Q1 2022 InspireMD Inc Earnings Call
Greetings and welcome to.
Inspired M D.
First quarter 2022 earnings call.
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A brief question and answer session will follow the formal presentation.
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Should meet operator assistance. Please press star zero on your telephone keypad.
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At this time I'd like to turn the call over to your host Chuck The dollar life life side Visors. Thank you you may begin.
Thank you operator, and good morning, everyone.
Thank you for joining us for the inspire and the first quarter 2022 financial results and corporate update conference call.
Joining us today from inspire M D R. Marvin Schlossman, Chief Executive Officer, and Craig Shore, Chief Financial Officer.
During this call management will be making forward looking statements not historical facts that are based upon managements current expectations beliefs and projections many of which by their nature are inherently uncertain.
They involve risks and uncertainties that may cause actual results to differ materially from those expressed in forward looking statements.
For more information about these risks please refer to the risk factors described it as Byrom DS. Most recently filed periodic reports on Form 10-K, and Form 10-Q filed with the U S Securities and Exchange Commission and inspire empties press release that accompanies this call, particularly the cautionary statements made in it.
The call contains time sensitive information that is accurate only as of today may 10 2022.
Except as required by law inspire indeed disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.
It is now my pleasure to turn the call over to Martin Saltzman Chief Executive Officer Go ahead. Please Martin.
Q1, 2022 proved to be a very busy and productive quarter against fire empty with approximately 1900 10 CCAR expenses can sold to our 31 served markets representing revenue of $1.161 million, we accelerated enrollment NRC Guardians F D. A try.
Bill, including initiating our first European site.
Preparing for enrollment of the first randomized patients in the crest to trial.
Received regulatory approval for our European logistics hub, enabling our direct sales in the U K and France and prepared for expansion into more direct sales markets.
We added five new members of our expanding global team, including seasoned sales and marketing professionals as well as bolstering our world Class Engineering Department to keep pace with our expanding R&D programs and commercial growth.
Our mission at inspire and D is to establish a new standard of care for addressing carotid artery disease, and stroke prevention, which is foundational any different than any other company.
Patient outcomes, both short and long term depend on a stent platform, which delivers unmatched clinical results to this ever expanding endovascular focused market.
The guard carotid stent system through its unique design and proprietary micro mesh protection delivers and maintain superior vascular patency compared to all of their stent devices and open surgery.
In order to enable this change to better patient care and to make segar ubiquitous in this market, we're focusing on all specialties treating carotid artery disease by approaching this market in this comprehensive stent centric approach. We believe we can enable the conversion of this surgically dominated 5 billion dollar global <unk>.
It'll addressable market to a less invasive endovascular standard of care, which sustained results.
Revenue for Q1 was $1.161 million, reflecting a 20% growth year over year and she guard sales on 1900, 10 procedures and units sold.
It is important to note procedural volume as a more accurate indicator of the strength and size of our business as we currently share a proportion of the average sales price in the major markets with our distributor partners further emphasizing our priority to convert more markets to a direct sales approach to fully capture topline revenue recognition or euro.
P N hub will facilitate and accelerate our planning of a more direct market conversion for distribution during 2022.
Turning to our advancing enrollment in the CE Guardians F D. A I D E trial.
Our expanded site training and enrollment continues with 13 sites currently enrolling in the U S with plans for three more along with our first site in Europe with plans to start three more they're all during the next two quarters.
Patient enrollment continues to accelerate rapidly, what's more investigators experience and gain confidence and see guard.
Our current outlook remains consistent anticipating the completion of enrollment of the trial in Q1 2023.
We continue talks in Japan, but distributor partners interested in representing C Guard, which would complement our distribution agreement in China signed last year, we believe the Asian market offers an opportunity for C Guard.
As the existing standard of care for procedural intervention is predominantly endovascular focused and less surgically dominated as.
As we announced in our previous reporting our commercial pathway to business growth for C Guard will be facilitated by a new trans femoral delivery system C Guard prime offering a greater navigation flexibility to address challenging patient anatomy as well as broader set of evolving indications.
The guard prime will be available in both standard and short shaft versions compatible with the development of our switch Guard T car accessory device, that's enabling a trans carotid option for our tool set designs for those clinical needs and conversion of greater surgical procedures to a stent platform with CRT P. S. Most.
Devices are planned to launch in early 2023, and we believe will foundational he changed the landscape of CCAR to utilization to the broadest group of specialists performing endovascular procedures.
Thus far the feedback from our Kols community has been enthusiastic and encouraging.
As we chart a new course of how carotid stenosis is managed and how strokes are prevented with our clinically proven CRT P. S system. Our mission is to provide the best patient outcomes and broad set of tools to unlock this tremendous potential in this rapidly growing and evolving market segment with that I'll turn the call over to Craig to review our first.
Water financials Craig.
For the first quarter of 2022 revenue increased 18% to $1.183 million from $1.006 million. During the first quarter of 2021. This increase was predominantly driven by a 20% increase in sales volume. So you got E. P. S from 969.
Thousands of dollars in the same period, one year ago to $1.161 million for the first quarter of 2022. This sales increase was mainly due to growth in existing and new markets as well as the returning demand from hospitals in a post COVID-19 environment integration U S sales increased due to <unk>.
<unk> used in the CRT in F D. A clinical trial due to the ongoing conflict in Russia, Belarus, and Ukraine and related currency restrictions, we do not sell to these three countries. During Q1, eliminating our reported growth if we eliminate the impact of these countries that would have been a 32% year over year growth in CCAR E. P. S.
Versus the 20% reported number.
Gross profit for the first quarter of 2022 increased by $16000 to $122000 compared to a gross profit of $106000 for the first quarter of 2021. This increase in gross profit resulted from decreases in write offs, which were driven mainly by component supply issues.
Gross margin was 10, 3% during the three months ended March 31st 2022 versus 10, 5% on the prior year period.
Total operating expenses for the first quarter of 2022 of our $4.6 million, an increase of $1.2 million compared to $3 4 million for the first quarter of 2021. This increase was primarily due to increases in expenses related to the commencement of the Guardian's FCA study and share based.
Sure.
Net loss for the first quarter of 2022 totaled $4.5 million or 57 cents per basic and diluted share compared to a net loss of $3 $2 million or <unk> 53 per basic and diluted share for the same period in 2021 as of March 31, 2022 plan.
Cash equivalents and short term bank deposits were $29 $9 million compared to $34 million as of December 31st 2021.
Like to now turn the call over to the operator for questions.
Thank you ladies and gentlemen at this time, we will be conducting a question and answer session.
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Our first question comes from the line of Ben Hayner with Alliance Global Partners. Please proceed with your question.
Good morning, gentlemen, and thanks for taking the question and Ah Congrats on the progress it seems like things are moving along nicely.
No no the co principal investigators that you have in Poland, I know he's been pretty prolific and do it. He guard cases in the past I was wondering if you expect his.
<unk> cadence to be similar to someone like docker metsker or slightly slower.
Yeah, Hi, Ben Thanks for the question Professor of P. O Jeremy Seattle like is a is the person you're referring to in and he has been a K O L of ours for quite some time probably has the most experience with the guard if anyone in the world and we certainly believe that his volume of procedures and contribution to the trial will be on par with.
With any of the top carotid stenting physicians in the world. So we're incredibly enthusiastic about a professor you see I like being involved in a as a co P. I and also driving incremental enrollment and in Europe in general it'll be leading the effort with with our investigators there.
Okay, Great and then on the the conversion to direct in the distribution hub.
Hub.
I agree with you guys cite what what what countries do you intend in Europe to go direct first I know you are to direct in France, but what are you. What are the next one is kind of out of less.
Yeah. So Ben it's were right now were direct in France, and the U K, both and where in the process of fine tuning the details on the other countries as you can imagine its a bit sensitive given the fact that Oh, we have distribution agreements in place and many of those areas. So we're working through the details now, but the first step was to.
Put this logistics hub in get it cleared from a regulatory perspective and make sure that we're in a position to be able to just sell efficiently on a direct basis there'll be much more information in subsequent calls, but our plan is to is to engage a number of countries on a direct model to take advantage of the higher E. S P and much more.
More control of of the market space with new products in the pipeline, we certainly want to control the the effort and make sure that we're doing that on a direct basis, but much more on that topic up in subsequent calls.
Okay. So so stay tuned there.
Did I hear you correctly in the prepared remarks that you're in the <unk> trial and have done the first cases.
And if so you know how many cases do you think might be available to you got to you guys.
I forget exactly where the enrollment stands on on that trial in the center.
Yeah, we were preparing for first cases right now obviously, there's a considerable amount of paperwork to be done and logistics to be sorted out where we're thrilled to have been approved to participate in the stenting Arbor crest. Two trial that was a huge milestone for us and we've been working diligently with the Crestwood Executive Committee to get the right locations why.
Some of which are currency guardians sites and so we will we'll have much more detail on that in enrollments hopefully during the quarter. The weekend, Sharon detailed but right now where we're preparing those sites and we don't have a firm number for you at the moment, but we certainly think that C guard is bringing a refresh view of.
Of those operators being interested in contributing to the stenting arm. So that that we believe will help considerably are in the the effort with with the crest to enrollment.
Okay. That's helpful. And then you know I don't know if you guys have better information, but I thought I had heard that the oh.
The second arm was a decent about behind the other arm there what a C. E. On there what are do you guys have any sense of that and.
Any additional color that you have on how that trial is progressing.
We don't ban we we don't have any specific details that we can share you know we we certainly.
Have her job similar feedback, but don't have a quantitative measure at this point, but with CCAR being available to enrollment we hope that that job you know continues to to provoke the dissenting side of the of.
The enrollment in and make that more robust, but we.
I don't have a specific number for you at this point.
Okay, that's fair enough.
Yeah.
Back on your your kill all of that I think a doctor Mascara and ductile iron both made statements kind of suggesting that CMS was it was kind of.
The reviewing the national coverage determination for <unk> and me have been likely to kind of expand coverage in the near term to kind of match D. A.
Is there anything more on that front that you guys have heard.
We are we don't have any more details, except we're certainly supportive of the effort and encouraged by the trend here. We we we hope that CMS does begin to cover standard risk.
And you know that that would be a tremendous milestone for us and obviously all of those that contribute to the to the stenting side of the business and an endovascular approach. So we're again encouraged by the progress we don't have any details other than we continue to support all of the efforts industry wide that are going on to try to.
You know enable that change and that would be a huge uplift obviously for us and for the space in general.
Not a big.
A big deal for sure and then lastly for me just you know what what activities remain.
We remain on CCAR crime and switch guard regarding development and submission and all that fun stuff and then what.
Geography geographies do you plan on launching that adverse and I guess is the decision to go direct partially driven by by those products.
Yeah, absolutely bad I think I think you're you're up you're right on there and our direct effort and many of the countries is driven by the fact that we've got new products to launch and we certainly want to take full advantage of that momentum right now, we're well into the R&D and what we call V. N V stage of of getting these products through the <unk>.
The pipeline and getting all the clinical data required to get that into the regulatory pathway. So you know our hope is to continue that effort and you have to have all of those approvals take place in a timely manner. We're anticipating a Q1 launch of both the products and we're incredibly enthusiastic about both of those because they offer.
Or you know tremendous access to a much broader base of physicians interested in stenting and most importantly that comprehensive approach to both the interventional list as well as vascular surgeons that is fundamentally different about how we approach the business week, we see this as a comprehensive approach in the ultra.
The goal is to place the guards dense that's that is the are the basis of our business and frankly from a from a patient quality of life and clinical outcomes perspective. The stent is really what matters, so where we're really looking forward to having those delivery systems in the pipeline and available in 2023.
Excellent.
Great updates and congrats on the progress gentlemen, that's all I had.
Thanks Ben.
Yeah.
There are no further questions in the queue I'd like to hand, the call back over to Marvin Sussman for closing remarks.
Thank you I'd like to thank everyone for taking the time today to join the call and for your ongoing support we're extremely proud of the progress from the quarter and look forward to 2022.
A breakthrough year for inspire M D.
Yeah.
Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.
Okay.