ABIOMED Inc (ABMD) 2011 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Q4 2011 Abiomed earnings conference call. My name is Steve. I'll be your operator for today.

(Operator Instructions).

As a reminder, this conference is being recorded for replay purposes. Now I'd like to turn the conference over to your host for today, Ms. Aimee Maillett, with the Corporate Communications department.

Good morning, everyone, and welcome to Abiomed's fourth quarter of fiscal 2011 earnings conference call. This is Aimee Maillett of Abiomed's Corporate Communications department. I'm here with Mike Minogue, Abiomed Chairman, President and Chief Executive Officer, and Bob Bowen, Vice President and Chief Financial Officer. The format for today's call will be as follows. First, Mike will provide you with strategic highlights for the fourth quarter. Next, Bob will provide details on the financial results outlined in today's press release, and we will then open up the call for your questions.

Before we begin discussing the fourth quarter, it is necessary to remind you that during the course of this call we will be making forward-looking statements including statements regarding future financial performance, product development efforts, Abiomed's strategic operational initiatives, market response to our new products, our progress towards commercial growth and future opportunities. Abiomed's actual results may differ materially from those anticipated in these forward-looking statements, based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, competition, technological changes, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, government regulation, future capital needs, and other risks detailed in our SEC filings.

Investors are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of today's conference call. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that maybe made to reflect events or circumstances that occur after the date of this conference call, or to reflect the occurrence of unanticipated events.

Lastly, comparative references made financially in this call to revenue, expenses, gross margin or other increases or decreases will be indicated by references to fourth quarter of fiscal 2011 as compared to the fourth quarter of fiscal 2010, or fourth quarter of fiscal 2011 as compared to the prior third quarter of fiscal 2011. I'm now pleased to introduce Mike Minogue, Abiomed Chairman, President and Chief Executive Officer.

Thanks, Aimee. Good morning, everyone. We are proud to announce another strong quarter with 24% growth in overall revenue, and 34% growth in Impella revenue. Q4 marks the completion of an outstanding fiscal year for Abiomed. Three impressive points for the year were US Impella commercial reorder revenue grew 82% to $62.5 million from $34.4 million, demonstrating the success of our go-deeper strategy. Net cash provided by operating activities totaled $1.6 million, the first year of positive cash generation from operating activities in the Company's history. Third, the gross margins of 78% for the full-year represent the value proposition offered from the Impella platform.

On today's call, we will highlight year-over-year progress on 2 fiscal year goals. So first, on goal number 1, increasing Impella utilization and independent usage. In Q4, we increased Impella utilization by 41%, and supported 769 Impella patients. All of the patient usage trends increased year-over-year, including high-risk PCI by 13%, AMI by 114%, and all other applications by 63%. Independent usage of 30% in Q4 was 67% higher than last year's 18%. We had a slower start in the first 2 weeks of January, and continued to ramp up throughout the quarter. It is possible that there was some Protect II customer confusion at the start of the year.

Our second goal was to advance the education of the science and benefits of heart muscle recovery. The Protect II study is a first-ever FDA study for high-risk PCI requiring hemodynamic support, the intra-aortic balloon pump with PCI, and high-risk PCI with atherectomy. Overall, our momentum continues to grow, as the Protect II outcomes are digested by the clinical community. We presented this landmark study at ACC in April, SCAI in May, and PCR this week.

To summarize Protect II, the Impella patients were treated more aggressively, and had significantly better outcomes at 90 days per protocol. Additionally, the Impella patients had lower hospital charges, with improved outcomes at 90 days. Abiomed is amassing a compelling body of clinical evidence for percutaneous hemodynamic support and heart muscle recovery, as demonstrated by the recent positive coverage decision by the New England Medical Director for CMS.

Protect II was specifically noted and quoted, in the inclusive decision for Impella hemodynamic support. In the last 5 months alone, we have had 12 publications or abstracts. As we close our fiscal year, we are very confident in our clinical and cost effectiveness data. In summary, we believe the Impella platform will be in every major cath lab, EP lab, hybrid lab and surgery suite, hemodynamically supporting high-risk patients on both sides of the heart.

Impella revenue has grown sequentially 9 straight quarters in a row in the US, demonstrating the market demand of this product. We are proud of our results in fiscal year 2011, and grateful to our customers and investors for their ongoing support. Abiomed is well-positioned in fiscal year 2012 to complete the process to improve this standard of care for high-risk PCI, and help thousands of patients, while creating significant shareholder value. I will now turn the call over to Bob Bowen, our CFO.

Thank you, Mike, and good morning, everyone. Before I get started, I would like to refer you to the Safe Harbor language noted at the outset of the call, as well as the risks and uncertainties noted in our SEC filings, particularly our most recently filed 10-K and 10-Q. I would also like to bring your attention to the GAAP/non-GAAP reconciliation that we have provided in the earnings press release, which is intended to aid investor understanding of our financial results.

As noted by Mike, we posted another strong quarter and year of revenue growth, driven by continued adoption of the Impella platform. Gross margin percent for the quarter was also strong, at 79.5% compared to 72.8% in the year ago period. The improvement was primarily due to a higher portion of revenues from Impella disposables, as Impella revenues accounted for 79% of total revenues, compared to 73% in the prior year.

Also, higher unit production volumes, which leveraged the fixed portion of our manufacturing costs, and lower inventory reserves related to legacy products, principally AbioCor as noted in the GAAP/non-GAAP reconciliation included in our Press Release. A partial offset to the improvement was a higher number of Console placements, related to the launch of our new automatic Impella Controller in January, which automates 60% of the Console set-up routines, and provides for improved patient monitoring.

R&D expenses of $6.8 million were flat, compared to the prior year. Clinical trial expenses totaled $1.7 million in the most recent quarter, compared to $2.1 million in the year ago period, largely reflecting somewhat lower expenses related to the Protect II trial. The remaining R&D expenses associated largely with existing and new product development, quality and regulatory efforts totaled $5.1 million, compared to $4.7 million in the prior year. The increase was largely due to timing of expenditures on new product development initiatives. Selling, general and administration costs were $16.9 million, up 13% compared to $14.9 million in the prior year as a result of the continued build-out of our US commercial organization.

Non-GAAP net income, as described in our press release was $0.6 million in fiscal Q4, compared to a loss of $4.1 million in the prior year. For the year, the non-GAAP net loss was $2.1 million, compared to a loss of $13.5 million in the prior year. Our non-GAAP earnings exclude stock compensation expense, depreciation, amortization of intangible assets, inventory reserves related to select legacy products, the cost of exiting our Athlone Ireland facility lease, and the gain from the sale of WorldHeart Stock.

The GAAP net loss for Q4 fiscal 2011 was $1.8 million, compared to a GAAP net earnings of $1 million in the prior year, which included a $6.4 million gain from the sale of WorldHeart stock. For the year, the GAAP net loss was $11.8 million, compared to a loss of $19 million in the prior year. The team did a great job leveraging the cost base in fiscal year 2011. For the year, total revenues grew by $15.5 million, and the loss from operations decreased by $13.9 million, 90% of incremental revenues went to reduce operating losses.

Since fiscal year 2008, our last full-year prior to the Impella 510(k) clearance, revenues have grown $42.3 million or 72%, and the loss from operations has decreased by $25.3 million, 60% of the incremental revenues went to reduce operating losses. Whether you look at the most recent year or the most recent 3 years, I think it is reasonable to conclude that this management team can both invest for revenue growth, and improve the profitability outlook.

Looking at the balance sheet, accounts receivable and inventory performance both improved, with day sales outstanding of 49 days, compared to 53 days in the prior year, and inventory turnover of 2.9 turns, compared to 1.7 turns in the prior year. We ended the year with cash, cash equivalents and short-term marketable securities of $60.3 million, which was higher than the $59.2 million at the end of Q3, and higher than the $58.3 million at the start of the fiscal year. Based on our current plans, we would expect to see an increase in cash, cash equivalents and short-term marketable securities in fiscal year 2012 as well.

To remind investors, we have no debt, and a non-operating loss carryforward as of 3-31-2011 of $180 million. Full-year revenue guidance for fiscal year 2012, as noted in our press release, is in the range of $121 million to $125 million, representing a growth rate of 20% to 24%, with Impella revenue growth of approximately 35%. Since most of our commercial focus in -- commercial focus in the surgery suite will be on the Impella 5.0 and LD, we expect to see continued declines in non-Impella revenues. We currently believe non-Impella revenues will decline by approximately 25%.

We expect the positive effects of the Protect II clinical story will materialize in the second half of fiscal year 2012, as the clinical community digests the outcome and economic benefits. As such, we believe the quarterly revenue profile will be similar to what we experienced in fiscal 2011, with approximately 45% of our annual revenue in the first half.

Last year, we were able to generate sequential growth in our fiscal second quarter, the summer quarter, compared to fiscal Q1, but we continue to believe that the summer months are slower from a schedule procedure standpoint. Our expectation for gross margin rates are in the range of 78% to 80%, depending on the number of AIC Console placements at existing sites, and the euro/dollar exchange rate. Since a large portion of our Impella production is in Germany, a stronger euro increases our manufacturing costs in dollar terms. In each of the past 2 quarters, the dollar/euro rate was approximately 1.36.

We do not see a significant change in our overall R&D spend, and currently expect slightly higher expenditures in the first 2 quarters. Our Q4 fiscal year 2011 expense was $6.8 million, and I think annualizing that number is about where we will end up in fiscal year 2012. We do expect to see some reduction in clinical trial expenditures as Protect II winds down. But we have the MINI-AMI trial getting underway, as well as likely higher product development expenditures for new products, some of which, like the right side Impella, we have disclosed.

As previously communicated, we plan to add 2 to 4 clinical or sales personnel in the field each quarter. Overall, we expect to continue to be non-GAAP profitable, generate cash, and move toward GAAP profitability. We will now open the call to questions. Operator?

Certainly, sir. (Operator Instructions).

And your first question comes from the line of Greg Simpson with Wunderlich.

Thanks, good morning, guys, and congratulations on quarter. First thing, Mike, you guys are halfway through the first quarter now. The revenue guidance was a little higher than where I expected you guys to come in, given that you tend to be fairly conservative. Any anecdotal comments with respect -- I mean Bob mentioned it, with respect to the impact of Protect II kicking in, in the second half, but any anecdotal comments from you with respect to the level of interest you guys are seeing on the heels of ACC and SCAI? And maybe any impact on utilization that you've seen as a result?

So Greg, as you know we can't comment on activity within the quarter, but we can comment on the feedback. So at ACC, I think we got very strong feedback, as folks looked at the clinical data. At SCAI, which is really the interventional cardiology meeting, again people were really zeroing in on, both the fact that the heart endpoint mace shows a reduction at 90 days. And also the hospital charges analysis that we released at SCAI, showed that Impella at best is neutral or potentially saves $3,000 in hospital charges per patient with better outcomes. So I think those two things are resonating. And then this week, we were accepted for late breaking trials at PCR, which is the biggest interventional cardiology show in Europe, and that will be presented this week by Dr. Jeff Moses to a -- in the big conference room.

Okay, great. And then with respect to, I was wondering if you could dig into the -- some of the other market opportunities for Impella. You mentioned -- you kind of lumped everything into all other. I wonder if you -- I get increasing feedback from doctors, with respect to the use of Impella for heart failure patients in decompensation, and also VT Ablation. Could you maybe talk about those a little bit, and what you saw in the quarter?

Sure. So the first component is, at the week of SCAI, there also was an EP meeting in San Francisco which we did have folks attend, and Impella was discussed as a tool to use for patients that have a low ejection fraction, when they are doing a VT Ablation. We have some good case studies in publications now, where you can actually demonstrate what happens to the hemodynamics, when you do an ablation with Impella, on versus off. And in the comparison abstract, a patient without the Impella on, can really only sustain 4 seconds of ablation, and with the Impella on, does essentially 40 seconds of an ablation where the hemodynamics lower, but they maintain a certain level with Impella. So it's a very compelling application for hemodynamic support.

We also have a study that, the permit study, which we're expecting to be presented and published at TCT in November, which is measuring -- not only do we know that Impella improves the coronary flow and blood flow to the rest of the body, it's also been measured to increase cerebral blood flow. But this study is specifically looking at -- as you increase cerebral blood flow, does that increase brain activity? We hear anecdotally that when the Impella is on, patients feel better. And so this would be one thing to talk about the brain activity, associated with increased cerebral flood flow from Impella.

The second one is the balloon aortic valvuloplasty for patients that have low ejection fraction. In some cases, they are doing high-risk PCI in association with it, and one of the publications that was out, was in the Journal of Interventional Cardiology in this April. This is on case studies specifically for using Impella for balloon aortic valvuloplasty to help these patients. When you do the balloon aortic valvuloplasty, you actually stop all of the blood flow coming out of the left ventricle, because you are putting in an inclusive balloon across the aortic valve, and opening and closing it. So, you have to rapid pace the heart. And with Impella in, it provides a continuous blood flow through that procedure which can help these patients.

And then last on cardiomyopathy, we continue to get interest, and have abstracts and patient studies that are -- folks are looking at, primarily right now outside the United States, where they're taking patients that decompensate. And they are putting the Impella in to look at how fast do they make urine, how fast do they return them to their baseline, and they can potentially avoid all of the harsh regimen of the drugs that these folks would have to go through, if it wasn't for an actively unloading catheter like Impella.

Okay. Great. Just one more, and then I'll get back in line, and save my rest. Bob, you gave great detail on R&D spending. And I made note of the comment, where you said about new products, that some of which we know about. With respect to SG&A though, you guys have been amazingly adept at controlling SG&A spending over the last 2 years. You're loosening up the purse strings a little bit, and obviously there was a lot going on in the quarter. Can you maybe give a little more guidance on that front, with respect to where we should be looking at modeling SG&A in fiscal 2012?

Yes, well, I think if you use -- and you're right, we do plan to let the purse strings out a little bit, because we want to continue to build-out our commercial organization, particularly in the US, to take advantage of the clinical data that's been released. But if you looked at Q4 2011 as a base point of $16.9 million, and then just move up a little bit from there each quarter, I think that's kind of the way we're thinking about it. We do plan to get leverage out of our SG&A cost base, but not as much in fiscal year 2012, as we got out of fiscal year 2011.

Okay. Fair enough. And I lied, but one quick question then. On profitability, when do you suspect you guys might give guidance on that? I'm not going to ask when you expect to be sustainably profitable, but when might we hear from you guys on that front?

We'll provide updates, Greg, as we go through the year.

Okay, fair enough. All right. Thanks, guys.

And your next question comes from the line of Tom Gunderson with Piper Jaffrey.

Hi, good morning. The -- let me tag off of some of the previous questions a little bit. SG&A was a little higher in Q4, than what we'd expected. Was that unusual marketing, higher commissions because of higher sales, is there anything unusual in there?

There's really nothing unusual in there, Tom. It's basically just the effects of building out our sales and marketing organization, somewhat higher commissions as a result of higher sales. And our fourth quarter is normally the largest quarter from an SG&A standpoint.

Got it. Thanks. And then, can you give us a little bit of an update on manufacturing expansion, and your belief for capacity in 2012 and beyond?

We have two full lines in our-- at Aachen, Germany facility, one of which provides nearly all of the current production needs. So, we effectively have a whole other line completely assembled. And we have begun to hire operators to train them on that line, so that we can be prepared for any level of increase in demand. We also have a smaller line here in our Danvers facility that we are in the process of getting operational, that we will use initially, largely for engineering test purposes, but also can be readily, easily converted to a production line when necessary.

We have the ability to add new lines. We have space. We know how to do it. It's not a significant expenditure. It's probably $1.5 million to $2 million worth of capital. And so we feel very comfortable that we can increase our manufacturing capacity as required.

Thanks, and then last question. At ACC, in response to one of the questions, Dr. O'Neill thought that maybe before ACC guidelines came through, there would be an SCAI position paper. Was there any discussion during or after the SCAI meeting, where you're meeting with some of the people and talking more about that going forward?

Tom, we -- there was a session at SCAI on hemodynamic support that was part of the program. So, a lot of the presentations had to do with hemodynamic support, and I think Impella was reviewed favorably. Additionally, in the local coverage decision that we just went through in the northeast, SCAI wrote a letter of support on behalf of percutaneous VADS. So, we're working closely with them, and we'll continue to move to publish, not just the Protect II study, but all the other studies in the registry as fast as we can, to work with them for that position paper.

Oh, that's very interesting. That letter to -- from SCAI was, did that include Protect II analysis?

The letter to -- from SCAI, in general, was overall on the position of the technology. And then specifically, this medical director did review the Protect II data with Dr. Bill O'Neill. And the Protect II data was quoted, and included in the document as part of his rationale for paying and reimbursing for Impella.

Thank you.

I just want to also point to that -- is the -- it also included the Protect II inclusion criteria, and the indications for coverage were specifically Impella by name, which included also cardiogenic shock, severe decompensated heart failure, acute MI, bridge to transplant, and high-risk PCI.

And your next question, sir, is from the line of Larry Neibor with Robert W. Baird.

Thanks, good morning.

Hi, Larry.

Good morning, Larry.

So you've got one region reimbursing through CMS. Can you give us an update on the other regions, and on the guideline issue and journal publication in general?

Sure, CMS as a policy does reimburse for Impella, and they have since 2008. From time to time, regional directors, I believe there's 12 of them, have the ability to ask for further analysis or an update of data. So about a year and a half ago, we had one review in the northwest, and we believe we came out of it with what we thought was positive, a positive outcome that allowed for this Impella support, and allowed for the Impella support when a physician believed that the hemodynamics were such, that in the case of a high-risk PCI, a counter pulsation, like a balloon would not be effective.

In this one, we did a full analysis, and in the actual documentation, they footnote all the papers that they looked at, including the meta analysis that was done in Europe on the balloon pump, and also the three year analysis on the Impella patients that are going through pre-shock. So, we do not believe that there will be another review. There is nothing else that is in print, or that we know of. And this last one that we went through in New England, it had already been out for three months in public comment period, so there's nothing out currently. In other cases, those reviews are done independently through the hospital with the CMS director, and they don't have to make a formal decision, since it's the policy of CMS is that it is being compensated already.

Great. You're making a -- or your paper is being presented at EuroPCR this week. Is there any realistic potential for significant sales in Europe?

Well, our focus in Europe is to be at selected centers in selected countries for folks that are doing publications for first-in-man. So, we do believe that they will have a beneficial effect for those sites that we're working, but we're being somewhat frugal with our spend in Europe, based on the reimbursement policy overall. We see growth now in France, and we have a program there as well for heart recovery overall, but our next big market that we will move to and invest in, will be the Japan market.

Great. And one final question. I think you mentioned that things may have been a little slow the first couple weeks of January, and you said that your high-risk PCI supported patients grew 13% in the quarter. Was most of that slowness that you saw in January in the high-risk PCI group?

It's -- it was probably a slow first two weeks in general, but as you see from the growth percent, that PCI was the one that had the lower growth. Obviously, the AMI growth grew again over 100%, and the all other 69%, so that's a reasonable assessment. On weekends, that's usually where we get the AMI patients, so those cases still continue.

Great. Thank you.

And your next question comes from the line of Joshua Jennings with Jefferies & Company.

Hi, good morning, gentlemen. Thanks a lot. Just wanted to know if you could give us an update on the right sided Impella device, where you are? I think you had an ID going, and maybe you could just frame that market opportunity for us?

Sure, Josh. So, the right side device is currently at a site in Canada, and also at a site in the Netherlands. And the population for that is a collection of unique patient populations from pulmonary dysfunction, to right side failure from a heart attack, also failed transplants, a lot of these patients have -- they struggle on the right side which they manage with drugs today-- chronic heart failure patients, myocarditis patients. So, it's a fixed bag of unique applications, which today there's very limited options other than drugs. And so there is a lot of demand and attention for this, both from the heart failure community, heart surgery and also interventional cardiologists. And so what we're going to be looking at doing, is collecting data on a mixed application basis, and then we'll be using that as we approach the FDA. Currently at this time, we do not have any updates on the status within the United States.

All right, thanks. And just -- you mentioned Japan being sort of your next international opportunity. Any update there or any color you can give, in terms of where you're at, in the regulatory pathway or submission pathway?

The Japanese market is -- aligns with our Company's mission of heart recovery for a couple reasons. The first is, that they are probably a little behind the United States when it comes to door-to-balloon time in their processes for opening up the vessel. The second is that they have a higher mortality rate, as a percentage from AMI or heart attacks. It could be partly due to their smoking population. And then third is, that if you don't recover in Japan, there's really not a transplant culture or process. And based on their size and the invasiveness, the implantable LVADs are not really practical for this group. We have publicly disclosed at the physician community, and also the Japanese government has reached out to Abiomed to bring Impella into the country. And we'll be giving more updates, as we move forward.

Great. Then, lastly, just you mentioned nothing on the horizon in terms of reimbursement proposals or changes from CMS or local carriers for CMS. Are you having any discussions on the commercial side, either positive or negative, the Blues, the United Aetnas of the world, in terms of looking back into reimbursement post-Protect II? Thanks a lot.

Sure, Josh. That's a great question. The harder argument was always the prophylactic, what-if discussion, and now we have randomized data. The hospital economic study was done, as part of the Protect II study by a third party. And so in the best sense, prophylactic use now, we can show that Impella gets better outcomes, and is either neutral or saves in hospital charges. So that's a very compelling story.

In the case of AMI shock, I'd argue that, this is probably one of the most cost effective quality of life technology platforms for this patient population. If a patient has a heart attack and goes into shock, and you can maintain their organs, and keep their kidneys and their heart from failing, they can avoid going into this spiral, which means that they are going to be getting an ICD, potentially open heart surgery, then followed by an LVAD, to a transplant, and then back again within five to ten years.

That population and that patient, becomes the most expensive person in the system. And by recovering a heart, not only do you spend 15% of the overall costs, you're going to get much better quality of life for this patient to go home with their own heart. And the great thing is, if you recover heart muscle, there isn't remission. You can go back to the life you had, and we see patients now that have recovered even on our surgical products, that are out more than ten and 15 years, and still having an active lifestyle.

And your next question comes from the line of David Lewis with Morgan Stanley.

Good morning, guys. This is Bill on for David.

Good morning, Bill.

So two questions here. First one, just looking at the quarter-over-quarter decline in the Impella reorder rate, just curious to see what's driving that? You saw about 106% in December, and we're down to 39% here in March.

Bill, that usually stays very close to the patient rates. So, the patient levels drive the reorders, and the patient rate in the most recent quarter was 769.

Okay. And then following up there, on the non-Impella business, it looked like we saw some stabilization here, I guess in the most recent two quarters, particularly last quarter. And we're expecting a little bit less deceleration in 2012. So were these last two quarters off trend, or has anything changed materially in the business that's really changing the outlook for the non-Impella sales?

Bill, I think as I mentioned in my comments, we have a -- I wouldn't say that there's anything fundamentally off trend, but as a business, we are -- we have continued an increasing focus on the Impella 5.0 and LD in the surgery suite. And we have an expectation that, that is where the physician community will move. And that in particular, our BVS product which was introduced in 1992, is going to continue to show declines going forward.

Okay, and then last one, you'd mentioned increased Console placements in the quarter here. Can you help us out with a little bit of, kind of how does that look compared to maybe the prior quarter in absolute dollar amount?

Our Consoles generally are placed at no charge.

Okay.

So, the revenues all come from disposables, and the Consoles are placed at no charge, title transferred. And what we did in the most recent quarter is, in addition to placing Consoles at new sites, we placed Consoles at some of the existing sites of high users, that we wanted to get some feedback on the AIC, which was very good. And we, of course, want those users to have the AIC, because it's a better device. It's an easier set up, it automates 60% of the steps, and it provides for better patient monitoring. So we believe that over time, that is going to support increased utilization.

All right. Thank you very much.

And we have a follow-up question from Greg Simpson with Wunderlich.

Yes. Thanks, guys. Mike, you gave the numbers on the increase in the different indications, but could you give the break down of Impella procedures by indication? I didn't -- I may have missed that, but I don't think I heard that this time.

Sure, Greg. So the high-risk PCI was right around 50% again.

Okay.

AMI was around 28%, and all other was around 22%. And then from our -- what we track is time to independence, more than 60% of the install base now has done more than five or more patients, which we believe makes them independent ready. And what we're also seeing from the new Console, the AIC, which 60% of the steps are now automated, but it still has 1.5- to 2 minute prep time. We believe that, that time to independence is going to be shortened on the text, just because of how much easier, and how much automated the steps are.

Got you. Okay. And then the follow-up on AMI, when might we see -- what's the timeline for some additional data on AMI? Specifically, I'm thinking about a follow-up to Dr. O'Neill's AMI data that he presented at TCT last year?

Yes. So we're kind of in a good situation. And we're trying to prioritize as much data as we have, in as many publications that's come out, we're trying to maintain a focus. The great thing about what we have, is the Impella product can apply to lots of applications. It doesn't require us investing in a whole new platform. So, you'll see more things coming from the registry on AMI. And we will be moving as soon as we can to start the MINI study, which is going to look at the patients that are having a STEMI interior infarct, so a heart attack on the left side of the heart, the pumping chamber. And these are not going to be patients that are hemodynamically unstable, that would require a balloon pump. What you're going to be looking at is the therapeutic benefits of unloading the left ventricle, and seeing benefits of that to reduce the infarct.

There was another publication this past quarter on the benefits of that. There's been a paper by [Bart Meyns] in the past, but there's another one that just came out of Japan that was -- that documented the benefits of unloading the left ventricle, and what it meant to, basically the muscle. And that was published in the journal, the ASAIO, and it was presented as well. It's a very interesting paper, so we're looking forward to the MINI study.

And then one last point, on the cost effectiveness of heart muscle recovery in the case of AMI, there was a publication or a write up in the Cardiovascular Business Journal, and it was specifically on Pinnacle, which one of our heart recovery programs. And they looked at their historical data to current data, and showed some benefits for Impella, both for patient outcomes, reduction of length of stay and readmissions, and overall hospital charges reduction. So, we're going to be moving forward on that as well.

Okay, great. And so, the next time we'll see the US Impella registry updated, would that be at TCT?

That's very likely.

Okay, great. Thank you.

And that concludes the Q&A portion of today's conference. I would now like to turn it back over to Mr. Mike Minogue for closing remarks.

Thank you, everyone for your time today. If you have any follow-up questions, please feel free to follow-up with Bob and I. Have a great day.

And thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Good day.