Greetings. Welcome to the Neovasc Incorporated second quarter 2021 earnings call. At this time, all participants are in 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. Please note this conference is being recorded. I will now turn the conference over to your host, Mike Cavanaugh, investor relations. Thank you. You may begin. Thank you, Alex. Good afternoon, and thank you all for joining us today. Earlier today, Neovasc Incorporated released financial results for the quarter ended June 30, 2021. 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'd 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, outlook, will, 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 Factor section of Neovasc's annual information report on Form 40-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, August 10, 2021. 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. Q2 was a strong quarter for Neovasc. We are particularly pleased with our sales results and the important strategic initiatives we undertook during the period. During this quarter, we streamlined our strategic focus to match our ambition with a medium to longer-term view, making use of the significant $72 million proceeds to pursue three value creation strategies. We continued expansion of Reducer revenue in Europe and outside the U.S. through reimbursement and new market penetration. We moved toward initiation of a new U.S. IDE clinical study in 2021, with the aim of supporting a future PMA submission to the FDA. We continued targeting a decision on the Tiara TA transapical device for CE mark, now under the new European Medical Device Regulation or MDR rules in late 2022. During the quarter, we made the clarifying decision to suspend activities related to the next generation Tiara TF transfemoral device. Overall, we are very pleased with the progress we made in the quarter to position Neovasc going forward. Moving to our top-line performance. Revenues for the second quarter were $633,000 compared to $284,000 in the second quarter of 2020, an increase of 123%, and compared to $440,000 in the second quarter of 2019, an increase of 44% over the last second quarter without COVID-related impact. More contemporaneously, we observed a 40% quarter-over-quarter growth compared to the first quarter of 2021. We also saw a record number of Reducer implants in the second quarter. This despite the fact that COVID remains a challenge in Europe. I would like to thank our direct sales team and partner distributors for their diligent work in achieving this milestone. I'd now like to take a few minutes to discuss the steps we took during the quarter to help establish the medium to long-term success for the company. As many of you know, in early June, we made significant changes to the Neovasc workforce. Making a necessary 40% reduction in our workforce, directly driven by our decision to suspend the Tiara TF development program. We were sorry to lose many valued colleagues. We wanted to extend the cash runway of the company to help establish our medium and long-term success. We are now more streamlined, the entire organization is focused on specific goals aimed at building shareholder value in the medium term as our top priority. As a result of the decision to pause the Tiara TF development program, we now expect to have adequate cash to fund operations for three years into late 2024, which should limit dilution to our current shareholders from further follow-on financings during that period. Following this strategic move to pause the Tiara TF development program, we did make two key additions to the team, hiring two industry veterans that we believe significantly strengthen our capabilities around our U.S. IDE COSIRA-II study. Just after the end of the quarter, we appointed Lisa Becker as Vice President, Regulatory Affairs, Global Angina Therapies, and Sarah Gallagher as Vice President, Clinical Affairs. Each of these very talented women bring over 20 years of experience in regulatory and clinical affairs respectively, and they will be invaluable members of the Neovasc team. I'd like to take a few minutes to discuss the progress we have made towards expanding the adoption of our unique Reducer device. First, as I mentioned earlier, we saw a record number of devices implanted in Europe during the second quarter. This despite the fact that COVID remains a challenge in Europe. We believe the number of implants reflect a strong and growing demand for Reducer. We will continue to push hard to expand the utilization of this unique and often life-changing device to address refractory angina and now have four personnel on the ground in Germany who are actively marketing the Reducer to cardiologists. We have relationships with multiple distributors offering Reducer throughout the European Union, including Switzerland, the U.K., Italy, Spain, the Netherlands, and Austria. We enjoyed an excellent Reducer symposium at the EuroPCR meeting with large virtual participation of many physicians throughout Europe. We are also seeing a flow of positive data supporting Reducer in the European Union. The most recent example being the paper published by Dr. Francesco Ponticelli at Maria Cecilia Hospital, Cotignola, Italy, describing the long-term outcomes of patients suffering from refractory angina treated with the Reducer. At a median follow-up of 502 days after Reducer implantation, almost 40%, in fact, 39.7% of patients improved by 2 or more CCS classes, which is a measure of angina severity, and 76% improved by 1 or more classes. The procedure appears safe given that procedural success was achieved in 96.7% of attempts. We believe that our marketing efforts, coupled with the flow of positive data supporting Reducer safety and efficacy, are working to support growing Reducer revenues. We also know that we have a lot more to do. Regarding the U.S. market, we are actively and with urgency working towards initiating the COSIRA-II U.S. IDE study, which will be a double-blind, sham-controlled, randomized controlled trial of the Reducer device versus a sham procedure to be conducted in North America. The core of this IDE study was already originally approved by the FDA in November 2017. Due to our past financial constraints, we were unable to initiate the study until now. We are in the process of supplementing this study to update and improve it with everything that we and the FDA has learned in the interim since its initial approval. We were pleased with the FDA's decision to designate Reducer as a novel breakthrough device in late 2018 and believed we had a good chance of PMA approval with that designation. The panel decision and subsequent not approvable letter turned out to be very disappointing for us all and certainly for many U.S. patients. As such, we have reverted to the original 2017 approved IDE study, which we will be supplementing instead of having to work on and file a completely new IDE study, which we have estimated has saved us up to a year of work before initiating this clinical study. As we stated on our last earnings call, we have created an executive steering committee to oversee the trial, and the IDE study protocol has benefited from their expertise council, coupled with the productive discussions we have had with the FDA. The company continues to work towards a first patient enrollment near the end of 2021. We are hopeful that the U.S. trial that should demonstrate the Reducer safety and effectiveness comparable to the real-world performance the Reducer has already demonstrated over a sustained period of time and over multiple studies will help us develop a successful PMA application to the FDA. I would also like to take this opportunity to update you on our efforts to expand reimbursement agreements for Reducer worldwide. As previously announced, the company has made significant progress against our reimbursement objectives in the U.K., France, Germany, and the United States. Earlier in the quarter, we announced that Neovasc worked with the American Medical Association to establish a new category 3 CPT code to report the transcatheter implantation of the coronary sinus reduction device, which became effective July 1st, 2021. Additionally, we were granted national reimbursement status for the Reducer by the National Health Service, NHS, in England. The NHS England has a nationwide purchase and supply system for specific categories of high cost, tariff-excluded medical devices used in specialized services designed to support the accelerated adoption of effective new technologies. Hospital providers can now order the Reducer and bill the cost of the device directly to NHS England. Expanding reimbursement for the Reducer remains a top priority at Neovasc, and we hope to have more positive developments to share with you in the coming months. Moving on to Tiara. As I previously mentioned, we paused all activities related to the Tiara TF development program during the quarter to focus on the advancement of the Tiara TA device, which we think could offer the best chance for near-term approval and a better return on investment. We are now actively pursuing the CE mark designation for this device under the newly implemented European Medical Device Regulation, or MDR, and we anticipate that a decision will be reached in the second half of 2022. We continue to be encouraged by the clinical data supporting the Tiara TA, and if and when the CE mark designation is issued, we believe this device could be a leader in the emerging and underserved mitral valve replacement space. We accomplished a great deal during the second quarter, importantly, strengthening our financial footing, expanding adoption and reimbursement of the Reducer, and adding seasoned professionals to enhance our clinical and regulatory strengths, among other things. However, we understand there is more to do on all fronts, and we hope to report more positive milestones during the balance of 2021 and beyond. As always, we want to thank our investors, our employees, and our customers for their continued support of Neovasc. I will now turn the call over to Chris for a review of our financial results. Chris? Thank you, Fred. As Fred mentioned briefly in his comments, we are happy to report that revenues grew significantly year-over-year. We saw a record number of Reducer implanted in the quarter, and we exceeded our internal pre-COVID revenue targets. Revenues have increased by 123% to $633,000 for the three months ended June 30, 2021, compared to revenues of $284,000 for the same period in 2020. We are very pleased with the recovery of Reducer implant volumes following the COVID-induced decline, but we are cautiously monitoring the impact of the Delta variant in our key markets in the coming quarters. Cost of goods sold for the three months ended June 30, 2021, was $109,000 compared to $75,000 for the same period in 2020. The overall gross margin for the three months ended June 30, 2021, was 83% compared to 74% gross margin for the same period in 2020. The company continues to focus on Germany, where the company sells the Reducer direct for higher margins. Total departmental expenses for the three months ended June 30, 2021, were $9.6 million, compared to $8.9 million for 2020, representing an increase of $748,000 or 8%. Notably, we saw an overall increase in non-cash charges of $1.9 million and an overall decrease in cash expenses of $1.1 million. The increase in non-cash charges were the result of the $1 million increase in share-based compensation and a $903,000 charge related to our decision to pause the Tiara TF program, consisting of a $594,000 charge for obsolete plant and equipment, and a $309,000 charge for employee termination expenses. Encouragingly, the overall cash expenses decreased by $1.1 million, principally driven by a reduction in employee expenses as our two recent reductions in force in December 2020 and June 2021 starts to take effect. Selling expenses for the three months ended June 30, 2021 were $832,000 compared to $452,000 for the same period in 2020, representing an increase of $380,000 or 84%, principally as we start to ramp up our selling activities from COVID driven lows in the comparable period. General and administrative expenses for the three months ended June 30, 2021 were $5 million compared to $3.8 million for the same period in 2020, representing an increase of $1.2 million or 32%. Non-cash charges increased by $2 million, comprised of $1.1 million increase in share-based compensation and a $903,000 increase related to the provisions for our pause in the Tiara TA program. Cash expenses decreased by $800,000, principally due to an overall decrease in legal expenses. In the comparable period, we incurred significant charges as we unwound and resolved the last parts of the 2017 financing. Product development and clinical trial expenses for the three months ending June 30, 2021 were $3.7 million compared to $4.6 million for 2020, representing a decrease of $900,000 or 18%, principally driven by a decrease in employee expenses. The operating losses and comprehensive losses for the three months ending June 30th, 2021 were $9.1 million and $9.3 million, respectively, or $0.13 basic and diluted loss per share, as compared with $8.7 million operating losses and $12.2 million comprehensive losses, or $0.81 basic and diluted loss per share for the same period in 2020. The overall decrease in comprehensive loss is principally explained by a $2.9 million decrease in the charges related to the valuation and accounting treatment of our derivative equity instruments and the overall increase of $434,000 in our operating losses. This increase in our operating losses is explained by a $314,000 increase in contribution from Reducer activities, offset by a $748,000 increase in departmental expenses, which, as previously mentioned, was made up of the $1.9 million increase in non-cash charges and a $1.1 million decrease in cash expenses. We ended the Q2 2021 with cash on hand of $63.3 million. We have substantially caught up on our payables, and the balance sheet absorbed more than $3 million during the H1. We have the last remaining $1.25 million collaboration and settlement payments due in the Q3. Following that, we anticipate that we will start to see a further reduction in our quarterly burn rate as a result of our decision to pause the Tiara TA development program and the associated reduction in workforce at the end of the second quarter. This anticipated reduction in burn rate is expected to create capacity to accommodate increased spending on the COSIRA-II IDE study once enrollment begins later this year. We are also pleased to report that there was only a marginal increase in our shares issued and outstanding, increasing by 80,249 shares during the quarter to 67,584,412 shares at the end of the quarter. As Fred mentioned, we're in a much stronger financial position and anticipate that we will reach critical value creation events before needing more capital. This is a complex process, but we hope to provide positive updates for the balance of 2021 and beyond. Fred? Thank you, Chris, and thank you all for listening to our opening remarks. We have made some significant changes during the quarter, some of them difficult, which have solidified our financial footing and increased our collective focus on advancing the three strategies, which we believe, combined with a cleaner balance sheet and a lower expense base, will uncover the vast potential of Reducer and Tiara TA, and in turn could improve our current market value. Ultimately, we are hopeful that this new strategy for our product assets and our execution of it in the next few years will be beneficial for all our stakeholders, investors, employees, and millions of patients around the world. Once again, thank you all for your continued support. I would now like to open up the call for questions. Alex. Thank you. At this time, we will be conducting a question and answer session. Our first question comes from Vernon Bernardino with H.C. Wainwright & Co. Please proceed with your question. Hi, Fred. Hi, Chris. Thanks for taking my question, and congrats on the quarterly results. Just wondering if you could give a little bit more detail as far as the results in Europe. One of the things you had mentioned was using a direct sales force in Germany. Is there a way you could perhaps describe how what geographies that did the best in during the second quarter? Yeah. Hi, Vernon. This is Fred. Good to talk. Thank you. to you on the call here. At the moment, we have a direct sales force in Germany with four folks. We are selling in other European markets through distributors. The situation in France, we are still working on the reimbursement project in France. If that were to be positive and successful, we would also start our activities in setting up a direct sales force in France. That might potentially become the second country with a direct sales force in Europe. At the moment, it is only Germany. It's quite interesting. I would say that in the second quarter, Germany in particular was the strongest contributor to our revenue growth. You also see that in the very strong growth margins, which went up into the 80%, 82%, from typically in the 70%. That's also because obviously with our direct sales force, we have higher margins in Germany. You can clearly see that it was in particular our direct sales force in Germany that was leading the way in the second quarter with a major recovery. They did meet expectations on the revenue side and on the implant side, actually came in a little higher than the original expectations. You should know that our original expectations for the second quarter were largely based on no COVID impact. Yet, you know, there still was some COVID impact, as you know, in particular towards the end of the second quarter. Nevertheless, you know, we have really done a great job in total with the revenue. We surpassed our internal goal for Q2 revenue, led by the German organization. We had a record amount of implants in Europe for the second quarter. It really was a strong performance, very encouraging. So far the third quarter is going well. It's kind of hard to, you know, the third quarter is always tricky because, you know, you have July and August as the vacation months, so it's kind of hard to judge. September, therefore, is obviously a very important month for any third quarter performance, and that's still ahead of us. I would say so far so good. Despite flare-ups of COVID and the Delta variant of the COVID that is plaguing not only the U.S., but certainly also many European countries. I think it is a testament to the fact that there really is an underlying demand for the Reducer. It really tells a story of the fact that, you know, patients and physicians are seeing the promise of this product, and they're seeing it more and more by their own experience. We also see more and more clinics signing up for it. We have still a few patients here and there that are promising candidates and then in the very end, decide to not to go to the hospital, mostly because they are concerned that they might pick up COVID in the hospital. We still see that here and there as well. But, you know, we really have done well despite all of that. We're actually quite encouraged with this, and it re-emphasizes the importance of our strategy to really focus primarily on the Reducer, on revenue expansion, on reimbursement, on new geographic growth, on success in the U.S. to really make a big investment in the U.S. market with our new clinical study as the highest priority. I think that strategy is gonna really pay off, as you can clearly see already from these numbers in the second quarter, Vernon. No, definitely exciting results. Regarding what you mentioned as far as the filing, you no longer will file in the U.S. an IDE supplement and just go back to the IDE for the 2017 study design? Yeah, I mean, I went through this in my script. I wanted to make sure that everybody understood that we already have an approved IDE. It was approved in November 2017. We have a protocol. That was a huge submission. That submission and work took well over a year to work with the FDA and to get through and to get approved by the FDA. We don't have to redo that or start all over again. We don't have to file a new IDE, but we are utilizing the IDE that we have and was already approved in 2017. However, in the meantime, we have also learned a lot, and FDA has also learned a lot. We had the panel meeting for good or for bad, with a lot of feedback. We want to make sure, and also FDA encouraged us to make sure that we incorporate all the learnings. There are a number of, I would say, small protocol changes that we do need to file as a supplement, and we're working hard on that. I expect that to be filed certainly still in the third quarter, hopefully in the near term, I would hope in August. That would be basically a supplement that would then be filed. The other advantage is that obviously the review time by the FDA for a supplement is a lot shorter than for a full IDE. There are several advantages of being able to go back to the original IDE, but actually improve on it by the learnings that we've had. We've also had a lot of valuable input in the protocol from the executive steering committee members. We now have some really powerful physicians from the U.S. on that panel, and that gives us very valuable insight. We've had a couple of very good and very cooperative positive meetings with FDA, where we talked about some of the protocol changes that we thought were appropriate and good to do, and they were in complete agreement with that as well. They actually supported that and encouraged us to do that. It's well worth doing because we want this study to be as strong and as powerful as it can be, and that's the path we're on. Last question, I'll get back in the queue. Can you remind us again then now what will be the primary outcome and second primary outcome? Yeah. The primary endpoint of the study is an improvement in exercise tolerance by a Bruce modified index. It's basically a treadmill test that patients do before they get the device and then six months after they get the device. You look at, are patients able to do more exercise? Can they do this longer, or can they just exercise in a much better way? There's a very well-defined protocol for this. Obviously, needs to be very well and disciplined performed. That is what the primary endpoint will be. We also have other endpoints, secondary endpoints. Obviously, there will be an endpoint that are associated with CCS class again, and others, and uncertain. There are many that are also secondary endpoints. There is an active arm for the control of the safety as well, where people are looking at, is there any difference between, for example, myocardial infarctions, death rates, stroke, et cetera, et cetera, which, you know, from a wealth of experience so far with the device, I've never really seen. That's all part of the protocol. It's a very well thought out clinical study. It is, again, a sham-controlled study, half of the patients will go through a procedure but will not receive the Reducer device. That is to really make sure that this is done in the most accurate scientific manner. Then, after the trial has been concluded, these patients will be enabled, then the patients that went through the sham procedure will be offered to then also be able to get the Reducer after the trial has been ended. That is something we actually want to make sure that was the case because many patients really are looking forward to getting this device, and when they get randomized to the sham arm, they really wouldn't get the device. Therefore, when we can tell them upfront, "If you do end up in the sham control arm, you will be able to get the device after the study is over," is really a benefit for the patients and will, I'm sure help us with recruitment of patients as well in the study. That's perfect, Fred. Sounds like you're really on track, to enroll the first patient, at the end of this year. Congrats. Looking forward to it. Great. Thanks so much, Vernon. I really appreciate it. Thank you. Our next question comes from Greg Aurand with Noble Capital Markets. Please proceed with your question. Hello. Thank you for taking my questions. I appreciate it. Nice quarter, gentlemen. Question first is just more of a housekeeping thing, really, but the gross margin number was better than expected. You mentioned, I think, Fred, direct sales is contributing a lot to that. Do you think there's some COVID overhang still in some of the other countries or is it still more of a reimbursement issue? Well, the gross margins, you know, typically what we see, and you can go back in our earnings reports, you know, we see, you know, north of 70%, typically 72%-75% range. When we have a quarter where there was a very strong dominant gross coming out of Germany because of, you know, the direct sales and direct margins, you know, it actually goes above 80%. A lot of it depends on the mix of where the sales is coming from. That's number one. We have established a high price essentially in every European country. We have done that very consciously over the years. We've always resisted to try to make a quick sale with a lower price. We've always resisted doing that. We kept a high price strategy, and really want to see the rewards of that over time. The reimbursements that we are after are very much in line with that because they go back to the base that you have, that you have set in these countries. We are looking at a very, very nice reimbursement numbers. In the different countries where we are working, very much in line, if not even higher than what we are seeing today in the market. It's all a very well-coordinated effort. Ultimately, when we do get to reimbursement, like we now see in the U.K., that will be another one where, as of the fall, we believe we're going to see quite a bit of a positive impact coming from the U.K. market, and that should also help with our gross margins because of the reimbursement we have now established there as well. In the future, a lot of this will be dependent on the mix of the different countries, the status of direct sales or distributor sales, and then the individual reimbursements in the different markets that we have. In the U.S., we're also working already on the reimbursement side. We have had several meetings with CMS already, very positive. If the device would have been FDA-approved, we would have had reimbursement for the device at a very nice level in the U.S. as well. We've talked about that in the past. We really have a high-price philosophy for the device, and I think you can understand why, because it's taking a very, very long time and a huge amount of investment to get this product to the market and get it established. We certainly wanna make sure that there is gonna be a good and positive return of investment for our investors in this therapy. I can see that. Second question regarding another housekeeping-type question regarding clinical trial expenditures. It was lower than expected. Is it related mostly to the discontinuation or pausing of Tiara TF? Can we expect sort of a slowdown in those expenses for the next two quarters? Do you anticipate them picking up when the IDE becomes effective? Yeah. The clinical expenses so far were largely driven by the Tiara side. Because of the pause in TF, as well as the fact that we have also paused implants for Tiara TA, because, you know, we are submitting for a CE mark with the clinical data that we have. We don't expect a significant increase in clinical expense on the Tiara side. However, having said that, we still need to finalize our REDUCER-I post-market clinical study in Europe. We are now just over 300 implanted devices of the 400 patients in that study. There's still gonna be some more patients included in the REDUCER-I study in Europe. That's post-market for Reducer there. Obviously, we are going to start on the expenses for the COSIRA-II IDE study, which is a substantial and big study, and it's gonna last a few years, and it's gonna be coupled with quite a bit of an additional expense, but it's spread out over several years as well. There will be a shift on the clinical expense side from Tiara to the Reducer side. That's the long and short of it. Excellent. Thank you. One more question, if you don't mind. I appreciate the time. Just in terms of the COSIMA trial, your first enrollment was back in May. How is that tracking? Is it going according to your expectations? The COSIMA trial? Yes. That has started. It was also severely impacted by the COVID situation, particularly in Germany. We now have had a few patients that are included in that trial in Germany. So far, it's being done only in the university clinic in Mainz. That clinic is the sponsor of the study, and they are working with several other clinics in Germany to get them started. We believe that the microvascular angina topic is gonna be another very interesting growth opportunity for the Reducer. It basically is the patient population that has microvascular disease, they don't have any problems in the coronary arteries. The patients that we today treat are the ones that have occluded coronary arteries, get treated for it with stents or bypass, and then still have microvascular angina. This population in the microvascular angina segment or ANOCA segment, is the patient population has microvascular angina but does not have coronary artery disease. It's a slightly different patient population, but there's also quite a few patients in that patient population that have really no therapy option at the moment outside of some drugs. Physicians are actually very interested in this trial as well. We expect a pickup of that over time. That is the COSIMA trial in Germany. There is another study, a smaller one, done at the clinic, at a clinic in Minnesota, where also a similar trial is being done, but a smaller amount under an IDE. There, we've had the first two patients included in the trial as well. There are a couple of centers in the world that have now started some clinical trials in that space. Oh, great. That's good news. Thank you. I appreciate the questions and appreciate the answers. Thank you so much. I'll jump back in the queue. Okay. Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I will now turn the call over to Fred Colen for closing remarks. Okay. Well, I think it was a productive call. I'm glad for the questions that I got, so I was able to explain a few more things a little more in detail. Appreciate your attention and your participation in the call, and we'll talk again in a few months again on the next call. Thank you all very much. Goodbye. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation, and have a wonderful evening.