All right. Welcome everybody to Optomed's Q3 investor call. My name is Sakari Knuutti, and we have also our CEO and founder, Seppo Kopsala, and CFO, Lars Lindqvist on the line. Our Q3 report came out this morning, and the presentation is available on our IR site. Seppo is going to walk through the presentation. Everyone can unmute themselves by pressing star six. All right, Seppo. The stage is yours.
Okay. Thank you, Sakari. Hello, everyone. Let's go through our Q3 results. Going to slide number three. First of all, same revenue like Q3 2020 compared to the reference period. Western markets there continued very strong growth, that was a good development there. Since Devices segment did not do any new camera deliveries to China during the quarter, Devices segment recorded negative growth. On a reference quarter, China sales was exceptionally large. Software segment made another record growth, that was, we were very delighted for that, and that was over 20%. Our most significant strategic initiative at the moment is a clinical trial in the U.S., which is very close coming to an end.
We are holding our breath and waiting for the results from the trial. There are now three possibilities that once the results come, either they are good and sufficient, which means that we will immediately proceed in submitting 510(k) application. The other possibility is that the results are not satisfying, which means that we need to go back to the drawing board and see what needs to be done in order to get the AI accepted in the USA in the future. The third possibility is that we need to make more patients so that then the trial would continue. I'm not speculating which is most likely, but the results will be available probably very soon.
Focus areas. Two key markets, China and U.S. As mentioned, in the first half of the year, we made a lot of deliveries to our new channel, People's Medicine Sinopharm, in China. The Q3 was now that no new deliveries were made. Right now we are in a process for working with the new channel and helping them to get started. During the following quarters, we will start seeing the results. U.S., strong growth continued in the U.S. market, and we continued this study, and now it's in a final status as mentioned earlier. Going to slide number five. Overall, the revenue was same as in Q3 2020.
Gross profit was the same level as well. Adjusted EBITDA was EUR 500,000 less. The main reasons are that we have hired approximately 10 new people in the company, especially in the U.S. and strengthening sales and marketing functions. That's now reflected in increased costs. Expenses were lower than normal in Q3 2020 because the COVID canceled all the events from the autumn, and there was no traveling and so on. Going to slide number six. First nine months revenue is 26% up compared to the last year same nine-month period. Gross profit is 32% up.
EBITDA is slightly less negative than in the reference quarter. Going to slide number eight. In the Devices segment, North America and European markets especially was very strong, and the sales to OEM channels have started to recover, so they are the positive development. Obviously, the negative thing compared to the year ago was that we didn't make deliveries in China, and that resulted in 24% negative growth in the Devices segment during the quarter. At the same time, we have started investing again in sales activities heavily. That's also shown as negative EBITDA right now. Going to slide number nine.
First nine months of the year, Devices revenue is 34% up and gross margin is 80% improved, gross profit 80% improved compared to the same period last year. First nine months, Devices segment EBITDA has been positive. Software segment highlights, going slide number 11. That was again a record growth for the Software. We made new screening and workflow software deliveries to new customers, and our recurring revenue from the existing customer base continued to grow. That was really good development continued in Software segment. That we are especially happy.
We have hired now quite much also new people, making software deployments and developments of our AI service and our Avenue screening solution. This is also now visible in a higher than earlier fixed cost. Still the EBITDA continued growing in a software segment. Slide number 12, first nine months of the software segment. During the year, revenue is 21% up, gross margin 11% up, and EBITDA is 3.7% up compared to last year. Looking at outlook for 2021, slide number 14. This remains the same.
We expect full year revenue to grow strongly compared to 2020, so no changes on outlook. Slide number 15, financial targets remains the same. Medium-term target is to deliver double-digit annual organic revenue growth. In a long term, growth to stabilize to 20%+ range. We don't have short- or medium-term EBITDA targets, as the company is in an investing stage where we prioritize new market openings and growth and introducing new products to the market. In a long term, since the business model is fully scalable, we expect EBITDA margin to start increasing, and the target eventually is to reach above 30% EBITDA margin.
For slide number 16, stage is now for Lars. He will go through the balance sheet and later cash flow.
Thank you, Seppo. I will, as always, I mean, not go through all the details. I will highlight that the equity ratio, it's 63% versus 66% last year. We believe that's a strong ratio. Our cash balance as per the end of the period is EUR 7.8. Total borrowings of EUR 6.8 versus EUR 6.5 last year. We added a new loan in September of EUR 1 million. Net working capital EUR 5.3 was EUR 3.9, an interest-bearing net debt of EUR -1.1 million, and last year -EUR 4.4 million. Next slide, 17, cash flow. Cash flow from operating activities amounted to -EUR 800 thousand versus -EUR 400 thousand last year.
Net cash from financing activities included the new loan plus proceeds from share subscriptions of EUR 500,000. Back to Seppo.
Right. Slide 18. As a reminder, we have three categories of growth initiatives. First of all, expansion into new geographical markets means especially growing in North American markets via our own subsidiary. At the same time building the distribution in new markets such as Latin America and new Asian markets. Opening new customer segments, primary care, bringing these eye examinations to primary care. That's the long-term, eventually our long-term goal, and that's our blue ocean market opportunity. A tool to get to the primary care market is bringing AI-integrated health screening to the market.
All our key initiatives are related on development and validation and commercialization of the products that integrate our cameras to our AI solutions and providing that mainly to the primary care customers around the world. USA is the key market in all of these initiatives, and that's where we focus most of our resources at the moment and also in the foreseeable future. That's it. That's the presentation, and I will be happy to answer the questions. Please remember, if you are muted, the way to unmute yourself is pressing star six.
Yeah. Hello, it's Pia Rosqvist-Heinsalmi from Carnegie. Can you hear me?
Yes, very well.
Good. Yeah, thanks. Now on the Q3 results, you say on device sales that it was strong or the growth in North America and Europe and to OEM partners, the sales growth was strong. Are we now talking about, you know, OEMs returning to pre-pandemic levels, or are we still, you know, clearly below pre-pandemic levels?
We are still below 2018 and 2019 levels. Recovery in that direction is well on the way at the moment.
Okay. Any changes in the dynamics, I mean, the OEMs, are they all equally strong or do you see differences with some being slower or some being faster?
All our three main OEM customers, they have now revived their orders. In the last one and half years, almost all of them went to very low levels and now gradually, finally, all of them are back.
Okay. Good.
That of course indicates a good overall sign for the market, in our opinion, that these large companies will sell globally. It seems that the recovery is proceeding.
Okay. Any highlights now, from China and your new distribution part? I mean, the ramp-up period has been ongoing for three quarters. So what are your learnings so far?
It's very hard to say. We estimated when we started that it takes about one, probably one and a half years before we really start getting good feedback on how this new channel might work. It's a massive company that we are working with. At the same time, our visibility towards their end customers is very limited. Especially now when the situation is that, still during the travel restrictions, we cannot travel from Finland to China at all, still. Very hard to really give a prediction on how this new channel starts working. We are relying on the reporting we get.
So far, we are not far from what is expected.
Okay. If we focus a bit on the U.S. and the device sales there and your overall development, what kind of sales efforts are you right now doing? Have you been able to engage with key opinion leaders to kind of increase the interest for your product? In sum, where are we? What are you doing in the U.S. today?
The awareness for our product is starting to build up. We clearly see that. We have six full-time people in the U.S. team, and about half of their work goes to the strategic customers and the reputable clinics. There is even those handful of large customers who we work directly with that represents a good growth opportunity alone. At the same time, another half of their work is building and establishing distribution channels that can reach smaller clinics and more clinics. I would say that the priorities has still been, during this year, mostly towards large strategic customers.
The bulk of our sales in the U.S. market is currently coming from a few large clinics and screening operators. The definite goal is that next year more and more starts coming through the resellers as well, which are now gradually being appointed.
Okay. Thanks. If we turn to software solutions, you say screening and workflow management solutions and recurring revenues from existing customers are driving the growth. Again, going back to what your software sales is. Is this growth coming from your proprietary software solutions, or do you also see growth from third-party software sales and consultancy service sales?
Consultancy services have not been growing much recently. That has been. We see very limited opportunities in that market because obviously we don't have very many customers on that side. But it's a very stable, very important part of the continuous revenue continues being and continuing that. The growth comes from this providing these same screening and imaging solutions what we have been doing into the healthcare customers for a long time. Yes, there are new deliveries done.
For example, in Asia, we have made now three deliveries, first time in a long time, during this summer and this autumn. At the same time, new deliveries in other Europe, as well. Of course, our biggest markets in software remains to be Finland, and new deliveries are made in Finland as well. In Finland, they are a combination of our own proprietary screening solutions combined with the third-party systems such as imaging archives and other third-party components. Usually, all the solutions what we provide and maintain, they are combinations.
Okay, good clarifying answer. On trade fairs, have you participated now in any trade fairs during the Q3 and what kind of feedback and interest have you seen?
There is no big couple of exhibitions. They are not big ones. Like, normally in autumn time, our main conferences are European ESCRS Congress, which is number one eye conference in Europe at the moment. That's not happening in the same way like before. The AAO conference in the U.S. is upcoming. We will be there. I think we have been couple of like smaller local conferences, and they are actually pretty good now because everybody who travel there now physically, they are quite serious.
Instead of having huge amount of people and meetings, we are having quite targeted amount of smaller amount of very targeted meetings. The results seem to be quite equal actually, even if the presence is smaller and the expenses are smaller.
Okay. Good. I still have further questions, but maybe I'll jump back into the queue for now and I'll come back if there is time.
Thank you.
Hello, can you hear me?
Okay. Yes. I can hear you.
I'm Gergana from Redeye. I just want to inquire about the Aurora IQ camera sales.
Yes. This is one of our key strategic goals to follow the amount of AI activations when we sell this new Aurora IQ camera. The numbers are growing. The percentage growth is obviously very fast because it's a new product and the numbers start from low level. The percentage of activations is also pretty high among the Aurora IQ users in those markets where it is now registered. But in terms of revenue, that's not visible very much in our revenue yet because numbers are still very small.
Where do you sell it most? Which is the main market for this camera? Does it drive the software news as well?
Mainly in Europe, CE region. There are certain countries. We don't want to single out the countries, since it's a very critical information for us to know which countries AI is progressing faster than the others. There are handful of European countries where AI is taking off faster than where the most of Europe is ongoing. We see that in a number of AI activations for our Aurora IQ camera as well. Then there are certain Asian countries where AI is taking off clearly faster than in rest of the world.
Our biggest expectation is obviously for the U.S. market, and our FDA approval study is aiming to have the FDA approval hopefully during the next year.
Okay, thank you. I just wanted to ask some more about the OEM sales. Is there something more you can explain about it? New product launches maybe, or do you plan on investing more in this area?
We continue supporting our OEM customers and also the new product development that goes quite much according to their own requests. Our model with our OEM customers is that from time to time they are requesting us to make product improvements or some modifications according to their own specification. Then we do those and implement in the new products. We are discussing also about new OEM opportunities and new, totally new products with them. At the moment, there are no news regarding the new products to be told. OEMs remain integral part of our business. We want Topcon, ZEISS, Volk, and others, other key companies to have our camera in their portfolio as well.
Okay. Should we understand that you are reorienting your sales towards Europe and the U.S. and kind of putting China on the back burner, uncertain?
Well, our own marketing efforts are definitely geared very heavily towards the U.S. market, so we are constantly adding resources. Once we are hopefully seeing positive results from the FDA study for our AI solution, there comes the time to decide if we really start scaling up sales and marketing activities in the U.S. market. That is the strategic area which we have decided that we will make U.S. our number one market. We are a small company, and that requires all of our focus and resources. We have been in China market for about five years. It has been excellent market for us, and we believe it continues being an excellent market for us in the long term as well.
Since we have a large strategic partner there, they are the key company leading the sales and marketing initiatives. We have less activities or investments what we need to do in Optomed in China. The expectation is that the China market should be within the next 5 and 10 years very important growth market for us.
Okay. Thank you.
Thank you.
Hello, do you hear me?
Oh, yes. Yeah, yeah, sorry. Please go ahead.
Okay. Sorry. I have just one question. I know that it's difficult to give any forecast for China, but what kind of action can you set in place in order to be ready for potential rebound? Or are you fully dependent from your Chinese partner?
At the moment, we are in a situation where 100% of our deliveries for all of our products goes through this one strategic partner. However, their sales is very heavily focused on selling our Smartscope PRO camera. Vast majority of their sales is that, and their strategic interest is mainly based on that. We don't know how the sales for our new Aurora camera will work in this new channel. That is something that we monitor especially carefully. We do the same for our EY80 product that is for pediatric screenings.
Those two products may be something that there may be other sellers as well coming. We will see about that. Predictability for this one big channel, it's not easy. We know that the demand is there in the market. We know that this large channel is able to meet these customers. Visibility is very hard to achieve, especially when we cannot travel to China. Therefore, the variance between the quarters in terms of revenue can be very large. In some cases, they may take deliveries worth EUR 1 million or it can be 0 or anything in between.
That makes the devices segment revenue vary very much.
Okay. Thank you.
Hello, this is Joakim Nyman from Inderes. Most of my questions have been asked, but I will just clarify a couple of things. In China, do you have visibility to your partners', other channels' inventory levels? Can you actually see what part of the sales have been going to the end customers?
Yes, we do. We get the frequent reports of their inventory levels.
Could you share that information with us in some level at least?
No, not unfortunately. Obviously, yes, we shared that much that obviously in the first half of the year, we made those quite much deliveries on their inventory. Now it takes a little bit time for them to get more sales tools started effectively. They are selling all the time, but still, the sales cycles for our type of products, they are pretty long. They can be 6-12 months, and to some hospitals, even more than 12 months. If they started early this year, it takes a little bit time. At the moment-
All right.
Yes, at the moment and during the Q3, the inventory levels were high.
All right. About the FDA approval that, of course, everyone is waiting for, I'm just wondering how confident are you in the timetable that it will come in this year, by the end of the year? Do you get at least some information before that or is it possible to go-
Yeah. Yeah, yeah. We know the status. This FDA approval aiming clinical study is arranged so that we have a third party CRO company in the U.S. doing the study. According to protocol, we as a manufacturer are fully blinded from the study. However, we have been informed that the data collection is completed and the analysis is ongoing. This is what we know and we can tell.
All right. Fair enough. Finally, about the software growth outlook, perhaps you could give us some kind of idea what kind of growth are you expecting? I know that you only give guidance on the group level, but is this current growth rate something that should be a good reference point also for the future?
Yeah, I would say that in a current environment, we have to still remember that the solution sales outside of Finland has been still very limited and difficult because travel restrictions still affect our business and traveling in many countries outside of Europe. We have had these large solution sales opportunities in Middle East and Asia, which are mostly on hold during the COVID, and that they will require traveling. In this environment, we could say that 20+% growth during this year in the software exceeded our own expectations.
If the travel restrictions are lifted, then we can get these large solution deliveries moving forward in other countries, then the growth can be pretty good and can continue being pretty good. It's very much depending on them. I will not be able to, I think at this moment, share more details for this, let's say, the 12 months or 24 months outlook for the growth rate of the software. So far it has been higher than expected.
All right. Thank you.
Yeah. Hi, it's Pia Rosqvist-Heinsalmi from Carnegie again. You launched consumables for your devices earlier this year. How has that sales development proceeded? Can you share anything on that?
There are now a few markets which have started selling more actively this product. They are mainly western markets, the high-income countries, where this consumable demand has been more. The launch has not been very wide yet, so it takes time. I think this is something that exhibitions would really help so that we could introduce this more effectively to hospital decision makers and doctors and their distributors. We could say that yes, we are definitely in a state where we are building awareness and distributors are now introducing them to the hospitals. It takes time also that it's not much visible in our revenue yet.
Okay. Thanks. To the finances. You say you raised EUR 1 million loan in the Q3. Why? What is that?
This was simply our working capital has increased as we have mentioned earlier. We have these big customers, both OEM and these new Chinese customers who we need to give very long payment times. Now the sales to both OEM customers and Chinese customer has been really big in the first half of the year with the long payment times. We just raised additional EUR 1 million loan to keep the cash balance in a high level. We also have repaid quite much loans on last year and this year. This is something that yeah we keep the lending level on the same level like it was about a year ago.
Yeah. All right. Good. That's all for me. Thank you.
Hello, this is Anne Posio from eQ.
Hello.
I have two questions left. First, on the camera production, has it been able to run normally, or have you had any capacity limitations due to component shortages? How about price pressures?
Yeah, very good question. We have no shortages in production, but that's only because we have proactively taken actions by purchasing more components into our inventories in advance than what we would in a normal environment. Second thing is that what we have seen earlier and we still continue seeing at the moment and also in the future is that we need to purchase certain components at much higher prices than what we needed, what are kind of like normal prices in a normal environment.
Yes, the price of the components, certain key components have increased very significantly, and they are visible at the moment in our COGS, and they continue being visible. This is for sure affecting negatively on our market margins at the moment. Actual shortages. It's a trade-off. If we and once we accept to pay higher price for the components, certain components, then we can have them still. I don't see immediate danger that production would stop because of shortages. We still can buy, but we just need to pay more.
Okay. I see. Thanks. Still getting back to the clinical trial that is ongoing, you said that during the or the partnering in data analyzing phase, and you said that you could get some results very soon. Could you elaborate a bit on that, what you expect? Is it like weeks or months or?
It's a good question. We are holding our breath at the moment and waiting for results to come anytime. Our initial goal was that analysis results would be ready and we could submit a 510(k) application already by end of this year. We are on that track, but of course this is something we are not able to fully control, the schedule. Results are ready when the CRO says that the results are ready. I cannot give promises when the results could potentially come, but our expectation is that it's the same as before, by the end of the year.
Okay, great. That was all for me. Thank you.
Please remember it's star six to unmute if you have still additional questions. If not, I suppose that concludes our Q3 conference call. Thank you very much for participating, and we hope to see you again in our Q4 conference call next year. Thank you very much.
Thank you.
Thank you.