Damien McDonald
Analyst · Stifel
Thanks, Matt. Welcome to our Second Quarter 2019 Conference Call. Today, we will discuss our results, provide some recent highlights, and reaffirm guidance. Our second quarter adjusted earnings per share reached the upper end of our guidance range. Along with strong performance across all business lines in cardiovascular, we were encouraged to see our neuromodulation business stabilize on a sequential basis in the U.S. I'm going to start off by discussing some recent highlights, then move to our sales results by business. After my comments, Thad will provide you with additional details on the financials. Then I'll wrap up with closing comments before moving on to Q&A. On June 12, we closed a tuck-in acquisition of Miami Instruments. The company was founded by Dr. Joseph Lamelas, an internationally recognized expert in minimally invasive heart surgery, and the professor-in-chief of cardiac surgery at the University of Miami Health System. Miami Instruments has a suite of products designed to enhance minimally invasive cardiac surgery procedures which fits well with our Perceval sutureless aortic valve. This transaction is expected to have an immaterial impact on our sales and earnings forecast. On June 18, Stacy Enxing Seng was elected to our board of directors. Stacy is currently a venture partner with Lifestone Ventures, and sits on the boards of Cala Health, Hill-Rom, PreCardia, Sonova Holding and the Fogarty Institute for Innovation. In addition, Stacy has previously held executive roles during her more than 25 years of experience in the healthcare and medical device industries. We are delighted to have Stacy join our board. On July 15, we announced FDA clearance of the LifeSPARC system, a new advanced circulatory support pump and controller. LifeSPARC is a completely redesigned system that includes a magnetic bearing, improved portability, a simplified interface, easier setup and a higher flow rate. Clearance came slightly ahead of our expectations and we will initiate a controlled release of LifeSPARC later this quarter. We expect CE mark for LifeSPARC before year-end. Turning now to our net sales results for the second quarter, which will all be stated on a constant-currency basis. Total net sales were down 1% compared to the second quarter of 2018. Cardiovascular showed strong operational growth in the quarter while neuromodulation was down due to U.S. performance. While our overall U.S. business declined 6% due to the softness in neuromodulation, Europe grew for the seventh straight quarter and rest-of-world grew double digits for the third consecutive quarter excluding the impact of a Canadian distribution exit. Cardiovascular sales were $172 million, up 1.2% from the second quarter of 2018 due to growth in cardiopulmonary, advanced circulatory support or ACS, and heart valves. Cardiopulmonary sales were $131 million in the quarter, a decline of 1.3% versus the second quarter of 2018. Heart-lung machine sales grew mid-single-digits, driven by strength in both S3 conversions and competitive placements, especially in rest-of-world. Our oxygenator sales declined due to the previously mentioned terminated Canadian distribution agreement. In the second quarter of 2018, sales from this agreement were $8.6 million and were located in the rest-of-world category of cardiopulmonary. Excluding this impact, oxygenator sales grew in the mid-to-high single digits. Turning to heart valves, sales for heart valves were $33 million in the quarter, up 4.6% versus the second quarter of 2018, driven by a strong rest-of-world performance. Perceval grew in mid-single-digits this quarter as continued softness in the U.S. was more than offset by growth in Europe and rest-of-world. ACS reflects our TandemLife business that we acquired in April of 2018. Sales in the quarter were $8 million, representing nearly 40% growth versus the second quarter of 2018, and consistent with the first quarter of 2019. Last year's sales force expansion continues to gain traction and we saw strong growth across all product lines, especially ProtekDuo. Now let's turn to neuromodulation. Sales were $104 million, down 4.8% versus the second quarter of 2018. In the U.S., sales decreased 9.9% to $81 million, and were ahead of our guidance range of $70 million to $80 million. While the competitive pressures and field turnover that we experienced in the first quarter stabilized in the second quarter as expected, we were encouraged to see our overall implant rates rise modestly versus the second quarter of 2018 led by mid-single-digit growth in end-of-service implants. We saw another strong quarter of double-digit sales growth in Europe based on the continued option of Sentiva and a strong performance in the U.K. The E.U. adoption of Sentiva is now 53% of generated sales with strong uptake in the U.K., Nordics, Germany and Spain. Rest-of-world delivered a robust quarter growing nearly 20%, driven by its strong performance in the Middle East, China and Southeast Asia. And finally, our neuromodulation pipeline continues to make good progress in both our treatment-resistant depression, or TRD, and heart failure programs. In TRD we continue to work with CMS to finalize our RECOVER trial protocol and still expect to enroll our first patient by the end of the third quarter. In heart failure, our ANTHEM-HFrEF U.S. pivotal trial continues to perform ahead of our expectations at over 65 active sites and more than 100 randomized patients. We are confident in our growth prospects and will continue to focus on execution, strong portfolio management and developing the talent and culture of LivaNova. I will now turn the call over to Thad for review of our financial results. Thad.