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HeartWare International, Inc. (NASDAQ:HTWR)

Goldman Sachs Healthcare Conference Transcript

June 12, 2013 11:00 AM, ET

Executives

Douglas Godshall – Chief Executive Officer

Analyst

David Roman - Goldman Sachs

David Roman - Goldman Sachs

Well, we’ll go ahead and get started here with the second day of the Goldman Sachs Healthcare Conference, but before I turn the call over to our first speaker, we are required to make certain disclosures in public appearances about Goldman Sachs’ relationships with companies that we discuss.

Disclosures related to investment banking relations that of compensation received of 1% of our ownership, but for -- prepare to re-dispose it for any issue now at the end of this presentation if anyone would like me to, that these disclosures are available in our most recent reports available to you as clients in our firm portals. In addition update to those disclosures are available by ticker on the firm's public website at gs.com. In addition disclosures are applicable to research with respect to issuers if any mentioned to herein are available through your investment representative.

With that, I want to turn it over to Doug Godshall from HeartWare International. Just a little bit different format for this presentation. Doug is going to go through a couple slides and then we will move into Q&A, but Doug, thank you for making the trip to California and it's all yours.

Douglas Godshall

Thank you. We also have forward-looking statements that we will be making disclosures. So that's always our first slide. At HeartWare we obviously had tremendous growth over the past few years and are looking to revolutionize the treatment of advanced heart failure with our pipeline of products. We were encouraged by the growth we saw in the first quarter as reported in our earnings release and hope that we continue to see this growth well into the future as the market continues to grow and we grow alongside.

For those who are unaware, we have a centrifugal pump that's placed in the pericardium and treats a variety of body sizes as a result of the small device as it's a full output device, so there is not really a limit on body size. The small device facilitates ease of use for the customer as to the very user friendly tools.

In terms of our launch, our IDE sites were converted from trial sites to customers by the end of December, which was ahead of our plan, as was the introduction in training of the next 25 sites. As of our earnings call, we were at 27 sites train. Our goal by the end of the year was to have a 100 sites all looking good to be north of that target come November, December of this year.

We have a growing body of clinical evidence to support our use of our device, starting with our CE Mark study several years ago followed by our BTT trial and CAP cohort. Our endurance study which has 300 wire devices enrolled in it and a post-approval study that is enrolling actively based to each device that gets implanted in the U.S. is entered into Intermax by the customer and that forms the basis for our post approval study and we are in active negotiation with the FDA on a continued access new patient cohort for the endurance study.

At this juncture, we don’t have an update on that, but remain optimistic that we will be launching into a new segment for our DT study, which will look more closely at blood pressure management and it's -- and how it affects patients.

And another way of looking at our outcome for the past several years is the number of units we sold between the U.S. and international given that the U.S. is a larger -- is the larger market relative to international, one would expect that the U.S. component will grow as a percent of our total as we saw in the first quarter.

We are incredibly bullish about MVAD, the more we see, the more enthusiastic we become. We were targeting the first half, first demand. With each passing day in June, I get a little more anxious to maybe we are not going to make it in the first half, but things have gone very well. Our testing has gone well. We've discovered things that you want to discover in testing and fix them before you get into people. So we are quite enthusiastic and as more importantly so, our customers.

What we underappreciated in the early days of MVAD was how important this picture was. So in the right hand is what the HVAD would look like outside the heart and the left hand is what the MVAD would look like outside the heart and as much as it's great that the MVAD is -- the HVAD is pericardial, you still have a reasonable amount of volume that sits outside the heart, obviously much smaller than other pumps, but still you would like it to be smaller all things being equal and it looks like we are going to achieve the -- pretty much achieve all things being equal with substantially smaller size than the MVAD.

Another area that is getting really great reviews at least in terms of the design, we’ll have to see in terms of functionality, once it actually rolls out is our next generation controller, which will first be seen in the MVAD trial and will then roll out to HVAD early next year and it's a really user friendly system. Patients, who have seen it, love it, coordinators who see it, love it. So really anxious to see it work in real life.

In also has much more advanced electronics, which has enabled us to incorporate substantially more sophisticated algorithms and software system, things like [pulse] algorithm which will see first in MVAD and we are exploring ways to incorporate it into HVAD although the regulatory challenges of getting new software algorithms incorporated even if they see -- they don’t see anything but upside to them you would still have to figure out a tolerable regulatory process to get them approved.

If all goes well with MVAD, our next device in people will be the Longhorn, which leverages all of the internal workings of the MVAD just with a much sleeker implant procedure. As the doctor told me yesterday, this would be the EDA approved design we've all been waiting for.

We are not starting with this in clinical trials before MVAD just because it goes across the aortic valve and we want to make sure first that the pump works before we try a really sophisticated new novel implant technique because if it didn't work, you would note it was because of the pump or because of the way you were implanting it. So we want to test one variable at a time, but so far in four legged animals at least the aortic valve looks pristine, which does not mean that in two legged 70-year old that it will also look pristine, but we are pretty optimistic about this as well.

So as we break out our pipeline, we see sort of the workhorse with MVAD, HVAD. We see potentially poor surgical risk in elderly, which is the lions share frankly of the heart failure population with Longhorn and there is a huge untapped population in the less sick Class III -- two, Class III. So we were -- we have a very active program looking at Class III and ultimately we think we need to get rid of a drive line for a true Class III system if you are not that sick and you can still walk around the mall and you just get tired. You don’t want to walk around the mall with a cable coming out of your skin, but we think MVAD is really an enabler to a broadening of the patient populations.

We just were recently approved by the FDA for our new -- our second facility in Miami Lakes, Florida. We don’t plan on keeping to because the new one gives us plenty of space. We could supply the world’s demand for VADs for quite some time out of this -- out of this facility. So we are migrating to the Miami Lakes two as call it in the coming months and shutting down our original facility.

We also announced today that we are in the process of delisting from the industrial and stock exchange, which has been really enabling for us as a company. We are not for the ASX. We would not have we -- would not be here today, it gave us the vehicle to fund the company. Went public there in 2005 and were able to raise money both from Australian and U.S. investors over time.

Although at this juncture, 5% or less of our shares are held there. Less than 1% of our volume is traded there and as Peter McAree, our new CFO came on Board and analysed sort of the burden, the administrative burden of managing all the work we have to do to comply with the NASDAQ and ASX.

It became evident that it was really the right thing to do to migrate, although we were migrating very methodically over the next six months from the ASX in difference to the great support we received from those shareholders. Thankfully they’ve had a fairly good return since our listing there. So as much as we hate to leave them, we are thankful that they have -- that they’ve done well by us and hopefully we've done well by them.

So we have lots of important milestones coming up. MVAD, Japan clinical trial later this year, we are getting very good progress with the regulators there. CAP for DT, U.S. roll out hopefully continues to go well. Thoracotomy study is in process of being drafted. So hopefully we will get an IDE later this year for thoracotomy and completion of enrolment of our post-approval study.

So with that, thank you for your time. Thanks for letting me go through some slides David and I think we are going to -- I am going to move to my chair and have a chat.

David Roman - Goldman Sachs

Sure. Thank you, Doug and appreciate the overview. It was probably helpful and just to get everyone sort of oriented on the HeartWare story. I was still going to sort of break our discussion into two parts that I never go this methodically, but my intention was sort of talk about the commercial landscape and then also clinical trials/pipeline, but maybe we will start with the commercial side of the equation.

If you look at maybe just the -- you had a very strong first quarter, looks like you pick quite a bit of market share. On your conference call before your competitor report, you had indicated, you thought VAD volumes were -- VAD market was pretty active in Q1, it looks like in the end, the U.S. market slowed quite a bit and may be just now to benefit of both communities having reported just latest here on market trends and I understand this market bounces around quarter-to-quarter, but any thoughts post the full picture being out there now?

Douglas Godshall

Yes, I was just having a conversation in the lobby with a friend about the -- my sympathy for Wall Street given the lumpiness of the VAD market. It's sort of good month, bad month for us. In our launch, it varies from good day to bad day and you try really hard not to be whipsawed. Critically at this early stage of us really building the base for future, what we think will be substantial growth.

So there is the inherent lumpiness of a low volume procedure like VADs. It's not like you got to a Cath lab and you are going to fight for the 10 stents that day or 20 stents that day. So the variability makes it awfully challenging to -- and we've cautioned ourselves as well as investors that they not overreact to good or bad days, quarters, months etcetera.

My very strong impression which has been reinforced when I go to visit sites and spend a day with physician all day yesterday and everything I see suggests the long term trend is going to hold whether this quarter is a good quarter or last quarter was disappointing I guess in terms of market growth. They don’t -- I don’t see anything that dissuades me from believing that both U.S. international long term growth is going to be quite substantial.

Patient populations don’t -- the patients don’t have other alternatives and the confidence in VADs just seems to be stronger than it was six months a year two years ago and without any real material new data that suggests that it should be stronger, I think it's just that the -- everyone’s personal experience is being reinforced that this is a viable option.

So we have felt that the international market would be back-end growth loaded because of the first two quarters last year were so strong and my sense is that, I don’t know if the U.S. will also likewise be back-end loaded but it certainly seems like the trajectory is positive and that I see enough sites that when I sort of find out how many VADs they have done over the past year and half, I am really pleasantly surprised that they are much more sizable than I had anticipated and they don’t -- and they seem to be investing to grow further.

David Roman - Goldman Sachs

And can we just talk about the dynamics of some of the sites as they picked up HVAD that commercial I mean there is -- I don’t know any of the clinical trial sites where it's probably just like putting a switch and you have experienced users who pick up utilization -- who pick up utilization [pretty much] to the newer cohort of sites that you've gone after, maybe if you could just -- I don’t know if you want to give an example of few anecdotes of how the progression goes in those newer commercial sties?

Douglas Godshall

So I would say that it is heterogeneous. We -- I would say the first few months we were all about sort of get on the shelf, convert sites that were IDE sites and put ourselves in a position to be part of the next plans and make sure we sort of understood how the site works because understanding how the site works for a clinical trial was fundamentally different than how the site works from a commercial basis, so that's different sort of influences.

Now, that we are on the shelf at a lot of sites and we are well positioned in terms of our infrastructure, really probably since February, we've identified that every site is dramatic, is its own entity. You will have some sites where the surgeon just does whatever they want and everybody is in too and that's the way it used to be at all sites two or three years ago.

It's the complexity of the influence has really changed over time as the VAD volume has grown. VAD coordinators are much more influential, cardiologist are more influential. Referring clinicians are much more influential than it used to be. So we treat each site now as it's with its own individual strategy because we can’t just say, well let's just win the surgeon over because that's not sufficient.

Likewise, many of our newer sites have actually come on much faster and more aggressively than some of our IDE sites. We've always known that some of our IDE sites would be slower to move because they did a couple of cases and they didn't get great outcomes or their major training centers or Thoratec. So they are heavily biased towards the other company even though they were in our trial.

So as we had expected, we have had some -- not a majority, but it's a handful of our IDE sites have been much slower to adopt than say our -- some of our newer sites. So there is not a -- I wouldn’t say there is as pattern where you look at the IDE sites and say, they behave one way and the new sites behave another way.

I would say the new sites on balance actually come on board a little bit more quickly than some of our IDE sites, may be a quarter of our IDE sites.

David Roman - Goldman Sachs

And in some of those newer sites, how much of a learning curve is there? I mean have you been able to sort of telegraph it takes X amount of weeks or implants or month for someone at a point where they are sort of a normal volume levels or get the procedure timed out or whatever metric you would consider to be sort of a normalized operating environment?

Douglas Godshall

So a surgical -- the surgical technique and implant is a two or three case learning curve where it's more hear all the things you don’t have to do versus do all these extra steps. So once you understand how our [current] works, how to put our [ring] on and coring tool is pretty easy. It's still major surgery, but they already were doing major surgery for their other VADs. So you don’t have to do the pump and there are some other things that are just a little bit more intuitive and we continue to go through our own money curve on the post-operative management.

Things like blood pressure management, we thought we understood and for years clearly we didn't quite understand it as well as maybe we could have or should have. So the post-op care also you will get -- learning how to run our system only takes a few days of training and you’ll -- as a staff you’ll get there pretty quickly, but you need to continue reinforcing and it's probably a similar three, four, five cases as long as they are in reasonable proximity to another that the hospital staff, cardiology staff would say okay, I can understand how the HVAD works, how the alarms work.

Luckily our controller is very intuitive. It tells you what to do if there is a problem. You don’t have to remember symbols and like patterns or anything to know how to intervene. So the curve -- the learning curve is fairly quick. I think the bigger -- the longer curve is trying to figure out okay, this is the first time I have ever had two devices to choose from, how do I choose? Like how do I talk about two different devices when before it was just default, the patient shows up to get a HeartMate II and so I think that's where we have found, we have to be more involved in the process, so that the whole system is cognisant of the fact that there are alternatives and make sure that there is no one in the mix that suddenly is steering people away from us that we are positioned evenly for BTT patients or preferentially would be our preference obviously.

David Roman - Goldman Sachs

And what would be -- and what are the key features or benefits that you are using to sort of sway people either to become an HVAD site or move their volumes from HeartMate II to HVAD?

Douglas Godshall

Yeah, so we were not -- we were not sort of market share obsessed by site, but what people seem to -- what seems to resonate ease of use of the system for the -- of the external system for the cardiologist and VAD coordinator, high survival that we've seen in every one of our studies, which appeals to obviously as one cardiologist said, last time I checked, my patients preferred to be alive.

We -- for the surgeon it's sort of no brainer. It's just much easier for them. They save meaningful time in their operative procedure. Small driveline and in the areas where we are being attacked, there seems to be a recognition that with appropriate management your overall adverse profile is going to be pretty similar between the two devices.

So that's the one where we have to sort of overcome an objection that's being at least putting in the minds for our customers and that doesn’t seem to had a material impact on creating resistance.

David Roman - Goldman Sachs

And do you have one question also from doctors or Wall Street?

Douglas Godshall

Wall Street.

David Roman - Goldman Sachs

And what -- and when you do hear about in the clinical community was that -- is that normally from the competitor or there are certain negative selling out there or is that -- is it sort of Canadian study or they have read about it in popular press or course of the information in the clinical community.

Douglas Godshall

Well, our competitor certainly is happy to bring it up and in some way itself because it gives us an opportunity to talk about something that we do think is important that is probably the one meaning other than ease of use where we have -- we like our chances on ease of use that difference between centrifugal pump and axial pump does seem to be at least in pump performance is evident in differences and how blood pressure manifest itself and we always knew that there was a difference in terms of how the pumps respond to pre-load that goes into the pump, but it was not obvious at least in our data for the when we had smaller data sets that then resulted in differences and being our Tier pressure and it wasn’t until we had broaden up data set that we were able to minus and discover that actually there is a fundamental difference.

So previously when we said, the pumps were different and therefore you should manage ventricular volume differently, there was not really a good reason to say why, so it was just -- well, but there is no difference why don’t I just do it the same way. So now there is a reason and there is growing -- a growing understating and research being done outside of the company that I think will be very helpful to get people to understand okay, I now see that it really is true that it's just a difference in how pressure is translated across centrifugal pump.

You get plenty of flow and that's what matters. So don’t overflow a patient just to try to create an image on echo that looks the same. You don’t need to.

David Roman - Goldman Sachs

And I’ve from some physicians that stroke thing is not a big deal if you manage the drug therapy and you change tweak the RPMs and that sounds simplistic for you know a pretty experienced user, but as you think about going down sort of the experience base and turns of users, to what extent do you think there are any more questions about that device safety and sort of active management of the device versus something that might just kind of run itself?

Douglas Godshall

Well, neither of the devices just run themselves. So unfortunately no one has created a perfect system yet. We are trying, but if there was a perfect system that we were competing with we would be using ours. Do I think that every doctor out there is totally comfortable with our adverse event profile? I think that would be foolish of me to think that that were true. Do I think it is helpful that we seem to be observing as we did in the first quarter of broadening of adoption of the device in the face of considerable push back from our competition? I think that will be helpful as you go down that curve of smaller centers.

Certainly smaller centers are going to take longer to get on board just because it's going to take longer for them to even [mind] a patient to do a case to see how they like the device. It's also we believe encouraging that we continue to see strong utilization and have seen strong utilization because this one issue has been so hypersensitive that if we were seeing a huge volume of that even in the clinic, it's not like the sites were unaware of the potential. So I think they would pull back a little faster even if the rate weren’t all that high.

So we certainly -- as I said, we don’t really obsess on share, but we do make sure we are constantly monitoring sort of level of enthusiasm at a site for our device. So you may not see a patient for a month, but that gets -- they mean not do any VADs or they may not do any bride VADs, but we want to make sure is that if they are doing a bridge patient, even if we don’t get that patient, we understand why.

then, why don’t you spend a couple of minutes on the clinical trial side and come back to a comment you made in the prepared remarks and I certainly want to make sure I understood when we say about studying blood pressure management, is that part of the DT CAP, is that a different study.

Douglas Godshall

You know the DT CAP and the reason that it's taken us longer than maybe a traditional CAP, the traditional CAP you just send and you are the same protocol and say we would like to treat the same -- we would like some extra patients under the same protocol. Once we understood the role that arterial pressure plays in both hemorrhagic and ischemic strokes, we felt it critical that we actually prospectively confirm what we have observed retrospectively and that would suggest you have to do something little bit different than you did in the original trial and track the data better prospectively and reinforce the importance and put it together in the protocol a procedure for blood pressure management.

Now it's not hard that there were sites that were already doing it. Several sites that were already doing it, which is how we discovered that there is a -- that there is a benefit to tighter management, but once you say the FDA, we would like to do a different protocol than it is a continued access protocol, but it kind of isn’t the continued access protocol because it's a different protocol.

So this is a just a more rigorous blood pressure million management protocol that will also enable us to track how are the patients doing on an ongoing basis and we expect it will also then prove out that if you manage blood pressure a little bit more tightly, that you are going to have materially better outcomes.

David Roman - Goldman Sachs

And why is it not a new trial?

Douglas Godshall

I would say it's a new trial if it was a standalone you are then going to use that data both for safety and efficacy, so it's -- that's what we've used different words to describe it CAP, new patient cohort but the intention is and the expectation is that this will be a safe -- sort of confirmatory safety arm of the DT trail, just to say if you do these things in a smaller set of patients with a shorter follow-up period that you -- the gap that we saw in terms of that particular adverse event shrinks or disappears so that you confirm safety.

We anticipate that we will be successful on our primary endpoint in the original trial, but we were also not delusional. We know the FDA clearly had some concerns about neurologic events. So we don’t want to assume that just because we hit our primary end points, that that will be adequate for approval. So we want to have this -- we expect, we are going to have a really robust data set in the post approval study and maybe that's enough to supplement the DT trial, but in the event that we can also get a new patient cohort CAP whatever to also prospectively confirm that we think would be even better.

David Roman - Goldman Sachs

So you look at it as an adjunct to the DT and insurance policy to try the wrong way to describe it but sort of a supporting part of your DT filing?

Douglas Godshall

Yes, that's sort of how we were -- we think the post approval study will be supportive and if we can also get this new patient cohort, then that would also be supported.

David Roman - Goldman Sachs

They still need it to get it DT approved?

Douglas Godshall

So looking at what happened with -- I don’t know that we will need it because I think knock on wood, if post-approval study works, they clearly look very careful at post-approval study and they also see the DT and BTT populations as more similar than different, which I think is one of the reasons they put the data into our BTT label.

So it may well be that the post-approval study is perfectly adequate. On the other hand, I don’t want to just -- I think it will be better to assume that more data would be more helpful and we also saw that while we blew away our primary endpoint in our trial, we still got a reasonable amount of heat for some of the safety secondary end points when it came to panel time, so I think it would be best to assume that some adjunctive safety data would be helpful whether it's PAS alone or post-approval study and this new cohort of patients.

David Roman - Goldman Sachs

And do you get any update on your third party data adjudicators, do you get any updates on in terms of if that's an open label trial or is there anything new since -- have they seen anything new since while it was in the November instructions for use into that? Do you ever see that?

Douglas Godshall

I do not personally see it. What I do -- what I do get confirmed is are we on track for primary endpoint and is there any risk that we should be thinking or we have a futile study because that obviously would be material? So at this juncture, based on the analysis, it would appear that we are on track for -- we are in range at least of being on track for a primary end point. I don’t have the exact stats, so I don’t know, but it's -- that's the thing that I want to know.

The embedded adverse events sort of are what they are and those patients have been enrolled for over a year now. We certainly pushed forward to make sure that all the sites know with the existing patients who are still supported by the device, it would be better if you manage blood pressure more rigorously and here is the protocol that we think is best. Some are adopting it, some are not and I think that's one of the -- that could be one of the real benefits for all of our patients if we get this expanded.

CAP is once it becomes sort of more habitual that instead of just managing some of your HeartMate II and HVAD patients with this protocol, which is what nine of these sites did, if all of the sites do it for our trial then they will probably do it just routinely and I think that will -- that will probably create better results for both devices frankly.

David Roman - Goldman Sachs

And any idea when you might hear from the FDA on the studies that are...

Douglas Godshall

So we are -- it still hasn’t been 30 days since we submitted and there is no -- they have no obligation to get back to us in 30 days and it's uncommon particularly for a new protocol that you get approved the first time through. So I don’t know that we will get a thumbs up right through sort of this month or if it will be fearsome questions or if they will even take a little bit longer to get back to us. So the dialog is ongoing and seems head in the right direction.

David Roman - Goldman Sachs

I only got a question here that -- now you go ahead and ask it and I can receive it.

Question-and-Answer Session

Unidentified analyst

Couple of follow-ups to what you've been talking about, so have you talked about what you expect the size of the DT CAP to be?

Douglas Godshall

We've not talked about it. Obviously, it's got to be more than like 20 patients because you are not going to learn anything. You might get lucky or it might really unlucky. So we've tried to size it or our proposal is to size it adequately in our -- again our proposal, so that we are protected in both directions where we have enough data that we would be able to detect a trend where we think it will be a positive trend, but not so large that it adds years and years to this -- of this process, but since I don’t have feedback from the agency on whether they like our proposal, I am reluctant to say, here is the quantity we've asked for.

Unidentified analyst

And this might be a dumb question, but the CAP is randomized two to one, same is the endurance study?

Douglas Godshall

Yes, if you look at the HeartMate II DT CAP that had ongoing randomization, so our assumption is that we are probably going to do -- have to do the same thing with HVADs or rather than ask for unrandomized and have them tell us we have to randomize. We would rather just say, it's more likely than not they are going to make us randomize anyway.

Unidentified analyst

I wanted to just ask the implant HVADs.

Douglas Godshall

Because if we historically, I mean just like with our BTT CAP was single arm compared to Intermax, so we discontinued that. We are pretty confident just based on reading the [TV] that randomization would be probably be required just as it was with HeartMate II, so I don’t want to go -- I don’t want to -- I want to eliminate as much delay as we could in the process and it was evident to us that we were probably going to have to randomize.

Unidentified analyst

And then just on timing of -- for the readout on endurance next year when do you expect it and it what form?

Douglas Godshall

So the final patient -- last patient, last follow-up is May and so assuming -- to some extent it also depends on how this CAP integrates into that study? Do we wait for some of this data to also be integrated if it truly is an integral part of the filing that we may wait for a component of the CAP cohort to then have the data a little bit later in the year versus right, it will take a little while for terms of data anyway, so is it like July, August or is it more like October, November that you have to have release the data.

It may be dependent on the CAP, but if not, it will be summer next year.

David Roman - Goldman Sachs

And I am sorry, with that, we are actually out of time. So as the red light is flashing, Doug, thank you very much and as the host of the conference, hope to see you again next year.

Douglas Godshall

Thanks very much.

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