Neovasc Inc. (NASDAQ:NVCN) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET
Company Participants
Mike Cavanaugh – Investor Relations
Fred Colen – President & Chief Executive Officer
Chris Clark – Chief Financial Officer
Conference Call Participants
David Martin – Bloom Burton
Operator
Good day, and welcome to the Neovasc Incorporated Third Quarter Earnings Call. At this time, I will turn the call over to Mark Cavanaugh. Please go ahead.
Mike Cavanaugh
Good afternoon. I’d like to thank everyone for joining us today. Earlier today, Neovasc Incorporated issued a press release announcing our financial results for the quarter ended September 30, 2022 and describing the company’s recent business highlight. You can access the copy of the announcement on the company’s website at www.neovas.com/investors. With me on the call today are Fred Colen, President and Chief Executive Officer; and Chris Clark, Chief Financial Officer.
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 and approval decisions, pricing and enrollment matters; our value creation strategies, the benefits of our products 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 note 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, November 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.
We will begin today with some opening remarks and recent business highlights from Fred, followed by Chris, who will review the financial results.
I’ll now turn the call over to Fred Colen, Neovasc’s President and Chief Executive Officer. Fred?
Fred Colen
Thank you, Mike, and good afternoon, everybody. Reporting our third quarter of 2022, I am proud of the results our team has been able to deliver as we continue to expand patient access to the reducer for the treatment of refractory angina in Europe as well as in the US.
The team has worked hard to advance the pivotal COSIRA-II clinical trial in North America, including several sub studies to support the use of the Reducer here and has continued to expand reimbursement coverage for this potentially life-changing device in the European Union, where it has already been in use for some time now.
We also took steps during the quarter to strengthen our financial position, most notably by indefinitely suspending for the development efforts of our TIARA Transapical device. The third quarter of 2022 was another record-breaking quarter with revenues up 31% year-over-year coming in at $923, 000. This is a great achievement for Neovasc, despite challenges negatively affecting the European markets, particularly a strong currency headwind with the weakening of the British pound and the euro.
Additionally, our revenues were negatively impacted by lingering COVID and hospital staffing issues, which resulted in fewer implants, as elective procedures were postponed in some regions. Germany was particularly impacted by a COVID surge that led to stricter rules, reduce staff and procedure cancellations.
That said we expect a recovery in procedure levels in the coming months. I am incredibly proud of my team for the progress made during the quarter, despite the macroeconomic challenges facing the medical device companies in general. As mentioned, in Neovasc’s previous calls, the first pillar of our value-creation strategy is to expand the use of the Reducer in Europe.
The team continues to make strides in reimbursement efforts, and those efforts are beginning to pay off, as evidenced by our accelerating revenue growth in the quarter. Earlier this year, we received reimbursement coverage for the Reducer in the U.K., and we are seeing accelerating adoption of the Reducer in the region.
We are placing significant focus on this market, and as previously reported, we now have a direct sales force on the ground in the United Kingdom, which is designed to steadily increase utilization and result in higher margins via the direct Neovasc sales force compared to the prior distributor model.
Another effect of expanded reimbursement is our more diversified revenue base, whereas we previously were heavily concentrated in the Dutch market, especially Germany. In the third quarter, approximately 80% of revenues were generated outside of the Dutch countries, which are Germany, Austria and Switzerland.
This exemplifies the great strides we have made towards our expansion goals. France is now our largest volume market. Anecdotally, we are seeing strong societal support and acceptance of the Reducer across the entirety of the European Union and the United Kingdom.
The second pillar of our value creation strategy is advancing acceptance and use of the Reducer in the key U.S. market, where the COSIRA-II clinical trial has been progressing following initial enrollment at the beginning of 2022. We currently have 48 patients enrolled and 25 randomized at 16 sites of the targeted 380 patients across 50 sites.
As a reminder, the COSIRA-II trial is pivotal to our efforts for a full PMA submission to the FDA for the Reducer potential clearance in the United States. The Reducer has coding, coverage and payment status from the Centers for Medicare and Medicaid Services, CMS, and is reimbursable in the study which is contributing to our top line. Revenues from trial devices comprised 6% of total revenues in the quarter. Revenue creation in a placebo-controlled US clinical study is rarely accomplished, and Neovasc not only achieved it, we also pioneered a novel way to accomplish it without putting the blinding of the study at risk.
The CMS, whom we closely work with regarding this topic, recently published new guidance for potential reimbursement in randomized placebo-controlled clinical trials and also referenced the coronary sinus reduction device in an IDE study in their guidance.
In July 2022, we announced that the COSIRA-II trial received approval to expand in scope as the FDA had approved a protocol supplement to the trial. The supplement importantly allows for us to study patients with non-obstructive coronary artery disease, or a NOCA, and includes the addition of two previously planned imaging sub studies as part of the trial designed to provide insights into the safety and mechanism of action of the Reducer.
Site activation of the COSIRA-II trial is proceeding, although at a slightly slower pace than we had initially hoped due to the administrative burdens and personnel shortages present throughout many large organizations in the United States. We expect enrollment to be complete in the first half of 2024, and expect an initial data readout from COSIRA-II in the second half of 2024.
In September 2022, the CMS published new codes for the diagnosis and tracking of refractory angina. The new codes will be utilized in the current tenth revision of the international statistical classification of diseases and related health problems clinical modification, the so-called ICD-10-CM report. This was an important step for both patients suffering with angina as well as clinicians. Prior to these new codes, there was no way to differentiate patients with the most enduring and costly form of chronic stable chest pain for condition we call refractory angina. Now clinicians have a mechanism to define and measure the treatment costs, which is an important step forward in treating the disease.
Finally, we recently announced outpatient reimbursement in the US by the CMS for the Reducer therapy effective January 1, 2023. We are very excited about our great progress on the reimbursement front. Neovasc is in a unique position to already now have adequate coding, coverage and payment in place to support reimbursement for the Reducer in the US CMS population for both inpatient and outpatient procedures, both during the COSIRA-II clinical trial and upon potential commercialization in the United States.
In addition to the COSIRA-2 trial, we have made great strides to generate additional clinical data supporting the Reducer. In September 2022, we attended the Transcatheter Cardiovascular Therapeutics Conference hosted by the Cardiovascular Research Foundation in Boston.
At the event, we presented preliminary data in a patient population suffering from ANOCA. This is a different patient cohort from the randomized arm of the COSIRA-2 trial, which focuses on obstructed patients.
This was the first time the company highlighted data on the impact of the Reducer on the objective measurement of coronary flow reserve, CFR, a measure of the heart’s ability to provide more oxygenated blood to the heart muscle during exercise or activity in patients that have angina chest pain without blocked coronary arteries. The outcomes here in this initial study were positive, which indicates that an even larger pool of potential patients might benefit from the Reducer therapy.
There is another important investigational device exemption, or IDE, clinical study ongoing at the US Mayo Clinic, evaluating the impact of the Reducer in patients with ANOCA. This study is also tracking the objective evidence of blood flow improvement measured by coronary flow reserve, or CFR, in ANOCA patients following Reducer implantation. We look forward to seeing the results of this study sometime in 2023. We expect the study to provide important insights into the mechanism of action and the utility of the Reducer in ANOCA patients.
The third and final pillar of our value creation strategy focuses on the development and expansion of the Tiara transapical mitral valve replacement device. We remain committed to the follow-up and monitoring of patients in the Tiara clinical trials, but we have otherwise paused, all our Tiara activities while we focus our efforts on the first 2 pillars of our value creation strategy, domestic and international expansion of the utilization of the Reducer device.
I will now turn the call over to Chris to discuss the financials. Chris?
Chris Clark
Thanks, Fred. The operating losses and comprehensive losses for the three months ended September 30, 2022, was $6.7 million and $8.2 million, respectively, or $3 basic and diluted loss per share, as compared with $6.7 million operating losses and $6.9 million comprehensive losses or $2.79 basic and diluted loss per share for the same period in 2021.
The increase in operating losses of $16,000 can be explained by $181,000 increase in operating expenses, offset by a $165,000 increase in gross profit. The $1.3 million increase in the comprehensive loss incurred for the three months ended September 30, 2022, compared to the same period in 2021 can be substantially explained by a $402,000 decrease in other income, primarily relating to the Canadian emergency wage subsidy received in September 2021, and not in the current period.
The $394,000 increase in interest expense primarily relating to the 2022 notes, and a $401,000 increase in other loss and other comprehensive loss relating to the accounting treatment of the 2019 notes, the 2020 notes, and the derivative liability warrants.
Revenues increased by 31% to $923,000 for the three months ended September 30, 2022, compared to revenues of $703,000 for the same period in 2021. The lingering impact of COVID is still prevalent in Germany. In addition, our revenues in France and Germany are denominated in euros, and our revenues in the UK in British pounds. During the third quarter, the euro and the British pound fell against the US dollar.
Cost of goods sold for the three months ended September 30, 2022, was $220,000 compared to $165,000 for the same period in 2021. The overall gross margin for the three months ended September 30, 2022, was 76% compared to 77% gross margin for the same period in 2021. The company will focus on Germany, France and the United Kingdom where the company sells the Reducer directly to customers for higher margins.
Total expenses for the three months ended September 30, 2022, were $7.4 million compared to $7.3 million for the same period in 2021, representing an increase of $181,000, or 2%. The increase in total expenses for the three months ended September 30, 2022, compared to the prior period can be substantially explained by an $844,000 increase in employee expenses, primarily related to the accrual of bonuses that were accrued in the prior period and a $624,000 increase in other operating expenses related to the COSIRA-II study, offset by an $862,000 decrease in non-cash share-based payments.
As expected, like share appreciation plan was adjusted from one year to four years. A $241,000 decrease in director and officer insurance and a $190,000 decrease in litigation expenses.
Selling expenses for the three months ended September 30, 2022, were $1.1 million compared to $786,000 for the same period in 2021, representing an increase of $276,000 or 35%. The increase in selling expenses for the three months ended September 30, 2022, compared to 2021, can be substantially explained by a $148,000 increase in employee expenses due to an increase in the headcount in Germany, France and the UK at a $221,000 increase and other expenses incurred for the commercialization activities related to the Reducer as the company increased its selling activities and expanded its markets, offset by a $94,000 decrease in non-cash share-based payments as the expected life of the share appreciation plan was adjusted from one year to four years.
General and administrative expenses for the three months ended September 30, 2022, were $2.3 million compared to $3 million for the same period in 2021, representing a decrease of $662,000, or 22%. Decrease in general and administrative expenses for the three months ended September 30, 2022, compared to 2021 to be substantially explained by a $677,000 decrease in non-cash share-based payments as the expected life of the share appreciation plan was adjusted from one year to four years.
A $241,000 decrease in direct earn offer insurance premiums as premiums begin to normalize in 2022 and a $190,000 decrease in litigation expenses related to a decrease in defense costs for class action litigation, all offset by a $251,000 increase in employee expenses due to the accrued bonuses that were not accrued in the prior period and $196,000 increase in other expenses.
Product development and clinical trial expenses for the three months ended September 30, 2022, of $4.1 million compared to $3.5 million for the same period in 2021, representing an increase of $567,000 or 16%. The increase in product development and clinical trial expenses for the three months ended September 30, 2022, can be explained by $444,000 increase in employee expenses due to the accrual of bonuses that were not accrued in the prior period and a $207,000 increase in other product development and clinical trial expenses, offset by a $91,000 decrease in non-cash share-based payments as the expected life of the share appreciation plan was adjusted.
The product development and clinical trial expenses, a transition from the development of the Tiara TF and TA programs, which were indefinitely paused at the end of June 2021 and September 2022, respectively, to the COSIRA-II clinical study. As of September 30, 2022, the company had $31.3 million in cash and cash equivalents. And as of November 8th, subsequent to the effect of the share consolidations, the company had 2,746,625 common shares issued and outstanding.
I will conclude my remarks with an update on our cash runway, which we now expect to last into the first half of 2024. Change in outlook is due primarily to administrative expenses related to the COSIRA-II trial and slightly higher than expected everyday operating expenses.
With that, I will now turn the call back over to Fred.
Fred Colen
Thanks so much, Chris. Operator, I would like now to open the call up for questions.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] And our first question is going to David Martin from Bloom Burton.
David Martin
Yes. Good evening. My first question is, you mentioned you’ve got 48 patients enrolled, 25 randomized. What’s the typical time between enrollment and randomization? And what percent of the patients that you enroll do typically get randomized?
Fred Colen
Yes. Hi, David, this is Fred. It’s a good question. Typically, it’s a matter of several weeks. Once you get enrolled, you still have to go through a lot of prescreening tests. In particular, the treadmill testing, and we could lose some patients there. I really can’t give you a fixed percentage for how many patients we would lose, because it really depends on the learning curve.
In the beginning, with new clinical sites, they may be too optimistic and enroll too many patients, and then they lose some more than they should when they go to randomization. But that’s really also a learning curve, and we see that being corrected over time.
So the ones that have been doing this now for a while have been much more experienced and see much better rate of actual randomization versus enrollment than the newer site. So it’s a complicated analysis and not as — while it’s a good question, not as easy to answer.
The other thing that I can say is that we are very, very active on several fronts in the COSIRA-II trial. One is to continue to activate clinical sites, because we have a way to go. And it is a very extensive administrative process, and we have taken longer in some cases than expected, mostly on — because of the time it takes for the clinics to be able to work through their part of the administrative work to get — to close out all the different parts that need to be closed out. So that’s one factor that is playing a role.
The other one that we are focused on is, engaging our entire organization, including the US field clinical organization in working with the clinics on identifying patients. We’ve also ramped that up quite a bit after the summer break. So we do believe that we will continue to see an acceleration also in enrollment.
We are also, and finally on that side, working hard on some Canadian sites, and we hope to be able to get maybe a one or two patients enrolled before the end of the year in Canada as well with one or two sites opened there. So there’s still a huge amount of activity going on as it relates to activation, but also as it relates to assisting clinics and the coordinators at the clinics to finding the right kind of patients.
David Martin
Did you say you’ve got 16 sites of 50 planned opened at this point?
Fred Colen
Yes, 16. Yes.
David Martin
And 50. So…
Fred Colen
Don’t be surprised at that because, obviously, we will continue to open clinical sites, even a few months before we get to the completion of enrollment. Opening clinical sites is the continuous activity through the entire — for the entire time period.
David Martin
And what’s the split between the US and rest of world on the 16? And are you going to focus on North America now going forward?
Fred Colen
So far, all the sites that we have activated are in the United States. The COSIRA-II trial is a clinical study that’s being executed primarily in the US, with some additional sites in Canada. We have made a commitment that the vast majority of the patients will come from the US to the FDA, but we can have also some additional sites and patients coming in from Canada.
David Martin
Okay. Okay. And then my last question is, you’re waiting to hear from Germany on potentially getting full reimbursement for Reducer. Is that still expected sometime this month?
Fred Colen
So we have heard back from the German authorities. It’s a complicated process as it is in every country for reimbursement. So far so good on that process, but it doesn’t mean that everything is done yet. The first initial response that we were waiting for, we have received and that was positive. But we have many more steps to go through, and we are not really expecting a definitive answer for Germany, until much later in 2023.
In the meantime, we have had reimbursement in Germany on the NUB scale for three or four years in a row, and we are actively working on getting that again in place for 2023 as well. So Germany is a continuous work in process, and we are on plan as it relates to dates and timing for the full reimbursement. But in the meantime, we also have reimbursement on an NUB basis, and we are working on getting that again in place for next year, too.
David Martin
Okay. That’s it for me. Thanks.
Operator
[Operator Instructions] I’ll hand it back over to Fred Colen for closing remarks.
Fred Colen
Okay. Thank you, Jenny. I appreciate it. So let me finalize the call with a closing statement, and I would just like to say that we have really made great progress in the third quarter of 2022 with record-breaking revenues, despite some great and very strong headwinds. And we have built strong momentum behind the Reducer with excellent reimbursement work, generating additional data, in particular, for the ANOCA patient population and ramping up the pivotal COSIRA-II trial. We are steadily making strides towards long-term success, and I look forward to the days, months and years to come.
We are grateful for your participation in today’s call, and thank you all for joining us today. Thank you, and until next quarter. Bye-bye.
Operator
And this concludes today’s call. You may now disconnect.
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