11/4/2025

speaker
Regina
Conference Operator

Thank you for standing by. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the OrthoFix third quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star and the number one on your telephone keypad. To withdraw your question, press star one again. We kindly ask that you please limit your questions to one and one related follow-up. I'd now like to turn the conference over to Julie Dewey. Please go ahead.

speaker
Julie Dewey
Chief IR and Communications Officer

Thank you, Operator, and good morning, everyone. Welcome to OrthoFix's third quarter 2025 earnings call. We appreciate you joining us. I'm Julie Dewey, OrthoFix's Chief IR and Communications Officer. Joining me on the call today are President and Chief Executive Officer 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 investor 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 investor section of our corporate website shortly after the conclusion of this call. During this call, we'll 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 third 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 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. We have posted a pro forma P&L excluding M6 on our website to assist you with updating your models. We will update it on a quarterly basis for the remainder of 2025. 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 third quarter results and our 2025 financial guidance before we open it up for questions. With that, I'll now turn the call over to Massimo.

speaker
Massimo Calafiori
President and Chief Executive Officer

Thank you, Julie. Good morning, everyone, and thank you for joining us today. OrthoFix delivered another strong quarter, reinforcing our track record of consistent execution and financial discipline. We achieved solid year-over-year and sequential revenue growth led by strong performance in our USA spine and orthopedics businesses. This marks our seventh consecutive quarter or adjusted EBITDA margin expansion and sustained positive free cash flow generation. clear evidence of our disciplined approach to operational efficiency and cost management. In our US spine fixation segment, net sales increased 8%, with procedural volume up 10%, both ahead of Q2 and the prior year. This above market growth was fueled by the continued adoption of our 7D flash navigation system and strong momentum across our spine portfolios. Lateral grew 24%, while posterior cervical and anterior lumbar both grew 17%, and MIS lumbar grew 18%. We are seeing encouraging momentum from recent distributor transitions, which are expanding our commercial reach. Our top 30 US distributor partners grew net sales 25% year-over-year in Q3 and 33% on a trailing 12-month basis. A clear validation of our go-to-market strategy and its ability to unlock accelerated growth. As we continue to optimize our channel, we are confident this trajectory will drive further market share gains and long-term value creation. 70 unit placements in the US are up year-to-date compared to prior year, and our Voyager earn-out program continues to outperform, with customers surpassing their purchase commitments by over 50% on average. The 7D technology remains a key differentiator, enhancing surgical precision and workflow efficiency, and is central to our ability to win shares in a competitive market. Let's turn to one of the most exciting developments in our spine portfolio, the limited market release of our new Virada spinal fixation system. Every aspect of Virada, from our proprietary pedicle screw design to intuitive instrumentation that integrates seamlessly with 7D flash navigation, is engineered to optimize the surgical workflow, boost surgeon confidence, and accelerate procedural adoption. All key differentiator that we fully intend to capitalize on to capture market share. To put this into perspective, the US pedicle screw market valued approximately 2 billion 2025 is projected to grow at a steady 4% to 5% CAGR through 2030, fueled by an aging population and increasing spinal disorders. Like our successful NorthStar posterior cervical system, we believe Virada will set a new standard in pedicle screw fixation. Driven by its integration with 7D, we expect Virada will become a meaningful growth driver following its fully launch in the second half of next year. And beyond Virada, we are advancing our data-driven deformity strategy with access to preoperative planning and patient-specific routes beginning in Q1 of next year, further strengthening our competitive edge. Our orthopedics business also had a standout quarter, with U.S. orthopedics growing 19%, marking the fifth consecutive quarter of double-digit growth. This performance was driven by the successful global launch of TrueLock Elevate and supported by new product introductions, including the FITBON bond transport, and the FITBON trochanteric lengthening nails. We are proud to be the only company in the US offering a complete suite of internal and external limb reconstruction solutions. And our dedicated focus on this $2.6 billion market is yielding strong results. Our bone growth therapies, BGT teams, continues to excel, delivering a bone market growth of 6% by leveraging cross-selling opportunities and multiple access points to reinforce our market leadership position. Looking ahead, we remain focused on three strategic priorities. sharpening commercial execution to drive deeper market penetration, and adoption of our 7D flash navigation system, improving gross margin through targeted operational initiatives, and maintaining disciplined capital allocation with a continued focus on adjusted EBITDA expansion and free cash flow generation. As we look towards 2026, I believe we are well positioned for our next phase of profitable growth. With a streamlined, differentiated product portfolio, optimized spine commercial channel, and unique enabling technologies, we are ready to deliver transformative innovation that benefits both surgeons and patients. With a healthy commercial pipeline, well-defined and transformative innovation roadmap, and strong execution, we believe we have a clear path to sustained growth that outperforms the market, driving margin expansion, free cash flow generation, and positive shareholders' returns. Thank you for your time and continued support. With that, I'll now turn the call over to Julie Andrews to review our third quarter financial results and our 2025 guidance.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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