Abiomed Executive Insights: cVAD, Impella
On Wednesday, Abiomed, Inc. (NASDAQ:ABMD) reported its fourth quarter earnings and discussed the following topics in its earnings conference call. Here’s what the C-suite revealed.
Brooks West – Piper Jaffray: Couple of things, on the guidance, you said cVAD was in the guidance RP not in the guidance. Can you tease out expectations of timing of cVAD and kind of how we should think about contribution of cVAD for the year?
Robert L. Bowen – VP and CFO: Yeah, sure Brooks. Well, as I mentioned in my remarks, we plan this to be a controlled release. We do have cVAD approval of CE Mark in Europe and we will be beginning a controlled rollout in Europe and we expect to get FDA approval later in the year in U.S., and again, it’s going to be a controlled step by step roll out. We really have to get a little bit further into the year before we get sufficient visibility to understand exactly how hospitals are going to be individually behave relative to the adoption of cVAD. We do expect it to be a product that is more focused at the emergent patient, but we are not quite sure exactly how hospitals are going to respond relative to whether or not they will put two cVADs for example on the shelf in addition to the two they might have for the Impella 2.5 or whether they’ll maintain the current quantities but just adjust the mix, so that’s something we are going to monitor over time.
Brooks West – Piper Jaffray: Then let me maybe ask that question in a different way, should we look at cVAD as upside to guidance? I mean is there risk to the guidance range you’ve given. If you don’t have a timely cVAD, I’m just trying to test around kind of confidence in the base Impella business being able to achieve the guidance you’ve laid out.
Robert L. Bowen – VP and CFO: We do not think there is, I mean, we do not think there is risk to the guidance based on the cVAD adoption and rollout.
Brooks West – Piper Jaffray: Then on gross margins, you gave operating margin thoughts. How should we think about gross margins trending for the year?
Robert L. Bowen – VP and CFO: Well, we’ve been over 80% for three quarters. I think 79% to 81% is probably a reasonable range it’s going to depend upon to some extent the pace at which we place the AIC consoles at those sites that don’t have it. But other than that, I would expect it to be pretty much within that range.
Brooks West – Piper Jaffray: Then two more quick ones if I could, just Mike, timing on PROTECT II publication or publications, and then you guys have almost $80 million in cash now, kind of thoughts on what you might do with that cash going forward, thanks.
Michael R. Minogue – CEO, President and Chairman: So we like our cash position in terms of that question and on the P II as I said in the call, it was submitted and it’s in the peer-review process and so we are diligently working back and forth with any clarification or questions.
Brooks West – Piper Jaffray: So, no other thoughts on other than you like the cash?
Michael R. Minogue – CEO, President and Chairman: We like the cash.
Greg Simpson – Wunderlich: Mike can I start out kind of anecdotally, maybe can you talk – you alluded to it in your prepared remarks that maybe since November. Can you kind of walk us through what you’ve seen in terms of Impella market dynamics, were the combined effects of everything that took place in November, you guys obviously had an incredibly busy TCT. Were the combined effects of that in terms of Impella interest utilization, things like – it was a little bit like flipping the switch to have really seen a big jump in the numbers obviously coming out of that.
Michael R. Minogue – CEO, President and Chairman: Sure, Greg. So I think we have seen, if you look sequentially we’ve actually started to see the jump in the prior two quarters because as I said in the call we have had sequential growth – double-digit sequential growth the last two quarters, this is the third quarter. SO what we think is going on, is the guidelines is a significant catalyst because it becomes almost a binary affect. And as we believe our intention is to become the standard of care for circulatory support you need to standardize processes and that is DRG for hospitals to be in the guidelines and then also to get a CPT code which is in the works. Aside from where do the guidelines go from here, we think that the additional publications that are coming are going to augment the strength of them relative to Impella. And what’s also not noted in the guidelines is what’s also going on in healthcare which is that cost-effectiveness is becoming a primary driver in adoption. And whether you’re looking at a patient that receives Impella for prophylactic use and then the PROTECT II the ICER score, incremental cost-effectiveness ratio score, was 39,000 which puts it in the best in class scenario and below dialysis. And if you go look at emergency patients you actually can see an improvement in quality of life and in many cases a reduction of costs for that improvement in quality. So I think all the factors are coming together. We are still doing our homework and we still have to execute each quarter. But we feel very confident that we are on the right path to become the standard of care.
Greg Simpson – Wunderlich: On the emergence side with respect to cost-effectiveness data do you – can you may be give us a little better sense of when we might see that?
Michael R. Minogue – CEO, President and Chairman: So some of these abstracts have been presented at medical meetings like ACC or some of the economic forums Pinnacle Health System has released a couple of abstracts for emergency patients and they also presented a poster at ACC and what they show is reduction of length of stay, a reduction of ICU time and a reduction of readmissions for emergency patients treated with Impella as compared to the control arm. So those there is multiple publications coming on that, that will be happening over this calendar year, and if you think about what it means for these patients they are not coming back in many cases to get an ICD and if their EF is high enough they can go back to more of a normal life and not have to have the invasiveness of that cascade of surgeries and potentially a transplant.
Greg Simpson – Wunderlich: Then next question I’ll combine two into one can you talk about, we saw the big jump in obviously prophylactic use which was obviously a big driver here in the quarter. Can you talk about that and then also maybe include kind of where you stand in terms of independent usage?
Michael R. Minogue – CEO, President and Chairman: So independent usage is about, still it’s about 30% one of every three. I think one of the things that’s significant in the new ACC AHA guidelines is for the first time they created a recommendation for a Class 2b for percutaneous hemodynamic support devices and to quote the recommendation, elective insertion of an appropriate hemodynamic support device as an adjunct to PCI maybe reasonable and carefully selective high risk patients. So this is the first time that this has been added to the guidelines and it shows that the patients are, that they are looking at as shown in PROTECT II 60% of them are turned down for surgery. They have heart failure. So, this is in many cases a new treatment option for these folks and I think that’s the way you all think about the market. Some of these patients might be converted from the cath lab, where in the past, maybe they were in intra-aortic balloon pump. But some of these patients are new to the cath lab, because they have more significant hemodynamic support.
Greg Simpson – Wunderlich: Just one more and then I’ll get back in line. With respect to the AIC console, I think you mentioned it’s in about 30% of the accounts now. I get rave reviews on that. It obviously had a nice impact on utilization. Are there any gating factors there on your ability to get that out to the rest of your accounts or could you maybe go a little deeper on kind of what the plan is to push that out to the rest of your users?
Michael R. Minogue – CEO, President and Chairman: So, what we are doing Greg is we are prioritizing the highest volume users and we are asking folks to sign service contracts longer term to get the latest software package. So on the AIC, we just released another new software package which is the auto flow capability. So rather than just selecting what level (PA P3) on the screen, what you want, you actually select the flow and it will optimize the motor speed to match the flow that the physician is trying to manage for the patient. As far as the gating factor, we can ramp it up or down a little bit. What we’ve chosen to do is match it in number that’s similar to what we are doing with new sites. We have to retrain those sites, but many of them are – they are users already. So it’s just a different level of training, and the console is very intuitive, and then longer term, the catalyst for all sites that have the AIC is based on the new platform, the Impella cVAD and the Impella RP only will run on the new AIC console.