4/24/2025

speaker
Emil
Company Update Presenter (CEO/President)

basically driven by continued adoption and a clear pickup in trauma. If you look at some of the highlights in the quarter, at the AAOS meeting, the American Academy of Orthopedic Surgeons, that meeting was held earlier this year, and bone support hosted a well-attended satellite symposium focused on bone infection, featuring a European professor with deep expertise in trauma-induced bone infections. In addition, there were several trauma patient cases presentations from prominent U.S. trauma surgeons. Their real-world cases showed excellent results, mirroring the positive patient outcome seen in large-scale published clinical studies from, among others, Manchester University Hospital. We're seeing a strong interest among trauma surgeons, especially those dealing with severe injuries from, in example, traffic accidents where infection risk is high. Many of these surgeons have not previously used any local antibiotics, mainly due to the lack of FDA approved options. Saruman G is now filling that gap and expanding their infection prevention toolkit for a large part of the market. As mentioned earlier, Cerament V market authorization request was submitted to the FDA at the end of the quarter. This is an important step in providing surgeons with a broader range of local antibiotic solution, especially in the face of rising antimicrobial resistance and the awareness of proper antibiotic stewardship. The submission is based on a very comprehensive data package, including Cerament's mechanism of action, bone remodeling data, biocompatibility, and elution data, supplemented with specific Cerament V patient data. The submission is tailored to meet the very strict and unique special controls that FDA has defined for the product category antibiotic elutin bone void fillers, which was created in May 2022 with the approval of CERNA G. These special controls create high demands on clinical effectiveness evidence for entry into such category. I mentioned that CMS is promoting NTAP for CERAMENTG of $5,688 in open trauma. In the April publication, it was also encouraging to see that CMS is proposing a general uplift of the DRG code, which means the reimbursement codes for orthopedic surgery in extremities. This proposed reimbursement increase for 2026 is 6%, which stands out versus the historical average of between 3% and 4%. Both topics are pending final decision in August. Let's go just shortly to the next slide. And to wrap up the U.S. section, we wanted to share the sales development of ceremony with sales in U.S. dollars since the product was launched. Naturally, the official reporting is done in Swedish krona, so this slide graphically displays the increasing trend in the original currency without any distortion of currency swings. The trend seen here is very strong and is representative of the number of procedures done with CEREMENT-G in the US. But let's now turn to Europe and the rest of the world. So sales in Europe, which is Europe and the rest of the world, came in at 52 million Swedish kronor, representing a growth of 22%. This would be 21% at constant exchange rates. We continue to see some short-term structural disruptions in certain healthcare systems, mainly in Germany and in the UK. The strains on staffing leads to regional limitations in market access. In the UK, we saw a lingering effect in quarter one, 2025, from the late 2024 programmes where political priorities had the NHS direct surgical capacity away from areas relevant to our current indications. Despite the regional swings in surgical volumes, we know that Cerament is growing five to six times the market growth and is steadily gaining market shares on both synthetic bone grafts as well as on autograft. In several of the markets where CERAMENT has been introduced over the last couple of years, we are seeing a rapid adoption once surgeons see the clinical impact and the improvement in patient outcome by themselves, so first-hand experience. Now, to support the transition to a standard of care which includes CERAMENT, We have launched a euro booster program modeled on the successful hybrid approach used in Spain and Italy. We plan to add about 10 full-time equivalents to drive penetration in under-penetrated markets with large potential. Several of the key recruitments in this program took place in quarter one. We have been granted market authorization for CEREMENT V in Canada and we expect to launch CEREMENT V in Canada during Q2. This achievement demonstrates our ambition to offer the complete portfolio in all markets where we are present. So with that brief overview, I will hand over to Håkan to bring us through a more deep dive into the financial data.

speaker
Håkan
Financial Presenter (CFO)

Thank you, Emil. So net sales improved from 184.4 to 283.5 million, equating a growth of 54% in reported sales or 50% in constant exchange rate. Emil has already spoken about the strong performance in especially the US and the major drivers behind the sales acceleration. So let's move to the next slide. The contribution from the North America segment improved with 41.3 million and amounted to 97.1 million. The improved contribution relates to increased sales after the effect from increased costs. Sales and marketing expenses during the quarter amounted to 121.6 million compared with 78.4 million previous year, of which sales commissions to distributors and fees amounted to 78.8 million compared with 47.8 million the same quarter last year. From the lower graph, Showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remains stable and strong and amounts to 95%. In Europe and the rest of the world, a contribution of 15.4 million was reported to be compared with 10.7 million previous year. Sales and marketing expenses increase with 2.5 million, including 1.8 million related to the previously communicated commercial investments in the Euro booster program. From the lower graph and orange marker, a minor drop in gross margin is noted following a higher share of indirect sales in the period. The increase in selling expenses reflects the investments made in both the US and Europe, and also the investments in organization as well as in systems to improve customer handling and inventory management to stay ahead of the increasing demand. R&D remained focused on the execution of strategic initiatives such as SPINE and the planned market authorization submission for Sermon V in the US. These initiatives have been progressing well during the quarter, which explains the increasing spend compared to previous year. And administration expenses, excluding the effects from the long-term incentive programs, remain on a stable level. The reported operating profit amounted to 29.6 million and was substantially impacted by unfavorable currency effects, totaling 30.4 million, of which 27.6 million are unrealized. And I will come back to this in the following slide. The difference between adjusted EBIT and reported EBIT operating results are cost regarding the long-term incentive programs amounting to an expense of 10 million in the quarter, compared with 9.3 million previous year. Following the mandate from the AGM in May 2024, a share swap agreement was entered into during the end of last year to secure the commitments within this incentive program. The difference between fair value and value of the equity swap agreement is reported as a financial liability and included in net financial items with a negative effect of 15 million. Cash conversion remains solid with a third consecutive quarter with strong cash flow and an increase in cash position during the period of 40 million. So during the period, the Swedish krona has strengthened against US dollar, euro and pounds with the largest strengthening effects related to the US dollar. Other operating income and expenses therefore contain foreign exchange gains and losses from the translation of the group's assets and liabilities in foreign currency amounting to a negative 30.4 million, of which 27.6 million is unrealized. Simply put, the negative 28 million is mainly driven by the operating assets in the U.S., such as inventories and trade receivables. These are originally valued in U.S. dollars at the end of the quarter and translated into a much stronger Swedish currency versus the last quarter. The term unrealized means that it's just an effect from updating the valuation of our assets. The graph on this slide shows with the gray bars how the relationship between the U.S. dollar closing rate and the Swedish krona has varied over time. This is readout on the right y-axis. The dotted line readout to the left y-axis shows reported adjusted operating result. The adjusted operating result excluding translation exchange effects is the orange line. So in Q4 2024, the US dollar to SEC rate was just above 11 SEC, which gave a positive effect of 20 million. And therefore, the blue dotted line is above the orange line. In Q1 2025, the US dollar to Swedish SEC rate was 10 krona, creating a negative impact of 30 million, meaning that the blue dotted line drops below the orange line. The orange line eliminates the translation exchange rates and gives a more comparable view of the underlying trend in operating profit. In the table below the graph, you can see the FX adjusted operating margin of 24.6% in the period, compared with 22.6% in Q4 of last year. And to round off the financials, a few words on the tariffs. As communicated in a separate press release, tariffs are not estimated to have a large financial impact. The cost of sales in the segment North America well reflects the import value to the U.S. With the assumption of the current 10% tariffs, gross margin would hypothetically drop from 92.6% to 91.8%, with a total estimated financial impact of 2.2 million in Q1 2025. And with this, I hand over back to Emil.

speaker
Emil
Company Update Presenter (CEO/President)

Thank you very much, Håkan. So let me then wrap up this presentation and summarize a bit. So Bond Support had a very strong start into 2025, well above our guidance, with 54% reported sales growth in the quarter, which then was 50% at constant currency. The continued success of Cerament G in the US with emerging momentum in trauma, the FDA submission of Cerament V, market share gains in Europe and strong cash conversion all speak to the strength of our business model and our execution. In a rather tumultuous world, bone support continues to perform solidly and steadily, gaining ground hospital by hospital and surgeon by surgeon, converting an outdated practice into a technically advanced and unique bone healing concept. We remain financially strong and committed to expanding into new geographies and indications And it is with high confidence we view our guidance of sales above 40% this year and with equally high confidence that we view the journey ahead. And with that, I would like to end this presentation and open the line for questions.

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