NuVasive, Inc.

Good day, ladies and gentlemen, and welcome to the Newvasive fourth quarter and full year 2021 earnings conference call. I would now like to introduce your host for today's call, Ms. Juliette Cunningham, Vice President of Investor Relations at Newvasive. Please go ahead, Ms. Cunningham. You may begin.

Thank you. Good afternoon, everyone. Joining me today are Chris Berry, Chief Executive Officer, and Matt Harbaugh, Chief Financial Officer. Chris will provide an overview of Nuvesa's fourth quarter and full year 2021 business results and trends, and Matt will review our detailed financial results and our 2022 financial guidance. Then we'll host a question and answer session. The earnings release, which we issued earlier this afternoon, is posted on the IR section of our website and has been filed on Form 8K with the SEC. We have also posted supplemental financial information on our IR website. As a reminder, this call is being recorded and an archive will be available on our IR site later today. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements which are based on current expectations and involve risks and uncertainties, assumptions and other factors. which if they do materialize or prove to be correct, could cause actual results to differ materially from those expressed or implied by such forward-looking statements. The factors that could cause actual results to differ materially are described in new basis news release and periodic filings with the SEC. Except as required by law, we assume no obligation to update any forward-looking statements or information which speak as of their respective date. In addition, this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included in today's earnings release and in the supplemental information, both of which are accessible from the IR section of New Basin's website. And now I'd like to introduce Chris Berry.

Thank you, Juliette, and good afternoon, everyone. Earlier today, we reported our fourth quarter and full year 2021 financial results. On today's call, I'll provide an overview of 2021 and why I'm excited about 2022, including product innovation updates and our commercial progress to deliver growth and shareholder value. Matt will share additional details on the fourth quarter and full year 2021 performance, as well as 2022 financial guidance. Our progress during the fourth quarter and in 2021 reflects how our market leading product portfolio and new product introductions are advancing the company strategy. I'm excited about how our investments over the past three years have positioned us to accelerate growth in 2022 and beyond. For the full year, our 2021 net sales came in at $1,139,000,000. an increase of 8.4% on a reported basis or 8.1% on a constant currency basis compared to the prior year. In a challenging environment, we grew our U.S. spinal hardware and U.S. surgical support business lines and delivered strong performance in our international business. Specifically, our core spine business in Asia Pacific, Europe, and Latin America delivered double-digit growth for the year. which reflects our progress to globalize our business in key strategic markets. As I've shared before, we have multiple vectors to drive growth. And during the fourth quarter, you saw us make progress on our strategy to extend our leadership position in less invasive surgery, take share in subsegments where we historically had underrepresented market share, deliver differentiated innovation in enabling technology, and grow our international business. In less invasive spine surgery, we have continued to invest into comprehensive, procedurally integrated solutions that provide surgeons the flexibility to treat any patient pathology with any procedural offering, all from Nuvasiv. Our clinically validated solutions help address the interior and posterior column from a lateral or prone position. We are well positioned to extend our market leadership in the $900 million anterior and $1.6 billion posterior spine subsegments. In support of XLIFT, the industry's only lateral procedure proven with 15 years of clinical evidence, we're excited about MODX XLIFT, our next generation expandable inner body for lateral spine surgery. This expandable inner body is manufactured with the latest technology from Advanced Materials Science research and development team. And we'll begin clinical evaluations in 2022. A key focus area within our X360 portfolio for single position lateral surgery is our X-ALIF procedure. We've seen continued growth from X-ALIF through increased access surgeon training and new product introductions, including modulus ALIF, and we are now the market leader in ALIF. We also expect growth from our TLIF portfolio, and we're expanding our offerings in 2022 to feature new technologies. ModXPL, our next generation expandable antibody for posterior lumbar procedures, will begin clinical evaluations in 2022. The Nevasiv tube system, a tubular retractor system designed to support less invasive posterior decompression infusion procedures, is scheduled to launch in the second half of 2022. These technologies help extend our market-leading TLIF portfolio. Our investments to deliver growth in the $2.6 billion cervical subsegment paid off in 2021. Our C360 portfolio delivered double-digit growth in both the fourth quarter and full year 2021, led by an invasive simplified cervical disc and an invasive anterior column plating system. The simplified disc has been well received by our surgeon partners, and I'm pleased to announce we exceeded our initial expectations for net sales in 2021. With the simplified disks now integrated into our supply chain, we've expanded capacity and expect future growth for this highly differentiated technology. Our investments to create a world-class manufacturing facility have provided a unique capability to integrate current and future technologies into our global operations. We received initial FDA PMA approval to move simplified manufacturing to our Ohio facility, and we have additional PMA approvals needed for assembly and packaging. which we expect in late 2022. To further extend our cervical portfolio, we expect to launch Relined Cervical, our next-generation posterior cervical fixation system, in the third quarter of 2022. Relined Cervical builds off the Relined Fixation System, one of Spine's most comprehensive fixation systems on the market, offering procedural versatility and compatibility with the Pulse platform. With our ACP system, Simplified Disc and Relined Cervical we anticipate continued strong performance from the industry's most innovative cervical portfolio. Moving to enabling technology, the Pulse platform continues to achieve key milestones following its commercial launch in the third quarter of 2021. With customer sites up and running across the United States and our first European commercial contracts received in the first quarter of 2022, hospitals and surgeon partners see the unique value of Pulse's software ecosystem that integrates multiple hardware technologies into a single platform. Pulse's seamless workflow provides surgeons the ability to utilize multiple technologies in a single procedure, providing utility in 100% of spine surgery cases, and helping to deliver improved operational, financial, and clinical outcomes. Operationally, the Pulse platform is a single unit of capital equipment with two fixed screens, wireless device connectivity, and multiple integrated software technologies. The reduced footprint in the operating room provides increased efficiency for the surgeon and staff. Financially, Pulse's extensible nature maximizes the hospital's investment. Through an initial purchase, providers can add future surgical applications from Nuvasiv and third-party partners that will integrate with the platform. And clinically, our internals testing shows navigation accuracy error rates are significantly lower than other leading navigation systems on the market. Our R&D teams are completing the next system-level software release for the Pulse platform, launching in the second quarter of 2022. The upcoming software release will include further integration with Siemens Healthineer's CO-SPIN 3D Mobile C-ARM and additional capabilities to improve remote system upgrades in support of customer go-live efforts. Pulse increases the procedural value across our entire spine portfolio. The value proposition of the platform is reflected in the growing global commercial pipeline in the United States, Europe, and Asia Pacific. As the excellent procedure defined much of our past success, the Pulse platform will help redefine who we are today and has the potential to change the future of spine care. International continues to be a significant growth contributor for the company through disciplined commercial operations and execution. We expect to see continued growth from our international core spine business in 2022, led by our teams in Europe, Japan, and Asia Pacific, as well as from our new invasive specialized orthopedics portfolio, which we are continuing to return to market in key geographies. And as we grow globally, we know that we must be mindful of the impact we have on the world around us. To support our social responsibility efforts, we recently published the company's first environmental, social, and governance report, which outlines our commitment to make a difference around the world. In our ESG report, we discuss our mission to manage our business ethically and responsibly, and the many actions we've taken to keep our employees safe and healthy, minimize our environmental impact, and give back to our communities. We recognize we have more work to do, and we will continue to lay the foundation to advance our sustainability efforts. In closing, I believe we are well positioned to win. When I joined the company three years ago, we were primarily focused on a single subsegment of spine. We are now set up with multiple vectors of growth and possess the industry's most comprehensive portfolio of procedurally integrated solutions. We've evolved as a company, and our evolution will continue in 2022 and beyond, as we help define the future of spine surgery. We have made purposeful investments to ensure that our portfolio is highly differentiated in anterior, posterior, and cervical spine surgery, and further complemented by enabling technology. Our R&D, marketing, and commercial efforts are aligned to target subsegments where we have historically been underrepresented. Our R&D pipeline reflects an increasing shift towards software-related and breakthrough innovation. And our commercial organization has the leadership and infrastructure in place to increase customer density. I'm proud of our company's response through another challenging year. While we can't control the macro environment, as the potential future impact of COVID-19 continues to be unknown, we can control how we lead our organization through these critical times. To that end, I believe our strategic plan and investments are paying off through the successful market response to the C360 portfolio, growing utilization and commercial pipeline of the Pulse platform, and best-in-class product introductions in 2022 across each spine subsegment. We remain focused on executing on our strategic plan to deliver growth and shareholder value in 2022 and for years to come. Now I'll turn the call over to Matt.