ABMD
#I think it's generally going to be a relatively smooth ramp.
And, we'll add capacity.
I mean, we are building out the capacity.
The operators, actually, will be hired over a hard period of time.
And so, I expect the ramp itself to be relatively smooth.
We just want to be prepared for the upside that we see in the business.
Hi, <UNK>.
I think our expectation is that the cadence will be not unlike its been in prior years.
We will see more growth in the second half than in the first half.
As you know, the first and second quarters, for us, have always been more challenging than the third and the fourth.
We have this new label, and this new protective PCI launch, but this is also new territory for us.
So, we are going to learn as we go.
And, I think that's pretty much what our guidance incorporates.
I would use a typical split, yes.
I think, <UNK>, right now, we think the right thing to do is to be investing in what we see as an extraordinary growth opportunity that comes along very few times in a lifetime.
We have the first PMA approval for the Impella 2.5.
We've got supplements to submit, and when those come along, those will be additional catalysts for the business.
So, our focus is really on driving the top line.
And, that is how we are basically operating the business right now.
On a longer-term basis, there's certainly no doubt in my mind ---+ and I think we have demonstrated this, by virtue of the fact that from time to time, our investment levels haven't kept pace with the growth of the business.
That could happen again in FY16.
But, there's no doubt in my mind that, in the long-term, we will have top-tier, industry-level operating margin rates.
<UNK>, this is <UNK>.
Now that we have the PMA approved, we're working through all the specifics with the FDA for the remaining supplements, for the products and the indications.
And, our current plan is to be prepared to submit the additional supplements by the end of September.
<UNK>, our main focus is, as you have stated it is, really to go deeper at the existing centers.
Now that we have the PMA approval, we can really engage with the heart-failure community, the referring physicians and also direct to patients.
And, we believe that our existing sites are trained and ready, and will provide the best quality and rigor, in the procedural success rate.
That's really what we're focused on.
And then, relative to the SG&A spend, <UNK>'s already outlined that this year.
And, we're really focused on getting the type of growth that maintains quality and rigor, in the outcomes and the training, because that's how you become the standard of care.
We're not going to try to run too fast.
And, we're not going to try to have any physicians starting to ramp the procedure, if we don't feel that they have the experience or expertise levels.
So, we're going to do extensive training.
And, we're going to be involved in opening up and supporting the physicians, to have better patient outcomes.
<UNK>, we will be submitting for the CP and the 5.0.
We'll be submitting for additional indications.
Some are larger, some are smaller.
Things that have to do with myocarditis and postpartum cardiomyopathy.
And, we do have several publications, and an FDA study, on the Impella 5.0, which tends to be more of a heart-failure patient, and more of a patient that has low cardiac output or shock.
And then, just to remind all our investors, our US Registry on Impella has been a significant investment.
And, we're going to continue to build that out.
We have established separate data collection.
We have our own executive committee.
And we are ---+ in the end, we will create what is the largest database of high-risk patients that exists in the world.
It's probably too soon to tell.
We're still working through all of the specifics.
And, we will give updates as we go, Jason.
It's just a matter of how fast the enrollment, and the sites that are willing to go through and create that type of rigor, on something that they're supporting commercially.
Sure.
The 2.5% this quarter was 26%.
The CP was 65%.
And, the 5.0 was 7%.
And there is 1% leftover.
It's some consult sales and a little bit of RP.
<UNK>, thank you for the question.
I think there's two pieces to the education for physicians.
The first is ensuring that our users, that have the most experience, have all the tools that they need, and all the support that they need, to continue to treat the patient population that is growing.
And, we also want to provide them tools that they can use with their hospitals, their administrators and their referring physicians, to create more awareness of the benefits of protective PCI.
The second piece of our education is really, directly to the heart-failure community.
And, this is a community that we haven't been able to engage in the past, because we did not have the regulatory approvals.
And, to ensure that they understand that, you can have a high-risk PCI patient that is class III or class IV, and if they have ischemic disease, and you do extensive revascularization on this patient, you have real benefits and improvements in their quality of life, and improving their heart-failure status.
And so, that's been documented in all of our European studies, and in the two FDA studies, Protect I and Protect II.
We're not looking to go out and create all new sites, with all new physicians.
The product has been out under the 510(k) clearance since 2008.
So really, it's about making sure our best users have all the tools they need to ensure their success.
And then, to bring on the next level of adopters that have used Impella, but have not created a protected PCI practice, or who have not used it as extensively as some of their best users.
And, that's really the focus right now, at our existing sites.
<UNK>, the amazing thing about our portfolio right now is that the Impella portfolio, from the left side to the right side, can potentially treat multiple types of patients.
And, we're very focused on being the standard of care for percutaneous hemodynamic support, which is a large population of patients, as well as now, this protected PCI population.
And if we do a good job here and provide a clinical solution for these patients.
We're looking at $2 billion opportunity in the US, Germany, and Japan alone.
So we're very focused on our existing product.
However, we do have the worlds smallest heart pump.
We do have extensive IP.
So, you're going to see us continue to improve the existing products, to make them easier to put in.
Better quality, as we expand the regulatory approvals on them.
And then, later this summer at our investor day, we'll show a little but more of things we're working on.
But again, we want to remain focused on this core opportunity, to become the standard of care.
Thank you.
We just want to thank all supporters.
And, if you have any follow-up questions, please feel free to call me direct.
Have a great day.
