Damien McDonald
Analyst · Piper Sandler. Your line is open. Please go ahead
Thank you, Matt. Thank you everyone for joining us. Today, we reported our fourth quarter and full-year 2021 results. With full-year results meeting or exceeding the high-end of our guidance range. Before discussing the results, I want to provide you a brief update on the SNIA litigation. On February 21, the Court of Appeal of Milan notified us that it's suspended payment of the €454 million judgment until a decision has been reached on the appeal to the Court of Cassation, which is the Italian Supreme Court. This suspension is subject to providing a first demand bank surety of €270 million within 30 calendar days. We believe that we can satisfy the condition of the surety. Now, turning to our fourth-quarter results. I wanted to start off by discussing sales results followed by a review of strategic portfolio initiatives, after my comments, Alex will provide you with additional details on our results and 2022 guidance. Then I'll wrap up with closing remarks before we move on to Q&A. We're proud about fourth quarter results where excluding Heart belts, we experienced sequential and year-over-year revenue growth across all regions. For the full year, we are pleased to have achieved all our key financial targets. I'd like to highlight that effective fourth quarter 2021, we changed our segment reporting from two to three reportable segments. These reportable segments are Neuromodulation, Cardiac Pulmonary or CP, and Advanced Circulatory Support or ACS. The change reflects the way we internally managed, evaluate performance, and allocate resources. This new structure drags further accountability and execution and provides greater transparency to growth and margin profiles. Additionally, due to the impact of the pandemic on our prior year results, today's commentary includes certain comparisons to 2019. We believe this provide helpful context for the underlying trajectory of our business. These comparisons are reflected on Slide 20 of the earnings presentation. Turning to our core growth drivers, Epilepsy and ICS. Global Epilepsy sales for the fourth quarter increased approximately 10% verses 2020 and 8% sequentially with growth across all three regions. Additionally, Epilepsy sales on a full-year basis were 28% above 2020 levels, which was in line with the midpoint guidance and 7% above 2019 levels. These results reflect our commitment to serving patient and delivering sales growth while navigating ongoing COVID related challenges. U.S. Epilepsy sales increased 11% versus fourth quarter 2020 and was 7% above 2019 levels. Total implants grew in the mid-to-high single digits versus the prior year and were in line with 2019 levels. Similar to prior quarter trends, total implant growth was driven by replacements, which continue to benefit from the catch-up in procedures deferred due to the pandemic. Additionally, sales and implants improved sequentially with increases in those new patients and end of service implant. Our progress in U.S. Epilepsy continues to be supported by our go-to-market initiative, which currently encompasses 12 dedicated CEC teams. These teams accounted for approximately 19% of U.S. sales on implants in the quarter. They continue to deliver sales and implant growth that trended above the baseline business compared to the fourth quarter of 2020 and 2019. Epilepsy sales in Europe grew 11% versus prior year, led by the U.K. and Italy. We achieved growth of nearly 10% in the rest of world region led by our recovery in China, Taiwan, and Brazil. Compared to 2019, Europe sales were unchanged while rest of world sales grew 23%. For the full-year 2022, we expect global epilepsy sales to grow 5% to 7%. Our forecast includes growth in new implants in the U.S. as patients and their caregivers return to in-person physician visits and hospital capacity improves. In addition, we anticipate a continued tailwind in replacement implants related to the backlog created in 2020 that has continued into this year. We are pleased with the progress of the go-to-market initiative and the plan on adding four new dedicated teams in the U.S. during 2022. ACS sales were $14 million in the quarter, representing an increase of 4% from the fourth quarter of 2020 and a sequential decline of 10%. Results were impacted by a reduction in patients treated with ECMO, given hospital staff shortages, as well as capacity limitations. Notably, ACS for the full - year with $55 million and grew over 30% in line with guidance. We expect ACS to grow at least 20% in 2022. Turning now to DTD, sales for the fourth quarter was $3 million and for the full-year were $9 million. For 2022, we anticipate DTD sales of approximately ten to $12 million primarily from the RECOVER study. RECOVER study continues to progress and we're very close to implanting at 250 unipolar patient, and we'll communicate when this milestone has been achieved. While we remain focused on enrolling both the unipolar and bipolar cohorts, the unipolar cohorts continues to enroll at a faster pace primarily, because it is more prevalent patients’ population. As a reminder, we can submit the data from the two cohorts separately for transition to the perspective longitudinal study or registry. We still anticipate a transition to registry to occur for the unipolar cohort, in late 2022 or early 2023. In Heart Failure, the ANTHEM HFrEF U.S. pivotal trial continues to advance. We are pleased to report that we recently achieved two key milestones. First, in late December, we enrolled the 400 patient. And second in mid-January, the 300 patients completed the nine months follow-up visit. Given these milestone achievements, the first interim analysis is being conducted by the independent statisticians. Once all pre specified conditions have been met, including safety, a trend towards the primary endpoint and success in the three functional endpoints, we may submit the functional data to the FDA, which could occur as early as mid-2022. If we do not meet all the criteria, the independent statisticians will take another look at the data after the 500th patient is enrolled. Moving to OSA, the OSPREY throughout continues to advance with approximately half of the 20 study sites currently screening patients. While we have experienced delays and scheduling, fleet and test -- sleep-testing surgery, we are excited to announce that our first patient is scheduled for surgery. We look forward to communicating when this came after and it's achieved. Importantly, we still assumed submission to FDA approval in mid-2024. For the Cardiopulmonary segment, sales were a $133 million in the quarter, an increase of 12% versus the fourth quarter of 2020. Oxygenator sales increased by approximately 20% globally with strong growth in Europe and the rest of the world regions. Heart-lung machines sales increased in the mid-single-digit with over 40% growth in the U.S., offset by declines in Europe and rest of world. Additionally, cardiopulmonary sales were generally in line with 2019 levels for the quarter. But we're below 2019 on a full-year basis, given COVID related pressures on procedure volumes and the cadence of the HLM conversion cycle. We expect cardiopulmonary sales to grow a 0% to 2% for the full-year 2022. Lastly, Heart Valves was divested on June 1, 2021 and Heart Valves sales for the fourth quarter of 2020 were $24 million. With that, I'll turn the call over to Alex.