ABIOMED Inc (ABMD) 2016 Q1 法說會逐字稿

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). I would like to introduce your host for today's conference Ms. Ingrid Goldberg, Director of Investor Relations. Ma'am, please go ahead.

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 objectives. Next, Mike Tomsicek will provide details on the financial results outlined in today's press release. We will then open the call for your questions.

Before turning over the 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 associated with product development and commercialization, expected capital expenditure for fiscal 2016, the company's progress toward commercial growth with future financial performance as well as future opportunities, and expected submissions to and regulatory approvals from regulatory bodies. These forward-looking statements contained in this presentation are subject to risks and uncertainties, and actual results could differ materially from those projected in such statements. Additional information regarding these risks and uncertainties appears in the heading Forward-looking Statements in the press release we issued in morning in Part I, Item 1A Risk Factors in our Annual Report on Form 10-K for the year ended March 31, 2015, filed with the SEC and available at sec.gov and on our website at www.abiomed.com. The forward-looking statements in this presentation speak only as of the original date of this presentation and 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.

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 for purchasing the percutaneous circulatory support and offering protected PCI for their patients.

Our performance over the past three quarters validates Abiomed as one of the fastest growing GAAP-profitable medical technology companies. overall Abiomed has now grown top line revenue, double-digit year over year for 23 straight quarters. US patient utilization set new highs with an impressive 62% increase driven by record number of patients in both prophylactic and emergent support. Prophylactic and telesupport now referred to as protected PCI through 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 support 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 plan and a brief agenda overview for our upcoming investor day on August 11 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 US. 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 and a 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 cardiologist but to the referring physicians and patients. Abiomed, along with the hospital's heart team, can now focus on these appropriate patients that may not have other options or may be unaware of the benefits of protected PCI. Abiomed can share our library of intelli-clinical data with over 225 publications referencing six medical guidelines, four FDA studies, our intelli-registry and real-world case studies after supporting approximately 30,000 patients in the United States. We are now able to unlock this 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, of 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 a 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-1 and our US intelli-registry and references 692 patients in 17 --

Ladies and gentlemen, please stand by. Your conference will resume momentarily, once again, ladies and gentlemen, thank you for your patience, please stand by.

Hello, everyone we're back. This is Mike Minogue. The power went out in Danvers. As a company we always adapt and execute, so let's get back on track. So 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 a longer duration of support. This submission is a PMA supplement or supplements from our Impella 2.5 PMA approval for high risk PCI and includes analysis on 415 patients from our FDA study Recover-1 and our US 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 will 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 request --

Ladies and gentlemen, please stand by. Your conference will resume momentarily. Once again, ladies and gentlemen, please stand by. All right. Speakers you're back in the main conference. You can resume.

Hello everyone this is Michael Minogue again, we're having a bad rainstorm here in Danvers. It knocked out power. The generators are back on so I'm going to do the rest from my cell phone and we'll call in as well and take questions. I apologize for the inconvenience hopefully everyone can hear me clearly on the cell phone.

Where we left off was the Impella CP and Impella, respective 5.0 products will 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 and the submission from four years ago. As is practice in medical devices in Japan, most products are usually a revision or two currently approved EU and US 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 reliability. 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 on a rule on July 31st reconfirmed Impella reimbursement and payment. Percutaneous heart plumps like Impella remain one of the most cost effective technologies based on multiple studies, some independent, evaluating patient improvement in survival and quality of life, reduction of length of stay in hospital, repeat procedures, and adverse event rates to 90 days of hospital discharge. We believe Abiomed's exclusive focus protect and recover heart muscle and return patients home with their native heart as well as specific clinical analysis in the 65 and older patient population 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, present our corporate strategy and five year revenue projection, proscribe a new patient population of interest, and unveil a future product for heart failure.

In summary, our license to become the standard of care has transformed into a reality, and I'm 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 patients-first culture that inspires and allows us to overcome any diversity with honor and integrity. With this mind-set as our foundation, we are confident of our journey forward, which is paved with clinical and cost effectiveness evidence, regulatory approvals, and profit innovation. This fiscal year, we are well prepared as we approach many years of high growth in a multibillion dollar market opportunity. As always, Abiomed is committed to meaningfully impacting the lives of our patients and helping our physicians improve outcome.

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 Mike Tomsicek. Mike?

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 to take the rains 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 finance 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 the 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 wherein broad based patient utilization momentum delivered industry-leading revenue growth. US Impella revenue rose 60% to a record $63.7 million, driven by 62% increase in patient utilization. Outside the US, 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 US patient utilization by segment is as follows -- for the prophylactic setting, here forward referred to as protected PCI, this represented 50% of patient utilization and grew 85% year over year. This segment is the focus of the Impella 2.5 PMA. We are very pleased with the initial revenue response to the Q1 launch of the protected PCI initiative. For the emergent setting, this represented 42% of utilization and grew 57% year over year. The remaining 8% of use came from all other applications and increased 2% year over year.

As of the end of the first quarter, the Impella 2.5 has been placed at 974 of approximately 1400 targeted hospital sites, for a penetration of 70%. Impella CP has been placed at 694 sites for a penetration ratio of 50% of total hospitals and 71% of existing 2.5 sites. Our primary focus is on increasing usage at existing sites. However, there remains room to grow the installed base as Impella CP, 5.0, and RP are added.

Average Impella 2.5 and Impella CP inventory at hospital sites was a combined 2.73 units compared to 2.71 units in the prior quarter and 2.62 units in the prior year. So inventory growth is far below the growth in usage. We believe average site inventory levels of Impella 2.5 and CP combined will transport three units per site as sites increase utilization. Nonetheless, we expect sites will continue to carry the lowest reasonable Impella inventory and rely on Abiomed for restocking based on patient usage which is our preferred model.

Gross margins for the quarter expanded to 85% compared to 80% a year ago driven by favorable product mix, euro exchange rate, as well as increased production levels. For fiscal year 2016, we are maintaining our gross margin rate guidance to be in the range of 83% to 85%. As previously advised, we have initiated a significant increase in our manufacturing capacity this year, including the addition of new staff and equipment to support future volume growth which may lead to modest fluctuations in margins as capacity expands.

R&D expense for the first quarter totaled $10.2 million and was approximately 14% of revenue, slightly below the 15% mentioned in May. R&D expenses include submission work for the PMA supplements for Impella CP and 5.0, the Japanese PMDA submission, investment in global Impella -- in the global Impella registry, additional expenses associated with post-market studies of Impella 2.5, and Impella RP, as well as new products development. During our August 11 investor day, there will be a presentation devoted it our existing pipeline and clinical expansion for multiple patient populations.

SG&A expense for the first quarter totaled $37.3 million, up 18% from the prior year. There are a number of investments that will boost SG&A for the balance of the year. We are continuing to appropriately invest in our US field personnel, training, customer support, and marketing initiatives. Expenses associated with market access in Japan, a growing facilities footprint, cost of expanding and maintaining our intellectual property, and higher equity compensation expenses are all part of the forecast for fiscal year 2016.

Operating profits for the first fiscal quarter was a record $15 million or 20.5% of revenue compared to a loss of $1.5 million in the prior year. Operating profits as a percentage of revenue for Q1 was above our guided range 12% to 15% and I would remind investors that quarterly operating profits will fluctuate during the year driven by our commitment to invest in a rapidly growing business.

GAAP net income for the quarter of $8.9 million or $0.20 per diluted share compared to a loss of $1.7 million in the prior year for a loss of $0.04 per share. Although we are recording GAAP income tax provision at an effective tax rate of 41%, our cash tax payments are de minimus as a result of utilization of $75 million of deferred tax assets on our balance sheet. The rest of the balance sheet remains in excellent shape and we ended the quarter with cash and short and long term marketable securities of $156 million.

Turning to guidance. As noted in our earnings release, we have increased full year fiscal 2016 revenue guidance to a new range of between $300 million and $310 million, representing growth of 30% to 35% from the prior year. This new range noted -- has changed from that which was noted in our last conference call of $285 million to $295 million, which was 24% to 28% growth from the prior year. The company is updating its fiscal year guidance of GAAP operating margins to a range of 14% to 16%. This new range compares to the 12% to 16% previously issued.

The increased revenue guidance incorporates our positive results for the first quarter post-PMA, anticipates normal summer vacation slowdown in the cath lab, with a slight sequential increase in Q2, and reflects our investment and customer training efforts of protected PCI impacting the second half of the fiscal year. Our guidance includes approximately $6 million to $8 million of revenue from the launch of Impella RP. We will continue to govern the pace of the RP launch, maintain rigor in training, and focus on optimal patient outcomes as the best route of becoming standard of care. Going forward, we expect growth in the top tier of the medical device industry for some time, and we will be sharing a longer range revenue prospectus at our investor meeting on August 11 in Boston.

Operator, will you please now open the line for questions.

(Operator Instructions). Our first question comes from the line of Danielle Antalffy with Leerink Partners. Your line is open. Please go ahead.

Good morning, guys. Thanks so much for taking the question and congratulations on yet another awesome quarter. Mike, clearly momentum is building on the US 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.

Thanks, Danielle, for the question. What is new and what we're saying today is Impella is now the standard of care. So we're more focused on capturing the untreated patient population that's likely turned down for surgery but that has heart failure and advanced coronary artery disease. We estimate this that population is over 100,000 patients in the US and we're going to give further clarification on that population at the investor day. So that puts us in the range of around 5% penetration.

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 I'm just wondering how to think about that going forward. Thanks so much.

Sure. Danielle, your question is on the penetration on the installed base, so let me just give you a couple numbers. Impella's in 973 of what we see as a 1400 patient or hospital patient opportunity. So 973 out of 1400. If we then compare the number of sites that have Impella 2.5, we're 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 hear around 20 per quarter for the next couple years as we penetrate into the 1400.

Got it. Thank you so much and congrats.

Thanks, Danielle.

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

Good morning and good luck with the thunderstorms there in Denver or Massachusetts, Danvers.

Thanks.

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.

So our general -- our general feedback on placing the device is not -- is not one of the things that we see as an impediment to the first adopters. They're very comfortable with the pigtail and the catheter. But as you suggested, the next wave of users who are a little bit more concerned with placing something that is a 12 French to a 14 French hole, but remember that the Impella has a 9 French catheter on all of our catheter pumps and that's really what drives and introduces some of the leg ischemia. In the FDA study, we had to compare vascular complications to the balloon pump per the FDA definitions and we actually had numerically lower vascular complications per use as the intra-aortic balloon pump because they're both under 10 French on a catheter perspective.

Per your question and a concern a lot of it is just 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 -- in the cath lab suggests 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's done up to three of these cases, I don't think you'll hear from folks that that's such a difficult thing to do. But the leg ischemia is a concern for that next wave of users.

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?

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

Great. Thanks.

Thanks, Ben.

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

Hi. Good morning.

Good morning, Raj.

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?

Well, according to results, it is going on fact -- we saw for the last three quarters we went off 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, it's the highest regulatory standard and we're now able to go out and educate them on the benefits of Impella. And most important, we can work with the heart team to help them identify the patients and even market to -- 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 FDA approval.

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.

We think the St. Jude Thoratec acquisition will have similar effect to a standalone Thoratec company since we believe they're required 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 as greater than 100,000 patients and our run rate is around 5,000 patients.

As from a percutaneous heart pump perspective, we are the leader. We have the intellectual property portfolio. We're most confident in our innovation, in our ability to maintain leadership. We support -- we supported over 35,000 patients. We have 1000 installed customers in the US. 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 asked on the PHP. We suggest that Thoratec or potentially St. Jude give their specifics on the PHP time line. However, we compare it our own time line in the US with our PMA, we believe it's going to take more than four years before commercial -- commercialization.

And in regard to your European question, we're primarily in Germany and most of that is driven by emergency use patients that require days of support. And I think they're going to have limitation in their distribution and that their CE mark it only up to six hours as compared to our Impella which are approved for five to seven days in Europe. And so I think it's during the early innings of kind of a new product design and we look forward to having them involved to help us educate the 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 an expandable 24 French mesh cage which sits on the aortic valve.

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

Thanks, Raj.

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

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 -- 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?

Yes. We listed a number of the items where we're going to invest -- this is Mike Tomsicek, by the way, in SG&A has become familiar with very thorough, very exciting plans here to open the market. I think they're well considered. And -- 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 for the plan for investment in a range of SG&A activities, still personnel, training, customer support both in the United States and in Europe, I think the plans are thorough in both are thorough and well-considered, as are the plans for expanding manufacturing. But again, the -- the revenue would outstrip the spend right after the protected PCI is probably not much of a surprise.

Okay. Got it. And then second, just on market sizing, relative to let's call it 1 million PCIs that are done in the US 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?

The analysis, given out more details yesterday but at a high level, there's over 2 million patients that have heart failure, a good percentage of those have advanced coronary artery disease. If you come at it 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 continue to break it down to those who have coronary artery disease, most turned down for surgery have poor hemodynamics, and still get diagnosed. You're still talking about 100,000 patients you're still talking a very small percentage of the overall patient population that could benefit from protected PCI. And when we've done is created a website called protectedPCI.com which is out there now for physicians, for referring physicians, and for patients so that people who have heart failure that thought they didn't have any other alternatives to learn about this and it's a lesson based play. You have a procedure that takes a day or two, and this shows statistical improvement in your rejection (inaudible) and your quality of life. So it's really a nice new paradigm and we think it's a new option that heart failure and interventional cardiologists can offer to a growing epidemic of heart failure patients.

Great. Thanks for taking the questions.

Thanks James.

Thank you and our next question comes from the line of Jan Wald with The Benchmark Company your line is soap. Please go ahead.

Good morning everyone congratulations on the quarter.

Hi Jan.

Hi. A couple of questions. Mike, if I heard you right, you said you may have reached ad 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 -- when the characteristics of the next wave are and when you're doing to try to capture those -- those folks?

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 the 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 class, heart failure class, the reduction of days to stay at the hospital and of repeat procedures. So those are things that are very important in today's world of healthcare reform. And even from 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 or kind of the next wave of adopters, it's really basically training and data. We have to get there on the training so they can 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 guides, 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 PMA 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 on and considered for a much more invasive and costly alternative.

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?

At Abiomed we really want to make sure in this rollout of protected PCI that we treat the right and appropriate patients. So in working with the sites to make sure that the appropriate patient selection, the physician is comfortable that the (inaudible) support the first cases. We know that getting optimum outcomes is the key to success and maintaining our leadership position 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 ten types of patients -- some are elective, some are urgent, some are emergent. So there's still the tendency for the different types of patients that some will be transferred to some of these places with Impella in place and some will be referred around the different markets for people that eventually can provide protected PCI. So we're coming at it with a -- with a focus on maintaining the rigor and 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.

Thank you very much.

Thanks, Jan.

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

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 is -- would be targeted by the 5.0 once that's up and running by midyear, let's say next year. Thank you so much.

Chris, I'll go to the Japan question first and then I'll 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 revenue and utilization similar to the US. And then over time, we're going to be submitting for the Impella PC and RP in Japan.

Understood.

from the RP standpoint, it's currently making up about 2% of US revenue, so as we said the (inaudible) rollout of that product makes up a material portion of revenue (inaudible).

Understood. Thank you so much and congratulations on a record quarter.

Thanks, Chris.

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

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?

Yes. From a US revenue standpoint, the -- 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 of is $5.1 million for a total Impella revenue of $68.8 million.

Gotcha. 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?

I -- in my spare time have been reading old scripts and that number does rang bell from past and our current outlook is $6 million to $8 million that I mentioned.

Okay. And then internationally, it was a little, I guess we could -- 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.

25% year on year (inaudible) would be considered very strong. We haven't had the inflection or sort of regulatory lift that we -- in Europe that we have from protected PCI but we continue to be bullish on our potential in Europe.

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 the standard of care, publish data, share best practices, and do a lot of education around the benefits of protected PCI.

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?

Correct, Jason. We are putting in for the CP and for the 5.0. They are approved in CE mark for five -- 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 up to 14 days. In duration the devices have, obviously, run much longer than that and we've had patients on -- from an engineering perspective longer than that time frame.

And just in terms of the actual approval, a year?

We expect it to be less than 12 months.

Okay. Thank you.

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

Thank you.

Thanks, Jason.

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

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

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.