Thank you for standing by. Welcome to the SomnoMed 2021 Full Year Results Conference Call. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. If you wish to ask a question, you will need to press the star key followed by the one on your telephone keypad. I will now return the conference call over to Mr. Neil Verdal-Austin, CEO. Sir, the floor is yours.
Well, good morning, ladies and gentlemen, and welcome to SomnoMed's webcast of the FY21 results. As said, my name is Neil Verdal-Austin, and I'm the CEO of this extraordinary company. We also trust that everyone is well and doing all that you can do to remain safe during this very difficult time.
Fiscal year 2021 was certainly a challenge, not only for SomnoMed but for everyone throughout the world. The fiscal year began four months into a global pandemic that created much uncertainty and unfortunately continues to do so today. SomnoMed, I'm pleased to say, has managed through this initial COVID-19 period extremely well.
After the usual disclaimer slide, it gives me great pleasure to start at slide 4, our financial and fiscal year 2021 highlights. Starting at the revenues, our revenues posted were just short of AUD 63 million and up 9% over the same period last year.
That's up 15% in constant currency. For us, really impressive results, full-year impressive results from both Europe and APAC, with North America turning the year around in quarter four to deliver the same full-year revenues as FY20 in constant currency terms. For us, an amazing final position considering the year we had in North America.
The EBITDA is AUD 3.9 million and down 17% on the same period last year and will be explained in more detail in the financial slides. However, we are very impressed and pleased with the gross margin from oral appliance products, our product range, which was maintained at the 70% level.
Our costs were very well managed within the context, of course, of the COVID-19 situation. The second half investment of EBITDA has begun and is aligned with our technology projects for the future and the future success of this company.
More on that a little later on in the presentation. Cash was at AUD 21 million at June of this year, and again, very well managed throughout the year with purposeful allocations against these technology projects that are now underway. Slide five highlights the strategic and operational highlights for the year. Just in some sort of summary for you, the patient-centric multidisciplinary approach of SomnoMed continues.
We are more than just a treatment company providing a treatment solution. Sales and marketing remain our focus, an ongoing focus investment in these growing teams globally. The reimbursement foundation continues and develops in all aspects of the world wherever that is necessary and is important as a foundational piece for medical device companies.
Medical education, of course, remains a cornerstone of what we do in all markets, and we believe that product differentiation within our range is critically important and has stood the test of time even through this pandemic. Our digital manufacturing platform encourages efficiencies and with that brings better margins, which again, we will see in the financial and fiscal slides later on.
Moving to the market opportunity in slide seven, it's clear that the obstructive sleep apnea market is large and the disease affects many, many people globally. The disease is progressive and that means it doesn't get any better if left untreated.
The various classifications that they have between the severity of OSA normally drive treatment options that are given by sleep professionals. All that can be seen from this slide is the significant opportunity that even exists in the mild and moderate category for SomnoMed moving forward.
As we move to SomnoMed itself, and we move to slide nine, our vision is clear. We are a patient-centric organization. We care about the treatment of patients who suffer from obstructive sleep apnea. Our mission is also very clear. We aim to do that in a multidisciplinary approach by engaging with all parties necessary to achieve that vision. SomnoMed will become, through that vision and mission, more than just a supplier of an oral appliance treatment.
Slide 10 shows what SomnoMed has actually achieved over the last 14 to 15 years. SomnoMed as a company has always had a global footprint in mind, and from the start has been instrumental in building the oral appliance industry within the sleep community across the world. Our reach is unparalleled actually across 28 countries and now having treated over 620,000 patients globally.
SomnoMed's hallmark has always been clinical evidence-based research and education. SomnoMed has actually set that standard across the world. Importantly, as we are concerned about patients, we also track and survey our patient base to ensure that the comfort provided by our product range means that our patients remain in treatment, and more about that a little later on.
Slide 11 speaks a little bit about the SomnoMed product difference. The difference that SomnoMed makes is around our mantra, treatment-focused and technology-driven. Treatment focus revolves around our product innovation, comfort, and retention. The technology-driven means that SomnoMed has embarked on specific transformational technology investments, not incremental, transformational technology investments that will build a smart product ecosystem in the very near future.
At the forefront of this is the SomnoDent Avant, our flagship digitally milled oral appliance that provides improved comfort because of the b-flex Comfort Liner and improved efficacy.
Slide 12 elaborates on the three main treatment options, if you like, offered to patients that are all quite different when it comes to an interesting perspective on two core metrics, levels of invasiveness and cost. In general, oral appliance treatment, and that option is very easy to fit and wear, is generally preferred by most patients, is definitely less invasive, and over time, far more cost-effective than either CPAP or surgery.
Slide 13 really gives you the concept of what SomnoMed's main aim in the sector. It's to grow the oral appliance sector itself. Growing that share of oral appliances within the total number of positively diagnosed patients worldwide is the main aim. Today, that's around 8% to 10%, and not really representative of the true patient choice opportunity and treatment compliance that our products offer.
SomnoMed's plan, this has been openly communicated for some time now, is to grow that sector such that a far greater number of patients are treated for their OSA, and that they remain in treatment. Too many are offered CPAP irrespective of severity and simply cannot tolerate that treatment.
Remember, this is a long-term disease that comes with very severe comorbidity if left untreated. As such, compliance is more critical to the equation than perhaps efficacy when looking at long-term effective treatment solutions. I think slide 14 tries to show that concept best. CPAP is highly efficacious, no questions about that. It does suffer from ongoing, and pretty much well-documented low levels of compliance.
Oral appliance therapy is slightly less efficacious. Not all severe patients are treated effectively, but enjoy significantly higher levels of compliance, therefore, patients remain in treatment. Therefore, patients get effective long-term treatment.
When patients are treated in that manner, they avoid the comorbidity, including the cost savings over many, many years. We believe this is a compelling argument for all our sleep medical professionals around the world. With that introduction, I'd now like to hand over to Hervé Fiévet , our CFO, to cover the financial slides for you.
Thank you, Neil. Good morning, ladies and gentlemen. Without further ado, let's have a look at this graph on slide 16 that shows the total group revenues by half year. While the first half was affected by the end of the first wave of COVID and down by 7% versus PCP, the second half, even in spite of further waves of COVID, showed a rebound by 33% versus last year, especially on Q4, which bodes well for FY22.
This led us, as Neil mentioned previously, to a growth of 9% versus FY20 or 15% at constant exchange rate to almost AUD 63 million revenues. Let's now move to slide 17. This graph breaks down the revenues by region, starting by North America.
That was more heavily affected on the first half of the year due to then pre-election and general health context, as well as the comparison with Avant launch during PCP. That recovered during the second half, and it is to be noted that at constant exchange rate, the -9% versus previous year becomes flat.
As for Europe and APAC, not affected by the effects previously mentioned during the first half, the excellent recovery during the second half, notably pulled in Europe by core investment markets like France, Germany, and Switzerland, has led to growth of 20% for Europe, or 23% at constant exchange rate, and 17% for APAC. The slide 18 is about gross margin.
It is really to emphasize the ability of the group through this difficult context to maintain its main product line gross margin at 70% of safe, which enabled to deliver all the value of the revenue increase to the P&L. This was achieved by efficiencies driven by an acceleration of the adoption of digital impression scanning.
That represents, for instance, almost 60% of orders in North America, combined with an increased amount of our digitally made devices. Slide 19. Talking about the EBITDA now. While there was an undeniable positive contribution of the gross margin and savings due to cautious cost management and increased digital milling, the EBITDA has eroded versus FY20 by 17%.
This was driven by a commitment to our staff during COVID-19, the reduction in government support scheme during successive waves of the pandemic, and the beginning of the investment in needed resources aligned to the technological transformation that will drive future growth.
On slide 20, this summarized version of the P&L illustrates clearly the investment in key roles across digital and R&D channels to support the technological transformation in both the regions with an increase by 11% of G&A expenses, and centrally, with an increase by 54% of the corporate and head office level expenses in critical IT resources, clinical affairs and reimbursement.
This also happened while the government support scheme dropped by 71%. These effects were partially made up by savings on meetings induced by COVID-19 context, as well as the gross margin contribution to only show an EBITDA reduction by 17%. Now slide 21.
While the gross cash level shows a drop by AUD 9.1 million over the period, it is actually the result of a principal action to repay the bank liability of AUD 4.9 million with HSBC. The remainder is due to the AUD 1.6 million reduction of government support, as well as an increase of capital expenditure by AUD 1.5 million on transformational projects, as mentioned by Neil previously, and AUD 1 million increase in working capital as our growth continues in our key markets.
While we were in this context of investment, a very careful cash management of all the other line items resulted in maintaining a net cash position of about AUD 19 million. This confirms the strength of our balance sheet at the end of FY 2021, ahead of a year of investment to achieve category leadership, as Neil will now detail. Neil, over to you.
Thank you, Hervé Fiévet. I think the next few slides really show that SomnoMed is very well-positioned for this upcoming opportunity and has a very clear idea of the future horizons that will require investment for the company's future growth. Slide 23 starts to show how we are positioned for this growth. SomnoMed has built a strong foundational platform over the years and underpins the next steps for the future growth we anticipate.
SomnoMed is worlds apart when it comes to the systematic building of a long-term medical device company, which will now enter its next phase for growth. Slide 24 shows how SomnoMed recognizes that to achieve this opportunity, a focus on awareness, acceptance, and adoption is critical in building that medical device company. SomnoMed will now also invest in technology and innovation to be that category leader.
Our transformational technology investment is progressing well at this stage and is now entering the beginnings of the clinical trial phase. This investment is critical to the future of this company and has come about by truly listening to the market. We have researched, consulted, and reflected on the key barriers that exist to prescribing more oral appliances, and are as such, committed to delivering those solutions to overcome these barriers.
SomnoMed is quite unique in this industry, as we are truly, again, patient-centric in thinking, multidisciplinary in approach, and technology-driven in execution. We've always been more than just an oral appliance treatment company, and will be even more so now.
SomnoMed will bring to the industry a smart product ecosystem, and unfortunately, that's about as much as I can say for now, that will drive the further acceptance and adoption of oral appliances in the OSA market, where proof of SomnoMed's long-term effective therapy model will be delivered. Slide 25, which I think you've seen before, shows you a little bit more about what the smart ecosystem will mean.
Really, an integrated and automated technology platform that creates a data-driven ecosystem. This will lift SomnoMed into a new category of oral appliance treatment, unique and on our own, and redefine how the industry will view SomnoMed oral appliance ranges in the future. Slide 26 shows how we're going to be doing this.
To maintain the oral appliance market category leadership, we will deploy the financial framework strategy, as noted before in previous presentations, and again in this presentation this morning. SomnoMed will purposefully invest our current EBITDA into these future horizons to accelerate future growth and market penetration globally. This is exactly what the company now needs to do.
Only slowed by COVID-19, but certainly nothing more. Our opportunity is now, and we intend to bring you that opportunity. Moving to the outlook for FY22 and our final slide, it clarifies that view and the year ahead. Even during a COVID-affected world, SomnoMed will now provide some guidance. Our revenues will be at least 15% growth for FY22, assuming that COVID does not get worse in any of the 28 markets in which we trade.
However, to achieve the long-term opportunity for SomnoMed and for its investors and for all its shareholders, we will also fully invest this year's EBITDA. Also to note, we will use around AUD 8 million in cash towards the two main projects that drive this transformational technology change. This investment and the new technology will herald in a new chapter, a new era for the company, and we are almost there.
Your patience will be worth it, and I will be able to disclose the details of this more fully towards the end of 2021. To conclude, SomnoMed has an incredible vision, talented, engaged, and passionate people, distinct competitive advantage, best-in-class products, a global footprint, and a purpose-driven investment plan for the future. Thank you, ladies and gentlemen, for your attention this morning. We are extremely excited about the journey ahead.
This ends the fiscal 2021 results presentation, and we will now move to questions. Thank you.
Okay. Thank you, sir. We will now begin the question and answer session. At this time, we'll just pause momentarily to assemble our roster. The first question we have will come from Melissa Benson of Wilsons. Please go ahead.
Hi, Neil. Thanks for taking my questions. I just had a question firstly around the U.S. market geography and the trading you've seen. We saw a good shift in momentum in the Q4 after kind of a slower first three quarters. Are you able to comment at all on the trading in the last month and a half or so in the U.S.? Are you kind of seeing that same Q4 momentum, or is there been some pullback in that run rate thus far?
Melissa, thanks for the questions. You always ask great questions. I think the U.S. is starting to see a rebound and a change. The first three quarters are not indicative of what we see, of course, in the fourth and what we've now seen so far into July.
There's no doubt that there's been a rebound and a shift and a change. Equally so, just to note, of course, that this quarter is the holiday season as it is always in the U.S. every time this year.
Equally so, we have a Philips recall that has caused an opportunity for sure, but also a little bit of chaos, if you like, where patients have been asked to either remain persevering with their treatment, unfortunately by some sleep physicians and DMEs, but others saying, "Look, we now need to find you an alternative," and it's taking some time to see that really come through into the oral appliance market.
To answer your question, we're seeing a rebound in the U.S. It's certainly much, much better than we've seen before, and we're hoping that, of course, as we progress with our initiatives and our medical initiatives, that this only gets better as the quarters progress.
Thanks, Neil. If I might ask a second follow-up question relating to your FY22 guidance. You've guided to 15% revenue growth. Just wondering what your kind of thoughts are around what's supporting that. Is it one key market or geography in particular? Noting that we're going to see some weakness in APAC, just due to lockdowns. Just any commentary on your internal thoughts there would be great. Thanks.
Yeah. No problem at all. I think what we're trying to indicate, Melissa, is that we feel pretty confident in our own abilities and in SomnoMed's ability to do pretty well this year, even under the current maybe COVID rules, restrictions, and lockdowns, if they don't get worse. What we're seeing in terms of current results and current trends and the programs we want to roll out in the next quarters, is that we should be able to achieve those revenue results.
We want to be able to provide a little bit more comfort and confidence around the revenue number as we invest the EBITDA into the transformational technology that we'll be able to talk about in December.
Great. Thank you. That was all for me.
Thanks, Melissa.
Again, if you'd like to participate in today's Q&A, please press star then one on a touch-tone phone. Again, that is star then one to ask a question. Again, we'll just pause momentarily to assemble our roster. Again, that is star then one. At this time, there appear to be no further questions. I will hand the conference call back over to the management team for any closing remarks. Gentlemen?
Thank you very much. Thank you, ladies and gentlemen, for attending. Thank you for listening to our incredible story. This is an extraordinary company, and I think we're very, very excited about the year ahead. Thank you.
Thank you.
We thank you, sir, and to the rest of the management team for your time also today. Again, the conference call is now concluded. At this time, you may disconnect your lines. Thank you. Take care, everyone.