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| Statement |
|---|
| We were pleased with our sales growth in Japan, and as expected, we grew faster than overall procedural growth |
| In addition, our scaling of patient activation initiative along with next-gen TAVR and additional evidence on asymptomatic and moderate AS patients, position us for healthy, sustainable TAVR growth well into the future |
| So, that's a very unique opportunity that we are taking very seriously |
| These breakthroughs, along with significant unmet patient needs, give us confidence in our ability to accelerate growth in 2025 and beyond |
| And in Surgical and Critical Care, we remain committed to healthy growth and expanded leadership |
| We are pleased with our strong 2023 financial performance, with full year sales up 12% to $6 billion, including strong growth across each of our four product groups |
| We invested more than $1 billion in research and development, and we achieved key strategic milestones, including the introduction of new technologies and indication expansion to ensure sustainable healthy growth in the near, mid, and long term |
| We exited the year with strong momentum, with Q4 growth of 13% and TAVR growth of 12% |
| These results were better than expected, driven by our broad portfolio of innovative therapies |
| In 2024, we are well-positioned to enter a new era of structural heart innovation |
| In TAVR, we are strengthening our leadership |
| We are experiencing strong adoption of our flagship SAPIEN 3 Ultra RESILIA and continuing enrollment in our ALLIANCE pivotal trial for next-gen TAVR technology SAPIEN X4 |
| Strong performance across our four product groups globally |
| We believe that all of these initiatives position us for healthy, sustainable TAVR growth well into the future |
| We continue to expect our full year 2024 adjusted gross profit margin to be between 76% and 78%, driven by high-value technologies that yield strong gross profit margins |
| Last year, Edwards' gross profit margin was lifted by a significant impact from FX |
| I mean, I know this isn't the first time we're hearing about the speed of enrollment in that trial that it's certainly a positive signal |
| So it's been certainly a global effort, but strong growth out of the emerging markets even with premium technology, which is encouraging to see too |
| It will enable access to a groundbreaking treatment option that not only has the potential to significantly improve their quality of life, but also shows favorable clinical trends in all-cause mortality, reintervention, and heart failure hospitalization |
| In closing, longer term for Edwards, we are confident in our plan to expand the structural heart opportunity, which reflects our sharpened focus on valvular and non-valvular patients and our commitment to innovation |
| And I think we're really gaining momentum on our RESILIA platforms in total |
| I am confident that we are reaching an inflection point as the only company with a commercially approved portfolio of catheter-based technologies to treat the millions of patients suffering from mitral and tricuspid disease |
| In addition to the meaningful progress of TAVR and TMTT, we are pleased with the company innovative RESILIA tissue, which was pioneered by our surgical business |
| As Bernard mentioned, we were pleased with our better-than-expected Q4 sales performance with strength across all product groups |
| In addition, this will give us more agility, increase our pace of innovation, and provide an expanded opportunity to serve a large and growing patient population |
| Because we are solely focused on structural heart disease, we are uniquely positioned to deliver sustainable growth and extend our leadership |
| In conclusion, we are proud of the significant progress we made in 2023, advancing new breakthrough therapies for patients and delivering solid financial performance and healthy profitability |
| We continue to see positive momentum in our innovation globally with continued adoption for patients best treated surgically, including those with complex and concomitant procedures |
| We are confident about the future of its tissue technology and its role in improving patient lifetime management |
| Growth was driven by strong global adoption of Edwards' premium RESILIA technology and overall procedural volumes |
| Statement |
|---|
| FX rates negatively impacted our fourth quarter gross profit margin by 320 basis points compared to the prior year |
| Foreign exchange rates decreased fourth quarter reported sales growth by 80 basis points or $9 million compared to the prior year |
| We've seen just TMTT, in general, whether it's mitral or tricuspid maybe ramp over the past few years a little slower than expected |
| Certainly, we've seen cases where US data has impacted international share in international markets |
| I think at the midpoint, it's slightly below Street |
| Larry Wood Just to add on to this, I mean, I think it'd be incorrect to say our patient activation efforts are just starting to pay dividends now |
| I think what happens when new technology comes into Japan, just because of the way the certification process works and people having to move through that process, that certainly had an impact for us |
| All those data just simply a signal that they're delaying their approval and waiting for additional data |
| And we knew from the beginning that one device, one therapy, a repair technology only will not be sufficient |
| Obviously, COVID really disrupted that, that upward trajectory |
| We think the mitral market had some early strength in kind of slowdown during COVID |
| I think one of the things that I talked about at the investor conference is I know there's a lot of speculation on -- and skepticism, frankly, on the under-treatment rates and are all those patients really there |
| So let me start on your earlier comment about a little slower than expected in the past years |
| This expected year-over-year reduction was driven by impacts from foreign exchange |
| It's tough to isolate those from the other efforts that we have underway to continue to support the growth of TAVR |
| And unfortunately, given the deadliness of the disease, a lot of people never actually make it to therapy |
| Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially |
| So, there are some factors like that |
| Maybe just speak to some of the bottlenecks that you see in the system, especially with tricuspid replacement, it's a totally new therapy |
| And so, a more price sensitive market, obviously, that's more of an issue |
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