Abiomed, Inc.
Q4 2018 Earnings Call Transcript

Published: 3 May 2018

[Operator:]

Good day ladies and gentlemen, and welcome to the Fourth Quarter Fiscal Year 2018 ABIOMED, Inc. Earnings Conference Call. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Ingrid Goldberg, Director of Investor Relations. Please go ahead, ma'am.

[Ingrid Goldberg:]

Good morning and welcome to ABIOMED's fourth quarter of fiscal 2018 earnings conference call. This is Ingrid Goldberg, Director of Investor Relations for ABIOMED 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. First, Mike Minogue will discuss strategic highlights from the fourth fiscal quarter and then turn to our key operational and strategic objectives. Next, Todd Trapp will provide details on financial results outlined in today's press release. We will then open the call for your questions. Before we begin, I would like to remind everyone that this presentation includes forward-looking statements about the company's progress relating to clinical, regulatory and commercial matters as well as government regulation, litigation matters, capital and other expenditures and financial performance. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding these risks and uncertainties appears under the heading Forward-Looking Statements in the press release we issued this morning, our Annual Report on Form 10-K in the year ended March 31, 2017 and our most recently filed Quarterly Report on Form 10-Q. The forward-looking statements in this presentation speak only as of the date of this presentation and we undertake no obligation to update or revise any of these statements. Thank you for joining us. I'm now pleased to introduce ABIOMED's Chairman, President and Chief Executive Officer, Mike Minogue.

[Michael R. Minogue:]

Thank you, Ingrid. Good morning, everyone. In Q4, ABIOMED achieved record results and continued adoption of the Impella product portfolio in the U.S., Germany and Japan. We closed the fiscal year with strong momentum and revenue growth of 40% to $174 million. For the full fiscal year 2018, ABIOMED generated $594 million in revenue with growth of 33% and operating income at $157 million with growth of 74% year-over-year. This year, ABIOMED marked several significant milestones and I'm proud of our Patients First execution and operational discipline from research to manufacturing to customer support. We earned multiple global regulatory approvals in the U.S., Germany and Japan on new products, new indications and reimbursement. For today's call, I will cover growth in Protected PCI and cardiogenic shock and briefly discuss fiscal 2019 expansion with new products, geographies and clinical studies. Q4 success was driven by U.S. patient utilization growth at 35% with Protected PCI and emergent patients at 26% and 43% respectively. We set new overall U.S. utilization records for every category, best quarter, month, week and day for both Protected PCI and emergent usage. Impella RP also delivered solid results in our second full quarter since the commercial launch with 48 new U.S. sites and growth of 93% in patients and 154% in revenue. However, Impella adoption is a function of training, data and time. And as a result, we are still in the early innings with a penetration rate of approximately 9% of 231,000 patients in the U.S. alone. To elucidate this adoption process, I would like to share two patient stories. Mr. Imogen Smiley, 77 years old, had bypass surgery in 1989 and more recently began experiencing severe shortness of breath, leaving him unable to walk a few feet without feeling completely fatigued. A primary care physician eventually referred him to a cardiologist at Parkwest Hospital in Tennessee. Fortunately, Parkwest Hospital has a Protected PCI coordinator that educates the community on high-risk PCI and identifies appropriate patients that are often turned down for cardiac surgery. The hospital's Protected PCI coordinator reviewed Mr. Smiley's clinical history and scheduled him for a consultation with Dr. (05

[Todd A. Trapp:]

Thanks, Mike. And before I get started, I just want to say that I'm really excited to be part of the ABIOMED team and I look forward to meeting the stakeholders on the phone in person and working closely with you in the future. So, now, let's get into the financial results. In the quarter, we delivered revenue of $174 million, an increase of $50 million or 40% versus last year. U.S. Impella revenue rose 35% to $146 million, driven by 35% increase in patient utilization. Outside the U.S., Impella revenue totaled $22 million and was up 107%, mainly driven by our performance in Germany. In the quarter, our German revenue increased 95% versus last year due to continued patient utilization and a greater adoption associated with high-risk PCI. Additionally, worldwide service revenue was $6 million in the quarter, up 19% versus prior year. In the U.S., at the end of fiscal year 2018, the Impella 2.5 and the Impella CP have been placed at 1,197 and 1,172 sites of the targeted 1,400 hospitals. Additionally, the Impella 5.0 and the Impella RP are currently at 516 and 270 sites, respectively. Both the Impella 5.0 and Impella RP are now being adopted by more sites and have significant runway. Reorder performance continued to be strong in the quarter. U.S. reorders increased 35% to 140 million versus prior year, which translated into our reorder rate of approximately 100%. Average combined inventory at the hospitals for the Impella 2.5 and the Impella CP rose slightly to 3.8 units per site versus 3.7 in the prior quarter and 3.4 units per site in the prior year. Gross margin for the quarter was 82.7% compared to 84.6% in the same period of the prior year. The decrease was mainly due to higher manufacturing investments to support future topline growth as well as geographic mix. RD&E expense for the fourth quarter totaled $21 million, a 31% increase from the prior year. The bulk of the increase was related to investments in new products, including enhancements and higher clinical costs related to STEMI and cVAD Registry studies. SG&A expense in the fourth quarter totaled $76 million, an increase of $15 million or 26% versus prior year. Incremental investments to expand our industry-leading U.S. commercial team and to support the Japanese commercial launch were the main drivers of the increase. Operating income grew 64% to $48 million in Q4. This translated into an operating margin of 27.3%, an increase of 400 basis points versus prior year. The strong margin expansion was due to higher patient volume and continued operating discipline, which confirms the leverage in our business model. GAAP net income for the quarter was $37 million or $0.80 per diluted share versus $0.33 in Q4 of 2017. The year-over-year net income increase was primarily driven by strong operating performance and a lower tax rate due to the impact of the tax reform act and excess tax benefits associated with our equity awards. Our balance sheet remains very strong. In the quarter, we generated $49 million of cash from operating activities. As a result, we ended the year with $400 million of cash. Our top priority for deployment continues to be supporting organic growth initiatives, including building on our intellectual property advantage. Now, I'll make a few comments on our record-setting fiscal 2018. For the year, we delivered revenue of $594 million, an increase of 33% or $149 million versus prior year. We saw broad-based growth in both the U.S. and outside the U.S. due to continued adoption of the entire Impella platform. For the year, operating income was $157 million, up 74% compared to the prior year. We delivered operating margins of 26.5% while continuing to make the necessary investments to support our future growth initiatives. GAAP net income for the year was $112 million or $2.45 per diluted share versus $52 million or $1.17 in the prior year. The 100%-plus increase was again driven by strong operating performance and a favorable tax rate. Finally, we increased our cash position by $123 million during the year while investing in our infrastructure and manufacturing capacity and we remain debt-free. Lastly, turning to our outlook for fiscal year 2019, as noted in the earnings release, we expect 2019 revenue to be in the range of $740 million to $770 million, which translates to 25% to 30% growth for the year. The guidance is based on the following assumptions

[Operator:]

Thank you. Our first question comes from the line of Bruce Nudell of SunTrust. Your line is open.

[Michael R. Minogue:]

Good morning, Bruce.

[Todd A. Trapp:]

Good morning, Bruce. We don't hear you. You might be on mute.

[Bruce M. Nudell:]

I don't think. Could you hear me now?

[Todd A. Trapp:]

Yeah. We can hear you now.

[Bruce M. Nudell:]

Okay. Sorry. We recently looked at 2015 inpatient data and saw 170,000 inpatients who received PCI who weren't coded for cardiogenic shock, but either had systolic heart failure, chronic kidney disease or very extended length of stay. In this group, 25% or around 40,000 were coded for acute kidney injury suggested of low perfusion and contrast adage. Overall mechanical support was only around 5% in the (23

[Michael R. Minogue:]

Bruce, the information you're referring to is – lead author is Michael Flaherty. It was published in the journal of Circulation Research in 2017. It has 230 patients and what it shows is that the use of Impella for low EF patients significantly reduced the risk of AKI acute injury. For Impella, it was 5.2 and for the control arm, it was 28%. Impella also significantly reduced the risk of dialysis, which is – increases mortality, length of stay and costs. So, the answer is, yes. We do have more extensive research that will be coming out over the next two to three years and what we believe is happening is the forward-flow driving more blood flow to the kidneys has a hormonal benefit. It increases urine production and it allows the kidneys to remove impurities in the blood. One of the Achilles' heels of all of PCI and now also TAVR is acute kidney injury because of the contrast, because of the stress to the heart and what the kidneys can do is sometimes shut down. So, you'll be seeing, over the next three years, a lot of publications around the research, the basic science, but also you'll be seeing this in patients and studies that are happening both in Europe and the U.S. in the future.

[Bruce M. Nudell:]

Thanks so much. Have a great day.

[Michael R. Minogue:]

Thanks for the questions.

[Operator:]

Thank you. Our next is from Raj Denhoy of Jefferies. Your line is open.

[Raj Denhoy:]

Hi. Good morning.

[Michael R. Minogue:]

Hi, Raj.

[Raj Denhoy:]

Congratulations on a good quarter. I wonder if I could ask maybe on a couple of things that – couple developments over the quarter. First, the expanded indications or I guess the reduction of some of the turns to using Impella in both high-risk PCI and shock, the FDA changed the use criteria there slightly, whether that's having much of an impact and your thoughts around that. And the second on the reimbursement change that happened just a few days ago, with the collapsing of Impella into one code at a slightly lower level, so any thoughts around what that's going to do to adoption of the technology.

[Michael R. Minogue:]

Sure, Raj. This is two big questions. So, first on new EF, the patient population, if they are already surgical turned down and they have everything I described about comorbidities or complex anatomy or severe coronary disease, they don't have the option to go to surgery if something goes wrong. And we do think it will have an impact and I think it will have an impact also in identifying patients that just do better with hemodynamic support. So, it allows them to do longer inflations, potentially atherectomy, potentially reduce acute kidney injury. So, we do think it will have an impact and we're watching it as it goes out and it takes time for this information to filter. The second question on the reimbursement, what's happened is CMS has now created a dedicated code for percutaneous heart pumps. It is now cath lab only patients as well as the ICU emergency patients are all in DRG 215. They maintained the focus on biventricular support and they also permanently created a DRG for biventricular Impella. So, we think the simplicity of having everything together will be beneficial, but we'll watch it and make sure that we have appropriate use and appropriate reimbursement. When they do the analysis, that is being proposed and potentially can take effect next October. They're usually looking at a subset of data that's two years old. And that data may or may not have the most recent trends of more emergency patients than elective patients. But the nice thing about the process is, one, if a hospital gets better outcomes (27

[Raj Denhoy:]

Helpful. Maybe just one quick follow-up. You mentioned – since it is a dedicated code now, with the initial reimbursement at about $71,000 for the Impella sites that you gave referenced to in the press release or the 8-K, I should say. Now, that these are specific for mechanical support, would you expect that that number over time is biased upwards as CMS gets more reflective data of what these procedures actually cost?

[Michael R. Minogue:]

The way their system works is as the costs or the patients get sicker, then costs goes up, the reimbursement goes up and what we try to do is bring those costs down by reducing length of stay and readmissions and additional resources. So, as the balance goes, we work with it, but just to remind all our investors, three years ago, we were being paid at a lower rate for a mix between DRG 216 and 221. The coding was difficult. We did not have biventricular support with Impella. Essentially, there was no additional support and many of the hospitals for transfer would not receive any reimbursement for patient management and explant of an Impella. So, we now have a dedicated system. We now have approval of essentially an extensive array for elective, urgent and emergent indications from the FDA and now it's up to us to continue to execute and partner with our hospitals to get better outcomes.

[Raj Denhoy:]

It's helpful. Thank you.

[Operator:]

Thank you. Our next question is from Chris Pasquale of Guggenheim. Your line is open.

[Chris Pasquale:]

Thanks and congrats on another strong quarter. Mike, a couple questions on the pipeline. Can you give us an update on the U.S. regulatory timelines for Impella 5.5 and Impella ECP? And then, with the DTU trial approaching completion, is it possible we could see some data from that study at TCT? I know the primary endpoint is at 30-days.

[Michael R. Minogue:]

It is possible. I'll answer the last question first. It is possible for the DTU. It depends on how fast we can close out here, but we're potentially planning for that. It may be a little after, but that's what we're looking to do and we're excited to look at the data. This is a EPIC study, because this is what we believe can impact the epidemic growth of heart failure. To remind our investors of today's standard of care for patients having heart attacks without shock, within five years, 70% have heart failure and 40% die. So, we think that helping to protect and work with the heart muscle will have a profound impact on preventing future heart failure patients. So, that – we're very excited about that. We're looking forward to getting into the feasibility. Now, we do have a lot of work ahead of us. We have to make sure that the feasibility is successful. We have to work with the FDA to design the pivotal study and we have to do it the right way and that's going to take time. So, that's what we're working on, but we're very focused and excited about looking at that and analyzing that data. On the question on the Impella 5.5, we are launching it under a controlled method in Germany this year. We have selected German hospitals that have established heart recovery protocols and we'll give more details on the U.S. timeline in the future, but again, it's not approved in the U.S. When we collect the data, we'll be working with the FDA to talk to them about how we'll enter the U.S. market, but we will definitely be studying it and collecting data initially at all our cVAD Registry sites. So, that's the plan. On ECP, will also happen late/mid summer timeframe as we've talked about and we'll give more details on that as we move forward.

[Chris Pasquale:]

Thanks.

[Operator:]

Thank you. Our next question is from Isaac Ro of Goldman Sachs. Your line is open.

[Isaac Ro:]

Good morning, guys. Thank you. A question on R&D spend as it relates to your 2019 guidance. You mentioned the STEMI program is a little ahead of schedule there and wanted to maybe get some context as to how we should think about the investment there ramping into 2019. Now that you've got sort of a head of schedule timeline, should we assume follow-up work starts to get pulled forward? And just want to make sure I get that probably dialed into the 2019 expense line items. Thank you.

[Michael R. Minogue:]

Sure, Isaac. We expect to finish here, as I said, mid to late summer. We'll have to collect the 30-days MRI images and analyze the data, which means we're going to be submitting that information to the FDA probably around the end of our fiscal year. In the back half, we'll start designing the pivotal study, again, if the feasibility study is successful, which means we'll be getting into next year, the next fiscal year to line up our randomized larger pivotal study and we'll be able to give you the details of that study moving forward. You don't need to plan for anything more extensive than what is currently in closing out the feasibility study.

[Isaac Ro:]

Understood. Thank you.

[Operator:]

Thank you. Our next question is from Matthew O'Brien of Piper Jaffray. Your line is open.

[Matthew O'Brien:]

Great. Thanks so much for taking the question. And, Mike, I kind of think I know how you're going to answer this and you've been doing this for a while, but the revenue guidance implies a meaningful slowdown. Somewhere in the business, there's a lot of momentum, Japan, Germany, RP, new indications, et cetera. So, what is it that you are building it outside of conservatism that we should pay attention to? It doesn't sound like it's reimbursement, but just anything specifically to call out there.

[Michael R. Minogue:]

You know, Matt, this is our sustainable growth target and I think it probably is one of the highest in all of MedTech, if not the highest. And so, we want to make sure it's sustainable growth and we're continuing to improve outcomes. We are replacing technology that's been around for 40 years and we're going for the global standard of care. If you look at last year, we gave a range of 25% to 29% and this year, we're giving a range of 25% to 30%. So we're actually increasing the top line forecast. We're definitely increasing the net increase in revenue and we're also maintaining this best in growth rate at a higher base and we're doing it while improving operating margin. So again, it's sustainable growth. It's strategic, but we have to continue to improve outcomes and go at the right pace to have the success we want, which is to achieve the best outcomes for patients.

[Matthew O'Brien:]

Makes sense. Thank you.

[Michael R. Minogue:]

Thanks, Matt.

[Operator:]

Thank you. Our next question is from Jayson Bedford of Raymond James. Your line is open.

[Jayson T. Bedford:]

Good morning and congrats on the success and welcome, Todd. So, just a question on Germany. The growth has obviously been quite strong. Just wanted to ask a few questions around the sustainability of the growth. Where are you in terms of coverage? Are there still the pockets of the country where you're expecting reimbursement and when you look at the market opportunity for the Impella 5.5, is it totally additive or is there any cannibalization of your existing business there? Thanks.

[Michael R. Minogue:]

So, Jayson, on the first part, do you mean Germany specific or overall?

[Jayson T. Bedford:]

Germany.

[Michael R. Minogue:]

Germany. So, the growth in Germany is a function of ausbildung, daten and zeit, which is training, data and time in German. And what's happening is, as you mentioned, we grew 95% in the quarter. You have a couple factors. One is we've been adding to the distribution and we have a training center now in Aachen, Germany. So, that's been very beneficial to have physicians come in where we go through hemodynamic science best practices. We've also seen an increase in the mix of increase in high-risk PCI. Years ago, Germany was 95% shock patients and now we have high-risk PCI growing. The third is that it's just continued reinforcement that in Germany the intra-aortic balloon pump is a Class III for cardiogenic shock, which means that it's harmful for patients. And then, we're now active with over 200 hospitals and there are 600 to go in Germany. So, we're making progress in opening new centers with our added distribution and as we do that, we'll continue to grow both indications, but also we'll go deeper in each site and that drives strong growth itself. Your question on the Impella 5.5, the answer is there's a little bit of cannibalization, because it will replace completed the Impella 5.0, but because it's longer term, the CE Mark were 30 days, because its peak flow is above 6 liters, it will have an optical sensor, because patient can get up and ambulate. There's a lot of interest in new science of unloading where they'll match the Impella use of things with stem cells or immunosuppressant drugs, but there's no question that when you put the Impella 5.5 in a patient, it completely unloads them. Their kidneys make urine. Patients feel better and they can get up and move around, because it's designed for the axillary implant and it avoids the sternotomy. So, we're very excited. We're going to go slow and steady. We're going to collect data to publish. I'm going to work with the FDA early, so they understand how this product will replace the Impella 5.0.

[Operator:]

Thank you. Our next question is from Margaret Kaczor of William Blair. Your line is open.

[Margaret M. Kaczor:]

Hey. Good morning, guys. Thanks for taking the question.

[Michael R. Minogue:]

Margaret.

[Margaret M. Kaczor:]

We've seen a pretty significant increase in shock utilization since TCT. So, as you guys look at your data and adoption curve, is the shock adoption curve, right now, different than what you guys have seen for high-risk PCI and maybe does that change if you look at those 15% to 20% of accounts that seem to have now adopted protocols and their adoption curves change relative to others? Thanks.

[Michael R. Minogue:]

Margaret, we've always believed and stated that cardiogenic shock adoption would take time and we mentioned that on the first call when we got approval. And the reason is because it requires a heart team and it requires an approach and an implementation of best practices. So, that takes a group of people. One of the things that's very rewarding for us is the Detroit CSI program, Cardiogenic Shock Initiative is now national. It's independent of ABIOMED and it's kind of call to arms by physicians to enable not only the Impella, but better processes of putting the Impella in before the PCI using a catheter to monitor the patient and we just had a recent publication showing that the Impella CP has a even higher survival effect over the Impella 2.5. So, there's a lot of information in there. We love seeing the improvement in outcomes and we really enjoy meeting these patients and seeing them having the ability to go home with their own heart. So, it's working well, it's growing, but again the key to success and sustainable growth is getting these improving outcomes and native heart recovery.

[Margaret M. Kaczor:]

Thanks.

[Michael R. Minogue:]

Thanks, Margaret.

[Operator:]

Thank you. Our next question is from Danielle Antalffy of Leerink Partners. Your line is open.

[Danielle Antalffy:]

Excuse me. Good morning, guys, and congrats on a really strong end to the year. Mike, I was wondering – and nice to meet you, Todd. Mike, I was wondering on STEMI, if you could talk a little bit about what might happen if the feasibility study isn't successful. Does that mean you abandon STEMI altogether? What are the different options here? I'm also curious about if it's not successful, what that could mean for current adoption and the existing indications and does that mean you're limited to just high-risk PCI and cardiogenic shock? Thanks so much.

[Michael R. Minogue:]

Danielle, thanks for the question. The current DTU study are patients that are not having cardiogenic shock. So, we do not treat any of them today. The thesis that we're testing is not just the unloading benefits of Impella where it takes the work demand and reduces the oxygen demand for the heart. And there's a publication on this thesis. It's that the unloading of Impella preconditions the myocardium. So, when the patient is a revascularized where they open up the blockage that, that pre-conditioning of Impella will reduce the re-perfusion injury that happens in the normal process and standard of care today, where they try to open the clogged artery within 90 minutes. And reperfusion injury results from that solution, because what happens is there is a process called apoptosis which is programmed cell death and that's why patients today that survive heart attacks, again the average – the statistics are that 70% of these patients that survived their first heart attack will suffer from heart failure in five years. So, we think that this has really a huge impact in looking at the way STEMI patients are treated. If it is not successful, it does not change the fact that Impella is proven to reduce the oxygen demand. It's been proven to help increase coronary cardiac power, reduce acute kidney injury and multiple other benefits that we've already studied with the FDA. What's unique about this again though is its new science on what unloading does in preconditioning and helping to reduce reperfusion injury.

[Danielle Antalffy:]

Thanks for that.

[Michael R. Minogue:]

Thanks, Danielle.

[Operator:]

Thank you. Our next question is from Chris Cooley of Stephens. Your line is open.

[Chris Cooley:]

Thank you. Good morning. And I appreciate you taking the questions and, Todd, welcome aboard. Just one quick one from me. If you could help us understand the uptick in expectations for Japan. I'm assuming you're going deeper within the existent facilities, but if you could maybe just expand upon your thoughts there on that marketplace in terms of number of centers, the way you want to roll it out and scale that business going forward. Thanks so much.

[Michael R. Minogue:]

Thanks for the question, Chris. As we've mentioned, it's going to be around $10 million in revenue for this fiscal year. It should be around $16 million in expenses. I believe we have about 40 employees currently in Japan. We have our office there and we also have a training center set up in Tokyo. We're going to kick off a meeting in May, which will be a basically hemodynamic training course for our current users as well as the next generation or the next group of hospitals that will be getting Impella. We're planning for another 30 this coming fiscal year and again, as you mentioned, we're planning on going deeper to get – again get great outcomes and show the benefit of native heart recovery in the country that really doesn't have transplants or do LVADs and prefers not to do sternotomies. One note that is important that just happened in Japan is the Japanese society guidelines just came out with classification and they have downgraded the intra-aortic balloon pump to Class III in cardiogenic shock, which again Class III means it's potentially harmful to patients and it's not recommended. So, we're glad to see that guideline has been updated and we're very excited again to bring our best practices to Japan to drive native heart recovery as a standard of care. And we'll give more updates as we go, but again, we think that Japan is the second largest market opportunity in the world and it's custom designed to our mission of recovering hearts.

[Chris Cooley:]

Thank you.

[Michael R. Minogue:]

Thanks, Chris.

[Operator:]

Thank you. Our next question is from David Lewis of Morgan Stanley. Your line is open.

[Jonathan Demchick:]

Hello. And this is actually Jon Demchick in for David. Thanks for taking the question. I had a quick question just broadly on Impella adoption, I guess both within hospitals and within surgeons within those hospitals. And data kind of points to Impella being maybe 85%, 90% penetrated in heart hospitals across the country, but do you have any sort of sense of what percent of cardiologists within these hospitals are using Impella? And some recent survey work we did showed intra-hospital penetration closer to 60%, but we just wanted to get your thoughts. Thanks.

[Michael R. Minogue:]

So, the question, I'd just clarify, is on how many people use, I would say you have to then look at which population you're talking about. If you're looking at interventional cardiologists where that's our primary user, I would say we have usually three to five champions at each center. 60% sounds a little high to me relative to how many interventional cardiologists are there and we're seeing that broadly increase as we're doing training centers and programs on access and closure. There's a lot of physicians that are a little bit nervous to close a 12 French or 14 French hole. So, I would say it's not 60% for interventional cardiologists yet. You also have multiple indications. So, you may have an interventional cardiologist using it for high-risk PCI, but not for shock or vice versa. For surgeons, we have only penetrated about half the market with the Impella 5.0. So, the Impella 5.0 has got a long way to go and, again, we think the Impella 5.5 will replace that and will be at all 1,000 heart hospitals in the U.S. alone. In the Impella RP, we're only 19% penetrated in the installed base. So, we have essentially many years ahead of new doctors, new indications and new products into all the existing U.S. hospitals in our current installed base. So, we're very excited, but again as we train people, we train to get the best outcomes both for high-risk PCI and for cardiogenic shock.

[Jonathan Demchick:]

Thank you very much.

[Operator:]

Thank you. And that does conclude our Q&A session for today. I'd like to turn the call back over to Mr. Mike Minogue for any further remarks.

[Michael R. Minogue:]

Thank you, everyone, for your time today and we appreciate your support for last fiscal year. If you have any follow-up questions, please feel free to reach out directly. Have a great day.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program and you may all disconnect. Everyone have a great day.