Damien McDonald
Analyst · Berenberg. Your line is now open
Good morning and good afternoon. Welcome to our first quarter conference call. We had a promising start to 2017. I'd like to walk you through some of the events that recently happened at LivaNova and then discuss our sales results by business franchise. After my comments, Vivid will give you some more color on the financials and then I'll wrap up with closing comments before moving to Q&A. Over the past couple of months we announced several key decisions in support of our efforts to advance strategic objectives. First, Caisson. We announced last month that we acquired Caisson Interventional, one of the equity investments. We've been a strategic investor in Caisson since 2012. They have a dedicated and innovative team of professionals and are working on one of the most revolutionary technology in the Transcatheter Mitral Valve Replacement or TMVR field. Our device is unique as it is the only product designed solely for the transseptal approach and delivered through a single venous access. The device is also designed to be fully retrievable once the function of implant is fully assessed but prior to final release. While that system is still in early feasibility stage, we believe that this deal makes clear strategic sense. Our cardiac surgery business currently sold at portfolio for surgical valve replacement and repair and this acquisition will position us as a leader in the field. We are now positioned to accelerate clinical and regulatory efforts in TMVR and ultimately deliver important innovative therapies to our patients. Caisson initiated human implants in June 2016 through a 20 patient FDA early feasibility study in the U.S. [indiscernible]. At the third annual Zurich Mitral Valve Meeting in early February, results were presented for six patients enrolled in the study with five of them successfully implanted. In the six patient, the valve was successfully retrieved which is an important clinical feature. Patient enrollment in the CE Mark trial which will be called INTERLUDE will begin this year. INTERLUDE has already been approved in Canada and we will begin patient enrollment midyear. That will be followed by patient enrollment in Europe and the U.S. later in 2017. We are currently targeting CE Mark in late 2018 or 2019 with U.S. FDA approval coming several years later. Today there an estimated 2 million people in the U.S. suffering from severe mitral regurgitation but only about 55,000 patients are receiving mitral valve surgery annually. That's approximately 3% of the total patient pool. External estimates show the market potential as a multibillion dollar global opportunity. We believe this market will develop comparably to the transcatheter aortic valve replacement or TAVR market with a vast majority of procedures taking place through a transseptal route which is our approach. This acquisition places LivaNova in a strong position to set the benchmark for TMVR systems and to be a leading player in the market. Regarding some of the specifics of the transaction, the purchase price for the remaining 51% of the company is $72 million, net of $6 million of debt forgiveness. The first payment of approximately $18 million was made at closing. The remainder we paid out over the next several years on a schedule largely driven by regulatory approval and sales earn-outs. We expect this acquisition to be dilutive to earnings for several years as we go through clinical trials, continue R&D spend, and invest in our production facilities and commercial activities. However, for all the reasons we have discussed, we believe that in the long term this opportunity will create value for our shareholders and be positively accretive to our earnings. Second, management changes. We announced several weeks ago that our Current CFO, Vivid Sehgal is leaving the company at the end of May to pursue other opportunities. Vivid has been an integral part of our Executive Leadership team and I want to thank him for his significant contributions in helping position the company for sustainable growth. We expect to announce the successor in the near future and Vivid has agreed to support an orderly transition. In addition, Jacques Gutedel, President of Europe has been succeeded by [indiscernible]. Most recently [indiscernible] was an executive of Danaher and prior to that was CEO of Hitachi Medical Systems in Europe. He has an extensive track record in healthcare throughout Europe, Asia, Latin America and the Middle East. I'd like to thank Jacq for his leadership and his contributions to the company over the last eight years Third, simplification. We've said numerous times that we are working on simplifying our business model. One of the areas we are focused on simplifying is our manufacturing footprint and we have taken several steps toward advancing this goal. During the first quarter, we completed the closure of our Costa Rica manufacturing operation where we had duplicative manufacturing of our VNS devices. We also made a decision to cease production of the oxygenator facility we were building in Suzhou, China. Market dynamics and expectations in the region have evolved and as a result we no longer believe that this facility is the best strategic auction or use of cash for LivaNova. This decision does not in any way dilute our commitment to delivering strong emerging markets growth. And finally, 3T heater-cooler devices. On our fourth quarter and year-end 2016 earnings call, we disclosed that we developed a 3T device remediation plan which included a loaner program, a deep disinfection service, and a design modification to address the issue of potential aerosolization. We said that in the design modification was subject to final verification and validation and we would begin implementing the modification in the second quarter. We are pleased to announce that we have completed final verification and validation for these design modifications which allowed us to obtain CE Mark in April. We will begin implementing the ceiling and vacuum solution in the next few weeks. These changes will be performed at no cost to our customers. Implementation will start in Western Europe followed by multiple other countries as we receive regulatory approvals. In the U.S., we continue to make progress towards approval as we work collaboratively with the FDA. As a leader in the industry we are pleased to offer many of our customers and patients a solution that enables lifesaving cardiac surgery. Turning now to our net sales results for the quarter. In our press release we provided table that shows both reported net sales and constant currency growth so you can see the impact of foreign currency fluctuations. For discussion purposes, we are going to focus our comments on net sales results with constant currency growth. Net sales was slightly up compared to the first quarter of 2016. Strong price and volume gains in Neuromodulation were offset by lower sales in cardiac surgery and CRM. If we look at each business franchise, cardiac surgery sales were $139 million, a decrease of 2.1% from the first quarter of 2016. Sales for cardiopulmonary were $107 million in the quarter, a decrease of 2.5%. As we discussed in the past, cardiopulmonary includes disposable sales which make up approximately 75% of the total and capital which makes up the remaining 25%. The higher sales product in disposable is oxygenators and due to the solid demand for Inspire, we continue to see very consistent growth in the 3% to 5% range. In capital, the higher sales product is heart lung machines or HLM. To the end of 2016, we saw relatively steady sales for HLM in the U.S. but it's started to see softness in Europe in the second half of the year. If you recall, we discussed that this was due to customers delaying new purchases and holding onto their machines longer in anticipation of the next round of innovation. This quarter we have started to see a comparable dynamic in the U.S. and hearing similar comments from our U.S. customers. I want to reiterate, we do not believe we are losing share to competitors in either region. We have 70% global market share with HLM and while our competitors have been more vocal in their discussions with customers, we are working on innovation which we will be discussing further at our Investor Day in the third quarter. Sales for heart valves were $32 million in the quarter, a decrease of less than 1%. Our tissue valve business increased 5% as a result of solid performance in Perceval as suture less valve particularly in the U.S. And this was offset by declines in mechanical heart valves which is starting to move more in line with market declines. The CRM sales were $58 million during the quarter, a decrease of 2.9% compared to the first quarter of 2016. In low voltage, pacemakers were up for the quarter driven by strong demand for KORA 250 in Japan. In high voltage, we saw softness in ICDs compared to a strong quarter last year with the launch rollout of PLATINIUM devices. This was offset by strong growth in our PLATINIUM CRT-D products due to the recent incorporation of the IS4 standards. Now let’s turn to Neuromodulation. Sales were $87 million up 7.7% versus the first quarter of 2016 with growth in all regions. AspireSR continue to perform well from both a volume and price perspective. The patient growth was strong once again with growth continuing in the mid to high single digits. This is reflective of demand for the product driven by a focused investments. Regarding innovation, we recently submitted our application to the FDA for SenTiva. SenTiva will be our newest VNS therapy device and will incorporate the same technology as AspireSR but will be smaller in size and we anticipate approval of the device in the latter part of the year. I’ll now turn the call over to Vivid for an overview of our financial results. Vivid?