Q4 2021 Cytosorbents Corp Earnings Call
Good afternoon, and welcome to Citrus Orbitz fourth quarter and full year 2021 financial and operating results conference call. At this time, all participants are in a listen only mode.
Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the company's request at this time I would like to turn the call over to our moderator Carrie Anne powers, Vice President of Investor Relations and corporate Communications. Please go ahead Mr. <unk>.
Thank you Sherry and good afternoon, welcome to Cytosorb in its fourth quarter and full year 2021 financial and operating results Conference call. Joining me today from the company or Dr. Phillip Chan Chief Executive Officer Vince.
Vincent Compony, President and Chief operating Officer.
Kathleen Bloch Chief Financial Officer.
Doctor Ft, Neil Steelier, Gareth Chief Medical Officer.
Dr. Christian Steiner executive Vice President of sales and marketing and managing director of Cytosorb into Europe and.
And Christopher Cramer, Vice President of business development.
Before I turn the call over to Dr. Chan I'd like to remind listeners that during the call management's prepared remarks may contain forward looking statements, which are subject to risks and uncertainties management may make additional forward looking statements in response to your questions today.
Therefore, the company claims protection under Safe Harbor for forward looking statements contained in the private Securities Litigation Reform Act of 1995.
Actual results may differ from results discussed today, and therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the SEC.
Any projections as to the company's future performance represented by management include estimates today as of March eight 2022, and we assume no obligation to update these projections in the future.
During today's call, we will have an overview presentation covering the operating and financial highlights for the fourth quarter and full year 2021 by management. Following that presentation. We will open the lines for your questions with the management team at this time, it's now my pleasure to turn the call over to Dr. Phillip Chan Phil go ahead.
Thank you very much Terry.
Despite the pandemic headwinds 2021 was a good year with sales growth driven by increased cytosorb utilization and advancement of key objectives.
Total revenue grew 5% product gross margins improved to 80% and we ended the year with a strong balance sheet with approximately $54 million in cash and no debt we.
We've made significant progress on our U S anti thrombotic removal clinical programs with the launch of two pivotal randomized controlled trials to start T and start D trials evaluating the intra operative use of drugs arb herc during urgent cardio thoracic surgery to remove certain blood centers under two FDA breakthrough device designation.
We also invested in key people and processes to ensure focus on our critical care and cardiac surgery applications to position the company for sustained future revenue growth means.
Meanwhile, we continue to drive awareness of Cytosorb through company and investigator initiated presentations and publications.
Although it seems like we just recently celebrated the milestone of 100000 cumulative devices utilized.
As at the end of 2021 you've now been more than 162000 cumulative cytosorb devices utilized up 34% over the end of 'twenty 'twenty.
Finally, we have been extremely focused on allocating our capital towards priority programs, which include our company sponsored clinical trials, our sales and marketing infrastructure and our new manufacturing facility build out.
Yeah.
As we've done in prior earnings calls I'd like to provide our view of the COVID-19 pandemic, given the ebb and flow of its impact on our business.
As you can see from the world maps on the new Covid cases in November of last year on the top left.
The current map on the top right Yeah, I'm, a proud variant led to a dramatic surge in COVID-19 cases, particularly in the U S Europe and the northern parts of Asia. However, as you can see on the bottom right. Although there were high rates of Covid.
Severity of illness has dropped significantly and sequentially with every new wave with peak mortality rates of about two 3% globally, a year ago compared to only 0.4% now.
This is likely due to the fact that on the lower left approximately 65% of the World population has now had at least one vaccine dose and 58% are fully vaccinated compare this to November 2021 when only 28% of the world population had one vaccine dose and only 14% were fully vaccinated.
You can see in the table that in most major countries in Europe , like the United Kingdom, France, Spain, Italy, and Germany. The race of full vaccination are very high in the range of about 73% to 83%.
In terms of Germany.
No cases of COVID-19 have only just recently peaked resulting in many of the same trends. We saw late last year to persist in the country, including hospital restrictions on sales reps and other outside or visits decreased elective procedures decreased ICU capacity and other factors.
What you see in this graph is that the peak mortality has dropped dramatically from early 2021 were 3% of patients who got COVID-19 died.
Only 0.1% peak mortality.
This 0.1% mortality is typical of what we typically see with seasonal influenza.
But we expect that new cases in Germany to drop rapidly soon like you can see here with the other major EU countries at which point, we believe our core business will begin to pick up already Germany has announced its intent to lift most social restrictions this month.
As with many companies. We are currently navigating through global uncertainty. The good news is that we expect that the COVID-19 pandemic will likely burn out in 2022 are.
Are we out of the woods, yet probably not.
But what we'll likely see minor spikes in COVID-19 as restrictions like masks are lifted.
But we believe the pandemic is likely coming to an end this year due to the natural history of viral pandemics. The very high current rates of vaccinations and natural immunity and the decreased severity of illness globally, yes, it'll likely be other COVID-19 variants, but they're more likely to be like the seasonal flu some are worse than others.
Most people have mild to moderate disease.
From the perspective of rush of the Russia, Ukraine War, we believe we currently have limited exposure with less than 4% of our 2021 product revenues coming from the region.
Overall, we expect continued and progressive improvement throughout the year and our core non COVID-19 business with 20% or more growth over $33 8 million in court non COVID-19 sales in 'twenty, 'twenty, one which assumes.
A recovery of normalized possible activity and sales access in Germany, and other key countries.
No major economic slowdowns caused by new variants of COVID-19.
And little to no sales from Russia, Ukraine and neighboring countries.
Also because of the trajectory of the COVID-19 pandemic worldwide. We expect limited COVID-19 related sales in 2022 as the severity of COVID-19 related illness, hospitalizations critical illness and deaths have dropped significantly.
That said, we are focused on driving our 2022 strategic priorities.
As you'll hear in more detail from the management team momentarily. We have four key priorities. The first is to advance the high priority starts you start D. U S clinical trials in pursuit of U S FDA marketing approval.
The second is to manage our business and resources to achieve 20% or more growth in.
Of course Cytosorb sales in 2022.
The third is to complete the build out and begin commercial cytosorb production out of our new manufacturing facility in New Jersey by the second half of 2022.
This is intended to increase that to start production capacity to support annual product sales of up to $400 million a year timber and also to improve product gross margin.
And finally, our fourth major priority is to expand both new and existing strategic partnerships to maximize the synergy between our technology and those of our partners, while creating new opportunities opportunities for global growth.
So with that let me turn it over to Cathy to discuss our fourth quarter and full year 2021 financial performance Kathy.
Thank you, Phil and Hello to everyone on the call today I will briefly review of Cytosorb in its fourth quarter and full year 'twenty 'twenty. One financial results. In addition, I will provide an update around our working capital and financial focus for 2022 next slide please.
Yeah.
Total product sales were $9 $7 million, a 16% decline over total product sales of $11.5 million in Q4 of 'twenty 'twenty direct sales declined $475000 were $6 two per cent and distributor sales decline.
And $1.4 million or 35%.
This decline in sales was due to decreases in sales to treat COVID-19 patients of approximately $900000 as well as the impact of the imposition of hospital access restrictions, which impaired our sales force's ability to meet with physicians in the <unk>.
Hospitals, particularly in Germany, our largest territory, which accounts for more than 50% of ourselves.
Notably in Germany, Q4, 2021 product sales were $5 $3 million, which is an increase of 45% over the third quarter sales in Germany.
Quarter of 2021 grant income was $1 $1 million versus $425000.
For Q4 of 'twenty 'twenty.
And product gross margin for the fourth quarter of 2021 remains strong at 78%.
Compared to 81% for Q4, 'twenty 'twenty the slight decrease in product gross margin in Q4, 'twenty 'twenty. One is due mainly to our scheduled manufacturing shut down for planned maintenance and year end inventory counts next slide please.
Next we'll examine Q4 2021 relative to our historical quarterly performance.
And this chart of historical sales shows our core.
Non COVID-19 product revenues, that's the blue part of the bar and our estimated COVID-19 revenues the light green part of the bar.
Revenue attributable to COVID-19 treatments was $9.4 million in 'twenty, 'twenty and $6 $3 million in 2021 .
Next slide please.
Turning to our annual results for 2021 product sales were $40 $2 million, a 2% increase as compared to $39.5 million for 2021 .
For non COVID-19 product sales were approximately $33 $8 million, which is an increase of $3.8 million or approximately 13% over the prior year given the challenges our sales team faced being unable to access physicians face to face in the hospital setting.
We are very pleased that we were still able to grow our core sales in 2020 one.
Grant revenue was $3 $1 million for 'twenty, and 'twenty, one as compared to $1 $6 million in the prior year.
And product gross margin was approximately 80% in 2020 one.
Versus 76% for the prior year next slide please.
Reviewing annual sales growth you can see the surge in sales that occurred as a result of COVID-19 revenue in 2020.
We generated less growth in 2020 , one as a result of lower COVID-19 cells and greater access restrictions on our sales team.
'twenty 2020 , 'twenty, one where atypical years impacted by the COVID-19 pandemic, but over a five year period total product sales grew at a compound annual growth rate or CAGR of 37% while core non COVID-19 sales grew 30.
3% during the same period, which indeed is very strong growth.
Product gross margins, which were impacted by costs associated with our 2020 ramp up of production improved in 2021 and are now at record levels and overall, 80% for the year 2021.
Slide please.
Turning to our working capital position as of December 31st 2021, we had a healthy cash balance of $53 $8 million. This includes $1 $7 million in restricted cash.
Also as of December 31, 2021 we have approximately 57 million shares outstanding on a fully diluted basis next slide please.
And finally I'd like to provide some color on our 2022 outlook and our financial objectives.
Some of the macro economic uncertainty and global complexity of our operations. We believe our business is very resilient specifically as Phil mentioned, we expect core non COVID-19 product sales to grow 20% or more over the prior year.
We intend to continue to run a tight shift focused on the scrutiny nation of expenditures and prioritization of capital usage to ensure that our spending is fully aligned with our strategic priorities. Those are of course first our robust clinical trial strategy with primary answer.
This is on our U S Star T and Star D trials second the strengthening of our sales and marketing organization and third the expansion of production capacity at our new manufacturing facility, we expect to be able to fund our operating needs and cat cash capital expenditure needs with.
Cash on hand, and we also have financial flexibility, if we need it in the first quarter of 'twenty 'twenty. Two we entered into a loan commitment with bridge bank, which provides us with the ability to access up to $15 million in debt financing.
We believe this provides an optional source of cash should we require in the future. In addition in the first half of 'twenty 'twenty. Two we expect to receive proceeds of approximately $7 million from the sale of our New Jersey, 'twenty 'twenty net operating losses in some.
We continue to prioritize our cash use and to fund initiatives that are expected to support near and longer term growth. Our balance sheet remains strong we expect to be able to fund our operating needs and capital expenditures with cash already on hand, but we have financial flexibility.
If needed.
It concludes my remarks for today and at this time. It is my pleasure to turn the call over to our executive Vice President of sales and marketing Dr. Christian Steiner.
Well, thank you Cathy.
Good afternoon to America and good evening here Neil.
Economies and societies are still suffering from the global stomach.
It's not over yet.
We are seeing light at the end of the tunnel.
In Q call several conditions have changed was earlier in 2021.
Mhm able to increase the.
Frequency and in person meetings.
We could also exhibit and promote cytosorb smoky, but the number of Congresses and symposium.
Kansas and the year before although the number of attendees are significantly lower than most of it used to be to have this all depends on.
Based on that we've been able to significantly improve all soon as compared to the Q3.
Germany sales increased 44, 45% compared to the Q3 numbers and represented 54%.
Our overall product suite.
The other door into small gets delivered the best results ever and the emergency use authorization Covid business.
In the United States was contributing as expected.
All of this from one distribution partners, we are on a good level, but not the same volumes a year ago since it was significantly less COVID-19 business.
However, approximately $1 7 million U S dollars revenues was COVID-19 related.
The increased usage during the day that'll be.
All as preparation for the expected only 12 days.
Excellent.
So <unk> already pointed out the macro economic factors all conditions that are impacting our business.
Colby China business with further declined due to lower severity of the disease.
Less ICU dependency of patients at a much lower mortality compared to previously.
However, health systems are still being significantly impacted by the number of patients.
In fact, as health care professionals, and otherwise limited capacity.
This again needs to limited elective surgery programs resolved or close ICU beds, and we are still facing some restrictions on the ability to see old customers as well as for sensors on the Congresses.
Despite these challenges we are seeing a lot of positive developments.
Eventually come to full effect missile pandemic fading away.
Our recently started initiatives and the cardiovascular if you are starting to generate the necessary momentum to jumpstart our post pandemic business.
New additions to our team and the tactical adaptations are leading to much more efficient and fruitful lets say its a month ago.
To support insulting leaders of the major institutions.
Increasing adoption of <unk> therapy, and the higher market penetration are expected to be as a result of these efforts.
You have started those initiatives and our strongest and most developed market Germany.
We wouldn't rule them out to all other bar at a major distributor markets in Q2.
Okay.
These efforts are also expected to be supported by new data.
Publications, we are leading in this field.
Similar projects are currently being prepared for the crew.
Okay indications.
Other therapeutic areas.
Excellent.
Hum.
2022 was an important year for us since we are celebrating the 10th year.
Finding cytosorb therapy to all customers and their patients.
That is almost as the pioneer and leader in U S. You can't lock simplification.
He started with Cytosorb.
Parental therapies, two phone calls with them.
First the approval, but with very limited data almost no treatment experience and only a limited idea of how this therapy could help patients.
Nevertheless, we had the big vision to change medicine.
So Dave you have treated tens of thousands of patients with more than 160000 treatments in several applications.
Application fees.
There's a lovely discussion about the opportunities and benefits of this therapy and medical and medical communities.
We have generated several hundred publications and reports on puzzled therapy multiple compared to combined number.
Comparable technological approaches.
Yes.
Furthermore, extends the Aussie labor for other indications, including removing blood centers.
And certain high risk cardiac surgery patients.
XOMA has started a movement to use blood purification.
Little weapon in the acute care, which was amongst all of them.
As you felt before.
Microsoft will comment more on this in the clinical and medical section.
Just focusing on a selected number of indications to reach a lot of care status.
Police Huntsville, and the only technology can provide the most clinical benefit.
This slide shows.
And pulled the causal role of Jesus meeting in July .
This is the key global event with X Cross insulting you. That's been presented is tough because deals in the future stuff, that's impactful and so.
I'm very excited about the opportunities we would pursue this year until they used to come.
Excellent.
As I said before the focus on selected for clinical applications is defining our priorities for strong sustained growth.
We have and we will further increase the firepower at whole commercial amenities.
Experts in the field and critical care and told you about.
And business strengthening and streamlining efforts.
Because optimization and improvement of our German sales force is ongoing and increases our focus on key opinion leaders and key account management.
Yeah implementing changes to support increased market penetration and no other direct territories to drive additional growth.
Also we are prioritizing the most important is to go to markets.
Considering the potential and development possibilities.
All of these structural changes will be supplemented with new commercial tactics, including hybrid or what a virtual conferences.
Programs and training as well as far as the development of highly efficient two other relationship punishment.
All of these efforts and initiatives will be more to come.
System marketing and branding campaigns.
You're already starting to see positive results of the lean initiatives, which fuels, our confidence and optimism to get back on the growth path and go on before the pandemic.
And now I'd like to turn the call over to our Chief Medical Officer talked of teammates do their nearest microphone. Please.
Thank you Christian and Hello to everyone on the call.
Next slide please.
As you heard already the theme for 2022, Cytosorb is execution and focus.
Accordingly, our updated clinical plan. He's now streamlined and comprises of seven programs that includes three randomized clinical trials three registries and one pilot study.
Three of the programs are executed in the United States, including our two top priority F. D. A randomized clinical study start T and the started the trials.
And also the Cytosorb therapy in COVID-19 registry under the emergency use authorization.
Granted for use of Cytosorb in COVID-19.
And the remaining four programs that are executed in Europe , including the randomized clinical study in patients with refractory septic shock.
Pilot study hip on fire patients with acute on chronic liver failure.
International Registries, the star Cosmo shreds, respectively.
As were engaging with institutions around the world. We note that they continue to struggle with personnel shortages and fatigue in the aftermath of the pandemic.
However, we're encouraged that we continue to see high levels of interest for participation in our clinical programs.
There will be numerous data readouts from 'twenty to 'twenty, two including data on COVID-19 from accepted abstracts from the CTC registry that will be presented at the international symposium of intensive care and emergency Medicine later this month in Brussels.
And the Euro also international conference in London in May.
These data will.
Follow up on the original results presented and published last year, showing high survival with the use of Cytosorb in COVID-19, and now extending the observation as to potentially additional valuable clinical benefits.
We have also completed enrollment in the CPC registry and we plan to publish the final results in a 100 patients later this year.
Yeah.
Later this year, we also intend to submit the first ever in vivo aren't they thrombotic drug removal data to the European Society of cardiology.
If our abstract is accepted this first ever results will be presented in the largest international cardiovascular conference later this year in August .
We may even have potential early readouts from the starter registry later in 2022 or early 2023.
To focus our resources to our top priority F. D. A start P and study trials. We have also discontinued the following three clinical programs.
First the refresh two Aki I trial, which will allow all our U S clinical team resources to now be focused on the star programs.
We also discontinued the small single arm studies Pfizer in the U K and say occasionally in Germany that we're both evaluating tabular removal.
Both now will be superseded by the much higher level of evidence that will be generated by the pivotal U S Star T randomized clinical study.
It's important to note that in.
Any of these three studies there were no safety concerns noted with the intra operative use of our device in patients undergoing urgent cardiac surgery as confirmed by each independent D. S. M. B in the three studies.
Next slide please.
Moving on to our top priority F D. A programs, namely the start T and to start these studies evaluating the use of the drugs of ATR device.
During our call.
Jim cardiac surgery in patients either on Tegra lore, and it started to study or apixaban or rivaroxaban and to start the study.
Both studies have now have left the station and they're actively recruiting patients.
The majority of the U S sites participating in the studies have now been selected with most of them actually over 70%.
Noting that they will participate in both trials.
And Suzie hasn't is very high for these two studies despite them that fat T. At these institutions.
Over the site staff shortages are real and were seeing them across the board at United.
Our U S institutions.
Based on the identical study design.
D startup times are moving faster by leveraging the synergies and the work already done to startup the start study.
Importantly in addition to the identical design both studies have identical execution paths highlighted by three major milestones that are there.
Listen the table below.
The first milestone is the enrollment of 33% of the patients that will trigger the first P. S. M B safety review.
The second milestone gets triggered after 67% of the patients are enrolled in this study and represents the second D. S. M. B safety review, but also importantly, the interim analysis of the trial.
And finally, the third milestone represents the completion of the study with 100% of enrollment unless of course. The study has been stopped for efficacy previously I think everyone else.
Now specifically for the two studies start T is actively enrolling at multiple sites.
Checked it to hit milestone number one this summer.
With enrollment of the study.
Expected to be completed within 12 months from today.
Four Star D.
It is also actively recruiting or multiple sites. However, it's too early right now to project the enrollment piece of this thing.
We do believe however that enrollment will be completed within 12 to 18 months. Following the first patient entered in the study.
Later this month, we will have a major event.
For both studies, the investigators summit, which we believe will introduce significant levels of excitement across all the studies all the study sites participating in both studies.
And we plan to communicate the study progress for both of these studies and our future earnings calls according to the progress we're making towards the milestones listed below.
Next slide please.
Moving on now to our non FTA programs.
We have five clinical programs listed on this table.
First the CTC registry has completed enrollment with 100 patients now critically ill COVID-19, requiring life support on Ecmo.
The database has been locked and as noted previously there will be multiple readouts later, this year, including presentations, so I need a national conferences and also publications of the of these data and the final results of the CPC rates.
We believe this.
Willing for them beyond COVID-19, including the use with Ecmo increased seemingly use platform around the world for patients suffering from severe respiratory failure.
Next the proceeds randomized clinical study in patients with refractory septic shock.
He is now actively enrolling at multiple sites in Germany.
We continue to bring more sites are opening to have all sites for the study.
And over the second quarter.
The next milestone is the interim analysis, which will be triggered after half of the patients are enrolled in the study and we anticipate that to take place next year.
The Star Registry and international Red cardiac surgery, specifically on anti thrombotic removal.
He is actively enrolling patients in the U K and Germany.
And we continue to expand to different countries around Europe that would be included.
In this registry.
This registry will continue to enroll and there will be data readouts. Once we have sufficient number of patients and we expect those data readouts to be ongoing.
Finally, the hip on fire in the Cosmos registry have both received approvals.
In Germany, and we are beginning to activate sites, we anticipate that both the Violet study in acute liver failure will begin enrollment in the first half of this year.
Cosmos registry and all inclusive registry among patients with critical care applications will also begin enrollment in the first half of this year.
Next slide please.
So in summary.
We have focused our resources to ensure a disciplined execution of our top priorities start the star D. F D programs.
As we engage with institutions both in the U S and Europe . We note that they are still struggling with pet that makes that the staffing shortages, but we continue to see high levels of excitement for our studies.
Both FTA programs are now actively recruiting at multiple sites with star team targeting first milestone this summer.
Process.
Priority a randomized clinical study.
Kerr is actively enrolling at multiple sites in Germany.
As noted before the CDC registry has completed enrollment there will be having multiple data readouts in 2022.
And finally, both the international Star and Kosmos registry, our mutual could progress and there are very important for supporting our data generation in the future as they both represent real world evidence platforms in cardiac surgery and critical care.
And with that I would like to turn it back over to Phil.
Phil.
Thank you Mike.
In summary, we strongly believe that Cytosorb has the potential to become a highly profitable medical device company with industry, leading operating profit margins, while helping to solve some of medicines. Most vexing problems are.
Our business is resilient and while macro uncertainties continue we remain well positioned to grow our core business in 2022 and beyond.
We're heavily focused on being prepared to return to our normal sales and marketing activities with the goal of driving strong sustainable growth not just in Germany, but worldwide.
We firmly believe that FDA marketing approval will be a key catalyst for growth in the company expects to complete enrollment of both the U S start D and Star T pivotal clinical trial programs for anti thrombotic removal as Mike has mentioned in the next 12 to 18 months. Meanwhile, we with our strong balance sheet, we have the ability to fund key investments.
And growth with a focus on clinical studies sales and marketing and manufacturing capacity expansion.
Thank you very much that ends our formal remarks.
Sherry if you would please open the call for the Q&A session.
Yes. Thank you.
As a reminder, if you have a question. Please press star one on your telephone keypad.
For me said tell me indicate your line is in the question queue. You May Press star two if he would like to remove your question from the queue.
And for participants using speaker equipment may be necessary to pick up your handset before pressing the star. He's please make sure. Your mute button is turned off to allow your stake now to reach our equipment.
We will take our first question today from.
Zach Weiner with Jefferies. Please proceed.
Hey, everyone. Thanks for taking the question two for me first just if you'd give some some color on how things are trending in Germany through the first two months of <unk> access to for for your reps to surgeons and whatnot and then second just wanted to confirm you guys will not be communicating.
Any milestones on Star D and Star T with the Street beyond your quarterly earnings calls or will you provide updates our intra quarter.
Yeah. Thanks Zack.
That lease as we spoke in our formal comments.
That the peak of Covid in Germany, just recently.
Path and so they're still high rates of Covid that has led to continued restrictions in German hospitals increased difficulty in and being able to see positions by our sales reps.
Decreased ICU capacity staffing shortages and other issues.
Issues that we faced in the second half of last year.
So the court has not yet over and we're expecting that Covid cases, new COVID-19 cases to drop significantly.
And the next month or two and a lifting of restrictions in Germany.
By the government, so I think that.
Things will hopefully return to.
Some new normal in the in the fairly near future.
From a milestone perspective on clinical studies I'll, let Mike comment.
Comment Mike.
Yeah.
Yeah. Thanks, Phil.
Well as we noted we're gonna be communicating progress based on the Prespecified muscles that we're showing on the slide previously so whenever earnings calls we will be stating how the studies are tracking to the smartphone. However, any of those milestones are hit between earnings calls, obviously, we will be announcing that.
We would not wait for the earnings call, but it would be a nursing it as it happens.
Got it that's helpful. Thank you.
Exactly.
Our next question is from Sean Lee with H C. Wainwright. Please proceed.
Good afternoon, guys. So I just have two quick questions first.
Robotic with Volvo now the company received the CE, Mark, especially I think back in mid 2020, So I was wondering.
How big are the indications, where you guys right now maybe a bit of color on what proportion of sales is coming from the syndication and do you expect it to be a big revenue growth driver in 2022, and where do you think it could get to.
Yeah. Thanks, Sean.
So you know as we said before COVID-19 has made it difficult to effectively market. This particular application, which we just received approval on.
And in 'twenty 'twenty.
And so I think that.
We continue to face similar challenges of getting out there, but I think as you heard from Christian.
That.
You know new efforts to get out there with some new resources that we have have been successful and have been able to generate some momentum in the space.
That the market in Europe is Ah is comparable in unit numbers.
As we would see in the United States, although given the Asps of.
Of Cytosorb in Europe , the dollar value is less.
And so Christian would you want to comment on that.
No I think so you have already described it very well so.
Hum.
As you said the Covid pandemic has.
A lot of these developments and there's still a lot of calls we have to make.
But what we've seen over the last few months and also with the activities in the U S with the Star T and to study our studies, there's a lot of enthusiasm and.
Our India and do different cardiac surgery departments and.
And all we have to build it and I think there is significant growth possible.
Oh, great. Thanks for the additional color.
Thanks, Sean.
As a reminder, the star one on your telephone keypad, if he would like to ask a question. Our next question is from Justin Walsh with B Riley Securities. Please proceed.
Hi, Thanks for taking the questions. Your clinical trial efforts give some clarity related to the near and midterm indication targets and given the large markets youre looking at there that makes sense and I wanted to ask you a couple of questions about the the published use case of Cytosorb to treat car T related neurotoxicity.
My question. My first question. There is if you believe there's an opportunity for the company to leverage niche use cases to continue bolstering awareness of the product and how that might.
Benefit the company as well as patients.
Yeah. Thanks.
You know the car T cell immunotherapy application is very interesting.
When patients develop complications of cytokine release syndrome, and separately neurotoxicity from car T cell immunotherapy, it can be quite devastating I think to patients it.
It manifests very rapidly often.
Two to three days after the car T cell immunotherapy infusion.
And when it happens it can be a full blown cytokine storm.
Currently it is being managed with steroids and some anti cytokine inhibitors like to sell as a map.
And the rates of Crs.
There, they're getting better at helping to manage a CEA.
However, neurotoxicity.
Which they often called icons or CRE, yes.
It is very difficult to control.
And when it happens.
It has been shown that steroids and.
Uh huh.
Cytokines blockers liked to sell it's a math do not help and can actually make it worse and that was the case for this publication landmark publication actually had the first case of severe neurotoxicity caused by a car.
Car T cell immunotherapy Ah Indeed, and this was the case published in the United States.
And so the fact that we were able to rescue this patient.
And despite.
Having failed.
Many other interventions.
With our therapy. The station was salvaged and actually was able to recover from that neurotoxicity.
As you recall, there's been some major car T cell immunotherapy trial for neurotoxicity.
Has killed patients and has closed down their studies.
So to.
To your point I think that.
Our business is a lot like us we have a lot of major indications right like sepsis trauma and management of intra operative.
And post operative complications and other applications.
Such as liver failure and pancreatic treatment of pancreatitis now with the new data on <unk> I think this will become a major application for us as well in the future.
But what I think is so exciting about our therapy and what drives the interest globally is a lot of it's just broad usage and a lot of little indications, where the fact is often very dramatic. So it is a part of the reason why we've been able to drive really.
Very strong growth in the usage and adoption of Cytosorb worldwide.
Got it and maybe just a quick follow up I'm just curious if you see other opportunities for expansion.
As the immuno oncology and cell therapy fields advance and and as you know there sort of a very limited number of patients who currently receive these therapies, but if there's potential for moving into earlier lines are beyond some niche indications wondering if you guys have sort of looked at that possibility and and if there.
There might be that I don't know partnership opportunities there or investigators who are interested in riding those types of trials.
Thanks.
Yeah.
The data are limited right now for the use of our therapy and in the cancer field. However, we do acknowledge that it's it's a it's actually a very large market you know what are the applications. We had discussed previously.
And has kind of been on the back burner has been the complication of cancer Cachexia cancer.
Cancer Cachexia.
Unfortunately, many people are aware, there's a wasting syndrome that happens in cancer patients that has actually caused by inflammation.
In fact, the factor called Cachexia that was identified and is driving this muscle and fat wasting syndrome.
That depletes the patient of physical reserve.
It is called Cachexia.
But the other name for it is tumor necrosis factor, which is a widely studied cytokines for example.
We have had a vision that perhaps.
Perhaps cytosorb could actually help treat cancer cachexia, which is often listed as the main cause of death for patients with cancer.
It is an end stage phenomenon in cancer and it is a problem that.
Prevents patients from being able to tolerate further immunotherapy or further cancer chemotherapy or radiation therapy for that matter.
So there is a vision that if we could potentially reverse cancer cachexia with our therapy it.
It may help by Ah patients time and give them reserve.
Are you able to ultimately have more definitive therapy.
Got it thanks for taking the questions.
Sure.
And now I would like to hand, the conference back over to management for any additional or closing remarks.
Well. Thank you everyone for joining us today on today's earnings Conference call. We appreciate your participation. If you do have any other questions. Please feel free to reach out to Terry on powers.
T powers at Cytosorb is dot com as you can see on the screen here and we'll try to reply to your questions as soon as we can thank you outgrew it.
Thank you that concludes our conference for today I would like to thank everyone for their participation have a great evening.
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Yes.
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