Abiomed Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 3, 2022

There are 11 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Abiomed FY 'twenty three Q1 Earnings Call. All lines have been placed on mute to prevent any background noise. During today's call, there will be a question and answer session. I will now turn the conference over to Nicole Knapp, Head of Investor Relations.

Operator

Please go ahead.

Speaker 1

Good morning, and welcome to Abiomed's Q1 fiscal 2023 earnings conference call. This is Nicole Nasse, Head of Investor Relations. And I'm here with Mike Minogue, Abiomed's Chairman, President and Chief Executive Officer and Todd Trapp, Vice President and Chief Financial Officer. The format for today's call will be as follows: 1st, Michael will discuss Q1 business and operational highlights and then Todd will review our financial results, which were outlined in this morning's press release. After that, we will open the call to your questions.

Speaker 1

During the call, we will discuss certain financial information on a non GAAP basis. This non GAAP information is provided to enhance your overall understanding of our current financial results or superior to results prepared in accordance with GAAP. Reconciliations between GAAP and non GAAP results are presented in the tables accompanying our earnings release. Finally, I would like to remind everyone that today's call with forward looking statements. The company cautions investors that any forward looking statements involve risks and uncertainties and are not guaranteed in the future.

Speaker 1

Actual results may differ materially from the company. We do not undertake any obligation to update forward looking statements. With that, let me turn the call over to Abiomed's Chairman, President and Chief Executive Officer, Mike Minogue.

Speaker 2

Thanks, Nicole, and good morning, everyone. In the Q1 of fiscal year 2023, Abiomed delivered a company record of $277,000,000 in revenue, up 10% on a reported basis and up 12% in constant currency year over year With quarterly records across the U. S, Europe and Japan, Abiomed has achieved record revenue in 5 of the last 6 quarters Despite ongoing headwinds with COVID variance, hospital labor shortages, supply chain constraints and most recently Contrast media shortages. Abiomed 2.0 has proven to be resilient because our technology and 20 fourseven hospital support Addresses the growing epidemic of heart disease in multiple emergency patient populations in the cath lab and surgical suite. Within the quarter, we supported a record number of patients in the U.

Speaker 2

S. And had the 2nd high on innovation and strengthening clinical evidence, Investing $41,000,000 in research and development, while achieving 23.8 percent operating margins. Our IP portfolio We ended the quarter with just a stated closure of the prior $200,000,000 plan. Our continued strong financial and operational Performance is a result of our disciplined execution of our Abiomed 2.0 playbook, which enables us to innovate breakthrough technology, Advanced clinical research and support record levels of patients in this dynamic environment. For today's call, I'd like to highlight the continued strength of our surgical products driven by heart recovery with Impella 5.5 second, we will review publications of clinical data that validate the benefits associated with Impella supported PCI procedures.

Speaker 2

And finally, we will cover the progress we've made in our due to Class I guidelines with multiple pivotal trials. Starting with surgery, in the U. S, surgical revenue grew 49% year over year, Driven by a 66% increase in Impella 5.5%. This revolutionary surgical heart pump with SmartAssist provides unique advantages for the chronic heart failure patient population suffering from cardiogenic shock. As presented during our June Investor call with doctors Jane Wilcox and David D'Alessandro from Northwestern Memorial and Mass General Hospital, respectively.

Speaker 2

This game changing technology has improved patient outcomes with 75% survival rate across all indications And 60% of patients returning home with their native hearts. These outcomes are particularly meaningful Because these patients previously fade irreversible heart failure, which ultimately would have required a durable implantable LVAD or heart transplant. I encourage all investors to watch this webcast on our investor website. In Japan, we have a strong collaboration to new sites and surgeons in Japan setting the stage for heart recovery in surgery and protocols for the future. Turning to recent clinical data, RESTORE was later this month in JSKY.

Speaker 2

It was most recently presented as an abstract at a large Cardiology meeting. After 90 day follow-up, study participants had a 29% relative improvement in their baseline LV left ventricular ejection fraction, an overall 76% reduction in New York Heart Dissociation Class III and Class IV Heart failure symptoms and an overall 97% reduction in Canadian Cardiovascular Society Class III for Class IV angina symptoms. The RESTORE EF study combined with PROTECT 1, PROTECT 2 And PROTECT3 FDA studies and multiple independent physician studies demonstrate definitive proof that Impella supported AMI cardiogenic shock has one of the highest mortality rates in the field of medicine. These are patients sometimes showing up at the hospital, Getting CPR and Rush to the Cath Lab. The survival rate has remained approximately 50% without Impella and associated best practices for the last 20 years.

Speaker 2

Impella technology is designed to not only improve survival, By enable heart recovery, Impella best practices such as placing Impella pre PCI And is published in multiple clinical studies over the last decade from the United States during implantation in AMI Cardiachenic shock. This publication summarized 13 papers totaling 6,810 patients and demonstrated a statistically significant lower mortality with Impella implantation before the PCI or the physician placing stents. Multiple INTELLA studies demonstrate greater than 70% survival with greater than 90% native heart recovery. Heart recovery after AMI cardiogenic shock improves patient quality of life And makes Impella one of the most cost effective therapies in the CMS Medicare population as well as private insurance. Lastly, I'd like to highlight our progress towards advancing clinical evidence through multiple pivotal trials.

Speaker 2

We had a record quarter for patient enrollment for both PROTECT 4 and STEMI DTU. Starting with PROTECT 4, in Q1, we enrolled 91 patients. PROTECT 4 is one of the most comprehensive studies ever done in the cath lab. This landmark trial will compare the benefits of an Impella High risk PCI versus high risk PCI without Impella support. Researchers will measure Complete revascularization, improvement in patient quality of life and ejection fraction.

Speaker 2

For the STEMI DTU pivotal trial, we enrolled 45 patients in Q1. If successful, this trial could expand our indications Into heart attack patients without cardiogenic shock, which represents a 200,000 patient population in the U. S. And 4,000,000 patients worldwide that we do not treat today. I'm also excited to announce that in July we received FDA IDE approval for RECOVER-four.

Speaker 2

This is an FDA randomized controlled trial comparing all cause mortality at 30 days in patients with an Impella based treatment versus a non Impella based standard of care treatment strategy. Our teams have worked closely with the FDA to generate a protocol focused on exception from informed consent or EPIC, which we believe will help enroll patients in what has historically been a difficult patient population to enroll due to ethical and logistical concerns. The study details are posted in our earnings slides. Our current RCTs are built off a decade of prior studies and best practices with the goal of achieving Class I guidelines, the highest level of medical guidelines for high risk PCI, Cardiogenic shock and STEMI. If successful, we believe we'll be the only company in MedTech with exclusive FDA approval guidelines.

Speaker 2

Before concluding, I'd like to share a patient story. Ethan Bradshaw, 30 years old is a state trooper from North Carolina. Motivated by a family history of heart disease, Ethan takes pride in living a healthy lifestyle. He exercises several times each week and is a Brazilian jiu jitsu instructor. On February 24, 2022, After experiencing chest pain and numbness in his arm at the gym, Ethan drove himself to Kernsville Medical Center.

Speaker 2

Upon arrival in the emergency room, Ethan collapsed. Medical personnel shocked Ethan multiple times and performed CPR Before transferring him to Foresight's Medical Center in Winston Salem, North Carolina. Ethan was in cardiogenic shock When he got to the catheterization lab with a reduced injection fraction of 20%, so his heart was working about a third of its strength. Doctor. Samuel Turner implanted Impella CP with SmartAssist before the PCI and played the

Speaker 3

role of the patient and played the role of the Impella CP with SmartAssist before

Speaker 2

the PCI and played the role of the Impella CP. After 3 weeks in the hospital, Ethan returned home with his native heart. Ethan's heart function returned to normal and in May, he In July, 5 months after his heart event, Ethan and his wife, Mikaela, welcomed a baby boy, Ryan. Today, Ethan and Mikaela are visiting our headquarters in Danvers. In conclusion, at Abiomed, we are developing a new field of heart recovery And relentlessly pursuing better clinical outcomes and Class I guidelines.

Speaker 2

In Q1, we made progress toward our goals And remain focused on developing smaller, smarter, more connected devices, accelerating enrollment in key clinical studies And building commercial excellence as we continue through our fiscal year. I would like to thank our employees and customers for their commitment to advancing the standard of care and recognize our shareholders for their continued support. I will now turn the call over to Todd Trapp, our CFO.

Speaker 4

Thanks, Mike, and good morning, everyone. In Q1, we delivered record revenue of $277,000,000 up 10% on a reported basis and 12% in constant currency versus prior year, With strong growth across the U. S, Europe and Japan, we executed our Abiomed 2.0 playbook to deliver these record results Despite tough year over year comparisons and headwinds, supply constraints and foreign exchange rates. During the quarter, we saw the U. S.

Speaker 4

Dollar continue to strengthen, which resulted in a more unfavorable impact on revenue compared to exchange rates at the time of our last earnings call and a 2 point impact on 1st quarter revenue versus prior year. Starting with the U. S, total revenue increased 9% year over year to 227,000,000 Despite the challenging environment due to a 6% growth in patient utilization and favorable sales mix. As a reminder to investors, we grew revenue 54% in Q1. High risk PCI was down 1% Due to challenging comps of 51% growth in the prior year and the impact from both hospital labor shortages In contrast media supply, our U.

Speaker 4

S. Surgical products had another strong quarter with 49% revenue growth, driven by continued demand for the Impella 5.5 with SmartAssist. At the end of our fiscal Q1, Impella CP is in 1598 sites in the U. S. The Impella Fi 5 is now in 4 44 sites, up 48 sites versus the prior quarter out of the potential 1100 hospitals with surgical suites.

Speaker 4

Lastly, the Impella RP is in 675 sites. Details of our product installed base are summarized in our quarterly slide deck. In line with the prior quarter and prior year, Average combined inventory at the hospitals for the Impella 2.5 and CP was 4.9 units per site, flat with the inventory levels we saw last quarter. Outside the U. S, revenue totaled 51,000,000 and 27% in constant currency.

Speaker 4

European revenue increased 19% year over year in constant currency On top of 50% growth in the prior year due to patient utilization and favorable sales mix, We continue to see strong patient growth in countries and regions like Italy, Belgium, Austria and the Middle East. Our Japan business delivered revenue of $13,000,000 in the Q1. Revenue increased 39% year over year in constant currency, a new record, driven by a 25% growth in patient utilization and site openings. In the quarter, we opened 8 new sites, bringing our total to 199 out of the potential 450 sites. This compares to the 4 site openings last quarter and 5 site openings in Q1 of 2022.

Speaker 4

Gross margin in Q1 was 81% compared to 82% in the same period of the prior year, primarily driven by lower production volume and manufacturing investment to support our future sales growth. R and D expense for the Q1 totaled $41,000,000 up 7% year over year. The increase was driven by the investment in both PROTECT 4 and STEMI DTU randomized control trials associated with site openings and patient enrollment, partially offset by a reduction in our contingent consideration liability. SG and A expense for the quarter totaled $118,000,000 An increase of 14% versus prior year, driven by headcount additions to our commercial team, our patient therapy awareness campaign and continued training and education. Non GAAP operating income was $66,000,000 in the quarter, which translated to non GAAP operating margin of 23.8% versus 26.2% in the prior year.

Speaker 4

The variance is due to ongoing investments in innovation, clinical research and commercial excellence as we pursue our goal of becoming the global standard of care for hemodynamic support. Non GAAP net income for the quarter was $57,000,000 This translated to earnings per share of 1.25 An increase of 14% versus Q1 of 2022. Our year over year guidance of 13% to 17% growth. At current FX rates, we now expect reported growth rates to be 10% to 14% for the fiscal year. This guidance continues to assume that COVID moves more to an systemic state and that future waves do not have a material impact On the business, hospital labor shortages begin to moderate as we move into the second half of the year.

Speaker 4

We are also maintaining our full year operating margin guidance of 23% to 24%. In summary, we delivered a strong Q1 through disciplined execution of our Abiomed 2.0 playbook despite The challenging environment. We remain focused on executing our fiscal year 2023 goals on innovation,

Operator

Your first Question comes from the line of Margaret Kaczor with William Blair. Please go ahead.

Speaker 5

Hi, everyone. This is Brandon on for Margaret. Just looking towards this fiscal 2023, it was really encouraging great results and seeing a slower recovery than they would have Starting the year. So curious if you guys have any comments on that and kind of what's sticking out for you guys that's allowing you to hold that guide and giving you confidence In that guide, despite what seems like a slightly slower recovery than much of the industry is seeing.

Speaker 2

Hi, Brandon. It's Mike. Thanks for the question. Our forecast put a little bit Of an opportunity for things to happen, good and bad. I think most people were surprised a little bit with the contrast media shortage, which definitely impacted A little bit of our revenue as well, but we are as a business have a elective business with high risk PCI, but we also have an emergency Because of our emergency patients in the cath lab and surgical suite and we are confident high risk PCI is going to come back and it always does and that will be further upside.

Speaker 2

But what's also exciting for us and for the year is every quarter that goes by this fiscal year, we get closer to more launches, more new products And more clinical data. So the RPIJ will be a failure. We're excited to launch the LP Keith, remind everyone, this is a smaller sheet that's compatible with single access. It's going to reduce the whole By a French and a half, I think it's going to be very helpful for high risk PCI and overall shock patients treated in a cath lab. We know access is a big issue for people and we're during this quarter, but we're going to have more progress on that And hopefully through the EFS, we'll be able to start generating revenue with reimbursement as a Category B by the end of the year And of course, announcements as we go forward.

Speaker 2

So we feel like we're in a very good place going into Q2 and very confident in the year, Not just because of the clinical data, but also the new innovation coming.

Speaker 5

Thanks, Mike. And just as Looking in the surgery side and 5.5, I mean those 2 continue to put up great growth numbers despite what's getting a large what's driving the underlying momentum there? Where is growth coming from? Is it coming from new accounts? Is it coming from going deeper into existing accounts?

Speaker 5

Maybe it's a little bit of both. What are we what can we expect from that set those 2 products or not products that product in that segment? And how should they trend through the rest of the year? Thanks.

Speaker 2

Great. Thanks. So there's a population out there that's not AMI shock, but chronic heart failure shock or acutely decompensating heart failure shock. So these are the frequent flyers, then and what's happened is the Impella 5.5 has become the go to product. So you have these 7 year olds Coming in, they're not patients can get up and walk around, the device has sensors, and they can get these patients back to what's baseline or Acute recovery while protecting the heart, unloading it and giving renal perfusion to the kidneys.

Speaker 2

So it's really been a great product. It is a revolutionary product Because now you have a minimally invasive weanable heart pump, all prior heart pumps required a sternotomy and then you have to core out The apex of the heart and then you bypass the blood out of the heart right to the aorta. So it's not ideal for older patients or patients that want recovery. For your question of where the volume is coming, it's more patients, it's more centers. The device does run longer in the engineering bay, It runs extensive periods of time and it really has transformed heart failure and the heart team to try to recover these I would encourage all investors to watch Doctor.

Speaker 2

David D'Alessandro and Doctor. Jane Wilcox, Both from Northwestern and Mass General because they really go deeper in that question and they show some live cases. So I hope everyone has the opportunity to see that.

Speaker 3

Thank you.

Operator

Your next question comes from the line of Marie Thibault with BTIG. Please go ahead.

Speaker 6

Hi, Mike, Todd. Thank you so much for taking the questions this morning. I wanted to start here with a quick question on The contrast media shortage impact, wonder if you could size that or quantify it for us. And where it is now, do you feel that it's been fully resolved with most of your centers.

Speaker 2

Thanks, Amari for the question. As we talked about each quarter, We've had a positive evolution of our customer base during COVID because the smaller hospitals have That trend has been continuing. However, what we saw in the quarter was that the smaller centers didn't have access to the contrast and that's what Potentially impacted was all over the U. S. And we believe that the majority of that's behind us, but certainly We're going to continue to monitor the situation.

Speaker 2

Todd, do you want to comment on the numbers?

Speaker 4

Yes. So Marie, to the best of our ability, we think it's somewhere around 150 Plus or minus a few, but 150 patients in the quarter, which obviously would have impacted our overall patient growth by about 2 points. And as Mike mentioned, it mostly occurred

Speaker 6

You're investing in manufacturing and adding sales headcount. So I want to hear a little bit more about where those new sales reps are going to be focused, what areas you're expanding capacity, manufacturing capacity and how you achieve some of R and D Control. Thanks for taking the questions.

Speaker 4

Yes, Tay, invest more on the surgical account team, just given where we are From a penetration standpoint, we're at 4 40 hospitals out of the 1100. So that's really where I would say some of our investment went on the commercial team. We are still, I would say, looking to potentially go to a few more regions, a few more franchises. And again, that boded well for us During COVID, as you know, that we grew smaller hospitals at a faster clip just because we had more feet on the ground. With regards to gross margins, 81% in the quarter, again, we are adding a little bit more, I would say, on the hourly workers As we think about ramping up our volume in the second half of the year.

Speaker 6

Thank you.

Operator

Your next question comes from

Speaker 7

updated enrollment numbers there, if possible. And then from a product perspective, Any major revisions to either hardware or software during the quarter?

Speaker 2

Sure, Peter. The pivotal protocol approved. So we're continuing to enroll patients. We're collecting all that data. We're going to utilize all that data in our submission.

Speaker 2

The IRB process and the legal administrative work at hospitals across the board for those that don't Follow this. It's a lot more complicated and at best it's a 3 month and an enormous can be 6 months. So As we're working through that, we have 3 IRBs approved, but we don't have a single site that has approved the site activity that we'll continue to make on the product And we'll do that throughout the pivotal. So that part will happen. That's the benefit of doing this early feasibility.

Speaker 2

That's also the benefit of working with the FDA on Something that has again breakthrough designation status as a product. Okay, great. And then Europe and And

Speaker 7

that's very strong growth year over year and actually accelerated sequentially. Just curious, is there some more details on those markets and what do you assume within your guidance for the rest of the

Speaker 2

Yes. The Japan market is ideal for our focus around native heart recovery. By providing now the Impella 5.5, we allow the heart surgeons to have a longer term pump, A device that in the engineering base has run over a year. The Japan protocol is they tend to keep their patients in the hospital And with their focus on myocardial recovery and stem cells, we are going to be coordinating and partnering With those institutions where we'll do extended unloading with 5.5, which we know immediately shrinks The left ventricular geography or geometry of the left ventricle, we know we get we rest the heart. We also know we get renal perfusion.

Speaker 2

So We're going to be doing continued advanced protocols now for getting back these chronic patients. And the society and the physician community there is very excited about And we'll be there in October. I'll be there in October. And we're out again traveling. The Shows are up and running and progress and the research is moving forward.

Speaker 7

Great. Thanks so much.

Operator

Your next question comes from the line of Chris Pasquale with Nephron Research. Please go ahead.

Speaker 8

Thanks. Congrats on getting RECOVER 4 approved and making some nice progress on the other study this quarter. It's great to see. Mike, it's been challenging to do randomized trials in cardiogenic shock prior attempts and ended up with some messy data. I see that you got an exception from On consent, we should help with enrollment, but are there other things you've done with the design of this trial to ensure that you end up with a well balanced Trial and a clean look at the clinical value of Impella in that population.

Speaker 2

Sure, Chris. So the Abiomed has attempted all of The cardiogenic shock studies in the space. In 2008, 2009, we did recover 2 in the U. S. And as you mentioned, we're only able to enroll one patient that was but the balloon pump did more flow.

Speaker 2

In Europe, they've been able to That was A balloon pump and that showed the balloon pump not only had zero benefit in clinical outcomes, it did not even improve the hemodynamics Because the hemodynamics for the balloon pump is generated by onotropic drugs, which work, but they work the heart harder And they also cause arrhythmias, which makes a balloon pump not work and almost is detrimental and dangerous. So now we've tried in press, We tried multiple times in Europe. We tried the CEFR paper. All of those studies started with the concept of randomized because as they got further into the study, The physicians felt it was unethical or the consent was too difficult, so they just started they ended up not being They are not randomized studies despite the fact that some of the authors of certain publications say they are. They're not there are studies we funded them.

Speaker 2

So we went to the FDA and we've been working with them now for a year and a half, two years. They are the authority on these What's called Epic exception for informed consent, they are the ruling body as far as an authority. They worked with us To get that step that they can now consider patients in cardiogenic shock can utilize the Epic channel. However, we still need the local IRBs To approve it, and we also need the physician to do it, we recognize not all physicians will randomize these patients. However, the leaders in the space, the published leaders in the space that want to treat these patients have developed this best practice protocol, which they've also published And they want to pursue this study.

Speaker 2

And what's new is that a lot of these centers, some of them use ECMO as first pass As the way they treat shock, not just oxygenation. So in the other arm, they'll have the option to do ECMO, anyone's FDA that will measure the adverse events of ECMO and ECMO has life saving components to it and it oxygenates the body, but it's not ideal For cardiogenic shock where you have a hematoc problem, it actually can cause other issues. So that will be in the other arm. Oxygenation will be a protocol. And really the customer base randomized their ability to execute.

Speaker 2

And this is where all of these other studies that we've been doing around pre PCI, we feel Like we have the formula for success, this best practice protocol, Kate. So we're excited to do Recover 4.

Speaker 8

Thanks. If I remember correctly, one of the issues within press was also that a lot of patients who got enrolled already had Evidence of a brain injury at admission, I'm getting support.

Speaker 2

Sure. So there was 48 patients, 24 of the patients got Impella. The majority of those patients, only 4 got INTELLA before the PCI, 4 out of the 5 lived. So we have an 80% survival in the Impella. Unfortunately, They stopped randomizing.

Speaker 2

15 patients within the 48 were not randomized, were not sequential and more than half of these patients were in cardiac arrest, Which is not ideal that this is not a cardiac arrest pump and many of them got randomized after they had done the PCI and even had a balloon pump in. So That IMPRESS and severe shock is really cardiac arrest. The original IMPRESS that we only did 18 patients was that protocol and we're looking to rule out cardiac arrest from the study. They will not be in the RECOVER four protocol. And as you know, Chris, there's a range of mortality in shock And the society, interventional cardioid sky has a class from A through E.

Speaker 2

And you can have a range of mortality at 3% in E and you can have an 85% mortality rate of in Stage E. So it really is that metric. And that's one of the challenges with these databases that they when people write a paper from data from 7 years ago is the balloon pump arm is biased Because the patients that get sick on the balloon pump come out, either you go to ECMO and are ignored and ECMO you'll notice is not in these analysis by people that are pulling databases or they go into the Impella arm and they're now in the Impella Or they go into the Impella arm and they're now in the Impella arm, but they don't disclose that. And it also includes Balloon pump patients that get bailed out in the Opella arm. So we have all the data.

Speaker 2

The world's experts are.

Speaker 3

Thanks.

Operator

Your next question comes from the line of Matt O'Brien with Piper Sandler. Please go

Speaker 9

Good morning. Thanks for taking the question. Actually, with that product, you talked a little bit about centers and Utilization, but can you just put a finer point on what you're seeing as far as some of the centers that have been using 5.5 for maybe a year now as far as There are trends and then are these new systems and centers that are coming on, are they adopting even faster just based on what some of the other centers are seeing as far as outcomes?

Speaker 2

Thanks for the question. I guess the best way to answer that is encourage everyone to watch The webcast we did with the experts because they go into detail and show some of the examples of why they now use 5.5 whereas in the past they might have done Lots of either inotropes or considered patients for LVAD to transplant. I do think you pointed out it's Still growing and what's most gratifying to see is that with the volume you're also seeing that Because it's forward flow. And it really does now add to the ability not just to get the patient up and better and wean the heart, But we routinely see now patients that have bad kidneys come back, the kidneys recover. And what's also interesting is patients that don't get better that Their cardiomyopathy is too advanced.

Speaker 2

We do see them listed for heart and kidney transplant. And during the 2 to 4 week wait, we see the kidneys also come back. So now these patients are just getting a heart transplant. But it's clearly a breakthrough product. And again, for those that have covered the LVAD space, there's not anything in the world like the Impella 5.5, Minimally in base station today that they don't know what to do.

Speaker 2

That's one of the biggest admissions into the hospitals.

Speaker 9

Got it. And then just wanted to put another finer point on ECP. I think you've got the pivotal study going, Did the EFS as well? I think collectively, because you can include those EFS patients in the pivotal. So you're up to 31 patients total.

Speaker 9

Just So to make

Speaker 4

sure that's clear. Thanks. Yes.

Speaker 2

Thanks for the question. To clarify ECP, so the EFS study Closed out after 26 patients. In March, we got the IDE pivotal protocol approved. IRB and the legal Activity site contracting, we are making some enhancements, but we're still collecting data and we did 5 cases in Q1. And that data is under the pivotal protocol, so we'll absolutely be utilizing that.

Speaker 2

Remember, it's a single arm study up to 217 patients For high risk PCI as the Impella 2.5 in CP that we have data from the PROTECT 2 and PROTECT 3.

Speaker 9

Got it. Thank you.

Operator

Your next question comes from line of Mike Polark with Wolfe Research. Please go ahead.

Speaker 2

Good morning. Thank you for taking the question. I will follow-up on that. One of the benefits of being in an early feasibility study is it gives you that flexibility. The other benefit of having a breakthrough designation is that you can make these enhancements as you go.

Speaker 2

We're confident in the enhancements that are lined out and but we're always going and we'll continue to make enhancements as we go through the study And we'll continue to file more round numbers centers in the June quarter. We have The data you've provided in the past on 5.0 is in 6.60 centers, but there's 1100 surgical suites in the U. S. I guess, As you roll this forward, is it a level or do you think there's a good chance that you're in more centers eventually With 5.5 then you were on 5.0. Thanks for taking the questions.

Speaker 4

Yes, Mike, this is Todd. I'll just I'll answer that one. In terms of the 5.0 sites, if you just went back and looked at the last several quarters, we really haven't opened up many 5.0 sites. Every new site we open up now is Going to be with the 5.5. And so if you just want 45.50 site openings for 5.5 and I think That should continue I think in the next several quarters that cadence.

Speaker 4

So I don't think you're going to see us opening many more sites with 5.0, it's just going to be Going forward with the 5.5. And again, we have 1100 hospitals with surgical suites in the U. S. We have a long runway of growth ahead of us just with the 5.5.

Speaker 3

Hi, good morning. Just one for Todd and then a couple for Mike. Todd, on the contrast dynamic, I appreciate the detail there. Just the missed patients in 1Q, are these patients unfortunately lost or do you think these procedures spill into 2Q?

Speaker 4

It's a great question, Jason. I think it's something we're trying to measure ourselves. I think unfortunately, there's probably a portion of that, but we think A portion of them will come back at some point in time. Again, similar to what we've seen over the course of the pandemic that these patients aren't essential. I mean electives, they're essential and they need to be treated.

Speaker 4

So we do expect some of these patients to come back into the system sometime Yes, I'd say Q2, the timing of it is tough to call, but I would say there's a portion that we expect to see to come back into the system.

Speaker 3

Okay. Thanks. And then Mike, just on ECP, a couple of follow ups. Of the five Patients enrolled in the pivotal protocol in 1Q, will they be included in the 217 patients needed for the trial?

Speaker 2

Yes. Remember, it's up to 217 patients. And so all the data we collect is being compared to The numbers that we know and can match on PROTECT II and PROTECT III on both Impella 2.5 and CP And what we're comparing is 30 day MACE, but we're also looking primarily at access closure and safety valve ish information. And so that's what we're working on. And we already have high risk PCI, the indication, and we're looking to get the ECP through that process, so we can Put the ECP into PROTECT-four as well as the STEMI DTU study, which is our intent.

Speaker 3

Okay. And when do you expect to enroll the first patient in the pivotal, not too much the pivotal protocol, but the pivotal?

Speaker 2

Yes. So the pivotal protocol is the difference will be that the center now has IRB approval and all the site activity, But we are collecting the data that we will collect in the pivotal. And so we're that's the benefit of doing this procedure and having the early feasibility. So we are I can get it now that we'll be using.

Speaker 3

Okay. I'm just I'm still just trying to reconcile.

Speaker 5

We're seeing

Speaker 2

the pivotal protocol approval at the existing centers that were in the early feasibility study. We're collecting the data now that was in that will be in the pivotal that we didn't collect in the early feasibility study. As we transition and get the site up with the IRB approval and the site activity, then That will just continue. And while we're waiting on that, we're making some enhancements to the product. We went out to 50 centers and the first twenty fleet.

Speaker 2

But everything we're doing now, the data we're collecting will be utilized for the PMA because it is the pivotal protocol.

Speaker 3

Got you. Okay. Thank you.

Operator

Please go ahead.

Speaker 10

Thanks for taking the questions. This is Calvin on for Sathiya. Just two really quick ones for me. First, just on particularly on your PCI side of the business, I'm just curious how meaningful is the outlook around staffing impact?

Speaker 2

So, Kevin, the staffing issues is across the board in MedTech. It impacts our Essential high risk PCI patients more than emergency. The emergency patients are priority. That's where they go. And then what we've also done is try to minimize The need is apparent and shown this quarter is emergency patients are the priority, they get treated and that's what drove our double digit growth both in the surgical suite and the cath lab.

Speaker 10

Okay. Thanks. And then the second one is just on IPPS. So IPPS final rule again was a positive outcome for you guys and I think rates continue to be stable, slightly. Specifically for DRG III, I think it's associated with Agtella.

Speaker 10

It was up 10%, which is a high growth number compared to, I think, historical period and also other DRG, so just curious any read through there, is this a sustainable trend that we can perhaps see going forward? Thanks so much.

Speaker 2

Yes. I think we're in a great place right now for the appropriate reimbursement because the system Set up by CMS and the physician experts has allowed a system of treatment for the sickest patients To be treated with DRG1, so that's biventricular Impella or a patient that needs oxygenation and hemodynamic Support, that's DRG3, that's AcTELLA, that's around 10% to 14% of our patients every quarter and that's growing 4 hours, that's DRG216. Then of course we have those that are in cardiogenic shock that we're going to acquire 3 to 4 days in the ICU and that's DRD-two fifteen. And last is that even the hub and spoke. So our ability now as the largest distribution team and the most the group of the most experts Out there that can be bedside or it can get the hospitals can get phone support.

Speaker 2

And again, we're tracking nearly all our patients in the cloud in the U. S. So we have this incredible network That we're able to also support patients at 1 smaller hospital and then assist in transferring that patient to a large center with the Impella already in. And that's now the hospitals that receive that patient with Impella can bill for DRG268 and that gives reimbursement to monitor and manage the patient in the ICU and explant the device. So we really appreciate Now the physician societies and the experts as well as CMS has really been very thoughtful about allowing heart recovery to occur.

Speaker 2

But again, Impella is one of the most cost effective technologies that Medicare pays for and all of our FDA studies incorporate those 65 year old patients and above. So it's taken us many years to get here, but we're appreciative because heart recovery can thrive now in the community.

Speaker 5

Great.

Speaker 2

Well, thank you everyone for your time today. And if you have follow-up questions, please reach out. Have a great day.

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Earnings Conference Call
Abiomed Q1 2023
00:00 / 00:00