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Abiomed Inc (NASDAQ:ABMD)
Q2 2021 Earnings Call
Oct 29, 2020, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to Abiomed's Second Quarter 2021 Earnings Conference Call. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Mr. Todd Trapp. Sir, you may begin.

Todd A. Trapp -- Vice President and Chief Financial Officer

Good morning, and welcome to Abiomed's Second Quarter Fiscal 2021 Earnings Call. This is Todd Trapp, Vice President and Chief Financial Officer, and I'm here with Mike Minogue, Abiomed's Chairman, President and Chief Executive Officer. The format for today's call will be as follows. First, Mike will discuss second quarter business and operational highlights, and then I will review our financial results, which were outlined in today's press release. After that, we will open the call to your questions. Before we begin, I'd like to remind everyone that today's call includes forward-looking statements. The company cautions investors that any forward-looking statements involve risks and uncertainties and are not guaranteed in the future. Actual results may differ materially due to a variety of factors identified in our earnings press release and our most recent 10-K and 10-Q filed with the SEC. We do not undertake any obligation to update forward-looking statements.

With that, let me turn our call over to Abiomed's Chairman, President and Chief Executive Officer, Mike Minogue.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Thanks, Todd, and good morning, everyone. Over the past seven months, we've navigated the challenges presented to our patients, customers and employees by COVID-19 and coronary heart disease. Our ability to put patients first and adapt and execute as an organization has been our strength. We have created the new Abiomed 2.0 operating procedures, while significantly investing in innovation and clinical research to revolutionize the standard of care for hemodynamic support. I am proud of the patients for this commitment, and leadership from our employees and customers to recover hearts and save lives every day. For fiscal '21, we designated a three phase red, yellow, green approach to address the evolving COVID-19 environment. Q1 was the red phase, reflecting the broad restrictions on elective cases, limited access to hospitals and limitations on travel, meetings and headquarters operations. In our Q2, we moved to the yellow phase with the acceleration of Abiomed 2.0 and preparing to return to growth during our summer quarter with essential procedures. We were focused on sequential and year-over-year growth, which occurred in hospitals and geographies better positioned to handle the resurgence of COVID-19 patients. However, two elements remain challenging in Q2.

First, patient anxiety caused delays in seeking treatment for urgent and emergent care. Second, hospital ICU availability impacted patient referrals, further causing delays in cardiovascular treatment for patients without coronavirus. These factors keep patients' home longer, suppress the referral network and simultaneously increase patient risk and cardiogenic shock and right. This phenomenon has been reported for high-risk PCI, STEMI and Cardiogenic Shock. However, in this COVID environment, staging PCI and high-risk open heart surgery called CABG, are less preferential. And the heart failure patient populations at the hospital tend to be higher risk and sicker. As a result, in our Q2 yellow phase, we have pockets of sustainable growth and recovery across the U.S., Europe and Japan. In Q2, Abiomed delivered $210 million in revenue, up 27% sequentially over Q1 and up 2% year-over-year. During the quarter, patient utilization increased each month, led by recovery in high-risk PCI essential procedures and positive growth in cardiogenic shock. We believe that this trend will continue, but we do not expect a perfectly linear upswing, given the volatility with COVID resurgence. Outside of the U.S., revenue increased 25% sequentially and increased 14% year-over-year as we saw strong recovery within the quarter in both Europe and Japan. Despite the crisis in Q2, we remained operationally disciplined and focused on our fiscal '21 goals and tactical plan. We delivered 29% operating margin while continuing to invest in research and innovation at record levels for the company.

Our balance sheet remains robust with $736 million in cash and 0 debt, and we continue to expand our lead with one of the strongest patent portfolios in Medtech, with 929 Impella patents and 835 patents pending. Overall, I am proud to report that we achieved our Q2 yellow phase goals and grew sequentially, stabilized revenue in the U.S. and increased revenue double digits outside of the U.S. while advancing our regulatory, clinical and engineering milestones. For today's call, I will provide three updates: first, on our planned transition to the green phase; second, the new Impella clinical data; and third, our progress on new technology milestones. So first, operationally, we achieved our Q2 yellow phase goals. We also ramped manufacturing back-up to full production in Danvers, Massachusetts and Aachen, Germany. And we continue to expand training and education online with over 1,000 physicians trained in the quarter with virtual calls and leveraging protectedpci.com and CAMP PCI weekly live and tele supported cases. We are preparing for our transition to the green phase by the end of the third quarter despite the resurgence of COVID-19. This transition to green means we're playing offense versus defense, utilizing hospital protocols to improve outcomes and grow Impella and ECPELLA adoption. Internally, we are now routinely screening and testing employees for COVID in our manufacturing facilities in Danvers and Aachen.

This enabled Abiomed to invest in innovation, achieve our time lines and treat a record number of patients in heart failure, including those with coronavirus. Abiomed 2.0 allows us to adapt our execution on training, data and time with the objectives to minimize patient anxiety and maximize the referral network with Protected PCI, cardiogenic shock protocols and FDA emergency youth authorizations for COVID treatment. Transitioning to my second update, two weeks ago, we presented the most robust clinical data at TCT in company history. Impella was highlighted with three prospective FDA post-approval studies and more than 20 presentations and abstracts, including our newest PROTECT III data presented from the TCT Connect main stage and the first look of the RESTORE EF Study, which demonstrates a clear improvement in ejection fraction and patient quality of life as a result of the Impella supported Protected PCI. The benefit of ejection fraction improvement with Impella Protected PCI is no longer debatable. And these clinical endpoints are validated in multiple prospective studies as compared to the in-and-out PCI treatment technique. The PROTECT III study also demonstrates even lower Impella rates of vascular complications, bleeding and stroke at 1%, 1.8% and 0.4%, respectively, compared to Impella 2.5 in the PROTECT II study. To note, the intra-aortic balloon pump stroke rate was statistically higher than Impella in PROTECT II at 30 days.

And the intra-aortic balloon pump is now deemed in the United States Class III or harmful for post-cardiotomy cardiogenic shock. As a reminder, we hosted a TCT recap call with Q&A led by our Chief Medical Officer last week, and the link to this webcast can be found on our investor website. Impella is the most studied heart pump in the history of the FDA with 14 years of studies originating in 2006 and continuing to today. Impella has over 780 clinical publications, seven completed FDA studies and five post-market studies completed or ongoing, validating Impella exclusively as safe and effective for Protected PCI, cardiogenic shock and right heart failure. Impella also received FDA emergency use authorizations for ECPELLA and Impella RP for COVID-related complications. We will continue to study and publish best practice protocols as we pursue Class I guideline recommendations with STEMI DTU, PROTECT IV and RECOVER IV studies. We are currently enrolling our STEMI DTU study and plan to initiate our PROTECT IV study with a goal for our first patient treated at the end of this fiscal year or Q1 of FY '22. Now I would like to share a recent patient story, highlighting the exclusive benefit of the Impella RP to percutaneously treat right heart failure. Andrea Fedder, a 57-year old retired teacher was visiting her daughter and son-in-law and her 2-day old grandson, when she began experiencing dizziness and other concerning symptoms.

Her symptoms returned the next day, followed by convulsions. Despite the pandemic, Andrea was rushed by ambulance to Palm Beach Gardens Medical Center in Florida, where Dr. Nishant Patel diagnosed right ventricle heart failure with a life-threatening clot. He inserted the Impella RP heart pump percutaneously to allow her heart to rest and administered a drug to dissolve the clot. After three days of support, the Impella RP was weaned and explanted. Andrea was discharged to home a week later with normal ejection fraction for her right ventricle. Today, Andrea is grateful for quality time with her family, and she's especially grateful to hold her grandson. Moving on to our third update on product pipeline. We continue to make our products smaller, smarter and more connected. The Impella 5.5 with SmartAssist is now at 121 U.S. sites, driving a 53% year-over-year increase in revenue for surgical heart pumps. This forward flow heart pump is smaller than the 5.0, easier to implant via the axillary artery and avoid the sternonomy and coring of the left ventricle to provide full hemodynamic support with smart algorithms designed for management, weaning and identification of right heart failure. We also continue to receive positive feedback on the blood compatibility with the most positive testing data on record for beds. This game-changing device is designed for heart surgeon and answers the clinical need. Our exclusive Impella Connect capability is now live at 477 U.S. sites, more than doubling the number of accounts compared to last quarter. Additionally, nearly half of our U.S. patients are now monitored in the cloud with Impella Connect.

We have an additional 484 sites with the hardware already on the console, requiring only hospital WiFi permission to activate the Impella Connect account. Lastly, we submitted our 510(k) approval last quarter with the XR sheet with the Impella 2.5 and remain on track for a limited market release by the end of Q3. We are delivering ahead of schedule on key regulatory milestones. On October 26, we announced 510(k) clearance of the Abiomed's Breethe OXY-1 System and will initiate our controlled launch at our first five hospitals in Q3. We are very excited to add ECMO clinical capability of end organ oxygenation and combined therapy to include unloading with ECPELLA. During the COVID crisis, we have further studied the ECPELLA benefits and will expand our patient population to include respiratory therapy alone. On October 28, we announced a successful first-in-man series of two patients in the U.S. FDA early feasibility study for Impella ECP, the world's smallest heart pump. The two procedures were successfully performed at Ascension St. John in Detroit and Christ Hospital in Cincinnati. The Impella ECP, which stands for Expandable Cardiac Power is an innovative true nine French access closure pump with CP-like flow. We believe this is a game changer for high-risk PCI. In conclusion, we executed during the yellow phase and are transitioning to the green phase in the second half of the fiscal year. COVID-19 patients present with heart, kidney and lung failure and the fear of COVID-19 keeps some patients with coronary heart disease at home causing them to be more high risk when they seek care.

Hospitals are now better prepared to handle the resurgence of COVID-19 patients. And Abiomed 2.0 is in full swing with online everything, allowing support of our patients and physicians in the cloud and at the hospital bedside 24/7. Our technology platform of Impella and ECMO provides unique solutions for heart muscle recovery and organ oxygenation for coronavirus, coronary heart disease and cardiogen shock patients. No other MedTech company has this innovative vision or core competency. At Abiomed, we remain steadfast in achieving our fiscal '21 goals focused on innovation, improving clinical outcomes and growing revenue. We are playing offense with technology and clinical research, and we will emerge from COVID-19 as a stronger company, uniquely positioned to change the standard of care. We appreciate our shareholders for their continued support on this journey. I will end by thanking our customers and employees for their hard work and dedication to recovering hearts and saving lives.

I will now turn the call over to Todd Trapp, our CFO.

Todd A. Trapp -- Vice President and Chief Financial Officer

Thanks, Mike, and good morning, everyone. In the quarter, we delivered revenue of $210 million, an increase of 27% sequentially and an increase of 2% versus prior year. While our business continues to be negatively impacted by the COVID-19 pandemic, we saw a gradual improvement in patient utilization in our key geographies over the course of the quarter. By region, the U.S. reported revenue of $172 million, up 28% sequentially and flat versus prior year. U.S. patient utilization increased 24% sequentially and was down 4% year-over-year. Sequentially, high-risk PCI and AMI cardiogenic shock grew 33% and 20%, respectively. Versus prior year, cardiogenic shock increased 1%, while high-risk PCI declined 8%. As we discussed on our last call, we saw resurgence in COVID cases in July across some of our key markets, such as Texas, California and Florida, which impacted our utilization in that month. Within the quarter, we did see a recovery in some of these regions. And overall, we saw a sequential improvement in U.S. patients in August and September. In the U.S., at the end of September, the Impella 2.5 and CP have reached 1,468 sites. The Impella 5.0 has been placed in 657 sites.

And the Impella 5.5 with SmartAssist is now in 121 sites, up 31 sites versus prior quarter. The full market release of the Impella 5.5 continues to deliver as our less-sided surgical portfolio, including the 5.0, TLD and the 5.5, reporting a 53% increase in revenue versus prior year. Finally, the Impella RP is in 552 sites, up 14 sites versus Q1, with RP revenue increasing 4% versus prior year. In the U.S., we continue to see favorable sales mix as we transition to Impella CP with SmartAssist and Impella 5.5 with SmartAssist. In the quarter, the reorder rate was 100%, a slight improvement over last quarter. Average combined inventory at the hospitals for the Impella 2.5 and CP was approximately 4.6 units per site, in line with the inventory levels we saw last quarter. Outside the U.S., revenue totaled $38 million, up 25% sequentially and up 14% year-over-year. Our European revenue increased 29% sequentially and 17% versus prior year, driven by a recovery in Germany, Switzerland and Italy and favorable foreign exchange. Specifically, German revenue was up 29% sequentially and up 17% versus prior year. The year-over-year performance in Germany was driven by higher patient utilization, favorable foreign exchange and timing of reorders. In Germany, both high-risk PCI and cardiogenic shock grew mid-single digits in the quarter. In Japan, patient utilization was up 32% sequentially and up 29% year-over-year. In Q2, we delivered $10 million in revenue, up 15% sequentially and up 7% year-over-year, primarily driven by higher patient utilization, which was partially offset by lower site openings and console sales. As discussed on our last earnings call, we communicated lower site openings in the quarter versus prior year. We opened up 14 sites in the quarter and now are in 142 sites in Japan.

Moving to key financial metrics. Gross margin was 81.5% in the quarter compared to 83% in the prior year. The year-over-year variance was driven by sales mix and incremental costs to accelerate the Impella Connect rollout. One of our main objectives during the yellow phase was to continue to invest in innovation despite the short-term headwinds. In the second quarter, R&D expense totaled $31 million, an increase of 27% versus prior year. We continue to focus on breaking the small bore barrier with investments in the XR sheet, the nine French ECP pump, and the Impella 5.5 with SmartAssist. We are also investing in clinical studies like STEMI DTU, PROTECT IV and RECOVER IV with the goal of achieving Class I recommendations in STEMI, high-risk PCI and AMI cardiogenic shock. SG&A expense for the second quarter totaled $79 million, down 8% versus prior year. We remain focused and disciplined on managing our discretionary costs and are also benefiting from lower expenses on COVID-impacted-related activities, including T&E and trade shows. In the quarter, operating income grew 2% to $161 million, translating to an operating margin of 29.2%. We delivered strong margins while making what we believe are the necessary investments in Abiomed 2.0, including innovation, clinical data and online training and education to drive long-term growth. GAAP net income for the quarter was $62 million or $1.36 per diluted share versus $13 million or $0.28 in Q2 of '20. The year-over-year improvement was primarily driven by a mark-to-market on our shockwave investment and a lower effective tax rate.

Our tax rate for Q2 was 14.7% versus 24.7% in the prior year due to higher excess tax benefits in this year's rate. We had another solid quarter on cash as we generated $77 million of operating cash flow. Our balance sheet is robust as we ended the quarter with $736 million of cash and marketable securities and no debt, which provides us continued security and flexibility. With the impact of the pandemic evolving differently across geographies, we will continue to adapt to meet the needs of patients and physicians. Although there is much that remains unpredictable to provide transparency to our investors during this time, we want to give color on our top line expectations for our third quarter. Similar to our performance in Q2, we do expect to see a sequential improvement in revenue throughout the quarter. We expect this to be a factor of hospitals being in a better position to anticipate and be prepared with the resources needed to manage patients under the current circumstances. We also expect an increase in volume as sicker, more high-risk patients begin to return to the system for care. At this time, we expect Q3 global revenue to be in the range of $221 million to $230 million, representing flat to 4% growth compared to Q3 of last year. So in summary, despite the unpredictable environment, we delivered solid operational and financial performance in the quarter. While we navigate through the uncertainties of the pandemic, we remain focused on executing our fiscal '21 goals and transitioning to our green phase, while we continue to progress toward changing the standard of care with Impella through our proven formula of training, data and time.

Operator, please now open the line for questions.

Questions and Answers:

Operator

[Operator Instructions] And our first question comes from Margaret Kaczor from William Blair. Your line is open.

Margaret Kaczor -- William Blair -- Analyst

Thanks for taking the questions. So first, I wanted to talk a little bit about the green phase and your comments, Mike, on being able to go on the offensive here. So can you give us a little bit more color around what that means? And then you had talked about patient cure is that something that Abiomed can directly address? Or is this more about being able to go out and kind of try to reinvigorate those referral networks and get some of these patients that maybe are backlogged or on the sidelines and get them into hospitals coming up in the fiscal third quarter?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Thanks, Margaret, for the question. And let me start by saying that I am very optimistic about the quarter and getting to green as well as the fiscal year, the impressive work the engineering and the clinical teams are doing and most important in the future. So let me cover what it means to go to green. So in this transition to the green, it means we want to treat more patients than ever before because the population at the hospitals is greater than it's ever been because the patients are sicker, door to balloon times longer, non-STEMI patients wait longer. So everything is -- every patient sicker has a higher risk. We don't have elective cases at Abiomed. We have high-risk PCI. We have urgent and we have emergent. And our patients have some of the highest risk factors of any patient in the hospital from a cardiovascular perspective. So that part of us needs, it means we need to be better able to adapt and execute. And the way we're doing that is working with the hospitals and the societies, which are much better prepared. I mean that it starts with being prepared. So have more knowledge around COVID. We know it's airborne. We have better testing from temperatures to looking your SpO2. And in house, we have testing for PCR, antigen and antibodies. And some of those tests are within 48 hours or some within one hour. And now we're routinely testing in our Danvers facility with over 100 a week, and we're starting at now in Aachen. Treatment is better.

There are those that have immunity from having it already, and then, of course, everyone is waiting for the vaccines. But what that leads us to is having our plan where we know what we can control, we know what we can influence and we know what we endure. And so we're controlling the things around heads and investments and the regulatory milestones, the engineering. We're influencing things by helping with training and education online. We're helping with CAMP PCI and directly connecting with physicians. And then we just have to endure certain things, like the referral pattern or the ICUs filling up. And where we seek to influence those things, we can do work by working with the societies, by working with our physician champions for roadshows and also running commercials that are a combination of public service to identifying needs of Protected PCI. So those are the things we're doing. And again, we're very optimistic about the second half of the year.

Margaret Kaczor -- William Blair -- Analyst

Okay. Great. And then if I can, I'll ask a little bit about the third quarter guidance, which sort of stems into that. You guys are assuming a pretty sequential -- a pretty nice sequential increase as we go into that third quarter, up mid-single digit. So as we think about what that number implies, it doesn't seem to necessarily imply some kind of incremental COVID headwinds you just spoke to potentially not getting those and thinking you're better prepared. But just kind of give me a range if you can of what gets you on the low and the high end and maybe above or below that range?

Todd A. Trapp -- Vice President and Chief Financial Officer

Yes. Thanks, Margaret. So this is Todd. I'll take that one. So we do -- as I mentioned in my prepared remarks, we do expect to see sequential improvement from Q2 to Q3 as the gradual recovery continues and the seasonality of our business. So again, forecasting, depending on the range, growth of 5% to 10% on a sequential basis. I would say, the low end of the guidance assumes some impact of the COVID resurgence within the quarter. As we see it today in the specific hot spots, really not expecting to see the full recovery within the quarter that we've seen in the past. So if you think about Florida, we saw resurgence cases in July, but made a strong recovery in August and September and actually grew year-over-year quarter. So the timing of the bounce back of the recovery is tough to call. But as you know -- but we know it's going to happen as hospitals are better prepared to handle the resurgence. And again, our patients are not elective. They are sicker and they're in the need of hemodynamic support. I would say the high end of the range, we continue to see a gradual sequential improvement, some lift from the robust clinical data from TCT that Mike highlighted earlier on the call around PROTECT III and our RESTORE EF. And again, we'll just continue to be transparent on the trends that we're seeing.

Margaret Kaczor -- William Blair -- Analyst

Great. Thanks, guys.

Operator

Thank you. And our next question comes from Matthew O'Brien from Piper Sandler. Your line is open.

Matthew O'Brien -- Piper Sandler -- Analyst

Thanks. Good morning. I'd like to just follow-up a little bit on the Q3 guide, especially in the U.S. I know it's a nice sequential bump that we're expecting here, but I think it's probably a little bit softer than some people may have thought just based on a little bit easier comp versus Q2 into Q3. And I think just based on what you said about the interest level in 5.5 and RP, it would imply that there's still a lot of weakness on the high-risk PCI side of things. So can you just talk a little bit about why that would be the case? And then, Mike, you've been doing this a long time. Is this kind of similar to what you've done historically, you're just trying to be as conservative as possible on that number, just given all these different variables that are difficult to predict?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

So Matt, I'll take the question. This is Mike. Thanks for the question. I think it's a good analysis to say where are we on our guidance knowing that most companies haven't given guidance for the fiscal year or for the quarter. To look back, last October was the highest patient month we've ever had in the United States in the history of the company. So October itself, as Todd mentioned, we do expect to be up sequentially from September, but it is a tougher comp. And then it gets a little bit easier as the quarter goes on. We think it's prudent to give this guidance, knowing that we are better prepared, knowing that we have new data and we do have access at most hospitals to get in with the exception of some areas in California. But we are confident that our patients are benefiting from the therapy, the societies and the hospitals are working together to treat these very sick high-risk cases or these shock cases. And we also believe that there's a range there for a reason. In Germany, what you're seeing is there's a -- the local team has coined it. It's a COVID light resurgent, meaning that if the numbers are way up, they're anticipating and they're seeing the ICUs fill back up somewhat, but they're not as sick. And so we're balancing not just the U.S. numbers, but the global numbers.

And we are taking into account that if the ICU beds fill up, it does restrict some of the care. And unfortunately, for many of our patients, we don't create a backlog. These are patients that need to be treated. And if they're not treated, unfortunately, they will die or they'll have some permanent damage that will limit the ability to treat them in the future. So we're in a situation here where, again, we're confident that we're going to be able to continue to grow sequentially with the ultimate goal of growing year-over-year, as we did in a summer quarter in Q2. But we're going to be prudent about our guidance and try to do the best to give full transparency to what we're looking at coming into this transition to green.

Matthew O'Brien -- Piper Sandler -- Analyst

Okay. Fair enough. And then on the sheet side of things, great to hear that the timing for that is on track. I think you said Q3 of '21 for the limited launch there. Can you kind of frame up how often 2.5 is even used anymore in these PCI cases that we don't really get into that at this point? So given that it's going to be 2.5 with that sheet, how impactful could that product be Q3, Q4 and even into fiscal '22? Thank you.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Matthew, question on 2.5 is used less because we have the Impella CP. However, there's probably a patient out there, population out there that doesn't get it used at all that are more female. You see that in our bail-out studies or smaller-sized individuals where that next physician group that's more worried about access closure might be more willing to use it for that patient population. And remember, the PROTECT II was only the 2.5. So we think we're going to get some of those new smaller patients, more female patients, get those doctors more comfortable. It certainly does a lot more than a balloon pump. In many cases, places are not using balloon pump, they're either just -- they're getting in and out or they're getting in and out and trying to stage and meaning they'll bring them back again in 60 days. And staging is something that is going down currently with the COVID environment. And a lot of these high-risk CABG patients are less likely to get CABG, so they're going to be referred in to interventional cardiology. We also know that for high-risk PCI, that single access by our more relaxed expert and experienced user is around 40% of the Protected PCI. So they have a product they're very comfortable with single access continues to grow. And what we're doing is we're really trying to address the different levels of our users, those that are early adopters versus the early majority versus the late majority.

And we know that access closure is very important, and that's why you're seeing us really leverage the PROTECT III data to show that the vascular complications are now numerically lower, and in some case, statistically better than the PROTECT II numbers, especially around the intra-aortic balloon pump. So we think that within the combination of the XR sheet and the new data that's out there and then our training and education program, we're really going to minimize that fear of access closure that keeps some of the physicians from holding back, and again the goal of doing a PCI is to get complete revascularization because by doing that, you enable the improvement in EF and the improvement in quality of life that's now been proven in multiple studies, including FDA studies as well.

Matthew O'Brien -- Piper Sandler -- Analyst

Very helpful. Thanks, Mike.

Operator

Thank you. Our next question comes from Chris Pasquale from Guggenheim. Your line is open, sir.

Chris Pasquale -- Guggenheim -- Analyst

Mike, just following up on the expandable sheet question, what's the timing on the CP compatible version because that's obviously more meaningful in terms of your current product mix?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

What we had said and we'll -- we continue is that we're going to follow-up in the following quarter. So we're talking about end of Q3 or Q4 to submit for the CP and then depending on the cycle for that 510(k), that will lead us to the limited market release on the CP.

Chris Pasquale -- Guggenheim -- Analyst

Okay. So still thinking about sometime in the first half of FY '22 for the market release?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Correct.

Chris Pasquale -- Guggenheim -- Analyst

Okay.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

And I would note, though, that when we talk about Impella, one of the things to look at is TAVR. So a lot of the same centers and some of those sophisticated users, they've already mastered doing at 14 French cannula, all the way through. Remember, the Impella for the CP, it just has a 14 French motor head. The rest of the catheter and the pump is nine French. So that's why our XR sheet is unique because it expands and recoils, so you can close with a nine French. So that's even significantly easier than the ones who are comfortable doing a TAVR. We also know that, again, the single access technique is very popular. And most important, what PROTECT III shows is over the last two years, the best practice is the training. You really are looking at adverse event rates on complications such as vascular complications and bleeding similar to the rates around the balloon pump and PROTECT II. And in the case of stroke, you're looking at statistically better outcomes than what we've seen historically with balloon pump.

Chris Pasquale -- Guggenheim -- Analyst

Yes. I think that's a good point, Mike. Maybe help square this for me. Given that context, vascular complications are down. We've gotten better at large bore closure. So is the expandable sheet a real catalyst for the business? Or is this sort of solving a problem that's already been solved by technology evolution in other areas?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

It's a combination. It's all of the above, Chris. So remember, we have different sized users and different comfort levels. So what we're doing is we're giving a solution, starting with regular education. Here are the actual results of what you get and what you see in the last two years for vascular complications, bleeding and stroke. And the one thing to point out in the circulation publication of amine, it does not give net outcomes for any of those three components. It just gives an odds ratio. So we continue to try to pursue circulation to put out the net numbers because in our own investigation and buying the data, you'll see that all of those are single-digit -- they're lower. But because you have 4,000 Impella patients and 40,000 balloon pump patients, you can get a p-value difference of 1%. When it's low single digits, it's reasonable in the database that doesn't even track it. So we're going to continue to drive the education. We believe that where we are today, in best practices, is that we've really gotten those adverse event rates to a very reasonable number and the overwhelming benefit of the hemodynamic support and being able to achieve complete revascularization is really the message you're hearing from the physicians around the PROTECT III data as well as in RESTORE EF, proving to physicians if we're going to do high-risk PCI, the ultimate goal is to do the best we can in a single setting because it has an improvement in the patient's quality of life and ejection fraction, the same way you get for CABG, where they remove and sow a vein in without having the invasive of a sternotomy.

So it's the most exciting time for us as far as clinical data, education and training. And the COVID world has really opened up a new opportunity for us. We have planned to do online training and education in live cases, but we're going to be able to have more input now than ever before with online training and education. We do weekly cases where our users log in. And because they have password protected identification, we know who they are. We know their outcomes. We know their indications. We know where they're at from Impella Connect with the sole goal of getting them trained and making them more comfortable so they can continue to improve outcomes for both high-risk PCI and cardiogenic shock. So while there's a lot of negative things with the COVID world, there's many things that are going to be very positive for us. And what we're trying to do is become the standard of care and train the masses from small to large centers, this whole network we have now with physicians logging on and watching cases and answering questions to each other did not exist a year ago. And so with everything we're doing from Impella Connect to online training, we think we're going to be able to get in 12 to 18 months, where we have -- it would have taken us four to five years in a normal world without COVID.

Chris Pasquale -- Guggenheim -- Analyst

Thanks. That's helpful. And just last one for me, picking up on your point about maybe some silver linings to what we've gone through this year. You've highlighted some of the COVID-related approvals that you've gotten over the past six months or so. Are you actually seeing meaningful utilization in COVID patients who you wouldn't otherwise be treating? Can you quantify the impact of that at all? Thanks.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

I think there's two pieces to that answer, Chris. First is that the majority of all our patients, because of COVID, they're sicker. So an average door to balloon time now is 3 times higher than it's been. The non-STEMI's have a higher mortality rates. STEMI's have a higher mortality rate. So the -- it is increasing that component of the patients are sicker when they get to the hospital. For COVID itself, we're getting some incremental opportunity, but I still think there's a lot more education we need to do both around pulmonary embolism for people that get right heart failure as well as ECPELLA and just unloading in general. So we're going to continue to further publish papers on that -- on those populations.

Operator

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

Raj Denhoy -- Jefferies -- Analyst

Hi. Thanks. Good morning. Maybe, Mike, I could start with the ECP news this week, some of the early feedback there seem to be quite positive on that device. Maybe you could describe a bit more about the path from here and what that initial early feasibility study looks like and when you transition to something a little broader?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Sure, Raj. So I was in Detroit for the first case. The Impella ECP has been in the works for a while. These are very difficult pumps to do. Thorsten Siess, our Chief Technology Officer, is a Co-Inventor of it. And when I bought the original Impella company, I was not able to secure ECP. And I had been trying to get it back from the day we closed on Impella. So that was a great acquisition back. That is probably the one competitive product that would compete with Impella CP, and it's now part of Abiomed's portfolio. And it did need to utilize our core Impella patents in order to come to the market. That being said, we see the market having different needs. So a high-risk PCI patient may need four to six hours of support, whereas a cardiogenic shock patient may need four days of support with SmartAssist algorithms, AI and run in the cloud. And then longer-term pumps that we're working with 5.5 and the Impella BTR can really focus on those chronic patients. So we've got components that we're working on. Now what the path is for ECP is you have a product -- early feasibility process with the FDA. So we're looking to do the first five patients, which we should be done with shortly for high-risk PCI, will do a preliminary screen with the safety monitor and go back to the FDA to do the next 20.

They consider that the pilot phase, and that will be an ongoing process. After the pilot phase is over, within anticipating -- and this has not been confirmed and agreed upon yet with the FDA, but our current plans would be that we'll move into more formal of a pivotal study. We'll be now going a bigger number in high-risk PCI, and we'll most likely be comparing it to our current data that we have coming in on the multiple studies for the Impella 2.5 and CP, especially from the PROTECT III data set. So that's the current plan. But the nice thing about the early feasibility process is once you enter the United States, and we're here. And it's not going to go away. We're going to continue now to expand the number of centers that get access to ECP as we continue down the path to get approval.

Raj Denhoy -- Jefferies -- Analyst

And just to put a finer point on that. So when you move into that pivotal, say, late this year -- late this fiscal year, maybe really next, when do you think that product might ultimately get approved for a much broader use?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Yes. Raj, it's a valid question. With everything going on right now, let us get through the early feasibility study. And we can tell you that, but it's going well. It's a pretty incredible product. nine French, now you're talking about something that's essentially a similar size to a balloon pump, but it actually can flow at rates similar to the Impella CP. So it's a dynamic breakthrough product. I think all the physicians that have been waiting for it are excited. And I hear from many physicians that say, now all my partners will use the ECP. But what we're trying to do with their partners is show them today, they can get low adverse event rates and vascular complications of bleeding with today's product with training, the XR sheet will make it better and then obviously, the ECP will make it even easier. So that's our path.

Raj Denhoy -- Jefferies -- Analyst

Right. Great. And then sort of similar questions on PROTECT IV. With PROTECT III now having been presented, it sounds like you're moving aggressively with PROTECT IV. But I don't think you've ever fully outlined for us the size of that trial, how many sites when you think it might be -- when it might be done? So anything you're willing to offer today on the path there?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Sure. One of the benefits, again, at COVID is the physicians now are routinely online. So we've had a weekly calls on PROTECT IV. If you look at the Executive Committee, the PIs, the Technical Committee, these are the world leaders in both their trialists, world leaders in studies around stenting or valves. And we've got complete engagement. We've locked in the protocol. We've locked in the steering committee, the country leaders. It will be a global study. It does not require an FDA IDE because we're already on label. However, we're working with the FDA to ensure that they know what we're doing, and we're looking at many things to potentially expand our label later on and we've routinely worked with the FDA and give them an update every quarter. So we'll let them know how we're moving, but it also give us the ability to move faster. We expect to have 1,200 patients. It will be an adaptive design plus there'll be a registry of another 30 or another 1,000 patients that are not in the study that will track. A big challenge will be to make sure from an ethics perspective that all patients are randomized. We'll be able to do that because we'll know every patient at every center because of Impella Connect and the IQ database. And we expect to have our first patient in PROTECT IV at the end of this fiscal year or the first quarter of next fiscal year. So we're moving fast. We're excited. The reason that this study is set up to have a long duration of tracking.

So after the first year, we're then going to start looking at the data from 30 days to six months to up to three years. We really believe there's a separation of the curve for patients that get better revascularization and see an improvement in their EF. And because of that and the way the study is set up is it really is designed to have the strongest recommendation to meet all the requirements for a Class I guideline, which would then essentially mandate usage of this device, not just here in the U.S., but in a sense, globally. And as you've been watching with the balloon pump, the balloon pump is Class III, meaning it's harmful for shock in Europe and Asia. And now the Class -- it's -- balloon pump is Class III harmful in the United States by the Surgical Associations for patients that can't come off the heart-lung machine post-CABG. So it's a really important thing that we both get Class I guidelines for Impella as the world moves the balloon pump to Class III and list it more as harmful. So it's an exciting time. That's a great group, and I think PROTECT IV is going to be probably one of the most revolutionary clinical studies in all of cardiovascular medicine.

Raj Denhoy -- Jefferies -- Analyst

But I guess, 1,200 patients and now you're describing a potential follow-up period that could be as long as three years. When do you think you'll be in a position with enough data to actually move to where it could justify moving to the -- to a Class I indication? Maybe a follow-up, too, is, when do you think that 1,200 patients might be enrolled, so we could even start to see some early 90-day kind of endpoint data from it?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Yes. It's a good question. And in some cases, a lot of times companies do 30 days or 90 days because they're rushing to get to the number to get the p-value. So they can go before the FDA panel and get approval. We already have that approval. So the way it's going to work, Raj, is at the end of one year after the last patient that we're going to have the data, then we have to process it. But it's really think of it as one year after the last patient is up to three years of tracking, we'll be then putting out the data. But what we'll have in that data is we'll have the 30-day to 6-month or one year and then beyond that. So that we'll have the kind of data that you really need to show what happens when you do better revascularization. And what we expect to happen is our patients will have better, yes, more active. And our PROTECT III data set shows our best practices, but the RESTORE EF protocol is similar to PROTECT IV, which really continues to show that you can treat these patients get a massive improvement.

So if you're talking about a net 10% to 15% improvement in EF. So if you have a 30% EF going into a Protected PCI, you come out with 45%. Your quality of life is different. If your EF goes up that much, it improves the curves on your survivability. So we're going to test that. And they also feel better, in many cases, avoid having to have an ICD. So there's a cost savings for that as well. So that's the reason we're doing this. We already have the label. We've already shown the best practices. But the PROTECT IV is really swinging for defenses to document that this is the way to go, similar to the way TAVR has proceeded and driven the conversion for their patients.

Raj Denhoy -- Jefferies -- Analyst

Great. I just want to squeeze one last one because I don't think we've had a chance to ask you about this since it came out last month. But the final reimbursement rates for Impella DRG 2.15 it was down, I think, roughly 11%. Any broad thoughts you want to offer on if that's going to have an impact and kind of really the future direction of reimbursement?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Yes. We always say the reimbursement exercise is a math exercise. So if the hospital charges go up, then the reimbursement goes up. If hospital charges go down, then it goes down. Remember, though, we have a mix of patients. We have a high-risk PCI to shock. So if a patient is high-risk PCI and they do well and discharge them, they can make a little money. If the patient is in shock and not everything goes well, they can lose money. So what they do for those is they submit outlier payments to get back some of the reimbursement. And if the CMS gets it wrong and that hospital charge is higher, it goes up the following year. So we continue to monitor it. I don't see this as an impact pro or negative, and we've talked about that for years. Because what's happened is CMS, HHS and the federal government has set up a system that there's multiple ways to get paid for Impella, whether you're at the hub or the spoke, you can get DRG 1, you can get DRG three with ECPELLA. You can get DRG one with biventricular Impella, you can get 2.15, which is the DRG you're talking about where you can get DRG 2.68, which means you've accepted Impella on -- a patient on Impella already. Three of the four have gone up. And so it's a system of care. We're very grateful to CMS and the FDA that they've given us exclusive FDA approvals as safe and effective. And we're especially appreciative to CMS that they've given us exclusive ways to get paid for Impella that they've deemed reasonable and necessary.

Raj Denhoy -- Jefferies -- Analyst

Great. Thank you.

Operator

Thank you. Our next question comes from Danielle Antalffy from SVB Leerink. Your line is open.

Danielle Antalffy -- SVB Leerink -- Analyst

Good morning. Thank you guys so much for taking the question. Todd, maybe this question is for you, but you mentioned that July was down -- utilization was down 4% sequentially. I think that was -- I'm sorry, year-over-year, I believe. And then -- but you were up 4% for the whole quarter. Is there any way you can give us a little bit more color on what happened in August and September, obviously, would have had to grow much faster than that 4%? And then I have one follow-up.

Todd A. Trapp -- Vice President and Chief Financial Officer

Yes, it's a good question, Danielle. I think what we talked about on the call in my prepared remarks is we did see sequential improvements in patients in August versus July and September versus August. So again, we continue to see the sequential improvement in both revenue and as well as some patients in the U.S. and now they really, that's what our focus is on getting better each month and seeing sequential improvement. And that's what we saw in July and August and September in the U.S.

Danielle Antalffy -- SVB Leerink -- Analyst

Okay. Is it fair to say maybe -- I mean, just doing the math, I mean, it would have had to be relatively meaningfully to get to that 4% for the quarter, is that fair to say?

Todd A. Trapp -- Vice President and Chief Financial Officer

If you look at -- if you do the math, and again, it's some of it's just a year-over-year comparison, I would say, 4% in July. We got a little bit better in August. In July -- in September, I'd say it's a little bit probably more kind of breakeven on a year-over-year perspective.

Danielle Antalffy -- SVB Leerink -- Analyst

Got it. Okay. And then my follow-up is around how to look at the go-forward growth outlook ex-COVID sort of getting rid of all the noise around COVID. And one of the things we've been hearing is that the high-volume users are still very much believers in Abiomed. So I was wondering if there's any -- it's been the lower volume users that have been sort of declining -- seeing declines in usage. And so I was wondering if you could help us sort of characterize how the high-volume users have been growing versus the low-volume users and sort of bridge us to, what's the go-forward ex-COVID outlook could be just sort of looking at those different dynamics? Thank you so much.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Danielle, thanks for the question. So it's a very good question. It's something we track. And we have such visibility to our doctors, our indications and our hospitals that we track this on a daily basis. And we get an email for every patient all day long. And if it's an independent, we ultimately find out about it, either it's on Impella Connect directly, so we know about it or in a reorder. That being said, as we've been analyzed, the actual smaller-to-medium hospitals have gone up sequentially in the 20% range, but they actually are up year-over-year in Q2. And the reason is, is because these patients don't want to go far. You're going to see this trend where you're going to end up with more spoke hospitals, those physicians are doing -- the patients are sicker when they do high-risk PCI or potentially that's where they're going for shocks. So collectively, we're doing pretty well in those centers. It's a good trend for us. It's widening online and training education is helpful. We can get those physicians to log in and watch cases on CAMP PCI. They can ask questions of the experts. They can even get proctored, if they go through the study or a curriculum that's online as well. Now when you end up looking at the large centers, so our top 20 centers that we've talked about in the past that do about 50%, they're up also in the 20% range sequentially in Q2, which is a good trend.

But you're looking at in being down a little bit from 5% to 10%. And we think there's a couple of things for that reason. One is they're already doing the high volume. So when their referrals get cut down or physicians in the community don't want to refer into the big center, that hurts them. And one of the reasons that we speculate is because they've become the COVID hubs, right? They're the big centers, and they're -- they tend to take the biggest bolus of the COVID patients. So that challenges them a little bit. And when you have a flare-up, a resurgence, their ICU beds either fill up or it's the fear of filling up. So that's one. The other reason that we think we can help them is we're going to go out and start running our commercials in these areas. And our commercials won't be the classic Protected PCI or cardiogenic shock. They're going to have a feel of a public service message that will then ask them if they do have chest pain, these are things they shouldn't stay home and then recommend that they, of course, consult with their physicians and look for experts. And so we'll get that referral program back. And last is on access. Even with the resurgence, with Impella Connect, we have access all the time for all these patients.

We also have a call center, and we also have our people that majority of -- all of our field-based trainers and people have access to the hospitals with exception of some hospitals in California. In Germany, where we're seeing another resurgence, remember that it's not for essential workers. So our Aachen facility staying open, and our field team is also maintaining revelance and access into those hospitals as well. So that's what we're watching. We think, we can help our largest centers. The interest is still there. They're super excited about PROTECT III. And you're going to see that, that PROTECT III is being presented. And the road shows we used to do where we have to fly into the city, those roadshows are happening online almost every week, multiple nights a week with 50 to 150 physicians on calls, learning about all our new data. So thanks for the question.

Danielle Antalffy -- SVB Leerink -- Analyst

Thank you.

Operator

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

Calvin -- Morgan Stanley -- Analyst

Hi. Good morning. Thanks for taking the question. This is Calvin [Phonetic] on for David. Just two questions for me. The first is, it's a little bit of a follow-up question to Danielle's question. Just could you help us digest a little bit more on business trends this quarter versus the June and July trends that you shared last quarter? It appears this quarter, Impella revenue is up 1%. So that's lower than June and July's monthly trends, which I think were 4% and 8% increases, respectively, although the underlying July patient trends is down 4%. So appreciate that September last year was a tough comp. So was there any other dynamic like were there any extra-selling days or perhaps extra patient days in the year ago period that further created some tough comp? Or what other factors could you share with us that could bridge that revenue growth relative to June and July? And I have a quick follow-up.

Todd A. Trapp -- Vice President and Chief Financial Officer

Yes. So Calvin, thanks for the question. I think when you look at how our patients progressed over the quarter from July to August, September, again, every month, they got better. And some of them more, as you mentioned, a comp issue. I mean our patient growth in fiscal year '20 in September was up 24%. So it was -- we were lapping some very difficult comps in September. But again, sequentially, the patients got better from July to August to September. And when you think about the revenue kind of walk from in Q2 from a patient to a revenue perspective. And again, patients were down 4%, but we continue to see positive sales mix as we transition from the 2.5 to CP with SmartAssist as well as the 5.0 to the 5.5 CP with SmartAssist. And so we're seeing a benefit of a positive sales mix there from a higher average selling prices. So when you kind of just think about the walk from a revenue standpoint in Q2, it's literally patients were down 4%. We saw probably three points of positive sales mix and then a little bit more, I would say, on the service side to get to walk from the negative 4% to the 0.

Calvin -- Morgan Stanley -- Analyst

Got it. Okay. I just -- and my second question is, I wanted to clarify one point about the PROTECT III data that was presented at TCT. So I think in the presentation, you showed P2 like patients in P3 versus P2 results across both arms. So I think in last year's TCT, when you presented the interim data, you also showed a similar slide that compared P3 data to P2. But I think the patient population shown in the year ago presentation for the P3 had 469 patients, and that number declined to 373 this year and was -- so could you help us understand the difference between those 2? Was the 469 number from last year, not the P2 like cohort and perhaps a broader cohort? Thank you so much.

Todd A. Trapp -- Vice President and Chief Financial Officer

Hey, Calvin, that's a really big question with a lot of things to clarify. So first is, I'd encourage you to go and watch the presentation again where Dr. Chuck Simonton, who gives all the details. Second I'm happy to get on the call with you after this, go through a line item. But at a high level, PROTECT III that was shown last year was interim post-approval study and the number had been growing. So now it's up to 1,600. And last year, we just gave an interim look to compare to PROTECT II, but we did not propensity match it. We did not have the landmark analysis, and we hadn't had the data adjudicated and reviewed by the core lab. So what you're seeing now is essentially a publication report where we've hit a number. We're able to check all the blocks and to compare it with propensity matching, which was not done at interim. And I think the numbers you pointed out on PROTECT II were off a little bit. So we'll take that offline, but I think that answers the high level of your question.

Calvin -- Morgan Stanley -- Analyst

Thank you.

Operator

Thank you. Our next question comes from Marie Thibault from BTIG. Your line is open.

Marie Thibault -- BTIG -- Analyst

Hi. Thank you for taking the questions. I wanted to ask one here on Breethe and the recent clearance you've got there. I would love to hear a little bit more about what you're planning for the limited release and what you hope to learn from that experience?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Thanks, Marie, for the question. Abiomed has been the leader in hemodynamic support. We've done over 10,000 patients with ECPELLA. And the reason they work well together is certain patients need oxygenation. But if you just oxygenate the body with retrograde flow, you will overwhelm or you will get retrograde flow and make the heart work more. So it's detrimental unless you can unload that patient within a period of time. Those publications have been studied, and we posted those slides online with our quarter update. And what we hope to see: one, is continue to find the best practices in the protocol whether the patient gets a 5.5 through the axillary with ECPELLA or has a CP; and then 2, we plan to start integrating with SmartAssist, looking at optimizing both the hemodynamic support and the oxygenation. So we can wean this patient appropriately so that they, again, get native heart recovery. One of the issues in the Popalato study from Europe showed that ECPELLA has not only had better survival, but the majority of patients had native heart recovery versus just survival. And unfortunately, when you oxygenate the body at the expense of the heart, these patients that are -- that remain alive tend to either require a transplant or an transplant or in some cases, won't qualify and never get discharged from the hospital.

They go to hospice care. So we really want to -- we want to maximize the integration of both functions. And there is a new population out there for just oxygenation. So it expands our patient population, and it gives us something else to add for our pediatric product line. So we're excited about it. We're going to turn our Abiomed engineering innovation and clinical research team on to ECMO. We know a lot about it. And to note with -- for the investors, I don't believe there's ever been a single FDA study on ECMO. We haven't seen an independent study sponsored by the ECMO companies in the last 15 years. And we're going to bring the research to it, the innovation and make it better. And I think we're excited now more than ever because ECMO is something that can help COVID patients and in the future, patients that also have just respiratory failure.

Marie Thibault -- BTIG -- Analyst

That's great, Mike. Just one quick follow-up along the lines of ASP pricing dynamics. It sounds like some of the shift toward the higher price devices, it sounds like a sustainable trend. I'm wondering if that's true or if there are other dynamics we should think about going forward on ASP? And then as kind of an accompanying question there. Notice that Japan, obviously, the patient performance, the growth there year-over-year was very strong, but revenue was a little weaker there. Was that just a result of fewer site openings, your console soles -- or sales there? Or was there another dynamic going on? Thank you for the question.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Yes. Thanks, Marie. I'll actually answer both them. So from an ASP perspective, we do continue to see that creep up. Again, it's a function of our CP pumps volume there going down. And our ASP on our 2.5 is somewhere in the $20,000 range and CP continues to increase faster. And the average selling price is somewhere around 24%, 25% there. And again, we have the same phenomenon occurring with the 5.0 and the 5.5. I mean, we're selling more 5.5s today at a higher average selling price anywhere from, let's call it, $35,000 versus the 5.0, which was somewhere in that 26%, 27%, 28% range. So I do expect to see that trend continue over the next several quarters as a mix with our business changes. Your second question with regard to Japan, again, I think we had a very solid quarter there. Again, as you mentioned, we had -- patients who were up 29% in the quarter, they were up over 30% in the last quarter. And it was just a function of just opening fewer sites in the quarter. And we talked about that last year -- last quarter as well as last year is that we front-loaded last year some of the site openings in Japan to accelerate the CP SmartAssist -- the CP rollout there as well as the PMDA study. So I think that will normalize in the second half of the year, but it was just more of a function of less site openings that we had versus last year. We saw that same phenomenon as well in Q1. And again, I think that normalizes in the second half of the year.

Operator

Thank you. And our next question comes from Ross Osborn from Stephens. Your line is open.

Ross Osborn -- Stephens -- Analyst

Good morning. This is Ross on for Chris. Just following up on Marie's question. Can you discuss expected contribution from Breethe in the fiscal 3Q and in the second half of the year on a stand-alone basis and in terms of ECPELLA cases?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Yes. So thanks, Ross, for the question. I would say right now, we're expecting a very minimal impact in Q3 and probably into Q4 as well. I mean we are launching at five sites during the LMR. We're still working right now, I think, finalizing the pricing strategy. It will be similar to, I would say, that razor blade model that we have with Impella, where we'll sell consoles for somewhere 60,000, 70,000, 80,000 with an annual service contract and then we'll continue to sell what I call the disposables, which are the pumps and the auctionators, again, ranging from to $6,000 to $9,000. So I think that's kind of where we think the business model will be right now. Again, we'll work through the pricing strategy with the first five sites. But I wouldn't expect much of an impact right now from a revenue standpoint really in Q3 and for that much in Q4 as well. It's probably more of a -- fiscal year 2022 story.

Ross Osborn -- Stephens -- Analyst

Great. Thank you.

Operator

Thank you. And our last question comes from Jayson Bedford. Your line is open from Raymond James.

Jayson Bedford -- Raymond James -- Analyst

Good morning. I'll keep it quick. It's been a long call. Todd, is there a way you could approximate the split between 5.0 and 5.5 in the U.S.? And just to be clear, you locked 5.5 last summer fall, correct?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

That is correct. It's more of a Q3. I mean, I don't have the numbers of time, but we are selling more 5.5s. We have more higher revenue in 5.5s in the U.S. today as a result versus the 5.0. Now it's a function of patients, and it's also a function of site openings. As I mentioned in my prepared remarks, we opened up another 31 sites for Impella 5.5s in the last quarter versus four for 5.0s. So we're getting higher patients as well as higher revenue coming out of 5.5.

Jayson Bedford -- Raymond James -- Analyst

Okay. How many patients did you enroll in the STEMI DTU study?

Todd A. Trapp -- Vice President and Chief Financial Officer

What was it. Let me see the numbers.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Yes. So we're at 15 sites now close to -- I think it's close to 30 patients now. That's where we're at.

Jayson Bedford -- Raymond James -- Analyst

Okay. And then just going back to an earlier question on PROTECT IV, will we see interim data either on 30-day or 90-day outcomes? Or will we have to wait for all of the data set at once after one year?

Michael R. Minogue -- Chairman, President and Chief Executive Officer

We're going to have to wait until one year after the last patient, but you'll already have most or much of that data already in-house. And the reason we're doing that is because now you're going to have something that will have up to one year that we believe is going to statistically show a difference in the curves. And we're setting the study up to have the highest level of evidence that we can meet every criteria for Class I guidelines. And to remind everyone, the people that are doing this study are the premier trialists are also the people that weigh in on the strength of guidelines in general. So that's why we're doing it this way, but we already have safe and effective FDA approval. We already have our best practices. And for those sites that are not going to be in the study, we expect to see further adoption with our training and data and time strategy.

Jayson Bedford -- Raymond James -- Analyst

Okay. Thanks.

Operator

Thank you. And that does conclude the question-and-answer session for today's conference. I'd now like to turn the call back over to Mike Minogue for any closing remarks.

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Just want to thank all our investors for your support during the journey. These are challenging times. Know that at Abiomed, we're grateful to help patients. We're optimistic about the future. And we're tracking as a company with close to $1 billion in sales, $1 billion in cash, 1,000 patents -- 1,000 patents pending and a product that will revolutionize the standard of care for patients that have heart failure and organ dysfunction that need oxygenation. So we'll follow-up with questions, if you have any. Thanks for your time, and have a good day.

Operator

[Operator Closing Remarks]

Duration: 76 minutes

Call participants:

Todd A. Trapp -- Vice President and Chief Financial Officer

Michael R. Minogue -- Chairman, President and Chief Executive Officer

Margaret Kaczor -- William Blair -- Analyst

Matthew O'Brien -- Piper Sandler -- Analyst

Chris Pasquale -- Guggenheim -- Analyst

Raj Denhoy -- Jefferies -- Analyst

Danielle Antalffy -- SVB Leerink -- Analyst

Calvin -- Morgan Stanley -- Analyst

Marie Thibault -- BTIG -- Analyst

Ross Osborn -- Stephens -- Analyst

Jayson Bedford -- Raymond James -- Analyst

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