Q4 2021 Rockwell Medical Inc Earnings Call
Ladies and gentlemen, and today's conference will begin shortly please continue to standby. Thank you for your patience.
[music].
Good afternoon, ladies and gentlemen, and welcome to the Rockwell medical fourth quarter and full year 2020 results call.
At this time all participant.
All lines are in listen only mode. So if you require operator assistance. Please press Star then zero.
After the presentation, there will be a question and answer session.
I'll ask a question during the session you will need to press Star then one.
And as a reminder, this conference call is being recorded.
At this time I would like to introduce Claudio stifling.
And Investor Relations. Please go ahead.
Good afternoon. This is cardio stifle and Europe Argot partners <unk> Investor Relations representative for Rockwell Medical joining me from Rockwell medical on today's call our Doctor.
Ellison, President and Chief Executive Officer, Russell sketched that executive Vice President and Chief Financial Officer, and Chief Business Officer, Dr. Marc Hoffman, Chief Medical Officer, and Tim Cole <unk> Senior Vice President and sales and marketing before we begin I would like to remind everyone that this conference call and webcast.
Russell contain forward looking statements about the company within the meetings of the federal securities laws, including but not limited to the types of statements identified as forward looking statements and our quarterly report on form 10-Q that was filed on November nine 2020, our annual report on form 10-K that we're filing.
Okay, and our subsequent periodic reports filed with the SEC, which will all be available on our website and the Investor Relations section.
These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward looking statements reflect our opinions only as of today.
Ellington, except as required by law, we specifically disclaim any obligation to update or revise these forward looking statements in light of new information or future events factors that could cause actual results or outcomes to differ materially from those expressed and or implied by such forward looking statements are discussed.
Gust in greater detail and our periodic reports filed with the SEC. This conference call can be accessed on Rockwell Medical's Investor Relations webpage. This call is being recorded on March 31, 2021 for audio rebroadcast and can also be accessed on the same webpage at this time I would like to turn.
The conference call over to Rockwell Medical's, Chief Executive Officer, Dr. Russell Ellison Russell.
Good afternoon.
Thank you for joining us.
2020 was an important year for us like most companies around the world.
We faced challenges during the COVID-19 pandemic.
And I'm proud of how our team stepped up.
And people created and followed strict protocols.
And we met our customers' demand without interruption.
Lives depended on it.
For the patients we serve do not have the option of sheltering in place.
2020 also mark.
A significant shift and the trajectory of our company we.
We are not the same company that we were even one year ago.
The purpose of my remarks today is to address our dedicated shareholders and with whom I want to ensure my enthusiasm for Rockwell future I also want to share our expectations for the near.
And lay out and clear terms the practical plan of action that we are following to evolve Rockwell medical into a higher margin and more broadly diversified company.
I was first brought to Rockwell medical by the board and mid 2019 as a consultant to take a hard look at the company the board for me.
Near term there was unrealized value.
Let me walk you through the process.
We had two key foundational assets.
One was our next generation parental iron technology platform.
Eric Pyrophosphate citrate or MPC as we call. It that I believe can positively impact a broad range of patients.
Not only and dialysis, but well be on.
The other was an asset that has been largely ignored over the past decade, except by the 125000 or so people whose lives depend on it <unk>.
And our concentrate business.
And the discussion that began when I joined the board and accelerated when I became CEO last April.
We're squarely centered on how we can re imagined and reinvigorate the business and drive long term future value our best could we unlock the unrealized value from our two foundational assets.
We already had a strong dialysis business the challenge was growth because we already.
<unk> already had a pretty large market share and concentrates we launch triferic and 2019, but since Medicare and determined that triferic would be reimbursed under the fixed bundled rate market adoption was and still is dependent on the generation of data showing improved patient outcomes and or lower costs versus.
Is the current standard of care.
Since this type of health economic evidence was not required by the FDA for the approval of Triferic at has been necessary for us to generate these data post approval.
As I thought.
We have three primary drivers for pillars for achieving accelerated higher margin growth.
And thereby improve shareholder value for <unk>.
First is increasing sales of Triferic and the U S, which meant we needed to generate data.
And second is getting Triferic set for sales internationally, which meant we needed to find the appropriate partners and help them with their efforts to get Triferic approved and launched and their respective.
Specter of countries third we needed to determine the next indications for our development of our FPC platform, which required analysis.
The strategy, we needed was pretty straightforward to accelerate our growth by combining the solid foundation strength and reputation of our dialysis business with.
The high growth potential from therapeutics generated from our FPC platform in multiple disease states, where patients can benefit the most from an effective treatment for iron deficiency, and where there are more favorable reimbursement landscapes.
It was clear to me that if we are and optimize our FPC platform.
And we needed to become a more medically scientifically and data driven company future.
Future clinical regulatory and commercial success.
Required the right people with the right experience to navigate us through the right data.
To achieve that and we need to accelerate the evolution of both our management.
And board for.
<unk> us with greater rather than experience, we completed key executive level hires, including myself and our CFO and CBO Russell Gibson and key appointments to our board of directors.
Strengthened our team with significant medical and commercial experience and iron deficiency anemia.
And dialysis, including our Chief Medical Officer, Dr. Marc Hoffman, and our senior Vice President of sales and marketing, Tim Cope both of whom you'll be hearing from later in this call.
And this strengthened our team with drug development and commercialization expertise as well as small cap public company finance and manage.
It's for fees and.
And we added critical strength and the clinical nurse educator patient support space.
I'm confident that these changes support and improve the execution of our strategy to be a more data driven company, which I believe will support future commercial growth fair reimbursement.
And and regulatory approvals.
We've already made progress.
Data were recently published by NYU that support future adoption of Triferic and dialysis.
We signed partnership agreements with established companies and both India and Korea.
Our partner in China has initiated.
And the clinical trial required for approval we've identified the first two new indications, which we believe will have the biggest impact from our FPC technology and expect to start a phase II clinical study and one of these indications later this year.
We've also begun the process of the ground up review of our concentrate business.
To identify not only ways to increase efficiency, but also to increase sales.
When we think about rockwell's business, we think of it as having three distinct areas of focus first on dialysis business, which includes concentrates and our two marketed triferic product.
And our clinical development program.
Graham for F. T C for iron deficiency anemia in the home infusion settings, and third the advancement of our pipeline.
Currently acute heart failure and hospitalized patients is the top priority and this pipeline.
I'll start with our dialysis business.
I think it is underappreciated that Rockwell medical.
<unk> is the second largest supplier of hemodialysis concentrates in the United States, we have core capabilities and the manufacturer of hemodialysis concentrates under GMP.
And three facilities.
As well as and the logistics of delivering these products to dialysis clinics throughout most of the United States.
Our reputation is based on more than 25 years of service for the kidney dialysis centers.
This business generates about $60 million and annual revenue and gives us a solid foundation on which to grow.
We are reviewing this business to identify potential ways to make it stronger.
Certainly.
This business is a core platform for our company's revenue.
The dialysis business also includes the first two branded products from our FPC platform Triferic Dialysate and Triferic average.
Which are used to maintain hemoglobin in patients undergoing hemodialysis.
Our strategy for increasing adoption.
Option is to continue to generate data and clinics showing the benefits of Triferic and real world protocols.
We also plan to study Triferic and use with the innovations that are anticipated to change feature medical practices and hemodialysis. For example, the introduction and adoption of potential fifth ph is like rocks to do that.
And which Mark will address later on on this call.
We believe that positive data from these studies would position triferic for long term growth for.
Currently we are developing strategic alliance partners for development regulatory approval and commercialization of Triferic outside of the United States building on our progress.
<unk> and 2020, with our partnerships and India and South Korea.
I view today's.
Triferic product portfolio and dialysis as providing the foundation for a higher margin business and the midterm.
Everyday that goes by with our two products and the market is another day of generating important new day.
Safety efficacy and health economics, such as potential cost savings and the health care system.
These data are important because they can provide the basis for more robust adoption of the triferic product over time and dialysis, while supporting the case for the utility of our future potential FTC.
On a base products and other indications.
This takes me to the next area of focus are first new indication outside of dialysis F. P. C for treating iron deficiency anemia, and the home infusion and setting.
Many patient groups requiring home infusion therapy.
Suffered from chronic diseases that are associated.
But with a high incidence of iron deficiency anemia patients with iron deficiency anemia can exhibit symptoms of fatigue shortness of breath rapid or irregular heartbeats and glass sizes, all of which affect quality of life.
And the infusion represents a large and rapidly growing segment of health care, where we believe.
And you see may have distinct advantages over currently available iron replacement therapy options.
Unlike our two triferic products, which are price within the catheter dialysis payment or bundle, we expect future FTC based products to be reimbursed under the Medicare part B scenario is separate.
F P distinct products. The FDA has confirmed that our proposed FTC treatment for iron deficiency anemia, and the home infusion setting will require a 505 b for on approval effectively. This means that we would submit a new drug application for the home infusion product that would then be eligible for a.
Separate and distinct Medicare reimbursement code.
We are on track to initiate our phase II FTC home infusion trial and the second half of 2021.
And our pipeline we are exploring the use of FCC for the treatment of hospitalized patients with acute heart failure.
We believe that FTC.
<unk> will deliver rapidly bio available wire to the heart and improve cardiac and genetics.
This effect could help patients recover faster, resulting in shorter hospital stays and potentially fewer 30 day, readmissions, which would be a meaningful reduction and health care costs and human suffering.
We are on track to.
To discuss our clinical development plans for acute heart failure with FDA and the second half of this year.
I opened todays remarks by saying Rockwell medical is not the same company it was a year ago.
What I would impress upon our loyal and investors is that in 2020, the new Rockwell medical leadership team laid out a new.
New and specific vision for.
And diversified and higher margin company.
We are driving towards decision by fortifying, our core revenue base and leveraging it to build the products of tomorrow.
I have every conviction that our proprietary FPC platform can yield important new innovations to.
And for long.
And I. Thank you for your patience and your belief and our efforts to unlock the value of our company.
I'm now going to turn the call over to Tim to further discuss our dialysis business and then to Mark who will give additional color on our hip thia and FTC opportunities and then finally.
To Russell skips and to provide a financial update.
Tim.
Thanks Russell.
First I would like to provide and update on the performance of the dialysis concentrates business.
Rockwell medical was built on the dialysis concentrates, we manufacture and sell on the U S and around the world.
We've grown to be one of.
The two major suppliers of dialysis concentrates and the U S.
And we have established a reputation as one of the most reliable suppliers and the business.
With best in class customer service, we were proud to maintain the highest level of customer service with no supply interruptions through the worst months of the COVID-19, pandemic and the Texas Winter.
For storm prices.
And 2021, our focus will be on maintaining our strong presence and the market serving our customers with excellence.
And implementing strategies that will create efficiencies and improve our profitability.
Our primary commercial focus and the dialysis space continues to be on growing.
Adoption of Triferic as Russell mentioned, we sell Triferic and the U S and to a dialysis market under a capital reimbursement model with extreme price pressure.
Nevertheless, Triferic is a novel product with distinct advantages for patients and clinics and we have seen steady growth and adoption among independent dialysis providers.
Knowing the during the fourth quarter, we made good incremental progress with Triferic dialysate, we entered into a new purchase agreements for Triferic with 12 additional clinics, bringing the total number of clinics on contract to 65.
This means the number of contracted patients increased to approximately 4800.
The overall.
Results for the quarter lagged somewhat behind expectations in part due to the continued impact of the pandemic.
Surge of Covid cases, and the fourth quarter proved again to be a burden for many dialysis clinics, particularly those in urban areas.
And some cases caused them to delay decisions about making any significant changes such as adopting.
And new products are changing treatment protocols.
Nevertheless, our experienced field force continues to find creative ways to leverage virtual engagement tools.
And get in front of decision makers.
We have been learning a tremendous amount about optimizing anemia management protocols with Triferic.
Through the gathering of real world data from our user clinics.
So we are focused on leveraging this real world evidence and showing health economic outcomes.
On the strength of this evidence our push for customers to bypass the evaluation program and move straight to purchase contracts has proven to be a successful approach we were able to accomplish.
And this in many cases by utilizing a value analysis toolkit.
And to help clinics calculate the potential financial impact of adopting triferic and.
And by connecting potential customers with nephrology experts that are triferic users and advocates.
We continue to believe that the publication of real world evidence that supports the use of <unk>.
Eric is the key to accelerating market adoption.
To that and we continue to collect clinical outcome and drug utilization data from customers.
In January of 2021, the outpatient dialysis program and why you Lingo and hospital long Island independently published a report and the journal of critical care Medicine.
And report described and observational retrospective chart review study of 100 patients.
Which looked at anemia drug utilization before and after use of Triferic dialysate.
The results showed a reduction and the use of traditional IV iron and and the use of erythropoietin stimulating agents after triferic implementation.
Leading to an estimate.
Weighted cost savings over one fiscal year of nearly $300000.
And this report from NYU provides another compelling real World example, which supports the potential pharmacodynamic impact of Triferic bye.
And by leveraging these data and with the continued execution of our targeted promotional and educational programs.
We believe we can continue to drive the long term adoption of Triferic.
Next I'd like to provide and update on Triferic Avenue.
Our new IV formulation of Triferic for Triferic Avenue as a line extension of our Triferic portfolio and.
And it joins Triferic dialysate as the only FDA approved products with a unique.
<unk> anemia management indication to replace iron and maintain hemoglobin and <unk>.
Adult patients with hemodialysis dependent chronic kidney disease.
Triferic Avenue is designed for direct intravenous administration.
And enhances the triferic platform by providing patients with greater access to Triferic bikes.
And the administration options for clinics.
With Triferic Avenue Triferic can be administered as an IV infusion to patients regardless of the mode of bicarbonate delivery being used that's more appropriate and cases, where the hemodialysis clinic is using dry bicarbonate technology.
And our Triferic dialysate product is not an option.
This represents about 40% of the clinics and our target market segment.
Our promotional outreach to prepare the market for the commercial launch of Triferic Avenue started the second quarter of 2020 and continued through Q for the focus has been on introducing Triferic Avenue to customers, who had expressed interest and triferic and the past.
But have been unable to adopt <unk> due to their use of.
Dry bicarbonate technology, and cases, where we have existing triferic contracts with independent dialysis organizations.
We have been working to add Triferic Avenue to agreements so that clinics within those organizations using solid bicarbonate technology, while the opportunity to use it.
The first stretch for our <unk> Avenue evaluation programs began in October 2020.
Interest and the program has been high among the targeted clinics. However, the number of sites to get up and running with active evaluations and Q4 was lower than expected.
Many clinics on a difficult to identify a convenient method for delivering.
Triferic Avenue B, a slow infusion.
And we anticipated this might be a challenge in some cases and we have been actively working to develop alternative administration methods that can be more widely adopted we've made significant progress and we expect to have alternative more convenient methods to present to customers later this year.
Triferic Avenue represents a step forward for the Triferic portfolio and the U S.
As a line extension of Triferic and provides us with an opportunity to access a new market segment and allows physicians to individualize treatment adopt.
Adoption of the product is expected to be limited until we can identify less labor intensive methods for administration.
However, we believe Triferic Avenue will help us to open more opportunities for the portfolio and help open doors for us to increase the overall adoption of Triferic dialysate and the U S.
It's also an important breakthrough to have Triferic Avenue approved and commercialized in the U S and increases our potential to find partners for Triferic outside.
Outside of the U S for an IV form of the drug may be a preferred formulation.
With respect to the global development and commercialization of Triferic, we continue to make important progress.
As we recently announced our partner in China has enrolled its first patient and its phase III registration trial.
We signed a license.
Agreement with <unk> pharma, and South Korea, who have filed new drug applications for Triferic, Dialysate, and Triferic Avenue and that country.
And our new drug submission continues its review by Health Canada.
Our partner and India Sun Pharma is working through the regulatory process with the Indian authorities.
Which has been.
And delayed by Covid.
I'll now turn the call over to Mark.
Thank you Tim.
First I'd like to touch upon and the anticipated introduction of an entirely new class of anemia management agents and hypoxia inducible factor polio hydroxylase inhibitors for his ph eyes, which were expected.
To change the management of the new year and end stage renal disease and hemodialysis.
We plan to strategically positioning triferic alongside the FPH is to provide a consistent and physiologic treatment of anemia in hemodialysis patients.
Although the approval of <unk> the first of the his ph agents expected to become.
And the U S has been delayed by the F D. A pending and advisory Committee meeting the publicly available clinical evidence from the rocks reduce that phase III trials indicates that there may be a reduced iron replacement requirement for dialysis patients treated with box to do stuff.
If we extrapolate these data to a real world scenario this requirement.
Come of bidders to be well within the range that can be achieved with triferic alone administrated each dialysis session such the triferic could be a sufficient source of iron and patients treated with a history of choice.
We are working with Kols and members of our medical Advisory Board to develop a clinical trial protocol to demonstrate these synergies.
And if you have any such study would be contingent upon the commercial availability of <unk>.
And turn this could represent a significant new market opportunity for our product and its nephrologist rethink how they manage and India.
We look forward to providing further updates on our strategy related to F ph eyes, and the coming months.
Turning to our foundational work and the area of home infusion therapy.
We conducted a clinical feasibility study to assess treatment and practice patterns and attitudes towards the management of iron deficiency anemia, often referred to as I I D E and the home infusion population.
The purpose of this study was to inform the design for future clinical protocols.
Protocols and the overall development program for a novel approach to iron replacement and the home infusion population.
Many patients with chronic disease, requiring long term home infusion therapy for at risk for iron deficiency anemia.
Iron deficiency anemia falls into the category of a condition that is relatively simple to.
And like with challenging to treat with current IV formulations for.
For example idea is estimated to occur and 40 to 55 per cent of all patients on long term parental nutrition.
The American society for parental and Enteral nutrition for Aspen recommends that patients receiving home parental nutrition and be screen.
And regular and treatment at home due to the formulation options that are available today.
Home infusion of traditional IV iron and is limited due to the risk of hypersensitivity and concerns about incompatibility with other infused drugs that the patient may be receiving.
As a result patients may be referred to the physician for and IV.
Infusion, which is costly and inconvenient and may not be available from that positions particular practice model.
Limitations with the current approach can lead to a vicious cycle of late diagnosis and inconsistent treatment.
Understanding that there are several key stakeholders and the treatment and management of <unk>.
Irony and home infusion patients, we surveyed U S physicians and pharmacists, who are actively engaged with patients receiving on parental nutrition.
E Survey participants were identified in conjunction with the only foundation.
Outreach was conducted in cooperation with key opinion leaders and gastroenterology and home parental nutrition.
T study was conducted in November and December of 2020, a total of 26 physician responses and 39 pharmacist responses were recorded and analyzed.
Key insights include the following.
With an 85 per cent of the physicians and pharmacists recommend IV iron and for home correctly on nutrition patients.
And all wire and remind remains a first line therapy and approximately 50 per cent of the respondents and both groups.
The standard Iron paddle, which is iron total iron and binding capacity Burton and transparent saturation are employed and the home infusion settings for the assessment of iron status.
Our outreach validates literature reports.
And approximately 50% of homecare and school nutrition patients suffer from idea. However, there was no clear consensus on treatment or practice patterns nuclear consensus for hemoglobin target to initiate therapy and no clear consensus from outreach for hemoglobin target for goal directed therapy.
And existing treatment plans R&D.
Got it but for the current therapeutic options available.
The study results validated our initial assumptions that management of iron deficiency anemia, and the home infusion population is suboptimal and remains an unmet clinical need.
This is not surprising considering the absence of any well controlled clinical trials for actual iron therapy and.
R and D population.
Further that are safe effective and convenient parental iron therapy should it for home infusion supported by randomized clinical trials could have a dramatic impact on patient care and quality of life.
For the first time, a well controlled randomized clinical trial will evaluate the safety and efficacy.
On the parental iron treatment and this case F. P C delivered at home.
The proposed study design incorporates the considerable knowledge and data that already exists for the SBC and molecule, including an extensive safety database of more than $1 3 million administrations and are very frail hemodialysis patient population.
And this patient well established kinetics, which provides strong rationale for the doses and dose schedules that have been developed for this setting.
F P C as a true second generation correct rollout and it.
It was developed to replace iron loss and patients with anemia, and an entirely different way.
F P C donates iron directly to circulating transfer.
As for and bypassing any potential upside and blockade for inflammation, which makes it immediately bio available for pretty critical body processes.
It is this unique property and the safety profile of the F. P. C that we believe make this proposed new indication and population for F. P C clinically feasible.
Commercially attractive.
We are confident that we approach. This study with many of the typical questions that exist in a phase II study already answered, which we expect to significantly derisk the study.
As you heard from Dr relatives, and the FDA has accepted our proposed development strategy to pursue and approval via the 505 day one.
And can play as a novel NDA for S. P C for treatment of Iga and adult patients.
This will create the opportunity for a unique and D. C code to be assigned and will allow us to apply for unique J code from CMS.
The agency further agreed with our approach to cross referenced non clinical pharmacology and toxicology.
One Palomar prior I and DS.
And it does not foresee the need for additional studies in these areas.
The FDA has provided us with valuable feedback on our proposed clinical development plans, which we intend to incorporate into the next iteration of clinical protocols and FDA correspondence and dialogue.
We plan to take advantage of day early consultation.
And he's provided by FTE and the pre IMD meeting to further clarify study design and patient selection and study endpoints for our phase II study of F. T C for treatment of idea and adult patients receiving home infusion therapies.
As a next step we plan to have a pre NDA meeting with FDA and where we will get.
And I'll put you on the protocol and development plan.
On the successful meeting we will initiate the clinical trial and the second half of this year.
For our pipeline and vacation acute heart failure, we enter we intend to meet with FDA to seek clarity on our proposed development strategy for F. P C as a therapeutic to improve cardiac energetics.
Feedbacks and hospitalized acute heart failure patients with iron deficiency.
Specifically, we want to confirm for F. B C. F T H publish guidance that drugs for short term treatment for heart failure that is less than 10 days do not require a mortality endpoint for approval.
If confirmed this would make the clinical development program.
<unk> on for Rockwell.
Following the successful dialogue, we would pursue the filing of and IMT for a phase II mechanistic proof of concept study we plan to submit this meeting request during the second half of this year.
Next I will turn the call for Russell skips dead for a financial overview Russell.
Thanks Mark.
Net sales in 'twenty, and 'twenty were approximately $62 $2 million, which was about $900000 more than 2019.
Net sales of hemodialysis concentrates were approximately $61 $1 million for the year, which was roughly flat.
Flat compared to 2019.
Net sales for Triferic were approximately $1 1 million for the year compared to half a million dollars and 2019.
For each year, 2020 and 2019 Triferic sales included approximately $200000 of deferred revenue.
Related to our international partnerships. It also included approximately $2 million each year and deferred revenue related to our agreement with Baxter.
We ended the year with cash cash equivalents and investments of approximately $58 7 million.
We believe.
Leave puts us in a good position to focus on the strategic initiatives that Russell Tim Mark previously described.
Russell mentioned earlier that we began a process of a ground up review of our concentrate business.
After visiting each of the manufacturing facilities I became increasingly convinced.
There were opportunities to make both our manufacturing and transportation operations more efficient.
I also believe there are opportunities to grow this business, we have launched projects to identify ways to improve the overall profitability of these core operations, which I hope to update you on later this year.
I'll now turn the call back to Russell Ellison for his closing remarks Russell.
Thanks Russell.
Our company has multiple near term commercial and development milestones coming up and 2021 and 2022.
These milestones include expected progress and the global expansion and Triferic.
Eric as well as the anticipated clinical development activities that we outlined on our call today.
For our FPC platform.
<unk> thousand 20 was a year of re imagining and our company and reinvigorating our business.
Our new strategy to become a scientifically and clinically driven company is.
And now in execution mode and progress has been made towards our key growth drivers I expect continued strong progress for the remainder of this year and next year as we execute against our plan to drive growth and increase value.
Now I'll turn the line.
Moving to the operator for questions.
Ladies and gentlemen, if you'd like to ask a question at this time. Please press the star and the number one key on your Touchtone telephone to withdraw your question press the pound key.
Again that is star then one to ask a question.
Our first question comes from the line of Brandon Folkes with Cantor Fitzgerald.
Hi, Thanks for taking my questions and congratulations on the progress.
And the quarter, maybe just three for me.
Can you just elaborate a little bit on.
And sort of what maybe if you have to pull on the concentrates business margin.
And obviously.
Could you do a good amount of revenue there and it can be quite meaningful with you'll have to pull that off and.
And secondly, maybe just since the publication of a N y U.
For the data.
One I guess any feedback you've had so far and then do you expect.
David you stand alone to drive uptake or should we think of as I said and maybe the first of many pieces that you think together will drive uptake and.
And then lastly on Rockies that.
And you can elaborate.
For lottery.
Question around that at the agency right now.
Yeah.
And what can you say just in terms of do you expect that rocky approval and study being key uptake for certain segments of the market or do you think you can infiltrate those segments of the market with the sort of day, so you're generating out of NYU. Thank you.
Well you have three questions there.
So thank you very much for that on the concentrate issue I'll turn this over to Russell and then.
And maybe we can take out for your other two questions. Thanks.
I was on great sure.
Sure. Thanks for the question Brandon.
And as I, just mentioned and see.
Since joining I've visited each of the facilities and.
And what struck me was I think there is is definitely some both bottom line and topline things we can do to help the margin.
So what we're doing is we're embarking upon this really a ground up analysis.
They were trying to where we're trying to optimize the supply chain materials handling logistics really the entire process to see where we can.
Increased margins and lower costs.
I think it's too early to say right now, but I I just have a really good feeling that.
We're going to be able to.
Find some sort of efficiencies there so, but we will have to wait until.
We've completed the assessment.
To be able to get a little more guidance on net and then the other side of it is working for you know we're looking at different ways too.
[noise] potentially bring.
In addition to.
And make any more efficient looking at ways that we can increase the topline so we.
We have available bandwidth within our manufacturing facilities and within our logistics. So we're looking at are there ways in which we can actually make other make other products that we can manufacture through there that we can.
And generate some topline on again.
And what if any of that turns out to be and we'll have to wait until we've we've gone through the assessment, but and I feel pretty pretty optimistic about it.
And.
Thanks, Russell and Mark do you want on.
Dress.
The data question.
Sure I'd be happy to Brendan could kind of just asking for it to repeat the question So I can and.
Entering and its proper Celtic.
I Gotcha and.
On the NYU data it looks it looks pretty impressive on the surface and maybe just one any feedback you've received to date and do you think there.
Peter will stand alone to drive uptake or should we think of this as one of many pieces of day to some of the pieces of data, we should expect to see over the coming years that collectively will drive that uptake.
And then secondly.
You may be lumped into the spa and Rocky do start at.
Do you think that hospital data.
That will drive uptake or do you within certain segments of the market or do you think that those segments of the market really all waiting for that royalty approval and study that you're going to run. Thank you for.
Okay, Great, Yes, and thank you for the question so with regard to the NYU data I think it's probably the latter of the options.
And that you articulated which is we look at this as the next and it.
Series of.
Long term real world data and real world evidence that we've been collecting one of the things that was particularly appealing about this data is that this data was published independently by NYU and and and the journal without any.
Input from Rockwell.
We have had the opportunity to share this from a peer reviewed journal. It has been very welcomed by clinics as we've shared this with the nephrology community.
I think it's fair to say that with each increasing body of evidence the story grows and it makes our story.
Dori more powerful and makes the uptake more appealing, but I think we will continue to.
Take advantage of the adoption of Triferic and the generation of new real World evidence.
Russell do you want me to take a stab at the Russia question, let's.
And do you want to repeat the question about Rosa.
Sure.
Maybe just sort of you know should we think of certain segments of the market.
And almost being beholden to Iraq and approval and you know running a study with their drug and that drug.
And all.
And do you think some of the state of generation on this sort of cost savings, maybe you're you may be able to generate significant amounts to drive those segments of the market and towards your product should rocks and you now have.
A few challenges of samples at the FDA.
Well lets take the scenario where.
And they have and advisory committee and its fine and they get approval.
Between now and then.
You know clinics are evaluating you know the claims are not yet using triferic are evaluating whether they should.
Want to adopt it and where.
Utilizing the data that we have are with respect to this and the context of.
The ethos.
And we haven't yet seen any hesitation about adopting this because clinics are waiting for IRAK say if that was part of your question.
I think with respect to <unk>.
Running a study with rock zone.
And we wouldn't wait for the results to recommend to clinics.
And that they use triferic.
To maintain hemoglobin and replace the IRA and that's been lost and dialysis that concept still applies.
And.
You know, whether you're using and Isa or you're using Raj. So just at the.
And the rationale for Triferic is to replace the iron that's lost and hemo dialysis, so and its.
Very straightforward way of doing that and very reliable on that respect you know.
Exactly how much iron and they're getting and.
So you know we're continuing we will continue to keep on and while we're running that study assuming bedrock and is approved then.
We can get the drug to put in a clinical trial and Meanwhile, Mark and his team is are now working out the protocols are such that they are ready.
To initiate this trial and rocks and do stats available.
Hope that answers your question.
That was very helpful. Thank you very much simple JV.
Thanks, Brian.
That concludes today's question and answer session now I'll turn the line back to a doctor Allison for closing remarks.
<unk>.
Well. Thank you all for joining us this afternoon.
And we really look forward to following up with many of you and the coming days and weeks have a great evening.
Ladies and gentlemen, this concludes today's conference call.
And for participating you may now disconnect.
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