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| But what we've seen typically with reimbursement in the US is it takes time to move behavior and change behavior patterns and what -- so we've not been on this kind of good run in coronary, and we have a really strong coronary business and momentum right now with the inpatient reimbursement continue to be a tailwind |
| The year will be another really strong year we anticipate for US coronary contribution as a percent of the business, we anticipate US coronary will be actually a larger percent of the total business than it was end of -- throughout the 2023 |
| We're pleased that if this plan delivers as expected, we're very pleased with a up to 100 basis point improvement |
| We witnessed excellent performance in all areas of the business with US peripheral and coronary businesses growing 47% and 41%, respectively, and our international IVL business growing 75% compared to 2022 |
| Really stellar performance |
| On the positive side, adoption within centers that had IVL on the pricing list before the anticorruption campaign started is growing nicely |
| Our products are approved in 70 countries, and we are pleased that we now have EU MDR certification for M5+, S4, and C2+ catheters and our Generator |
| Our US coronary business continues to shine, and we have a couple of meaningful reimbursement tailwinds that will support continued adoption |
| We are very pleased with the integration of Neovasc and are starting 2024 with strong teams in place to both accelerate enrollment in the CR2 trial and build the international reducer business |
| It was a strong fourth quarter, obviously, we were pleased with the first quarter |
| And we continue to have really nice momentum, particularly on coronary in India |
| We had another record quarter of IVL sales as revenue was up 67% from a year ago, and 14% sequentially compared to Q3 |
| It feels good to see such strong and seamless execution from the direct selling teams in Europe |
| We achieved record revenue of $203 million in the fourth quarter, which was 41% -- which was a 41% increase from a year ago and a 9% sequential increase from the third quarter of 2023 |
| This reimbursement uplift nicely complements the upcoming advances in our below-the-knee product offering that starts later this year |
| We witnessed a very positive response from our customers when we made this same upgrade going from M5 to M5+ |
| We had our first full quarter of direct sales in Italy and are very pleased with the execution by that team |
| Germany is the largest market in Europe, and we think there is tremendous upside for coronary penetration from the current level of just over 2% |
| 2023 was a great year for ShockWave, and we are even more excited about what lies ahead in 2024 |
| We're, we obviously had a very strong international performance last year |
| We have a premium device that we priced at a level that we thought both reflected the value and would ultimately lead to a strong reimbursement position that would be beneficial to the hospital |
| Finally, the European Reducer team posted a very nice quarter |
| The team continues to execute at the highest level as we achieve our mission to help treat underserved patient populations around the globe with our innovative solutions, and we're excited to continue this work in 2024 |
| Sales in Germany doubled during 2023 due to the improved coronary reimbursement |
| Our record results in both the fourth quarter and the full year of 2023 reflect outstanding contributions from our businesses and teams around the globe |
| Q4 2023 was strong for our US coronary business |
| That gives us tremendous amount of strategic flexibility that we're, we feel really fortunate to have for a company at our stage to be growing at our rate to be profitable and have this much cash on the books is really, we recognize the unique position we're in |
| We have sort of strong confidence in these combinations of codes and then qualifying for complexity adjustment |
| We launched over 1,000 accounts and the product has been very well-received |
| So, ex-China, another strong contribution year from the international business |
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| In China, we are still experiencing the impact of the ongoing anticorruption campaign, which is slowing ideal adoption at new centers |
| So those are really the two of the big headwinds we had faced the biggest being the economics |
| So, the biggest reason historically has been A, is the economic concern |
| We weren't afraid of contagion from Aetna, but I know a lot of folks who are probably listening to this call we were a little worried that it was going to be multiple payers we're going to do what Aetna was doing, and we certainly aren't seeing that |
| It's -- it will always be impossible to disaggregate new product launch and reimbursement that happened simultaneously, and it's now going to be even harder because now we've got the CPT goods |
| I think in many of the markets, it's unlikely that at least with our coronary and our peripheral IVL that will amass enough evidence that those systems, kind of the National Health Systems will increase or give extra payment for IVL |
| Similar to the pattern we saw in 2023, we do expect a step-down in Q1 operating margin from the prior Q4, reflecting compensation and benefits costs, which reset at the beginning of the year as well as the timing and increased costs related to our global sales meeting held in March |
| Meanwhile, multiple medical societies have come together to form a working group, and they have been applying pressure on Aetna and hopes of getting them to reconsider their policy |
| So, there's a there's always been a reluctance in many physicians' hands and minds to, like I'll only use ShockWave when I absolutely have to because it's an expensive device |
| At some juncture, you start to get yourself in a challenging situation with your customers if you load too many IVL products into a single procedure |
| So, but the initial reaction to the price was so this is a high-priced device, and there was a lot of anxiety with CPT that's a little unusual in terms of a reimbursement mechanism, and so there's always been a perception amongst physicians that were not really reimbursed even though we have been |
| And so the product utilization will get curtailed, and then at smaller accounts, it would essentially be zero because they just didn't have enough money within the hospital system to cover these extra costs and the administration would clamp down |
| That's a little bit below kind of where The Street is pre call |
| It's, it just makes it a little more challenging |
| So, we do expect that our cost of goods will come down in Costa Rica |
| It certainly doesn't, it did not hurt at all |
| So, it would have been -- we would have been a little soft on peripheral and then you compounded that with Aetna |
| And when we first, when we did our call last year, I don't know that we described the underlying sort of slowness of procedures that we were seeing in the third quarter into the fourth quarter for peripheral |
| So, really unclear if that's a, so I see that as a feasibility of that tool versus something that's going to be just positive about the Reducer |
| That said, the worst thing you could do is just because you have cash run out and buy something that is not smart to buy |
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