Q2 2021 InspireMD Inc Earnings Call
Ladies and gentlemen, thank you for standing by and good morning, and welcomed and inspire M. D first quarter, 2020, 1 financial results and corporate update conference call.
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Now I'd like to turn on the call over to Mr. Jules Abraham of core I R companies and bolster relationship. Please go ahead sorry.
Thank you Nick and good morning, everyone. Thank you for joining us for the inspire M. D second quarter 2021 financial results and corporate update conference call joining us today from inspire and Dr. Martin Swanson, Marvin and philosophy excuse me on cheap.
<unk>, Chief Executive officer of inspire and D and Craig Shore Chief Financial Officer.
During this call management will be making forward looking statements, including statements and address inspire and deeds expectations from future performance or operational results, particularly in light of COVID-19 of the COVID-19 pandemic.
Forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements for more information about these risks. Please refer to the risk factors described and and small R&D is most recently filed periodic reports on form 10-K, and form 10-Q and the flow.
Okay.
The 8-K filed with the SEC today, and inspire indeed press release and accompanying this call and particularly the cautionary statements and act.
The content of this call contains time sensitive information and is accurate only as of today August 10, 2021, except as required by law inspire R&D disclaims any obligation to publicly update or revise any information to reflect events or.
Circumstances like on RASK and this call. It is now my pleasure to turn the call over to Martin Schlottman, Chief Executive Officer Marvin.
Thank you Joe.
Good morning, and thank you all for joining the second quarter 2021 call and webcast also joining me today is Craig Shaw, our Chief Financial Officer.
And inspire and D. Our mission remains clear to establish CCAR to EPS and the standard of care solution to change the way carotid artery disease is managed and strokes are prevented the free gold carotid stent system enables this change through its unique design and proprietary micro net mesh protection, which has yielded and unmatched and growing body of <unk>.
Clinical evidence and real world practice as well as ongoing clinical studies, we served equally all physician specialists treating carotid artery disease with focus on the stent system and patient outcomes as we create greater awareness of the advantages and see guard as a first line option to broad physician base as well as advance.
New delivery systems and accessory solutions, we believe we can enable the conversion of debt surgically dominated 1 billion dollar global market with a less invasive endovascular standard of care the.
The second quarter of 2021 proved highly productive for inspire empty gaining traction and our execution milestones of global expansion commercial growth and development of new pipeline offerings.
Our revenue performance for the second quarter showed consistent improvement as elective procedures normalized and our commercial momentum group, we achieved revenue of 1.037 million for the quarter by 231% growth year over year.
During the quarter, we sold 1006 hundred 60 devices and increase of 210% as compared to the second quarter of 2020 with renewal of scheduled procedures and a return to pre pandemic levels.
Of our top stated priorities for 2021, most notably we began steps and the path toward commercial registration and see guard and the United States with the initiation of our C Guardians pivotal trial.
We've completed 12 cases of the targeted 315 total enrollment and the first 3 weeks led by our global principal investigator, Dr. Chris Metzger and ballad health system, and Eastern Tennessee, as we launch the trial and the United States at 15 plant sites and what the top carotid stent leaders, we look to establish a foundation.
And of awareness and credibility through the utilization of C Guard, which will position us for a successful and accelerated post approval commercial launch.
In terms of global expansion and we continue our progress and China working with our distributor partners on a regulatory trial execution plans, along with progress and expansion into new markets and Asia, such as Japan, Taiwan and Korea. We believe these markets offer and accelerated opportunity for C guard as the existing standard of care for procedural.
And the intervention is predominantly endovascular focused and less surgically dominated and.
And France, we've received clinical approval for C guard from the French and National Authority, and health and are anticipating reimbursement approval in the coming weeks to enable our plans to launch our next direct sales market along with the U K, we're evaluating other direct sales possibilities to drive higher average sales price and more control of current and developing offerings.
And to enhance our growing commercialization efforts globally, we appointed a new member of our board of directors and formed a medical Advisory Committee with key opinion leaders to guide our progress.
Season, Med Tech marketing executive Katy Arnold with more than 2 decades of strict strategy and commercialization and the medical device industry joined our board of directors Kt's knowledge and leadership will be invaluable and helping our company shape, our strategic plan and expand commercially and business development.
We also appointed a claimed interventional cardiologist starts opinion rosenfield the chair as the chair of the New Medical Advisory Board. The board will provide guidance and direction on clinical need technology advancements and planting the company's growth and strategic direction.
We continue to invest heavily and our pipeline of innovation and advancing platforms that enable more cash procedures, we have and development to new delivery systems advancing to a possible approval in 2022, which we believe will facilitate greater accelerated access to the overall global market potential and specifically address.
And the conversion of surgical procedures to Endovascular stenting.
We're pleased with our progress focusing on establishing segar carotid stent system and the foundational enabler of the stent market conversion, our commercial focus and execution and our current 33 served markets along with building market experience and awareness of C Guard and the United States and Asia III regulatory trial process.
Our building foundations for future success.
And we chart, a new course, and Hell carotid artery disease is managed and stroke, which prevented with our clinically proven and CCAR to EPS system, demonstrating superior clinical outcomes for patients compared to alternative carotid stent types conventional or next generation double layer stents as well as invasive surgical procedures such as endarterectomy.
We're encouraged by our progress and mission and we continue to invest and our future to leverage and unlock the tremendous potential to change the way carotid artery disease is managed and stroke has prevented with that I'll turn the call over to Craig to review, our first quarter financials Craig.
Thank you Marvin and to everyone for joining today here are some key financial highlights for the second quarter ended June 30th 2021 total revenue for the quarter was $1.038 million and increase of 232% compared with the $313000. During the 3 months ended June 32012.
And so you've got an EPS had revenue of $1.019 million from increase of 276% from $271000 for the same period last year. This sales increase was mainly due to procedures with CRT P. S, which are generally scheduled for non emergency cases began this quarter to return to normal levels as compared to the 3.
3 months ended June 32000, and 'twenty on procedures with CCAR and EPS from mostly postpone as hospitals shifted resources to patients affected by COVID-19, and this increase and sales of cigar was partially offset by a decrease of 55% and sales of the MLR crime EPS from $42000. During the 3 months ended June 32.
<unk> thousand 20 to $19000 trying to 3 months ended June 32021 for the 3 months ended June 30th 2021, we had a gross profit of $262000 compared to a gross loss of $120000. During the 3 months and the same period last year. This increase in gross profit primarily.
Resulted from a $237000 increase and revenues less the related material and labor costs, and a decrease and write offs of $144000, which are driven mainly by changes related to components supply issues gross margin increased to 25, 2% during the 3 months ended June 32021.
From a negative 38, 3% during the 3 months ended June 32020 for similar reasons as I just stated.
Total operating expenses for the quarter were $3.7 million and increase of 59% compared to $2.3 million for the same period and 2000 and 'twenty. This increase was primarily due to increases of $705000 and salary expenses and related accrual expense is mainly driven by temporary salary reductions during the 3 month.
And at June 32020 that were implemented in response to the COVID-19 effect on revenues as well as additional resources, mainly and our product development and sales infrastructure.
$437000 and expenses related to the commencement of the seek audience FPA study $315000 and share based compensation expenses due to the expense recognition of grants made after June 32020, 297000, and development expenses associated with cigar and EPS accessory solutions.
And $180000.108000 or directors and officers liability insurance expense due to the increased premiums caused by recent trends and the overall insurance industry. This increase was partially offset by a decrease of $400000 relating to a settlement agreement with an underwriter of our prior offerings, which occurred in the 3 months ended June.
30th 2020, and a reduction of $86000 and miscellaneous expense.
Net loss for the second quarter totaled 3 million and $507000 or <unk> 46 cents per basic and diluted share compared to a net loss of $2.480 million or $2 and 93 per basic and diluted share for the same period and 2020. The average amount of shares outstanding used for the earnings per share calculation.
And were $7.7 million and Q2, 2021, and 845000 and Q2.2000 and 'twenty both adjusted to reflect the 1 for 15 reverse split effected by US on April 26.2021.
As of June 32021, cash and cash equivalents were $41.4 million compared to $12.6 million as of December 31, 2020 with that I would now like to turn the call over for questions. Operator. Please go head.
Yeah.
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I'm on monthly for the first question.
Our first question comes from Brian Hey, Lora Alliance Global Partners. Please go ahead.
Good day, gentlemen, and thanks for taking the questions.
First off from me just just on the well first congratulations on getting the C. Guardians trials started and.
Oh, and that's great to see on the dozen or so patients that you've enrolled so far I would imagine you know I don't know if you can talk about procedural success at all but are there any kind of non outcome measures and procedure times. All of these cases are scheduled.
You know things of that nature that you might be able to share.
Yes, Ben Thanks for the question. So so far on the enrollment has gone and accordingly, and we're actually thrilled by the number of cases.
And this particular case that Dr. Chris Metzger has scheduled.
It's an aggressive schedule and he is quite excited to use C guard.
And with its many appropriate cases as possible. So we're looking forward to to that trend continuing and the cases, continuing to enroll and an accelerated pace, which was always our our hope and our intention to try to get the enrollment phase of this trial completed as soon as possible. So so far it's been.
It's really exceeded our expectations in terms of the usefulness of C Guard.
And the number of cases did and it's been enrolled and we plan to bring 2 or 3 more sites on within within the next month. So it's a it's now and move to to get more people enrolling so so far so good.
Well, I mean and juice it looks like Doctor Master could almost enrolled by himself away the way he's going with it.
He certainly has the cases right. Okay. So yes. So that's not just you know I know that they're not necessarily completely elective procedures, but you know that there are things that can be postponed a little bit was there kind of a backlog that is that he is working through on those first 11, or so cases that you mentioned.
No. He obviously wants to find the appropriate cases to be done related to the trial, but he has that kind of volume, but we certainly want to spread out the work amongst the with 15 other operators and the U S. So that we get a nice diversity within the community. So he just hedged and that number of cases that he's often doing well.
Okay.
And maybe I'm asking too many questions on this and does he kind of schedule like a CCAR day or.
And each week or how how does see you tend to do them.
Yes. Most of it is is a specific patient related and case related so he evaluates its patients and as you said the majority of these are elective and so he is able to do a thorough evaluation and then it goes to a committee for review with Jeff.
It's a very defined process of which cases get enrolled and so he has a high volume and and schedules accordingly. So it's.
And just happens to be that the volume is significant.
Okay now that makes sense and then it's nice to hear about the C Guard prime and the new Embolic protection device.
And.
What are the thoughts there on you know kind of capturing a greater share of the procedure I assume is the plan with you and Bob Embolic protection device and then I assume it's it's the improvements and the and the transfer Emerald device delivery system there.
Is that just to make it easier on docs.
And the color that you can offer there.
Sure Ben it's a it's a great question and as I've mentioned in previous calls our objective is to make sure that we have the appropriate delivery systems for.
For any specialists, that's interested and managing carotid artery disease.
And whether there interventional or current surgery focused so we're continuing to make sure that our delivery systems match those those objectives and CCAR time is that next generation transdermal system that we are we believe that we will just make the delivery process and that transdermal approach.
Zero for the physicians, it's just that next generation device that we always look to make improvements and the feature set and and the pipeline.
In terms of the the other device, it's a little premature at this point to share the specifics.
On the details of the delivery system.
Just say that we're incredibly pleased by the progress and we believe that this will in particular and enable this conversion of a vascular surgery over to endovascular procedures, which which is really a.
A significant goal for the company as you know so we are all about focusing on the stent system and patient outcomes and.
And I want to make sure that our delivery systems are available to whatever sub specialists, we don't discriminate amongst.
Amongst groups.
They are involved with carotid artery disease management, we want to make sure that we're their first line solution with <unk>.
Okay and that makes a lot of sense and then.
Maybe just digging a little bit deeper on the the improvements of the trends several device I mean are those kind of.
Yes.
You know ergonomic improvements or the day, you know what what sort of improvements are or have been made on the device. If this if you could share yeah. We we we've taken kind of and end to end solution and any multi generational product development plan that every good company has we tried to look at every feature and.
Aspect of the device from the catheter tracking through the handle design and device and so we're really trying to just step up.
The delivery system from end to end to make sure that it's and functional as possible and that it makes delivery of the sea guard.
And as easy as possible even under acute cases are symptomatic cases, where physicians are just very comfortable with the device and how it performed so it's really been a comprehensive and.
And looked at and making sure that the devices as it should be and we've been guided and get direct feedback from our physicians obviously on those those things that we wish to improve which is which is the way it should be.
Okay, Great and then just lastly from me I guess, you mentioned regulatory approvals in 2020.2 does that encompass a you know and kind of outside the U S. I would imagine and CE Mark for sure but are those also kind of 5.10-K products that are the <unk>.
Get cleared and buy the F D a.
Well prior to the the clearance will see guard or or what's the.
Thought there.
We're evaluating all the options at this point Ben as you know the M D. Our conversion and and the CE Mark and Europe has changed a lot of the regulatory landscape.
We are certainly looking at a comprehensive regulatory solution for both of these devices and making sure that we're keeping up with with the markets as they evolve and unfolds, so where we're looking at both and in terms of the the possibility and potential.
Okay Fair enough and that's all I had for this morning, Thanks, a lot gentlemen, and congrats on all the progress.
Thanks Ben.
Yeah.
Okay.
This concludes our question and answer session on the call a lot was done on the call to Mr. Marvin and last 1 for closing remarks.
Thank you I'd like to thank everyone for taking the time to join today and your ongoing support and inspire M D. As fundamentally a stronger company today than ever before and I'm very proud of the extraordinary efforts from our expanding team and creating excitement for the future for the company and look forward to updating everyone on the third quarter results and the future.
Thanks very much.
Yeah.
And so now concluded. Thank you for attending today's presentation you may now disconnect.
Okay.
Okay.