Neovasc Inc (NVCN) 2021 Q4 法說會逐字稿

Greetings, and welcome to Neovasc Fourth Quarter 2021 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Mike Cavanaugh. Thank you. You may begin.

Thank you. Good afternoon, everybody, and thank you for joining us today. Earlier today, Neovasc Inc. released financial results for the quarter and year ended December 31, 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 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, 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 Factors section of Neovasc's annual information 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, March 10, 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, and as usual, I will review our progress since the last earnings call before turning it over to Chris to discuss our financials.

Q4 was a strong quarter operationally for Neovasc as we continue to advance our 3 value creation strategies. We achieved record revenues for Q4, which Chris will touch on later. We continue to make great progress on reimbursement initiatives in Europe, which will continue to drive adoption and expedite revenue growth. And lastly, our financial footing remains strong with a runway expected to last to mid-2024, deep into the COSIRA-II clinical trial.

One of the 3 pillars of our value creation strategy is expanding the use of Reducer outside of the United States. In November, we were thrilled to announce the National Institute for Health and Care Excellence of the United Kingdom, NICE, provided positive feedback for the Neovasc Reducer system. This was a tremendous milestone for Neovasc as it supports the first therapeutic intervention for stable angina patients who have not responded to treatment.

Shortly following the Neovasc Reducer system was granted Prise en Charge Transitoire or PECT reimbursement in France by the National Health Authority, also known as the HAS. The Reducer is the very first therapy to be approved under this newly established French packed process. We are on our way now to build a ramping direct commercial revenue stream in France. The HAS decision builds upon the recent reimbursement expansion in the United Kingdom, as well as a positive American Medical Association decision to establish a new Category III CPT code for coronary sinus reduction procedures in the United States.

Earlier this month, we announced the German Institute for the Hospital Remuneration System has awarded the Neovasc Reducer NUB Status 1 Designation again for 2022. The Reducer has 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. Additionally, we recently announced that 500 patient has been treated in Germany, which marks another meaningful step forward towards wider adoption.

We are proud of all the progress our team has made in securing reimbursement for Reducer in the largest markets in Europe. The Reducer is now available for use more widely with patients suffering from severe angina who have no other treatment options to turn to. It is gratifying to see the growing acceptance and use of the Reducer for the treatment of refractory angina, and we believe demand will follow the more it is successfully used to treat this debilitating disease.

Shifting to our efforts towards commercialization domestically in the United States. In early January, we were pleased to announce the enrollment of the very first patient in the COSIRA-II clinical trial towards the target enrollment of approximately 380 patients across as many as 50 investigational sites. The COSIRA-II clinical trial is pivotal for our efforts to gain approval for the Reducer in the United States. This is a major step forward for patients in the United States suffering from chronic chest pain and other often debilitating symptoms and, for the very 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 clinical trial.

We remain on track, expecting the enrollment of about 380 patients in up to 50 U.S. and Canadian sites. This is a pivotal milestone in our path towards the commercialization of the Reducer in the United States.

Last week, the Centers for Medicare and Medicaid Services, CMS, issued a new health care common procedure coding system, HCPCS C code specifically for the COSIRA-II clinical trial. This is a significant event for the trial and for the company. The new code is designed to be used for hospital billing and it allows all outpatients in the trial to be coded the same way. It's important for 2 reasons: First and most importantly, it will help to ensure that trial suspects will remain blinded to which arm of the trial they are in by avoiding different codes on hospital bills; plus Neovasc has now established coding and coverage for both inpatient and outpatient procedures during the IDE clinical trial.

This is a huge accomplishment and it reflects years of work on the part of our team. Another significant milestone achieved. It means that we are well on our way to see U.S.-based revenue coming in already during the clinical trial phase.

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. We continue to work with our notified body in Europe to advance our CE Mark application and we are now anticipating a decision under the new European Medical Device Regulation or MDR rules in late 2023. The notified bodies in Europe are generally overwhelmed towards applications even for products already on the European market today, and this has resulted in much longer review cycles at notified bodies in general.

As many of you will recall, we made the difficult decision to suspend the development of the next-generation Tiara transfemoral device, which entailed a significant reduction in headcount in mid-2021. This strategic move allowed us to focus on the Reducer and on the Tiara TA, which are both much further along in their development cycles and resulted in significant savings which helped us to extend our cash runway, which is expected to last into mid-2024.

I'd also like to take a moment to comment on the class action lawsuits that had been pending against Neovasc. Earlier this month, we announced the dismissal of the consolidated amended complaint in the shareholder class action case. The consolidated amended complaint was dismissed in its entirety with pre-justice and without a need to amend. Nevertheless, the plaintiffs have appealed the decision of the lower court to the Court of Appeals, and we will patiently and vigorously defend ourselves once again. The process to hear the appeal on our motion to dismiss the case may take approximately a year, and unfortunately, will divert management time and capital away from our focus on our value creation strategies.

Before I turn the call over to Chris, I would like to provide an update about the written notification from the NASDAQ in late November. NASDAQ informed us that it has granted the company an additional 180-calendar day grace period, or until May 23, 2022, within which to evidence compliance with the $1 minimum bid price requirement. Despite great operational news, our stock price has unfortunately not moved closer to and above the required $1 bid price. The company believes it to be in the best interest of our shareholders to stay listed on the NASDAQ and having exhausted all those strategies, including an improved website, increased investor relations and social media interactions. And utilizing an extension to the grace period, we have no of a choice than to call on our shareholders to approve a reverse stock split.

Neovasc will be holding an Annual and Special General Meeting on April 12, 2022, to vote on a reverse stock split, which will mechanically increase the stock price by reducing the number of issued and outstanding shares, but the consolidation will not materially change or dilute the percentage ownership held by any shareholder.

I will also reiterate, as we have announced before, that the company does not currently needs to meet the $35 million minimum market capitalization requirement as it currently meets the $2.5 million shareholders' equity requirement instead.

We finished the year 2021 strong, and this despite lingering COVID issues in Europe and in Germany, in particular. We accomplished a lot in the fourth quarter and in the fiscal year 2021. Our financial footing remains strong, with a cash runway expected to last to mid-2024. And we are beginning to see widespread adoption and reimbursement of the Reducer, enabling us to plan for a meaningful increase in revenue during 2022.

We look forward to continuing to achieve positive milestones in the weeks, months and years to come. As always, we thank our investors, our employees and our customers for their continued support of Neovasc. And with that, I will now turn the call over to Chris for a review of our financial results. Chris?

As Fred mentioned briefly in his comments, we're happy to report that we recorded record revenues and units sold during the quarter, despite the continuing pandemic which restricted access to better doctors and reduced the number of electric surgical procedures performed. However, we did see a resumption of some activity out of necessity and after the initial COVID surge began to subside. As a result, revenues increased by 30% to $2.55 million for the year ended December 31, 2021, compared to revenues of $1.96 million for the same period in 2020.

For the 3 months ended December 31, 2021, revenue increased by 48% to $759,000 compared to revenues of $514,000 for the same period in 2020. The operating losses and comprehensive losses for the year ended December 31, 2021, were $31.1 million and $25.2 million, respectively, or $0.40 basic and diluted loss per share as compared with $35.2 million operating losses and $30.2 million comprehensive losses, or $1.72 basic and diluted loss per share for the same period in 2020.

The decrease of $4.1 million in operating losses can be explained by a $3.6 million decrease in operating expenses and a $600,000 increase in revenues. The $5.0 million decrease in comprehensive loss incurred for the year ended December 31, 2021, compared to the same period in 2020, could be substantially explained by the $4.1 million decrease in operating losses and a $1.8 million increase in other income related to the accounting treatment of derivative instruments, offset by a $600,000 decrease in income tax recovery.

The operating losses and comprehensive losses for the 3 months ended December 32, 2021, were $0.509 basic and diluted loss per share as compared with $9.2 million operating losses and $4.9 million comprehensive losses or $0.18 basic and diluted loss per share for the same period in 2020.

The cost of goods sold for the year end is 2021 were $556,000 compared to $446,000 for the same period in 2020. The overall gross margin for the year ended December 31, 2021 was 78%, compared to 77% gross margin for the same period in 2020. There has been no significant change in the cost of the Reducer year-over-year, and the company continues to focus on Germany by the company's Reducer direct for higher margins.

Cost of goods sold for the 3 months ended December 31, 2021, was $209,000 compared to $97,000 for the same period in 2020.

The overall gross margin for the 3 months ended December 31, 2021 was 72% compared to 81% gross margin for the same period in 2020, and a nonmaterial inventory adjustment was booked in the fourth quarter of 2021.

Total expenses for the year ended December 31, 2021, were $33.1 million compared to $36.7 million for 2020. The decrease in total expenses for the year ended December 31, 2021, compared to 2020 could be substantially explained by a $2.5 million decrease in employee expenses due to the company's reduction in force by the end of 2020 ended June 2021, a $2.0 million decrease in legal and underwriting fees related to the 2020 financings and a $600,000 decrease in other expenses as the company indefinitely paused all activities related to the Tiara TF, transfemoral mitral valve replacement program in June 2021.

Total expenses for the 3 months ended December 31, 2021, were $5.7 million compared to $9.6 million for 2020, representing a decrease of $3.9 million or 41%.

Selling expenses for the year ended December 31, 2021, were $3.0 million compared to $2.2 million for 2020, representing an increase of $800,000 or 36%, substantially explained by a $360,000 increase in noncash share-based payments and a $405,000 increase in other expenses incurred for commercialization activities related to the Reducer, as the company increased its selling activities from the COVID-driven low point in the comparable period.

Selling expenses for the 3 months ended December 31, 2021, were $739,000 compared to $692,000 for 2020, representing an increase of $47,000 or 7%.

General and administrative expenses for the year ended December 31, 2021, were $14.7 million compared to $14.1 million for the same period in 2020, representing an increase of $575,000 or 4%, substantially explained by a $981,000 increase in noncash share-based payments, a $637,000 increase in litigation expenses, a $594,000 noncash impairment charge of fixed assets as we paused our activities on the Tiara TF program, a $373,000 increase in other expenses in part related to an increase in the directors and offices insurance premiums and a $211,000 charge for employee termination expenses.

These increases were offset by a $2.1 million decrease in legal and underwriting fees related to the 2020 financings, and a $245,000 decrease in noncash charges for accretion on collaboration license and settlement agreement provisions, as we have made the final initial payments on these licenses.

General and administrative expenses for the 3 months ended December 31, 2021, were $1.3 million compared to $3.1 million for the same period in 2020, representing a decrease of $1.8 million or 58%, substantially due to a $1.7 million decrease in noncash share-based payments as we accounted for our incentive programs.

Product development and clinical trial expenses for the year ended December 31, 2021, were $15.4 million compared to $20.4 million for 2020, representing a decrease of $5.0 million or 24%. The decrease in product development and clinical trial expenses for the year ended December 31, 2021, will be substantially explained by a $2.6 million decrease in employee expenses due to the company's reduction in force at the end of 2020 and in June 2021.

A $1.3 million decrease in other product development and clinical trial expenses as the company indefinitely paused all activities related to the Tiara TF in June 2021; and a $1 million decrease in noncash share-based payments.

Product development and clinical trial expenses for the 3 months ended December 31, 2021, were $3.6 million compared to $5.8 million in 2020, representing a decrease of $2.2 million, or 38%, substantially due to a $1.5 million decrease in expenses as we paused all activities related to the Tiara TF in June of 2021.

As of March 8, 2022, the company had 67,748,061 common shares issued and outstanding. Our fully diluted share count as of March 8, 2022, was 114,518,437.

As Fred mentioned, we are in a strong position financially and expect that we will continue to build momentum and reach critical value inflection points before needing more capital in the future. In the meantime, we believe a shareholder vote to approve the proposed reverse split share consolidation will ensure that the company remains on the NASDAQ and consequently retains better access to capital and a lower cost of capital when the time comes. We strongly recommend that our shareholders vote in favor of the share consolidation resolution.

Back to you, Fred.

Thank you, Chris, and thank you all for your continued support of Neovasc. Let me start by reiterating what Chris just stated. We strongly recommend that our shareholders vote in favor of the share consolidation resolution. We are convinced that staying on NASDAQ is essential and in the best interest of our shareholders.

We made great strides in 2021, in particular, with advancing reimbursement for Reducer in the largest markets in Europe, which we are confident will drive demand for our potentially life-changing device. Furthermore, it was a long process that during 2021, we designed and received approval for the U.S. COSIRA-II clinical trial in the U.S., which is designed to inform a full PMA submission to the FDA. It was most gratifying to announce the first patient enrollment right at the beginning of the new year. We continue to advance in the right direction, and we are confident that we are making the right moves to ensure Neovasc a long-term success.

Thanks again for joining us today. I would like to now open the call for questions. Rob?

(Operator Instructions) Our first question comes from Vernon Bernardino with H.C. Wainright.

Congrats on getting the COSIRA-II started with the first patient enrollment. That's very exciting. And congrats also on the reimbursements that you have put in place, that also too is very exciting. I'm sure the idea of revenues accelerating in 2022 is something that -- with all your hard work, is now something that will help you plan better for the future.

Just had a few questions. With the reimbursement in France, so usually, it takes a little bit of time for reimbursements like this to show up as far as implants are concerned. Just wondering if that is true and whether you can say -- you expect reimbursement in France, for example, to continue -- or rather to start in the second half of this year, you expect it to start in the second quarter. And then with the Germany NUB Status 1, is there a continuation there? Or does that -- is that seamless? Or is there some kind of delay also there?

Yes. Vernon, this is Fred. So yes, so all in all, very, very good progress in general. So first of all, it is not that typical that a company is able to get essentially reimbursed during its clinical trial already in the United States. There are all kinds of different rules for that. You have to have what I call a Category B designation by the FDA, as well as approval from CMS in order to be able to do that. And we have received that Class B categorization from FDA. And now with the special code that we got for the COSIRA-II clinical trial, we are going to be able to basically start generating revenue already in the United States from our COSIRA-II clinical trial without jeopardizing the blind of the study.

And this was quite a challenging task. You can imagine because normally, a hospital would charge for the services that they have provided. In this case, did they implant a Reducer or not. But that information on the billing side would potentially harm the blind of the study and could lead to potential unblinding, which we have to avoid by all costs. But all -- anything we can do, we have to avoid that from happening.

So we got the best possible approach here in coordination and very well interactions with CMS over a lengthy period of time and in several meetings, we now were able to actually obtain a separate code for the COSIRA-II trial in itself, which is different from the code we already have for outpatient commercial reimbursement of the Reducer in the U.S. once we get to that point. But this now is a separate code, just for the COSIRA-II trial. And basically, what -- how it's done is that CMS basically knows the way the trial is designed and that have the patients do go through the procedure, but do not get the Reducer. And the other half do go through the procedure and they do get the Reducer, they know what the costs are for both sides. Then they basically add those 2 up and divide them by 2, so the code is basically an average reimbursement for the costs of any patient in the trial.

And so with this special code -- and this was just done last week, with this special code, the hospitals can use that code, which basically only says that the patient has been included in the COSIRA-II trial. And then the hospital gets this average reimbursement, which also means that for the Reducer patient, we can actually charge for the device. So that is a very positive development, and it absolutely ensures that the blinding will not be risked at all.

That is still going to take some time. Going back to your question on France, about how long does it take, that's still going to take a little bit of time to get implemented. Best case scenario, that will be implemented on April 1, this coming up, April 1. But there's still a few moving parts that we have to get through to get that finalized. Once that's finalized, we'll certainly also announce that. So all of that could fall in place as soon as and early as of April 1, which would be great news for the clinical trial and for these patients that are treated in outpatient setting.

So that's one bucket of additional revenue for us that we believe we can start creating in 2022, it actually comes from the U.S. as part of the COSIRA-II trial. The next one is the one you talked about for France. So until now, we were not able to sell anything in France. You basically can't sell in France unless you have reimbursement. And so now with this new process, this packed process, we were the very first company going through this process. And actually, we're granted a reimbursement under that process. It wasn't Medtronic, it wasn't Edwards or Boston Scientific or Abbott. It was Neovasc who actually was the very first to go through the process and got our product reimbursed and approved in France.

That has -- that decision and that reimbursement code for the Reducer has, in the meantime, already been communicated in the official French Journal. It's called Journal Officiel. So that has already been communicated and will be implemented and will be usable in France as early as March 23. So that's only less than 2 weeks away, where the hospitals can start using that. So that's a rather quick implementation.

We were fully prepared for this. We have already hired 1 sales rep that's already in place in France, because as you know, we're going to go and sell this product direct in France. Just like in Germany, in France, we will have a direct sales force. And we are in the process of hiring a second rep. We already have identified that rep and on the process of finalizing the employment agreement with that person. So that person should be on board well as soon as well.

In parallel, we already have worked with clinics in France, and we already have a list of patients in several hospitals in France that we're kind of waiting for this reimbursement to fall in place. So to your question, we actually believe we're going to be able to already achieve some revenue from France even at the very end of the first quarter, but really obviously starting to take in strongly as of the second quarter, and then there will be a ramp up throughout the year and really starting to generate a nice revenue stream from France, that portion.

Now the next one is the U.K. is in a much stronger position, too, because of not only the NICE recommendation for the Reducer, but also the fact that we already have reimbursement in place as well for the Reducer in the U.K. So we are seeing an uptick in sales in the U.K., and we expect that to continue through the rest of this year.

As it relates to Germany, the NUB process is the regular process for a new therapy in Germany. Typically, companies do that several years in a row, and we have been doing that several years in a row. I think this is the third or fourth year in a row that we're actually getting NUB 1. One is the highest status you can get. And the amount of clinics that actually apply for this has been increasing every year. This year, it was 256 clinics in Germany that, on their own, not the company, not Neovasc, but the clinics, 256 of them, actually applied for this NUB 1 status, which puts them in a position to then negotiate reimbursement with the local insurance companies.

We are working on the next step in Germany, which is a -- let's call it a country-wide generic reimbursement process. That is also in the works, and we believe that that's going to take a little bit more time to get implemented. But in the meantime, the product is reimbursed as it is on a hospital basis in Germany.

And then last but not least, as it relates to other expansion opportunities, we are already starting to work with Australia. We believe that also in this year, we should see some revenue coming in, some starting revenue coming in through a distributor in Australia. We are in the process of filing there for approval. And we are also working on the Brazil market. We have some highly capable and interested distributors in Brazil that would like to work with us, and we're preparing for the submission in Brazil. That's a more lengthy process. We don't think we're going to see revenue coming in from Brazil yet this year, it's probably more of an event sometime next year.

But anyhow, so as you can see, there's a lot of positive momentum as it relates to reimbursement and therefore, potential for revenue growth, and I'm really very, very excited about all these opportunities in Europe, in particular. But also, and very importantly, also as it relates to the U.S. because we are going to actually see some revenue coming in from the U.S. just because of the fact that we're doing the clinical trial, which is, I believe, just absolutely awesome. So that's kind of like where we are on that, Vernon.

Thank you for the very, very comprehensive answer. And if Bill is there, congrats, Bill. I'm sure that was -- the separate code was probably a result of work that was directly from his experience. And so congrats, and you've got a good man there.

Yes, Vernon, absolutely, yes. Certainly, Bill was very engaged in that and still is in that entire process. And as it relates to the COSIRA trial, I can tell you that we do see a lot of enthusiasm from all the key and large and well renowned U.S. clinics. Everybody wants to be in on this trial. Every renowned interventional cardiologist is interested in this.

This is not just an easy and quick device-related clinical trial, it's a bit more involved and complicated. We have to make sure the patient is really a last resort patient. We have to make sure that the medication has been stabilized. So it takes some time to get all of that organized in these clinics. But I can tell you, the clinics are extremely enthusiastic about being participating in this trial. And they all have patients lined up to want to be participating in the trial. So we're very enthusiastic about all of that.

And Bill is a big part of all that, together with Sarah, our new leader on the clinical side, and Lisa, our new regulatory expert on the angina side. So -- we have a strong team in place, and I think you see that. We also have that in place on the commercial side with Mark in Europe and with Andreas in Germany, who leads Germany, Austria and Switzerland. We have a good commercial team in place as well.

So I couldn't be prouder of the team. And so thank you for recognizing Bill, and that's certainly very true. And it goes for a lot of people in my organization. We're very proud of them.

That's all the time we have now for our Q&A session. At this time, I'd like to turn the call back over to Fred Colen for closing comments.

Yes. And I guess all I have to say at the very end is thank you all very, very much for participating in this live conference call. I hope it was informative and we'll talk again soon. Take care. Bye-bye.

This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.