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NuVasive, Inc.
5/4/2022
Ladies and gentlemen, and welcome to the New Basis First Quarter 2022 Earnings Conference Call. I would now like to introduce your host for today's call, Ms. Juliette Cunningham, Vice President of Investor Relations at New Basis. Please go ahead, Ms. Cunningham.
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 NuVasive's first quarter 2022 business results and trends, as well as innovation highlights and updates on our strategy. Matt will review our detailed financial results and updated 2022 financial guidance, and 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 website 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 risk 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 releases 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 the supplemental financial information. both of which are accessible from the IR section of NuVASA's website. And now, I'd like to introduce Chris Berry.
Thank you, Juliette, and good afternoon, everyone. Earlier today, we reported first quarter 2022 financial results. On today's call, I will provide an overview of our first quarter 2022 performance, a review of key innovation highlights, and updates on our strategy, which continues to unlock multiple vectors of growth. NuVASA delivered strong first quarter 2022 net sales of $290.8 million, an increase of 7.2% on a reported basis or 9.1% on a constant currency basis compared to the prior year period. Despite COVID-19 impacts during the first half of the quarter, we saw procedural volumes return across February with continued growth in March. This was evident in our U.S. and international commercial performance. Overall, I am very pleased with the health of our business, and I remain confident in our near and long-term strategy to execute on new opportunities for growth. In particular, U.S. spinal hardware delivered high single-digit year-over-year growth, led by continued growth in cervical, including the C360 system and the simplified cervical disc, further adoption of new product introductions in our anterior portfolio, and growth in thoracolumbar fixation. The U.S. surgical support business rebounded well in the first quarter, with pulse platform unit sales performing as expected and biologics benefiting from the increase in procedural volumes. This was partially offset by a decline in our invasive clinical services business, driven by headwinds due to payer mix. We continue to see strong performance in our international business as we delivered low double-digit growth over the prior year period on a reported basis and high teens growth on a constant currency basis. Europe continues to execute well, despite impacts related to COVID-19 in Southern Europe. Latin America delivered solid performance throughout the region, and in Japan, we continue to see growth due to our differentiated technology offerings. Another key growth driver is enabling technology, led by the Pulse platform. We are executing against our plan as expected and recently surpassed the 500 commercial case milestone for Pulse. With additional Pulse units up and running in the United States in the first quarter and our first international commercial cases in the United Kingdom, the Pulse value proposition is resonating with hospital executives and surgeon partners around the globe. As a reminder, the Pulse software ecosystem integrates multiple hardware technologies into a single platform. This unique ecosystem provides surgeons a seamless workflow when utilizing multiple technologies in the operating room. and can be used in 100% of spine surgery cases. Most importantly, its extensible software architecture allows for integration for current and future technologies. We're pleased with our collaboration with Siemens Healthineers to enable seamless integration between the Pulse platform and the COspin mobile C-arm, which provides hospitals and surgeon partners a leading intraoperative 2D and 3D imaging solution. We continue to invest in robotics R&D and execute on our Pulse Robotics roadmap. We've completed numerous labs with surgeon partners and have additional labs scheduled throughout the year. While early surgeon feedback has been very positive, we have not yet submitted for regulatory approval, and thus, we will not complete first in human this year. Pulse Robotics will be a key application for the Pulse platform, and we will provide information on upcoming milestones at a later date. Our team is making progress on building out the broader Pulse ecosystem. Integrating new applications, new tools, and new capabilities is what we believe will resonate most with our surgeon partners. To that end, we've made strategic investments to advance our data and analytics and preoperative surgical planning strategies, which will support the development of new applications for the Pulse platform. Turning to cervical, another key strategic growth driver for the company. our C360 portfolio delivered greater than 20% growth in the first quarter. This was led by the simplified cervical disc, which continues to receive tremendous surgeon feedback as the most clinically effective technology in the cervical total disc replacement procedure segment. To further support the disc's growing body of clinical evidence, the simplified disc two-level U.S. FDA IDE study data was recently published in the Journal of Neurosurgery Spine. The peer-reviewed publication reiterates that the simplified disc has a significantly greater success rate at the 24-month follow-up compared to ACDF when used for two-level CTDR. The disc continues to demonstrate superiority in comparison to alternative techniques, and I look forward to seeing more patients benefit from this differentiated technology. To advance our portfolio and position in the $2.6 billion cervical subsegment, We remain on schedule to relaunch Relined Cervical, our next-generation posterior cervical fixation system, in the third quarter of 2022. Relined Cervical provides compatibility with the Pulse platform and integrates with our Relined fixation system, one of the most comprehensive fixation systems on the market today. We continue to receive positive surgeon feedback on Relined Cervical and clinical evaluations, and are excited to incorporate this new technology and further expand the industry's most innovative cervical portfolio. In less invasive surgery, we continue to invest in differentiated technology to extend our leading position in the $900 million anterior subsegment and to take share in the $1.6 billion posterior spine subsegment. Our comprehensive, procedurally integrated solutions address the anterior and posterior column from a lateral or prone position, providing surgeons the flexibility to treat any patient pathology with an invasive procedure. We continue to see growth in ALIF due to strong surgeon adoption of Modulus ALIF. Commercially launched in 2021, Modulus ALIF is our latest 3D printed porous titanium implant designed for both supine ALIF and XALIF procedures. Research and development continues on our next generation expandable interbody for anterior and posterior surgery. We remain on track to begin clinical evaluations in 2022 on MODX XLIF for lateral spine surgery and MODXPL for posterior lumbar procedures. In addition, will remain on schedule to launch the new invasive tube system in the second half of 2022. The new invasive tube system, a new tubular retractor system designed to support less invasive posterior decompression and fusion procedures, will be a key addition to our comprehensive portfolio of instruments for prone procedures. International will remain a key growth driver in 2022 and beyond. Anchored by our differentiated technology and global infrastructure, we anticipate continued growth around the globe. We expect that our international business will also benefit from the return of our Precise system from Nuvasiv specialized orthopedics in key markets outside the U.S. This is supported by our recent announcement that Precise has now surpassed 100 peer-reviewed publications. The milestone is significant as it further supports the clinical benefits and efficacy of the novel technology. I am pleased with our surgeon education efforts at our West Coast Experience Center in San Diego and our recently opened East Coast Experience Center outside of New York City. In 2021, we had a record year, training more surgeons than any other year at Nuvasys. As the industry leader in surgeon education and training, surgeon demand for our clinical professional development program remains high in 2022, with training courses at both centers focused on PULSE, SIMPLIFY, X360, XLIFT, and MAS TLIFT. In closing, I'm excited for what's ahead for an evasive. I'm encouraged by the momentum in our business and our progress to extend our leadership position in less invasive surgery, take share in subsegments where we historically had underrepresented market share, deliver on our differentiated innovation in enabling technology, and drive continued growth in our international business. We are evolving from a company focused on a single subsegment of spine to a company that is helping transform the future of spine care. We're committed to delivering sustained growth, unlocking value, and making progress against our vision to change a patient's life every minute. I will now turn the call over to Matt to discuss the company's financial results in greater detail.
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