Good evening and welcome to the Neovasc first quarter 2022 earnings call. At this time all participants are on a listen only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder this conference is being recorded. I would now like to turn the call over to Mike Cavanaugh of Investor Relations. Thank you. You may begin. Good afternoon, and thank you for joining us today. Earlier today, Neovasc Incorporated released financial results for the quarter ended March 31, 2022. The release is currently available on the investors section of the company's website at www.neovasc.com/investors. Fred Colen, President and Chief Executive Officer, and Chris Clark, Chief Financial Officer, will host this afternoon's call. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of applicable securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing, and enrollment matters, and our future financial expectations and results, are based upon current estimates and various assumptions. Words such as expect, anticipate, estimate, outlook, will, may, should, continue, strategy, potential, intend, try, believe, plan, and similar words or expressions are meant to identify forward-looking statements. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For more information on risks and uncertainties related to these forward-looking statements, please refer to the Cautionary Statement Regarding Forward-Looking Statements and Risk Factors sections of Neovasc's annual report on Form 20-F and the discussion in Neovasc's MD&A, which are available on EDGAR and SEDAR. The information provided in this conference call speaks only to the live broadcast today, May 12, 2022. Neovasc disclaims any intention or obligation, except as required by law, to update or revise any information or forward-looking statements, whether because of new information, future events, or otherwise. I will now turn the call over to Fred. Thank you, Mike, and good afternoon, everyone. As always, thank you for joining us today. I'll start today's call with an overview of the quarter and a business update before turning the call over to Chris to discuss our first quarter financials. The first quarter of 2022 was a record-breaking first quarter with revenues up 35% year-over-year, coming in at approximately $611,000, which Chris will touch base on a little bit later. As many of you know, the fourth quarter tends to be our largest quarter in terms of sales, and to see such a strong result in the first quarter is encouraging and is a testament to the continued focus of the entire Neovasc team. Our team continues to build on all three legs of our value creation strategies, making great strides across the board. Now a few highlights for Neovasc's first quarter. The reimbursement efforts in Europe and elsewhere, including the United States, have been tremendous, and we have seen strong momentum beginning in November of last year. As we announced in January, we have begun enrolling our first patients in the pivotal COSIRA-II clinical trial, which is intended to prepare the Reducer for a full PMA submission to the FDA. One of the pillars of our value creation strategy is expanding the use of Reducer outside of the United States. In our fourth quarter and year-end earnings call, we discussed various milestones for reimbursement abroad. In November of 2021, we announced that the National Institute for Health and Care Excellence of the United Kingdom provided positive guidance for the Neovasc Reducer system. This supports the first therapeutic intervention for stable angina patients who have not responded to treatment. As a result of the positive guidance, we are seeing an increase in utilization in the United Kingdom. We expect further growth in the coming quarters, driven by increased utilization and expanding margins. Shortly thereafter, the Neovasc Reducer system was granted prise en charge transitoire or PECT reimbursement in France by the French National Authority for Health, or HAS. The Reducer is the first therapy to be approved under this newly established PECT process. In February, we announced the German Institute for the Hospital Remuneration System awarded the Reducer NUB 1 status 1 designation again for 2022. The Reducer was previously been granted status 1, which is the highest priority designation available. For 2022, 256 German hospitals applied for the Reducer NUB, and they can now negotiate full reimbursement coverage for the Reducer therapy in Germany. Securing reimbursement in three of the largest markets in Europe has been very fruitful. Our team has done great work, but we also think this is a testament to benefits the Reducer can provide to healthcare systems across the globe, especially improved outcomes for patients and resulting cost savings to payers. We continue to see a steady increase in the use of Reducer in those areas of Europe, and we are grateful to see the growing acceptance and use of the Reducer for the treatment of refractory angina. Shifting to the second pillar of our value creation strategy, the U.S. market. In January 2022, we announced the first patient enrollment in our COSIRA-II clinical trial. As a reminder, the COSIRA-II clinical trial target enrollment is approximately 380 patients across as many as 50 investigational clinical sites, and the trial is pivotal for our efforts to gain approval for the Reducer in the U.S. For the first time, patients that experience the debilitating effects of refractory angina will have access to an FDA-designated breakthrough medical device in our placebo-controlled trial, marking this as a major step towards commercialization in the United States. Today, we are on track with 21 patients enrolled in the clinical trial. We are expecting the first readout from the COSIRA-II trial in the third quarter of 2024, which would potentially put us on track for an FDA decision around mid-2025. Please keep in mind that enrollment is not linear over time, but should increase over time as more clinical sites are being activated. As for the third leg of our value creation strategy, we are continuing to pursue the CE mark designation for our Tiara TA mitral valve replacement device. As noted in our fourth quarter and year-end update, we continue to work on the critical bench tests and new tests required by the new European Medical Device Regulation or MDR requirements. We anticipate a decision under the new MDR rules in late 2023. The European Union's MDR process requires a higher standard for approval than the previous Medical Device Directive, MDD, process of the past. As a result, we are seeing delays as we work to clarify and potentially meet those requirements. There can be no certainty that we will be able to meet these requirements in a timely manner or at all, but our team continues to work towards that goal. I would also like to discuss various third-party publications supporting the Reducer device in the first quarter of 2022. On January 18th, we announced the publication of a case series in the peer-reviewed journal Cardiovascular Revascularization Medicine, which describes the successful uses of the Neovasc Reducer under a compassionate use protocol in the United States. Also in January, we were thrilled to announce the publication of an article entitled The Effectiveness of Reducer for the Treatment of Refractory Angina, A Meta-analysis in the Canadian Journal of Cardiology. The authors of this publication concluded this meta-analysis of clinical studies describing the outcomes of patients with refractory angina implanted with the Reducer for CS narrowing demonstrates its safety and efficacy. The vast majority of patients experience improvement in angina severity, quality of life, and functional performance. In February, we announced a third publication authored by Americo Cicchetti, Graduate School of Health Economics and Management at the Catholic University of Sacro Cuore, Rome, Italy. The analysis included a budget impact analysis and a cost utility analysis, which were both positive for the Reducer therapy. The various publications in the first quarter of fiscal year 2022 signal the continued spread of adoption and awareness we are driving in various target markets. I am incredibly proud of the team for all of the hard work and positive milestones we have hit in the first quarter, as demonstrated by the various publications and strides in reimbursement. Finally, following the activation of six clinical sites, the enrollment of 21 patients into the trial, medication stabilization, and the required pre-procedural testing, we have now randomized our first four patients into the COSIRA-II trial. Notably, due to the strong efforts of our team in coordination with CMS, FDA, and our clinical trial sites, the device is reimbursable in the COSIRA-II study without endangering the blinding of the study. Thus, we generated our first-ever U.S. revenue with Reducer in the first quarter, another important milestone. We now have CMS coding, coverage, and payment for the Reducer device in the United States, including during the COSIRA-II clinical trial. We also had a number of key events during the quarter from a corporate perspective. In early April 2022, we were pleased to announce the results of the votes on matters considered at its annual general and special meeting of shareholders held on April 12th, 2022 in Vancouver, British Columbia, Canada. The shareholders of the company reelected the board of directors, appointed Grant Thornton U.S. as our new auditors, and approved the proposed one for 25 share consolidation with over 95% of the votes in favor. That became effective on April 29th, 2022. As many of you recall, we received a written notification from The Nasdaq Stock Market LLC in late November 2021, granting an additional 180 calendar day period until May 23rd, 2022, within which to evidence compliance with the minimum $1 bid price requirement. The impact of the share consolidation was to reduce the number of common shares issued and outstanding from approximately 68 million common shares to approximately 2.7 million common shares, and increase the share price from $0.29 per share to $7.25 per share. As a result, it is anticipated that the company's share price will remain above $1 per share for 10 consecutive trading days, ending on May 12, 2022, meeting the requirements to regain compliance with the Nasdaq $1 minimum bid price rule. Additionally, in late March, we announced the consolidation and extension of the convertible debt with the Strul Medical Group. The 2022 restated note was issued in an aggregate principal amount of $13 million and consolidates the amount owed by the company under certain convertible notes the company issued to Strul Medical Group in 2019 and 2020. The company paid out in cash an additional amount of $290,961 that was owed under the 2019 and 2020 notes. This restructuring further solidifies the company's balance sheet and provides the company with a cash runway into mid-2024. Before I turn over the call to Chris to discuss the financials, I would like to thank our investors, employees, and customers for the continued support of Neovasc. It is gratifying to see momentum across our various value creation strategies, reimbursement initiatives, and adoption of the Reducer in many prominent markets. With that, I will now turn the call over to Chris for a review of our financial results. Chris? Thanks, Fred. I will keep my comments on this quarter brief. Revenues increased by 35%, $611,000 for the three months ending March 31, 2022, compared to revenues of $452,000 for the same period in 2021. As Fred has already mentioned, this is a record first quarter revenue for Reducer. The cost of goods sold for the three months ending March 31, 2022 was $136,000 compared to $72,000 for the same period in 2021. The overall gross margin for the three months ending March 31, 2022, was 78% compared to 84% gross margin for the same period in 2021, as our mix of sales was skewed towards sales through distributors due to a COVID-19 wave in Germany, where we sell direct, that restricted Reducer procedures in that country. Total expenses for the three months ending March 31, 2022, were $7.1 million compared to $10.6 million for 2021, representing a decrease of $3.5 million or 33%. Substantially explained by, one, a $1.6 million decrease in legal and underwriting fees related to the February 2021 financing. Two, a $1.3 million decrease in non-cash share-based payments due to an adjustment in the expected life of the share appreciation plan and due to voluntary forfeit of certain incentive options by certain employees. Three, a $1 million decrease in employee expenses and other product development and clinical trial expenses as we indefinitely paused all activities related to the TMVR, a transformable mitral valve replacement program, in June 2021. The other losses for the three months ending March 31st, 2022 were $3.5 million compared to other income of $8 million for the same period in 2021, a change of $11.5 million. The change in the other loss can be substantially explained by an $11.3 million change related to the accounting treatment of the 2019 notes, 2020 notes, 2022 notes, and the derivative liability warrants. The operating losses and comprehensive losses for the three months ending March 31st, 2022, were $6.6 million and $10.4 million, respectively, or $3.75 basic and diluted loss per share, as compared with $10.1 million operating losses and $2.9 million comprehensive losses, or $1.11 basic and diluted loss per share for the same period in 2021. The company ended the quarter with $44.2 million in cash. The company spent $5.7 million to fund operations during the quarter, absorbed $1.4 million onto the balance sheet, paid approximately $290,000 to Strul Medical Group for accrued interest on old notes in excess of the new $13 million note. Back to you, Fred. Thank you, Chris, and thank you all for joining us today. We have made great strides in the first quarter of 2022, driving awareness, adoption, and demand for our life-changing device. Importantly, you, the shareholders, voted for the share consolidation, which is expected to cure our breach with the Nasdaq. We strongly believe that remaining listed on the Nasdaq was in the best interest of the shareholders. We continue to advance across all pillars of the business, and we are confident that we are marching towards long-term success. I look forward to the days to come, and I'm grateful for your participation in today's call. With that, I would now like to open the call for questions. Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. The 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 using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your question. Our questions come from the line of Vernon Bernardino with H.C. Wainwright. Please proceed with your questions. Good afternoon, everybody, and Fred and Chris, congrats on the progress. The 21 patients, very intriguing. I think that was quite an accomplishment, especially in this environment. Even though things are getting looser, you know, people are still careful, and, you know, sometimes it takes a little bit of dipping your toe in first before you can have an idea of how quickly you can get back to normal, this including electric procedures. What are you seeing out there? Perhaps you can share as to what has driven enrollment and if there are any things that you're seeing that may actually add and therefore accelerate. Yes. Hi, Vernon, this is Fred. Thanks for joining us today and for your question. Yes, I mean, I would say that similarly to Europe, where we see enthusiasm in the market, we see, you know, physicians seeing the benefit of the Reducer in their own patient population, and that continues to drive demand. You know, similarly, in the U.S., we see quite a bit of enthusiasm from, I would say, the most prominent clinics. First of all, we had a couple of clinics in the U.S. that had actually implanted the Reducer under a prior possibility of a consent by the patient and the FDA. Those two clinics actually saw really remarkable success with the few patients that they treated before the COSIRA trial, and therefore they were very enthusiastic in getting going right away in the COSIRA trial. That's just for those two. We also see this from a number of other clinics in the U.S. I would really say we work with the most prominent clinics in the U.S., in New York, in Florida, you know, all over the country. These leading clinics are really enthusiastic about finally having an option for a patient population that so far they really couldn't treat. It really has to do with enthusiasm by these physicians and these clinics. That's one. The other part of it is that, obviously, the fact that we are getting reimbursement by CMS for the trial also helps. You know, the clinics are getting paid by us for their, for their work, their expenses. For the implant, you know, they're able to get reimbursement by CMS, and we are able to obtain a payment by CMS for the device. All these things help to really create an enthusiasm in the market for the device. I would say it is a testament to primarily to the physicians and the clinics that we work with that are really excited about being able to participate in this trial. It is, I have to say, quite a complex trial, and I just wanna explain. I mean, there are a huge amount of steps that we and our clinical team has to go through to get a clinical site up and going. There's a lot of different steps that they have to go to just get a clinical trial site approved. Outside of that, when you start looking at the patients, there are a lot of requirements for this, I would say, highly scientific clinical study and the safeguarding of the treated populations versus the control population. For example, there are strict requirements for these patients being on a stable medication regimen, and that has to be in place for a while so that these patients really are stable on their medications, and that no medication change can be impacting the results one way or the other, depending on if the patient gets to be in a control or in the Reducer arm. That's one. There's also a requirement for example, the patient cannot have another procedure relatively shortly before being enrolled in the COSIRA trial. Even if a patient does get, like, for example, a stenting procedure, pretty quickly before enrolling in our study, that's another issue that is not possible. Then we have to do these treadmill tests, before the patient, you know, can be subject to randomization. There are strict requirements for the treadmill test. If a patient, I mean, some patients have difficulty doing a treadmill test at all, and some may be too good. They may be actually doing the treadmill test and are just way too good, and they fall outside of the time stipulated. That basically points to the fact that the patient is not sick enough because we are supposed to treat Class 3 and Class 4 angina patients. There really are a lot of hurdles that you have to go through. This really takes a clinical site and a group of clinical researchers in these clinics that are really dedicated to work with us. I'm really happy to say that that is what we see. That is the case because these physicians and their clinical staff are really interested in a therapy that they could not offer to a patient before. That's really the driving factor. That plus all the international success that has been publicized in so many journals, where physicians and patients talk about the successes that they have had. I mean, physicians have, you know, high expectations in the U.S. also with the success of this device. I think that kinda like describes the environment we see, Vernon. That's terrific. It's great that you have these sites which already have had e-experience implanting the Reducer. How much education do you still have to go through, for example, when you visit sites who have not? What kind of conversations, if you could share any, regarding what looks to be a promising environment as far as reimbursement from CMS? Thank you. Yeah. The training, there's a lot of training. There's a lot of training going on by us to each individual site to basically educate them on all the requirements on what all needs to be done to get to the right kind of patient to be enrolled. Then obviously, there's also training that we provide with our own staff as it relates to how the device has to be implanted. The clinical sites that had patients before in the compassionate use environment already had a certain amount of training. That certainly helped. You know, we are doing still a lot of training in general for all the requirements from the clinical trial and then also for the first several implants of the Reducer because that is something we have to safeguard as well, that these physicians are properly trained as to how to implant the device. It is not really a complicated implant, but there are some tricks that you need to learn that are important so that you really have the best possible outcome for the patient. There is a training component there as well that is important. As it relates to CMS, we did spend quite a bit of time with CMS over the last, I would say, year and a half, that has accumulated really in a very good outcome for us. The last piece of it was basically a separate reimbursement code for patients in the COSIRA-II clinical trial. Basically the way this works is how do we get paid for our device without endangering the blind? It's basically done by CMS on our suggestion, by the way, taking the approach of, well, let's take one patient who goes through the entire procedure but doesn't get the device. Let's look at the next patient who would go through entire procedure and all the costs for that, but then including the device. You take those two together and divide it by two, so you get an average cost for the statistical average patient. That is the reimbursement amount that CMS has stated now for patients in the COSIRA-II trial. All that the clinic does is basically state that this is a patient that participated in the COSIRA-II clinical study, and then there is this particular reimbursement code and particular reimbursement amount that is being provided, which is basically an average of the two different scenarios. That is how we are still being able to get paid for the device without endangering the blind. We really have been able to work this out nicely with CMS. I can tell you that, I mean, Neovasc has really done quite a bit of groundbreaking work in the space of reimbursement. You look at the U.K., for the very first time, you know, we get a positive statement from NICE. Before the statement recommending the use of the Reducer by NICE, before that, NICE was basically recommending that the patients had to go through psychological counseling in terms of how to deal with the pain. Then when we worked with them, they are now basically recommending the use of the Reducer. That is a absolute first for these angina patients. In France, we were the very first company that was able to get reimbursement under the new French reimbursement PECT process, the very first. It wasn't Medtronic. It wasn't none of the big companies. I'm sure they all would have liked to be the first. Neovasc was the first to actually get this process done and actually got the reimbursement out of it. Last but not least, I can tell you that Neovasc is the company who has worked with the CMS, and as far as I know, is the first and only company who actually is executing on reimbursement for a device in a clinical trial the way I described it. I don't think that this actually has been executed this way before. There are a lot of novel ways that we actually are going and actually have succeeded in to be able to work with authorities in the U.K. and France and in the U.S. to really put the Reducer therapy in the forefront of these authorities. Last but not least, Vernon, and I think to put it in perspective, it's not just that we are saying, "Well, you know, you should be using the Reducer, you should be doing the Reducer." We are recommended in the European guidelines, that's one, for cardiology. The second one, I would say that's equally and maybe even more important, there is more and more evidence and studies out there that demonstrate that the use of the Reducer device and the therapy for the patient will actually save the healthcare system's money. That part is extremely important. This is a good therapy for patient. It actually does good for the patient. The patient, in most cases, not always, but in most cases, the patient will do better. The healthcare systems will actually save money because this is such a very expensive patient population that needs a lot of attention in any healthcare system. Those are the things that really help us in getting these firsts accomplished. I just want to explain that to you one more time. Perfect. Those are very helpful insights and thank you for sharing and thank you for taking my question. Appreciate it. Thank you, Vernon. Thank you so much. Thank you. That is all the time we have for questions today. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.
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