Bill Cozy
Analyst · Stiefel. Rick, your line is now open. Please go ahead
Hey, thank you, Matt, and thank you everyone for joining us. Welcome to LivaNova’s conference call for the third quarter of 2023. Before turning to results for the quarter, allow me to provide a brief update on the CEO search. Our process remains on track, and the board and I are currently interviewing select candidates. We are encouraged by our progress and are committed to selecting the right individual to lead the company. For the remainder of the call, I'll discuss our third quarter results and then turn to our strategic portfolio initiatives. After my comments, Alex will provide additional details on our performance and updates to 2023 guidance. I'll wrap up with closing remarks before moving on to Q&A. In the quarter, we achieved 12% revenue growth versus the prior year marked by double-digit growth across all regions and improved profitability. Our performance reflects strong execution throughout the organization as demonstrated by the growth in all three business units. Notably, we maintained our commitment to modest leverage, achieving adjusted operating income growth of 23%, contributing to value creation in the quarter. Now turning to segment results. For the Cardiopulmonary segment, revenue was $145 million in the quarter, an increase of 18% versus the third quarter of 2022. Oxygenator revenue grew in the mid-teens, driven globally by higher-than-expected demand, again. And I'd like to acknowledge our cardiopulmonary manufacturing and supply chain team on their excellent performance in the quarter. Heart-lung machine revenue increased more than 25%, driven by Essenz installations in the U.S. and Europe and S5 placement in the rest of the world region. At the end of August, we received U.S. FDA 510(k) clearance and CE Mark for the Essenz In-Line Blood Monitor in the U.S. and Europe respectively. These clearances are important product milestones that enable increased customer adoption of Essenz. Accordingly, our commercial rollout is now fully underway, and we have been successful in both evaluations and placements, including shipments to highly prestigious hospital systems in the U.S. While we continue to anticipate increased contribution from Essenz through year-end, we should see a more meaningful benefit in 2024 and beyond. We now expect cardiopulmonary revenue to grow 12% to 14% for full-year 2023. Our revised forecast incorporates the strong performance through the first nine months of the year in HLMs and oxygenators, with our current oxygenator production capacity running at its limit. As previously stated, we continue to expect a modest ramp in Essenz revenue through year-end. Epilepsy revenue increased 6% versus the third quarter of 2022. U.S. epilepsy revenue increased 7% year-over-year, driven by higher realized price and favorable product mix. We achieved 815 new patient implants in the quarter, representing 1% growth versus the prior year, but well aligned with our expectations after the 13% growth experienced in the second quarter. We achieved 1,827 replacements representing a decline of 1% versus the prior year, again, though, very much in line with our phasing expectations. Epilepsy revenue in Europe grew 7% versus prior year, led by the U.K., and epilepsy revenue in the rest of world region decreased 3%, primarily due to uneven distributor ordering patterns and the sanctions. Building on our commitment to invest in our core businesses, we had a very successful Go Live in Houston with our first manufacturing execution systems, widely known as MES. And we now have 15 super users in the LivaNova organization. This initiative represents a meaningful operating upgrade to fully digitized manufacturing quality systems. For the full-year 2023, we now expect global epilepsy revenue to grow 7% to %. Our revised forecast incorporates the performance during the first nine months of the year. ACS revenue was $11 million in the quarter, an increase of 27% versus the third quarter of 2022, reflecting growth in cardiac and respiratory case volumes, partially offset by product mix. For 2023, we continue to expect ACS to be flat year-over-year. Turning now to the strategic portfolio initiatives, DTD revenue for the third quarter was $2 million. For 2023, we continue to anticipate DTD revenue of approximately $6 million to $8 million, primarily from the RECOVER study. The RECOVER study continues to advance. As a reminder, enrollment for the unipolar cohort of the study has been completed. Upon receipt of the 12-month follow-up data for the 500 unipolar patients in June of 2024, we will conduct a final analysis. We continue to expect the publication of that study results by late 2024. The bipolar cohort continues to enroll as expected, and we're pleased with the success we had in refocusing our recruitment efforts from unipolar to bipolar patients. As a reminder, the bipolar cohort is similar to the unipolar cohort in that the randomized controlled study is designed with frequent interim analysis that assess, if predictive probability of success or futility was reached or if the study should continue enrolling. Moving to OSA. The OSPREY trial continues to progress with all 25 sites actively recruiting patients. In heart failure, the closeout of the ANTHEM clinical study is progressing. We continue to expand the overall R&D spend related to heart failure this year to be approximately $24 million, the majority of which occurred in the first-half of the year. With that, I'll turn the call over to Alex.