May 8, 2020
Operator
Good day. Welcome to the Neovasc, Inc.
First Quarter 2020 Earnings Call. Today's conference is being recorded.
At this time, let's turn the conference over to Mr. Mike Cavanaugh, Managing Director at Westwicke.
Please go ahead, sir.
Mike Cavanaugh
Good afternoon and thank you for joining us today. Earlier today, Neovasc, Inc.
released financial results for the quarter ended March 31, 2020. The release is currently available on the Investors section of the company's Web site 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 federal 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 fact 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 those 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 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 7, 2020. Neovasc disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events or otherwise.
I will now turn the call over to Fred.
Fred Colen
Thanks, Mike, and good afternoon, everyone. Let me start by commenting on the macro environment.
This is an unprecedented time for the company, our shareholders, and the world. I would first like to thank the healthcare providers and first responders who are fighting around the clock against the COVID-19 pandemic.
Life has changed dramatically for all of us, and I'd like to also thank all Neovasc employees for continuing to advance our core value creation strategy, and we believe we will emerge from this stronger than ever. Neovasc delivered a solid quarter, making progress in all four of our value creation strategies.
Starting with our value creation strategies around Reducer in 2020, our Reducer commercialization efforts in Europe, the company was on track for its highest quarterly revenue total and number of Reducer implants, until the pandemic precipitated a sharp decrease in elective procedures mandated in Europe as of mid-March. Reducer implants have been impacted by the reduction or cessation of elective procedures in Q2 as well, and we expect a slow increase in implantation rate in the quarter, or only Q3, as elective procedures resume.
It is important to note that, while Reducer implant procedures are considered elective, many patients are suffering severe pain from refractory angina, and we believe the backlog of delayed implantation will proceed in the second half of 2020. We continue to work our reimbursement strategies in the European Union, and during the quarter, the NUB status 1 reimbursement for Reducer was renewed in Germany.
On regulatory approval and commercialization of the Reducer in the United States, the PMA was submitted to the FDA at the end of 2019 and was formally accepted in January. We continue to have positive ongoing discussions with the FDA, and we appreciate their efforts to communicate with us during the COVID epidemic.
Moving on to the value creation strategies around the Tiara device in 2020, on the CE Mark submission process for the transapical Tiara, we remain focused on CE Mark submission for the transapical Tiara device, and we will provide an update to the market when appropriate, and the Tiara transfemoral first-in-human development pathway, we continue to develop the next-generation Tiara TF transfemoral device. During the quarter, we reached a designed fleet on this new device, and we are now progressing towards a first-in-human implant targeted for late 2020.
We have established a global position steering committee, comprised of some of the most respected leaders in the field, and we look forward to leveraging their expertise as we advance the program. Since the end of the quarter, and announced on May 1st, we received notice that the NASDAQ Hearing Panel has granted the company's request for an extension through to August 17, 2020, to comply with the $35 million minimum market value of listed securities requirement for continued listing on the NASDAQ.
We believe that remaining on the NASDAQ is an important piece of our strategy, as we work to overcome the last capital structure hurdle that may be impacting our valuation. We can now focus on our fundraising activities to ensure we have sufficient capital on hand to reach our key milestones into the first quarter of 2021.
Overall, we are very pleased with the quarter and believe we have put the building blocks in place to achieve significant advancement in Neovasc's value creation strategies in 2020. We, like everybody else, are adversely affected by the pandemic, but we believe we will emerge from this stronger than before.
I will now turn the call over to Chris to discuss our financial results.
Chris Clark
Thank you, Fred. Before I talk about our financials, I would echo Fred's comments that the company was performing well prior to the slowdown associated with the coronavirus, and we are taking steps to minimize costs, where possible.
In the U.S., in Canada, and Germany, we are looking at government programs to minimize our startup costs, and we have reduced selling expenses, while elective procedures for Reducer remain restricted. Turning to the financials, the operating losses and comprehensive losses for the three months ended March 31, 2020, were $7.2 million and $2.7 million respectively, or $0.38 basic and diluted loss per share, as compared with $6.8 million and $7.9 million respectively, or $0.21 basic and diluted loss per share for the same period in 2019.
The increase of $300,000 in operating losses can be explained by the increase in product development and clinical trials expenses, as it continues to incur development and clinical costs related to Tiara, and regulatory costs related to Tiara and Reducer. Revenues for the Reducer increased by 9% to $533,000 for the three months ended March 31, 2020, compared with revenues of $586,000 for the same period in 2019, as the company experienced a significant reduction in Reducer procedures in mid-March as a result of the COVID-19 pandemic.
Cost of goods sold for the three months ended March 31, 2020 was $125,000, compared to $141,000 in the same period in 2019. The overall gross margin for the three months ended March 31, 2020, was 27%, compared to 75% gross margin for the same period in 2019.
The company continues to focus on Germany, where the company sells the Reducer direct for higher margins. Total expenses for the three months ended March 31, 2020 were $7.6 million, compared to $7.3 million for 2019, representing an increase of $275,000 or 4%.
The increase in total expenses for the three months ended March 31, 2020 compared to 2019 can be substantially explained by a $283,000 increase in product development and clinical trial expenses, as the Company continues to incur development costs. Selling expenses for the three months ended March 31, 2020 were $554,000, compared to $368,000 for 2019, representing an increase of $185,000, or 50%.
The increase in selling expenses for the three months ended March 31, 2020 compared to 2019 can be substantially explained by a $64,000 increase in employee expenses, as we have added two extra sales reps since March 2019, and a $117,000 increase in other expenses incurred for commercialization activities related to the Reducer. General and administrative expenses for the three months ended March 31, 2020 were $2.5 million, compared to $2.7 million for the same period in 2019, representing a decrease of $193,000.
The decrease can be substantially explained by a $79,000 decrease in non-cash charges for collaboration, license and settlement agreements, as such liabilities have been reduced by scheduled payments in August 2019, and a $85,000 decrease in other expenses, as the company continues to constrain costs where possible. Product development and clinical trial expenses for the three months ended March 31, 2020 were $4.5 million, compared to $4.2 million for 2019, representing an increase of $283,000, or 7%.
The increase can again be substantially explained by a $211,000 increase in employee expenses and a $75,000 increase in other expenses, as the company continues to incur development and clinical costs related to Tiara and regulatory costs related to Tiara and Reducer. I will now turn the call back over to Fred.
Fred Colen
Thank you, Chris, and thank you all for listening to our opening remarks. Overall, we are pleased with the quarter, despite the negative impact of the pandemic.
We are continuing to make progress with our four value creation strategies. We believe that we will get through these difficult times and get back again to growth after Europe gets through issues related to the coronavirus.
The FDA is reviewing our Reducer PMA submission, which process has not been impacted by the pandemic. During this crisis, we have held together our valuable employee base.
We are all safe and feel that we have the team in place to execute on the value creation strategy. I would like to thank our loyal investors for their confidence in us to realize the great potential of Reducer and Tiara.
I will now open the call up for questions.
Operator
Thank you [Operator Instructions]. We will take our first question today from Danielle Antalffy from SVB Leerink.
Danielle Antalffy
Hey, good afternoon, guys. Thanks for taking the question.
Fred, I was hoping to get a little bit more color on what's happening with Tiara during this COVID period. Are any patients being enrolled in any of the trials at this point, or has that been halted, and particularly, you know, in the centers ex-U.S.
[technical difficulty]
Fred Colen
Yes, Danielle, thank you for your question regarding enrollment in clinical trials, in particular for the Tiara. So, first of all, as you know, the TIARA-I study was closed, so we have the TIARA-II clinical study open in Europe.
The clinical study activities in Europe are extremely limited because of the fact that most clinics are really focused on the treatment of the pandemic patients, and clinical trial enrollment has been severely hampered, I would say for us and for all companies. Nevertheless, we actually have at the moment one request out of Germany for an implant, for a Tiara implant in the TIARA-II trial, and that is -- and that is even despite the fact that, really, there is no clinical activity going on, in general, but I would like to say something else that I think is even more important, and that is that we have determined, in the CE Marking process, that we have sufficient clinical data as it is, with our clinical data in TIARA-I and TIARA-II, and as well in compassionate use, to be able to fulfill CE Mark requirements.
So, in fact, the whole process of us getting to a European approval is not really impacted by additional enrollment in our clinical studies. It is primarily impacted by the questions around MDR and MDD, and as you probably have heard, it's looking very, very likely that the European Union and the European countries are going to adopt a one-year delay in MDR transition and continue to stick to the MDD rules, and that has been basically suggested by the commission, has been approved by the European parliament, but still needs to be formally approved by the individual European countries.
Once that's the case, then the notified bodies can continue to work on submissions under MDD. So, we actually believe we have an advantage because of this, and actually, the pandemic doesn't work against us, because we already have sufficient data, as opposed to probably all the other companies that still need a lot of clinical data we have the clinical data already, so we're not really being delayed because of the coronavirus in Europe, just to explain that point.
Danielle Antalffy
Got it, okay, that's really helpful. Fred -- excuse me, Fred, I don't know if this is for Chris or Fred, but given that you are a research and development company, essentially, at this point, you know, as you're pursuing a PMA, waiting for the PMA [indiscernible] here in the U.S., how do we think about -- you know, I appreciate you have enough capital until 2021, but the reduction in spend during this time period, we're generating little Reducer revenue, how do we think about the levers you can pull to save money, but still advance some of the pipeline products?
Thanks so much.
Fred Colen
Yes, so let me take this also, Danielle. So, like Chris said, we have applied for government support programs in Germany, in the U.S., and in Canada.
And we actually feel very optimistic about receiving some major additional financial support from these government programs. So, then it all boils down to, when is the Reducer revenue going to come back?
We see some positive signs already starting, in particular, in Germany. Italy is, as you might imagine, still extremely problematic.
It will all depend on how fast the revenue will come back, but given the financial support that we are able to gain from government programs, we think that the overall impact will be rather limited, but it will all depend on how quickly the Reducer revenue can come back again. And you know, obviously, we think there's going to be an uptick starting in May, but really in June, and then probably going through July and August, but then you obviously have the summer months in Europe.
That could be another issue. So, this is why we really talk about we think Reducer revenue is going to come back in a much more pronounced fashion, you know, late in Q3, and then, obviously, strongly in Q4 again.
That's our belief, but yes, we -- in the meantime, we are trying to save expenses as much as we can, without impacting our four strategies of value creation. I can tell you that the transfemoral Tiara program has continued to make great progress.
We did not really incur a lot of delays. We had some delays with some clinical parts from vendors that we were awaiting because of the impact of the pandemic, but overall, we have been able to keep the programs going.
So, it's not that we're just sitting here not doing nothing and just twiddling our fingers. We are actually continuing to make great progress in all of our programs.
Danielle Antalffy
Thank you so much.
Operator
And that's all the time we have for questions today, and that will conclude today's call. Thank you for your participation.
You may now disconnect.