OssDsign AB

STO:OSSD

Earnings Call Transcript 2024-Q1

[Operator]

Hello, and welcome to today's press conference presentation, where we have OssDsign who'll be presented the Q1 report for 2024. With us presenting, we have the CEO, Morten Henneveld; and CFO, Anders Svensson. [Operator Instructions]

And with that said, please go ahead with your presentation.

[Morten Henneveld, executive]

Thank you very much, and welcome to this first quarter of 2024 webcast, which is also our first quarter as a pure play of a biologics company. My name is Morten Henneveld, and I'm the CEO of OssDsign, and with me, I have our CFO, Anders Svensson.

Today, we want to walk you through our Q1 results and highlights of the quarter. As always, when we do this presentation, the normal disclaimer.

Overall, we've had another good quarter with sustainable growth and some very positive developments in the company, both during the quarter and after the quarter ended. We'll go into details on all of these, so the key takeaway here is that we continue the strong momentum we've seen previously, where we keep building broader access in the U.S. market with some significant contract wins with Premier and the VA. The meaningful investments we are making in clinical programs have also started to pay off with a strong 93% fusion rate published from our first clinical trial TOP FUSION. And last but not least, we are delivering on our strategic guidance with a significant uplift in gross margin, and we are showing clear signs of operating leverage.

Anders will now take you through our financial performance, and then I will come back to talk more about the highlights in greater detail.

[Anders Svensson, executive]

Thank you, Morten. So before we go into the numbers, I just want to clarify that given that the company no longer operates in the cranial space, so going forward, we will only compare to previous periods of orthobiologic sales. But when it comes to gross margin, this can't be separated out. So therefore, we will compare gross margins to the previous blended period.

Now if we turn to the results for the first quarter, we reported SEK 27 million in sales, which equals 207% growth versus the same quarter last year. That's a quite a pleasing number, and this is the same actually on a constant currency basis. There was no big difference in gross -- in exchange rates.

Now as Morten mentioned, we are seeing sustainable and accelerating growth in the business with another underlying uplift this quarter. So what you see here on this slide is now the last nine quarters, with the bars being quarterly sales and the circles above showing the reported growth rates against the same quarter of the previous year. Now for '22, of course, we have no comparison period. Now as you can see, sales are increasing at a very meaningful rate quarter-on-quarter, and we continue to be a high-growth company, significantly outperforming the industry peer average. But in terms of the quarter-on-quarter sales between Q4 and Q1, we really have to adjust for the large extraordinary orders that we saw in Q4, which we mentioned at the time, and we've also indicated that in the slide. Otherwise, you won't really have a reasonable comparison on the development in Q1.

Now as usual, I want to deep dive into how the U.S. [ continuously ] exponential growth trajectory. And perhaps we've done this for many quarters now but perhaps it's especially relevant now that we only sell in the U.S. Now what you see in this bar chart is the last 12 months sales in each bar. And we've seen this trend for many quarters now starting in Q2 of '22 and we see good underlying acceleration in the first quarter again, an excellent performance. We are really satisfied with that.

Turning to the gross margin then. In the first quarter, the gross margin continued to develop favorably compared to last year, and we reached 93.7%, which is an increase of 23.3% against the blended rate in Q1 2023. As we previously guided, we expect to operate with a gross margin at or above 90% as a pure-play orthobiologics company. So it's very pleasing to see that we're actually delivering on that. So just -- one thing I just want to remind everyone is that given the nature of this business that we're in, with the manufacturing and biologics products, they undergo significant testing and so on. We will inevitably have some products that occasionally don't pass these tests. And combined with the fact that we're still in the early stages of commercialization with relatively low volumes, it means that the gross margin may be subject to some percentage point fluctuations between quarters going forward.

Looking at the operating leverage then. If we go to the income statement, which I don't plan to go through in detail, I just want to call out how we now as a pure play orthobiologics company can see clear signs of improved operating leverage in the business with a significant improvement in the net result year-on-year.

Just to set the right expectations, though, I also want to remind everyone that the company is currently in full motion to transition more functions to the U.S. And consequently, the start of year operating expenses were somewhat lower than the expected level going forward. Now while the transition is completed, which we believe will be during Q2, we expect to see somewhat higher operating expense level, which will then also naturally impact the operating leverage development. Nevertheless, we are extremely pleased that, as we also mentioned during our strategy announcement last year, we already see operating leverage in the very first quarter as an orthobiologics company.

I will now hand you back to Morten to talk about the other significant developments.

[Morten Henneveld, executive]

Thank you, Anders. I know we've covered this before, but I want to spend some time recapping the strong clinical outcome we reported from TOP FUSION at the end of January, which were published in the peer review journal, Biomedical Journal of Scientific & Technical Research. TOP FUSION included 17 patients to evaluate the safety and efficacy of OssDsign catalyst in patient undergoing spinal TLIF surgery. Of the 17 patients recruited, 3 were withdrawn for reasons unrelated to catalysts and all of the remaining 14 patients completed the follow-up 12 months after surgery. The postoperative follow-up took place at 6 weeks, 3 months, 6 months and 12 months, and we had CT scans taking a 3-, 6- and 12-month postoperatively to assess the presence of fusions.

Quite importantly, because there is unfortunately a lot of buyers in many public or many clinical publications, the CTs were independently radiologically reviewed by medical metrics. So we've tried to take out the bias in the assessment of the fusion rate, which means that you can read them with a higher level of credibility.

There are 4 important clinical points I want to draw your attention to. One, we reported a 93% fusion after 12 months. And albeit this is not statistically significant, it is above the average in the industry, which, as you know, is typically around 75% or maybe up to 80%. Perhaps even more importantly, we saw a very fast progression to Fusion, which you see on the right side in the red box. All patients were either fully fused or had progression to fusion after only 3 months. And this confirms the high potency we see in the technology, which we also saw in the preclinical data and it's a strong confirmation of everything we've seen on the product so far. And as you know, speed of bone formation is directly correlated to a reduction in complication such as implant loosening infection or other adverse incidents.

The third data point is looking at the [ other scores that ] were used to quantify pain and function, which showed an improvement in quality of life over time at all postoperative follow-up evaluations. And finally, no device-related adverse events were reported during the study. This is again a confirmation of what we previously reported in our first post-market safety report. The offers were, therefore, very clear in their conclusion and I quote, "this prospective [indiscernible] indicated OssDsign catalyst bone graft substitute demonstrates consistent and rapid bone healing and remodeling with correspondent improved patient outcomes." So therefore, the publication of these outstanding clinical results coming from TOP FUSION is a crucial step in our process to establish OssDsign catalyst as a clinically proven synthetic bone graft and we are very pleased with these first results.

Now moving on to some of the more recent news that came after the quarter ended. Just in case anyone don't know what Premier is and I can tell you, it's one of the absolute giant GPOs in the U.S. covering approximately 4,300 hospitals and health systems and 300,000 other type of providers and organizations. And that means essentially, they cover a very large part of the entire U.S. market.

As you can imagine, we are extremely pleased with winning this contract, which is a very clear recognition of our market offering, and it opens a large valuable network, providing many more hospitals and patients access to OssDsign Catalyst. While the contract in itself doesn't provide immediate access to hospitals and therefore, will not generate sales overnight, it does represent a very significant building block for future sales and it removes a very real obstacle when submitting for new [indiscernible] approvals. And just to clarify, the contract starts on July 1, and it runs for 3 years. And the pricing is volume dependent and within our standard market pricing tiers that we have used since we went to market a few years ago.

The second exciting news that we shared after the quarter ended was that we have won a new contract with a Veteran Affairs, what's also just called VA, that gives us immediate access to approximately 100 additional VA orthopedic hospitals nationwide. The new contract is a continuation of our collaboration with Red One Medical, which is one of the most respective medical technology private sector representatives to the U.S. government. The distribution and pricing agreement, which is also called the DAPA contract that we entered in 2021 has gradually been expanded last year with the ECAT which provided access to all military -- active military sites and now to all veteran orthopedic hospitals nationwide. So this essentially means that with this new contract, we are now in a position where we have complete and full access to everywhere under the -- in the military system in the U.S.

From the beginning of our entry into orthobiologics, we've been highly focused on building access to hospitals throughout the U.S., including active military and veteran hospitals, and this contract, therefore, signifies another important step in improving this as well as the deepening access of our military presence.

And lastly, besides the obvious sales opportunity that this will bring us, it will also be accretive to profitability as military pricing, as you know, is well above the average selling price in the U.S. market.

So as a final remark, I know we've mentioned it a few times today, but I want to remind everyone that OssDsign is now a pure-play orthobiologics company. We have been that since the start of the year in a strategy shift, which is expected to generate much higher shareholder value. It means that from now on, and at least for the foreseeable future, we will have a sole focus on the U.S. market, which is the biggest market in the world characterized by high volume, high pricing and solid underlying growth. We are seeing high scalability in this business, one that we have proven over the last two years, and which is also very evident in our first quarter results today.

As Anders mentioned, we may see some fluctuations in the gross margin going forward, but we do expect it to operate at 90% or above. And even though we are now reallocating much of the cranial savings into biologics to accelerate growth in both the short and the medium term, as this business grows, we will naturally start to see a positive effect on cash flow over time.

So with those words, I want to thank everyone for listening to the presentation, and I'll hand back to the operator for questions.

[Operator]

Thank you very much for that presentation. And like you said, now it's time for the Q&A section here. We'll start with the first one. In how many hospitals is OssDsign established today and how should one think about the new contracts that has been signed?

[Morten Henneveld, executive]

Yes. I'll -- after Q4 in the beginning of April, we shared that we were approved in approximately 90 hospitals. So I don't think we'll update that statement. Of course, we keep adding hospitals on a weekly and monthly basis.

When you think about the two new contracts, you have to think about them in two different ways. So if we start with the last one, which is the VA contract, that is immediate access. It is a system we are in. We actually did our first case under that contract on Friday last week. So it is still exactly the same dynamics as before. You still have to find a doctor and persuade a doctor that Catalyst is a better product for use for his or her patients. And you still need to find a distributor to get into those hospitals. So nothing changes on the dynamic, but it is a more immediate access.

When you win a GPO contract, that in itself doesn't bring you access. You still have to also go through the same dynamics with finding a doctor to [indiscernible] your product and go through the normal bank approval processes in each hospitals. But it does happen that a hospital is part of a Premier or a different GPO and insists on only buying under that contract. And we have had cases where we are all the way through VAC approval. And then the question is raised by the way, are you on the Premier contract, and we had to say no, in which case they couldn't do business with us. So the way to think about GPOs is that these are potential obstacles for growth that if you don't get on them over time, then you will be carved out from a certain portion of the market.

And then I think quite importantly, because that is generally a worry for many [ major ] companies as they're dealing with GPOs because of their bargaining power that they have to give up on price and therefore, essentially cannibalize on the existing sales. As we also disclosed when we sent out the press release on the contract, that contract is signed on absolutely standard market pricing terms, which means that we do not expect any kind of adverse impact at all on pricing. So we see it as being accretive to the company going forward.

[Operator]

And sales commission at 45% of sales feels exceptionally high. Will it remain at that level going forward?

[Anders Svensson, executive]

I think the sales commissions, we see in Q1 is probably a level that we should expect to see in the next few quarters as well. It's a combination of distributor commissions and internal sales commissions. But I think the general level is probably where we will be at.

[Operator]

And can you elaborate on the strategies that led to the continued strong growth in the U.S. business over the past 8 quarters?

[Anders Svensson, executive]

Yes. I think it's pretty simple. It's some good thinking and blood, sweat and tears and hard work. To be honest, we went to market, having lots of experience in this field, having strong relationship with doctors, knowing dynamics, knowing competitor products, already having a strong network of potential distributors, which, as you know, is not the easiest network to build. And that is essentially what we have worked on since we went to market, very targeting a select number of surgeons, and that list keeps getting expanded. And then, of course, over time, you start to -- once you have more users, then you can do two things.

You start to have a stronger user base that you can leverage because at the end of the day, a surgeon is by far the best ambassador for your product also to his or her peers. And as you have a broader usage generally in the market, it also means you can start to approach more of the large institutions because you have evidence of broad users in the market. So I think that's the only thing that has changed other than that. We haven't fundamentally changed the strategy. We went to market with a very strong positioning on the product, which is called dual bone formation, a chemical way or not chemical, but I think the bio compensation of the product drives bone formation in a very similar way to what surgeons are seeing on the most potent product in the market called [ BNP 2 ], which is a drug, not a bone graft. But essentially, we are sticking to our [ brands ], and we are executing on the exact same plan that we went to market with, and things are going well.

[Operator]

And have you stopped announcing numbers of treated patients?

[Morten Henneveld, executive]

No. But we don't want to dilute the message by keep reporting every 500. So we will be announcing that going forward when we hit, I would say, new bigger milestones, but it's not going to be at the same cadence as we did early on.

Just to remind everyone that as we've also said before, one of the reasons we did that is because when you are new technologies, it is extremely meaningful to surgeons to know how many patients that have been treated. So that was the main reason why we reported it with essentially 500 patient cadence. But we'll do it when we hit bigger numbers going forward.

[Operator]

Understood. And what are the potential implications of the long-term agreement with Premier and the expansion of military access for OssDsign's future revenue and market penetration?

[Morten Henneveld, executive]

Well, it's a big question. We don't have a crystal ball. But of course, the -- all things equal, the broader access you have, the bigger potential to drive higher sales numbers and incremental sales going forward. So we've said from the beginning that building access, which is probably the hardest part as a new technology, that is the most important thing for the company. And I think we've done exceptionally well.

We have -- even though we think we have really good coverage today, and we have, there was still a very, very significant part of the market, the majority of the market that we're not even touching today. So we will keep building access. And of course, with these big contracts in place, it certainly increases the likelihood of us meeting our financial ambition.

[Operator]

Yes. And you have previously talked about cash flow positive at a revenue level of SEK 150 million to SEK 200 million. It sounds like you're taking on a bit more cost now going forward. Will this be revised?

[Morten Henneveld, executive]

I don't think we are saying that we are taking on more cost. What we are saying is that we are reinvesting the savings from the cranial, which means that we'll be operating at, give or take, a same OpEx level as we were in '23. I think when you think of that in that context, then you should probably think more about the SEK 200 million than the SEK 150 million, but our sense is we will stick to the statement that we gave earlier.

[Operator]

What initiatives have been implemented to achieve such a high gross margin, especially compared to the previous year?

[Anders Svensson, executive]

I mean that's -- it's pretty much a natural consequence of the new strategy. Previously, we were a company with two franchises and the gross margin in the cranial business was a lot lower than in orthobiologics and also the European business had a lot lower margin than the U.S. So just the fact that we're concentrating now in the U.S. and only in orthobiologics, that drives gross margin up to the level that we see today.

[Morten Henneveld, executive]

And if I can just add to that then, we did also establish OssDsign Catalyst in the absolute premium segment of synthetic bone graft, which means that we've also gone head to head with some of the most prominent other synthetic bone graft in the market from a pricing perspective. And we can see that we are able to get the price that we estimated, maybe we're even slightly ahead of our initial pricing estimates. So in the combination of what Anders said and the fact that we are able to maintain a high price level on the product, that is what's causing the strong gross margin.

[Operator]

Can you provide more details on the factors influencing the cash flow from current operations, especially the impact of year-end bonuses and nonrecurring accruals?

[Anders Svensson, executive]

Sure. As we mentioned in the report that we had a very good and improved underlying cash flow, even if that's not visible in the reported figures. And as you can see, the change in current liabilities was huge compared to last year. So at the end of the year, we had larger ordinary accruals than the year before. We certainly had larger bonus accruals. And then we had a whopping SEK 12 million in accruals for the non-recurring costs that hadn't been paid in '23.

A big part of that has run out in -- and being paid in Q1, which is why you see SEK 17.5 million change in current liabilities instead of SEK 5 million from the previous year. So that's obviously a one-off thing. It's not going to happen again. And we'll see that stabilizing in next quarter.

[Operator]

Okay. And we'll take final question here. How do the recent appointments of key executives such as the Chief Technical Officer align with your strategic objectives?

[Morten Henneveld, executive]

That was a very fundamental appointment. Being a biologics-focused company, clearly, we need someone to head up the -- not only the production side, but also the regulatory and the quality side that has a strong -- not only a strong track record specifically within this field, but who also happens to be a PhD in this field, which means a profound technical understanding of the product. And Tom, as you know, came with us from the acquisition of Sirakoss where he was setting up as a CEO. So to me is probably the most natural appointment we've done in recent years to put Tom at the helms of these areas since they are the ones that need to be significantly scaled, not at least on the production side in the coming quarters and years.

[Operator]

Okay. Thank you very much, Morten and Anders, for presenting today and answering all our questions. And also thank you everyone to follow along for this Q1 presentation with OssDsign and until next time. Thank you very much.

[Morten Henneveld, executive]

Thank you very much.

[Anders Svensson, executive]

Thank you.