speaker
Operator
Conference Operator

Good day and welcome to the Integra Life Sciences fourth quarter 2025 financial results. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1. To remove yourself from the queue, press star 1-1 again. This call may be recorded. I would now like to turn the call over to Chris Ward, Senior Director of Investor Relations. Please go ahead.

speaker
Chris Ward
Senior Director, Investor Relations

Good morning, and thank you for joining Integral Life Sciences' fourth quarter 2025 earnings conference call. With me on the call are Melissa Pohl, President and Chief Executive Officer, and Leah Knight, Chief Financial Officer. Earlier this morning, we issued a press release announcing our fourth quarter 2025 financial results. The release and corresponding earnings presentation, which we will reference during the call, are available at IntegralLife.com under Investors, Events and Presentations, 2025 earnings call presentation. Before we begin, I want to remind you that many of the statements made during this call may be considered forward-looking. Factors that could cause actual results to differ materially are discussed in the company's exchange tax reports that are filed with the SEC and in the release. Also in our prepared remarks, we will reference reported and organic revenue Unless otherwise stated, all disaggregated and franchise-level revenue growth rates are based on organic performance. Lastly, in our comments today, we will reference certain non-GAAP financial measures. Reconciliations of non-GAAP financial measures can be found in today's press release, which is an exhibit to Integra's current report on Form 8K filed today with the SEC. And with that, I will now turn the call over to Moshe.

speaker
Melissa Pohl
President and Chief Executive Officer

Good morning, everyone, and thank you for joining us for our fourth quarter 2025 earnings call. Before I review our 2025 performance and outline our priorities for 2026, I want to briefly acknowledge the recent Supreme Court decision and the administration's announcement regarding new Section 122 tariffs. While these are meaningful developments, there remains substantial uncertainty around the implementation and timing. As a result, Our 2026 full year and first quarter guidance do not incorporate these tariff changes. We are actively monitoring the situation, and Leah will provide more details and context in her remarks. In the fourth quarter, we advanced our transformation, continued to deliver for our customers and patients, and met our financial commitments with revenue of $435 million and adjusted earnings per share of 83 cents. both above the midpoint of our guidance range. This performance builds on a year of meaningful operational and strategic progress. During the year, we further strengthened our quality management system, advanced our compliance master plan, and progressed execution of our risk-based remediation plan while maintaining constructive engagement with the FDA on our warning letter commitments and routine inspections. We also improved supply reliability, enhanced our execution capabilities, and delivered significant outcomes in key supply chain resiliency efforts. Additionally, we advanced our In China for China strategy, completing submission of our initial regulatory requirements. These accomplishments, supported by our portfolio prioritization and disciplined capital allocation, are reinforcing the foundation for future growth and innovation. I want to thank our employees for their significant contributions throughout 2025. Their efforts and steadfast focus on our purpose and our customers have been instrumental in solidifying our foundation and positioning us well for the opportunities ahead. Throughout 2025, we took several important steps to strengthen our company. We welcomed six new leaders to our executive leadership team, adding depth and capabilities that collectively represent decades of global MedTech experience, supporting our focus on quality, execution, and long-term growth. We improved our quality and manufacturing organizations and established operating mechanisms that are driving disciplined execution. We created a transformation and program management office that is focusing the organization on our most important priorities and driving greater accountability across the company. We also launched a supply chain control tower providing daily visibility into key operational metrics and performance across our global network. These mechanisms are already translating into improved operational performance. Our manufacturing resiliency efforts are delivering meaningful yield and supply improvements in Integra Skin and in rebuilding safety stock across critical product lines. We also completed the early relaunch of Primetrix Indoor Repair through a dual sourcing strategy with strong reception from our customers. In parallel, we continued our investment and progress in innovation and clinical evidence. We launched the Mayfield Ghost in the U.S. and received an expanded indication for KUSA clarity in cardiac surgery. We also advanced key clinical evidence programs in support of our wound care portfolio growth and are seeing a meaningful early start in the era of pediatric registry, part of our ENT business. As part of the next phase of our transformation, we have put in place a new operating model to reduce complexity and improve efficiency, alignment, and accountability. Some of the changes associated with the implementation of this new model have impacted our team members. We care deeply about our people and do not take these decisions lightly. These changes are necessary to deliver consistently for our customers and their patients while ensuring the long-term growth, profitability, and success of our company. We remain disciplined in balancing the investments required to strengthen our foundation with improved profitability and cash flow, enabling us to reduce our balance sheet leverage in 2026. If you turn to slide five, you'll see how our long-term value creation model is defined by two parallel reinforcing horizons. As we look to 2026, we are focused on four strategic imperatives that guide our priorities, actions, and resource allocation. These are delivering best-in-class quality, driving supply chain reliability, accelerating growth, and igniting innovation. Delivering quality and supply chain reliability have been and will continue to be the focus of the first horizon of our transformation, while accelerating growth and innovation define horizon two. Both horizons are critically important for our longer-term sustainable growth, profitability, and value creation. Importantly, these two horizons are not binary. We are executing priority programs that support both horizons. While Horizon 1 remains focused on strengthening quality, supply chain reliability, and execution discipline, we are also selectively investing in targeted growth and innovation initiatives that support our growth acceleration in Horizon 2. We will accelerate growth in Horizon 2 by innovating and expanding category leadership where we have clear differentiation and by investing in opportunities that are aligned with our portfolio prioritization. We will continue to build our new product pipeline, advance clinical evidence, and pursue category expansion to drive sustainable growth into the future. A growth priority for us this year is to bring our key products back to the market. We remain on track to have the new Braintree manufacturing facility online by the end of June with equipment qualification and validation progressing as planned. Once operational, Braintree will support the build-out of the inventory to enable the return of Surgimen to the market in the fourth quarter of 2026. Upon receipt of TMA approvals for both Surgimen and Dorazorb, we will have a compelling portfolio of biologic and synthetic products that can capture a meaningful share of the large and growing market for implant-based breast reconstruction. We have additional growth opportunities in outpatient wound care following the CMS reimbursement changes that went into effect on January 1st of this year. These changes have created a level and economically rational playing field in the outpatient setting. Our portfolio was already aligned to the new reimbursement levels, and along with our strong clinical evidence and presence in hospital-based care, we are now uniquely well-positioned to broaden our reach across all sites of care. Lastly, but importantly, impactful innovation and clinical evidence generation remain central to our growth strategy. We are strengthening R&D processes, program management, and execution discipline. Portfolio prioritization is directing investments towards a focused set of high-growth, high-margin opportunities where we have a clear right to win. To accelerate innovation with greater focus, speed, and impact, we recently added a chief technology officer role to our executive leadership team. Teshar Elavia joined Integra in February as the Chief Technology Officer and brings us more than 20 years of MedTech R&D experience, most recently as Vice President of R&D at Beckton Dickinson. Looking ahead, we see continued demand for our products and our future innovations. As we further strengthen our quality management system, supply reliability remains the main driver of performance predictability for us. The progress achieved in 2025 gives us confidence for the year ahead, and we are excited about Integra's long-term growth and value creation prospects. With that, I will now turn the call over to Leah.

Disclaimer

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