Q4 2020 CHF Solutions Inc Earnings Call
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Good morning, and welcome to the C. H S solutions earnings conference call for the fourth quarter ended the.
Eastern but 31st 2020.
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I would now like to turn the conference over to Claudia Drayton, The company's Chief Financial Officer. Please go ahead Madam.
Thank you the Cameroon.
Thank you for joining today's conference call to discuss CHF solutions corporate developments and financial results for the fourth quarter ended December 31, 'twenty and 'twenty.
With us today are Mr. Head of me you of the company's CEO, John <unk> Chairman of the board and myself Claudia Drayton the company's CFO.
And at a M. Eastern time today CHF solutions released financial results for the quarter ended December 31, 'twenty and 'twenty. If you have not received CHF solutions earnings release. Please visit the investors page at Www Dot CHF desk solutions Dot com.
During the course of this conference call the company will be making forward looking statements.
Except for historical information mentioned during the conference call statements made by the management of CHF solutions are forward looking statements are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.
Forward looking statements involve known and unknown risks and uncertainties and are based on managements beliefs assumptions expectations and information currently available to management.
Those risks include but are not limited to risks associated with the possibility that the company may be unable to grow revenue in future quarters that the company, maybe unable to execute and its commercialization strategy. The possibility that it may be unable to raise the funds necessary for the company's anticipated operations.
But the company may not be able to commercialize its products successfully.
And the other risk factors described under the caption risk factors and elsewhere in the company's filings with the Securities and Exchange Commission.
By providing this information the company undertakes no obligation to update or revise any projections and forward looking statements.
And whether as a result of new information new developments or otherwise.
You should review the cautionary statements and discussion of risk factors included in the company's press release issued today the.
The company's latest 10-K subsequent reports as well as its other filings with the Securities and Exchange Commission under the titles risk factors or cautionary statements related to forward looking statements.
The additional discussion of risks of free.
Factors that could cause actual results to differ materially from management's current expectations.
Those discussions regarding the risk factors as well as the discussion of forward looking statements and such sections and incorporated by reference in this call and are readily available on the company's website of WWE. The I believe that CHF solutions dotcom.
With that said I would now like to turn the call over to John Erb CHF solutions Chairman of the board.
Thank you Claudia I am pleased to have this opportunity. This morning to introduce CHF solutions, New Chief Executive Officer, Mr. Nestor Hawrami of junior.
Nestor joined CHF solutions, just under two years ago, as our Chief commercial officer and quickly strategically guided the company into a couple of exciting new markets and restructured our high caliber commercial team last year Nestor moved up to become President and Chief operating officer, and not only led our growth during the <unk>.
Challenging pandemic crisis also oversaw the development of important product enhancements and new technologies that we will expect to bring to the market shown. It gives me great pleasure to know, let you hear from our new CEO.
Thank you John and good morning, everyone and welcome to the fourth quarter, 'twenty and 'twenty earnings call and corporate update.
2020 was a challenging year for the global health care system due to the ebb and flow of the COVID-19 pandemic.
Although the world has dramatically changed our business model has not and we remain optimistic about the durability of our business and the value we can bring to our customers investors and the patients we serve.
We anticipate that when health care of returns to some level of the new normal we will see accelerating sales growth by continuing to position ourselves as the primary provider of ultrafiltration therapy for cardiologist for all of just hospitals index.
Intensivists cardiac surgeons, and pediatricians, who treat patients suffering from fluid overload.
The company achieved a very solid performance and the fourth quarter of 'twenty and 'twenty with 49, 5% revenue growth over prior year.
For the fifth straight quarter, we were able to generate sequential revenue growth.
Specifically revenue and the fourth quarter increased seven 4% sequentially compared to the third quarter of 2020.
We believe this strength is an indicator of the underlying momentum within our pediatrics and critical care business segments.
During the fourth quarter and critical care delivered a strong result, driven by increased utilization and unit placements of our <unk> system in the ICU setting.
As mentioned in previous earnings calls, we experienced strong unit placements in ICU centers in response to the COVID-19 pandemic.
The tailwind from this from treating COVID-19 patients early and the year establish a unique synergetic effect, leading to increased aqua ex utilization to treat non COVID-19 critical ill patients in the ICU.
Due to the effectiveness of the equity ex system treating COVID-19 patients early in the pandemic, we believe and increased number of hospitals, we want our device in the ICU to treat non COVID-19 critically ill patients.
With the likelihood of declining COVID-19, hospitalizations in 'twenty and 'twenty. One we view these utilization trends to be favorable for the company as awareness and the clinical benefits of the athletic system builds.
As we announced in 2019, we expanded the utilization of the athletic system from the primary focused on the chronic needs and heart failure to the acute needs and cardiac surgery and pediatric care.
And we retool our sales organization with competencies to drive this expansion strategy.
And we believe this strategy has shown early signs that it will be fruitful in 2021 and beyond despite the obstacles that this pandemic has imposed on the med tech industry.
Two and the year our U S revenue mix was comprised of 47% critical care, 27% pediatric and 26% of heart failure.
Our revenue mix have shift meaningfully over the last 12 months, given our strategic focus on pediatric and critical care opportunities.
Specifically critical care revenue increase materially compared to 2019 levels due to the tail winds from treating COVID-19 patients early in the year and the synergetic effect of treating non COVID-19 critical ill patients in the ICU followed by a strong growth.
From our pediatric segment due to our regulatory indication expansion early in the year.
With her while how failure remains an integral part of our business revenues declined in the mid teens compared to 2019, given the impact of COVID-19 has had and patient behavior overall procedure volume and our limited access to hospitals.
However, we expect revenue in the segment to increase in 'twenty and 'twenty, one fueled by the recent clinical evidence and the expected category III CPT code approval, which I will discuss in a few more minutes.
Before I move to our heart failure business I'd like to mention a few more important points about our pediatric business.
During the fourth quarter, we increased pediatric utilization of the athletics therapy amongst our current installed base.
We are seeing the most traction among some of the leading research hospitals in the United States, including Stanford University Medical Center.
Children of Alabama, Cincinnati children's.
Silver and hospital of Philadelphia, and Seattle Childrens and others.
We believe the increase and utilization is a direct reflection of our commitment to educate and train key opinion leaders within the pediatric hospitals.
In the fourth quarter, we opened five new pediatric hospitals and in the year with 25 total pediatric accounts.
From 10, when we started the year.
Entering 2021, we remain excited about the pediatric opportunity in front of us.
Given the underlying momentum and our pediatric business and the dedication and focus of our expanded sales team all of them.
Pipeline of pediatric accounts remains robust.
As mentioned on the third quarter earnings call, we initiated the pediatric registry in partnership with two important organizations the acute kidney injury critical care and research Foundation.
And the Watermark research partners.
The radio strength is dedicated to collect real world evidence on the use of the Aqua ex of smart flow in pediatric patients with fluid overload.
And the registry will include data on ultra filtration and utility performance and safety profile in pediatric patients from approximately 10 research institutions.
And the anticipated two and a half year period.
The parties anticipate collecting data on up to 500 patients.
We expect the race to win of spread awareness within the pediatric community regarding the clinical efficacy of the Atwood ex therapy and the increased utilization.
We expect our first patient to be enrolled in April of this year.
Now of regarding our heart failure of segment, while we deliver a strong results and critical care and pediatric there were a number of key milestones, we achieved and the quarter in our heart failure business.
On October six and six of last year during the 24th annual scientific meeting of the heart failure Society of America. There were two important studies presented that support the use of ultrafiltration in heart failure patients.
First the real World retrospective study of 335 consecutive patients treated with the Aqua the ex flex flow system.
The study was presented demonstrating the ultrafiltration that ultrafiltration compares favorably in reducing heart failure re hospitalizations and renal function response and weight volume loss.
The patients had a substantial mean fluid removal of 3.8 gallons.
No negative changes in renal function and had a 12% and 27% re hospitalization rate after 30 days and one year after treatment respectively.
I would like to emphasize the importance of the reduction reported in the study because the current national rate for 30 days recourse Brutalisation in heart failure patients is 24%.
That is twice as high as the rate reported in the study in other words the use of the Agua ex therapy reduces the rate of re hospitalization by 50%.
And therefore with the use of the athletic system that is of significant economic savings to the national Health care system.
Specifically.
When compared to direct ex fluid removal by ultrafiltration reduce hospitalization readmission days, leading to a cost savings of almost $4000 per patient at the 90 day follow up.
The author of the studies and stated that the ability to adjust the rates of fluid removal with the <unk> system is believed to be a major contributor to the favorable outcomes.
The second study presented at the Heart failure Society of America meeting, what the case study titled outpatient Ultrafiltration to prevent hospital Readmissions during COVID-19 pandemic in net Uretic intolerant patient.
This study details the successful outpatient treatment of a 70 year old female with heart failure.
The patients did not respond to therapy is outside the hospital setting including oral uretic.
And the experienced multiple hospitalizations due to reoccur and congestion.
Given the patients core morbidities and high risk status and the patient received ultrafiltration treatment with the Aqua ex smart flow system in an outpatient setting to avoid exposure to COVID-19.
Because the ease of use and simplicity of the athletics system over the course of four days a total of almost five liters of isotonic fluid was removed.
The patient showed immediate improvement and clinical symptoms and what to expect and <unk>.
What's effectively stabilized in the outpatient setting and advocate good Samaritan hospital in Downers Grove, Illinois.
This is a good indication that the act what decks ultra filtration system can be of kidney clinically effective therapy to treat heart failure patients and the outpatient setting.
Turning to reimbursement in November we successfully submitted our cargo retreat CPT code application for ultra filtration and using the Atwood exit smart flow, which we expect will provide access to the outpatient market.
In conjunction with this submission will receive strong endorsements from the for the application from two major medical societies.
And in January we received positive news from the regulatory body, allowing us to use the recent published meta analysis, demonstrating ultrafiltration is better than the red ex therapy for the management of flu volume overload in acute decompensate of heart failure patients.
Our support for our reimbursement submission.
Given the current timeline of events, we expect to obtain a new CPT code category III for reimbursement and the third quarter of this year.
Before I turn it over to Claudia to review the financial results I want to and by providing an update on our investments in new technology and innovations demonstrated by the filing of three patent applications and the fourth quarter of 2020.
One pattern involves the peripheral vascular access catheter for use with the Atwood ex system.
This new dual lumen ultrafiltration catheter is designed to optimize blood flow to prevent thinking and to be customizable for each patient facilitating the use of the athletic system in the inpatient and outpatient setting.
As a reminder, a key advantage of the Atwood <unk> system is the ability to provide venous access and the patients arm rather than the common and less comfortable central venous access.
The addition of this innovative dual lumen catheter included in this patent will help streamline processes for uninterrupted therapy and.
And would reduce inventory burdened with the ability to customize the single catheter for any patient.
Which represent the future advantage for outpatient clinics.
A second patent and involves new and improved diagnostic parameters to support hemodynamic stability during therapy.
The non invasive technology included in the second pattern is designed to provide accurate and more timely cardiovascular parameters for metrics, such as systemic vascular resistance and hematocrit in and intuitive presentation.
The reason for the importance of these two patents is that for us to be successful and drive long term durable growth, we need to continue to push innovations and solve clinical problems at the point of care.
Going forward, we believe advancing the ease of use to access the venous system.
The flexibility and applications and the predictability of outcomes Ethan is important for the use of the <unk> system in the outpatient setting.
I will now turn of the cold to Claudia.
And we'll walk you through our Q4 of 2020, we sold and financial details following that we will open the call to questions.
Thanks, Nestor good morning, everyone.
Turning to our financial results revenue for the fourth quarter was $2 million up 49, 5% from Q4 of last year and seven 4% up sequentially from Q3 of 2020.
Revenue performance for the quarter was driven by increased utilization among our established critical care and pediatric accounts.
And the addition of five new pediatric accounts.
One of the year 2020 revenue totaled $7 4 million of 35% increase over 2019.
Regarding our cost of sales and operating expenses I will briefly comment about major drivers.
First regarding our cost of sales our gross margins were 56, 1% for the quarter and increased from Q3, 'twenty and 'twenty margins of 46, 1% and from Q4 2019 margins of 58%.
Overall, our margins for the quarter were favorably impacted by increased volumes of consumables and improved manufacturing efficiencies.
Of the year 2020, our gross margins were 54, 5% up from 2019 margins of 51, 7%.
Next regarding our SG&A expenses, Q4, 'twenty and 'twenty expenses were $4 4 million and increase of 5% over Q4 of 2019.
The increase results from having fully staffed territories, partially offset by reduced travel expenses.
Our R&D expenses were $1 million in Q4, 2020 of 10% increase compared to Q4 of last year.
The increase in R&D expenses over the prior year were primarily driven by clinical expenditures related to the pediatric registry.
During the quarter, we recognized the gain of $1 $2 million related to the dissolution of and inactive subsidiary in Australia.
The gain relates to cumulative foreign exchange adjustments that were previously recorded on our balance sheet as unrealized gains.
The net loss for the quarter was $3 1 million or $8 13 per share compared to a net loss and the fourth quarter of 2019 of $4 4 million or $33 and 46 per share.
For the 2020 year, the loss was $15 8 million or $10 67.
<unk> per share.
Regarding our liquidity position, we used $3 4 million of cash in the quarter to finance and operations were $16 6 million for calendar year 2020.
We ended the year with approximately $14 4 million and cash and cash equivalents and no debt.
In terms of modeling Q1, 'twenty and 'twenty one we continue to closely monitor the situation caused by the COVID-19 pandemic.
While we have seen increased utilization of our therapies in areas of the country, where we have and establish Preston I access to hospitals continues to be limited and thus we believe that it will continue to impact our traditional business.
At this point, we expect Q1 revenues to increase low single digits sequentially.
Regarding our gross margin, we expect Q1 margins to be similar to the prior year period in 2020.
Of hospital capital budgets continue to be constrained, we know we may experience temporary impacts to our margins.
Unexpected and an annual basis, our margins will continue to benefit from increased volume.
Regarding our operating expenses, we expect our sales and marketing spend to remain consistent with the fourth quarter as the impact of having fully staffed territories is offset by reduced travel expenses.
In R&D, we expect spending to increase slightly as we continued to increase activities in our pediatric studies and development projects.
Operator, please open the call to questions.
Thank you to ask a question. Please press star one on the telephone keypad again that the star one to ask a question to withdraw your question. Please press the pound key.
The first response is from Jeffrey Cohen of Ladenburg Thalmann. Please go ahead.
Oh, Hello card and Austria, and John are you.
Hi, Jeff.
So a few questions from me.
Thank you for providing the percent of our revenue for 2000 and corners of the home from critical care of Pediatrics and heart failure could you give us a better sense of how Q4 was and what kind of the trends, we could expect to 'twenty or 'twenty one.
Yes.
The Q4 was the strong year as the strong quarter excuse me as Claudia and I mentioned before the.
The trends for 2021 continues to be very similar to what we have seen and the last two quarters of very strong we have a strong pipeline.
And the utilization that we've seen on the Aqua ex in the ICU not only treating COVID-19 patients, but the synergetic effect, including non COVID-19, plus our maturity and our sales organization will lead us to believe that we're going to have a good and strong.
'twenty one.
Got it and you've got to pediatric centers up to 24 of open now and I'm assuming the.
And the representative Mark and for the Columbia were large portion of that sector would be in the order.
50 or 60.
Could you give us strength.
And sort of.
What.
Things might look like for 'twenty, and 'twenty, one and as far as future openings just to kind of five and the quarter, we should think of it all.
Yeah.
It's hard to say, Jeff because you know we still have the effects of the lack of access to the hospitals.
But the underlying momentum that we've seen on our pediatric business.
Would lead us to believe that yes, we could probably have another.
10% to 20, new centers in 2021.
Got it Okay, and then can you give us a sense of our units per center or any type of interim look into the registry data.
And when we may see some of it due to.
Through the midpoint of post the midpoint.
Yes.
The the utilization.
Percentage depends on the volume of how large the hospitalist, but we've seen anywhere from three to six consoles per center and.
The utilization is much larger than the adult as you as we have discussed in the in the past.
And we expect the registry the centers participating in the registers to have the same type of of <unk>.
Volumes that we have seen and we expect to see.
Regular updates on the registry analysis.
And while the year throughout the.
And the length of the study of the registry.
Okay got it and can you talk a little bit about hospital access and what have you seen in the past.
Three or four months through Q4 and early this year as far as the access to hospitals and the returns are recruiting and true.
Yeah, Jeff does the major concern was we still seeing limited axis and the hospitals.
And we hope that one of the bass the nation's started to.
Cover more of the country that we will see more access to hospitals, but we still have a very limited axis.
Got it Okay and then lastly from me could you talk about and your activity outside the U S. And are you got and recognized the gain of $1 2 million from your four and subsidiary in Australia, but could you talk about any traction or penetration of placements outside of the U S.
And Jeff we're seeing the same thing that we see here and the United States outside of the U S.
We limited hospital access.
And.
Elective procedures are not been schedule and as you know the changes that have happened in patient behavior in volumes of <unk>.
<unk> has really had a negatively impacting our sales outside of the United States.
Got it Okay, and you talked about some of some R&D activities related to patents and IP.
Could you give us a general sense of modeling purposes and are we're thinking about the midterm.
The mid to high single digit increases on your R&D expenditure for 'twenty, one and beyond and your commentary there.
Well as Claudia mentioned the increase that we expect in 2021 on our R&D.
We're really focusing on how the we aim hands our current products.
In terms of diagnostics to guide therapy in our catheter line to improve and to make it easier the access to the venous system.
And to provide more flexible applications and more predictability in terms of outcomes. So we do expect to see those increases in R&D.
Okay.
Perfect got it that's it from me and thanks for taking the questions.
Alright, Thank you Jeff.
Thank you. Your next response is from Anthony Vendetti of Maxim. Please go ahead.
Thank you.
And congratulations Nestor on and the.
The CEO of appointment.
Thank you Anthony.
How are you doing good and Claudia and John how are you.
And I just wanted to focus a little bit more on the pediatric opportunity. So so five new hospitals opened I know thats been a been a focus.
Okay.
Just as a follow up I know, it's hard to gauge.
On a quarterly basis, how many you could open up there, but as you look at the overall opportunity and pediatrics what how.
Would you how would you categorize that overall market opportunity for CHF assets.
Mhm.
I would characterize it as being a very strong opportunity for us.
<unk> seen it.
A very good momentum in terms of.
Opening new accounts, our commitment to age of Cade key opinion leaders and the medicine and the pediatric community continues to be very strong and our sales organization is gaining well train.
And the very proficient on cell and the values of the Auckland ex in the pediatric.
Segment.
Okay, and then and then you said the the timeframe for the CPT code did you say third quarter of of this year.
<unk> <unk> 21.
That is correct yes.
Okay, and it's not just just to clarify and the pediatrics not just pediatric specific hospitals, but it could be pediatric units within.
Within any hospital correct.
That is correct.
And what those hospitals Dar would utilize our products to help babies that are born with disease or absence of kidneys are more specialized hospitals.
We've seen the use of the <unk> in all the Gatwick patients much older patients that come in and the ICU with some sort of a bacterial sepsis and those also could be done in the in the majority of the pediatric hospitals or adult hospitals that deep that treat older. The ASIC patients.
Okay. It makes sense and then just on the critical care side I know.
Critical care and pediatrics, both both of focus critical care.
It appears to have maybe benefited from from COVID-19.
In terms of the opportunity for CHF fast too to utilize.
The <unk> system for COVID-19 patients if as COVID-19, and hopefully continues to recede.
And.
Do you think too.
Opportunity and critical care.
Still still growth, even if COVID-19 receipts.
Or do you think that you know that.
Could be that could slow down I was just curious how you think of the critical care opportunities.
Now over the 19th.
No.
Anthony we're very excited.
Excited about and optimistic about the critical care opportunity not only for treating continue treating COVID-19 patients, but more important for the synergetic effect that treating COVID-19 patients has had in the ICU used to treat non COVID-19 not.
And <unk> 19, and critically ill patients. So we have seen that these hospitals are learning a great deal of how to treat COVID-19, and critically ill patients to non COVID-19 patients.
In the ICU.
In addition to that there is a pent up demand right now for elective procedures that we believe that is going to also help increase and accelerate the sales of the <unk> in the critical care segment.
Okay. It makes sense so so.
And the ability to treat COVID-19 has you believe it sounds like increase the exposure.
For for the <unk> system to show that it can be used for all types of critical care patients does that is that a good way to summarize it.
That is of very good way to summarize it.
Tony.
Okay, and then are there any other studies that are currently underway.
And that you can point to the.
And that continue to validate the use of the <unk> system is there anything else.
Currently in progress.
Yes, we know of two abstracts that were submitted for the upcoming meeting at ACC.
So you will hear from us more on that to own. These studies very promising data.
The.
And I cannot disclose at this moment, but in the near future you'll see how we're going to disclose the data that is coming out of this clinical studies very promising very promising.
And and and.
When do you expect those to be released approximately.
And I believe that they are going to be released in.
And the date of the ACC is may of this year.
Okay.
Okay excellent and Claudia I don't I don't have any questions for you because you've given us.
Very good good guidance. So thank you I'll hop back in the queue.
Great.
Thank you. Your next response is from Brooks O'neil of Lake Street Capital. Please go ahead.
Good morning.
Gratulation Nestor good morning, John and Claudia.
Good morning, Good morning, Washington.
I just wanted to follow up on the Anthonys excellent questions I'm curious.
And if there's any way for you guys to help us think about the ultimate market potential in your three.
Basic areas right now critical care pediatric and the heart failure and.
And I'm not I'm not asking for what it's gonna be and 2021 of what it could be and 22, but as you think about those markets.
What rough how do you decide.
In terms of the opportunity you see out there.
Good question Brooks.
Yes.
When we take a look at the three segments and the addressable market. These are the patients that can benefit from all of them were products, we estimate that the three together to be about $2 billion.
And mark outside.
And then zone.
And that trend of be too picky here, but is there any way you could break that out between the three just so I can sort of general sense for are the.
Each.
700, 700 million or is one bigger than the other and your opinion.
Yes.
A critical care and car failures are very similar somewhere between 800 and of $1 billion, each $800 million and $1 billion each of those two.
And the pediatric age smart and much smaller we think that is somewhere around $150 million.
So that's why do we believe that is about a 2 billion dollar total addressable market.
That's extremely helpful now.
Again following up on the Anthony.
I was trying to assess if you guys think.
The long term impact of Covid is that likely the turn out to be the.
Positive driver of your business and your opinion or is it and recognize theres still the headwinds that are out there right now, but I'm thinking of longer term.
How do you view it as the.
The bad part.
Will it ultimately proved to be of positive driver of the business are or will it be something and we still got to get past and move on from.
No absolutely Brooks and we believe that the COVID-19 has helped us a great deal.
The we've been able to prove and our our customers have been able to prove that the use of the aqua ex in critical yield pace COVID-19 patients has worked extremely well.
So therefore dose patients that come into the ICU critically ill non COVID-19 can be treated equally effective with the athletics and hospitals are seeing that so we do expect that many hospitals want to have our equinix system in their IC used to.
Three non COVID-19 critical yield patients, yes, we believe that these would be net a very positive impact.
And that's what I referred in my notes I referred that the synergetic effect of treating COVID-19 patients in non COVID-19.
Yeah, that's great and then I know you went through a lot of of things about the research that's underway and whatnot, but I was hoping you might highlight the one or two things you're particularly the looking forward to for 2021 in terms of milestones of our advancement that you think will will really.
The significant for the company this year.
Okay.
In addition to seen the bid.
Business, the underlying increase and the use of the act Windex. There are a couple of particular events that were really looking forward to it one is the registry of the pediatric registry that is going to be a significant event for us to promote the awareness of the utilization of the Aqua the accent.
And the Africa, but also some of our key opinion leaders or.
Producing a lot of good data that is getting to be published and the journals presented in.
In Tradeshows and so we're very excited about how we're building not only of momentum in sales, but also of momentum and the clinical evidence of the efficacy of the <unk> and treating patients suffering from fluid overload.
Okay. That's great. That's very helpful. Thank you very much I'm looking forward to this year for you guys very much.
Brooks I'm, sorry, let me add one more thing that I can't believe I forgot and that was the reimbursement.
We are yes, the reimbursement.
Category III CPT code is going very well every indication that we have received from the CPT editorial panel and some of our consultants.
Continued to be very positive.
Great Fantastic Thanks, a lot.
Oh of Ray Brooks. Thank you.
Thank you there are no further questions in the queue at this time.
Okay.
I want to thank you for joining our fourth quarter 2020 conference call and I wish you all and good day. Thank you.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation have a wonderful day and you may all disconnect.
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