Abiomed, Inc.
Q1 2016 Earnings Call Transcript

Published: 7 Aug 2015

[Operator:]

Good day, ladies and gentlemen, and welcome to the ABIOMED First Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions] As a reminder, today’s conference maybe recorded. I would like to introduce your host for today’s conference Ms. Ingrid Goldberg, Director of Investor Relations. Ma’am, please go ahead.

[Ingrid Goldberg:]

Good morning, and welcome to ABIOMED’s first quarter of fiscal 2016 earnings conference call. This is Ingrid Goldberg, Director of Investor Relations for ABIOMED, and I'm here with Mike Minogue, ABIOMED’s Chairman, President and Chief Executive Officer; and Mike Tomsicek, Vice President and Chief Financial Officer. The format for today’s call will be as follows. First, Mike Minogue will discuss strategic highlights from the first fiscal quarter and then turn to our key operational and strategic objectives. Next, Mike Tomsicek will provide details on the financial results outlined in today’s press release. We’ll then open the call for your questions. Before turning over to call, I would like to remind everyone on the call that this presentation includes forward-looking statements about the development and commercialization of ABIOMED’s existing and new products, costs associate with product development and commercialization, expected capital expenditures for fiscal 2016, the company’s progress towards commercial growth with future financial performance, as well as future opportunities and expected commissions to and regulatory approvals from regulatory body. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding these risk and uncertainties appears in the heading forward-looking statements in the press release we issued this morning in Part 1, Item 1A, Risk Factors and our Annual Report on Form 10-K for the year ended March 31, 2015 which is filed with the SEC and available at www.sec.gov and on our website at www.ABIOMED.com. The forward-looking statements in this presentation speak only as the original date of this presentation and we undertake no obligation to update or revise any of these statements. Thank you for joining us. I am now pleased to introduce ABIOMED’s Chairman, President and Chief Executive Officer, Mike Minogue.

[Michael Minogue:]

Thank you, Ingrid. Good morning, everyone. ABIOMED achieved our best ever quarterly results with revenue of $73.4 million. Revenue growth of 50% and income from operations of $15 million. Our employees should feel proud of our continued execution and grateful to our dedicated customers. Who are changing the standard of care from percutaneous circulatory support and offering protected PCI to their patients. Our performance over the past three quarters validates ABIOMED as one of the fastest growing GAAP profitable medical technology company. Overall, ABIOMED has now grown top-line revenue double-digits year-over-year for 23 straight quarters. U.S. patient utilization set new highs with an impressive 62% increase, driven by record number of patients in both prophylactic and emergent support. Prophylactic Impella support now refer to as protected PCI grew 85% and includes elective and urgent high risk patients. These results within one quarter of our PMA approval confirm the growing clinical need and new patient population in the cath lab. This FDA approval makes Impella the only safe and effective percutaneous circulatory device for high risk PCI indication. Today, ABIOMED declares that Impella is now the standard of care in the United States and we will continue to invest in our field and our headquarters capabilities for training and manufacturing. For today’s call, we will provide a summary of our fiscal 2016 plans and a brief agenda overview for our upcoming Investor Day on August 11th in Boston. Our main focus in fiscal 2016 will be establishing protected PCI as the new treatment paradigm in heart failure. The elective and urgent high risk PCI indication is growing in the catheterization lab and we now estimate this patient population at over 100,000 patients in the U.S. These patients may benefit from PCI, but have poor heart function, complex coronary artery disease and comorbidities that likely require hemodynamic support for complete revascularization in the high-risk intervention. Most of this patient population has likely been turned down or not considered for surgery by a heart team, because of age or prior surgical risk factors. We estimate a 5% penetration into this population. The growth this quarter signals the importance of our FDA approval and clinical education to not only the intervention cardiologists, but to the referring physicians and patients. ABIOMED along with the hospital heart team can now focus on these appropriate patients that may not have other options or maybe unaware of the benefits of protected PCI. ABIOMED can share our library of Impella clinical data with over 225 publications, referencing six medical guidelines, four FDA studies our Impella registry and real world case studies after supporting approximately 30,000 patients in the United States. We are now able to unlock the significant market opportunity through rigorous training and education. This is the first time, ABIOMED is able to assist our users in the patient identification process and highlight the clinical benefits of protected PCI, which include a 29% reduction in MACE, a 58% reduction in heart failure classification, and a 52% reduction in repeat procedures. Moving to other major initiatives, we continue to make progress as well. Our Impella emergent patient population is also experiencing strong growth and was up 57% in Q1. Impella CP continues to be a strong driver in our growth and increased 93%, while the Impella 5.0 usage increased 36%. This quarter, we are submitting the FDA PMA supplements for the Impella CP and 5.0 products including the indication for shock with the longer duration of support. This submission is a PMA supplement or PMA supplements from our Impella 2.5 PMA approval for high risk PCI and includes analysis on 415 patients from our FDA study recover one and our U.S. Impella registry and references 692 patients from 17 studies. Additionally, 24,000 Impella patient uses were analyzed for safety utilizing the FDA MDR database. The Impella CP and the Impella 5.0 products remain on the market under their respective 510(k) clearances until the anticipated PMA approvals within 12 months from our submission this quarter. Moving to Japan, PMDA recently requested we submit a supplement for the latest Impella platform approved by the FDA as compared to the device in the submission from four years ago. As is practice in medical devices in Japan most products are usually are revision or to behind currently approved EU and U.S. products. This creates added complexity in the industry around audits, manufacturing, supply chain and customer training. Our new anticipated approval will allow ABIOMED to launch our latest Impella 2.5 and 5.0 products, which includes our product enhancements around ease of use and the liability. This is a positive outcome that will streamline our manufacturing operations and likely improve our Impella adoption in Japan upon approval. This new submission will also likely delay our commercial rollout by three to five months now expected in the summer of calendar year 2016. On the CMS front, the recently released Medicare Inpatient Prospective Payment System or IPPS final rule on July 31st reconfirmed Impella reimbursement and payment. Percutaneous heart pumps like Impella remain one of the most cost effective technologies based on multiple studies some independent, evaluating patient improvement and survival and quality of life, reduction of lengthy stay in hospital, repeat procedures and adverse event rates to 90 days of hospital discharge. We believe ABIOMED’s exclusive focus to protect and recover hard muscle and return patients home with their native heart as well as specific clinical analysis in the 65 and older patient populations are well aligned with ongoing healthcare reform and the CMS focus on patient preferences and quality of life. We will further elucidate this topic and hope to see many of our investors at next week’s Investor Day. ABIOMED will host a physician panel of experts, presents our corporate strategy and five year revenue projection, described our new patient population of interest and unveil future products for heart failure. In summary, our license to become the standard of care has transformed into a reality and I am proud of the discipline and execution we have demonstrated to get to this phase of the company’s financial and regulatory success. We know our success derives from our patient’s first culture that inspires and allows us to overcome any adversity with honor and integrity. With this mindset as our foundation, we are confident of our journey forward, which is paid with clinical and cost effectiveness evidence, regulatory approvals and product innovations. This fiscal year, we are well prepared as we approach many years of high growth and a multibillion dollar market opportunity. As always, ABIOMED is committed to meaningfully impacting the lives of our patients and helping our physicians improved outcomes. Before I turn the call over to my new CFO, I would like to thank Bob Bowen for his years of support and sage advice all these years. I am now pleased to turn the call over to Michael Tomsicek. Mike?

[Michael Tomsicek:]

Thanks, Mike and good morning, everyone. It’s a great pleasure to be joining the ABIOMED team during such an exciting time and it’s terrific take a range from Bob Bowen, who clearly established a strong financial record here a tradition I’ll look to continue. I’ve experienced rapid growth businesses in my previous financial role. And most recently as CFO of Cubist Pharmaceuticals up to their acquisition earlier this year. In my observation, the ABIOMED opportunity is remarkable and I look forward to working with this team to execute, invest and maximize our potential. As noted in this morning’s earnings release, fiscal first quarter revenue increased 50% to a record $73.4 million. This is the third consecutive quarter we’re in broad based patient utilization momentum, delivered industry leading revenue growth. U.S. Impella revenue rose 60% to a record $63.7 million, driven by a 62% increase in patient utilization. Outside the U.S., Impella revenue totaled $5.1 million on a constant currency basis was up 25%. Lastly, worldwide service revenue up $4.1 million was up 24%. The breakdown of U.S. patient utilization by segment is as follows

[Operator:]

Thank you. [Operator Instructions] Our first question comes from the line of Danielle Antalffy with Leerink Partners. Your line is now open. Please go ahead.

[Danielle Antalffy:]

Good morning, guys. Thanks so much for taking the question and congratulations on yet another awesome quarter. Mike, clearly momentum is building on the U.S. Impella side of things, so I was hoping you could give a little bit of color, as much as you can give some prospective on how much of it is capturing share from balloons, which I sort of view as the low hanging fruit, versus - and to get a sense of how much runway is left on the balloon side of things versus actually expanding the market, i.e. bringing in more patients to high risk PCI.

[Michael Minogue:]

Thanks, Danielle for the question. What is new and what we're seeing today is that Impella is now the standard of care. So we’re more focus on capturing the untreated patient population that’s slightly turned down for surgery, but that has heart failure and advanced coronary artery disease. We estimate that that population is over 100,000 patients in the U.S., and we are going to give further clarification on that population at the Investor Day. So that puts us in the range of around a 5% penetration.

[Danielle Antalffy:]

Got it. Okay. That’s helpful. And then, obviously, you added fewer centers this quarter 15 versus I think you were averaging 20 to 25 historically. How much of that had to do with you guys sort of focusing on your existing centers post the Impella PMA approval and how do we think about center adds going forward? I know we're nearing sort of the full penetration of cath labs but just wondering how to think about that going forward. Thanks so much.

[Michael Minogue:]

Danielle your question is on the penetration in the installed base. So let me just give you a couple of numbers. Impella is in 973 of what we see as a 1,400 patient or hospital patients opportunity. So 973 at a 1,400. If we then compare the number of sites that have Impella 2.5 were only in 71% of them with the CP, 38% of them with the 5.0 and 2% of them with the RP. So we have a long way to go of placing more of the Impella portfolio, but we still expect to do around 20 per quarter for the next couple of years as we penetrate into the 1,400.

[Danielle Antalffy:]

Got it. Thank you much and congrats.

[Michael Minogue:]

Thanks, Danielle.

[Operator:]

Thank you. And our next question comes from the line of Ben Andrew from William Blair. Your line is now open. Please go ahead.

[Benjamin Andrew:]

Good morning, and good luck with the thunderstorms there in Denver or Massachusetts Danvers. Two questions for you, I guess. As we talk to clinicians, one of the things we hear back is that there’s some logistical challenges with getting the device implanted, to support patients in more of an emergent setting. How big is the training requirement that you guys undertake when you talk to physicians and to centers? And how have you overcome that in the field? Because, obviously, the patients are there, but it seems like it’s almost an access issue in a lot of cases.

[Michael Minogue:]

So Ben, our general feedback on placing the device is not one of the things that we see as impediment to the first adopters. They are very comfortable with the pigtail and the catheter. But as you suggest the next wave of users who are little bit more concerned with placing something that is a 12 French to a 14 French fold. But remember that the Impella has a 9 French catheter on all of our catheter pumps and that’s really what drives and reduces some of the legacy here in the FDA study we had to compare vascular complications to the balloon pump for the FDA definitions and we actually had generically lower vascular complications statistically the same as the intra-aortic balloon pump because they are both under 10 French from a catheter perspective. For your question and if there is a concern a lot of it just have to do with educating the physician on how to introduce the device and how to remove it and I think a lot of that we’re making great progress and the more use we see in the cath lab suggest that that part of the process can be done in two to four minutes and clearly that’s something that when you do talk to someone who has done up to three of these cases. I don’t think you’ll hear from folks that such a difficult thing to do. But the legacy in it is a concern for that next wave of users.

[Benjamin Andrew:]

Okay. And then as we think about that next wave, I guess, that’s where the real questions I guess are because we all see this market exploding here. Your guidance does sort of assume a deceleration. Is that a reflection of that concern into the next phase or is that conservatism? And again as we think about SG&A spending over a longer period of time to try to penetrate that group, does it need to go even further higher to do that or how should we think about kind of longer term expense structure?

[Michael Minogue:]

Well we’re in the early innings of this growth and we’ve definitely reached an inflection point in the business and we know the growth is sustainable. If you look at the just the last three quarters, we’ve grown $22 million sequentially, which is kind of a best in class growth rate in med-tech. We are planning to continue to invest in manufacturing and our field team. In the past we were looking to add 4 to 10 folks per quarter and now we’re ramped it up to 5 to 10 people per quarter in the U.S. field and we’ve said that we’ll exceed that if we find the appropriate candidates. We also remained - we’re focused on independent use which is one out of 3 patients if the Impella is put in independently. So it’s combination of training, it’s a combination of ease of use and we’re going to invest in the business from a manufacturing perspective and the field team perspective to stay ahead of the growth curve.

[Benjamin Andrew:]

Great, thanks.

[Michael Minogue:]

Thanks, Ben.

[Operator:]

Thank you and our next question comes from the line of Raj Denhoy with Jefferies. Your line is open. Please go ahead.

[Raj Denhoy:]

Hi, good morning.

[Michael Minogue:]

Good morning, Raj.

[Raj Denhoy:]

I wonder if I can ask I’m not sure if it really matters, but in terms of acceleration in growth we’ve seen, how much can you attribute to the PMA and your ability now to market the product as opposed to sort of the natural adoption we've already seen building up to this point?

[Michael Minogue:]

According to results it is going on fact, we saw for the last three quarters we went up 35% on protected PCI to 53% to 85% this quarter. So we know the results are there and for those not yet experienced users achieving a FDA indication is the highest regulatory standard and we’re now able to go out and educate them on the benefits of Impella and mostly important we can work with heart team to help them identify the patients and even market to patients direct. So I think it has a big effect and I think it’s something that we won’t really see and understand completely until four quarters from now, but we’re very pleased with the first quarter and with the PMA approval.

[Raj Denhoy:]

Okay. And then I was going to ask just about the emergent competitive situation. I guess, obviously Thoratec and the PHP product is only recently CE-marked so probably not a lot of impact yet. I don’t believe they’ve begun the trial yet in the United States. And while I won’t ask you to comment on the technology in particular is there anything you can offer in terms of how you’re modeling for them coming into both the European market and also running ago trial in the United States. I don’t know if you have any thoughts around the potential acquisition of that company by St. Jude, and how that might change the competitive dynamic, as well.

[Michael Minogue:]

We think the St. June Thor acquisition will have similar effect to a standalone Thor company since we believe they require largely for their implantable LVAC technology. In relationship to the percutaneous heart pump market. We hope that St. Jude’s larger footprint and relationship with the heart failure community will be helpful in validating the benefits of protected PCI and market development the untreated market is much bigger than the treated market today, we see it is greater than 100,000 patients and our run rate is around 5,000 patients. As from the percutaneous heart pump perspective we are the leader, we’ve got the intellectual property portfolio, we’re most confident in our innovation and our ability to maintain leadership, we supported over 35,000 patients, we have 1,000 installed customers in the U.S., we make multiple devices on the right and left side with implantation from the femoral artery to the axillary and we feel very confident in our commercial team. You specifically ask on the PHP we suggest that Thoratec or potentially St. Jude give their specifics on the PHP timeline. However if we compare to our own timeline in the U.S. with our PMA, we believe it’s going to take more than four years before commercialization. And in regard to your European question, we’re primarily in Germany and most of that driven by our burden to the used cases that require days of support and I think they’re going to have a limitation in their distribution and their CE mark is only for up to six hours as compared to our Impella products, which are approved for five to seven days in Europe. And so I think they are in the early innings of kind of a new product design and we look forward to having them involve to help us educate this installed base and for our investors that have not seen the Thoratec PHP it is a 14 French catheter, it has an external drive shaft running at expandable 24 French mesh cage which sits on the aortic valve.

[Raj Denhoy:]

Okay. That’s all very helpful. Thank you and nice quarter.

[Michael Minogue:]

Thanks, Raj.

[Operator:]

Thank you. And our next question comes from the line of David Luis with Morgan Stanley. Your line is open. Please go ahead.

[James Francescone:]

Hey, this is James in for David. Thanks for taking the question. And congratulations on a very good quarter. First want to do get back to this topic of leverage spending and SG&A in the quarter of about 18% on a revenue that was up 50%. While many investors want to see profitability, I’m sure you can certainly argue, as well that for a top line that’s growing this fast you can certainly spend more. And what would you say are the let’s say the bottlenecks, the reason why you wouldn’t increase SG&A spending? I think historically part of the reason why you gated your investment SG&A has been an effort to preserve outcomes as you open new centers. I think as you shift away from opening more new centers to supporting existing centers, does this give you a little bit more room to open up a throttle on sales and marketing expenses?

[Michael Tomsicek:]

Let’s say the number of the items we’re going to invest this is Mike Tomsicek by the way. In SG&A have become familiar with very thorough very exciting plans here to open the markets I think they’re well considered and at stage. Not surprising with an inflection quarter following the PMA like we just had the revenue would probably strongly outstrip your ability to spend, but when I look at the plans for investment in range of SG&A activity field personnel, training, customer support both in United State and in Europe, I think the plans are thorough and well considered as are the plans for expanding manufacturing. But that revenue would outstrip the spend right after the protected PCIs probably not too much of a surprise.

[James Francescone:]

Okay, got it. And then second, just on market sizing relative to let’s call it 1 million PCIs that are done in the U.S. today, you’ve cut that number down to about 100,000 so 10% of the market. Conceptually whatever the major things that you’ve looked at that gives you confidence that $100,000 excuse me 100,000 patients is the right number?

[Michael Tomsicek:]

In the analysis we given out in more details in yesterday, but at the high level there is over 2 million patients that have heart failure, a good percentage of those have advanced coronary artery disease. If you come out at under the Class 3 Class 4 population, you’ve got 1.4 million Class 3 and 250,000 Class 4 which also suffer from low EF and coronary artery disease. And what we do is we continue to break it down to those who have coronary artery disease, most turned down for surgery have poor hemodynamic and then get diagnosed. So we are still talking that 100,000 patients. We are still talking about a very small percentage of the overall patient population that could benefit from protected PCI and what we’ve done is created a website called protectedpci.com, which is up there now for physicians, for referring physicians and for patients so that people that have heart failure that have thought they didn’t have any other alternatives can learn about this and it’s a lesson based play to have a proceed that it takes a day or two and that shows a statistical improvement in your rejection fraction and the quality of life. So it’s really a nice new paradigm and we think that it’s a new option that heart failure and interventional cardiologist can offer to a growing epidemic of heart failure patients.

[James Francescone:]

Great, thanks for taking the questions.

[Michael Minogue:]

Thanks, James.

[Operator:]

Thank you. And our next question comes from the line of Jan Wald with the Benchmark company. Your line is open, please go ahead.

[Jan Wald:]

Good morning everyone. Congratulations on the quarter. Hi. A couple of questions. Mike, if I heard you right, you said you may have reached an inflection point with what I guess we’ll call first wave of users. The next wave could you talk a little bit about what you - what the characteristics of the next wave are and when you’re doing to try to capture those folks?

[Michael Minogue:]

Jan, our first answer to that question is we’re actually able to educate and train for the first time and we are able to work with the heart, which means we have access to heart failure group the referring physicians to just educate them on the benefits of doing a protected PCI, which if you look at our clinical studies they do show an improvement in their heart failure class, a reduction of the length of stay at the hospital and repeat procedure. So those are things that are very important in today world of healthcare reform and even for an administrative perspective building a protected PCI program is something that they can offer to the community. So that’s at a high level. On a more direct level for the kind of the next wave of adopters it’s really basically training and data. We have to get them the training so they feel comfortable. We have to provide the data for them and we’re doing that now with our education and training. We have marketing tools for them, we have marketing tools for administrators we’re able to share best practice guys, we’re able to proctor different sites, we’re able to have physicians that have more expertise and experience, conduct sessions for them, for site protocol development. So we’re just really able to do things now with the Impella TMA that we weren’t able to do for the last several years. But effectively in the end it’s all about patient care and all these physicians are looking for another alternative for patients that today could be either turned down for surgery or sent to hospice care or moved down or consider for a much more invasive and costly alternative.

[Jan Wald:]

As we talked to doctors and listen to webcasts and things like that on protected PCI and complex PCI, it seems as if what some of the doctors are recommending is that there become centers of excellence. And would that reduce the number of documents and make your job easier or is it going to make it harder because now you really have to worry about referrals and those kinds of things?

[Michael Minogue:]

At ABIOMED we really want to make sure in this rollout of protected PCI, that we treat the right and appropriate patients. So we’re working with the sites to make sure that it’s an appropriate patient selection, the physician is comfortable, that we’re there to support for first case because we know that getting optimal outcomes is the key to success and maintaining our leadership positions and standard of care profile. So, we’re doing everything around that education, but the one thing to point out Jan is that we have up to 10 types of patients, some are elective, some are urgent, some are emergent. So there still the tenancy for the different types of patients that some will be transferred to somebody’s places with Impella and place and some will be referred around the different markets for people that potentially can provide protected PCI. So, we’re coming at it with a focus on maintaining the rigor in training and getting the best outcomes and that won’t restrict us in our growth, it will allow us to maintain this long-term vision of the standard of care.

[Jan Wald:]

Thank you very much.

[Michael Minogue:]

Thanks, Jan.

[Operator:]

Thank you. And our next question comes from the line of Chris Cooley with Stephens. Your line is open. Please go ahead.

[Chris Cooley:]

Thank you. Good morning. Just a couple of quick ones, I guess, left for me at this point. When you look at RP contribution to the quarter, were there any RP sales or was that, I’m assuming in other in the quarter, Mike, or just I guess point one. And then point two I apologize you guys are kind of like the Super Bowl a couple years cutting in and out so when you talked about Japan, you mentioned the 2.5 and the 5.0 under the supplement. I’m just kind of curious when percentage of the population in Japan you think would be targeted by the 5.0 once that’s up and running by midyear, let’s say next year. Thank you so much.

[Michael Minogue:]

Chris I’ll answer the Japan question first and then turn it over to Mike to answer the question on the RP revenue. We expect as we get started in Japan that the 2.5 will be the bulk of the revenue and utilization similar to the U.S. and then overtime we’re going to be submitting for the Impella CP and RP in Japan.

[Chris Cooley:]

Understood.

[Michael Tomsicek:]

And from the RP standpoint it’s currently making up about 2% of U.S. revenue. So as we said updated rollout of that product that making up with real portion of revenue at this point.

[Chris Cooley:]

Understood. Thanks so much. And congratulations on a record quarter.

[Michael Minogue:]

Thanks, Chris.

[Operator:]

Thank you. And our next question comes from the line of Jayson Bedford with Raymond James. Your line is open. Please go ahead.

[Jayson Bedford:]

Good morning and congrats. You guys have done well with this. A couple questions, just to follow the last one, can you break out revenue and I apologize if I missed it, but break out revenue by product line?

[Michael Tomsicek:]

Yeah. From a U.S. revenue standpoint we’re running at 27% of revenue from the 2.5, 63% of revenue from the CP, 8% of revenue from the 5.0 and 2% from RP and then our international revenue is $5.1 million for a total Impella revenue of 68.8 million.

[Jayson Bedford:]

Got you. And the RP, I think you mentioned $6 million to $8 million for the year. Was the prior guidance $4 million to $6 million or did I get that incorrect?

[Michael Tomsicek:]

In my spare time I’ve been reading old the script and I said number does range about from past and our current outlook is the $6 million to $8 million that I mentioned.

[Jayson Bedford:]

Okay. And then internationally, it was a little I guess you could it’s not a big hole but the only hole you could point to would be a little slower growth internationally. Did anything occur there to cause a bit of a slowdown there? I realize it was a tougher comp.

[Michael Tomsicek:]

25% year-on-year I’m pleased that, that performance would be considered very strong, we haven’t had the inflection or sort of regulatory lift that we in Europe that we have from selected PCI, but we continue to be bullish on our potential there.

[Michael Minogue:]

And Jason this is Mike Minogue. Our focus is really the United States first, Germany and then pending is Japan. So, we have other markets, but we really want to establish ourselves soundly here as these standard of care, publish data, share best practices and do lot of education around the benefits of protected PCI.

[Jayson Bedford:]

Understood. Last question for me just on the CP filing, I think you said it included shock and a longer duration of support. What length of support do you think you can attain and then just in terms of the turnaround time, I think you mentioned 12 months. Is that the timeline we should be thinking about?

[Michael Minogue:]

Correct, Jayson. We are putting in for the CP and for the 5.0, they are approved in CE mark for five days for CP and seven days for the 5.0 and in the FDA studies Impella was approved for five days for Impella 2.5 and 5.0 and the RP is approved for up to 14 days. In duration, the devices have obviously run much longer than that and we’ve had patients from an engineering end perspective longer than that timeframe.

[Jayson Bedford:]

And just in terms of the actual approval a year?

[Michael Minogue:]

We expected to be less than 12 months.

[Jayson Bedford:]

Okay. Thank you.

[Michael Minogue:]

And we will be submitting that - we will be making that submission this quarter.

[Jayson Bedford:]

Thank you.

[Michael Minogue:]

Thanks, Jason.

[Operator:]

Thank you. And I am showing no further questions at this time. And I would like to turn the conference back over to Mike Minogue, Chairman, President and CEO for any further remarks.

[Michael Minogue:]

Thank you everyone for your time today. We apologize for the thunderstorm and we look forwarding to seeing you at our Investor Day and we also will be broadcasting it as well. Have a great day.

[Operator:]

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