Morning, and welcome to Shockwave's conference call. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I'd now like to turn the call over to Debbie Kaster, Vice President of Investor Relations at Shockwave, for a few introductory comments. Thank you all for participating in today's call. Joining me today from Shockwave Medical are Doug Godshall, President and Chief Executive Officer, and Dan Puckett, Chief Financial Officer. Also joining us is Dr. Gregg Stone, Director of Academic Affairs for the Mount Sinai Heart Health System, Professor of Medicine and Population Health Sciences and Policy, and Principal Investigator on Neovasc's COSIRA-II trial. Earlier today, Shockwave announced it has entered into a definitive agreement to acquire Neovasc, a company focused on the minimally invasive treatment of refractory angina. Additionally, Shockwave announced its preliminary fourth quarter and full year 2022 revenues, as well as full year 2023 revenue guidance. A copy of the press release is available on the Shockwave website. Before we begin, I would like to remind you that management will make forward-looking statements during this call within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to the potential benefits of the proposed transaction and advantages of the Reducer, Shockwave's preliminary unaudited financial results for the three months and year ended December 31st, 2022, Shockwave's outlook for the year ending December 31st, 2023, are based upon Shockwave's current estimates and various assumptions. Important factors that could cause Shockwave's actual results to differ materially from those indicated in the forward-looking statements include, among others, the completion of Shockwave's 2022 financial statements, Shockwave's 2023 operational and financial performance, whether the acquisition of Neovasc is completed, and if so, whether and when the Reducer receives FDA approval and whether the Reducer is ultimately commercially successful. Other risks and uncertainties discussed in Shockwave's filings with the SEC. Accordingly, you should not place undue reliance on those statements. For a list and description of the risks and uncertainties associated with Shockwave's business, please refer to the Risk Factors section of Shockwave's annual report on Form 10-K on file with the SEC and available on EDGAR, and in Shockwave's other reports filed with the SEC. Please note that the preliminary financial results discussed on this call are an estimate and subject to completion of Shockwave's financial closing and other procedures for the year ended December 31st, 2022. Please see the press release for additional information. Shockwave disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, January 17th, 2023. With that, I'll turn the call over to Doug. Thanks, Debbie. Good morning, and thank you all for joining us on short notice for Shockwave's announcement for the signing of the definitive agreement to acquire Neovasc for an upfront cash payment of $27.25 per share, corresponding to an enterprise value of approximately $100 million, inclusive of certain deal-related costs. Neovasc shareholders will also receive a potential deferred payment in the form of a non-tradable contingent value right, or CVR, entitling the holder to receive up to an additional $12 per share in cash if certain regulatory milestones are achieved. As a brief aside, I recognize that it's not necessarily the norm to hold a conference call when announcing transactions of this nature, but we wanted to ensure that both sets of shareholders had a clear appreciation of why we believe this will be such a strong combination. Neovasc's activities in refractory angina, a widespread disease that is not as visible as many other cardiovascular diseases, are quite compelling, but have not historically been as well known to the investor community as was their prior work in mitral valves. Our team at Shockwave has been patiently assessing external technologies to add to our portfolio, and we've been looking for novel therapies that have the potential to treat a large, poorly served patient population, much like lithotripsy for treating calcified arteries was when we started. We've steered away from opportunities that would be a distraction to our U.S. sales team in the next couple of years, as we need to maintain our focus on aggressively growing our IVL franchise. We preferred that our first strategic move would remain in the cardiovascular space, and ideally, it would be a new therapy we could deliver to our current customers. Obviously, it's a pretty short list of technologies that fit through our screen, but we believe our patience and diligence have paid off and that we have found just such an opportunity in the Neovasc Reducer system. The Reducer is a balloon expandable stainless steel frame that is implanted in the coronary sinus, which is a large vein in the heart, via a catheter-based intervention that generally takes about 30 minutes. Implantation of the Reducer increases the pressure in the coronary sinus, which has the effect of redistributing blood to the ischemic areas of the heart and thereby improving symptoms of angina in most patients. Refractory angina is an increasingly prevalent condition where, due to an inadequate supply of oxygen-rich blood to the heart muscle, clinically known as ischemia, patients suffer chest pain that cannot be controlled by conventional pharmacological or interventional therapies. Refractory angina imposes a high financial burden on the healthcare system due to the significant resource utilization required to manage these patients. This condition affects millions of people worldwide, and there are two primary distinct patient populations. The first are patients who have obstructive coronary artery disease, but for whom a stent or bypass does not or cannot successfully resolve the chest pain. This condition is common not only in patients who are not candidates for revascularization, but also in many patients following a successful revascularization. It has been estimated that persistence or recurrence of angina after PCI or CABG occurs in over 20% of patients. Neovasc is currently studying the obstructive population in the COSIRA IDE trial, which is underway in the U.S. This group represents a total addressable market that is estimated to be almost $2 billion in the U.S. and Europe alone. The second group of patients have angina but have no obstructive coronary artery disease, which is known as NOCA. Neovasc is just beginning to conduct feasibility studies in the NOCA population, which is even larger and yields an estimated addressable market in the vicinity of $3 billion in the U.S. and Europe. Dr. Stone will provide more color on the clinical need for a solution, as well as providing an overview of Neovasc's clinical program a bit later in the call. First, I want to share some more details about our strategy for the Reducer. In acquiring Neovasc and the Reducer system, we will be adding a groundbreaking clinical trial and technology development program that we anticipate will lead to U.S. approval for the obstructive population sometime between 2025 and 2027, depending on enrollment rate and the length of time required for FDA review. We expect to refine our estimated timelines after the transaction is closed. The Reducer system will be implanted by the same interventional cardiologists who are using our C2 product today, which should make for an efficient launch when the time comes. In the meantime, we plan to continue fortifying our IVL stronghold via account penetration and our steady cadence of multiple IVL product launches each year. Since the Reducer already has a CE mark, we plan to use the international availability as an opportunity to both continue building a market for the Reducer in countries where payment is adequate and to optimize the selling and education process in advance of the COSIRA-II data and ultimately U.S. approval. This is the same playbook we used when we launched C2 in Europe three years ahead of U.S. approval. In the U.S., the Reducer system was granted abreakthrough device designation by the FDA in 2018. Prior to COSIRA II, Neovasc conducted the COSIRA study, which was a prospective, multicenter, randomized, double-blind, sham-controlled clinical trial which showed statistically significant results that were published in "The New England Journal of Medicine." This study supported CE mark approval of the Reducer. COSIRA II is a larger sham-controlled double-blind randomized IDE trial to evaluate the Reducer system for safety and effectiveness in patients with refractory angina due to obstructive coronary disease that is not amenable to conventional revascularization. It is the quality of this trial that Dr. Stone helped create and its potential to prove convincingly that the Reducer significantly reduces pain in the vast population of patients with refractory angina that compelled us to move forward with this acquisition. The potential NOCA indication for the Reducer system is a bit further off and will likely require an additional randomized clinical trial. Of the more than 2 million diagnostic angiograms performed in both the U.S. and Europe each year, it has been estimated that 25% of these procedures are performed in patients who suffer from angina but do not have obstructive coronary artery disease. Over the past few years, industry peers have developed tests to diagnose microvascular dysfunction, the largest subset of NOCA. Yet physicians have no therapy to offer these patients at present. We look forward to working with the clinical community to further study the use of Reducer technology for these patients. Since we've not met all of Neovasc's team members, it's premature to discuss integration plans or organizational designs. Obviously, we've been hiring aggressively at Shockwave just to staff our IVL business. We fully expect to build around the Neovasc team to help accelerate their momentum. We look forward to getting to know the Neovasc team better over the coming weeks. I'm very encouraged by the potential of the Reducer system. As with IVL, the Reducer addresses a significant unmet clinical need. The efforts required for us to get the Reducer to market will be considerable, but it will clearly be worth the effort if the trial performs as we expect it to. We believe that this sort of clinical validation of a paradigm-changing therapy and subsequent market creation is the sort of thing we do reasonably well at Shockwave. It is what we love doing, and it is what will continue to drive shareholder value. I'll now turn the call over to Dr. Stone, who will talk a bit more about the clinical aspects of the Reducer. Dan will then provide some additional financial commentary. Dr. Stone? Well, thank you. That was a beautiful overview, and I want to congratulate both Shockwave and Neovasc on the news today. As you're going to hear, I'm excited about this technology. I think it offers the potential to help hundreds of thousands of patients that really have no other treatment alternatives that are satisfactory. I think the direction that Neovasc is going on is an important one, and I think that they can really also benefit from the additional infrastructure, clinical trial, and ultimately distribution expertise and infrastructure that Shockwave has in place. Let me go over some of the issues that were discussed just in a little more detail, and I'll try to also speak both plainly and scientifically, and of course, I'll be open for any kind of questions that you would like. I'm an interventional cardiologist and a clinical trialist, and as you heard, I'm the Director of Academic Affairs for the Mount Sinai Heart Health System in New York City and hold a dual professorship. I've led a lot of clinical trials in the area of coronary artery disease. The number one symptom that patients present with is angina, okay. Which is usually exertional when they walk, when they go upstairs, when they carry heavy packages, after they eat a large meal, when they're under stress. They can feel an oppressive heaviness or tightness in their chest, sometimes arms, neck, jaw. Our traditional thinking is that that's caused usually by restricted flow to the heart muscle itself, and the heart develops ischemia, which means it basically doesn't have enough blood, oxygen, and nutrients, and it changes its metabolism. It's like if you have a weight and you exercise your biceps, you do 20 bicep curls, and your bicep starts burning. The exact same thing as angina from the heart when it's just not getting enough blood. Usually, the patient rests, then the blood flow requirements go down, then the angina resolves. As an interventional cardiologist, we usually think of the most common cause of angina as due to blockages in the coronary arteries, the arteries on the surface of the heart themselves. Those are the big arteries that we can see, and we can usually, not always, but usually fix them either with some sort of angioplasty technique, usually stenting, and sometimes a bypass surgery. There's a subset of patients that have obstructive coronary disease, that is, blockage in those coronary arteries, wherein PCI is unsuccessful, and bypass surgery is unsuccessful. Sometimes we haven't treated the right narrowing. Sometimes the narrowing recur after PCI. Sometimes the surgeons can't bypass all of the lesions, and this leads to second, third, fourth procedures. Sometimes the recurrent procedure is successful, but sometimes they're not. There are hundreds of thousands, we don't know the exact number, but at least hundreds of thousands of people that have so-called refractory angina due to obstructive coronary disease. Some people would call this end-stage coronary artery disease. There's really nothing you can do from either a stent or balloon, or IVL approach, or bypass surgery to continue to help them. They've got blockages. Either they keep coming back, or they're in small vessels, or there's a lot of occluded blockages. There's a lot of different patterns. These patients actually often live a long time. They often don't die, and they often don't have heart attacks, but they're miserable because whenever they walk across a room or whenever they try to carry a bag of groceries, they get chest discomfort that is quite disturbing and often associated with shortness of breath or other symptoms, and it makes them stop. They can't live and perform their activities of daily life. The problem in those patients is often that the arteries that we can fix, we've done everything that we can, and either those big arteries have reblocked again or, again, are totally blocked off. A lot of the small vessels that we can't fix with either angioplasty or surgery have become occlusive, that is, narrowed or totally blocked. All you can do in that case is try medications. Medications, such as beta blockers, calcium channel blockers, nitrates, have a little bit of an effect, but are mostly ineffective. They're very, very weak. You've got all these patients who have refractory angina, and they're getting ischemia. The Reducer was developed based on a cardiac surgery procedure that was developed at the Cleveland Clinic in the 1950s. The surgeons, one particular surgeon, discovered that if he had tied off or narrowed the coronary sinus, which is the big vein in the heart where almost all the blood drains out of the heart. It goes into the heart. Most of it gets into the heart, if you will, through these arteries on the surface of the heart, the coronary arteries. It then percolates through the heart muscle itself, which is like a sponge. Other veins collect it and drain the blood out of the heart, and they drain into this big vein, the coronary sinus, before returning to the general circulation. It was discovered that if you narrowed the coronary sinus, what it does is it creates back pressure on the drainage of the blood from the heart. It, one, it causes the blood to stay in the heart longer, so it's got a better ability to extract the oxygen from the blood, but also it redistributes the blood flow. This gets a little bit complicated, but the heart is a muscle, and it's got thickness associated with it. The part of the heart muscle that tends to get ischemic or starved for blood is the deep muscle itself. That's because the little blood vessels themselves can get narrowed, or the heart can get thick and squeeze those little blood vessels. When there's very little blood flow, the blood and the oxygen's already kind of been depleted by the time it gets to the deeper regions of the heart muscle. If you narrow the coronary sinus, it was shown that a lot of those patients would feel better. You would redistribute the blood flow to the deeper portions of the heart. Obviously, surgery was a really big procedure to go through, and that technique in the 1950s, they didn't even know how to do studies in the 1950s, and it never really caught on. It was there. It was a concept. In comes the Reducer, many, many years later, as you heard, the Reducer is basically a coronary stent. It's a bare metal stent, but it's got an hourglass configuration. It looks like, think of what an hourglass looks like. It's pinched in the middle. Excuse me. When you put it in the coronary sinus. It gets covered with tissue in about six weeks, it creates a back pressure in the coronary sinus. It's a very simple procedure for an interventional cardiologist to do because the coronary sinus is like a normal coronary vein. We're used to working in very terribly diseased arteries, some of the worst of which are very calcified, that's what lithotripsy is for. As an interventionalist, we can work through almost any blockage these days, but it's a lot of work and very difficult. A normal vessel is nothing. It's very simple. For most procedures, to implant the Reducer in this normal coronary vein is a very straightforward 15-minute procedure. Sometimes the vein is in an unusual position. It's a little hard to access the vein. Sometimes it's got valves in it and some other unusual anatomy. Maybe 10% of the time, there are tips and tricks that are required to implant the Reducer. The bottom line is 99% of the time, the Reducer can get implanted. Most of the time, it's a very straightforward procedure. It narrows, again, over about a six-week period or so. When it increases the back pressure, as the theory goes, it would decrease the amount of ischemia in the deep wall of the heart and relieve some of the angina. It's not as perfect as if they were totally normal coronary arteries, but pretty good. After a lot of patients were done, in particular in Israel, but in other countries in Europe, it had to be tested in a randomized trial. All those preliminary studies were very promising. In addition to patients feeling better, there were also studies suggesting that ischemia, as measured by an objective test, like a thallium test or a PET scan or an MRI, was decreased. They performed this COSIRA study, which was a 100-patient randomized trial, where 50% of the patients got the Reducer and 50% got a sham control. What a sham control means is that you go in, you do the procedure, you take the picture of the vein, you do everything the same, but you just don't put the device in. Of course, the doctor knows whether he put the device in, but the patient doesn't know, the patient's family doesn't know, and everybody outside of the cath lab doesn't know. It's as close as you can come to doing a true double-blind procedure where absolutely nobody knows. That's called a sham control procedure, those are difficult types of studies to do, but they're considered the gold standard for this kind of investigation. They had an endpoint in COSIRA of less major angina measured by the Canadian Cardiovascular Society class. It was a positive study. In the sham control trial, at six months and a one year, there was less angina. The study was of sufficient quality that it got published in The New England Journal of Medicine, which is, I can tell you from personal experience, very difficult to get a manuscript into. Again, they only publish really breakthrough work. This got everybody's attention. Neovasc, which was developing this product, as you heard, was basically developing two products. They were developing not only the Reducer, but they were also developing the Tiara mitral valve, a percutaneous mitral valve. To me, transcatheter mitral valves have tremendous potential but are very complicated. Kind of the opposite of the Reducer, which is really relatively simple, and is addressing, again, hundreds of thousands, if not 1 million or more patients. The company, unfortunately, because of legal issues and whatnot, which has since been resolved, got very distracted from Reducer because they had to focus on legal issues with the Tiara, the mitral valve. What we tried to do is to go to the FDA, at Neovasc's request, and see if the data from the European and Israeli COSIRA-I trial was sufficient for FDA approval in the United States. We developed a very close working relationship, and I've brought well more than 12 new devices through the FDA to the United States. The FDA is very much interested in new devices to meet unmet clinical needs, such as refractory angina. They were very interested because there's no other therapies that work for this patient population. They looked at the data, they were impressed by the data, but it was a relatively small study, there were no U.S. patients involved, they thought that a different study was going to need to be done. Neovasc wanted to see if there was any possible way that based on this first study, if they could speed up the process and get regulatory approval. An advisory panel was held of a dozen experts, patient advocates, ethicists, and physicians that scrutinized all the data. The sham control COSIRA data, individual case reports, registries that were done, mechanism of action, et cetera. After a full day meeting in an open hearing in Washington, the panel concluded that the device was safe. They voted almost, I believe it was unanimous or maybe one person abstaining, that clearly we demonstrated safety, that wasn't surprising. This device had almost no side effects. Every interventional procedure can have some side effects and complications, but this device is as safe as anything that we do in the cath lab, and that's really important. They voted unanimously that it was safe, but they weren't convinced that this one study of 98 randomized patients was sufficient to have demonstrated effectiveness. They felt that another study was necessary. With that in mind, we worked very hard, and we developed the current study, which is the COSIRA-II trial. The COSIRA-II trial, and I've been involved in developing approximately 150 studies to date, many of which have led to randomized approval of new devices and drugs. We wanted to design a study that was going to really address all of the questions and, if positive, lead to near-certain FDA approval, as certain as you can get going in. So the COSIRA-II trial is a prospective, randomized, double-blind, sham-controlled trial, kind of a similar design, where we're taking patients with refractory angina of a certain degree that have obstructive coronary artery disease and no options for either angioplasty or bypass surgery. We're making sure those patients really have no options. We're putting in a lot of controls, including what's called an eligibility committee, that reviews all of the patients with the sites to make sure that they really meet all the enrollment criteria. They have to have ischemia demonstrated in the heart artery. We're very convinced that the pain the patient's feeling is really due to those blockages and due to the lack of blood flow to the heart muscle itself. Then they have to be able to exercise on an exercise test for a certain amount of time, 2-8 minutes, before they can't go anymore because of oppressive angina. It makes them stop. They can't go more than eight minutes. Okay? Then we randomize them in the same sham-controlled trial, which is not that difficult to do. We've done this many times before. You just have to use a particular script, and you can really effectively blind the patients to half the patients getting the Reducer and half the patients getting a sham control. Then we follow them at regular intervals, and we do repeat stress tests and other tests to assess the safety and effectiveness of the device, including, importantly, quality-of-life assessments. We don't just ask them, "Are you having angina or not?" There are special tools, such as the Seattle Angina Questionnaire, which is a series of standardized questionnaires that have been very well-validated and have shown to be correlated with survival and other measures of either health or illness, depending on your perspective, in patients with coronary disease. Then what we do is we have a primary endpoint at six months, and that's the change in their exercise performance from baseline to the six-month test. Our hypothesis is that it's going to be greater in the Reducer arm than in the control arm. We keep following the patients for a total of five years. At one year, the patients who actually got a sham control who are still doing poorly are allowed to be unblinded, hear that they did not get the Reducer, then can get treated with the Reducer. It's called crossover, it's a common thing that we do in these trials, it's a nice incentive for enrollment, it's a good way to be able to treat patients that don't have any options. There's a lot of excitement about this trial, particularly because, again, there's no other therapeutic options for these patients. We've started randomizing it. I think we've got about 30 patients randomized in the trial. We're really just getting going. I'm particularly very excited about Shockwave coming in. Shockwave is now a very mature company with both excellent, one, physician relationships and distribution pathways, but also clinical trial expertise with Keith Dawkins and others on the team that have performed not only the Disrupt CAD trials, which I also was the chairman for, basically for Shockwave in the U.S., Disrupt CAD III and IV trials. They know how to complete successful trials, collaborate effectively with FDA, and I think this is going to substantially accelerate enrollment into COSIRA-II. At the same time, in addition to the randomized COSIRA-II study, we have several sub-studies that are built into COSIRA-II. Two of them are imaging sub-studies. In some of the patients that get the COSIRA, we're doing CAT scans of the arteries or, in this case, the coronary sinus itself to make sure the device doesn't move and the device narrows the way it's supposed to narrow. We're very confident that 100% of those cases are going to look fine. The other, more interesting one is that we're doing what's called a PET sub-study, positron emission tomography, which is the most sensitive way to look at ischemia in the heart. It's difficult to show the benefits that the Reducer provides because it redistributes blood flow, again, from the top of the heart to the bottom of the heart, and that seems to be its main mechanism of action. PET's the only emerging imaging test that has a chance to show that redistribution in blood flow in addition to what we're usually looking for, which is just more total blood flow to the heart muscle. FDA asked us to do a sub-study of the sites that can do PET sub-studies to see if we can demonstrate statistically an improvement in ischemia or redistribution of blood flow, just to try to understand the mechanism a little bit better. They made it clear that it's not a requirement for approval in the study. I think even more exciting is we actually have three interesting single-arm patients that can be enrolled in the study. One is patients with predominant right coronary artery ischemia. To get into the COSIRA-II trial, you put the Reducer in the coronary sinus a few centimeters after the origin of the coronary sinus, and it drains into the right atrium of the heart, one of the four chambers in the heart. That's how we get into it, and you go into it several centimeters, and that's where you implant the Reducer. That actually will create back pressure in the left side of the heart, and that's about 70% of all the blood flow in the heart, maybe 75%. About 25% of the blood flow from the heart comes from the right coronary artery. The vein from the right coronary artery usually implants before or proximal to where you implant the Reducer. You wouldn't think the Reducer would work if that's where most of the ischemia is coming from. Interestingly, there have been a number of cases done where those patients also seem to get symptomatic benefit. Now, whether that's an unblinded placebo effect or whether it's real, we don't really know. Within the trial, we're going to be enrolling 50 patients with predominant right coronary artery ischemia, which does not allow them to be randomized. We can implant the Reducer in those patients. If that group looks like it does very well, that might open up the Reducer to, again, another substantial tens of thousands of patients. Even more exciting to me is, as you heard in the introductory talk, is a group of patients that have ANOCA, which is angina with non-obstructive coronary arteries. We have all these patients, and it's definitely a bigger group of patients than the ones that we're treating with obstructive or end-stage coronary disease that have the right symptoms of angina, the same symptoms, and they have ischemia, so they have the same abnormal types of stress tests, PET scans, SPECT, thallium scans, et cetera, but you can't see any coronary artery disease. It's not obstructive epicardial coronary disease. What we've learned in the last 7-10 years is that the majority of those patients have what's called microvascular disease, which is where they have disease of the small, little, tiny vessels that are so small that we can't see them on standard tests. We have tests to measure the blood flow, where we can measure that the blood flow through those vessels is abnormal. A series of case reports came out where it looked like you would expect that those patients that are having the same mechanism of angina, but they just don't have epicardial coronary disease, they should respond to the Reducer. In particular, two groups, one in Israel led by Shmuel Banai and one at the Mayo Clinic led by Amir Lerman, started to treat some of these patients. Lo and behold, they found that these patients who seemed like they were getting better, and their coronary physiology, which was abnormal at the beginning, was also improving with implanting the Reducer. This is really exciting because there's absolutely nothing to do for these patients. Drugs don't work in these patients. There's no angioplasty or stenting that you can do for these patients. Right now, within the trial, we have another 50 patients to learn about these patients with ANOCA that we're going to be implanting the Reducer in a non-randomized, open-label fashion to see how they do. We're in very deep talks with Neovasc, and now we'll be in the same deep talks with Shockwave about doing a second big randomized trial just in this patient population. Because we do have now two separate series that suggest that the Reducer probably works in this patient population. It's an extraordinary opportunity that I'm very excited about. It would probably take another randomized trial similar to COSIRA-II, but it can create a whole new avenue of treatment for a whole segment of the population that currently has no therapeutic options. FDA is very excited about this as well. Again, we have a very good collaborative relationship with them. I've been working with them, gosh, for probably 8 years now on the design of these trials. I can tell you they are equally as excited as these trials, hopefully being positive, as we are. Finally, I'll say that again, as I've mentioned, we've given a lot of talks on this now. The clinical community, general cardiologists are very excited because these are very frustrating patients to take care of. They're very unhappy patients. There's just nothing you can do for them. They're always calling you, so it's very stressful, and you try to reassure them, but basically, you're limiting their activities. You're limiting what they can do in their life. You're giving them three or four different medications to try to treat this angina, whether it's with obstructive or non-obstructive coronary disease, and these drugs have side effects, and it's very unpleasant. General cardiologists are very excited about the potential for this therapy. Interventional cardiologists who love to help their patients through doing procedures are also very excited because, again, it's a very simple, low-risk procedure, and so it may bring a new tool to our so-called toolbox or armamentarium of ways that we can help people with vascular heart disease. For me, it's been a thrill for the better part of the last decade to work with Neovasc, a very high-quality organization, really good people. I couldn't be more excited now that Shockwave is going to bring even a greater level of expertise, experience, and success to this clinical program. Thank you. Thank you, Gregg. Good morning, everyone. I'll start by further outlining some of the deal terms related to this acquisition. Upon closing of the transaction, we have agreed to pay Neovasc shareholders an upfront cash payment of $27.25 per share. Neovasc shareholders will also receive a potential deferred payment in the form of a non-tradable contingent value right CVR, entitling each shareholder to receive up to an additional $12 per share in cash if certain regulatory milestones are achieved. These payments amount to a total consideration of approximately $100 million up front and an additional potential payment of approximately $47 million if the contingent value right is achieved at the highest level. Both payments will be made in cash. It is too early to comment on top-line contribution from the Reducer. However, we do expect our operating expenses to increase by about $30 million in 2023 to support the clinical and regulatory efforts related to the Reducer. While we typically do not pre-release our numbers, we thought it was important in this instance to share our early results and guidance so we can speak to you all more candidly today. We had a strong fourth quarter of 2022, and we expect our revenue for the quarter will be in the range of about $143 million-$144 million, which is approximately a 70%-71% increase compared to the fourth quarter of 2021. This brings our expected full-year revenue in between $489 million and $490 million, or about 106%-107% increase compared to the full-year revenue in 2021. In terms of U.S. coronary, as you have heard from many others, there was some pressure on PCI volumes in the first half of the fourth quarter. We were happy to see this begin to recover during December. Despite this pressure, sales from our C2 product in the U.S. still grew nicely, and we expect U.S. coronary revenue will be in the range of $81 million-$82 million for the fourth quarter of 2022 and $288 million-$289 million for the full year 2022. We're clearly strengthening the long-term visions for Shockwave and our business momentum, and we're very confident in our continued growth, both in the short and long term. As a result, we expect our full-year 2023 revenue to fall in the range of $660 million-$680 million, representing growth of 35%-39% from 2022. With that, I'll turn the call back to Doug for some closing remarks. Thanks, Dan, thanks, everyone, for joining us today. We're obviously very excited about the proposed acquisition of Neovasc for our internal team, for our customers, for our shareholders, and most importantly, for patients. The Neovasc acquisition is a long-term strategic opportunity to expand Shockwave's footprint with a technology that will be timed optimally for our pipeline and sales organization. Thanks again for joining the call today. With that, we can open the line if there are any questions. Thank you. If you'd like to ask a question today, please press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions. Thank you. Thank you. Our first question comes from the line of Adam Maeder with Piper Sandler. Please proceed with your questions. Hi. Good morning, guys. Thank you for taking the questions. Congrats on the deal and the print. Maybe the first question is, why is now the right time to tack on this asset? It sounds like you've been exploring or looking at other external technologies. You obviously announced Neovasc today. Do we expect others to follow? Any read-through to your other kind of internal pipeline initiatives, such as aortic, mitral, carotid, either from a timeline or enthusiasm standpoint? I had a follow-up or two. Thanks. Thanks, Adam. I'll try to remember all the questions you just asked. So there's no read-through on lack of enthusiasm or lack of conviction and commitment to our internal pipeline. Fortunately, we have the financial wherewithal to sort of walk and chew gum. We can invest aggressively to advance our myriad sort of 20- plus internal programs, and we can afford to add another leg to the stool, so to speak, by acquiring Neovasc. We've talked about publicly a little bit about potential acquisitions as people have asked, and we've always said we're in a fortunate position where we kind of don't need anything and don't want anything to add to the bag right now. We're not sort of growth starved in the near term, nor do we expect to be growth starved in the longer term. We would have the capacity from a U.S. sales marketing organization to incorporate an entirely new procedure and technology a couple of years from now, 2, 3 years from now. Whereas right now it would be a distraction and dilute our selling efforts on IVL. Who knows whether we'll have exactly the same structure for our sales organization by the time the Reducer shows up. That'll be something we'll determine as we get closer. In terms of timing for Neovasc, their team has done a yeoman job of getting this trial up and running. As you listen to Dr. Stone describe what's required, it's not trivial. It's a very sophisticated trial, requires a lot of pre-work of the patient, a lot of training of the sites, and support. While the procedure is relatively straightforward, the trial has a complexity that is somewhat uncommon in medical devices. Given the challenge of financing a trial like that and the financial position that Neovasc was in, there was always a level of tension for sort of, can you staff up enough to really drive execution and accelerate the timing of the trial? Fortunately, they did a very high-quality job and continue to do a high-quality job. There was just always a tension between what the trial needed to really get up and running faster and the financial wherewithal to do so. Our determination was, if we waited longer, it would just take longer to bring an important technology to patients and bring it to market. Our hope and belief is, combining forces, our sort of high-caliber execution on the Neovasc clinical side and support from our team as well as incremental resources that we can flow into the trial, greatly increases the sort of likelihood that the trial will execute timely and hopefully will accelerate so that we can incorporate it into our portfolio and start providing to U.S. patients sooner than could've been accomplished if Neovasc continued to run it on their own. That's really helpful, Doug. I appreciate all that. For the follow-up, maybe for you or Dan, I just want to make sure I understand the messaging around incremental OpEx. I heard a $30 million figure tossed out. Can you put some context around that? Is that specifically for the Neovasc COSIRA-II trial? Any change to kind of how you think about driving leverage going forward over the near to medium term? Thanks. Yeah, we can tag team this. It's likely going to be circa $30 million for the next few years in terms of incremental OpEx, both their product development activities, clinical trial activities. Those would be the principal spend. There is a small commercial organization in Europe right now that Neovasc has, and we have not had the pleasure of meeting those folks yet, so we'll have to sort out how we'll integrate the commercial activities into the Shockwave commercial activities over the time. That's sort of a ballpark estimate for what we think our incremental OpEx will be relative to our baseline and our own growing OpEx. In terms of leverage, we're certainly not going to cut back on any Shockwave IVL activities. It's not as if we're going to try to hit a specific percent of R&D relative to revenue that may have been where we would've landed without Neovasc. This is incremental spend. We will de-lever a little bit on R&D in the near term and hopefully leverage very substantially once the Reducer starts to pick up steam commercially. Yeah. Okay, great. Doug covered it. Sorry, go ahead, Dan. Doug covered it, Adam. Oh. Doug covered it. Our basic strategy that we've talked about before this acquisition has not changed, and this is just incremental spend. Okay, perfect. Sorry, guys, if I can sneak in just one more, not sure you're going to comment on the guidance or not, healthy 2023 revenue guidance of $660-$680 above the street. Maybe just talk a little bit about the construction of the guidance for 2023, kind of what's assumed between coronary, peripheral, U.S., OUS, contribution from Asia, et cetera. Any more color on the outlook for 2023 would be great. Thanks again. Sure. We're keeping an eye on China. Other people have talked about China more. We expect we'll see a bit of a slowdown since the hospital is a little bit full right now. Everybody got sick at about the same time in China. I think we'll feel a little bit in the, I don't know, late first quarter, early second quarter, but that's all incorporated into our guide. We're seeing, as we saw last year, a really encouraging acceleration on peripherals. We actually anticipate peripheral will outgrow, on a percent basis and potentially on a dollar basis, outgrow the U.S. coronary. The new product introductions and a real sort of booster shot from improved reimbursement that we got last year, we believe will continue to pay dividends this year in spades. Then, in the sort of 2024, 2025 timeframe, we're anticipating a similar booster on coronary reimbursement. We'll sort of hand the time back to coronary, potentially in the 2024, 2025 timeframe. That's a thumbnail for how we're thinking about it, and obviously, we'll provide more color when we get to our earnings call. Thank you. Our next question is from the line of Travis Steed with Bank of America. Please proceed with your questions. Hey, Doug. Just, I guess more of a follow-up on the 2023 guide question. I guess maybe just kind of walk through your confidence. You're guiding above the street. The last couple of quarters have been smaller beats. What are you seeing now to give the confidence to come out and guide above the street? The second part of that question would kind of more be in terms of what the inorganic contribution is in the 2023 guide? I think consensus had like $10 million for Neovasc, where there's only one estimate out there. Curious what you're assuming on the revenue side from inorganic contribution. That is not in our guide. Neovasc is not in our guide. We're optimistic, obviously, that we'll be closing the transaction in the next couple of months, but we're not in a position where we can incorporate that. The OpEx, I think is worth penciling in post-close. Revenue, I think we'll probably be able to give a little bit more color after we finish some of the integration planning. I would not pencil in more than 10. Again, we're not close enough on the revenue front to be able to give greater certainty on that. The confidence we have is, one would expect, obviously, our ability to guide one quarter, the fourth quarter of last year, would be more precise than the ability to guide with precision a full year, which is why we're a little bit closer to consensus as we guided Q4. Still above consensus where we landed. While we saw the sort of somewhat curious softness in PCI in the sort of October into November timeframe, we don't anticipate that that's going to persist. We are on plan for expanding our U.S. sales team, which was our sort of core mission to drive increased volumes in the U.S., both in peripheral and coronary, and that's very much on track, and we believe that that plan, when executed, will deliver the growth that we've described in the guide. While Japan will be a somewhat smaller contributor than China this year, we're beginning to launch in Japan presently. We expect a post-COVID wobble in China, that the combination of China and Japan will be really strong contributors. U.S. peripheral, U.S. coronary, international, sort of all three cylinders should be firing very nicely, and TBD on whether there's upside to $10 million on Neovasc. All right. That's good color. On the U.S. coronary piece, you've kind of gone from a transition from opening new accounts to increasing account penetration. Curious how you think the coronary growth in the U.S. transitions, as you move from that increasing penetration. If you think you can get about the same level of market penetration in 2023 as you did in 2022, or does that start to slow down? The follow-up to that would be on the TPT. There's been a lot of questions on reimbursement and when that gets finalized. Curious if there's a way you can kind of accelerate that, and we could see some color on that later this year. Yeah, we should start having more visibility on TPT transition to APC level. As a reminder for those who don't follow as closely, currently, coronary stents get paid at $10,000. Atherectomy gets paid at about $17,000. With a transitional pass-through, we land at circa $ fourteen and a half thousand when you add in the transitional pass-through on top of the stent code. We get more and more confident every day. All of our data indicates that we will land in the highest paying APC with that $17,000 band. It's a question of when, not if, in our mind, by middle of this year, we should have a sense is that going to be concurrent with TPT sunset in the middle of next year? Will it be before that? Will it be slightly after that? We'll be working with CMS to also find a logical way to ensure that the Medicare beneficiaries continue to have great access to IVLs, since clearly they've been benefiting to date, thanks to the TPT. We don't know exactly the timing yet, but we certainly have high confidence in where it's going to land. In terms of the U.S.- In terms of coronary, given the remarkable growth that we saw in coronary, as I indicated just a second ago, we don't expect the same growth rate. We do expect, given the trajectory that we see in our peripheral business, we expect peripheral to grow faster this year, because it has that sort of accelerator of reimbursement that we will enjoy in coronary in the not too distant future. Coronary will grow slightly below. If you take sort of our total growth, coronary will grow slower than the corporate growth, but still sort of an enviable growth rate by industry standards. It's not going to be slow or non-growth. It's going to be very handsome growth. It's just that peripheral's going to grow even faster. Okay, great. Thanks, Doug. Our next question's coming from the line of Bill Plovanic with Canaccord Genuity. Please proceed with your questions. Hey there. Thanks. Good morning. Thanks for taking my questions. Two on the deal, real quick is, One, the purchase price is in U.S. dollars, not Canadian dollars, just to confirm that. Correct. The timing, do you think that'll be before the mid-year or just based on normal timelines? Can I confirm that? It's US dollars, but Canadian process because it's headquartered in Canada. Our understanding is that that could be as soon as 45 days from now, that this would be closed. They're nice and organized and efficient. That's kind of our baseline assumption is by early March, this should be closed. Perfect. Okay. Thanks. Just clarification on the commentary on U.S. coronary in the fourth quarter, that it started out a little slower in the beginning of the quarter and gained momentum. Any more granularity you could give us on that would be greatly appreciated. Thanks. Yeah. I will say that when we provided guidance last quarter, it was a little uncomfortable because the procedure sort of hit an air pocket right after September. We believed they would start to come back, and they did start to come back. It's not on the verge of becoming a fast-growing clinical procedure segment, but it hasn't been a fast-growing procedure segment for some time. We believe that it will be fairly stable and likely a small percent, single-digit percent growth year-over-year. Particularly because some of the baseline comps on procedures are low from last year. We don't believe there's a sort of deteriorating PCI volume. We think it's going to be stable to slightly up. Okay. That's all I had. Thanks. Yep. Thanks, Bill. The next question's from the line of Larry Biegelsen with Wells Fargo. Please proceed with your question. Good morning. Thanks for taking the question. Is Dr. Stone still on? Yeah, I'm here. Hi, Larry. Hey, Gregg. It's Larry. Thanks for doing this call. A question for you on COSIRA-II. clinicaltrials.gov has the primary endpoint completing June 2024. I know the study just started. What's your best guess? How accurate is that? Hopefully, I'm not off base on this, looking at the COSIRA in The New England Journal of Medicine publication, there was no between-group differences in exercise time. COSIRA-II, the primary endpoint is exercise duration. What makes you confident we'll see a benefit in exercise time in COSIRA-II? COSIRA wasn't really powered for exercise time. That was one of the problems with it. They chose an endpoint of angina class, which is relatively subjective. That said, you could see the trends there. We know again anecdotally and from case reports and from the uncontrolled REDUCER-I experience that exercise time increases. We know that control patients don't really increase exercise time. They're maxed out on the drugs. We're reasonably confident that it's a good endpoint for this trial. Your first question was about the timeline. That was the original timeline that was put in years ago. It's taken, again, from a research point of view, longer to get going than we had hoped. One of the things I'm excited about here is that Shockwave's going to, again, bring a lot of resources and a lot of clinical trial expertise that's going to speed it up. It could take another possibly even 18-24 months to enroll and then a six-month endpoint, so that could get pushed back somewhat, but we're going to try to make up as much time as possible. Maybe Gregg, sorry to interrupt. Can I just interrupt real quick? Maybe to Larry's first point on exercise tolerance, maybe describe how you modified the tests from bike to treadmill and why that matters. Yeah. No, that's a great point. Thank you. In COSIRA, they also did a bicycle exercise test. The bicycle exercise test is much more difficult to show a difference in, compared to an upright treadmill test. In addition, we chose a very specific interval of 2-8 minutes for the upright modified Bruce protocol that we're doing in COSIRA-002. The reason we did 2-8 minutes is because, which is a fair limitation due to angina, to not be able to exercise nine minutes or more. At 9 minutes, you go into a new stage where the speed increases and the elevation increases slightly. We're giving kind of a one-minute buffer. We've kind of been very, I think, creative and selective the way we chose that. What we think will happen is that the control arm will stay within the stage that they're in, where we expect that the COSIRA arm will be able to get to the next stage. Whereas if, let's say, a control arm patient starts at eight minutes and 30 seconds, as soon as that thing starts changing in nine minutes, they're going to stop. Okay. We expect the COSIRA patients to be able to exercise through the next change. Anyway, that's the thinking, and we'll see how it goes. Gregg, I've just got to ask one follow-up. Any concerns that there'll be a placebo effect in the control arm, i.e., I know there's a sham, but the sham will actually have some impact on exercise? There might be a little bit of a placebo effect, and when we built that in, but I don't think it'll be much in this patient population. Okay. Just quickly, Dan, if we look at your comments on the $30 million for next year, for 2023, in OpEx incremental from this deal. Can we still get to about a 25% operating margin for overall Shockwave, assuming, call it, I don't know, close to $410 in OpEx and an 86% op margin? It still looks like mid-20s is achievable. Is that fair? Yeah, we're not really providing guidance at this point, Larry, but $30 million off a $670 million mid-range is about 4.5% off the operating margin. Ballpark, you're not bad. Okay. Thank you, guys. Our next question is from the line of Cecilia Furlong with Morgan Stanley. Please proceed with your questions. Great. Good morning, and thank you for taking the questions. I wanted to ask, just on recent enrollment in COSIRA-II, what you've seen as a result of the pandemic staffing, how you think about that in 2023, and being able to accelerate that with Shockwave now leading the charge. Also, just wanted to follow up too on what you've seen internationally recently, just as a result of COVID too, and the ability to continue to drive Reducer procedures. Yeah. Go ahead, Gregg. Thank you. I was just going to say, and definitely Shockwave should give their impression as well, there's no doubt that the COVID pandemic and the fact that it's had on permanent hospital employees, and also distraction from research, for other activities, obviously other activities, has had an impact. The travel nurse situation, way beyond the purpose of this call, has been a big issue. Hospitals are struggling with budgets. Research personnel have been laid off. It's been very selective. Some centers are affected, others are not, and it does seem like it's getting better in general. Not a huge difference overnight, steadily getting better. We're working through it, is all I can tell you at this point. We're trying to work with those hospitals that do have the right infrastructure. We'll be bringing on new hospitals. There's a lot of hospitals that want to participate in this study, so we'll keep bringing on new centers that can participate, and working with the other centers to help them, whether we provide part-time FTEs or other solutions. There are creative ways to work around this. Yep. I can't add much more to that. I think we'll spend a lot of time now that we're moving forward, understanding what the pinch points are on enrollment, so we can find ways to accelerate. One of the biggest ones is just get more sites open because more shots on goal equals more enrollment. It's pretty simple, and they're still not even halfway towards sort of number of sites activated as the trial has capacity for. Not through absence of effort on the Neovasc side. Again, it's sort of a resource constraint plus some of the logistics of getting through the negotiations with hospitals. In terms of procedure volumes internationally, they had a very good quarter last quarter. I'll let them speak to their revenue on their side, but it was the best quarter from a revenue perspective that it had. They have done early work on reimbursement in multiple countries, France, U.K., Germany. We think there may be some opportunities to take advantage of that, particularly in the U.K. We'll have a better sense of how much upside there is relative to their run rate. We really think the big driver to increased adoption, aside from reimbursement, the big driver globally is going to be the results of COSIRA-II. Right now, you have a very nice trial in COSIRA, but just like the FDA didn't feel it was powered adequately for efficacy, it's not such a large study that it compels physicians globally to adopt the device as aggressively as we think they will after COSIRA-II data is published, and then that data will serve for U.S. approval. Again, assuming it's successful. With that caveat, I can't say with certainty that the trial will be successful, but I'm encouraged that Dr. Stone is optimistic about the likelihood of success. Thank you for the color, and if I could follow up too, and recognizing you're not including contributions in your 2023 outlook, but can you just speak to how you're thinking about your commercialization efforts in Europe with Reducer, leveraging that model ultimately to help inform your U.S. model? Just to follow up too, how are you thinking about Tiara and any plans to look to invest in that, or what is the long-term outlook there? Thank you for taking the questions. Yeah, we have no plans to reinvigorate Tiara. We are going to follow the protocol and follow the remaining handful of patients who are still in that trial. Beyond that obligatory follow-up, we don't have any expectation to move into mitral valve replacement. Regarding commercial approach internationally, we're just now able to start thinking about integration planning, inclusive of sales structure. They have a sales team in, say, Germany, as they do. Do we. We just got reimbursement in Germany. We are scaling up our German team to take advantage of the improved coronary reimbursement. I don't want to also give them COSIRA to go sell. In all likelihood, we'll have a split team selling COSIRA and Shockwave in Germany, for example. TBD in countries generally. We're not going to be overly focused on trying to maximize revenue internationally. At the same time, if there's revenue upside in certain geographies, we also don't want to walk away from it. Great. Thank you for taking the questions. Thanks, Cecilia. Thank you. Our final question is from the line of Mike Polark with Wolfe Research. Please proceed with your questions. Hey, good morning. I just want to confirm on this $30 million of incremental spend in 2023 that funds the development. Is that a stub 2023 number, or are you viewing that as the 12-month run rate? Just the deal's not going to contribute for a full calendar 2023. I may be squinting here, but I want to understand if that's a sub 2023 contribution or the full 12-month number. Dan? This is Dan. It's up to $30 million for the full year, but we definitely have a stub period where we're going to be spending in. Okay. Yeah. It's more like a 30 annualized. We will have some incremental expenses. With deal-related costs and everything, it'll be an expensive year. Okay. Yeah. Then the second topic was just putting together some of the numeric estimates here for Reducer TAM and new patients a year in the U.S. and Europe. I heard $2 billion TAM for the initial indication, and the press release says 300,000 incremental new patients each year in the U.S. and Europe. If I put that together, the ASP for the device implied $6,000-$7,000 per patient. Am I putting together the math correctly? Specifically, the question is, what is the ASP to Neovasc or now Shockwave for Reducer moving forward? Yeah, good quick math. That's about what they're selling the device for in Europe right now, in that circa $6 range. Would you expect the U.S. to land in that zone or potentially be higher? Too early to say, we thought for TAM, if we can piggyback on the international number, that would be conservative. A lot of work to yet to do on reimbursement to say with certainty if we're going to be at or above that number. Yep. Understood. All right. Thank you. Thank you. At this time, we've reached the end of our question and answer session, and I'll hand the call to Doug Godshall for closing remarks. Thanks, everybody, particularly thanks, Dr. Stone, for the educational opportunity. I learned a lot again, as I have each time we've talked about Reducer. Appreciate everybody's interest, and we look forward to following up further both regarding Shockwave and Reducer. Thanks to the Neovasc team for the good work, and I look forward to meeting you all soon. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.