Q3 2020 Rockwell Medical Inc Earnings Call
Momentarily. Thank you for your patience and please standby.
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Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical 2020 Q3 results call.
As a reminder, this conference calls are recorded.
At this time I would like to introduce audience size Swinger Investor Relations. Please go ahead.
Welcome to Rockwell Medicals third quarter 2020, <unk> earnings results call. This is called East Icelander Argo partners, the Investor Relations representative for Rockwell Medical joining me from Rockwell Medical on today's call are Dr., Russell Ellison, President and Chief Executive Officer, Russell Skibsted Executive Vice President Chief.
Financial Officer, and Chief Business Officer, Tim Cole, Vice President of marketing and Dr., Marc Hoffman, Chief Medical Officer, who will be joining us for QNX before.
Before we begin I wanted to note that certain matters, we will discuss may constitute forward looking statements within the meaning of the federal securities laws, including but not limited to Rockwell medicals intention to commercialize Triferic Dialysate Triferic Avenue and any future products based upon Rockwell, It's fair pirates phosphate platform.
Words, such as May might will should believe expect anticipate estimate continue could potential predict forecast project plan intend or similar expressions or statements regarding intent belief or current expectations.
Our forward looking statements well Rockwell medical beliefs. These forward looking statements are reasonable undue reliance should not be placed on any such forward looking statements, which are based on information available to us on the date of this release, which are subject to inherent uncertainties. These forward looking statements are based upon current estimates and assumptions and are subject.
To various risks and uncertainties, including without limitation those set forth in Rockwell Medicals SEC filings, many of which are beyond our control and subject to change actual results could be materially different accordingly, you should not place undue reliance on these forward looking statements Rockwell medical exports expressly disclaims.
Any obligation to update or alter any statements, whether as a result of new information future events or otherwise except as required by law.
This conference call can be accessed on Rockwell Medicals Investor Relations Web page. This call is being recorded on November 9th 2020 for audio rebroadcast rebroadcast and can also be accessed on the same web page at this time I would like to turn the conference call over to Rockwell Medicals, Chief Executive Officer, Dr. Russell Allison Russell.
Thank you Claudia good afternoon, everyone and thank you for your time today.
On today's call we will address.
Our vision and our strategy to build value for the company.
Two new potential indications for our PC platform and our next steps for each continued progress on the commercialization of our first FDA approved product Triferic dialysate.
Our preparations for the upcoming launch of our second that FDA approved product Triferic Avenue, an update on the international partnering activities and other pertinent corporate update and a review of our financials and then we'll take questions from covering analysts and we will answer some other questions we received by email.
Rockwell medical is focused on transforming the treatment of iron deficiency anemia around the world to improve outcomes for patients. Our vision is to establish a new standard of care for patients suffering with iron deficiency and iron deficiency anemia.
Iron deficiency anemia, flicks, a subset of 2 billion people worldwide, who are nutritionally iron deficient and in the United States alone approximately 10 million people or iron deficient, including 5 million, who have iron deficiency anemia pace.
Patients suffering from iron deficiency anemia can experience extreme fatigue, dizziness and reduce cardiac function.
Current treatment options have limitations, because elements wire its toxic and iron absorption that availability to cells is tightly regulated by the body by the hormone upside in iron deficiency is challenging to effectively manage orally.
Due to poor absorption and side effects and intravenous iron is often required in many situations. However.
However, current Ivy forms of our I O M. P release are into white blood cells, and then the liver.
Which slowly releases irons, the transport protein transparent, which makes the are available to sell this release can be substantially reduced by upside in inflammatory situations such as dialysis.
Our company's fair higher phosphate fit trade for S.P.C. technology platform have potentially transformative attributes FPC releases iron directly and immediately to the transport protein transparent and ducks, the army's immediately available tissue independent of inflammation.
To unlock the value of this platform. We are focused on transforming the way I mean his marriage for hemodialysis patients and developing a few cdthree other medical condition with unmet medical needs, where iron can be important searches for patients with iron deficiency anemia, receiving home infusions and potentially in cost.
Our lives patients with congestive heart failure to improve their cardiac function.
We believe that we now have a management team that has a relevant experience in hemo dialysis.
Sales and marketing to dialysis clinics commercial strategy drug development clinical trials and public bio pharma company management.
We strongly believe that we put our company ought to track that we anticipate will build significant value over the next several years.
We have a solid core business that generates over $60 million annually and gives us a presence in dialysis clinics across the country, where we have an excellent reputation for reliability and service we have one branded product in the market Triferic and the second one about to be launched Triferic and we had.
International partnerships that we expect to generate significant growth over time.
We have a pipeline of new uses for F. P. C being developed that we expect will not only help with group sales in the future, but will also provide us with multiple potential lead value enhancing well so.
Well before their launch.
Those of you are that are familiar with the bio pharma sector already understand the significant value that can come from achieving certain milestones.
Such as commencing clinical trials.
Obtaining full enrollment in completing the trial data read outs and F.D.A. interactions all of which occur well before these new uses actually generate sales.
I'm delighted to welcome Russell Skibsted to Rockwell in his new position as CFO and Chief business Officer.
Russell joined US in September from the Biotime family of companies and has extensive experience in the management of small cap public Biopharma company financing partnering drug development and M&A and thanks to his efforts on joining we are now well capitalized to meet our goal.
With our recent capital raise.
We have sufficient resources to drive value creation for our company no early next year and into the future across three concurrent tracks.
Maximizing U.S. sales of Triferic dialysate and seem to be launch Triferic Avenue.
Expanding the global commercial reach for Triferic through our key partners and strategically developing our F. P. C platform for new indications beginning with our home infusion program.
In the United States, we continue to build momentum for the sales of Triferic Dialysate and are prepared to launch Triferic Avenue. The IB formulations to dialysis centers nationally in the first quarter of 2021.
Our global efforts are progressing on many fronts, India, China Korea, and Latin America.
For new indications, we believe there is potential for important value creation, both near and long term through the development of the FPC platform for indications outside of the hemo dialysis setting where there are significant needs to transform the way iron deficiency, and iron deficiency anemia managed and where we will leverage.
The clinical and medical experiences to be up to an FDA approved product.
Our top priority new indication to pursue its PC for the treatment of iron deficiency anemia.
In patients undergoing home infusion therapy.
Currently iron requirements can only be met with.
With either an oral iron supplement, which is often not well tolerated or a suboptimal because of the inflammatory conditions or by Ivy irony infusion, which requires an office business due to the hypersensitivity risk with these products.
However, we believe FPC could be safely administered through the already available Ivy line at home.
Home infusion therapy is a rapidly growing area of medicine with over 3.2 million patients or every year and.
A large subset of patients treated with home infusion the incidence of iron deficiency anemia is estimated to be as high as 60%.
The growth trend of home infusion therapy is likely to continue.
Driven by cost savings versus office based or hospital care, and improving reimbursement landscape under Medicare and emerging standards, resulting from the global pandemic.
We estimate that the market access for FPC will be favorable largely because payers want to reduce costly hospitalization and office visits for the administration of these drugs are nutrients with.
Approximately 50% of patients covered by commercial payers and Medicare coverage currently available through a specific part b home infusion benefit I.
We intend to submit our clinical development plan to ft answer.
And to hold the type C meeting in the first quarter of 2021.
Pending this discussion next quarter. We currently estimate that phase two studies could commence in the second half of 2021.
The second opportunity under consideration is FPC for patients with congestive heart failure.
More than a million patients are hospitalized each year with Decompensated heart failure, and we feel that FPC, maybe able to address some significant unmet clinical need in this patient population.
A growing body of evidence exists to support the use of Ivy are as replacement therapy. The current therapeutic options, our I O and peas, which are limited in iron uptake and clinical benefit because of the relative bio availability, particularly in a plane patient population such as patients with heart failure.
However studies with older forms of parental iron have consistently demonstrated meaningful benefit in heart failure patients in the outpatient setting but.
But with these products the release of iron from the liver is likely to be too slow to produce a health benefit in the acute hospital setting.
We look forward to providing future updates to you regarding the syndication.
Now this slide provides a snapshot of our upcoming clinical and commercial milestones.
As you can see our current three track approach to value creation.
Focused on U.S. sales for Triferic Dialysate Avenue.
Expanding global commercial reach of Triferic through key partners and strategically developing new indications for our PC platform.
It includes numerous milestones starting in Q1 2021 and throughout the following 24 months and beyond.
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These milestones include our U.S. product launch new funds.
Consultation with the FDA and active U.S. clinical development of FPC for home infusion console.
Consultation with the FDA regarding the regulatory pathway for FCC for heart failure, and multiple clinical development milestones and expected product approvals as well as product launches throughout Asia, North America, and Latin America.
We are the number two supplier of concentrate products of U.S. from which we generate more than 60 million in annual revenue through nearly 20 million lifesaving treatment each year.
And we continue to reliably supply concentrates to our customers.
While our pharmaceutical business is clearly the growth and profit driver for our business going forward. The concentrate business allows us to develop and harvest relationships with key customers in the industry and facilitates discussions we have with current and prospective triferic customers.
Regrettably the COVID-19 pandemic is not yet a beat.
And continues to impact countries around the world and states within the United States.
The dialysis industry faces unique challenge.
From the pandemic because many patients are already carrying multiple comorbidities and patients lives are quite literally dependent on the treatment that they received three times per week in.
In addition, one of the downstream impacts of probing 19 can be multiple organ failure, including kidney failure and this has put further stress on both acute and outpatient dialysis clinics are.
Our role in supporting health care providers and patients is absolutely critical.
I am pleased to share that we continue to see no disruption to our supply chain for either concentrates for Triferic. This.
This is a testament to our hardworking employees, who adapted to the challenges posed by the pandemic.
As we have mentioned in prior earnings calls this year dialysis clinics have restricted access to facilities by non essential workers, including our sales representatives and nurse educators and they have caused any significant change in clinical protocols to focus on managing the crisis.
This has impacted our ability to continue the promotion of and medical education for Triferic, though we have been working to continue our efforts virtually where possible with.
With the resurgence of COVID-19 in many states. It is unclear for how long. These restrictions will continue in the states that have reopened we have taken measured steps to resume in person clinic visits taking necessary safety precautions.
We are in close contact with our global partners to evaluate the potential impact of coping Knight Peter on these partners timelines for clinical development and commercialization.
I'll now hand over the call to Tim call hold to discuss commercial metrics and the Triferic have new launch plans Kim.
Thank you Russell.
In the third quarter, we continued to make important progress in the commercialization of Triferic dialysate.
Despite the challenges of the COVID-19 pandemic.
As of the end of the third quarter, we increased the number of contracted patients to approximately 3400.
Which translates to an annualized treatment volume of approximately 500000.
Meaningful increase compared to last quarter.
The overall growth and Triferic sales was lower than expected.
Primarily due to the restrictions dialysis clinics of levied on in person visits from our field staff.
However, we are pleased with the results our sales and clinical nurse educator teams have produced by leveraging virtual engagement tactics to complete training programs and close contracts.
In the quarter certain U.S. geography has continued to relax restrictions, which has allowed us to reengage with more clinics.
And get back on track with planned in person training programs.
We're continuing to monitor the increase in COVID-19 cases happening this fall and we will adapt as needed.
With real World data on hand, and experience from the first year of the Triferic launch we have instituted a number of new initiatives in the third quarter first.
We're encouraging clinics to move straight to purchase contracts and bypass the evaluation process when possible.
Second we have adopted a more aggressive pricing strategy.
While these combined efforts our recent implementation has been slowed by COVID-19.
They have allowed us to shorten the overall sales cycle for Triferic in some cases.
Third we have introduced new promotional and educational programs to jump start a much needed increase in broader awareness of triferic and its place in the management of the media in dialysis.
New programs include a non branded disease awareness education campaign for both Nephrologist and dialysis nurses.
A refresh triferic promotional speakers program series.
And a clinic level triferic value analysis tool kit.
Fourth we've upped our presence at scientific Congresses, including the recently concluded American Society of Nephrology Congress.
Well, we sponsored a virtual exhibit booth posted.
Posted a scientific symposium and submitted three scientific abstracts that were accepted as posters.
Last we had increased our presence on social media to highlight rockwell's key activities and dedication to the dialysis community.
Let's see I think the execution and culmination of these programs that we believe will drive the long term adoption of our groundbreaking product.
Once the coldest Ted amick moves towards resolution, we expect to see a re acceleration of adoption of Triferic. This is importantly, specifically important for triferic as the sales process.
As a high touch high support hands on approach by our field personnel.
Which leads yields us the best results.
So next I'll turn to Triferic Avenue, which is our IB formulation of Triferic.
Triferic Avenue is a line extension of our Triferic portfolio.
And joins Triferic dialysate as the only FDI approved products indicated to replace iron and maintain hemoglobin.
In adult patients with hemo dialysis dependent chronic kidney disease.
Triferic Avenue is designed for intravenous administration.
And enhances the Triferic platform.
By providing patients with greater access to Triferic by expanding administration options for clinics. The therapy allows dialysis centers to administer triferic to patients regardless of the mode of the bicarbonate delivery being used.
And that's it's more appropriate in cases, where the hemo dialysis clinic is using Dri bicarbonate technology, and our Triferic dialysate product is not an option.
No our outreach to prospective customers to increase awareness of the upcoming commercial launch of Triferic add new started in the second quarter of 2020 and is ongoing.
Currently this includes reaching out to customers, who have already expressed interest and triferic in the past but.
But have been unable to adopted due to their use of dry powder dry bicarbonate technology.
We're also in discussions with current Triferic customers about adding Triferic avenue to existing agreements nor to pave the way for adoption once the product is commercially available.
We have started to generate excitement in the market for Triferic Avenue and included introduction to Triferic Avenue as part of our exhibitor spotlight program.
At the recent Asan annual Congress, while promoting our evaluation program at our virtual exhibit.
In parallel we are now finalizing the integrated marketing communications and educational programs.
That will signal commercial availability of the product expected in Q1 of next year.
Originally we had planned for the commercial release of Triferic Avenue in the fourth quarter of this year, but.
But the timeline has been extended due to a minor scheduling delay in the production of packaging for saleable product.
We initiated the first Triferic add new evaluation programs in early October these programs provide samples of Triferic Avenue to clinics at no cost to trial the product.
While it's too early to report comprehensive results customers have shown interest in the program.
In a selected patients that they feel will benefit from treatment with Triferic Avenue.
Our experienced field team of nurse educators scheduled regular lab in medication use reviews to help them evaluate the impact of Triferic, while also assuring proper training and education of the field staff.
We believe these evaluation programs afforded important marketplace introduction for Triferic Avenue.
And we will support our commercial efforts when saleable product is available.
In the first quarter of 2021.
We look forward to continuing to provide updates regarding the commercialization of Triferic Avenue in future reports.
In terms of reimbursement.
Triferic Avenue will be reimbursed within the SRT bundle payment that has been established for Medicare patients.
But importantly, we believe the cost structure for Triferic Avenue enables us to make an attractive gross margin, while ensuring that the product is price competitive.
And provides clinical and financial value to dialysis clinics.
Lastly, I would like to touch upon the anticipated introduction of an entirely new class of anemia management agents that Hes Phd rise, which.
Which are expected to change the management of anemia in hemo dialysis.
We plan to strategically position Triferic alongside the hit Phs to provide a reliable and physiologic treatment of anemia in hemo dialysis patients. We expect that the introduction of the hit PHH agents. The first of which Roxadustat is expected to come to market in early 2021.
Presents an important opportunity for Triferic, the mean I'd be iron requirement in the patient in the Roxadustat phase three dialysis trials was presented at this year's asset.
The requirement is well within the range that can be achieved with triferic given with each dialysis session such that triferic could be a sufficient sources of iron in patients managed with Roxadustat.
We look forward to providing further updates on our strategy related to his ph eyes in the coming months.
So with that I'll turn the call over to Russell Skibsted to discuss Triferic international updates.
And our Q3 financial results.
Russell.
Thanks Stan.
As Dr. Ellison mentioned earlier, our partner long bunk biopharmaceutical is making great progress in China.
We hope to soon announce the first patient has been enrolled in the pivotal study once some logistical issues with shipping has been resolved.
Access to chemo dialysis in China has been continuing to increase at a rapid rate in recent years with over 600000 hemo dialysis patients in China. It is the largest single market in the world.
Earlier this year, we entered into a partnership with Sun pharma for the rights to commercialize Triferic in India.
India is also an attractive market with over 120000 hemo dialysis patients.
Sun is working to get regulatory approval for launch from the Indian Central to drugs set standard control organizations Technical Committee.
We entered into an exclusive license agreement with jail pharmaceutical company in the third quarter for the rights to commercialize Triferic in South Korea.
South Korea represents a sizable and growing market opportunity with over 78000 patients receiving chemo dialysis annually.
We believe the jails an ideal partner.
They will be responsible for all regulatory and commercialization activities.
Jay ill advised us that it will not require a clinical trial in advanced Sip approval. So we anticipate sales to begin in early 2022 of course this is subject to regulatory approval in Korea.
We are also making progress in discussions with potential partners in other key markets like Japan, Europe, and Latin America.
Now turning to our third quarter results.
We ended the third quarter with a strong liquidity position and.
In anticipation of uncertainty and increased volatility in the capital markets due to the elections COVID-19, the economy, we had the foresight to raise capital in September.
This raise allows us to continue to execute on our growth strategy without worrying about having to raise cash during a volatile and potentially close capital market.
We ended the quarter with cash cash equivalents and investments of more than $67 million.
Cash used in operating activities for the nine months ended September Thirtyth was approximately $21 million, which is comparable to the same period last year.
Net sales for the third quarter were $15.3 million, which is comparable to the same period last year.
Triferic net sales for the three months ended September Thirtyth 2020 were approximately $284000.
But since Triferic was launched in the second quarter of 2019, there were only nominal revenues during the third quarter of last year.
Cost of sales for the third quarter of 2020 was approximately 14.9 million.
Resulting in a gross profit of approximately 350000.
This compared to cost of sales of 15.4 million in a nominal gross loss during the third quarter of 2019.
Finally.
Net loss for the third quarter of 2020 improved to approximately $7.4 million from $7.9 million in the third quarter of last year.
The improvement in operating loss compared to the prior year was driven primarily by reductions in both commercial and Gionee spending.
Which was partially offset by an increase in R&D spending and interest expense.
I will now turn the call back to Russell Ellison for closing remarks.
Thanks Russell.
We've made significant progress in the third quarter across many fronts.
And we continue to drive value creation for our company now early next year and into the future across three concurrent tracks.
Maximizing use sales with Triferic and soon to be launched Triferic Avenue expire.
Expanding the global commercial reach of Triferic through our key partners and strategically developing new indications for our PC platform, beginning with patients requiring home infusion therapy.
In the U.S., we continued to drive adoption of Triferic dialysate, Despite COVID-19 headwinds and.
And we expect to see a reacceleration of adoption and Triferic when the COVID-19 pandemic begins to resolve.
And we are making final preparations for the commercial launch Triferic Avenue.
Expected soon.
In China, our partner Wanbang Pharmaceuticals is about to enroll the first patient in its pivotal phase three trial of Triferic.
In India, our partner Sun Pharma submitted all regulatory appeal process documents for its approval for marketing.
Sun pharma and navigating the next steps due to the country's temporary suspension of regulatory review due to cold at night Pete.
And in South Korea, we entered into an exclusive license agreement with jail pharmaceutical company in the third quarter for the rights to commercialize triferic in that country, where a clinical trial is not expected to be required prior to marketing.
We are progressing home infusion as the priority new indication for our PC platform with.
With submission of our clinical development plan to FDA expected in Q4, 2020, and a type C meeting expected in Q1 2021.
We ended the quarter in a strong financial position to enable our execution of our three parallel strategies for value creation.
With that we'd now like to address some questions that we've received by email.
The first set of questions regarding the stock price performance and whether we believe it reflects the value of the company.
No I can't really talk about stock price.
But we can talk about value.
We're driving as I said value creation across three concurrent track Maxim.
Maximizing unit sales of Triferic dialysate and soon to be launched Triferic Avenue Ics.
Expanding the commercial the global commercial reach I'm triferic through our key partners and strategically developing new indications for FCC platform.
And we are confident that our strategy to build will build value as we move through these milestones that we have laid out.
And most programs do have potentially multiple value driven milestones.
Another set of questions address the performance of Triferic dialysate in the quarter and the progress we are making in face of headwinds from Nicole Good 19 pandemic.
I mean, I think Tim has addressed this already but perhaps Tim you have more comments on this.
Yes, Thanks, Russell just to reiterate.
Certainly Q3 growth for Triferic was lower than we expected and that was primarily due to the restrictions from co bid dialysis clinics not only restricting.
In person visits but also.
Being resistant to making protocol changes during this time.
But we have implemented virtual engagement tactics that we have been pleased with our field forces brace of these tactics and that is helping us to continue making progress.
And as I mentioned as geography is relaxed restrictions.
And they did relaxed restrictions in quarter, three and allowed us to reengage in many cases and the real world data we have on hand.
Allows us to encourage clinics to move straight to purchase contracts in some cases.
Where they see the data and do not needed evaluation process, and along with and more aggressive pricing strategy, we see a shortened overall sales cycle for triferic.
Definitely wants coded starts to move towards resolution, which is an uncertainty.
But at that time, we do expect the trajectory of Triferic sales to improve.
Thanks, Tim.
Now I'll turn the line over to the operator for questions.
Ladies and gentlemen, if youd like to ask a question. Please press Star then one on your Touchtone telephone.
Yourself from Q press the pound key.
Again, Thats star one to ask a question.
Our first question comes from Brandon Folkes of Cantor Fitzgerald. Your line is open.
Hi, Thanks, taking my questions can you hear me.
Yep.
Yes.
Uh huh.
Just to add.
The ongoing.
Full commercial launch in one Q 21 can you talk about any gating factors that a stone required or needed to get through before launch will that may have an impact on the timing of launch.
Yes, sorry, I think about Threed somebody.
Hi, when fusion type C meeting can you provide any additional are you able to provide any additional color in terms of when one Q, we could expect us then.
Then lastly, Chris.
Gross margin in the quarter seem to be have a lot better than we've seen in the past and any color on that thank you.
Okay. So Tim.
Tim maybe.
You want to.
Well, we have a brand im sorry, let me take the type C meeting.
Question that.
Pretty straight forward.
We expect this.
Probably in.
The late.
Wary.
Early March.
That would be our estimate.
Tim do you want to address.
Another.
One of his questions.
Yeah, I can speak to the Avenue launch so the delay that we saw was minor it was related to as I mentioned scheduling of the production of packaging with our supplier in Europe.
Certainly there could always be further delays, but for the moment, we do not anticipate any further manufacturing issues.
And there are no other.
So I would say barriers to introduction and on that basis, we're comfortable with the expectation of commercial delivery in the first quarter.
Okay, Great and then I think you had one other question which is.
Yes, just on the gross margin guidance.
Looking at it continues to be a lot higher than we experienced last year looking at this asset any color in terms of that or was it just product mix from.
To say, it's mostly product mix, but Russell do you have any further comments on that.
Well I would say that you know the one thing is we are trying to.
No.
Make our processes more efficient.
And cost effective so hopefully.
The early stages of that were being seen here, but I think it's one of the focus we're going to be taking going forward as well to hopefully try to.
Have have not only gross margin, but but also net margin that.
Is it.
Is as efficient as possible. So we can take excess costs out of it so.
Stay tuned for that that is a process that were going.
Going out very very heavily right now.
Great. Thank you very much.
Our next question comes from Rahm Silverado of H.C. Wainwright. Your line is open.
Thanks, very much for taking my questions just to start with a few questions on the international development that Triferic.
Can you give us a sense of how long.
One volume.
Take to reach full enrollment in the pivotal Triferic trial in China, or if they havent given you any real guidance regarding that timeline.
Mark.
Talk about this.
We'll get some more journal Duff <unk> Phelps.
Sure. Thank.
Thank you for the question so.
As you heard from Russia, we are anticipating a started the study sometime.
Early next year and depending on the speed of enrollment we should have a fully subscribed study sometime in the first half of 2023.
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Okay.
And then with respect to the situation in India.
Do you have any sense of what.
Indian regulators are looking for with regard to when they would.
Since the suspension of regulatory review due to cold at night, or that's likely to persist indefinitely.
Oh, that's a very good question and.
I wish I really had a firm answer for that but I don't.
That seem to be very much related to.
The incidence rate of cases, which as you know and and dealers.
Really bad.
And.
I haven't we haven't certainly got any guidance about.
What sort of incidence rate.
You know allow regulatory meetings to happen in that sort of thing so.
We really don't know, but the good news is we.
We are.
Don't know that it.
To be a very long time, but the bad news is we don't know that it's going to be short time. So.
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We're just waiting to hear from you.
The authority than Sun pharma, which is a pretty major company in India.
No really very connected with the authorities and I'm sure that.
As soon as they open up or start to open up we should be able to get it.
Okay.
Okay, and then can you just very quickly provide us any kind of update metrics regarding valuation programs on Triferic Avenue and when you expect those evaluation programs to effectively close following the formal rollout of the product and then secondly, if you can.
Comment on what the status is of the real World data program with.
With dialysate.
Okay.
Kim do you want to.
Take the first two questions and I'll.
Yes, the second the last one.
Yes, absolutely. So thanks for the question and our first.
Relation programs started only in early October so for now it's it's too early for us to really report.
Comprehensively on on how this is going to go and how many clinics are going to adopt.
Well, we have done heavy promotion of the program.
Among eligible customers in our target segments.
In various channels as mentioned as well through our HSN.
American Society of Nephrology Congress, which occurred in October two.
To increase awareness of the program built.
The length of the evaluations vary based on what I explained to earlier, which is our negotiation with clinics about.
Evaluation program length versus cost and product. So we're trying to accelerate the sales cycle there.
But but early to say what the results are there, but we certainly will apply learnings from.
The evaluation program to our commercial launch in the first first quarter.
[noise] and the real world data questions. Good one.
We've been.
Weve contracted affirmed too.
Do an in depth dive on.
United States renal disease service data set.
As provided by Rev deck, which is current.
And.
Weve very recently received that David said, it takes a while to get it.
And so we'll be evaluating multiple clinics with about a nine month to 12 month tenure of using the product.
So we should have a and b information and the risk that gave us that it's pretty comprehensive.
And includes also outcomes data, such as hospitalizations and depth and so on.
As well as.
Dialysis drug and device input so we should have.
Very nice datasets the hope.
Certainly.
In the first quarter next year.
We are analyzing it now.
I would hope that that would be earlier in the first quarter.
Great. Thank you very much.
This concludes our question answer session ill now pass the call back to Russell Olsen for closing remarks.
Well.
Well. Thank you all for joining us this afternoon.
In these interesting times for.
Taking the time to be on this call and.
And we look forward to following up with many of you in the coming days and weeks.
Oh, thanks very much.
Ladies and gentlemen, this does conclude the conference you may now disconnect everyone have a great day.
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