Orthofix Medical Inc

NASDAQ:OFIX

Thank you for standing by. My name is Tina, and I will be your conference.

[Operator Instructions] I will now turn the call over to Julie Dewey. Please go ahead.

Thank you, operator, and good morning, everyone. Welcome to Orthofix' First Quarter 2025 Earnings Call. We appreciate you joining us. I'm Julie Dewey, Orthofix' Chief IR and Communications Officer. Joining me on the call today are President and CEO, Massimo Calafiori; and Chief Financial Officer, Julie Andrews.

Before we get started, please note that our earnings release and the supplemental presentation accompanying this call are available on the Events and Presentations page of the Investors section of our corporate website at orthofix.com. Also, this call is being broadcast live over the Internet to all interested parties, and an archived copy of this webcast will be available in the Investors section of our corporate website shortly after the conclusion of this call.

During this call, we will be making forward-looking statements that involve risks and uncertainties. All statements other than those of historical facts are forward-looking statements. We do not undertake any obligation to revise or update such forward-looking statements. Factors that could cause actual results to differ materially are discussed in our most recent filings with the SEC and may be included in our future filings with the SEC.

In addition, on today's call, we will refer to various non-GAAP financial measures. Please refer to today's news release announcing our first quarter 2025 results for information regarding our non-GAAP results, including our reconciliations of these non-GAAP financial measures to our U.S. GAAP results. Additionally, and unless otherwise stated, all net sales percentage changes discussed will be on a pro forma same sales day, constant currency, year-over-year basis excluding the impact from the discontinuation of the M6 artificial disc product lines and all results of operations that we will refer to will be on a non-GAAP as adjusted basis.

Moving to today's agenda. Massimo will open with comments on our performance and business updates. Julie Andrews will then review the specifics of our first quarter results and our 2025 financial guidance. With that, I will now turn the call over to Massimo.

Thank you, Julie. Good morning, everyone, and thank you for joining us for our first quarter earnings call. I'll spend some time providing business updates and information about our key initiatives before I turn it over to Julie Andrews, to cover the specifics of our Q1 results and 2025 guidance.

During the first quarter, we continued to execute the priorities that we outlined in our 3-year plan to transform our business and deliver on our commitment to drive disciplined profitable growth. On a same sales day basis, our first quarter pro forma net sales of $189.2 million represent year-over-year constant currency growth of 6%.

I'm also pleased to report that we delivered another quarter of excellent progress in adjusted EBITDA margin expansion that exceeded expectations. As we move forward in 2025, I'm confident we are well positioned for profitable growth as our efforts to further optimize our spine commercial channel begin to bear fruit and we continue to build on our financial foundation and prudent depo capital to create long-term value for our shareholders.

Our excitement continues to build in our orthopedics business and the greenfield opportunity we have to redefine the category of limber construction, which I'll discuss in more detail shortly as well as prospect we have in our Bone Growth Therapies business to further capitalize on cross-selling opportunities and drive penetration in the tractor market with AccelStim.

Now I'd like to provide additional detail for each of our businesses. Our U.S. spinal succession business grew 5.4% on a same sales day basis. We are successfully accelerating targeted distributor transition in a few U.S. territories in order to maximize our growth opportunity and more closely align with our strategic focus. As a result, we did experience some short-term incremental softness in Biologics and Spine Fixation.

This transition won't be completed until later this year, and will require some time to take full effect, but is expected to result in a stronger, more scalable commercial organization as we shift into our next phase of growth. Once our optimization efforts are completed, we expect growth to return to historical levels. During the quarter, we continued to gain in product categories where we recently launched new products, including our ELF, MIS and cervical fusion portfolios all of which significantly outperformed the market.

Beginning in Q2, we have several product launches planned, including the full launch of [indiscernible] lateral lumbar interbody and additional solution in our Meridian ALIF portfolio. This new interbody design features our proprietary advanced surface technologies and expand our portfolio of lumbar interbody fusion products to address varying surgeon preference and patient anatomies.

In parallel, we will integrate our hardware products with access and navigation, creating a comprehensive procedural solution to enhance efficiencies and predictabilities in the OR. At the same time, we continue to leverage our differentiated 7D flash navigation platform to create long-standing relationships with our surgeon partners.

With continued investment, we expect that our next-generation advancements in enabling technology and our hardware portfolio will build upon this unique foundation and establish us as the partner of choice for surgeons seeking [indiscernible] data-driven interoperative solution in the OR. We believe that our comprehensive portfolio of spinal hardware, biologics and enabling technologies and steady cadence of innovation will enable us to attract top sales talent, increase exclusive distributor relationships and drive sticky relationships with surgeons and hospital accounts, which we expect to results in incidental product pull-through as well as ASP lift from mix benefits.

Now turning to Bond Growth Therapies. On a same sales day basis, BGT net sales grew 7% overall in Q1 and investments in the structured market sales channel drove 8% growth in BGT structure with AccelStim bond growth therapy device to continuing to outperform the market. Our BGT business is focused on maximizing our market-leading position with the most comprehensive portfolio and the most indications on bone growth stimulation devices in the market.

We will continue to focus on cross-selling with orthopedic spine, adding new market channels with established sales representative and driving penetration in the fracture market with AccelStim. Speaking of AccelStim, we received an earlier-than-anticipated FDA approval for our AccelStim 2.0 in the first quarter. This approval reinforces Orthofix's position as the market leader in bond growth simulation and represents a significant advancement in low-intensity post ultrasound technology as the first and only such device to incorporate remote therapeutic visibility through integration with the Stim onTrack mobile app and physician portal.

AccelStim 2.0 is expected to be available later this year. I continue to be impressed by the commercial execution of the BGT team. Our global orthopedic business had a strong start to the year, delivering constant currency growth of 13% on a same sales day basis in Q1 compared to prior year. U.S. orthopedics benefited from strong execution and grew 12%, also on a same sales day basis. Growth was led by the combination of our TrueLok and FITBONE products as well as growth in the KarXfixation product family and Oscar bone cement removal products.

As we covered in our last earnings call, Orthofix is redefining the category of limber construction with a unique portfolio solutions that empower surgeons to excel a limpreservation, the formation action, limb lengthening and complex structure management. Together, these segments represent a market opportunity in excess of $1.7 billion, one of the fastest-growing categories in orthopedics.

We are particularly excited about the upcoming full market release of the TrueLok Elevate TBT system, which is indicated to correct nonunion and bone or soft tissue deformities are the facts, which could include non-healing wounds, ulcers and deep tissue ones.

According to the American Diabetes Association, over 160,000 amputations occur each year in the U.S. As a result, of diabetic-related complication, representing a sizable market opportunities of approximately $1.2 billion. The TrueLok Elevate TBT system is currently a limited market release at select centers in the U.S. and Europe. Surgeons participating in the limited release are witnessing first hand, the transformative potential of this product in treating condition that previously would have almost certainly resulted in computation and drastically reduce patients' quality of life and their life expectancy.

TrueLok Elevate is already making a real difference. We are continuing to prepare for a full market launch of TrueLok Elevate in Q3. These include confirming reimbursement cutting and actively gathering feedback from surgeons involved in the initial rollout. This feedback will be crucial for successful full launch in the coming months. With over 90 TrueLok Elevate cases completed so far, surge response has been overwhelmingly positive, and interest from the orthopedic community continues to grow rapidly.

TrueLok Elevate now enables surgeons to effectively address, challenging condition in a patient's extremity by allowing for an efficient and reproducible method to create a bond segment in the tibia that can be gradually destructed over a period of several days. Published clinical research has shown this approach and proves broad circulation to the affected limb and promote wood dealing in their [indiscernible] food, potentially reducing the need for an amputation, lowering associated mortality risk and alleviating the long-term health care cost linked to limb [indiscernible] Lima.

Thus, TrueLok Elevate offers the potential to not only be a limb and cost-saving device but most importantly, a life-saving solution to a challenging patient population. In addition to TrueLok Elevate, orthopedics growth in 2025 will be fueled by a number of new product introductions that we expect to capture additional market share with existing and new customers. These include the FITBONE transport and lengthening nail the only bond trust Parnell available in the United States. And the FITBONE and Terna, we expect all of this product to be in full market release in the second half of 2025.

Our focus on limber construction is yielding significant results, particularly in the U.S.A. market. And we anticipate this will be a key growth driver for Orthofix for many years to come. Overall, we are in great position to capitalize on our recent product launch successes and deliver meaningful innovation to improve outcomes and efficiencies for our surgeon customers and their patients.

We have a healthy commercial pipeline that we believe is poised to deliver substantial revenue growth in the coming months. Importantly, the breadth and depth of Orthofix Spine and Orthopedic offerings provide multiple paths to grow the business as sustained above market rates. We remain the market leader in bone growth therapies have a comprehensive market-leading biologic portfolio and differentiated products in several specialized orthopedic markets such as complex drama construction and limbeformity correction.

Additionally, our broadened [indiscernible] portfolio is world-class and is fully supported by a highly differentiated and compelling enabling technology. Looking ahead, we are focused on 3 strategic priorities: first, further sharpening our commercial execution to drive deeper market penetration through our comprehensive portfolio offering, including the adoption of our 70 fresh navigation system. Second, implementing projects to improve our gross margin and finally, focus on a disciplined capital allocation, adjusted EBITDA expansion and positive free cash flow generation.

In short, we are well positioned to create long-term value for our shareholders in 2025 and beyond. At the same time, we are confident that our emphasis on responsible capital deployment within our businesses and deemphasizing areas where we have less scale or share will also drive our transformation, support profitable growth and increased penetration of our technology and product platforms in areas where we can win.

In summary, after 1 year with this new management team, Orthofix is operating with greater discipline executing priorities and strengthening our balance sheet. I believe we are very well positioned to deliver on our commitment to drive profitable growth and innovation while increasing long-term shareholder value. With that, I'll now turn the call over to Julie to review our first quarter financial results and our 2025 guidance.

Thank you, Massimo, and good morning, everyone. As we get started, all net sales growth rates that I referred to in my prepared comments will be on a pro forma constant currency same sales day basis over the prior year quarter and exclude the impact of net sales related to the discontinuation of the M6 artificial cervical and lumbar disc that we previously announced. These pro forma comparisons are non-GAAP financial measures as described by Julie during the introduction of our call.

As a reminder, this quarter had 63 selling days, which was one less selling day than Q1 2024. Please refer to the non-GAAP reconciliations in our press release, and I strongly encourage you to review the information posted on our website. We have provided you with information to assist you with your modeling and to provide you with pro forma information through the first quarter of 2025.

During the first quarter, we continued to prioritize investment in innovation, rigorously allocating resources to high-return opportunities to further sustain our share capture in U.S. Spine and U.S. Orthopedics and focus on improving margins and cash, positioning the company for near- and long-term profitable growth.

Global Spinal Implants, Biologics and enabling Technology's first quarter pro forma net sales of $104.3 million with year-over-year growth of 4% on a pro forma same sales day basis. These results were slightly below our expectations, primarily due to some incremental softness in Biologics and Spine Fixation. In our U.S. Spine Fixation business, procedure volume growth on a same sales day basis was 7%, which was partially offset by the outsized impact of a price decrease due to a joint venture between one of our largest hospital accounts in the Midwest and a large regional group purchasing organization that already had an Orthofix pricing agreement in place. We will be working through this for the remainder of the year.

Moving now to Bone Growth Therapies. BGT revenue grew 7% on a same sales day basis to $55.1 million in Q1, driven by above-market performance in both the spine and fracture channels. BGT fracture growth was 8% on a same sales day basis driven by investments in the fracture market sales channel. We do expect our BGT growth to remain above market growth rates, currently estimated to be 2% to 3% and continue to moderate somewhat as we move forward in 2025 due to our #1 market position in the BGT Spine business and lapping the gains from surgeons acquired last year.

We will continue to focus on adding new surgeons and competitive surgeon conversions and BGT Spine and continue our commercial focus in the BGT fracture market, where we currently have a lower market penetration and see a substantial opportunity to drive new business with orthopedic surgeons. The global Orthopedics business grew 13% to $29.8 million in the first quarter, led by 12% growth in the U.S. as a result of strong performance across our portfolio as well as distributor expansion and sales channel investments.

The international Orthopedics business grew 14% versus prior year. As we've previously said, due to the nature of this business, particularly around the timing and volume of stocking distributor and tender orders, we expect to see variability from quarter-to-quarter in the growth rate. Pro forma non-GAAP adjusted EBITDA, excluding the impact of the discontinuation of the M6 was $11.4 million with pro forma adjusted EBITDA margin expanding approximately 200 basis points compared to reported non-GAAP adjusted EBITDA for the first quarter of 2024.

The discontinuation of M6 which has been a negative drag on our profitability in prior periods, drove the majority of the improvement in the quarter. In addition, we continued our efforts to optimize our shared service functions executing actions to deliver annual savings of $3 million. We remain encouraged by these results as we see our ability to drive leverage on sales growth materializing as we continue to focus on disciplined profitable growth.

From a cash standpoint, our total cash balance including restricted cash at the end of Q1 totaled $60.5 million. As a reminder, the first quarter of each year is always a high cash outflow quarter primarily due to the payment of the prior year's annual bonuses and Q4 commissions. In addition, we had higher than normal cash severance payments related to the discontinuation of M6 and the rightsizing of our shared service functions.

Excluding these items, uses of cash were in line with normal business operations and slightly better than the company's projections. As we said on our last earnings call, Q1 was expected to be the lowest cash flow quarter of the year. While we continue to expect to generate positive free cash flow, excluding the impact of restructuring charges related to M6 discontinuation for the full year 2025, we do not expect it to generate positive free cash flow in every quarter.

As we announced on our Q4 earnings call, we are discontinuing the M6C artificial disc and the M6L artificial lumbar disc product lines. It is important to note that the M6 product lines were a headwind to the company's top line revenue growth rate, gross margin, adjusted EBITDA and free cash flow. This product phaseout is in line with our commitment to direct resources to more profitable growth opportunities. We have posted a pro forma P&L for M6 on our website to assist you with updating your models.

We will update it on a quarterly basis for the remainder of 2025. We expect to have onetime cash restructuring charges of approximately $8 million, primarily due to the closure of the dedicated M6 manufacturing facility in Sunnyvale, California. We expect most of the charges to be incurred during 2025. We will continue to support customer demand in the U.S. market as we burn through remaining inventory. In addition, we intend to fulfill all requirements related to post-market surveillance activities and meet our [indiscernible] with respect to premarket approval of the M6 devices, including completion of the IDE study in the United States, which we expect to have an annual cost in the range of $2 million.

Overall, we continue to be confident in our ability to drive profitable revenue growth moving forward. We remain focused on pursuing the vital few initiatives in our long-range plan and prudently deploying capital and resources to areas where we have a differentiated advantage, all of which we believe will support the achievement of our 3-year financial targets and propel our business forward.

Moving on to 2025 full year guidance. First, regarding tariffs. Recognizing that this is still a fluid situation, we have exposure to tariffs in the EU, Canada, China and Taiwan. We now estimate our annual exposure to be approximately $3 million to $4 million, which is better than our original estimate of $5 million. This estimate includes currently applicable tariffs as well as the additional tariffs that were announced on April 2 by the U.S. that would take effect following the 90-day pause and assume such tariffs remain in place.

This exposure is very manageable primarily reflected in cost of goods sold and are already contemplated in our guidance. We now expect full year net sales of $808 million to $816 million which excludes sales from the discontinued M6 product lines, representing implied constant currency growth of 5% year-over-year at the midpoint of the range.

While we no longer expect foreign exchange rates to have a negative impact, our updated guidance reflects the anticipated short-term impact from the targeted distributor transitions that Massimo discussed earlier, which we believe will set us up for success and generate significant future returns. Our guidance also assumes a $5 million negative impact from U.S. funded nongovernmental organization business as compared to the full year 2024.

This guidance range is based on the current foreign currency exchange rates and do not take into account any additional potential exchange rate changes that may occur this year. We expect the majority of the impact from our revised net sales guidance to be reflected in the second quarter due to the timing of international stocking orders, the anticipated short-term effect of the targeted distributor transitions and the quarterly impact from the reduction of U.S. funded NGO revenue. We continue to expect full year 2025 non-GAAP adjusted EBITDA of $82 million to $86 million, this range includes the anticipated impact from the discontinuation of the M6 product line that was previously announced in February 2025 and represents 190 basis points of EBITDA margin expansion at the midpoint of the range compared to 2024.

We also continue to expect to generate positive free cash flow for the full year 2025 excluding the impact of restructuring charges related to the discontinuation of the M6 product lines. Now for some specifics on individual line items for the P&L for 2025. We expect our gross margin to be approximately 71%, consistent with previous estimates and in line with 2024. We now expect our operating expenses to improve by 200 basis points this year versus 2024 compared to the 100 basis points of improvement we previously communicated.

This improvement is expected to come from our continued focus on disciplined investments as well as lower stock-based compensation and depreciation and amortization. Stock-based compensation is now expected to be in the range of $29 million to $30 million while depreciation and amortization is expected to decrease to $37 million to $39 million for the full year 2025. We still expect interest and other expenses to be approximately $5 million per quarter. Throughout 2025, we will maintain a heightened focus on disciplined, profitable growth and free cash flow generation to build on our financial foundation and prudently deploy capital to create long-term value for our shareholders. Now before we open the call for questions, let me turn it back to Massimo for concluding comments. Massimo?

Thanks, Julie. I want to thank our Orthofix team and our committed commercial partners for their efforts in Q1. We believe our focused commercial strategy and broad differentiated technology combined with a robust innovation pipeline and our pace setting, enabling technologies position us well to drive commercial execution and operational excellence, deliver on our financial commitments and create long-term sustainable value for shareholders. .

I'm excited and energized about the path we have set for ourselves and the opportunities for the business to deliver exceptional value to our surgeons their patient and our shareholders in 2025 and beyond. Operator, let's now open the line for questions.

[Operator Instructions] Your first question comes from the line of Ryan Zimmerman with BTIG.

This is Izzy on for Ryan. So to start out, Mama, I was wondering if you could talk about the rationale for the optimization within the spine channel. What prompted the decision to take this on right now? And if you could put a little bit of a fine point as to how long the process might take? This is a bit of a multipart, so sorry about that.

But are there any chance that these impacts could lead into next year or any implications that we should keep in mind for the long-range plan as a result of optimization?

No, definitely not. To give you more color, we're entering -- when we enter the second year of our tenure, we believe that we are a much stronger footing than when we started. Our balance sheet is very strong. We are making a lot of progress on our EBITDA expansion keep performing, we're redefining the orthopedics and where we are -- as you see, we start to achieve sustainable growth.

So for us, it was the moment to really think about our Spine business, and we want to start to be much more deliberate and intentional and how we see how we go to market. So given our strengths, we realized that our current distribution network was already at capacity from the growth standpoint.

So we are accelerating our transformation by investing in larger, much more capital-efficient commercial partner to drive the long-term growth that we are expecting to create shareholder value. And I can tell you that the commercial pipeline is already primed and ready to deliver substantial revenue growth starting later this year. It's coming with some pain point short term. But again, we believe that we can create a higher growth business now investing in the right partner.

That's helpful. And Julie, I heard your comments on the 2025 guidance, but I was curious what is enabling you guys to maintain our adjusted EBITDA while lowering the top line?

Yes. So as we mentioned, we've been very focused on making sure that we're making investments that have a return. We did do some rightsizing of care service organization at the beginning of the year as well, which was kind of delivering more on our synergies. As you remember, we had about $10 million going into the year remaining on synergies, and we've kind of now taken actions for about an additional $6 million of that. And so a combination of continuing to deliver on our synergies as well as looking at all of our costs and investing in what we're going to get the highest return on.

Our next question comes from the line of Matthew Blackman with Stifel.

Maybe to start, Julie, you mentioned one less selling day. I just want to make sure I get the simple math. That have amounted to something like 1.5 points percent growth headwind or about, call it, $2 million or $3 million of a year-over-year drag in the first quarter. Is that the right ballpark? And then I've got some follow-ups. .

Yes. It was a little bit over 1.5 points of headwind on the quarter growth rate.

Okay. I appreciate that. Any -- and I guess, are there any other quarters this year that we should be sensitive to in terms of days selling days versus last year?

The remaining quarters all have the same days as prior years.

Okay. And then I just want to make sure I wrap my head, arms, whatever you want to use around the moving pieces on the updated guide as well as the first quarter. So revenue for the full year comes down about $10 million at the midpoint, $5 million, I think very clearly, federal funding being cut, the remaining 5 because you obviously mentioned the channel optimization initiatives.

But then you also mentioned the pricing headwind in spine from one particular customer. Can you just maybe put a little bit more detail against each of those buckets. I guess the last piece is of all these disruption. You mentioned some in the first quarter in the Spine and Biologics business and then there's the channel optimization and the pricing. Did we see any of this impact in the first quarter?

So for instance, that $10 million, I know you said a lot of it in the second quarter, but do we already absorb some of that $10 million headwind here in the first quarter? That's -- those are my 3 questions. Sorry about all that.

That's fine. Yes. So let me try to unpack that. So out of the takedown, yes, $5 million is related to the U.S. funded business. The remainder is really Spine and Biologics, I would say, channel disruption. The price we primarily had included in our original guidance. It's a little steeper than we originally, but I would say that was in our original guide.

We did see -- yes, we did take some of that in Q1, both the price and the softness in the distributor channel. We did see some of that in Q1, but we expect the majority of it to be in Q2. And then if you think about the $5 million from NGO that was -- they generally placed a quarterly order, so that's going to spread evenly throughout the year. So we had $1.5 million or so of that in Q1, and you'll see that throughout the remainder of each year, each quarter of this year for that as well as far as we are aware at this point.

Okay. And if I could just add, just to make sure I'm doing all that math right. I mean it sounds like the first quarter, if you add back the selling day difference, which I don't think we had contemplated and then some of those moving pieces, you're sort of excluding M6 still in the low 190s. Is that sort of the right way to think about it, if I just add back some of that..

Yes. Yes, that would be the right way to think about it, Matt.

Our next question comes from the line of Caitlin Conan with Canaccord Genuities. .

Taking the question I guess just to start off, just a quick clarifying question for the NGL impact, where is that going to hit specifically within the different segments? And then just with the guidance change, really, any thoughts on the longer-term guidance and the risk to that staying the same?

Yes. So the NGL business is ortho. So it will be in the international ortho business is where you would see that. And then we are not updating our long-term guidance at this point. we'll provide an update on our Q4 call.

Okay. Great. And then just a follow-up. Any more color on 70 this quarter and kind of the capital environment?

Yes. I mean we're still continuing to make progress with 70. We're focused. Our focus is really on earn-out because we believe that is the best return for us in the long term with the pollster to our spine business but no specific updates as it relates to the capital environment.

[Operator Instructions]

And our next question comes from the line of Jeffrey Cohen with Ladenburg.

I guess 2 for me. I guess firstly, could you talk about AccelStim a little bit. We're particular on timing, but could you talk about some of the functionality that's available on the unit? And could you talk about the form factor and manufacturing [indiscernible] ?

Look, AccelStim 2.0, what it does, it pretty much connections to our -- our physician portal team's on track. So it's going to do what all of the other systems that we sell do. So give the opportunity to the surgeon to keep follow the patient during the utilization of the device to make sure that the patient is compliant and the monitor progress. So I think that this one is going to help us because it give -- like it's something that also the physician -- the physician can bill, it can -- given that there is a DRG code for it. So I get the opportunity for us to keep pushing into the specific market segment.

So there won't be any change as far as the functionality in the settings of the actual unit.

No. It's just the integration with Stim on track.

Got it. Perfect. Okay. And [indiscernible] talk about the true large a little bit as far as the cases that's been done. What's being measured as far as data and outcomes? And how many SKUs would you ambition having when when launching this year. .

Yes, the SKUs of the TrueLok Elevate is pretty much similar to all our other systems. So it pretty much is one is one SKU with some accessories. And right now, we are in a limited clinical release that is doing very well. So we are having a lot of interest of surgeons that are going to help us to collect data to demonstrate the benefit of our -- of this new of this technique. There are already a good amount of literature available about the benefit.

But of course, we want to make sure that we keep pushing this highly differentiable highly differential procedure that can help us to enter a market segment that is pretty large. And also, as said, there are 160,000 amputations that are happening in United States because of diabetes, because of diabetic food. And we think that this procedure can be game changing. So something that we are very excited about. And like I said, already, we did an in cases just in a very limited market release. So a great opportunity for us.

There are no further questions at this time. I will now turn the call back over to Julie Dewey for closing remarks.

Thanks, everybody, for joining us today. We appreciate your time and interest. If you have more questions, please reach out, and we look forward to talking to you next quarter. This concludes our call. .

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.