where it's effectively being advertised online. There are some companies who are offering home sleep tests at like $169 direct to consumers. So I do believe that's actually having a positive effect on the entire category. So I would think CPAP is benefiting from that as well. But certainly, our belief is that the easier transition for any patient to a diagnosis and then subsequently to then a therapy choice, still needs to [indiscernible] sleep clinicians. So they still are a gatekeeper in that process. So we -- I mean, that part of the process is still pretty much remaining in place. But what we are seeing is that there is certainly more adoption of, if you like, a recommendation towards alternative therapies. And certainly, oral therapy is seen as probably the most obvious alternative to CPAP and sleep clinicians more and more as well as larger sort of sleep groups are sort of saying, this is your alternative. So -- and a lot of patients are saying, yes, please.

So next is Dennis Hulme from Taylor Collison.

Thanks very much for the guidance that you've given on the backlog. But I was just wondering if you could give us a little more color, particularly that reduction in the backlog. So did that occur in the current financial year? Or is it the reduction that's occurred since you've taken over? And secondly, just with the reduction, if it has occurred in the current financial year, if I was to say, if it was say, a 15-day reduction in the backlog, can you give us some idea of how much of the reduction occurred in the first half versus how much has occurred since 1st January?

Dennis, thank you for your question. So the reduction of backlog that we are referring to from being over 2 weeks down to 2 days is the overall reduction that we have focused on since Karen and I began, and we realized it was a priority we needed to get on top of. So that reduction has been over since we noticed the capacity ceiling over the past year. Now in regards to when we managed to get it down to nearly negligible, we did have a Christmas rush in November, December, as you know, with -- definitely with the peaks of North America coming through there with the close of reimbursement. But the latest read we have had is it dropping off throughout this second half, and we've tried to give a more recent view of where the backlog is as we see it at this current point of time. So we're currently sitting at very low backlog, and we try to give a very recent view.

Okay. Great. And in relation to Rest Assure, it looks like that the time line is a little longer than you're talking about at the AGM. Particularly, you mentioned plans for an FDA pre-submission meeting. Can you give us some indication about when you expect that meeting to be held?

Yes. So in terms of the -- well, first of all, in terms of the meeting with the FDA, we won't be having that meeting until we've got the protocol sort of in place because obviously, that will be the topic of conversation with the FDA. So we haven't yet booked a time with them because we haven't finalized the protocol. So that is a work in progress, and the team is busy on that right now. In terms of the timing, there has been a little bit of a delay. We are obviously in the process of quite a lot of moving parts on this particular development. And as a result, we're probably going to have to sort of start the trial a little later. So that will be in -- it will still be in 2025, but just a few months on from when we had originally hoped for.

Okay. And just turning to expenses. We've seen a strong reduction in expenses, particularly regional expenses. Can you give us some indication of what we should expect when we're looking in the second half? Would we anticipate much of a change in the expense lines from -- going from first half to second half?

No. I mean, essentially, what we're trying to do, obviously, is keep a pretty even keel on managing costs across the business. We are obviously in the process, as I indicated a minute ago, of looking at Rest Assure, but that is primarily a CapEx area. So that's not going into our OpEx line. Fundamentally, when it comes to OpEx, I guess the message certainly across the business is that costs are an area that one needs to be extremely focused on. And obviously, we have been investing in capability, as you've seen from what Amrita shared earlier, the team has definitely been added to in a very, very positive way across certainly the leadership levels and to some degree, also in manufacturing, of course, in order to address capacity uplifts that were needed.

So is that investment in capability likely to increase costs in the second half compared to what we saw in the first half?

We're hoping not significantly. At this point, our plans are essentially to maintain pretty much the outlook that we've already published, which is that they are fairly much in line with the first half.

And just finally on tenders. You mentioned that you won a tender in Norway. My understanding was that, that tender had been lost at some point. Can you just give us some color on the time line in Norway from when you previously had that tender and when you lost it and when you regained it?

Yes. So the tender was won late last year, but I need to check the final timing, but it actually comes into effect in 2025. So I believe it's come into effect now. It was lost about 2 years ago, and it was lost to -- at that point to a competitor. So we've now been successful, obviously in regaining that. So that tender then runs for another 2 years, and then there's a year in which basically they run the new tender. So effectively, it's -- you have it for 3 years.

Congratulations on a great result.

All right. We have no further questions. So I wanted to thank everybody for attending. And just a reminder that this webinar and Q&A has been recorded and will be shared on the SomnoMed website. Thank you very much.