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DATE

Tuesday, May 5, 2026 at 8:30 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Massimo Calafiore
  • Chief Financial Officer — Julie Andrews
  • Senior Vice President, Corporate Communications — Julie Dewey

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TAKEAWAYS

  • Total global net sales -- $196.4 million, representing 3% pro forma constant currency growth for fiscal Q1 2026 (period ended March 31, 2026), with growth reduced by 1.6% due to one less selling day.
  • Global Spine Fixation net sales -- Increased 6% on a constant currency basis, with U.S. Spine net sales up 4%.
  • Top 30 spine distributor partners -- Delivered 27% year-over-year net sales growth; trailing 12-month growth reached 24%.
  • Therapeutic Solutions (BGT) net sales -- $57.8 million, growing 5% year-over-year, continuing to outperform the broader market.
  • Fracture sales -- Rose 6% during fiscal Q1 2026; management expects growth above market rates of 2%-3% in this channel.
  • Global Limb Reconstruction net sales -- $32.8 million, up 3% in fiscal Q1 2026; U.S. performance was flat due to timing of OSCAR Capital sales.
  • Pro forma non-GAAP adjusted gross margin -- 70.7%, improving by 40 basis points, primarily due to freight and logistics productivity gains.
  • Pro forma non-GAAP adjusted EBITDA -- $9.7 million for the quarter, attributed to geography mix and commercial transitions.
  • Total cash (including restricted cash) -- $120.9 million at quarter-end, with the increase attributed to a draw on the second tranche of the debt facility.
  • Fiscal year 2026 net sales guidance -- $850 million to $860 million, implying approximately 5.5% pro forma constant currency growth at the midpoint.
  • Fiscal year 2026 EBITDA guidance -- Non-GAAP adjusted EBITDA expected in the $95 million to $98 million range, with margin expansion of approximately 70 basis points at the midpoint.
  • Fiscal year 2026 free cash flow forecast -- Expected to be positive, excluding potential legal settlements.
  • Innovation pipeline updates -- VIRATA full market launch on track for second half of 2026; full-year contributions anticipated from TrueLok Elevate and Fitbone platforms.

SUMMARY

Orthofix Medical (OFIX +3.58%) reported fiscal Q1 2026 results that management described as a disciplined start to the year, with operational focus on innovation and commercial execution. The company highlighted the successful realignment of its spine distribution network, noting that distributor transitions are now largely complete. Management emphasized ongoing investments in new technologies, including the planned launch of VIRATA, and expressed confidence in sequential margin improvements driven by targeted product platforms and operational discipline.

  • Julie Andrews stated, "our Q1 growth rate was within the range implied by our full year guidance of 5% to 6%," illustrating alignment with previously communicated targets.
  • Management clarified that international geopolitical disruptions, primarily in the Middle East, had minimal and largely transient impact on results and are not incorporated as a headwind in the guidance for the year.
  • Plans were indicated to apply operational playbooks that succeeded with the top 30 spine distributors to a broader set of distribution partners in 2026.
  • Leadership noted recent changes in Biologics leadership, with the portfolio now overseen by an executive with sector-specific experience aimed at improving execution and account penetration.
  • The company confirmed that future 7D FLASH navigation system placement data will be updated biannually or annually, referencing 30% growth in Voyager earnout placements and accounts exceeding purchase commitments by more than 50% in 2025.
  • Actions taken in the U.S. Limb Reconstruction portfolio included the elimination of 30 low-return product lines and a capital sales team restructuring, with double-digit growth targeted for the second half of 2026.

INDUSTRY GLOSSARY

  • 7D FLASH navigation system: A proprietary intraoperative guidance platform designed to enhance surgical precision and workflow in spine procedures.
  • VIRATA: Orthofix Medical’s forthcoming spine fixation system, scheduled for market launch in the second half of 2026.
  • TrueLok Elevate and Fitbone: Internal limb reconstruction systems used for bone lengthening and alignment corrections.
  • OSCAR Capital sales: Sales of capital equipment related to the OSCAR limb reconstruction platform.
  • Therapeutic Solutions (BGT): Business unit previously known as Bone Growth Therapies, focusing on devices that stimulate bone healing.
  • Voyager earnout placements: Installations of the 7D FLASH navigation units tied to performance milestones outlined in the Voyager acquisition agreement.
  • MTF service fee: Revenue component from Musculoskeletal Transplant Foundation tissue allograft services reported in certain Orthofix Medical filings.

Full Conference Call Transcript

Massimo will start with business performance and operational highlights. Julie Andrews will follow with her financial results and guidance, then we'll open up the call for Q&A. With that, I'll turn the call over to Massimo, who will discuss how our early year execution and recent operational actions are beginning to support improved performance as we move through the year. Massimo?

Massimo Calafiore: Thank you, Julie. And good morning, everyone. I appreciate you joining us today. We delivered a good start to 2026. First quarter results reflect steady execution, improving stability and sharper strategic focus. As the quarter progressed, we began seeing the expected progress from our spine commercial channel actions, along with stronger operating discipline, supporting our confidence that performance will continue to build through the year. While these results reflect meaningful progress, they also crystallize where we could further raise the bar. That's why in April, we took deliberate steps to simplify our spine leadership structure, a proactive move as we continue to scale, enabling technologies like 7D and advance the launch of VIRATA later this year.

By bringing decision-making closer to the field and increasing accountability through direct oversight, we're improving speed, consistency and commercial focus where it matters the most. Stepping back, Q1 reflects where we are as a company today, moving into the next phase of our journey, executing with greater consistency and strengthening our position to benefit from our innovation pipeline as the year unfolds. What we delivered this quarter supports our confidence in continued improvement. Our priorities are straightforward: execute consistently, convert opportunity into results, and demonstrate progress quarter-by-quarter. Let me turn to business performance highlights, starting with Spine. In Spine, Global Spine Fixation net sales grew 6% on a constant currency basis, with U.S. net sales growth of 4%.

Results were supported by enhanced commercial focus, deeper procedural penetration and the ongoing benefits of our distributor transitions. Importantly, those transitions are now largely behind us. As alignment has improved, we are seeing positive momentum from more consistent field execution. In Q1, our top 30 distributor partners delivered net sales growth of 27% year-over-year and 24% on trailing 12-month basis, reflecting the success of our strategy to prioritize larger, more dedicated distributors and deeper relationship with our top partners. A key driver of that momentum is 7D, which remains a core differentiator in our surgical ecosystem, enhancing precision, workflow and surgeon engagement.

Following our leadership realignment, we are intensifying our commercial focus on adoption of our 7D FLASH navigation system to deliver a more integrated spine offering. While Spine is benefiting from better alignment, we are applying the same discipline to Biologics. Performance improved sequentially during the quarter as we implemented targeted actions to strengthen execution, expand account penetration and increase utilization across the portfolio. We are refining our go-forward strategy, building clinical evidence and supporting advocacy. Collectively, these actions are designed to drive improvement through the year and position Biologics to exit 2026 with stronger momentum and a more durable growth profile. Beyond Spine and Biologics, our other growth platforms remained resilient.

Our Therapeutic Solutions business, formerly Bone Growth Therapies, delivered 5% year-over-year net sales growth and continue to outperform the broader market. Demand remained stable, utilization is improving and prescribing activity is increasing across both spine fusion and fracture care. With its consistent performance and healthy margins, this business continues to be an important contributor to margin and cash generation. Global Limb Reconstruction posted 3% constant currency growth, reflecting steady demand across our core fixation and reconstruction systems. Over the past year, we sharpened our focus by prioritizing high-value categories, enhancing our mix with platform like TrueLok Elevate and Fitbone and deemphasizing lower return product. We believe this action positions limb reconstruction for acceleration as we move through 2026.

A common thread across the business is the increasing impact of our innovation pipeline. We will have a full year contribution from TrueLok Elevate and Fitbone, and we remain on track for the full market launch of VIRATA in the second half of the year. Together with the continued inspection of our 7D FLASH ecosystem, this platform are designed to deliver differentiated clinical value and support durable multiyear growth. In closing, Q1 was a solid start of the year. We are carrying that momentum forward with disciplined execution and targeted investment. The quality and the commitment of our U.S. spine distributors is greater than ever and meaningfully contributing to our success. Our innovation pipeline is strong.

Our operating model is more focused, and we believe we have the right team and the financial foundation in place. There is more work to do, and we are increasingly confident in our ability to execute, doing fewer things better, sharpening accountability, generating cash and delivering on what we said we would do. With that, I'll turn the call over to Julie Andrews to review our financial results and guidance.

Julie Andrews: Thank you, Massimo, and good morning. All growth rates I'll reference today are pro forma constant currency, excluding the impact from discontinued M6 product lines. We delivered a disciplined start to 2026 reflecting an execution that is consistent with our plan. For the first quarter, total global net sales of $196.4 million increased 3% year-over-year. Results reflect steady execution following the Spine Commercial channel actions, and we expect further improvement as productivity continues to increase. Spine Fixation was in line with market growth, while Therapeutic Solutions delivered above-market growth largely offsetting the remaining impact of commercial channel transitions and softness in Biologics.

While timing of certain international stocking orders benefited Q1 in results by approximately $2 million, the majority of performance reflected underlying execution across our core franchises. As a reminder, Q1 had 1 less selling day than last year, which reduced first quarter growth rates by roughly 1.6%. In addition, the CMS TEAM pilot program that began in January and includes bone growth stimulation had a onetime impact of less than 0.5% on our fourth quarter growth rate, slightly less than the 1% impact we had originally anticipated. Taking these factors into account, our Q1 growth rate was within the range implied by our full year guidance of 5% to 6%.

From a segment perspective, global spinal implants, biologics and enabling technologies delivered $105.8 million in net sales for Q1. Our performance was supported by continued growth from our top 30 distributors in the U.S., partially offset by the timing of stocking orders from our Middle East distributors due to the impact of the war. Therapeutic Solutions, BGT, net sales were $57.8 million, up 5% as we continued to outperform the market. Fracture sales grew 6% in the quarter. We expect growth to remain above market rates of 2% to 3%, driven by disciplined execution, new surgeon additions and competitive conversions, especially in the fracture channel. Global Limb Reconstruction net sales were $32.8 million in the first quarter, up 3%.

U.S. performance was flat, largely due to the timing of OSCAR Capital sales. We have recently restructured our capital sales team, which we believe positions us for future growth. Early indicators are encouraging with a strengthening capital pipeline. Additionally, we are seeing continued acceleration in the worldwide adoption of TrueLok Elevate and Fitbone. As we sharpen our focus on our core limb reconstruction pillars and benefit from ongoing portfolio and commercial enhancements, we expect to return to double-digit growth in the U.S. in the second half of 2026. Moving down the P&L.

Pro forma non-GAAP adjusted gross margin was 70.7%, a 40 basis point improvement over prior year, reflecting the impact of freight and logistics productivity improvements, partially offset by unfavorable geography mix. First quarter pro forma non-GAAP adjusted EBITDA was $9.7 million, in line with our expectations, reflecting impacts from geography mix and commercial transitions. We ended the quarter with $120.9 million in total cash, including restricted cash, providing ample liquidity to support our operating needs and strategic priorities. The cash increase was a result of financing activities during the quarter, including our draw on the second tranche of our debt facility.

As we move through the year, our focus remains on disciplined execution, strengthening our commercial foundation and supporting upcoming product launches that we expect to contribute to growth and margin improvement over time. Now let me turn to our full year 2026 guidance. Against the backdrop of our fourth quarter performance and current visibility, we are reaffirming our full year 2026 guidance. As Massimo noted, we expect performance to improve as we move through the year, driven by a steadier commercial cadence and increasing contributions from recent and planned product launches balanced against macro and operational considerations. Net sales are expected to range between $850 million and $860 million, representing approximately 5.5% pro forma constant currency growth at the midpoint.

Net sales growth is anticipated to be approximately 5% in the first half of the year and about 6% in the second half of the year. These projections are based on current foreign currency exchange rates and do not account for any further changes to exchange rates for the remainder of the year. Non-GAAP adjusted EBITDA is expected to be between $95 million and $98 million, reflecting approximately 70 basis points of margin expansion at the midpoint. Free cash flow is expected to be positive for the full year, excluding potential legal settlements. In closing, while progress is evident, we are still early in the year and remain focused on converting improved activity levels into consistent above-market profitable growth.

We remain grounded in operational rigor, disciplined capital deployment and prioritizing high-value opportunities across our Spine, Therapeutic Solutions and Limb Reconstruction portfolios with the objective of creating sustainable long-term shareholder value. Now let me turn it back to Massimo for closing remarks. Massimo?

Massimo Calafiore: Thank you, Julie. I am pleased with the progress we made in the first quarter and our anticipated trajectory for the remainder of the year. As we move through 2026, our focus is clear: deliver quarter-by-quarter progress, expand margins, generate cash and translate our innovation and execution into durable shareholder value. Before we open the line for questions, I want to thank our global teams and commercial partners for their performance in Q1 and their continued focus and execution as we continue to build Orthofix into their unrivaled partner in medtech, delivering exceptional experience and life-changing solution. With that, let's go ahead and open the call for your questions.

Operator: [Operator Instructions] Your first question comes from the line of Tom Stephan with Stifel.

Thomas Stephan: Nice start to the year. First question on U.S. Spine. Massimo, you talked about the distributor transitions now largely behind you. U.S. Spine up 4%, probably a bit stronger adjusting for selling days. So Massimo, maybe talk about how we should think about growth in this business as we move through 2026 and beyond as well would be helpful. And then I have a follow-up.

Massimo Calafiore: As we described 2026, you're going to see an acceleration of the business towards the year. I think that you have a couple of drivers. All of this, you're going to see a phase out of the annualization of the distributor termination that we made in order to optimize our distributor infrastructure, so a natural acceleration there. But also, as you know, we have a very focused and strong innovation pipeline that is coming. We are on time for the full market launch of the VIRATA open system and on time on the alpha launch of the VIRATA MIS.

So we're going to see a very good strong contribution of these two foundational systems for us in the second half of the year. So the combination between innovation, annualization of the distributor transition and key capital investment that we're making, I'm very confident they're going to drive a very strong 2026. And as you know, we made -- we shortened, let's say, the distance between myself and the business. I think that the optimization on the leadership side has let me be very close to the field, very be present and keep nurturing the talent that we have. So I'm very excited about where we are with Spine.

And we made bold decisions to create a strong foundation and now it's on us to execute.

Thomas Stephan: Got it. That's great. Super helpful, Massimo. And then my follow-up just on sort of guidance and cadence for rest of the year. Julie, this may be for you. By reaffirming 1H constant currency growth of 5%, you did 3% in 1Q. I guess, do we think about 2Q as around 7% constant currency? I just want to make sure I'm contextualizing the 5% correctly for 1H. A, is that correct? And then B, for 2H, any comments on selling day dynamics, maybe other fundamental considerations sort of from a headwind perspective in the back half that we should be mindful of for top line?

Julie Andrews: Yes, so Tom, we are reaffirming our guidance. Our comments were we do expect growth in the first half of the year to be around the 5% and then accelerating to 6% in the second half of the year. And if you look at Q1, when you adjust it for the selling day, 1 less selling day, and the TEAM's impact, we were right at kind of that 5% growth rate in Q1. In Q2, we would expect our growth rate, I think, to be in the 6-ish percent, 6% range would get you there for Q2.

Operator: Your next question comes from the line of Caitlin Roberts with Canaccord Genuity.

Caitlin Cronin: Maybe just a little bit more color on the geopolitical impact in the Q1. And then just any expectations that might be built into the guidance there?

Julie Andrews: Caitlin, so built into our guidance, we expect very minimal impact for the full year related to the activities in the Middle East. Q1, there was a little bit of what we see as timing just in our Spine business primarily with orders, but kind of more than made up for with other stocking orders. So very limited impact that we have from that and not necessarily in our guidance for the year.

Caitlin Cronin: Understood. And then maybe just talk a little bit about putting the Biologics business under the Limb recon leadership and where you would expect Biologics growth to end 2026?

Massimo Calafiore: For Biologics, I think that we are expecting to go back to market growth. It's clear that we have still work to do. But since the realignment, the performance has improved sequentially during the quarter. So the targeted actions that we are putting in place are working. We have strengthened the execution. We expand account penetration. And also, we increased the utilization of the portfolio, as you hinted before, not just in spine, but also in the orthopedic side. So I'm very confident about the quality of our Biologics portfolio. I think that the optimization that we are putting forward in terms of sales channel and leadership is working. But let me highlight a specific comment that you made.

It's not a realignment under orthopedics. It's more a realignment under a leader that is Patrick Fisher, who has a lot of experience in the space. So of course, as I said before, you're going to see a natural expansion in the orthopedic side, but the idea of the realignment was mostly driven by the talent and the experience that we have in the company around this specific space.

Operator: Your next question comes from the line of Mathew Blackman with TD Cowen.

Mathew Blackman: Can you hear me okay?

Massimo Calafiore: Yes.

Mathew Blackman: Two little housekeeping questions for Julie, and then one question for Massimo. Julie, you didn't call it out, so I'm assuming it wasn't a headwind, but any impact from weather in the quarter? And also there was a big hospital strike on the West Coast. Just any other headwinds to call out besides the ones you did mention already? And then can you give us just a sense of the size of the Biologics business, even the roughest sense, whether it's as a percent of the total business or a percent of Spine, just for some context there, and then a follow-up for Massimo.

Julie Andrews: Okay. Matt, no, we didn't see any sustained impact from the weather, and we didn't have an impact from the hospital strike on the West Coast. So those did not impact our business. From a Biologics perspective, we don't break that out separately. So I can't give you a context in terms of the size. I think I'd point you to a couple of places, you can look at pre-merger results, and then also a portion of our Biologics revenue, you can see in our Q with our MTF service fee for that portion.

Mathew Blackman: I'll remember that. And then Massimo, as you sort of look at the top 30 distributors, obviously, tremendous performance there. Is there anything that you can take from that playbook and pour it over to the rest of the distributor book, such that you can sort of bring along that rest of the business? I mean, obviously not sort of approaching 30% growth. But anything that you could do to sort of bring up the tail of the business now that you're seeing, obviously, really solid execution on a large part of the business there. Just curious how you can execute across the entire distributor network now.

Massimo Calafiore: The plan that we put in place was divided in different phases. Phase number one is the one that we just accomplished. Now phase number two is really started to pick among the networks that we have, the next tier of distributors that we want to help to grow. And as you hinted, we're going to apply the same discipline and rigor that we apply for our top 30 distributors to the second tier to make sure that over time, they can grow and create the operational excellence we are expecting by our partner.

But 2026 is going to be mostly for us working on the next 30, more than -- keep fueling the growth with our top 30 and laser-focused on the second tier.

Operator: [Operator Instructions] And your next question comes from the line of Mike Petusky with Barrington Research.

Michael Petusky: I'm juggling on a couple of conference calls, I may have missed this. Did you guys give any detail around 7D placements, any percentages or just any detail around that this morning?

Julie Andrews: Mike, we're doing that more on a biannual or annual basis updating this. So our last update on those were in our Q4 call. And as a reminder, for 2025, our Voyager earnout placements increased 30%. And our purchase commitments on those placements exceeded their purchase -- the accounts exceeded their purchase commitments by more than 50%.

Michael Petusky: Okay. And then I guess I just want to ask around U.S. Ortho or Limb Reconstruction. It feels like the momentum has slowed there last couple of quarters. Can you guys speak to that and maybe speak to actions that you may be taking to try to reaccelerate growth there?

Julie Andrews: Mike, the momentum hasn't slowed. We've had some transient issues or things that we're dealing with. So we did sunset about 30 product lines last year. We really saw that start to impact in Q4. And then we talked -- and continue some into Q1 as well. And then really the timing of OSCAR sales, which is a capital sale, in Q1 impacted the overall growth rate. But very good results and adoption that we're seeing on Elevate and Fitbone. So again, we expect that business to return in the U.S. to double-digit growth in the back half of 2026.

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

Julie Dewey: Thank you for your questions and for joining us today. We appreciate your time and interest in Orthofix. If you need any additional information, please reach out. We look forward to updating you next quarter. This concludes today's call.

Operator: Ladies and gentlemen, thank you all for joining. You may now disconnect.