Edwards Lifesciences Corp Deutsche Bank 2026 Healthcare Summit

No, let's get into it. Good morning, everyone. It's great to be here. I'm glad you have an interest in the company. We are very pleased about all what we do. We take care of patients in the best way possible. We are very proud of the impact we are having.

Yeah. Thanks, Peter. Let me start with a couple of comments. One is Doretta, our new CFO, has been with us two months now. She's an amazing partner. She gets the strategy of a company, and she's fully on board to enable this strategy and to accelerate this strategy. Let me talk about strategy very quickly. What I love about this company is we have strategic clarity. It is all about structural heart disease. It is a very large space. There is a lot of unmet patient need, and it is growing. As a company, we spend a lot of time on execution. The entire leadership team, which is a rather smaller leadership team. Everybody is deep into structural heart disease, and we deliver flawless execution. You have seen that. Finally, you have a culture of a company. There's 17,000 employees. They know that it is mission-driven.

They know it is about their patients. Every day they wake up, and they are motivated to make a big impact. These three things together basically have resulted in what you have seen. Top-tier performance. Top line, bottom line, and us being predictable, having durable performance. Now to address specifically your questions, Peter, you are right. The way we are thinking about the company today is mainly five therapy areas. All of them in leadership position, all of them with many catalysts. You have TAVR AS, you have PASCAL, you have EVOQUE, you have SAPIEN M3, and you have surgical. This gives us this reach of scale to be confident short term, to be confident long term, and to be able to be confident about durable top-tier performance as a company.

Thank you. The news last week was very positive news for patients, for the field, and for the company. CMS, after 15 years of a ton of evidence, physician experience, great patient outcome, and this technology being one of the most proven, one of the most studied, declared that basically it is now reasonable and necessary. Which is a big step, if you think about it. We look at the NCD along four key elements. The first one is about providing flexibility. Flexibility at two levels. One is around the patient access. In the past, the former NCD, the patients for an evaluation had to go twice to the hospital and see a surgeon and a cardiologist. Today, there is only one on-site, face-to-face physician visit. The other one could either be done through a remote kind of visit.

That is providing the patient who are very sick, all patients, an easier access to being evaluated for TAVR. Also an additional flexibility at the point of treatment. In the past, it was mandatory to have a surgeon and a cardiologist in the room during a TAVR procedure. It is not anymore the case. One is mandatory. One operator. It could be a surgeon. It could be a cardiologist. What CMS has done very well in our mind is it provided the opportunity to the heart team to decide. If they want to be two in the room, they can, and both physician will be covered. In my mind, this is extremely well done in a sense that it will protect high quality of care.

It is empowering the heart team to decide what is best for the patient, but also it is streamlining the processes where it is necessary. That is about flexibility. The second element is about volume requirement for a hospital to have a TAVR unit. In the past, for a hospital to have a TAVR unit, they had to have a certain number of procedure per year. It is not anymore the case. The operative requirements remain the same, which is very good, again, to maintain excellence in care. This will provide an opportunity for some cardiac surgery centers who do not have a TAVR unit to open a TAVR unit, and it will happen in cardiac surgery center only. It is mandatory in this NCD. Here an opportunity here to increase patient access across the U.S.

The third one, also very important, is now asymptomatic, is covered with CED under this NCD, so it is an additional patient population will be able to receive this very proven therapy. The fourth one, also very important, it is providing a pathway for upcoming FDA approvals, new indications. What we need you all to step back and think about is, NCDs are more of an exception and MAC coverage is more of a norm. There are only a few hundred of NCDs, 300 or so, and thousands of technologies are covered for MAC. What CMS has done here is clearly providing guidelines that for upcoming FDA approval, the MAC will be very well-positioned to cover these new indications. If you think about all together, it is empowering the heart team.

It is maintaining excellence of care, at the same time, providing flexibility in term of access to care, in term of at the treatment, at the point of treatment. All of this very positive, very well done, all thinking about, at the end of the day, the patients that need the best care.

Let me start with potentially the new centers. There are about 1,100 cardiac surgery centers in the U.S. and about 850 TAVR centers in the U.S. The difference between these two numbers is the potential of this cardiac center opening a new TAVR unit. I do not believe all of them will do. My guess is some of them will do that. It will be a decision between the physician, the administration at these centers, also looking at the patient access gap or need happening in this region, in this town, in this city. So it could be 100, it could be 200. It will take time, though. This hospital will have to make their decision, get an approval. Our team will be ready to train them and do TAVR for sure. But our guess is it is going to take time, it will happen over time.

It is also a positive if you think about it, because at the end of the day, what do we want? We have worked very hard in the last 15 years to build something very special with TAVR. And we want to make sure we maintain that. So excellence of care is very important, and we are ready to train all of these centers. That is the first part of your question. The second part of the question is about how much this flexibility is going to help low-volume centers. It is a good question. I say it is going to be team-dependent, hospital-dependent, but it has the potential to help. When now you have the flexibility. So let us take a few example. If it is a very easy TAVR case, one single operator is most likely going to be sufficient, and the heart team will decide.