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Abiomed, Inc. (NASDAQ:ABMD)

515i Reclassification Panel

December 12, 2012 1:00 pm ET

Executives

Mike Minogue – Chairman, President & Chief Executive Officer

Bob Bowen – Vice President & Chief Financial Officer

Susie Lisa – Senior Director of Investor Relations and Corporate Development

Analysts

Raj Denhoy – Jefferies & Company

Greg Simpson – Wunderlich Securities

Dan Garofalo – Piper Jaffray

Mike Rich – Raymond James

Steve Beuchaw – Morgan Stanley

Matt – Credit Suisse

Bruce Nudell – Credit Suisse

Operator

Good day, ladies and gentlemen, and welcome to the Abiomed 515i Reclassification Panel Conference Call. (Operator instructions.) As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Susie Lisa, Senior Director of Investor Relations and Corporate Development. Ma’am, you may begin.

Susie Lisa

Thanks very much, and thanks to everyone for joining us for the Abiomed 515i Reclassification Process Post-Panel Conference Call. I’m Susie Lisa and I’m joined today by Mike Minogue, our Chairman, President and CEO, as well as by Bob Bowen, CFO of Abiomed.

Before we begin I need to mention that statements made during this conference call concerning our expectations for the 515i process and regulatory approvals for our Impella products, our future business and operating results, our existing or new products, our progress toward commercial growth, future opportunities, expected regulatory approvals and similar matters are all forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties.

Information contained in these forward-looking statements is inherently uncertain and actual performance or results may differ materially due to many important factors. Our actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors including uncertainties associated with the 515i process and regulatory changes including the contents of any final rules adopted by the FDA, development and testing, and related regulatory approvals; the results of any clinical trials, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in our filings with the Securities and Exchange Commission including the most recently filed Annual Report on Form 10(k) and Quarterly Report on Form 10(q).

You should not place undue reliance on any forward-looking statements which speak only as of the date of this conference call. Abiomed undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that may occur after the date of this conference call or to reflect the occurrence of unanticipated events.

Now, on to the call. Our format is simple. Mike will start with some overview commentary and takeaways from the FDA 515i Reclassification Panel meeting held on December 6, 2012, in which the FDA panel recommended Class III status for temporary ventricular support devices in the non-roller type cardiopulmonary bypass blood pump category. After Mike’s opening remarks we will then take your questions.

Two things of note before I turn it over to Mike. One is that we encourage you to consult Abiomed’s [ATA] filing dated as of December 7, 2012, which contains three items: first, our press release from December 6, post the panel; secondly, Abiomed’s presentation to the FDA 515i Panel “Classification Determination for Non-Roller Type CPB Pumps” dated December 6, 2012; and thirdly, the Impella clinical literature summary given to the FDA 515i Panel.

The second thing to note is that as per our December 5, 2012, press release, this conference call is being held to discuss 515i Reclassification Panel and further details. Therefore, our discussion is limited to that topic and as per usual we will not be making any comments about the current quarter. With that I’d like to turn it over to Mike.

Mike Minogue

Thanks, Susie. Hello everyone. As you know, last week the FDA 515i Program Panel deliberated about the classification for all current and future devices in a non-roller type cardiopulmonary bypass blood pump category and recommended the devices in the temporary ventricular support category which [includes that] Impella should be confirmed as a Class III device.

This recommendation will likely be outlined in a proposed order by the Agency in the near future and require more feedback during an open comment period. Following a review of the comments the Agency will issue a final order to implement the final classification. However, it appears likely that all devices in the temporary ventricular support category will require a premarket approval or PMA in the future. As per the 515 reclassification process, and confirmed by the FDA Panel, products will remain on the market with current indications while manufacturers submit and move through the PMA application process.

I’d like to use the call to clear up any confusion from the Panel’s discussion as well. Specific to our clearance, the FDA 510(k) clearance letter and summary from June 2008, which is available online, states that “Abiomed provided a detailed analysis based on clinical data from a combination of 109 outside of the US and 20 US patients to address patient safety.” The Panel also discussed guidelines. To note, the current ACC, AHA and SCAI Guidelines do not include a review of PROTECT II nor the US Impella registry nor the SHOCK II intra-aortic balloon pump study which were all published after the update in November, 2011.

Abiomed believes these data may alter the guidelines upon inclusion. We believe the FDA received the following feedback on Impella from the 515 panel members: the device should remain available during the 515 process due to an existing clinical need; confirmation at further clinical studies, Impella may provide hemodynamic benefit; and finally, that these are difficult patient populations to study and randomize based on protocol and ethical considerations.

So what does this mean moving forward? Moving forward we believe this recommendation by the 515 Panel has the following outcomes: #1, there is no change to the way we currently market the Impella under the 510(k). Our indication for Impella is partial to full circulatory support for up to six hours for patients undergoing procedures requiring or not requiring cardiopulmonary bypass. Number two, all Impella 510(k) products including the recently FDA-cleared Impella CP will stay on the market while we pursue a PMA regulatory approval. This process starts immediately for Abiomed. It may take years to complete the final rule for the FDA process.

Number three, the feedback from both the panel physicians and the FDA indicated there could already be sufficient existing clinical data to file a PMA for Abiomed without the need to conduct another trial. This will be an ongoing discussion with the FDA based on the data from our FDA studies for PROTECT I, PROTECT II, RECOVER I and both published registries in the US and Europe.

Abiomed has collected 245 patients in FDA-approved protocols for high risk PCI alone and a control arm exists in PROTECT II as a comparison for safety and effectiveness. Additionally, the US Impella registry is approaching 1000. However, there can be no guarantee of receiving a PMA which would have a material adverse effect on our business if the device was pulled off the US market.

And finally, yesterday we had a call with the FDA to address the next steps in the process related to Impella. We do not plan to wait until the final rule to discuss steps for a PMA. The FDA has proposed that Abiomed prepare a summary report on all of our clinical data and prepare our best analysis supporting a reasonable level of evidence for safety and effectiveness.

We will submit this analysis in advance of the meeting with our clinical investigators and the FDA. After this meeting we do not expect a final answer but we’ll be better able to address the next steps of the process. We will work with the FDA to support these 515 regulatory processes involved in transitioning to a PMA submission with a focus on the Impella platform as compared to the broad temporary ventricular support category.

In summary, the US operating procedures for the Impella under a 510(k) clearance will evolve in the future and align with our 30-year-old surgical business requiring PMA and HE approvals. Impella has proven that it is the recognized leader in the market for percutaneous circulatory support and is valued by the interventional cardiology society as demonstrated by the current ACC/AHA/SCAI PCI guidelines.

We have built a greater than $100 million Impella business in the US and the 510(k) clearance has allowed for an ongoing registry with rapid innovation on the catheter, console and 510(k) clearance of the Impella CP. Most important it allows for patients in need to receive the Impella products for hemodynamic support. We look forward to working with the FDA on next steps and look forward to the opportunity to receive a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients. I will now open up the call for questions.

Question-and-Answer Session

Operator

(Operator instructions.) Our first question is from Raj Denhoy of Jefferies & Company. You may begin.

Raj Denhoy – Jefferies & Company

Hi, thanks for taking the question. Maybe I can start with what you imagine a data gathering or trial might look like. If the FDA was not satisfied with the information you’ve gathered would it be possible at this point for you guys to randomize patients in that sort of trial or do you think there’s some reason why you couldn’t at this point?

Mike Minogue

So Raj, I think the question has a couple components to it, and number one is we do believe that we have in the totality of the data the ability to show a reasonable assurance for safety and effectiveness. And then specifically to your comment around another study of high-risk PCI, we believe it would be unlikely that we could enroll another PROTECT II-like population to the control arm, partly because what we saw at the end of the trials, the improvements of the product and also some of the – in the physical analysis some of the pre-specified endpoints, whether it’s for protocol or the learning curve – has shown the significance of those metrics around either the measurement of atherectomy or CK-MB at three times versus today the 10 times for the largest PCI study the FDA is doing.

And then just maybe it’s worth noting that we have 245 patients studied under the protocol of the FDA, and for [VADs], whether it’s (inaudible) they’ve been approved in the past under a performance criteria in studies that range from 65 to 145 patients enrolled.

Raj Denhoy – Jefferies & Company

Well maybe I can just press you a bit on that because I think in the briefing documents the FDA included some wording about the belief that there’s a lack of scientific evidence at this point to support the safety and efficacy of it in high-risk PCI. I think they specifically said that, and so one interpretation of that could be that they’re not looking at PROTECT II as actually showing a difference at this point to intra-aortic balloon pump. And so it just strikes me again in the language that they put out there that perhaps in their minds enrolling against that population might still be a valid protocol.

Mike Minogue

I think what they kept saying over and over again on the panel is that it was for a category, not for any one product. And there was comments that it was beginning to sound like a panel so they were never given the opportunity to make the decision on that or go to a write-up to talk specifically about one type of product. So it not only applied to us; it applied to the existing product on the market and any future products, so they would not be able to show safety and effectiveness for the category no matter what the PROTECT II study showed.

The second point of that is PROTECT II was done for a few reasons but remember, it was set up for superiority as a goal, not necessarily just to show safety and effectiveness. One of the reasons we did PROTECT II was to establish a control arm, again using the balloon pump because that’s the first intra-aortic balloon pump study. We did it because we wanted to have a study to strengthen the guidelines for the use of our technology. We also wanted to have an economic independent study to show the benefits of hemodynamic support during a procedure like high-risk PCI.

Raj Denhoy – Jefferies & Company

Okay, just last question, sorry. So if you didn’t have to do a trial then what would you use for a control? What would you be comparing yourself to, or the device to I should say?

Mike Minogue

Well, we have to work with the FDA and there’s lots to be worked out in detail. But what we have done is we have established a control arm for high-risk PCI with an intra-aortic balloon pump. That is established and I think the other studies in our registry also show the consistency, the use of this technology both in the US and Europe and it matches similar to our PROTECT II results. And then last you can directly compare the Impella to the intra-aortic balloon pump by looking at the [MOG] database or the MDR reports and our percent of MDRs per usage is actually comparable and numerically [less] than the aortic balloon pump.

Raj Denhoy – Jefferies & Company

Okay, that was my last question so I’ll jump back. Thanks.

Mike Minogue

Thanks.

Operator

Thank you. Our next question is from Greg Simpson of Wunderlich Securities. You may begin.

Greg Simpson – Wunderlich Securities

Okay, thanks, good afternoon everyone. Let me follow up on Raj’s point real quickly, Mike. I realize it’s impossible to know yet until you sit down with the FDA, so am I hearing that if you thought you had to gather more data for high-risk PCI, most likely instead of a randomized trial it would be Impella outcomes versus established data? Is that what I’m hearing?

Mike Minogue

I think what you all are hearing is that we had a call with them. You saw a lot of the data that was presented at the Panel and it will be an ongoing discussion with the FDA. It will not be one magic bullet. It will be the totality of the data to show the reasonable assurance of safety and effectiveness and that can incorporate PROTECT I, PROTECT II, RECOVER I, the US Registry, the Europe Registry, a future ongoing registry; and our current registry’s approaching 1000 patients because what we have now established in the literature and with the FDA is a control arm for high-risk PCI that prior to PROTECT II and PROTECT I never existed – and that these patients have never been studied under an FDA protocol or with an intra-aortic balloon pump.

So I think we have valuable information and it’s really going to be an ongoing process in working with them to establish again not a magic answer; the reasonable assurance of safety and effectiveness which again should be based on the totality of the data.

Greg Simpson – Wunderlich Securities

Okay, it was an unfair question of me I guess; maybe I could rephrase it. Does it seem logical based on, again, this is administrative process given the flexibility that was indicated at the Panel in establishing these PMA requirements for all the companies; and given the difficulty and quite frankly the hatred that doctors would have for having to randomize to balloon pumps – I guess the question is, is it logical to assume then if you had to gather additional data it would be against an established body of data that you’re referring to?

Mike Minogue

I think the short answer is that the FDA has difficulty as do physicians and companies to randomize something when it’s already been incorporated into the guidelines. So to recommend now to randomize certain patient populations that goes against the current guidelines is not something that people are apt to do or have done in the past.

Greg Simpson – Wunderlich Securities

Okay, good deal. And then so here’s my main question: hypothetically, would this kind of situation, because the Panel’s comments seem certainly very supportive and very I guess acknowledging of the superiority of Impella as far as just where hemodynamic support was concerned – and then we can just veer off into the guidelines, things like that. But is it realistic to think that maybe you could pursue a PMA for hemodynamic support, and then given the comments by the FDA repeatedly during the Panel with respect to not regulating practice of medicine that you pursue hemodynamic support PMA first and then work with the FDA to broaden that to high-risk PCI and anything else that you guys see fit?

Mike Minogue

You know Greg, I think that safety is certainly something that we have evidence and we’ll be putting in our argument. I think we want to have more than just hemodynamics because as has been shown Impella does have the ability to increase hemodynamics and unload the left ventricle. So it really then [asks] what’s the clinical benefit, and that’s again something we’ll address in the totality of the data.

Greg Simpson – Wunderlich Securities

Okay, good enough. And then I don’t know if this veers outside of the scope of this call but you’ve talked about it on recent conference calls, and I know one of the plans that you’ve talked about publicly is pursuing some [HDEs]. Is that fair game for today?

Mike Minogue

Sure. I mean we’ve submitted a few HUDs already to qualify to then submit the data for the HDEs, and we’ll continue to approach the patient population specifically where we believe we have data to show safety and probable benefit as well.

Greg Simpson – Wunderlich Securities

And pardon me, I don’t remember you guys talking details on those indications. Are you prepared to talk about those or should we just use our best guess?

Mike Minogue

So pediatrics is one, post-partum cardiomyopathy is another HDE that we’ll pursue; and post-partum cardiogenic shock which is similar to the FDA study RECOVER I which had 18 patients and had very good survival. So those are three that we currently are evaluating.

Greg Simpson – Wunderlich Securities

Okay, thanks very much. I’ll get back in line.

Operator

Thank you. Our next question is from Brooks West of Piper Jaffray. You may begin.

Dan Garofalo – Piper Jaffray

Hi, it’s Dan Garofalo for Brooks. Thanks for taking the questions. Hey Mike, so during the Panel there was some discussion around anatomical versus morbidity demographics, really kind of aimed at fleshing out what a high-risk PCI patient profile is. You guys have used grids in the past to depict who is and isn’t a candidate for Impella support during PCI but without getting into the details too much I guess I was wondering if you could give us your sense of where the consensus would be in defining the anatomy and/or morbidity attributes that could potentially be noted in a formal PMA indication around high-risk PCI?

Mike Minogue

That’s a good question, Dan. So the PROTECT II defined high-risk PCI as unprotected left main with a [diap] of 35% [of that] or triple vessel disease with an EF of 30% of less. So one of the requirements to be in PROTECT II was even if they met that criteria of low EF and complexity the physicians had to believe that the patient would require some hemodynamic support, either the Impella or the intra-aortic balloon pump. So that was what separated this patient population, and then what was discussed in the panel is are some of these patients a [cavatche] based on the SYNTAX study in the past that said if you had a higher SYNTAX core you should be in a Class I open heart surgery [cavatche] patient population.

And when you compare the SYNTAX study to the PROTECT II patients they’re similar age so around 67, but only about 1% had low EF on SYNTAX which was a generic PCI versus open heart surgery versus 90% of the patients in PROTECT II had a low EF or an EF of less than 35%. So you’re looking at a totally different patient population and then the last piece of that, which is most important, is this is not necessarily a turf battle. The majority of all our patients are turned down by all the surgeons because of their morbidity and what you saw in PROTECT II was two-thirds were formally turned down for surgery after a consult and another 10% turned surgery down for personal preference.

So it’s really now you’re moving to the right of what would be considered PCI in [cavatche] and you enter an area that’s truly a high-risk population. And again, what PROTECT II represents is the first study ever done on this sick of a patient population having PCI, and one of the benefits of the study is it showed that these patients saw an increase in their EF; and in both arms, the patients that were in Class III and Class IV, 58% of them had improved by at least one Class, one American Heart Association class, by 90 days.

Dan Garofalo – Piper Jaffray

Great, that’s helpful. One follow-up if I could just as far as the reaction in the field – any color on physician responses either in existing centers or secondly from a new center expansion perspective? Is there any kind of a recalibration we should think about for the next few quarters with the thinking that once some of these challenges are behind you you’ll ideally have a PMA and perhaps a more compelling pitch to go in with?

Mike Minogue

Hey Dan, we obviously can’t comment about that and we’re not commenting on anything about the quarter or even next quarter. But what we can say is that we saw, and you all were witness to a lot of support from the physician community at the Panel. The Society of Interventional Cardiology, SCAI, is supportive of the use of these devices to help them treat their patients. There was individual physicians that attended as well as patients. So we’ll continue to work with the FDA and to move forward.

Dan Garofalo – Piper Jaffray

Great, thanks for taking my questions.

Mike Minogue

Thanks, Dan.

Operator

Thank you. Our next question is from Jason Bedford of Raymond James. You may begin.

Mike Rich – Raymond James

Hi, this is Mike Rich calling in for Jason. I’m sorry if I missed this; I just wanted to make sure I have the timeline down correctly here. If I understand correctly you’ve already had a conversation with the FDA over the phone; the next step is to have a face-to-face and then you’ll submit your existing PROTECT II and registry data? Is that accurate?

Mike Minogue

So Mike we had a formal call yesterday to discuss the assessment of the panel, lessons learned and next steps. The FDA recommended that we submit a packet analysis of the totality of our data and it will be specific to Impella. It will not be on the broad category of temporary ventricular support which is how it was described and discussed at the panel. We will submit that in advance and then we will have a face-to-face meeting with several of our physician investigators, the FDA and the company to talk about next steps.

Mike Rich – Raymond James

Okay, is there any timeline expectation there on the submission?

Mike Minogue

We plan to… It’s not a submission as far as it’s not a PMA submission but we plan to do that as soon as possible, basically over the next three to four months.

Mike Rich – Raymond James

Great. And then just as a follow-up, hypothetically if you were to have to run some sort of clinical trial would that be – or this might be way too early to know this, but would you expect that to be on an individual device like a 2.5 or would you be able to do multiple arms at a time for a CP 2.5 to 5.0?

Mike Minogue

Well, I don’t think we’re there yet, Mike. I think that’s a good question but essentially what we expect would happen is it would be for an Impella product, whether it was 2.5 or CP or to some extent even 5.0 which is very similar to the way the balloon pumps work. They have a 30 cc, a 40 cc, and a 50 cc balloon and they’re all seen under the same classification. Most likely though our 5.0 is not used in the case of prophylactic support as much as the Impella 2.5 and the CP are utilized.

Mike Rich – Raymond James

Okay, very helpful. Thank you very much; I’ll get back in queue.

Operator

Thank you. Our next question is from Steve Beuchaw of Morgan Stanley. You may begin.

Steve Beuchaw – Morgan Stanley

Hi, good afternoon everyone. Just for planning purposes based on what your sense of what a study might look like, let’s say it’s hypothetically a single arm and given your sense of what the FDA is looking for. Can you give us a sense for what the size of the study might be and how we could think about the potential financials there, the cost of that study over some period of time?

Mike Minogue

Sure. So assuming we had to do another study on high-risk PCI we’ve already spent over $20 million doing that to date and several years. And again, we believe that when we come back and work with them and utilize our existing data we’re not looking at what potentially could be perceived as the same level of what we’ve done over the last four years. So we’ll get more information as we move forward but again what you did hear from the Panel and even from the FDA is that there may be a sufficient level of data; and whereas PROTECT II was stopped for fertility and missed the 30-day endpoint that was again for superiority. That was not for safety or even to some extent looking at the effectiveness after 90 days.

Steve Beuchaw – Morgan Stanley

Got it. And then would any work that you do here to potentially fold into a review under the work that we’ve seen proposed here recently by CMS on the potential for [NCDs] over the next couple of years – could this potentially be a way to proactively address any of their questions? Thanks so much and I’ll drop.

Mike Minogue

Sure, so Steve I think we’ve already, as I said we already have 245 patients studied in the FDA protocol for high-risk PCI. Relative to CMS we just had a review with CMS or the Society just had a review for physician payment which takes effect on January 1st, and we think that what drives most of this topic of reimbursement is essentially the clinical practice and the guidelines and the physicians of the societies. So we will continue to work with them and we will continue to publish more papers, some of which were published at the Panel on an [8X] analysis of CK for P2 and the learning curve; and as we move forward we’ll continue to update CMS as we go. And we do maintain contact with them and we do formally review our data with them on an ongoing basis.

Operator

Thank you. Our next question is from Bruce Nudell of Credit Suisse. You may begin.

Matt – Credit Suisse

Hey, this is Matt in for Bruce. So you talked about the high-risk PCI. Do you expect the FDA to request a separate trial or a retrospective review for SHOCK?

Mike Minogue

For the greater than six hours population which we’ve talked about in the past, we think that will come down to something that could be along the lines of a bridge to recovery which is like our surgical products, which are compared to a performance criteria – and those studies in the past have looked like 65 to 100 patients compared again to a criteria of the [VES and EB5000]. The other option for that could be this prospective registry that would be able to collect data and then that data could be utilized for expanded label, so that’s more of our discussions with the FDA. We are discussing that element as well and ultimately what we want to get to is a level that allows the physicians to use the Impella support as required and give the FDA comfort that we’ve met a reasonable assurance of safety and effectiveness.

Matt – Credit Suisse

Okay, thanks.

Operator

Thank you. Our next question is from Raj Denhoy of Jefferies & Company. You may begin.

Raj Denhoy – Jefferies & Company

Hi, thanks for taking the follow-up. I think the question was asked on the NCD and the LCD potential. I’m curious if you’ve given any thought to whether or how you think any sort of process like that would play out in this interim period that we’re in now where you don’t have a PMA, there’s some support for the product, you’re working to get a PMA? Is there a heightened risk that you could see some pushback from insurers through this period?

Mike Minogue

I think there’s always risk and I think this is a topic that has been a Wall Street priority. Since 2008 Impella has been reimbursed by CMS. Over the last two years, CMS with the Society and AMA, evaluated the need to create a dedicated CPT code for physicians for Impella – that takes effect in January. And we still do not believe that one is pending. In 2011 there were lots of products listed; none of those went through a national coverage decision. Less than 10% of the products will go through a national coverage decision, but in the event that we would have to go through it we would be confident because it would not be a category review – it would be a review on specifically Impella and it would allow us to have more time to discuss the clinical impact of all our studies and the safety of the device in general.

Raj Denhoy – Jefferies & Company

Okay, that’s helpful. Thank you.

Operator

Thank you. We have a follow-up question from Bruce Nudell of Credit Suisse. You may begin.

Bruce Nudell – Credit Suisse

Hi Mike, this is Bruce for Bruce. My question is regarding reimbursement and just strategically how you’re thinking about it. So let’s say, you know, how important is it ultimately to get a superiority claim relative to the balloon pump so that on one hand the charges that are presented to CMS are appropriate for the higher DRG; on the other hand without a superiority label you know, it’s hard to argue a priori that it should be paid more than a balloon pump. How do you, which is more important ultimately and how do you think it plays out long-term; and what do you think the company needs to do to position itself for long-term optimal reimbursement?

Mike Minogue

Bruce, the superiority label doesn’t exist in most technologies compared to older technologies. If you think about what’s in the space of acute hemodynamics, there’s the intra-aortic balloon pump which does not have an FDA study. There’s [ECMO] which does not have an FDA study, and then there’s Impella. And Impella does provide a direct unloading. In the secondary endpoint in PROTECT II it showed that it had a better cardiac power output.

So the hemodynamics of it can be measured and tested, and then it comes down to having certain clinical outcomes which we feel confident that we can show in both the quality of the procedure but also in the support and the validation of the use of the physician community. So there is no placebo effect with our pumps and I think that that in some way confounded the PROTECT II and the relative use of atherectomy but it doesn’t take away the fact that this is a very unique technology, there’s not a lot else you can do for many of these patients and you really are talking about a population that in some cases does not have any other alternatives.

Bruce Nudell – Credit Suisse

Thanks so much.

Mike Minogue

Thanks, Bruce.

Operator

Thank you. I’m showing no further questions at this time. I would now like to turn the conference back over to Mike Minogue for closing remarks.

Mike Minogue

Great, well we appreciate everyone’s time today and if you have follow-up questions please let us know.

Operator

Ladies and gentlemen, this concludes today’s conference. Thank you for your participation and have a wonderful day.

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