Q2 2021 Neovasc Inc Earnings Call
[music].
Greetings and welcome to the Neovasc incorporated second quarter, 2020.1 earnings call. At this time, all participants are in a listen only mode.
And I'll answer session will follow the formal presentation and.
And no 1 should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note. This conference is being recorded I will now turn the conference over to your host Mike Cavanaugh Investor Relations. Thank you you may begin.
Thank you Alex good afternoon, and thank you all for joining US today earlier today Neovasc incorporated released financial results for the quarter ended June 32021.
The release is currently available on the investors section of the company's website at Www Dot Neovasc com slash 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'd like to remind everyone that management will be making statements. During this call that include forward looking statements within the meaning of the 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 annual information report on form 40, F and the discussion and Neovasc and DNA, which are available on Edgar and SEDAR.
The information provided in this conference call speaks only to the live broadcast today August 10.2021.
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.
Q2 was a strong quarter for Neovasc.
Are particularly pleased with our sales results and the important strategic initiatives, we undertook joined the period.
Joined this quarter, we streamlined our strategic focus to match, our ambition with a medium to longer term view, making use of the significant $72 million proceeds to pursue 3 value creation strategies.
And we continued expansion of reducer revenue in Europe, and outside the U S through reimbursement and new market penetration.
And we moved towards initiation of a new U S. IDE clinical study and 2021, whereas the aim of supporting a future PMA submission to the FDA.
And we continued targeting a decision on the chair at Ta trends apical device for CE, Mark now under the new European medical device regulation or <unk>, our rules and late 2022.
Also joined the quarter, we made the clarifying decision to suspend activities related to the next generation <unk> T F <unk> femoral device.
Overall, we are very pleased with the progress we made in the quarter to position Neovasc going forward.
Moving to our topline performance.
Revenues for the second quarter were $633000 compared to 284000, and the second quarter of 2020 and increase of 123%.
And compared to 440000 in the second quarter of 2019 and increase of 44% over the last second quarter without COVID-19 related impact.
More contemporaneously, we observed a 40% quarter over quarter growth compared to the first quarter of 2021.
We also saw a record number of reducer implants, and the second quarter. This despite the fact that Covid remains a challenge and Europe and I would like to thank our direct sales team and part of distribute distributors for their diligent work and achieving this milestone.
And <unk>.
I'd now like to take a few minutes to discuss the steps we took during the quarter to help establish and medium to long term success for the company.
And as many of you know in early June we made significant changes to the neovasc workforce, making a necessary 40% reduction in our workforce directly driven by our decision to suspend the chair at TFS development program.
We were sorry to Louis and many valued colleagues, but we wanted to extend the cash runway of the company to help establish our medium and long term success.
We are now more streamlined and the entire organization is focused on specific goals aimed at building shareholder value and the medium term as our top priority.
As a result of the decision to pause the tiara TF development program. We now expect to have adequate cash to fund operations for 3 years into late 2024, which should limit dilution to our current shareholders from further follow on financing.
During that period.
Following this strategic move to pass a tier of Ta T F and sorry to pause the tiara TF development program, where it did make 2 key additions to the team hiring 2 industry veterans that we believe significantly strengthen our capabilities around our <unk>.
U S I D equals <unk> 2 study.
Just after the end of the quarter, we appointed Lisa Becker as Vice President of regulatory Affairs Global engine, our therapies and Sarah Gallagher as Vice President clinical affairs. Each of these very talented women, bringing over 20 years of experience and regulatory.
Maury and clinical affairs, respectively, and they will be invaluable and members of the Neovasc team.
I'd like to take a few minutes and discuss the progress we have made towards expanding the adoption of our unique reducer device.
As I mentioned earlier, we saw a record number of devices implanted and Europe joined the second quarter.
This despite the fact that Covid remains a challenge and Europe.
We believe the number of implants reflect a strong and growing demand for reducer and <unk>.
We'll continue to push hard to expand the utilization of this unique and often life change and device to address refractory angina and now have 4 personnel on the ground and Germany, who are actively marketing the reducer to cardiologists and we have relationships with multiple distributors offering we do so.
Our European Union, including Switzerland, The U K, Italy, Spain, the Netherlands and Austria.
We enjoyed an excellent reduce some policy and at the Euro PCR meeting with a large a virtual participation of many physicians throughout Europe.
We are also seeing a flow of positive data supporting reducer in the European Union and people.
Most recent example, being the paper published by Dr. Francesco Ponticelli at Maria Cecilia Hospital cost and Yola, and Italy, describing the long term outcomes of patients suffering from refractory angina treated with reducer.
At a median follow up of 502 days after reducer implantation, almost 40% and fact 39, 7% of patients improved by 2 or more to ECS classes, which is a measure of angina severity and 70.
6% improved by 1 or more classes.
The procedure appears safe given that procedural success was achieved and 96, 7% of attendance.
We believe that our marketing efforts, coupled with the flow of positive data supporting reduce of safety and efficacy and efficacy.
Working to support growing reduce our revenues, but we also know that we have a lot more to do.
Regarding the United States market, we are actively and with urgency and working towards initiating the coursera to U S. IDE study, which will be a double blind sham controlled randomized controlled trial of the reducer device versus a <unk>.
And procedure to be conducted and North America.
The core of this <unk> study was already originally approved by the FDA in November of 2017, but due to our past financial constraints, we were unable to initiate the study until now.
We are and the process of supplementing this study and to update and improve it with everything that we and the FDA has learned in the interim since its initial approval.
We were pleased with the Fda's decision to designate reducer as a novel breakthrough device and late 2018 and believed we had a good chance of PMA approval was that designation.
The title decision and subsequent not approvable letter turned out to be very disappointing for us all and certainly for many U S patients.
As such we have reverted to the original 2017 approved IV study, which we will be supplementing instead of having to work on and file a completely new IV study, which we have estimated has saved us up to a year of work before.
We're initiating this clinical study.
As we stated and our last earnings call, we have created and executive steering committee to oversee the trial and the <unk> study protocol has benefited from their expertise console coupled with the productive discussions we have had with the FDA.
The company continues to work towards a first patient enrollment near the end of 2021.
We are hopeful that the U S trial that should demonstrate the reduce of safety and effectiveness comparable to the real world performance. The reducer has already demonstrated over a sustained period of time and over multiple studies will help us develop a successful PMA.
Application to the FDA.
I would also like to take this opportunity to update you and our efforts to expand reimbursement agreements for reducer worldwide.
As previously announced the company has made significant progress against all reimbursement objectives in the U K, France, Germany, and the United States.
Earlier in the quarter, we announced that Neovasc worked with the American Medical Association to establish a new category III CPT codes to report the Transcatheter implantation of the coronary sinus reduction device, which became effective July 1.2021.
Additionally, we were granted national reimbursement status for the reducer and by the National Health Service NHS in England.
And as England has a nationwide purchase and supply system for specific categories of high cost tariff excluded and medical devices used and specialized services designed to support the accelerated adoption of effective new technologies.
Hospital providers can now order the reducer and build the cost of the device directly to NHS, England.
Expanding reimbursement for the reducer remains a top priority at Neovasc and we hope to have more positive developments to share with you and the coming months.
Moving on to <unk> as I previously mentioned, we paused all activities related to the tiara TF development program during the quarter to focus on the advancement of the Cherokee a device, which we think could offer the best chance for near term approval.
And a better return on investment.
We are now actively pursuing CE mark designation for this device under the newly implemented European medical device regulation or MBR, and we anticipate that a decision will be reached and the second half of 2022.
We continue to be encouraged by the clinical data supporting the chair at Ta and if and when the CE Mark designation is issued we believe this device could be a leader in the emerging and underserved mitral valve replacement space.
We accomplished a great deal during the second quarter importantly, strengthening our financial footing, expanding adoption and reimbursement of the reducer and.
And adding seasoned professionals to enhance our clinical and regulatory strength among other things.
However, we understand there is more to do and all fronts and we hope to report more positive milestones joined the balance of 2021 and beyond.
As always we want to thank our investors our employees and our customers for their continued support of Neovasc I will now turn the call over to Chris for a review of our financial results Chris.
Thank you Frank.
And as Greg mentioned briefly in his comments Rapids reported net revenues grew significantly year over year.
We sold a record number of producers and plant and partnered and the quarter and.
And we exceeded our internal pre COVID-19 revenue targets.
Revenue increased by 123% to $633000 for the 3 months ended June 30th from 'twenty to 'twenty 1.
And Baird to revenues of $284000 for the same period and 2020.
We are very pleased with the recovery of reducer and sand volumes. Following the COVID-19 induced decline, but we are cautiously monitoring the impacts of the delta there and in our key markets and a couple of quarters.
Cost of goods sold from the 3 months ended June 32021 was $109000 compared to $75000 from the same period and 2020.
We are growth gross margin for the 3 months ended June 32021 was 18, 3% compared to 74% gross margin from the same period and 2020.
The company continues to focus on Germany, when the company sells to reduce the direct margins.
Total departmental expenses for the 3 months ended June 32021.9.
$9.6 million compared to $8.9 million for 2020, representing an increase of $748000 or 8%.
Notably we saw an overall increase in non cash charges of $1.9 million and an overall decrease and cash expenses of $1.1 million Boes.
The increase and non cash charges were the result of the $1 million increase and share based.
<unk> $903000 charge from making 12 decision to pause the tiara TF program.
<unk> of the $594000 charge for obsolete plants and equipment.
And at $309000 charge.
<unk> termination expenses.
Encouragingly, the overall cash expenses decreased by $1.1 million.
Basically driven by a reduction and employee expenses and our 2 recent reductions in force and December 2020, and June 2021 'twenty to 'twenty, 1 stops take effect.
Selling expenses for the 3 months ended June 32021.
$832000 compared to $452000 from the same period in 2020, representing an increase of $380000 or 8.4%.
Principally as we start to ramp up our selling activities and COVID-19 driven loans and the comparable period.
General and administrative expenses from the 3 months ended June 32021.
And $5 million.
Debt to $3.8 million for the same period and 2020.
Representing an increase of $1.2 million or 32%.
Non cash charges increased by $2 million.
It's comprised of $1.1 million increase and sharply compensation and a $903000 increase related to provisions for cause and the tiara.
Program.
Cash expenses decreased by 800000, principally due to an overall decrease and legal expenses and the comparable periods and include.
Difficult charges as we unwound and resolved the last past the 2017 financing.
Product development and clinical trial expenses from the 3 months ended June 32021.3.
And $3.7 million compared to $4.6 million Boes from <unk> 20.
Representing a decrease of $900000 or 18% print.
Principally driven by a decrease and employee expenses.
The operating losses and comprehensive losses for the 3 months ended June 32021 were $9.1 million and $9.3 million respectively.
And for 13, and basic and diluted loss per share.
As compared with $8.7 million operating losses, and $12.2 million comprehensive losses, or <unk> 81, basic and diluted loss per share for the same period and 2020.
The overall decrease and comprehensive loss is principally explained by $2.9 million decrease and the charges related to the valuation and the accounting treatment of our dilutive equity instruments.
And the overall increase of $434000 and our operating losses.
This increase and our operating losses is explained by a $314000 increase and contribution from Meg and their activities.
Set by us from moving $48000 increase and departmental expenses, which as previously mentioned was made up of a $1.9 million increase and non cash charges and a $1.1 million decrease and cash expenses.
Yeah.
We ended the second quarter current and 'twenty, 1 with cash on hand of $63.3 million.
We have substantially caught up on our payables and the balance sheet absorbed more than $3 million during the first half.
We have the last remaining $1 million to $5 million collaboration and settlement payments during the third quarter and 40.
And we anticipate that and you'll start to see a further reduction and our quarterly burn rate.
As a result of our decision to pause the tiara TF development program and there.
Associate and reduction in workforce at the end of the second quarter.
This anticipated reduction and formulate is expected to create capacity to it.
Accommodate increased spending on the consumer 2 <unk> study once enrollment begins later this year.
We're also pleased to report that there was only a marginal increase market shares issued and outstanding increasing by 80000 tons and 49000 shares during the quarter.
The $67 million 584000, and 412 shares at the end of the Covid.
As Fred mentioned.
And a much stronger financial position and anticipate that we will reach critical value accretion events before needing more capital.
This is a complex process, but we hope to provide positive updates from the balance of 2021 and beyond.
Got it.
Thank you Chris and thank you all for listening to our opening remarks, we have made some significant changes during the quarter and some of them difficult, which have solidified our financial footing and increase our collective focus on advancing the 3 strategies, which.
We believe combined with a cleaner balance sheet and a lower expense base well.
Uncover the vast potential of reducer and tiara P. A.
And in turn could improve our current market value.
Ultimately we are hopeful that this new strategy for our product assets.
And our execution of it and the next few years will be beneficial for all our stakeholders and investors employees and millions of patients around the world.
Once again, thank you all for your continued support.
I would now like to open up the call for questions Alex.
Thank you.
At this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star 1 on your telephone keypad, a confirmation tone will indicate your line is and the question queue. You May press star 2 if you'd like to remove your question from the queue.
All participants using speaker equipment and they've been at this.
Sorry to pick up your handset before pressing the star keys.
Our first question comes from Vernon Bernardino with H C. Wainwright. Please proceed with your question.
Hi, Chris Thanks for taking my question and congrats.
And the.
And quarterly results.
And.
Just wondering if you could give a little bit more and see.
Sales force.
And the results and you are.
Europe.
1 other thing so you had mentioned was.
Using a direct sales force and Germany.
Is there a weighted if you could.
Describe.
And how.
What's your own coffee because it's the best.
During the second quarter.
Yeah, Hi, Brian This is Fred good too.
Talk to you on the call here.
So.
At the moment, we have a direct sales force and Germany with a 4.
For folks.
And we are selling and other European market through distributors.
The situation in France, we are still working on the reimbursement project and friends and if that were to be positive and successful and then and we would also have starved our activities and setting up a direct sales force and France, so that might potentially become.
The second country was it a rep with a direct sales force and Europe, but at the moment. It is only Germany and it's quite interesting I would say that in the second quarter, Germany. In particular was the strongest contributor to our revenue growth and you'll also see that and the very strong.
Gross margin, which went up and 30.80 80, I think it was 82% from.
And typically into 70% and that's also because we obviously with our direct sales force, we have higher margins and Germany. So you can clearly see that it wasn't particularly on our direct sales force and Germany that was leading the way and the second quarter.
And with a major recovery.
Day.
They did meet our expectations on the on the revenue side and on the implant side actually came in a little higher than your original expectations and you should know that our original expectations for the second quarter were based on largely based on no COVID-19 impact yet you know there still was some cash.
And what impact as you know and particular towards the end of the second quarter.
Nevertheless.
We have really done a great job in total with the revenue we surpassed our internal goal for Q2 revenue led by the German organization.
And we had a record amount of implants in Europe for the second quarter. So it really was a strong performance very encouraging.
And so part of third quarter is going well.
Kind of hard to third.
And third quarter is always tricky because you know you have July and August as the vacation months.
So it's kind of hard to judge September therefore is obviously, a very important month for for any third.
Third quarter performance and that's still ahead of us.
But I would say so far so good and again despite.
Flare ups of Covid and the Delta variation.
Of the Covid that has plagued and not only the U S. But certainly also in many European countries.
So yeah I I think it is a testament to the fact that the really is and underlying demand for the reducer and it really it really tells the story of the fact that.
You know Ah patients and physicians are seeing the promise of this product and they're seeing and more and more by their own experience we.
We also see more and more clinic signing up for it.
We have still a few patients here and there that are promising candidates and that and the very and decide to not to go into the hospital, mostly because they are concerned that they might pick up COVID-19 and the hospital and we still see that here and there as well.
But.
You can see from our numbers.
We really have done well despite all of that so we're actually quite encouraged with this and would reemphasize. This.
The importance of our strategy to really focus primarily on the reducer on revenue expansion on reimbursement on new geographic growth and success in the U S to really make a big investment and the U S market was all new clinical study.
And as the highest priority and I think and that strategy is going to really pay off as you can clearly see already from from these numbers and the second quarter of women.
No definitely exciting results and then regarding which we mentioned and as far as the filings and you no longer will file.
And the U S and my view.
And your supplement and just go back to the RB quarter too.
So 2017 studies zone.
So so yeah I mean I went through this in my script I wanted to make sure that everybody understood that we already have and approved IV. It was approved in November of 2017.
So we have a protocol that was a huge submission and and that subrogation and work took well over a year.
<unk> to work with the FDA and to get through and they got approved by the FDA now.
So we don't have to be do that or start all over again, we don't have to find a new IV, but we are utilizing the IEEE debt, we have and was already approved and 17. However in the meantime, we have also learned a lot and FDA has also learned a lot we have the the panel meeting for good or for bad with a lot of feedback.
<unk>.
And so we wanted to make sure and also FDA encouraged us to.
And to make sure that we incorporated all the learnings and so there are a number of I would say small protocol changes.
And that we do need to file as a supplement and we're working hard on that I expect that to be filed certainly stills and a third quarter.
And hopefully into and the near term and I would hope and August.
And so that would be basically a supplement that would then be filed and then the other advantages that obviously the review time by the FDA for a supplement is a lot shorter than for a full ITE. So there are several advantages of being able to go back to the original IV, but actually improve on it and by the learnings.
And that we've had we've also had a lot of valuable input into protocol from the executive Steering Committee members. We now have some really powerful positions from the U S. On that panel and that gives us very valuable insight and we've had a couple of very good and very cooperative positive meetings with FDA, where we talked.
About some of the protocol changes that we thought were.
Rhopressa and good to do and day, we're in complete agreement with that as well so they actually.
Supported that and encouraged us to do that so it's well worth doing because we want they started to be a strong and as powerful as it can be and that's the path we're on.
And our last question and I'll go back and a clear can you remind us again and now what will be the primary outcome and second primary outcome.
Yes, and so the primary endpoint of the study is an improvement in exercise tolerance by Bruce.
And Bruce modified.
Index. So it's basically a treadmill test that patients do before they got to device and then 6 months after they get the device and then you look at our patients able to do more exercise can they do this longer.
Our 10 day, just exercise and a much better way there was a very well defined protocol for this obviously needs to be very well and disciplined performed and.
So that is what the primary endpoint will be but we also have other endpoint and secondary endpoints.
Obviously, there will be.
Endpoints that are associated with Ccs class again.
And and others.
And NGL questionnaire.
There are many that are also a secondary endpoint and then there is an active and.
Arm for the control of the safety as well where people are looking at.
Is there any difference between for example, a myocardial infarction and fast rate stroke et cetera et cetera.
From a wealth of experience so far with the device and I've never really seen so that's all part of our of the protocol.
And it's a very well thought out.
And clinical study it is again, a sham controlled study so half of the patients will go through a procedure, but will not receive the reducer device that is to really make sure that this is done and the most accurate scientific manner.
And then <unk>.
After the trial has been concluded these patients will be enabled them to patients to win from the Sham procedure will be offered to then also be able to get to reducer. After the trial has been and debt. So.
And that is something we actually want to make sure that was the case because many patients really are looking forward to getting this device and when they get randomized sham arm and I really wouldn't get to device.
Therefore, when we can tell them upfront if you do end up and the Sham control arm, you will be able to get to the price. After the study is over and it's really a benefit for the patients and will.
I'm sure and help us with the recruitment of patients as well under study.
That's perfect for it sounds like they are really on track.
To.
And all of the first patient and so at the end of this year and growth and I'm looking forward to it.
Great. Thanks, so much for and are really appreciate it.
Yeah.
Thank you. Our next question comes from Greg <unk> with Noble capital markets. Please proceed with your question.
Hello, and thank you for taking my questions I appreciate it nice quarter.
Gentlemen.
Yeah.
A question first.
But housekeeping thing really but the gross margin number was better than expected and you mentioned I think fredrik direct sales as Katrina plot to debt.
Do you think.
There is some.
Covid overhang still and some other countries or is it still more of a reimbursement issue.
Well so so the gross margin typically what we see and you can go back and all of our earnings report, we see you know north of 70% typically and 72% to 75% range and then when we have a quarter, where there was a very strong dominant growth come and go to Germany.
Cost of the direct sales and direct marketing.
<unk>.
And it actually goes above 80% so a lot of it depends on the on the mix.
And where the sales is coming from that that's number 1 we have established a high price essentially and every European country.
We have done that very very consciously over the years, we've always resistant to try to make a quick sale with a lower price. We've always resisted doing that we kept a high price strategy and really want to see to reward from that over time.
And the reimbursement that we are after all very much in line with that because they go back to the base debt that you have set in these countries. So we are looking at a very very nice reimbursement numbers and the different countries, where we are working.
Much in line, if not even higher than what we are seeing today and the market. So it's a it's it's all very well coordinated effort and so then ultimately when we do get to reimbursement like we now see and the U K that will be another 1 where as of the fall.
We are we believe we're going to see quite a bit of a of a positive impact coming from the U K market and that should also help with our gross margins because of the reimbursement via from all established there as well so.
And the future a lot of this will be dependent on the mix of the different countries. The status of direct sales or distributor sales and then the individual reimbursement and the different markets that and behalf.
And the U S. We're also working already on the reimbursement side, we have had several meetings with CMS already and are very positive.
And if the device would have been FDA approved we would've had a reimbursement for the device and a very nice level and the U S as well.
We've talked about and in the past so.
On that front.
And we really have a high price.
And my philosophy for the device and I think you can understand why because it's taking a very very long time and a huge amount of investment to get this product to the market and get and established and we certainly want to make sure that there is going to be a good and positive return of investment.
For our investors and their therapy.
I can see the.
Second question regarding I.
And I never housekeeping type question regarding.
Clinical trial expenditures.
It was lower than expected is it related mostly to the discontinuation of causing us to Europe.
And we expect sort of a.
The slowdown and those expenses and a couple of next couple of quarters and do you anticipate them picking up when the IV and terms okay.
Okay.
Yes, the clinical expenses, so far were largely driven by the <unk> side.
And so because of the pause and T F as well as the fact that we have also paused and plans for share at Ta.
Because we are submitting for CE mark with the clinical data that we have so there is we don't expect a significant increase and clinical expense on the Trs side. However, having said that we still need to finalize our reducer, 1 post market clinical study in Europe.
We are now just over 300.
Implanted devices of the 400 patients and that study. So they are still going to be some more patients included and to reduce a 1 study in Europe that sports market for reduced sort there and then obviously, we're going to start on the expenses for the <unk> 2 study, which is a substantial and big study and.
It's going to last.
And a few years and it's gonna be coupled with a quite a bit of and additional expense.
But its spread out over several years as well so there will be a shift on the clinical expense side from tier 2 to reduce the side, that's the long and short of it.
Excellent. Thank you 1 more question if you don't mind I appreciate the time just.
And just in terms of the Pulsar trial and first of all on what we're back in May and how is there.
Tracking.
And according to your expectations.
The cozy and my trial, yes.
Yes.
Yeah. So yeah. So that is and that has started it was also severely impacted by the day.
The COVID-19 situation in particular in Germany.
We now have had a few patients that are included in that trial in Germany, So far it's being down only and the University clinic and mines.
But and that clinic is the.
Is the sponsor of the study and they are working with several other clinics and Germany to get them started.
We believe that the microvascular angina.
Topic is gonna be and other very interesting growth opportunity for the reducer. It basically is the patient population that has microvascular disease.
We did but they don't have any problems and the coronary arteries. So the patients that we today to read all the ones that have alluded to the coronary arteries get treated for it withstands or bypass and then still have microvascular disease. This population and the microvascular disease segment.
And <unk> segment is the patient population has microvascular disease, but does not have coronary artery disease.
So it's a slightly different patient population, but there is also quite a few patients in that patient population and that that have really no therapy option at the moment outside of some drugs.
And so physicians and actually very interest in this trial as well so we expect a pickup of that over time.
So that is causing much Robyn and Germany. There is another study a smaller 1 and done at the.
At the clinic at a clinic and Minnesota.
Ware.
And also a similar trial is being done, but a smaller amount Andre and I E.
And there we've had the first 2 patients included in the trial as well.
So yeah, there are a couple of cents.
And the world that have no startups from clinical trials and that space.
Okay, Great. That's good news. Thank you I. Appreciate the question. Our question you should get the answer. Thank you so much I'll jump back in the queue.
[laughter].
Thank you ladies and gentlemen, we have reached the end of the question and answer session. I will now turn the call over to Fred Colen for closing remarks.
Okay, well I think it was a productive call I'm glad for the questions that I got so I was able to expand a few more things a little bit more in detail and I. Appreciate your attention and your participation to call and we'll talk again.
And a few months ago and Mexico. Thank you all very much goodbye.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation and have a wonderful evening.