Hello, and welcome to the Abiomed FY 2022 Q3 earnings call. My name is Katie, and I'll be coordinating your call today. If you'd like to ask a question during the presentation, you may do so by pressing star one on your telephone keypad. I will now hand over to your host, Nicole Nath, to begin. Nicole, please go ahead. Good morning, and welcome to Abiomed's third quarter fiscal 2022 earnings conference call. This is Nicole Nath, Manager, Investor Relations, and I'm here with Mike Minogue, Abiomed's Chairman, President, and Chief Executive Officer, and Todd Trapp, Vice President and Chief Financial Officer. The format for today's call will be as follows. First, Mike will discuss third quarter business and operational highlights, and then Todd will review our financial results, which were outlined in this morning's press release. After that, we will open the call to your questions. During the call, we will discuss certain financial information on a non-GAAP basis. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Reconciliation between GAAP and non-GAAP results are presented in the tables accompanying our earnings release. Finally, I would like to remind everyone that today's call includes forward-looking statements. The company cautions investors that any forward-looking statements involve risks and uncertainties and are not guaranteed in the future. Actual results may differ materially due to a variety of factors identified in our earnings press release and our most recent 10-K and 10-Q filed with the SEC. We do not undertake any obligation to update forward-looking statements. With that, let me turn the call over to Abiomed's Chairman, President, and Chief Executive Officer, Mike Minogue. Thanks, Nicole, and good morning, everyone. Abiomed delivered record revenue of $261 million in the quarter of 14% year-over-year in constant currency. Despite its lower start in October due to the COVID resurgence and hospital labor shortages, Abiomed achieved record revenue. These results were driven by patient utilization records in both the U.S. and Japan of 10% and 35% year-over-year, respectively. Even with the headwinds, our Abiomed 2.0 playbook allowed us to adapt and execute, grow sequentially, and support the most patients ever in a quarter. These results would not have been possible without the dedication of our customers and employees supporting critically ill patients 24/7 on-site, online and in the cloud with Impella Connect. From a financial perspective, we achieved a 25% operating margin while investing $41 million in research and development as we remain fanatical and focused on creating breakthrough technologies, advancing clinical research and guidelines, and improving real-world outcomes by supporting hospitals with a premier clinical team. Our long-term outlook is robust and strengthened by our balance sheet with $932 million in cash and zero debt, with over 1,300 patents and over 1,300 patents pending. On today's call, I will highlight how we are executing our Abiomed 2.0 playbook in the current COVID environment and provide updates on our patented breakthrough technologies. Abiomed 2.0 is helping our hospital partners by supporting their staff to improve patient outcomes for many of the sickest heart and lung patients. Our company provides a unique and exclusive service with a premier clinical field team, educating, training and supporting hospitals 24/7. This support is even more critical as hospitals today struggle with labor shortages, COVID impact or reinfection rates, and ICU capacity, all impacting procedural volume. For protected PCI today, the majority of our patients transition to the non-ICU unit after the procedure. This compares to a majority of our past high-risk PCI patients before COVID that routinely went to the ICU post-procedure. To improve physician access and closure outcomes, our single access procedure for protected PCI has grown with education and training. In Q3, 55% of our high-risk PCI patients received single access and strong clinical signal now exists for lower bleeding rates and quicker recovery. This 55% single access, so a single hole for both the PCI procedure and the Impella, compares to 4% of our high-risk PCI patients with single access before COVID. These new high-risk protocols help open beds in the ICU for emergency shock patients who tend to be younger and higher priority for treatment. Our ability to share Impella and cardiogenic shock best practices has improved real-world outcomes, validated in multiple studies from the U.S., Japan, Italy, and Germany. Recently, a cardiogenic shock 24-hospital multi-center U.S. observational study published in JACC demonstrated that centers with shock teams were more likely to obtain invasive hemodynamics, use advanced types of mechanical circulatory support like Impella and less IABP, resulting in lower risk-adjusted mortality for patients. Our hub and spoke strategy continues to demonstrate that community spoke hospitals are growing their Impella patient volume. This shift to treatment in outlying centers allows scheduling availability and flexibility for referring physicians and patients when large transplant hospitals get overwhelmed with COVID patients. As a result, we're seeing community volume growth both sequentially and year over year. COVID has also accelerated the rollout of Impella Connect, our remote monitoring technology. Today, this technology is now available in 1,564 hospitals worldwide, and approximately 90% of weekly US patients are monitored in the cloud. This allows our field team to support our patients 24/7, even with COVID hospital restrictions and labor shortages, which helps ease patient management and optimize care in the ICU. In addition, we adapted our business model to include more online training and education by launching our password-protected user community called CAMP PCI. CAMP PCI is an online and interactive education and training endeavor that hosts live cases, allows for confidential user interaction, and has a dedicated clinical research community for our STEMI DTU and PROTECT IV studies. CAMP PCI is led by a faculty of experts in the field of cardiology, creating a virtual platform for experts to share live cases, best practices, and techniques. For ICU nurses and cath and surgery technologists, in addition to on-site training and education, we offer online training modules and credits at our Abiomed Academy HeartRecovery website. Now turning to our innovation update. The Impella 5.5 with SmartAssist received Japanese PMDA approval. We are excited to bring this game-changing technology to Japan, a country where we recently hit our 5,000th patient milestone. Culturally, the Japanese are averse to heart transplants and invasive sternotomies. This makes Japan ideal for Impella 5.5, given the pump's ability to provide minimally invasive, longer-term unloading heart support, enabling native heart recovery. We expect this first Japanese Impella 5.5 patient to be treated this spring. The Impella ECP received Category B status from the FDA, and we established our pivotal protocol. We also received FDA approval for the Impella BTR early feasibility IDE study, clearing the way for their first patient in the world. The Impella BTR will provide patients a home discharge option with over one year on full hemodynamic support at up to five hospitals and supported by Impella BTR for up to 28 days. The first Impella BTR patient is expected to be treated in March or April this year in the U.S. Abiomed has also entered the ECMO space with our innovative Breethe technology. During our initial limited market release and study, we have treated 61 patients, have a 71% survival for respiratory failure, and have logged 873 patient days. The average duration of use is 14 days, and 80% of patients have been for VV ECMO, a majority with COVID complications. We've worked closely with these leading hospitals to provide support, gather feedback, and learn best practices on every patient. In general, we are pleased with overall survival, blood compatibility, durability of the pump lung unit, hemodynamic flow rates, and ease of patient ambulation. Based on our early patient study and analysis, we've identified areas of improvement around electronics of the console and have implemented a voluntary recall at our seven hospitals. Until this field corrective action is completed, we are not expanding our number of patients or new centers. The console upgrades may require a 510(k) clearance, and so we're working with the FDA on the next steps. We also announced the successful results of the first-in-human early feasibility study of the preCARDIA system, published in Circulation: Heart Failure. The multicenter prospective single-arm study examined 30 patients with acutely decompensating heart failure, or ADHF, who were assigned preCARDIA therapy for 12 or 24 hours. The study met its safety and feasibility endpoints and documents that preCARDIA system can rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava. This product has also been awarded Category B designation by the FDA. This technology may enable the heart and kidneys to work more effectively, potentially providing therapy for patients non-responsive to diuretics, estimated to be approximately 300,000 of the one million U.S. ADHF admissions per year. We summarized all of these studies for our shareholders and posted on our quarterly slide deck. Our leading in innovation and technology principle to be smaller, smarter, and more connected remains a cornerstone of our sustainable success. At the J.P. Morgan Healthcare Conference, I gave more detail about our innovation, and the presentation is available on our investor website. Before concluding, I'd like to highlight a patient story. John Kapelos, 85, is a husband, father, and retired attorney from Jacksonville, Florida. John previously had mitral valve replacement but was living an active lifestyle and enjoying retirement. When John began experiencing shortness of breath and intermittent chest pain in August 2021, he went to see his cardiologist, who diagnosed John with heart failure. Tests also revealed multi-vessel disease and a lesion in his left anterior descending artery. John was evaluated for CABG or Open Heart Surgery, but due to his age and previous surgery, was deemed too high risk for another surgery. John was referred to Dr. Sameer Gafoor, who identified John as a candidate for a protected PCI procedure with Impella. Dr. Gafoor inserted the Impella heart pump pre-PCI to provide hemodynamic support while placing stents and performing a complete revascularization. The Impella heart pump was removed in the cath lab, and John was transferred to the CCU unit for overnight observation. John left the hospital the following morning and was home in time for lunch. Today, John has a normal heart function and feels better than he has in years. He and his wife Anne plan to travel, resume their passion for gardening, and spend time with their six grandchildren. In conclusion, our focus on extending our lead in innovation, advancing clinical evidence, and building a premier commercial team enables the pursuit of becoming the global standard of care for hemodynamic support. We are now in the final stretch of our fiscal year 2022. As we cross the $1 billion revenue threshold, we know it is our commitment to patients first that has inspired our innovation, improved our outcomes, and led to our success. I'd like to thank our employees, customers, and shareholders for their continued support. I will now turn the call over to Todd. Thanks, Mike. In Q3, we delivered record revenue of $261 million, up 13% on a reported basis and 14% in constant currency versus prior year, with double-digit growth across all geographies. As Mike mentioned, we saw month-over-month improvement within the quarter and set a global monthly revenue record in December. In the U.S., revenue grew 12% to $212 million. This performance was driven by 10% growth in patient utilization and favorable sales mix. We saw strength across our broad-based portfolio with Impella CP up 9%, Impella RP up 15%, and Impella 5.5 up 65% in the quarter. As we discussed on our last earnings call, some of the headwinds we encountered in the summer, specifically the impact of the Delta variant and hospital labor shortages, continued into October, which put pressure on procedural volumes. However, we executed our playbook and saw a recovery in patient utilization in the last two months of the quarter while continuing to face ongoing hospital labor shortages and the emergence of the Omicron variant. Our execution led to a quarterly record for patients and a monthly revenue record in December. In the U.S., at the end of the quarter, the Impella CP has reached 1,567 sites. The Impella 5.0 is in 666 sites, while the Impella 5.5 with SmartAssist is now in 349 sites, up 43 sites versus the prior quarter. Finally, the Impella RP is in 650 sites. As a reminder to investors, details of our product installed base are summarized in our quarterly slide deck. In the quarter, the U.S. reorder rate was 103%, slightly below prior year. Average combined inventory at the hospitals for the Impella 2.5 and CP was approximately 4.8 units per site, flat with the inventory levels we saw last quarter. Outside the U.S., revenue was $49 million, up 22% in constant currency versus prior year due to strength in both Europe and Japan. In Europe, we generated $32 million of revenue, up 18% in constant currency versus prior year. This growth was driven by strong performance in Italy, Spain, Belgium, and the Middle East, which more than offset softer conditions in Germany due to COVID and ongoing nursing shortages. Our European business also continued to see a positive benefit from sales mix as we fully transition to Impella CP with SmartAssist and begin to launch Impella 5.5 in Germany. In Japan, we delivered a record revenue quarter of $14 million, up 27% year-over-year in constant currency, driven by strong Impella adoption. Patient utilization increased 35% versus prior year. In the quarter, we opened seven new sites, bringing our total to 187 out of a potential 350 hospitals. Japan saw COVID cases significantly decline in Q3 after the surge in August around the Summer Olympics. However, in January, we saw Omicron cases escalate to record levels in Japan. In the third quarter, gross margin was 81.8%, down 50 basis points versus last year due to manufacturing investment, primarily more operators in both Danvers and Aachen to support our sales growth. R&D expense for the quarter totaled $41 million, up 24% versus Q3 of last year, driven by accelerated investments in breakthrough technologies like Impella ECP and preCARDIA and randomized controlled trials such as STEMI DTU and PROTECT IV. SG&A expense was $108 million in the quarter, up 25% versus prior year. The year-over-year increase was driven by headcount additions to our commercial team, our direct-to-patient initiative, and higher spend on education and customer training. In the third quarter, non-GAAP operating income was $65 million, down 9% versus prior year, translating to an operating margin of 24.9%. As we said at the beginning of our fiscal year, we are all in on investments in innovation, clinical research, and building a premier distribution team as we pursue our goal of becoming the global standard of care for hemodynamic support. Non-GAAP net income for the quarter was $52 million or $1.13 per diluted share versus $54 million or $1.17 in Q3 of 2021. The year-over-year variance was driven by accelerated growth investments which offset a favorable tax rate. In the quarter, we generated a record $90 million of operating cash flow and ended December with $932 million of cash in marketable securities. Our top priority for cash remains supporting organic growth initiatives and strengthening our intellectual property advantage. Now, turning to our guidance. Despite the rise in Omicron and ongoing hospital labor shortages, given our performance in Q3, we have increased the lower end of our fiscal year 2022 revenue guidance to $1.025 billion-$1.03 billion, representing 21%-22% growth versus prior year. This guidance projects Q4 revenue to be in the range of $263 million-$268 million, up 9%-11% versus a tougher comp last year. As a reminder, Abiomed reported 17% growth in Q4 of the prior year during the COVID pandemic. This range assumes improvement in patient utilization and hospital capacity in February and March, consistent with the trends that we have seen throughout the pandemic. We expect non-GAAP operating margin to be in the range of 24%-25%, consistent with our prior quarter guidance. In summary, we delivered a record quarter and are executing on our Abiomed 2.0 playbook. We are investing in innovation focused on clinical research and continue to add to our industry-leading commercial team, which we believe will drive long-term sustainable growth. As we enter the fourth quarter of our fiscal year 2022, we are optimistic about our ability to continue to reach our goals as we create the new field of heart recovery. Operator, please now open the line for questions. Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad now. If you'd like to remove your question, please press star followed by two. When preparing to ask your question, please ensure your phone is unmuted locally. We take our first question from Margaret Kuntz from William Blair. Margaret, please go ahead. Hi, everyone. This is Brandon. Thanks for taking the question. If I could just start first on guidance, Todd, maybe just to follow up on the updated guidance. Can you just talk a little bit about what gets you to the high end of the range and the low end of the range? I appreciate kind of assuming a little bit of an improvement in COVID. Is that the one main factor that we wanna keep in mind here? Is there anything else that gets us to the high and the low end of the range? Yes. Thank you for the question. I would say at the low end of the range, the $263, we assume some sequential improvement in February and March, but more of that bolus of patients coming in probably towards more March and maybe even into early April, where I think the high end of our range, the $268, which is again a 3% sequential improvement, is that we see some of that softness that we've encountered in January come back more in that February timeframe. That's really the high end, the $263 versus the $268. Just again, a reminder that I mentioned in my prepared remarks. You know, we're coming off of a more of a challenging comp with Q4 last year being up 17%, but that's kinda how we look at it from the low end of the range to the high end of the range. Got it. Then the international update on the guideline changes is really encouraging. I'm curious if that opens any new doors for you in the international markets, especially in Europe. I think when we've talked in the past, maybe some of those. It seems like you guys have been making some investments in trying to open market access in those international markets. I'm curious if you guys could update us on maybe what new European markets might be next? What kind of timelines are we looking at, and what efforts are going on there to open up new markets? Thanks. Thanks, Brandon, for the question. This is Mike. We have been planting seeds all around Europe and parts of Asia, and although Germany got hit with Omicron and also had some labor shortages, we had record patients and revenue in Italy, Benelux, Spain, and some of the other European countries. We're seeing strong growth there, and we continue to plant seeds around Asia. Obviously, Japan is very important to us, but you also saw that we got the Impella 5.5 approved in Hong Kong. That's key, and again, what also allows us to have the quality control is we insist wherever we go, we want Impella Connect. Anywhere in the world, these patients will be in the cloud. We'll be able to monitor them in the ICU, along with the hospitals and the physicians. Great. Thank you. Next, we have a question from Matt O'Brien from Piper Sandler. Please go ahead. Hey, good morning, guys. This is Drew for Matt, and thanks for taking the questions. I know you're still in your fiscal Q4 here. You're probably not providing guidance for 2023 today. You're making a ton of investments into the business. Just wondering what your general comfort level is with where The Street is on for fiscal 2023, especially on the merchant side with some of those investments and some of the macro headwinds out there. Anything you wanna call out as far as models go? As you said in the question that we really can't comment yet on fiscal 2023, but we will give that on the next earnings call. You know, innovation drives growth, and we have three breakthrough-designated products. We have two ongoing studies to drive Class 1. We also have more penetration for high-risk PCI, which is, you know, over 400,000 potential patients. Shock in the U.S. alone is over 200,000 patients. The STEMI DTU is targeting a four million patient population worldwide, which we don't treat today. preCARDIA gives us another 300,000 patients just in the U.S. We have to continue to grow the innovation. We have to continue to strengthen our clinical research and also with the goal of getting Class 1 requirements for high-risk PCI, cardiogenic shock, and STEMI DTU, which a Class 1 guideline essentially means that it drives and requests that not only do the hospitals should treat the patient that way, but the government systems will usually compensate for it. Last is we have built a premier field clinical team connected real-time in the cloud with Impella Connect, and we're using all that data to process artificial intelligence algorithms that help us see how the patient's gonna do, predict right heart failure, and measure hemodynamics from the pump itself. We feel very confident. As we've always said, one of our goals is to be one of the fastest-growing, most profitable medical device companies in the industry. Okay. Very, very helpful. Thank you. Then just on 5.5, it looks like you're still around halfway through the 5.0 conversion process here in the U.S. You know, maybe you could just give us an update on how utilization is trending in those accounts, just, you know, what the playbook is as far as addressing new surgical accounts once you get through that conversion. Then just how do we think about Japan from a revenue acceleration perspective? Thank you. Yeah, I mean, you're right in terms of the penetration where we are in the U.S., you know, in the 5.0, we're in over 666 sites, and we're about half of that right now for 5.5. We got a long runway of growth ahead of us. When I look at the 5.5 itself, most of the performance in the quarter was really driven by patients as opposed to more site openings or patient growth for 5.5, and the quarter was over 70%. We continue to see really the growth from the 5.5 being driven by patient utilization versus necessarily site openings. Your second question with regard to Japan, we expect to do our first patient in 5.5 in Japan sometime fiscal year 2023. We're gonna go slow and steady, train, educate, just get the best possible outcomes. We're very excited to bring that pump to Japan, and we think it's gonna. You know, we're gonna be the standard of care there for the next 10 years, but we're gonna follow the playbook that we've always followed, go slow, train, educate, get great outcomes, and then, and we'll go from there. This is Mike, and I attended a heart failure conference this week in New York City, and there were hundreds of people in person and online. It's become very clear that for this chronic heart failure patient population, there's really nothing between these inotropic drugs and an implantable invasive, either LVAD or transplant. What I think the community is looking for is a longer-term, minimally invasive, weanable heart pump that you don't have to core out the apex of the heart. With Impella, it's a forward flow pump. As it works, it works with the heart, and as you start to try to wean the heart back, as you lower the Impella flow, the left ventricle pumps with it itself. You still get the pulsatility. It's training your heart to come back. We have sensors on the pump, so we can see the pressure in the left ventricle, which is also helpful for the physicians. You have an optimized science now to get the weaning protocol right. Because if you get it right, you can potentially return the patient back to a baseline heart function. While the Impella is running, you're able to help the kidneys produce urine and come off the inotrope drugs completely, which are somewhat toxic to the system. This is an entirely new treatment therapy. The 5.0 did not run as long. It was not as small or as powerful. It didn't have sensors, and it didn't have the ability to use the SmartAssist software programs itself. You're gonna see what we believe will be the Impella 5.5 at every single transplant center in the world, and you'll see it at every single heart surgery center in the world that does advanced surgery on high-risk patients. As a reminder, last year in the United States, the surgical society made the intra-aortic balloon pump a class three or harmful for patients that have post-cardiotomy cardiogenic shock, so they can't come off the heart-lung machine. You're also seeing the Impella used for those patients as well, specifically around the shock and again, giving them the ability to get up and walk around. We're very excited about it. We're excited to have the product approved in Japan. There's another longer-term version of this same technique coming with the Impella BTR pump, Bridge to Recovery, that will now be a pure VAD through the axillary artery, will allow the patient to go home and still be monitored in the cloud and to help that patient, again, get their heart back to baseline. There is no other product in the world like Impella 5.5. Thank you. The next question comes from Chris Cooley from Stephens. Please go ahead. Good morning, and thanks for taking the questions, and congrats on the record quarter. If I may, I'd like to actually go back up and focus a little bit more on the innovation pipeline to start. Mike or Todd, if you could just elaborate a little bit more first on the ECMO data that you shared. Pretty encouraging there on the 71% survival rate. I just wanna clarify, though, you think that the electronic changes you identified. I'm assuming these are ease of use. Could you maybe just elaborate a little bit more there and why you think that would, you know, maybe lead that to be a refiling requirement with the agency and what that could do to timelines? I have a quick follow-up. Sure, Chris. Thanks for the question. For those that don't know, the ECMO product has been around in general for more than 25 years. They were grandfathered in by the FDA, and ECMO is approved as a heart and lung machine for less than six hours. While it took us over 10 years and over $100 million to get the approval for a shock on Impella, it's a 90-day 510(k) submission. When we did that, we got clearance, but we're treating the ECMO product as if it was a PMA product like Impella. For the first 61 patients, we were present at every single patient. We are tracking the data, and we found with the console itself, so nothing to do with the outcomes or the blood contacting. The most important component of our product is the pump lung unit, which allows the patient to get up and walk around. On the electronics and circuit, we want to ensure the reliability is there, and we're going to upgrade some of those components. What we're gonna do is with the FDA, if we have to submit for the testing of that through the 510(k), that'll be a resubmission for the console. If it's a note to file, it'll, we'll do that. Again, we think that this technology should be a PMA. We report things in our bedside that we know some of the other ECMO companies do not report because we are present even with all of their pumps when they do ECMO, and we wanna make sure that this is the best product, especially around ambulating the patient and also around VV ECMO, because we see the benefit of that in working with ECMO. We're, again, confident and pleased with our clinical outcomes. As a company that has thousands of consoles all over the world, there's a certain level of reliability that we wanna see. That's why we're bringing it back. We also recognize there's an ethical bar here, since many companies do have ECMO products already out there that are doing the job for the patients. We wanna make sure that our product is up to the standards like Impella, and that's what we're working on. It may not be a 510(k) clearance. It may be a note to file, but we're gonna be cautious. We're committed to being the innovative leaders in ECMO or especially around ECMO. Recently, there were some presentations at another online virtual conference which reiterate again the benefits of ECMO, so the combination of heart and oxygen support over ECMO only, not just on survival, but also it significantly increases the chance that the native heart can recover, compared to just an ECMO-only loop, which tends to pump against the heart. Appreciate the additional color there, Mike. Thanks for clarifying that. Just lastly for me on the innovation front, you know, the company's been historically quite successful when we think about deploying cash and investing in early-stage technology. I can think of one publicly traded company that's done extremely well for you. Just curious, as you talk about continued investment in innovation, very robust pipeline, obviously with ECMO, preCARDIA, et cetera. Should we expect to see additional investments there in the private portfolio? Are there opportunities there now that are presenting themselves that you could augment the existing either IT capabilities or alternatively just the channel there for HeartRecovery that we should be thinking about here from an investment perspective going forward? Thanks again. Hi, Chris, this is Todd. I'll take that one. I think when we look at our deployment strategy for the cash, you know, I think we continue to assess, you know, what's the right strategy. We look at, you know, several factors, including, you know, our cash balance and what are some of the investment options that are out there as well as overall market conditions. I think what's great about Abiomed is that we have a strong balance sheet that really allows us to fund both internal and external opportunities. You know, with that said, I still think our top priority remains investment just in our organic growth opportunities, given the amount of opportunities we have within our four walls. You know, with that said, you know, we'll continue to look to augment our organic growth as we look to invest in some new technologies really around our core competencies. I think M&A is part of our strategy, especially investments in early-stage companies. You know, if you look at last quarter, we have over $100 million of investments on our balance sheet. Again, we'll continue to look for differentiated technologies that can, you know, increase Impella utilization and improve patient outcomes. Again, looking for technology that can bring additional value to our patients, really in the cath lab, in the ICU or the CCU. You know, we'll remain disciplined on our approach and stay close to our core. Thank you. Thanks, Chris. The next question comes from Chris Pasquale from Guggenheim. Please go ahead. Thanks. Mike, a record December makes you guys a bit of a positive outlier across the sector there. It sounds like from Todd's comments that January was weaker for you, like it was for most med tech companies. Could you just talk a little bit about what you've seen over the past month and how the impact compares to prior COVID waves we've gone through? Sure, Chris. We're giving a little color on January. We did have a record in December, and we think it is a little bit of the Abiomed 2.0 playbook, right? We were able to be there in the cloud. The hospitals do allow the Abiomed representatives in, though, so we're a little bit unique from that perspective. But the fact that we can be monitoring the patients with phone support and Impella Connect is also helpful. We did adapt and find ways at hospitals not to have to put all our high-risk PCI patients in the CCU or the ICU versus the CCU or a step down or a hybrid. That does give focus, and the hospitals are now prioritizing the resources, the labor shortages into the patients that are the emergency patients at the ICU that are priority in treatment. That tends to be some of our younger shock patients. That's what happened in December. In January, the numbers, and everyone can see the news, you saw that Omicron set new records in December going into January. It wasn't so much just the COVID, it's the Omicron impacted with the labor shortages also impacted the nurses and doctors that are still there. That caused a little bit of some pullback on some of these procedural issues around either cath lab or surgical suite. It's not to the level it was in October relative to year-over-year. We're a little more comfortable year-over-year, but we also recognize that sequentially, it did impact a little bit in January. We do feel confident in Q4. We feel very confident in the final quarter of the fiscal year, especially for February and March. We also, you know, think that the model is working with and without COVID, with and without the resurgence. You know, we're able to provide a solution for hospitals to treat their sickest patients, to support them in the cath lab and the surgical suite, and also most important, to help support the nurses and physicians and train people on-site or online. We feel very confident in Q4. Great. Thanks for including the clinical slide in the deck. That's helpful to have all that information in one place rather. I don't think I heard an update on the timing of first in human implants with ECP. When do you expect those to begin? Did you say ECP, Chris? Yeah. I'm sorry. Yeah. So the E- Yeah. Yeah. Obviously we did do the first in man already. We've done over 25 patients already. We have locked in the pivotal protocol. We expect to do our first patients in that protocol in March and April. This March and April. A lot of stuff going on. It's Great. We did that slide for you. The benefit of having all this new innovation and these studies is it's exciting and it's growth for the future. The downside is it's likely very tough and confusing. We'll continue on every quarter this tracking slide, and if you haven't seen it to our investors, it covers everything, study detail, patient enrollment, total sites, and status. We'll update this slide every quarter for our investors to make it easy for you to track and see all the new products and the studies. We have our next question from Marie Thibault from BTIG. Please go ahead. Hi, good morning, and thanks for taking the questions, and congrats on a very nice quarter. I wanted to ask one here. Perhaps I missed it in the commentary, but we're certainly hearing from some of your peers across the med tech sector about heightened pressure on the supply chain, inflation, hiring costs, et cetera. I wanted to hear a little bit about how Abiomed has been managing through some of that. Thanks, Marie, for the question. I think when you look at it from an inflation perspective, just a reminder to investors, we do not have a high material content, you know, as a percentage of our COGS compared to some of our other peers. Like everyone else, we are seeing pressure on price increases, mostly, I would say, in the electronic side or on the logistics side. I think overall, the team is doing a nice job looking to negotiate some of the increases away. We've locked in prices in certain cases for up to a year. In other areas, we're looking to really pre-buy some of our raws and some of our components really before some of the price increases go into effect. We're also being proactive just looking at how we can reduce, for example, intercompany shipments and obviously be proactive to bid out to some of the other international freight carriers. I think the procurement team is doing a nice job. They're working aggressively to minimize some of this inflationary pressure, but it's there. We're also seeing some pressure on wage inflation, but I think we've taken that into a consideration for our operating margin guide for the year of 24%-25%. Okay, that's great. Very helpful, Todd. Maybe a related question here. You mentioned, you know, there is so much going on in the pipeline. You have a lot of clinical trials about to start or ongoing. I'm wondering if you're needing to hire up a lot of new staff, either in sales or R&D, and whether there are efforts you're making beyond Impella Connect, beyond the shift toward a single access procedure, to help customers with the staffing shortage they're facing. You know, our diligence points to this being a continuing problem, even beyond the pandemic. I'm curious if there are larger shifts you're sort of making within the business or investments to help those customers out from that. Thank you. Marie, I think I got the question. There was a little bit of noise or static on the line there. The question is, are we doing more and is there other things we can do for the hospitals to help them out? The way I would answer that is you have labor shortages, which we identified in the last earnings call. You also have the spread of COVID, which impacted more of those people that are remaining. What that means for Abiomed is you might have some less experienced or turnover nurses or traveling nurses. We do still provide with COVID, with restrictions, hospitals let us in because we are providing this training, we are bedside, and we are continuing to train nurses and physicians and cath lab techs on-site. We have the ability for both physicians, nurses and techs to log into a virtual platform, and they can get credits and we can train them. We also have a per diem bullpen of employees that we hire that they get super training so that it also allows us to, as we add places and add more people, we get qualified per diems. While those per diems are out there in the community, they are a little bit more of subject matter experts. We're doing all those things, but there's again, we're just trying to engineer in as much as we can ease of use. You know, that's what SmartAssist does. That's what ECP will be for access closure, for 5.5, having the sensors and, you know, these are the things that make it easier for you to manage that patient in the ICU. If you have a patient that can get up and walk around, that's an easier patient to manage. That's our 5.5. Even with our ECMO product, it doesn't require the same amount of nurses to help get a patient up and walk around. We have a built-in oxygen concentrator, so you don't have that big tank along with it. Everything we're doing, again, around smarter, smaller, more connected, is to just make the learning curve easier on everyone, the patient management experience more positive, and it usually ends up with improved outcomes as a result. Very good. Thank you for the detail. Our next question is from Jason Bednar from Piper Sandler. Please go ahead. Good morning. Also, thanks for the pipeline slide there. It's helpful. Wanted to ask about the quarter here in terms of last call, you talked about a portion of your sites that didn't grow. Did those laggards improve in the quarter? Maybe you can just comment on utilization across the customer base in the U.S. Sure, Jason. Thanks for the question. This quarter, 84% of the regions grew. 100% of the West region. We divide the country up into East and West. The Omicron really impacted more the East Coast. Again, it, the West Coast, 100% all grew year-over-year, they were less impacted. We saw strong overall growth in shock, that was up 14% year-over-year, and high-risk PCI was up 5% year-over-year. It was mostly down or lower in the East Coast, which did not and which had a bigger impact of Omicron. For the overall what we continue to see, whether it's in the East or the West, is a positive trend that our small and medium-sized customers are doing more at their facility. It gives more flexibility. If a patient doesn't wanna drive into the city to the transplant center, which might be the COVID hub, they can do the procedure there, whether it's high-risk PCI, or if it's a shock patient, they can put an Impella device in that patient, stabilize that patient, and then transfer that patient if there's a bed available to the ICU at the transplant hospital. We've learned a lot about how to interact and how to move patients around. If I look at the last quarter, which you're talking about to this quarter, there's two territories that were down that we highlighted, and one's in Texas, and the other one was in the Midwest, and both of those returned and had strong growth. So the answer is yes, and that's one of the benefits that we're able to track is some of these high-risk patients, we do try to track them and schedule them in advance. If they don't get treated, they're still in the system. We're glad to see that they're able to ramp back up in these areas and treat those patients. Okay. That's helpful, Mike. Just on a similar vein, in terms of getting back to normal, what do you think the rate limiting factor here is on your growth? Meaning is the bigger concern demand, just simply reluctance of folks coming into the hospital, or is it more of a staffing dynamic issue that's impacting growth? Jason, I think that the normal process is going to continue to drive our growth. The normal process will be these flare-ups, the anxiety. Unfortunately, what's happened with people waiting longer is they tend to be sicker when they show up at the hospital, whether it's high-risk PCI or whether it's a certain patient population turned down for CABG. They maybe they're gonna get a high-risk PCI. The resistance to do staging now, which staging was a big part of PCI, meaning that they get a procedure done, and they come back 45 days later and get another one. That's positive for Impella in that they'll try to do everything in one procedure. There's... Then on the shock side, I think the shock protocols are gonna continue to grow. For the lung problems, we expect VV ECMO to continue to be a standard of care for COVID complications. Of course, we have emergency use authorizations for COVID with our right side device and our ECPella combination usage. The new normal is that Abiomed treats the heart, the lung, and the kidneys, whether it's from the AMI or whether it's from COVID. You know, we help save the sickest of both populations. Okay. Mike, it doesn't sound like hospital staffing dynamics are impacting your growth at all. Is that fair? Well, Jason, you can always have more growth, but the hospital staffing will slow us down. In the examples of what I talked about as that 84% of the reason it grew, the other 16%, they might have not had enough cath lab techs or enough surgical techs or ICU nurses, so it likely impacted us more on high-risk PCI, less on shock. Over time, we become, you know, part of the partnership with the hospital, and they depend on us, and we depend on them to work together to optimize the outcomes, whether it is shock or whether it is high-risk PCI. I don't think that's gonna change in the short term, and I think companies that can offer this kind of 24/7 service are gonna be welcomed in, and I think that's part of our business model. Okay, that's helpful. Thanks, Mike. The next question comes from Danielle Antalffy from SVB Leerink. Please go ahead. Hey, good morning, everyone, and congrats on a really good quarter in a tough working season. Mike, just a question for you, and then Todd, I have a follow-up for you. Impella 5.5 continues to exceed our expectations, and you're clearly getting strong adoption there. I'm just curious if you're seeing any sort of increased receptivity on the Impella 2.5 and CP side of things in the interventional cardiology community, where 5.5 is being adopted, thinking of sort of a halo effect, when the cardiac surgeons are adopting 5.5 or getting interventional cardiologists on board, or is that too much of a stretch to make? Danielle, it definitely helps. I'd encourage all the investors, if they wanna truly understand the 5.5 and how it's changed the practice in surgery and for the heart team, is on our investor website, there's a presentation by Dr. Edward Soltesz, who chairs surgery at Cleveland Clinic. You can kind of see the hybrid between sometimes these patients decompensate. They are heart failure patients. They're not having their first heart attack. They have some worn-out hearts. After they put the Impella 5.5 in, now they have options and therapies that they can utilize. Whether it's some patients are sent to the EP lab for VT ablation, some go on for open heart surgery, and some go to the cath lab and have a PCI, depending on the protocol there. That heart team mindset is where there is this benefit because you're giving the heart surgeons a tool they didn't have before. You don't have to commit somebody to a transplant. It's very clear that when we have this kind of innovation, all the surgical departments at the transplant centers are working with us now. Therefore, in the hub and spoke model, it gives us the ability to really partner, whether we're referring in a cath lab patient to that center or a surgical patient, it strengthens our relationship. I think it's just great to have this innovation. You hear us talk about the heart team now, and what most people are starting to understand is there's two types of shock patients. One is the acute AMI shock. Someone has a heart attack, that's their first symptom. The other is a chronic heart, which is worn out over time, that needs therapy. Sometimes that therapy is protected PCI, sometimes that therapy is CABG or other items. It really does give now more options to the entire heart team. That's the benefit. Got it. Okay. Thank you for that. Todd, this question is probably for you, and I appreciate, you know, this was already asked around how to think about 2023. You know, just looking at numbers, your CAGR, taking the midpoint of your 2022 guidance range, versus fiscal 2019 is about 10%, but looks like the street is assuming a bit of an acceleration to the mid-teens-ish range for fiscal 2023. You know, I guess I'm just, I know you're not going to give guidance here, but just qualitatively, is there a reason to believe on presumably less easy comps, maybe even a little bit tougher comps, just given how growth has progressed through COVID in fiscal 2023? Is it fair to assume growth can accelerate off of the last three-year CAGR, or is that maybe a little bit too optimistic? Well, Danielle, I'd love to answer that question. Again, as Mike mentioned, we will provide full year guidance, you know, on our earnings call in April. When I look at the large opportunity you have with us in terms of some of the catalysts for next year and growth drivers that I can point to, again, I come back to Impella 5.5, right? We're still, again, in only half the sites where we have Impella 5.0. We have, you know, Impella RP Flex. We got ECP, we got, obviously, OUS growth. I think we have a lot of catalysts. We have Breethe. We have a lot of catalysts, either products or new geographies really to get into as I think about next fiscal year. Okay. I think some of the headwinds that we faced this year with regard to, you know, Delta and Omicron are gonna subside as we get into next year. Also, the investments we've made. You know, we've added a lot to our commercial team, probably heads are up 70 heads year-over-year. The direct-to-patient initiative that we're undergoing. I just feel like we have a lot of catalysts, irons in the fire to help drive growth next year. We'll provide a more formal guidance in April after our Q4 earnings call. Got it. No, that was a helpful way to frame it. Thank you for that, Todd. Thanks, guys. Yep. Thanks, Danielle. We have a question from Cecilia Furlong from Morgan Stanley. Cecilia, line is now open. Great. Good morning, and thank you for taking the questions. I wanted to ask just on your comment around 55% of single access high-risk PCI, just where you think or think about that going in a post-COVID world. Somewhat tied in with that too, but just XR Sheath for CP, any updates around your expectations for LMR? Thank you. Thanks, Cecilia, for the question. It will continue to go up because it's a superior technique on the Impella CP. As I said, we're collecting the data, but we have strong signal that it's better clinically, it lowers bleeding and has faster recovery. We also have improvements coming to our sheath. There's gonna be two improvements coming for two different options that will be able to capitalize on reducing the French size of the hole, making the single access part of that design, and also having a solution for the patient to go to the ICU, where you don't have to peel away a sheath. Longer term, that will be incredibly helpful. However, the Impella ECP is the easy button for high-risk PCI. It's a nine French pump going in and coming out. We see the Impella CP as the ideal pump for a AMI cardiogenic shock patient that gets treated in the cath lab and goes to the ICU for four days, and you're really focused on weaning them back. We feel very good about the XR sheath as well as the single access. Combining the two is gonna help alleviate some of those concerns for those late adopters that are concerned with closing a 14 French hole. Great. Thank you. If I could just follow up on Japan, the strength you saw in the quarter, utilization at 35%. Can you just speak to kind of what you saw in the quarter, specifically, how much of that was, or if any kind of COVID backlog coming back in? As you look out ahead of 5.5 and factoring 5.5 in the back half of the calendar year, how do you think about just the ramp in adoption overall in Japan? Thank you for taking the questions. Yes, Cecilia. I'll answer the first one about Japan. In terms of the bulk of patients, I would say it mostly has come just from a reorder rate. Our patient growth in Japan has been north of 30%, you know, for the last several quarters. Again, I think this quarter up 35%. Again, it's mostly reorder rate from a revenue standpoint. Also, we opened up a few more sites, but I don't think any of the revenue is really coming in from a bulk of patients. As I mentioned earlier, the 5.5, we're gonna go slow and steady. You know, probably not a big growth driver for us next fiscal year because again, we're gonna go enroll certain sites. We're gonna educate the physicians, train, get great outcomes and continue to, you know, roll out thereafter. It's the playbook we follow, and we're gonna continue to follow in Japan with the 5/5 launch for SmartAssist. Great. Thank you. Our next question comes from Imron Zafar from Deutsche Bank. Please go ahead. Hi, good morning. Thank you very much for taking my question. I wanted to ask a couple of follow-ups on 5.5. First, I guess, staying in Japan for a second. Are you gonna be pursuing a separate reimbursement for 5.5 or are you just simply gonna be using what's the existing codes for Impella there? I guess my question is, are you gonna be getting a premium reimbursement ultimately for 5.5? Imron, we are working with MHLW now and pursuing an add-on payment, and specifically looking at and creating an opportunity to identify the potential of native heart recovery. In Japan today, they do have incredibly high reimbursement for stem cells, and you'll also likely see some of the patients that are getting stem cells be combined with a therapy with the Impella unloading as well. Okay, thanks. In terms of U.S. 5.5 launch, can you talk a little bit more about you know, what's driving the patient growth and how much is coming from this displacement of 5.0 versus you know, conversion of heretofore LVAD cases? Maybe also just remind us how big the BTT population is in the U.S. Thanks. It is growing, and it's grown over 100%. 5.5 has grown over 100% in spite of COVID. It runs longer, it's smaller, it's easier to put in, it's more powerful, it gives information with SmartAssist, and it allows the shock patients that have decompensated to be able to stabilize them, get them off of their inotropes, get them up walking around or riding a bike or getting ready for rehab. Again, I would reiterate, there's a great presentation on the investor website from last year by Dr. Edward Soltesz from Cleveland Clinic, and you can kind of see how it's become the way they stabilize these chronic patients. With regard to transplant, that actually has been growing in spite of the fact that it doesn't have actually the premium position as a status two. ECMO and CentriMag devices are status one, so they get their earlier implant. That and the balloon pump is status two. So when Impella patients get transplanted with the Impella 5.5, they're getting it through status two, which means they're sicker, but the average wait time in the U.S. for transplants is now around three-four weeks. Whether they get transplanted or whether they get back to baseline, this is a different option. If you choose ECMO, basically, you have the patient on their back, you have adverse events, inflammatory and risk of stroke. These are all documented, and the patients really aren't getting up and moving around. You're taking a transplanted heart, it's a precious item with only 2,000 a year in the U.S., and you're potentially giving it to a patient that might have a lower success rate. For implantable devices, they are down because they are status three, and that is a great product and a blessing for people that are going to have very long wait times or are looking to live out more years through destination therapy. I think what you're gonna see over time is that all the transplant centers will be reliant on the Impella 5.5, and most important, start to think about native heart recovery or getting the patient back to baseline compared to the options they have today. Okay, great. Just one last one. There was a new retrospective study published in the last few days, sort of implicating a higher mortality rate with Impella versus balloon pump. A little bit reminiscent of the Dhruva study we saw in JAMA a couple years ago. Obviously not something we've seen in our PROTECT II. I just guess my question is there any acute risk of some, you know, volume impact? Maybe you can answer that by reminding us if there was any such impact after the Dhruva paper was published a couple of years ago. Thanks. Sure. The Dhruva paper actually is, when you go into the details, it reinforces our best practices. The Dhruva paper is actually balloon pump patients that are less sick, that do not get escalated to ECMO or to Impella, compared to balloon pump patients that get escalated to Impella and Impella patients that get it before, during or after. It's not a balloon pump to Impella comparison. When we look at that same period, we see statistically higher survival where you put the Impella in before. We bought the NCDR data for 2018 and 2019 because those are the only years they actually had the Impella data. The original Dhruva paper factually doesn't have whether or not it's only a balloon pump or Impella or Impella. That also reiterates that the Impella put in before the PCI has higher survival. There is some noise out there, but even the noise agrees with our best practices, and that's why the leaders in the space publish their actual data and are in the studies. Perfect. Thank you very much. I can confirm we have no further questions, so I'll hand it back to our speaker team for any closing remarks. We just want to thank everyone for the time today. Stay safe, and if you have follow-up questions, feel free to reach out. Have a great day. This now concludes today's call. Thank you all for joining. You may now disconnect your lines.