Orthofix Medical Inc. Common Stock (DE) 2026 Q2 Earnings Call

Thank you. Good morning, everyone. Welcome to Orthofix's second quarter 2026 earnings call. I'm Julie Dewey, Orthofix's Chief IR and Communications Officer. Joining me today are President and Chief Executive Officer, Massimo Calafiore, and Chief Financial Officer, Julie Andrews. Earlier today, Orthofix released its financial results for the second quarter ended June 30th, 2026. A copy of the press release and supplemental presentation are available on our investor relations website. A replay of this call will be posted shortly after we conclude. Before we begin, please note that our remarks include forward-looking statements. These statements involve risks and uncertainties, and actual results may differ materially. 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. We will also reference certain non-GAAP financial measures during today's call, including certain growth rates presented on a pro forma constant currency basis and excluding discontinued M6 artificial disc product lines. Reconciliations to the most directly comparable U.S. GAAP measures and additional information are included in our press release and supplemental materials. Here's today's agenda. Massimo will start with business performance and operational highlights. Julie Andrews will follow with our financial results and guidance. We'll open the call for Q&A. With that, I'll turn the call over to Massimo to discuss our second quarter performance and the progress we're making across our strategic priorities.

Massimo? Thank you, Julie. Good morning, everyone.

I appreciate you joining us today. Our second quarter results provide further evidence that the operational actions we have taken over the past year are showing up more clearly in the business. While that progress is encouraging, our transformation remains a work in progress, and we are staying disciplined in how we evaluate growth quality, commercial productivity, and returns. We delivered 5% pro forma constant currency net sales growth over prior year and saw encouraging trends across several areas of the portfolio, including double-digit growth in global limb reconstruction and spine fixation, sequential momentum in biologics, and the restoration of Medicare reimbursement for bone growth stimulators, which removes a meaningful headwind for our therapeutic solutions business as we enter the second half of the year.

While we recognize that transformations are rarely linear and not every part of the portfolio will improve at the same pace, we believe Orthofix today is operating from a stronger position than it was a year ago. Our approach remains disciplined and focused. We believe the underlying drivers of our performance are becoming more constructive, supported by clearer execution priorities and better visibility in key parts of the business. With that context, let me walk through our business performance in Q2, starting with Spine. In Spine, global Spine fixation net sales grew 10% on a constant currency basis, with U.S. Spine fixation net sales up 3% in the quarter. Our top 30 distributors, who represent approximately 80% of our Spine fixation sales, continued to perform well. At the same time, we saw a steeper decline across the remaining smaller distributors, where productivity has been below our expectation for several quarters.

We are actively evaluating where we can generate the best long-term returns among this group. As part of the process, we are being disciplined about where we invest resources and where we may choose to consolidate or exit relationships that are not delivering sustainable growth. This approach reflects our focus on profitable growth and strong returns. We expect these challenges with our smaller distributors to continue through the balance of the year. Longer term, our objective is to build a higher quality, more productive distributor network that can support sustainable growth, stronger adoption of new products, and better returns on future commercial investment. We are also preparing to bring new innovation into the channel. We completed our first clinical cases with our VIRATA minimally invasive system in Q2, and are continuing to prepare for the full market launch of our VIRATA spinal implant system later in the fourth quarter.

Importantly, the initial surgeon feedback has been encouraging and supports our continued focus on building an integrated procedural platform that combines VIRATA with our interbody solution, surgical access technology, a 7D enabling technologies portfolio. Beyond Spine, we believe early signs indicate that our focused execution is contributing to better performance in areas that had been under pressure. In Biologics, we saw encouraging signs that the business is moving in the right direction. Net sales were approximately flat year-over-year, represented a market improvement from the contraction we experienced through 2025. This was the second consecutive quarter of improved year-over-year performance, moving from double-digit declines last year to approximately flat performance in Q2. While we are encouraged by this progress, we believe more consistency is needed before declaring a sustained return to growth.

Our priority now is converting this more constructive trajectory into durable growth, supported by stronger account engagement, higher utilization, and targeted commercial focus around key product such as OsteoCove bioactive synthetic bone graft. To further support the long-term growth potential of the business, we are pairing improved commercial execution with targeted investment in clinical evidence generation for OsteoCove and Virtuos and product registry for Strand Plus. This investment is intended to support a more durable recovery. We saw a different but equally important dynamic in Therapeutic Solutions, where underlying demand remained resilient despite the reimbursement pressure that affected part of the quarter. Therapeutic Solutions, formerly Bone Growth Therapies, delivered 3% year-over-year net sales growth, despite the impact from the Medicare reimbursement decrease that was in effect for a portion of the second quarter.

That performance reinforces the durability of the franchise, which continued to benefit from steady demand, a strong margin profile, and favorable cash generation characteristics. We were also pleased that CMS restored Medicare reimbursement for bone growth stimulator to its prior level following stakeholder feedback, including concerns we raised. This decision removes a meaningful headwind and supports improved second half visibility, with utilization and prescribing trends during the quarter remaining constructive. As we return to more supportive reimbursement environment, we plan to continue investing in elevating the patient and physician experience within the therapeutic solution franchise. During the quarter, we launched AccelStim 2.0. This award-winning bone growth therapy device was redesigned with a streamlined form factor to provide enhanced ease of use.

It is now compatible with our STIM onTrack mobile app, a STIM MD physician platform, giving patient and physician greater visibility into device utilization and therapy progression, further strengthening the value proposition of the franchise. We view therapeutic solutions as more than a highly profitable franchise. Its established physician and patient reach provides a valuable channel for evaluating adjacent growth opportunities where we see clear clinical relevance and attractive returns. Global limb reconstruction demonstrated solid performance during the quarter, supported by strong international momentum and sustained demand across key product families. Net sales grew 11% on a constant currency basis, led by the TrueLok Elevate and Fitbone. In the U.S., growth was below our expectation, but the primary dynamic was not a lack of clinical interest. Rather, we are still building the commercial infrastructure required to more consistently convert that interest into revenue in what remains an emerging limb reconstruction market.

Our focus is on improving distributor productivity, expanding market development activities, increasing commercial consistency. As those capabilities mature, we expect U.S. performance to become more consistent over time. We also see opportunities to extend our limb reconstruction expertise into adjacent areas of unmet clinical need. One example is diabetic foot ulcers, a large and underserved market where we believe our core technologies may have broader clinical applications. Our near-term focus is on generating the clinical evidence needed to support a potential expanded indication while maintaining a disciplined approach to investment and development. We view this as an important pipeline opportunity that could expand the reach of our limb reconstruction portfolio and support durable long-term growth. To recap, Q2 showed tangible progress in several areas of the business while also reinforcing where continued execution is required.

Our focus remains on improving quality of revenue, strengthening commercial productivity, and building a more consistent path to profitability and cash generation. Just as importantly, we believe the combination of focused innovation, a more productive commercial organization, and disciplined capital allocation position us to create sustainable long-term value for shareholders. With that, I'll turn the call over to Julie Andrews to review our financial results and guidance.

Thank you, Massimo, and good morning. For purposes of consistency, the growth rates I'll reference today are on a pro forma constant currency basis and exclude the impact from discontinued M6 product lines. From a financial perspective, Q2 results reflected improving revenue trends across several areas of the portfolio, while profitability was impacted by geographic mix and continued investment in priority growth initiatives. Let me briefly review performance by business segment. Global spinal implants, biologics, and enabling technologies generated $109 million in net sales, an increase of 4% versus the prior year period. Growth was led by spine fixation, which benefited from continued international momentum and timing of international distributor orders. Therapeutic solutions generated $64.2 million in net sales, up 3% year-over-year. The business grew despite temporary reimbursement pressure, reinforcing our view that underlying demand remains resilient.