Hello and welcome to this Q4 presentation with OssDsign. With us today we have CEO Morten Henneveld and CFO Anders Svensson. My name is Kristofer Berggren, and I work for Finwire Media. After the presentation there will be a Q&A session, so if you have any questions, please visit finwire.tv and click on this Q4 webcast. To the right on the page you will find a question form. With that said, I hand over the word to Morten and Anders.
Good morning everyone, and welcome to this Q4 webcast covering Q4 2021, but also the full year for 2021. My name is Morten Henneveld, and with me today here I have our CFO, Anders Svensson. Today we really want to walk you through our Q4 results, and the highlights of the quarter as well as our full year results. 2021 has, of course, been a year dominated by the pandemic, and I think we've navigated this in a real good manner. Of course, the market has been depressed throughout the year. We've seen cancellation of surgical procedures, a shortage of staff and so on. As we'll show you today, we have still managed to grow the business substantially.
I think equally important actually, we have succeeded with getting many important building blocks in place, including a number of strategic investments that will allow us to accelerate even further in the future. To me, 2021 therefore marks the start of a new era for OssDsign, and I do believe we ended 2021 in a much better place than where we started in January. As always, when we have these presentations, the normal disclaimer. With that, I'll hand over to Anders to walk us through some of the highlights of the quarter, and then we'll go into detail on those a little bit later.
Yes, good morning. Anders Svensson here. This quarter has been quite an exciting time again, and a number of big events happening both within the quarter and also after the quarter ended. I'll just run quickly through a few of those. We had a record-breaking sales quarter in Q2 and then another one in Q3. We managed, despite the Omicron spread in Q4, to actually come up a little bit better still. It's another all-time high on sales. In Q4 we also got our first cases on OssDsign Catalyst, which was launched in Q3. First cases in Q4. Parallel to that, we also started our TOP FUSION clinical study for OssDsign Catalyst.
We have had a few big GPO wins in the U.S. and in Q4 we had Vizient, one of the really big GPOs over there. And finally, we had expanded market clearance from FDA regarding our Cranial PSI products. Continuing on the highlights. We have had updated post-market surveillance data, which shows very low complication rates with OssDsign Cranial PSI, even lower than previously shown. We have got the IRB approval in the U.S. to start our PROPEL multicenter prospective spinal fusion registry, which will be very valuable to us. A few weeks ago, we also announced that we have recruited Melanie Marshall in a new position as the VP of Clinical and Medical Affairs.
Thank you very much, Anders. We'll go through in some of these highlights in a bit more detail. As you can see, yet another extremely eventful quarter for us. Just before we get into the results, I do want to spend some time on why we are actually here and the clinical challenges that we are solving. As you know, we now have two franchises. We have our cranial franchise, and we have our bone graft franchise that we are right now targeting at spinal surgery. If we start on the cranial side, unfortunately a lot of people get injured and the current bone replacements fail to heal those skeletal defects.
For cranial, we're seeing 10% or perhaps even more of implants that end up with post-op infections, many of which will need to be removed. For spine, we're seeing an even higher number of what we call unsuccessful outcomes, with probably a median in the literature around 20% of spinal fusions. We are dealing with some very real unmet clinical need that has a profound impact today on patients, but certainly also a profound impact on the cost of care worldwide, because these numbers of revisions, of course, are extremely costly. What is our response? Essentially what we have for both cranial and also for our bone graft Catalyst is really the next generation bone replacement products. What is it that makes them different?
Well, we are using cutting-edge biomaterial science, and we're working very closely with some of the world-leading surgeons to really develop the next generation products that stimulate the body's own healing capabilities. That is significant difference, and we'll go through it in a little bit more detail in a second. If we start on the Cranial PSI, what we have shown, you know, the Cranial PSI is essentially made up of a reinforced 3D-printed titanium mesh, and then we have a regenerative calcium phosphate composition, which is essentially the secret ingredient here. Those two in combination have just constantly shown a much lower observed complication rate. As Anders said, recently now with a 1.6%, and we're also seeing a growing body of peer-reviewed evidence.
If you go to our Catalyst, this is really a highly innovative synthetic bone graft because it is composed of proprietary nanocrystalline structure of calcium phosphate as well. What really makes this difference is that instead of mimicking bone on a macro level, Catalyst is actually so much nano, if that's the right way to put it, that what we're mimicking is the mineral crystals inside the bone. Essentially, that is leading to a bone biology response which is much more profound, it's faster, and it's growing, simply growing more bone. As you know, Catalyst received FDA clearance in 2020 based on some extremely strong results that were later published in The Spine Journal, on this demanding discriminating model called the Boden model, which is also used for Medtronic's BMP-2 or Infuse.
What we've seen in that model is results that are significantly better than any other synthetic bone graft. Why is that relevant? Well, it is because this model essentially is a strong predictive model also for the clinical outcome in human beings. We truly believe that OssDsign Catalyst has the potential to dramatically improve the success rates of spinal surgeries, which as you know, and you heard me say before, would be a very much welcomed innovation into the market. We're dealing with some very unmet clinical needs and now have two very strong offerings that is resonating with the market and the needs that are out there today. I think with that, we'll go into the numbers, and I'll hand back to Anders.
Okay. If we look at the fourth quarter first, we reported SEK 9.2 million in sales. That's about SEK 200,000-SEK 300,000 better than Q3. More importantly, it's 34% better than Q4 last year, which we're quite happy with. Similar picture if we look at the full year, SEK 31.7 million in reported sales, which is 33% growth versus 2020. Just breaking it down a touch into U.S. and Europe, we can see that, U.S. grew very well in Q4, 100% growth, so doubling up on sales. For the full year, 52% growth. They had a more challenging start of the year because the year before had such a good start. Still 52%, we are very happy with that.
For Europe, 5% for the quarter and 15% for the full year. Of course, both the U.S. and Europe were heavily impacted by COVID towards the end of the year, very much so in our main markets in Europe, which tends to explain some of that lower growth in Europe versus the U.S. As we're on the subject of COVID-19, just pointing out a couple of things here. We've seen again stops or postponement of elective procedures which impact both our products. Prolonged processing time for product approvals means it takes longer to get into the hospitals, especially with the new Catalyst. We've seen the no-visit hospital policy being reinstated towards the end of the year with Omicron. We've also seen some impact from our vendors in terms of raw material supply.
We've actually managed to manage those, so we've had no adverse impact on sales from raw material shortages.
Good. All right. Let's go a little bit into the highlights. Some of those we've talked about before as well, so we'll go a little bit light on them. As Anders said, we launched in Q3. We started treating the first patients with OssDsign Catalyst. The real focus, as you've heard me say before, is around building these early ambassadors and centers of excellence and really go deep into some very targeted care engagement in the U.S. to make sure that you're building a strong foundation when you start to go broader in the market and target even more customers going forward. It is out there. There's a lot of stuff happening right now on the product.
As Anders also said, we received an innovative technology contract from Vizient. Previously, we informed you that in July we announced that we were selected to showcase the solution to the member-led councils in Vizient. During the quarter, we were therefore extremely proud to actually announce that we did get the contract, which is based on a recommendation by hospitals and experts who serve on Vizient's member-led councils. I think the criteria for getting a contract are quite relevant here because they need to signify unique qualities that potentially bring improvement to the healthcare industry. That is a criteria you need to fulfill. We therefore also see it as a very clear and a very strong testimony to the high level of innovation presented in our bone replacement technology.
I also just want to remind you, and this is really a first time for me in all my time, I have never been part of a company that has won three major U.S. GPO contracts within a period of six months. We have done that with Vizient. We won Premier earlier in the year. As you remember, we also won what we call the DAPA contract, so the contract with the military and selected VA centers. During the quarter, we also obtained an expanded market clearance for Cranial PSI. It's building on the initial market clearance we got in 2017. What it means is that FDA has now cleared the osteoconductive ceramic component of our Cranial PSI and acknowledged that it is resolved and replaced with bone tissue during the healing process.
To our knowledge, we are the only cranial implant in the U.S. that can actually claim this right now. Equally important, we also came out with post-market surveillance data. As we've said before, we believe now that actually the results that we are showing that really should set the standards for what should be expected by patients and surgeons and hospital systems going forward. The new data covers almost 1,500 implants. It spans across 214 clinics. It showed now that the infections leading to implant removal is only 1.6. That needs to be seen in the context of the 10% that I talked about before. This is also done on a median follow-up of 22 months.
We are now constantly confirming the unique qualities of this product and even this time with better results. Extremely strong data, probably the strongest one that you see on the market right now globally. And we are more than happy with it, I can tell you. Just after the quarter ended, we also made a very important announcement. PROPEL, which is our multi-center prospective spinal fusion registry that we are setting up in the U.S., is really one of the core pillars in our long-term strategy. Why is that? Well, you know, a registry as such plays a very important role in bridging the gap between device performance in clinical trials that tend to be a lot more controlled, and they're used in daily practices over time.
Given the fact that it's a multi-center and prospective registry means that we can collect clinical data on a large number of patients that receive care in very diverse settings. The primary endpoint, as we've said before, is really the fusion rate at two months that is done through CT or radiography. But we also have secondary points where we look at the quality of life, neurological functions, as well as, of course, as you always do, a safety profile of the spinal implant. This has immense value for us. It is a very strong complement to the clinical trials that we're already running and contemplate to run in the future.
What it allows is access to a very large amount of data that we can mine, we can drive publications on it, we can look into specific topics, patient groups, indications, procedural types, et cetera, et cetera. As I said, really one of the core pillars and getting the approval also means that we can start to enroll patients now during 2022, and we're already doing that. Last but not least, you've heard me talking about this since we launched the strategy early in 2021. Clinical is one of the most important priorities in the company's, in our five-year strategy. We need to do a lot more, but we also need to do different types of medical programs or clinical programs.
Previously, we've probably done a lot more what we call pre-clinical, so animal testing and so on. What you're seeing us design now is a lot more active working for surgeons and with surgeons on generating data. So the sheer nature of the clinical programs we are running are different, and therefore I was extremely happy we decided to create a new vice president role to lead that effort. Extremely happy that we managed to attract Melanie. She is a U.S. native. She's coming with global experience across U.S., EU, Australia. She has been working also, you know, in smaller companies scaling them, but she's also seen what good looks like in some of the biggest in the world with Boston Scientific, Baxter, Medtronic, and so on. She's really covering the full range.
She's done virtually everything that you can within clinical studies, including a number of very large IDE studies. She also has 20 years experience specifically within spine and bone graft, and therefore also an extremely well-established network of key opinion leaders, both within neuro but also orthopedic spinal surgeons, and of course, giving her native status a lot of those in the U.S. Being able to attract someone like Melanie is something we are very proud of. Now that we are on the topic of clinical, I also wanted to give you some more insight into our progress. As we shared last time, there are some key components we are working on within our Cranial PSI franchise, but also within our bone graft franchise with OssDsign Catalyst.
Post-market surveillance, as I said last time, is extremely important. You've seen the very strong results. We are of course collecting them on an ongoing basis and publish them on an annual basis. You also heard me talk about last time about the cranial registries that we are working with KOS to set up, essentially because we know that the more data we get published, the better for us, given the outcome data that we are continuously able to report. Those are really the most important ones. On TOP FUSION, as Anders said, we started that just after we launched Catalyst in the U.S. Also very happy to report we now have 75% of all subjects recruited. We expect to complete that within the coming month.
As I said before, on our PROPEL registry, we now have what we call the Western Institutional Review Board approval, but we also have our principal investigator identified and signed on. We're really ready to go there, and we will start to enroll sites fairly soon. Some really good progress. I feel in particular when it comes to clinical, we are really delivering on what we said we would do and accelerating the effort here. I think with that, I'll just hand over to Anders.
Yep. A few words about strategy execution. This will not come as any news to you because we mentioned this several times before, but we will continue to work along the lines of the ASCENT25 strategy that we launched earlier in 2021. We will focus on neuro and orthopedic spinal surgeons primarily. We will move away from being a niche player in CMF and now also enter the orthobiologics and spine space. The five very clear strategic priorities we've set, both for this year and for years to come, is what we're executing on now, investing heavily towards the U.S., building a global bone graft business, starting in the U.S. of course, driving innovation in the product portfolio and accelerating the clinical work, as Morten was talking about with PROPEL, et cetera.
also focusing hard on driving operational efficiency, especially in terms of delivery time and costs for our Cranial PSI product. Just as a final note from me in today's presentation, if we look into first half of 2022, we are pretty confident and excited that we have some important milestones in the first half. The first one being the big Paris tender, AP-HP, where we have submitted our bid. That's the largest tender in France, so that's a really important one for Europe. We will be enrolling our first sites into PROPEL in the U.S. in the first half year. We will complete the patient inclusion for the TOP FUSION study. Last but not least, we're preparing to launch in Japan with the Cranial PSI.
We've started to take the first steps there. We've entered what I would call a soft launch mode. However, we've now got Omicron, and it's arrived late in Japan, so we'll probably still have some uncertainty and challenges there with respect to the exact timing. It's happening.
Good. Thank you very much. I think just final words for me, really around the 2021 recap. This was truly a very exciting and eventful year for us. We launched a new strategy targeting neuro and orthopedic spinal surgeons. We also built a brand-new bone graft franchise that will contribute with scalability and higher margins, and we managed to launch this in August. Despite the pandemic, we've managed now to break our quarterly sales records for the last three consecutive quarters, and we've also won three giant GPO contracts in the U.S. within a period of six months. Finally, we delivered on the promise to really accelerate our clinical work.
We launched TOP FUSION, which is, as you know, our first in-man study on OssDsign Catalyst, and we've started to set up PROPEL, our multi-center U.S. spinal registry. Simultaneously, as we also talked about today, we've continued to build more and better clinical evidence on our cranial business, and we also obtained an expanded FDA that really sets us apart in the marketplace in the U.S. right now. All in all, I believe 2021 is a year we can be extremely proud of, and it's also a year that really marked the start of a new era for OssDsign. We managed to grow the business substantially, and we have started to get a lot of the important building blocks in place for future growth, both of which brings us into 2022 in a much better place than where we started.
Therefore, I look forward to 2022 with a great deal of excitement. I think with that, I wanna thank you all for listening on today's webcast, and I'll hand over to the operator for questions.
Great. Thank you, Morten and Anders for the presentation. Let's start the Q&A session. The first question, could you please comment on how sales performance measures up to your own internal forecasts and budgets?
I think it's fair to say that we always aim higher. We had higher hopes and aims for 2021 as well. I think equally fair is to say that we had counted on the pandemic not being with us for the whole year. That's the main reason.
I think it's important, and if I could just jump in, Christoph. I think it's important when you look at what other companies also reporting and so on. I mean, 33% in a year with a full pandemic and the arrival of Omicron having an even bigger impact in Q4. I think we can be extremely pleased with the results we are showing right here. Of course, we had hoped in a world without a pandemic, that things were higher. Given that the market conditions are what they are these days, we're extremely pleased with the results that we're showing here.
Okay. Thank you.
The next question. In your report, you partially attribute the increase in operating expense to higher levels of personnel costs. Could you please comment on this?
Well, we had a few organizational changes during the year, and I think we spoke about this before as well, that in Q3 we were unusually low on personnel costs because some people had left us, and we'd taken the cost for that, and we hadn't got the new ones on board yet. The new people, plus some extras, have come on board in Q4. We're scaling up.
To me, I think this is a natural consequence. We are a growth company. We are on a journey of transforming the company, and therefore we're also making some strategic investments in both the business but also in people to make sure that we can drive that forward. You will also see that in the executive management team, where there's also been a number of changes. I think that explains that.
It's all planned. It's all part of the plan, yeah.
Okay. Thank you.
Next question. Could you give any high-level information on the revenue or number of patients that you have treated with Catalyst so far?
I think I don't think we want to go into giving away for obvious reasons about the exact number of patients that are treated. You can see in the TOP FUSION study, we are now 75% in, and things are going well in the U.S. I mean, we are covering fairly okay broad now. We are starting to set up these centers of excellence. We are seeing a really good momentum in the military and some of those accounts. Of course, the pandemic, as Anders said, you know, you need to get VAC approvals in the U.S. I think we've seen a delay in the processing time in some of those. I think we actually have a few that are up to 5 months right now.
We've also seen others go faster. Of course there was an impact on the pandemic there. Things are going well. We feel good about what's happening in the U.S., and it's virtually on plan.
Okay. Thank you.
Next question. Any noteworthy sales contribution from Catalyst this quarter?
No, it's still fairly low. You know, the vast majority is still Cranial PSI. You know, Q4 was still in the ramp-up phase. We're going through lots of VAC approvals that I just talked about before. I would say it's fairly insignificant still in Q4 relative to the total number.
Okay. Thank you.
Volumes up Q-on-Q, but gross margins down. Could you shed some light on the dynamic and the likely mix effects?
The recent margin going down and volume still keeping okay in Q4 is basically a country mix. If you compare quarter-over-quarter, you will see in Q3 we had a very good margin quarter. We had very high sales in the U.S. They were a large part, took a large share of our sales. In Q4, it was the reverse. The Omicron effects hit very hard in the U.S., slowing down sales there a bit. Meaning that other countries, especially France, moved ahead, keeping volumes up. As soon as the U.S. with their much higher prices go down in share, then we have a margin effect. That's the main reason.
Okay. Thank you. Regarding the clinical registry for Catalyst, when do you believe there is enough data for you to utilize in marketing and sales?
Well, it depends what you mean in terms of utilizing, right? I mean, the registry is still gonna have the primary endpoint being the 12-month data. What we will have is that we will have access to CT scans the minute they are entered, right? The first CT scans go in, data on the patients go in on the day of the surgery. This will be something that we're gradually building on. I can tell you it will be, it'll be much faster than what you typically see in clinical trials where you don't really do a lot until you have the full cohort and you are one or two years into the future.
This will be something that we, on an ongoing basis, will be able to use, both in terms of initial case stories, but also actually in terms of showing potentially early pictures of patients and how they're healing with Catalyst.
Okay. Thank you.
The next question then. The data we're tracking for elective surgery activity has recovered very rapidly during February. Are you seeing a similar trend reflected in orders?
Yeah. I think we. As Anders said when he talked about COVID, I think we saw probably the biggest impact we've seen actually during the two years of the pandemic, coming in towards the end of Q4, in particular in Europe from November onwards, and then really hitting the U.S. again in December. Coming into January, it was pretty bad. I think what we are seeing now is, it's not like it's something that happens overnight of course, but we are starting to see here, in particular in the last couple of weeks, some gradual improvements, both in Europe but also now in the U.S. We're seeing cases go down in states again.
Of course we all hoping now that it's peaked and we can get out on the other side. Yeah, we are seeing improvements here in the second half of February.
Okay. What are the quarterly cost run rate related to TOP FUSION and PROPEL?
That's not data we are gonna go into. This is a reimbursement cost that we have with the site. I think we won't answer that question. It's all part of our total OpEx.
Okay, are there any investments that have to be made regarding production facilities if sales volumes rapidly increases for Catalysts?
No, I can't see that. As you know, the production is outsourced, and there's plenty of volume, spare volume capacity available, so I can't see that happening.
I think it's also important to note here, given the high margin we have on Catalyst, any kind of what I would say is a production increase, you won't see that in a significant way on the COGS as such, right? It is a fairly low cost production. So even accelerating that, even if that comes at a marginal cost to produce more, the impact of that would be fairly insignificant. So it's not something that we see as a risk in the company.
Okay. Thank you.
The next question. The launch in Japan, is it still in collaboration with Muranaka Medical?
Muranaka. Yeah. Yes, it is. We are still. As Anders said, we've moved closer now. Simply also because we're running out of patience and, you know, similar to I'm sure you are, getting tired of hearing us talking about Japan. We have taken first step now. We have what we call a soft launch mode. Of course right now Omicron is spreading heavily in Japan. We actually can't travel there right now. The big events in Japan are in Q2. Of course right now we are hoping that those events will not be canceled because of Omicron. Then that's probably the timing we should be looking at for what we would call a full launch mode.
We are actively working on a weekly basis with Muranaka to spread the word and warm up the market.
What's the potential from the AP-HP tender?
Well, it's difficult. I can tell you it's the largest in France. It's covering, well, you know, at least seven main hospitals in the greater Paris region. There may also be some satellites in there. I think this is something where you could easily look at, you know, up to 100 implants a year or maybe even more. You know, in these tenders they are very reluctant to say anything. If they state a number, it will be probably much lower than what's the reality because they don't want to be held accountable to that number. It is by far the biggest tender in France.
Of course, if we were to win that, it would have an important impact on the priority for France going forward.
Okay. Thank you.
Next question. Are you seeing any contribution from the three new GPO contracts yet?
Yeah. You know, the contracts are not volume committed, right? We'll see, and we are seeing continuous contributions there, but primarily initially from the DARPA contract to the military. We've seen a fair bit of business already.
I think it's important to note here that when you combine the Vizient and the Premier contract, they're essentially covering the vast majority of the U.S. You will see a ramp up in those contracts on a gradual basis going forward, in particular as the market hopefully starts to normalize and elective procedures start to take place again. Measuring a specific impact from any of those two won't be a one-to-one. Of course, the DAPA contract, as Anders says, is black and white. Without the contract, you're simply not allowed to enter the facilities. Now we are, and we have access now to a fair amount of customers within that group already, both Catalyst and PSI.
Okay. Thank you.
Next question. Do your competitors have a clinical registry like PROPEL? Is it a unique advantage for OssDsign?
I mean, some have and some don't. I think it really depends on who you define as the competitors. There are a few that we know of that also are running their own registry, but it's not something I would say that is omnipresent. If you look at the many competitors in the U.S. that everyone has that's certainly not the case. There are a few others we know of that also has a registry.
Okay. Thank you. I think that was the final question, or that was the time that we have for the Q&A session during this presentation. I will go through the questions again, and if there's any questions that haven't been answered, I will send them through to the company, and they could answer you via email. With that said, big thank you to Morten and Anders for the presentation and a big thank you to all of our viewers and to all of you who have sent in questions. I hope to see you next time on the quarterly webcast with OssDsign. Thank you and have a good day.
Thank you very much.
Thank you very much.