Q4 2019 Earnings Call

To follow at that time, if anyone should do require assistance during the conference. Please press Star then zero on your Touchtone telephone as a reminder, this conference call is being recorded I would not make it tends to come over to your host Ms. duty Diclemente ma'am.

Thank you May welcome to Rockwell Medical fourth quarter 2019 earnings results call. This is Judy Clemente of insight Communications Investor Relations representative for Rockwell medical.

Judy DiClemente: Thank you, May. Welcome to Rockwell Medical's Q4 2019 earnings results call. This is Judy DiClemente of Insight Communications, the investor relations representative for Rockwell Medical. With me on today's call are Stuart Paul, Chief Executive Officer of Rockwell Medical, and Angus Smith, Chief Financial Officer of Rockwell Medical.

With me on today's call Stuart call, Chief Executive Officer of Rockwell Medical and Angus Smith, Chief Financial Officer of Rockwell Medical.

Judy DiClemente: 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. 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 are forward-looking statements. While Rockwell believes 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 and which are subject to inherent uncertainty. 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's SEC filings, many of which are beyond our control and subject to change. Actual results could be materially different.

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. 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 are forward-looking statements.

Before we begin I wanted to know that certain matters. We will discuss may constitute forward looking statements within the meaning of the federal securities laws.

Words, such as me, Mike will should believe expect anticipate estimate continue could potential predict forecast project plan intend or similar expressions are statements regarding intent belief or current expectations are forward looking statements.

While Rockwell believes 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 and which are subject to inherent uncertainty. 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's SEC filings, many of which are beyond our control and subject to change. Actual results could be materially different.

Well Rockwell believes 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 and which are subject to inherent uncertainty.

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 does he see filings many of which are beyond our control and subject to change.

Actual results could be materially different risks and uncertainties include statements about the any J code for the Triferic powder packet timing in the success of our Andy a submission for I.D. triferic timing and regulatory approval process for dialysate Triferic in China, the potential market opportunity in commercialization.

Judy DiClemente: Risks and uncertainties include statements about the unique J code for the Triferric powder packet, timing and the success of our NDA submission for IV Triferric, timing and regulatory approval process for dialysate Triferric in China, the potential market opportunity and commercialization of dialysate Triferric in China upon regulatory approval, the timing and regulatory process for our NDA filing for IV Triferric as filed with the FDA, the potential market opportunity for IV Triferric and other Rockwell products, pricing and reimbursement status for IV Triferric, dialysate Triferric, and other Rockwell products, CMS's announced final rule relating to the eligibility criteria for TDAPA, liquidity and capital resources, expected duration of Rockwell's existing liquidity and working capital, success of our commercialization plans for dialysate Triferric, and the success of our efforts to maintain, grow, and improve the profit margin of our concentrates business, and the impact of our general economic, industrial, healthcare, and political conditions in the United States and internationally, as well as those risks more fully discussed in the company's SEC filings.

Risks and uncertainties include statements about the unique J code for the Triferric powder packet, timing and the success of our NDA submission for IV Triferric, timing and regulatory approval process for dialysate Triferric in China, the potential market opportunity and commercialization of dialysate Triferric in China upon regulatory approval, the timing and regulatory process for our NDA filing for IV Triferric as filed with the FDA, the potential market opportunity for IV Triferric and other Rockwell products, pricing and reimbursement status for IV Triferric, dialysate Triferric, and other Rockwell products,

Dialysate Triferic in China upon regulatory approval, the timing and regulatory process for India filing for Ivy Triferic as filed with the FDA the potential market opportunity for Ivy Triferic and other Rockwell product pricing and reimbursement status for Ivy Triferic Dialysate, Triferic and other Rockwell product.

CMS's announced final rule relating to the eligibility criteria for TDAPA, liquidity and capital resources, expected duration of Rockwell's existing liquidity and working capital, success of our commercialization plans for dialysate Triferric, and the success of our efforts to maintain, grow, and improve the profit margin of our concentrates business, and the impact of our general economic, industrial, healthcare, and political conditions in the United States and internationally, as well as those risks more fully discussed in the company's SEC filings.

CMS is announced final rule relating to the eligibility criteria for Dabaa liquidity and capital resources expected duration of Rockwell its existing liquidity and working capital success of our commercialization plans for dialysate Triferic and success of our efforts to maintain grow and improve the profit margin of our concentrates.

And the impact of our general economic industrial health care and political conditions in the United States and internationally as well as those risks more fully discussed in the company's SEC filings.

Judy DiClemente: Accordingly, you should not place undue reliance on these forward-looking statements. Rockwell 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 Medical's investor relations webpage. This call is being recorded on 12 March 2020, 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's Chief Executive Officer, Stuart Paul. Stuart? Thank you, Judy. Good afternoon, everyone, and thank you for your time today.

Accordingly, you should not place undue reliance on these forward-looking statements. Rockwell 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 Medical's investor relations webpage. This call is being recorded on 12 March 2020, 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's Chief Executive Officer, Stuart Paul. Stuart?

Accordingly, you should not place undue reliance on these forward looking statements.

Rockwell 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 March 12, 2024 audio rebroadcast and can also.

The access on the same web page.

At this time I would like to turn the conference call over to Rockwell's, Chief Executive Officer Stuart call Huh.

Stuart Paul: Thank you, Judy. Good afternoon, everyone, and thank you for your time today. As we shared in our recent business update and in our press release this afternoon, we're providing key updates today on our progress on numerous fronts, including, first, the continuing progress of our launch of Dialysate Triferric, second, the status of IV Triferric with a 28 March PDUFA date, third, an update on our medical platform and our real-world data program, next, an update on our international activities for Triferric, and finally, our initial focus on additional high-potential therapeutic indications outside of end-stage renal disease.

Thank you Judy good afternoon, everyone and thank you for your time today.

Judy DiClemente: As we shared in our recent business update and in our press release this afternoon, we're providing key updates today on our progress on numerous fronts, including, first, the continuing progress of our launch of Dialysate Triferric, second, the status of IV Triferric with a 28 March PDUFA date, third, an update on our medical platform and our real-world data program, next, an update on our international activities for Triferric, and finally, our initial focus on additional high-potential therapeutic indications outside of end-stage renal disease. Before I get into the metrics, let me briefly reiterate our overarching goal at Rockwell Medical, which is to transform the way anemia is managed, not only in ESRD patients undergoing hemodialysis treatment, but also across a wide variety of therapeutic indications.

As we shared in a recent business update in our press released this afternoon, we're party cheap updates today in our progress on numerous fronts, including first.

Continuing progress of our launch of Dialysate, Triferic shark and the status of RV Triferic with a March 28 PDUFA date.

Third and update on our medical platform and our real World data program.

Next an update on our international activities for Triferic and finally, our initial focus on additional high potential therapeutic indications outside of end stage renal disease.

Before I get into the metrics, let me briefly reiterate our overarching goal at Rockwell Medical, which is to transform the way anemia is managed, not only in ESRD patients undergoing hemodialysis treatment, but also across a wide variety of therapeutic indications.

Before getting to the metrics, let me briefly reiterate our <unk> auction goal at Rockwell medical which is to transform the way anemias manage not only in iOS or de patients undergoing human dialysis treatment, but also across a wide variety of therapeutic indications.

Judy DiClemente: We're focused on changing the standard of care, and as we've stated previously, this will not happen overnight, but will take three to five years to achieve in ESRD. Our initial therapeutic focus in end-stage renal disease addresses the anemia that is a common side effect in this patient population. Now, Triferric is an important new and exciting therapeutic that delivers the iron and maintains the hemoglobin that hemodialysis patients need without increasing ferritin levels and without the risks of chronic inflammation, and other adverse events. Triferric avoids the problem of iron overload and toxicity that we believe many patients experience with traditional IV irons. To remind you of the size of the market opportunity, more than two million people receive hemodialysis annually worldwide, which translates into more than 250 million hemodialysis treatments each year.

We're focused on changing the standard of care, and as we've stated previously, this will not happen overnight, but will take three to five years to achieve in ESRD. Our initial therapeutic focus in end-stage renal disease addresses the anemia that is a common side effect in this patient population. Now, Triferric is an important new and exciting therapeutic that delivers the iron and maintains the hemoglobin that hemodialysis patients need without increasing ferritin levels and without the risks of chronic inflammation, and other adverse events.

We're focused on changing the standard of chair and as we've stated previously this will not happen overnight, but we'll take three to five years to achieve many years Saar D.

Our initial therapeutic focus in end stage renal disease addresses the anemia that is the common side effect in this patient population.

No Triferic is an important new and exciting therapeutic that delivers the iron and may change the hemoglobin that he would dialysis patients need without increasing ferritin levels and without the risks of chronic inflammation, another adverse events and triferic avoids the problem of iron overload and trucks.

Triferric avoids the problem of iron overload and toxicity that we believe many patients experience with traditional IV irons. To remind you of the size of the market opportunity, more than two million people receive hemodialysis annually worldwide, which translates into more than 250 million hemodialysis treatments each year.

The city that we believe many patients experience with traditional I'd be hires.

To remind you of the size of the market opportunity more than 2 million people perceive hemo dialysis annually worldwide, which translates into more than 250 million hemo dialysis treatments, each year and with increasing rates of diabetes obesity in hypertension. These numbers you're likely to growth.

Judy DiClemente: And with increasing rates of diabetes, obesity, and hypertension, these numbers are likely to grow. Our Triferric platform, which includes Dialysate Triferric and IV Triferric, pending FDA approval, has the potential to disrupt the way healthcare providers, both in the US and globally, treat anemia. Let me start off with an overview of our first FDA-approved formulation, Dialysate Triferric, which we launched in the United States in May of last year. Our evaluation program, which we introduced as part of the launch last year, allows clinics to sample Dialysate Triferric for three months, and this has been a very successful program for us to date. 75% of clinics that completed an evaluation program during the Q4 have now converted to contracted customers.

And with increasing rates of diabetes, obesity, and hypertension, these numbers are likely to grow. Our Triferric platform, which includes Dialysate Triferric and IV Triferric, pending FDA approval, has the potential to disrupt the way healthcare providers, both in the US and globally, treat anemia.

Or try shirt platform, which include style will see triferic in Ivy Triferic pending FDA approval has the potential to disrupt away health care providers, both from the U.S. and globally treating anemia.

Let me start off with an overview of our first FDA-approved formulation, Dialysate Triferric, which we launched in the United States in May of last year. Our evaluation program, which we introduced as part of the launch last year, allows clinics to sample Dialysate Triferric for three months, and this has been a very successful program for us to date. 75% of clinics that completed an evaluation program during the Q4 have now converted to contracted customers.

Let me start off with an overview of our first FDIC approved formulation dialysate, Triferic, which we launched in the United States in May of last year.

Our evaluation program, which we introduced as part of the launch last year allows clinics to sample dialysate Triferic for three months and this has been a very successful program for us to date, 75% clinics that completed an evaluation program during the fourth quarter have now converted to control.

I have to customers and this is consistent with the conversion rate we saw earlier in the year and we believe it represents very important validation for the clinical benefits the dialysis clinics see when they initiate triferic therapy in their patients and as we've stated in the past the interactions that we have with clinics during the evaluation program.

Judy DiClemente: This is consistent with the conversion rate we saw earlier in the year, and we believe it represents very important validation for the clinical benefits that dialysis clinics see when they initiate Triferric therapy in their patients. As we've stated in the past, the interactions that we have with clinics during the evaluation program allow for smooth implementation of Triferric and a dialogue regarding the benefits of Triferric, which we believe helps to reinforce the value of Triferric long-term. We're also pleased that last November, we signed our first contract with a medium-sized dialysis organization, or MDO. As we said from the outset of the launch of Dialysate Triferric, our initial targets were small and independent dialysis organizations with a plan to broaden our customer acquisition efforts to include medium and ultimately large-sized dialysis organizations.

This is consistent with the conversion rate we saw earlier in the year, and we believe it represents very important validation for the clinical benefits that dialysis clinics see when they initiate Triferric therapy in their patients. As we've stated in the past, the interactions that we have with clinics during the evaluation program allow for smooth implementation of Triferric and a dialogue regarding the benefits of Triferric, which we believe helps to reinforce the value of Triferric long-term. We're also pleased that last November, we signed our first contract with a medium-sized dialysis organization, or MDO.

I am allow for smooth implementation of Triferic and a dialogue regarding the benefits of Triferic, which we believe hopes to reinforce the value of Triferic long term.

We're also pleased.

Last November we signed our first contract with a medium size dialysis organization or MTO.

As we said from the outset of the launch of Dialysate Triferric, our initial targets were small and independent dialysis organizations with a plan to broaden our customer acquisition efforts to include medium and ultimately large-sized dialysis organizations.

And as we said from the outside of the launch of Dialysate Triferic. Our initial targets were small and independent dialysis organizations with a plan to broaden our customer acquisition efforts to include medium and ultimately large size dialysis organizations. So the signing of of the San Diego is significant.

Judy DiClemente: So this signing of this MDO is significant, and it gives us access to approximately 160 clinics within the system that are appropriate for dialysate Triferric, representing an estimated 10,000 patients. We began our launch within this MDO by working with three leading KOLs within their system, targeting five key clinics to fully introduce Triferric. As of year-end 2019, these five clinics fully converted to use of dialysate Triferric and initiated purchasing of dialysate Triferric. During the first two months of 2020, we've been working closely with the MDO to expand the launch within their system and to ensure appropriate training, implementation measures are in place, and we're expecting to see continued acceleration of adoption in the first half of this year as a result.

So this signing of this MDO is significant, and it gives us access to approximately 160 clinics within the system that are appropriate for dialysate Triferric, representing an estimated 10,000 patients. We began our launch within this MDO by working with three leading KOLs within their system, targeting five key clinics to fully introduce Triferric. As of year-end 2019, these five clinics fully converted to use of dialysate Triferric and initiated purchasing of dialysate Triferric.

And it gives us access to approximately 160 clinics within the system that are appropriate for dialysate triferic.

Representing an estimated 10000 patients we began or watch within this MTO by working with three leading tail wells within their system targeting five key clinics to fully introduced triferic as of yearend 2019. These want clinics fully converted to use of dialysate.

Triferic and initiated purchasing of Dallas say Triferic.

During the first two months of 2020, we've been working closely with the MDO to expand the launch within their system and to ensure appropriate training, implementation measures are in place, and we're expecting to see continued acceleration of adoption in the first half of this year as a result.

And during the first two months of 2020, we've been working closely with the audio to expand the launch within their system and to ensure appropriate training implementation measures are in place and we're expecting to see continued acceleration of adoption in the first half of this year as a result, and importantly, as part of the contract clinics.

Judy DiClemente: And importantly, as part of the contract, clinics have the option to provide us with data, which will add to the growing database that we're building to support the clinical and pharmacoeconomic benefits of Triferric. Let me provide a snapshot of where we stood at 31 December 2019, in terms of clinics and patients. During the Q4, we entered into 10 additional contracts representing more than 650 patients for a 77% increase in clinics under contract compared to 30 September 2019. And that brings the number of contracts in place at 31 December 2019 to 23, representing more than 1,650 patients. In addition, as of 31 December 2019, we had more than 10 additional clinics representing over 600 patients in various stages of an evaluation program. From Q3 to Q4, we saw a 67% increase in the number of annualized treatments under contract.

And importantly, as part of the contract, clinics have the option to provide us with data, which will add to the growing database that we're building to support the clinical and pharmacoeconomic benefits of Triferric. Let me provide a snapshot of where we stood at 31 December 2019, in terms of clinics and patients.

Option to provide us with data, which will add to the growing database that we're building to support the clinical and pharmacoeconomic benefits to try Sir.

Let me provide.

Now shot at where we stood at December 31, 2019 in terms of clinics and patience during the fourth quarter, we entered into 10 additional contracts representing more than 650 patients for a 77% increase in clinics under contract compared to September 30 20.

During the Q4, we entered into 10 additional contracts representing more than 650 patients for a 77% increase in clinics under contract compared to 30 September 2019. And that brings the number of contracts in place at 31 December 2019 to 23, representing more than 1,650 patients. In addition, as of 31 December 2019, we had more than 10 additional clinics representing over 600 patients in various stages of an evaluation program. From Q3 to Q4, we saw a 67% increase in the number of annualized treatments under contract.

Hi team and their brings the number of contracts in place at December 31st to 23, representing more than 1600 50 patients. In addition, as of December 31, 2019, we had more than 10 additional clinics representing over 600 patients in various stages.

Of an evaluation program on the 10-Q, three two Q4, we saw 67% increase and the number of annualized treatments under contract that equates to an increase of 100000 annualize treatments under contract compared to September 30, 29 team.

Judy DiClemente: That equates to an increase of 100,000 annualized treatments under contract compared to 30 September 2019. Furthermore, more than 80% of customers order Triferric on an ongoing basis. We are gaining traction in the market and believe that these trends will accelerate as we go through 2020. If uptake continues, as we believe it will, Rockwell Medical stands to make significant inroads into the large and growing anemia management market around ESRD in the United States. Let me turn now to our IV formulation of Triferric. We're now just 16 days from our PDUFA date of 28 March 2020, and we're looking forward to receiving approval and launching this innovative extension of our Triferric platform.

That equates to an increase of 100,000 annualized treatments under contract compared to 30 September 2019. Furthermore, more than 80% of customers order Triferric on an ongoing basis. We are gaining traction in the market and believe that these trends will accelerate as we go through 2020. If uptake continues, as we believe it will, Rockwell Medical stands to make significant inroads into the large and growing anemia management market around ESRD in the United States. Let me turn now to our IV formulation of Triferric.

Furthermore, more than 80% of customers for Triferic on an ongoing basis again, we are gaining traction in the market is try and believes that these trends will accelerate as we go through 2020.

Oh, Hey continues as we believe it will people Rockwell medical stands to make significant inroads into the large and growing Neemia management market around you certainty in the United States.

Let me turn out to our RV formulation of a transfer.

We're now just 16 days from our PDUFA date of 28 March 2020, and we're looking forward to receiving approval and launching this innovative extension of our Triferric platform. As a reminder, IV Triferric is designed for intravenous administration to adult hemodialysis patients and was developed pursuant to a special protocol assessment, or SPA, through which the FDA agreed that an equivalence approach to our dialysate Triferric would be acceptable for review.

We're now just 16 days from our produce the date of March 28.

And we're looking forward to receiving approval and launching this innovative extension of our Triferic platform.

Judy DiClemente: As a reminder, IV Triferric is designed for intravenous administration to adult hemodialysis patients and was developed pursuant to a special protocol assessment, or SPA, through which the FDA agreed that an equivalence approach to our dialysate Triferric would be acceptable for review. Now, if approved, IV Triferric provides a great deal of flexibility for dialysis centers in that they can customize treatment to individuals at the bedside. It also allows dialysis centers to administer Triferric to patients regardless of the mode of bicarbonate delivery being used. The IV formulation is more appropriate in cases where the hemodialysis clinic is using dry bicarbonate. In recent years, a number of US-based hemodialysis clinics have been shifting toward reliance on dry bicarbonate and away from a central liquid bicarbonate loop.

As a reminder, I'd be Triferic is designed for intravenous administration to adult hemo dialysis patients in was developed pursuant to a special protocol assessment for Sta through which the FDA agreed that an equivalents approach to our dialysate triferic would be acceptable for review.

Now, if approved, IV Triferric provides a great deal of flexibility for dialysis centers in that they can customize treatment to individuals at the bedside. It also allows dialysis centers to administer Triferric to patients regardless of the mode of bicarbonate delivery being used. The IV formulation is more appropriate in cases where the hemodialysis clinic is using dry bicarbonate. In recent years, a number of US-based hemodialysis clinics have been shifting toward reliance on dry bicarbonate and away from a central liquid bicarbonate loop.

No if approved IB Triferic provides a great deal of flexibility for dialysis centers and that they can customize treatment to individuals that bedside. It also allows dialysis TB to administer triferic patients regardless of the mode of bicarbonate delivery being used.

The Ivy formulation is more appropriate in cases, where the hemo dialysis clinic using drive by carbonate in recent years, a number of U.S. based hemo dialysis clinics have been shifting toward reliance on dry bicarbonate and away from a central liquid bicarbonate loop and as we've noted previously many dial.

Judy DiClemente: As we've noted previously, many dialysis centers in the international markets already use the dry bicarbonate cartridges or bags that require the IV formulation. We believe FDA approval should support the potential for expanding Triferric adoption both domestically and internationally. Together, our two formulations will offer dialysis clinics flexibility, a higher load of bicarbonate delivery, and preferred treatment approach, including offering the flexibility to treat certain subpopulations of patients, such as ESA hyper-responders or patients with high ferritin levels. These are some of the considerations as we develop and finalize our positioning strategy for IV Triferric vis-à-vis Dialysate Triferric in the marketplace. In terms of our commercialization plans for IV Triferric, if approved, we plan to leverage the launch infrastructure we've established for Dialysate Triferric and many of the learnings from the last nine months.

As we've noted previously, many dialysis centers in the international markets already use the dry bicarbonate cartridges or bags that require the IV formulation. We believe FDA approval should support the potential for expanding Triferric adoption both domestically and internationally. Together, our two formulations will offer dialysis clinics flexibility, a higher load of bicarbonate delivery, and preferred treatment approach, including offering the flexibility to treat certain subpopulations of patients, such as ESA hyper-responders or patients with high ferritin levels.

Plus the centers in the international markets already use the dry bicarbonate cartridges for bags that required the Ivy formulation.

So we believe FDIC approval should support the potential for expanding triferic adoption, both domestically and internationally.

Together, our two formulations will offer dialysis clinics flexibility am I supposed to Mexico, neither boats are bicarbonate delivery.

For treatment approach hearing offering the flood your ability to treat certain subpopulation patients second Esa hypo responders or patients with high Ferragamo base that these are sort of the acceleration that you crept up right well under that reduction as we develop and finalized our positioning strategy for.

These are some of the considerations as we develop and finalize our positioning strategy for IV Triferric vis-à-vis Dialysate Triferric in the marketplace. In terms of our commercialization plans for IV Triferric, if approved, we plan to leverage the launch infrastructure we've established for Dialysate Triferric and many of the learnings from the last nine months.

I'd be triferic vis-a-vis dialysate triferic in the marketplace.

In terms of our commercialization plans for Ivy Triferic, if approved we plan to leverage the launch infrastructure, we've established for dialysate Triferic and many of the learnings from the last nine months. Initially in Q2, we will apply the learnings from or Dialysate launch as we laid the groundwork for Rolling Ltd.

Judy DiClemente: Initially, in Q2, we will apply the learnings from our dialysate launch as we lay the groundwork for rolling out the IV version, and we'll invest time engaging with clinics, helping them understand the unique benefits and mechanism of action of Triferric. In Q3, we plan to launch evaluation programs for IV Triferric. We would then plan to commence commercial sales of IV Triferric in the Q4 of this year as targeted clinics for early adoption reach the three-month completion point in their IV Triferric evaluation program. As we've stated on our last call, we anticipate that IV Triferric will be reimbursed within the ESRD bundle. But importantly, we believe the cost structure for Triferric enables us to make an attractive gross margin while ensuring that this transformational therapy is broadly accessible to the patients who need it most.

Initially, in Q2, we will apply the learnings from our dialysate launch as we lay the groundwork for rolling out the IV version, and we'll invest time engaging with clinics, helping them understand the unique benefits and mechanism of action of Triferric. In Q3, we plan to launch evaluation programs for IV Triferric. We would then plan to commence commercial sales of IV Triferric in the Q4 of this year as targeted clinics for early adoption reach the three-month completion point in their IV Triferric evaluation program. As we've stated on our last call, we anticipate that IV Triferric will be reimbursed within the ESRD bundle.

Be version.

And we'll invest time engaging with clinics, helping them understand the unique benefits mechanism of action of Triferic.

In Q3, we plan to launch evaluation programs for I'd be Triferic. We would then plan to commence commercial sales the by be Triferic in the fourth quarter of this year as targeted clinics for early adoption reach the three months completion point in there I'd be Triferic evaluation program.

As we've stated on our last call, we anticipate that I see triferic will be reimbursed within the SRT bundle, but importantly, we believe the cost structure for Triferic enables us to make an attractive gross margin, while ensuring that this transformational therapy is broadly accessible to the patient.

But importantly, we believe the cost structure for Triferric enables us to make an attractive gross margin while ensuring that this transformational therapy is broadly accessible to the patients who need it most. We look forward to providing an update on this significant extension to the Triferric portfolio in the next few weeks. Now, during the Q4 of 2019, we also continue to strengthen and enhance our medical capabilities.

Who knew that most.

Judy DiClemente: We look forward to providing an update on this significant extension to the Triferric portfolio in the next few weeks. Now, during the Q4 of 2019, we also continue to strengthen and enhance our medical capabilities. Specifically, we hired Dr. Mark Hoffman as our new Chief Medical Officer, expanded our medical advisory board with the addition of three world-renowned nephrologists, Steve Fishbane, MD, Jay Wish, MD, and Anatole Besarab, MD. And these are physicians with deep renal and anemia experience who have already had a positive impact on advising our strategy for Triferric. We also added Russell Ellison, MD, to our board of directors. Dr. Ellison has held leadership positions in both emerging biotechnology and large pharmaceutical companies for more than four decades.

We look forward to providing an update on this significant extension to the Triferic portfolio in the next few weeks.

Now during the fourth quarter of 29 team. We also continued to strengthen and enhance our medical capabilities, specifically, we hired Dr. Marc Hoffman as our new Chief Medical Officer expanded our medical Advisory Board with the addition of Threed World renowned Nephrologist, Steve Fishbaine MD.

Specifically, we hired Dr. Mark Hoffman as our new Chief Medical Officer, expanded our medical advisory board with the addition of three world-renowned nephrologists, Steve Fishbane, MD, Jay Wish, MD, and Anatole Besarab, MD. And these are physicians with deep renal and anemia experience who have already had a positive impact on advising our strategy for Triferric. We also added Russell Ellison, MD, to our board of directors. Dr. Ellison has held leadership positions in both emerging biotechnology and large pharmaceutical companies for more than four decades.

Jay wish him be Anatole, Sarah BMD and these are physicians with deep renal and media experience with already had a positive impact on advising our strategy for triferic.

We also added Russell Ellison MD to our board of Directors Dr. Elson has held leadership positions in both emerging biotechnology and large pharmaceutical companies for more than four decades.

Judy DiClemente: His broad experience includes board of directors, chief executive, and medical executive roles with expertise in medical strategy, clinical development, global medical affairs, regulatory affairs, and public health policy in major markets in developing countries. Dr. Ellison has a deep understanding of the renal space based on experiences with companies developing therapeutic products that address kidney disease and renal anemia, including Hypoxia-Inducible Factor, or HIF, Prolyl Hydroxylase Inhibitors, or PHIs. We have also continued to engage with key centers of excellence and expect to add a number of these influential centers to our customer base in 2020. Finally, we expanded our real-world data program ending the year with eight clinics with over 700 patients in the program. During the Q1 2020, we expect to more than double the number of clinics in our real-world data program.

His broad experience includes board of directors, chief executive, and medical executive roles with expertise in medical strategy, clinical development, global medical affairs, regulatory affairs, and public health policy in major markets in developing countries. Dr. Ellison has a deep understanding of the renal space based on experiences with companies developing therapeutic products that address kidney disease and renal anemia, including Hypoxia-Inducible Factor, or HIF, Prolyl Hydroxylase Inhibitors, or PHIs. We have also continued to engage with key centers of excellence and expect to add a number of these influential centers to our customer base in 2020.

His broad experience includes board of director, Chief Executive and medical executive roles with expertise in medical strategy clinical development Global Medical Affairs regulatory affairs, and public health policy in major markets in developing countries.

Dr. Ellison has a deep understanding of the renal space based on experiences with companies developing therapeutic products that address kidney disease, and renal anemia, including hypoxia inducible factor work, if frolo hydroxyl ace inhibitors were PHR.

We've also continued to engage with key centers of excellence and expect to add a number of these influential centers to our customer base in 2020.

Finally, we expanded our real-world data program ending the year with eight clinics with over 700 patients in the program. During the Q1 2020, we expect to more than double the number of clinics in our real-world data program. We now have data from the first eight clinics in the program, and we've been working with external vendors to format the data for analysis and review key trends. Our dialogue with the physicians at these centers indicates that they are seeing very stable hemoglobin maintenance and reductions in the utilization of traditional IV irons and ESAs.

Finally, we expanded our real world data program ending the year with eight clinics with over 700 patients in the program and during the first quarter of 2020, we expect to more than double the number of clinics in our real World data program. We now have data from the first a clinics in the program and we've been working with him.

Judy DiClemente: We now have data from the first eight clinics in the program, and we've been working with external vendors to format the data for analysis and review key trends. Our dialogue with the physicians at these centers indicates that they are seeing very stable hemoglobin maintenance and reductions in the utilization of traditional IV irons and ESAs. As we continue to refine our analysis and expand our database of real-world evidence, we will proactively pursue opportunities to have data published or presented at prestigious industry conferences. Let me turn now to opportunities for Triferric outside of the United States. As we've said all along, we see Triferric as a large global market opportunity. The opportunity for Triferric in hemodialysis alone is potentially in excess of $1 billion. We are working to establish partnerships and position ourselves to expand our footprint into these important markets.

Internal vendors to format the data for analysis and review key trends.

Our dialogue with the physicians at these centers indicates that they are seeing very stable hemoglobin maintenance and reductions in the utilization of traditional Ivy irons any assays.

As we continue to refine our analysis and expand our database of real-world evidence, we will proactively pursue opportunities to have data published or presented at prestigious industry conferences. Let me turn now to opportunities for Triferric outside of the United States. As we've said all along, we see Triferric as a large global market opportunity. The opportunity for Triferric in hemodialysis alone is potentially in excess of $1 billion. We are working to establish partnerships and position ourselves to expand our footprint into these important markets.

And as we continue to refine or analysis and expand our database of real world evidence, we will proactively pursue opportunities to have data published or presented a prestigious industry conferences.

Let me turn now to opportunities for Triferic outside of United States and as we've said all along we see Triferic is a large global market opportunity the opportunity for Triferic and hemo dialysis alone is potentially in excess of $1 billion.

We're working to established partnerships and position ourselves to expand our footprint into these important markets in January we announced that we entered into license and supply agreements with a wholly owned subsidiary of Sun Pharmaceutical Industries limited for Sun pharma for the rights to commercialize Triferic in India, we're very.

Judy DiClemente: In January, we announced that we entered into license and supply agreements with a wholly owned subsidiary of Sun Pharmaceutical Industries Limited, or Sun Pharma, for the rights to commercialize Triferric in India. We're very excited about this opportunity. Sun Pharma is the largest pharmaceutical company in India with more than $4 billion in annual sales globally. It has a market-leading nephrology franchise and experience with license and distribution partnerships that it will use to promote Triferric to nephrologists throughout India. We will supply Triferric, and Sun Pharma will be our exclusive development and commercialization partner. Together, we will map out the development and execution details for Triferric in India, and Sun Pharma will be responsible for all clinical, regulatory, and commercialization activities. Rockwell Medical receives an upfront fee and will be eligible for milestone payments, and royalties on net sales.

In January, we announced that we entered into license and supply agreements with a wholly owned subsidiary of Sun Pharmaceutical Industries Limited, or Sun Pharma, for the rights to commercialize Triferric in India. We're very excited about this opportunity. Sun Pharma is the largest pharmaceutical company in India with more than $4 billion in annual sales globally. It has a market-leading nephrology franchise and experience with license and distribution partnerships that it will use to promote Triferric to nephrologists throughout India. We will supply Triferric, and Sun Pharma will be our exclusive development and commercialization partner.

Say that about this opportunity.

Sun Pharma is the largest pharmaceutical company in India with more than $4 billion annual sales globally. It as a market leading nephrology franchise in experience with license and distribution partnerships that it will use to promote triferic to nephrologists throughout India.

We will supply Triferic and Sun pharma will be our exclusive development and commercialization partner together, we will map out the development and execution details for Triferic in India, and Sun pharma will be responsible for all clinical regulatory and commercialization activities.

Together, we will map out the development and execution details for Triferric in India, and Sun Pharma will be responsible for all clinical, regulatory, and commercialization activities. Rockwell Medical receives an upfront fee and will be eligible for milestone payments, and royalties on net sales.

Rockwell medical receives an upfront fee and will be eligible for milestone payments in royalties on net sales.

Judy DiClemente: As you know, we're also working with our partner, Wanbang Biopharmaceuticals, to commercialize Triferric in China. In December 2019, we and Wanbang had a meeting with the NMPA, China's equivalent to the FDA, to discuss the PK studies we completed in 2019 and a potential regulatory submission. While it was acknowledged that the PK studies met their objective, the NMPA indicated that an additional clinical trial would be needed to support a submission for approval in China. Since the December meeting, we've continued to engage with our partner, Wanbang, and the regulatory body as well to explore clinical development options to move forward. Options for the clinical study have been drafted, and Wanbang has selected a CRO with the goal of initiating the required clinical study in 2020.

As you know, we're also working with our partner, Wanbang Biopharmaceuticals, to commercialize Triferric in China. In December 2019, we and Wanbang had a meeting with the NMPA, China's equivalent to the FDA, to discuss the PK studies we completed in 2019 and a potential regulatory submission. While it was acknowledged that the PK studies met their objective, the NMPA indicated that an additional clinical trial would be needed to support a submission for approval in China. Since the December meeting, we've continued to engage with our partner, Wanbang, and the regulatory body as well to explore clinical development options to move forward.

As you know we're also working with our partner one big biopharmaceutical to commercialize Triferic in China.

In December 2019, we and one being had a meeting with the and then PA China's equivalent to the FDA to.

To discuss the PK studies, we completed in 2019.

And the potential regulatory submission and while it was acknowledged that the PK studies met their objective. The ended PA indicated that an additional clinical trial would be needed to support a submission for approval in China. So since the December meeting, we've continued to engage with our partner one being and the regulatory.

Body as well to explore clinical development options to move forward.

Options for the clinical study have been drafted, and Wanbang has selected a CRO with the goal of initiating the required clinical study in 2020. In Canada, our NDS submission for IV Triferric is ready for submission, and we're awaiting the FDA approval decision before moving forward with the submission later this year. Finally, we're continuing to make progress in our discussions with potential licensing partners in other key geographies, including Europe and Japan. Let me take a moment now to share some other initiatives underway at Rockwell.

Actions for the clinical study at the drafted and one being has selected a CR ROE with the goal of initiating the required clinical study in 2020.

Judy DiClemente: In Canada, our NDS submission for IV Triferric is ready for submission, and we're awaiting the FDA approval decision before moving forward with the submission later this year. Finally, we're continuing to make progress in our discussions with potential licensing partners in other key geographies, including Europe and Japan. Let me take a moment now to share some other initiatives underway at Rockwell. As I mentioned earlier, Triferric is a unique therapeutic that has the potential to transform the way anemia is managed in a wide variety of disease states. And to that end, we've launched a strategic initiative to identify and prioritize other therapeutic indications for future development. We've established a team comprised of internal and external resources to focus on this project, and we hope to have an update on our plans later this year.

And in Canada, our NDS submission for Ivy Triferic is ready for submission and we're awaiting the FDA approval decision before moving forward with the submission later this year.

And finally, we're continuing to make progress in our discussions with potential licensing partners and other key geographies, including Europe in Japan.

Let me take a moment now to share some other initiatives underway at Rockwell as I mentioned earlier Triferic is a unique therapeutics that has the potential to transform the way anemia is managed in a wide variety of disease states and to that end, we've launched a strategic initiative to identify.

As I mentioned earlier, Triferric is a unique therapeutic that has the potential to transform the way anemia is managed in a wide variety of disease states. And to that end, we've launched a strategic initiative to identify and prioritize other therapeutic indications for future development. We've established a team comprised of internal and external resources to focus on this project, and we hope to have an update on our plans later this year.

And prioritized other therapeutic indications for future development.

We've established the team comprised of internal and external resources to focus on this project and we hope to have an update on our plans. Later. This year. This is a very exciting project for us as we look to build out the technology platform and address other indications were honored plays a critical role such as in.

Judy DiClemente: This is a very exciting project for us as we look to build out the technology platform and address other indications where iron plays a critical role, such as in cardiovascular disease, total parenteral nutrition, or oncology. In summary, 2019 was a pivotal year for Rockwell Medical. We launched Dialysate Triferric in the US. We submitted the new drug application for IV Triferric, developed and expanded our medical and commercial infrastructure to position the company for future success, and we began to lay the groundwork for additional value-creating milestones in the years to come. Looking ahead, we believe 2020 will also be an exciting year for Rockwell as we build upon our early signs of success for Dialysate Triferric, seek approval for IV Triferric in the US, continue our progress for Triferric outside the US, and take more concrete steps to position Triferric for use outside of end-stage renal disease.

This is a very exciting project for us as we look to build out the technology platform and address other indications where iron plays a critical role, such as in cardiovascular disease, total parenteral nutrition, or oncology. In summary, 2019 was a pivotal year for Rockwell Medical. We launched Dialysate Triferric in the US. We submitted the new drug application for IV Triferric, developed and expanded our medical and commercial infrastructure to position the company for future success, and we began to lay the groundwork for additional value-creating milestones in the years to come.

You are disease total parenteral nutrition war on colleges.

In summary.

29 team was a pivotal year for Rockwell medical we launched dialysate triferic in the US we submitted the new drug application for Ivy Triferic.

Developed and expanded our medical and commercial infrastructure to position the company for future success, and we began to lay the groundwork for additional value, creating milestones in the years to come.

Looking ahead, we believe 2020 will also be an exciting year for Rockwell as we build upon our early signs of success for Dialysate Triferric, seek approval for IV Triferric in the US, continue our progress for Triferric outside the US, and take more concrete steps to position Triferric for use outside of end-stage renal disease. I'll now turn the call over to our CFO, Angus Smith, to review our Q4 financials. Angus.

Looking ahead, we believe 2020 will also be an exciting year for Rockwell as we build upon our early signs of success for dialysate Triferic seek approval for Ivy Triferic in the U.S. continue our progress for Triferic outside the U.S. and take more concrete steps to position Triferic for you.

Outside of end stage renal disease.

I'll now turn the call over to our CFO Angus Smith to review, our fourth quarter financials Angus.

Judy DiClemente: I'll now turn the call over to our CFO, Angus Smith, to review our Q4 financials. Angus. Thank you. Thank you, Stuart. Turning now to our Q4 results, net sales for the Q4 of 2019 were $15.5 million compared to sales of $16.9 million during the three months ended 31 December 2018. Net sales of hemodialysis concentrates to dialysis providers and distributors in the US and abroad were $15.3 million for the three months ended 31 December 2019, compared to $16.8 million for the three months ended 31 December 2018. The decrease in net sales was due to a decrease in international concentrate sales of $1.1 million and a decrease related to true-ups under the Baxter Agreement for cost of sales and transportation costs, partially offset by increased concentrate sales to DaVita and an increase in Triferric sales.

Angus Smith: Thank you. Thank you, Stuart. Turning now to our Q4 results, net sales for the Q4 of 2019 were $15.5 million compared to sales of $16.9 million during the three months ended 31 December 2018. Net sales of hemodialysis concentrates to dialysis providers and distributors in the US and abroad were $15.3 million for the three months ended 31 December 2019, compared to $16.8 million for the three months ended 31 December 2018.

Thank you. Thank you Stewart, turning now to our fourth quarter results.

Net sales for the fourth quarter of 2019 were $15.5 million compared to sales of $16.9 million. During the three months ended December 31 2018.

Net sales of hemo dialysis concentrate to dialysis providers and distributors in the U.S. and abroad.

$15.3 million for three months ended December 30, Onest 2019, compared to $16.8 million for three months ended December 30, Onest 2018.

The decrease in net sales was due to a decrease in international concentrate sales of $1.1 million and a decrease related to true-ups under the Baxter Agreement for cost of sales and transportation costs, partially offset by increased concentrate sales to DaVita and an increase in Triferric sales. Net sales of Triferric were approximately $228,000 for the three months ended 31 December 2019, compared to $68,000 for the three months ended 31 December 2018.

The decrease in net sales was due to a decrease in international concentrate sales of $1.1 million and a decrease related been true ups under the Baxter agreement for cost of sales and transportation costs, partially offset by increased concentrate sales to davita and an increase in triferic sales.

Net sales of Triferic were approximately $228000 for three months ended December 30, Onest 2019, compared to $68000 for three months ended December 31st 2018.

Judy DiClemente: Net sales of Triferric were approximately $228,000 for the three months ended 31 December 2019, compared to $68,000 for the three months ended 31 December 2018. For each of the three months ended 31 December 2019, and 2018, Triferric net sales included approximately $68,000 of deferred revenue recognized under the company's license in the People's Republic of China with Wanbang Biopharmaceutical. Triferric net sales for the three months ended 31 December 2019, also included approximately $160,000 of Triferric product sales to US customers. Cost of sales during the Q4 of 2019 was $14.4 million compared to the cost of sales of $15.7 million during the Q4 of 2018. The decrease was due primarily to a decrease in distribution costs for our concentrate products due to reduced rates for third-party shipping and reduced costs for materials and overhead tied to the reduction in concentrate sales volume.

For each of the three months ended 31 December 2019, and 2018, Triferric net sales included approximately $68,000 of deferred revenue recognized under the company's license in the People's Republic of China with Wanbang Biopharmaceutical. Triferric net sales for the three months ended 31 December 2019, also included approximately $160,000 of Triferric product sales to US customers. Cost of sales during the Q4 of 2019 was $14.4 million compared to the cost of sales of $15.7 million during the Q4 of 2018.

For each of the three months ended December 30, Onest 2019 in 2018 Triferic net sales included approximately $68000 of deferred revenue recognized under the company's license in the People's Republic of China, but Wanbang biopharmaceutical.

Triferic net sales for the three months ended December 30, Onest 2019 also included approximately 160000 of Triferic product sales to U.S. customers.

Cost of sales during the fourth quarter 2019 was $14.4 million compared to the cost of sales to $15.7 million during the fourth quarter of 2018.

The decrease was due primarily to a decrease in distribution costs for our concentrate products due to reduced rates for third-party shipping and reduced costs for materials and overhead tied to the reduction in concentrate sales volume. Gross profit for the Q4 of 2019 was $1.1 million compared to gross profit of $1.2 million during the Q4 of 2018. The decrease in gross profit was primarily due to a reduction in concentrate sales compared to the Q4 of 2018, partially offset by an increase in Triferric sales. Operating loss for the Q4 of 2019 was $7.4 million compared to $9.4 million in the Q4 of 2018.

The decrease was due primarily to a decrease in distribution costs for our concentrated products due to reduced rates for third party shipping and reduce costs for materials and overhead tied to the reduction in concentrate sales volume.

Gross profit for the fourth quarter 2019, with $1.1 million compared to gross profit of $1.2 million during the fourth quarter of 2018.

Judy DiClemente: Gross profit for the Q4 of 2019 was $1.1 million compared to gross profit of $1.2 million during the Q4 of 2018. The decrease in gross profit was primarily due to a reduction in concentrate sales compared to the Q4 of 2018, partially offset by an increase in Triferric sales. Operating loss for the Q4 of 2019 was $7.4 million compared to $9.4 million in the Q4 of 2018. The improvement in operating loss was due to a decrease in G&A expenditures and expenditures related to licenses acquired, partially offset by an increase in R&D and selling and marketing expenses. Selling and marketing expenses were $1.9 million during the Q4 of 2019, an increase of $1.6 million compared to the Q4 of 2018. The increase in sales and marketing expense reflects the investments we are making in developing a commercial platform to support the launch of Triferric.

The decrease in gross profit was primary primarily due to a reduction in concentrate sales compared to the fourth quarter of 2018, partially offset by an increase in triferic sales.

Operating loss for the fourth quarter, 2019 was $7.4 million compared to $9.4 million in the fourth quarter 2018.

The improvement in operating loss was due to a decrease in G&A expenditures and expenditures related to licenses acquired, partially offset by an increase in R&D and selling and marketing expenses. Selling and marketing expenses were $1.9 million during the Q4 of 2019, an increase of $1.6 million compared to the Q4 of 2018. The increase in sales and marketing expense reflects the investments we are making in developing a commercial platform to support the launch of Triferric. General and administrative expenses were $4.7 million during the three months ended 31 December 2019, compared with $7.6 million during the three months ended 31 December 2018.

The improvement in operating loss was due to a decrease in DNA expenditures and expenditures related to license has acquired partially offset by an increase in R&D and selling and marketing expenses.

Selling and marketing expenses were $1.9 million during the fourth quarter of 2019, an increase of $1.6 million compared to the fourth quarter of 2018.

The increase in sales and marketing expense reflects the investments, we are making and developing a commercial platform to support the launch of Triferic.

General and administrative expenses were $4.7 million during the three months ended December 31st 2019, compared with $7.6 million. During the three months ended December 30, Onest 2018.

Judy DiClemente: General and administrative expenses were $4.7 million during the three months ended 31 December 2019, compared with $7.6 million during the three months ended 31 December 2018. The decrease of $2.9 million was primarily driven by reductions in compensation, legal, consulting, and recruiting expenses, partially offset by an increase in insurance and facility-related expenses. Research and product development expenses were $2 million for the Q4 of 2019 compared to $1.6 million during the Q4 of 2018. The increase was due primarily to an increase in clinical trial and consulting expenses, partially offset by a reduction due to our write-off of calcitriol inventory that occurred in the Q4 of 2018.

The decrease of $2.9 million was primarily driven by reductions in compensation, legal, consulting, and recruiting expenses, partially offset by an increase in insurance and facility-related expenses. Research and product development expenses were $2 million for the Q4 of 2019 compared to $1.6 million during the Q4 of 2018. The increase was due primarily to an increase in clinical trial and consulting expenses, partially offset by a reduction due to our write-off of calcitriol inventory that occurred in the Q4 of 2018.

The decrease of $2.9 million was primarily driven by reductions in compensation legal consulting and recruiting expenses, partially offset by an increase in insurance and facility related expenses.

Research and product development expenses were $2 million for the fourth quarter 2019, compared to $1.6 million during the fourth quarter of 2018.

The increase was due primarily to an increase in clinical trial and consulting expenses, partially offset by a reduction due to our write off of calcitriol inventory that occurred in the fourth quarter 2018.

Judy DiClemente: We expect our research and product development expenses will increase in the future due to additional clinical development of dialysate and IV Triferric, including the pediatric clinical trial for Triferric, expenses associated with real-world data collection and analysis for Triferric, an increase in headcount to support medical education efforts for Triferric, and potential investments in developing Triferric for new clinical indications. Net loss for the Q4 of 2019 was $7.3 million, or $0.11 per basic and diluted share, compared to a net loss of $9.4 million, or $0.17 per basic and diluted share in the Q4 of 2018. As of 31 December 2019, the company had approximately $26 million of cash, cash equivalents, and investments available for sale. Net cash used in operating activities for the Q4 of 2019 was approximately $5.3 million.

We expect our research and product development expenses will increase in the future due to additional clinical development of dialysate and IV Triferric, including the pediatric clinical trial for Triferric, expenses associated with real-world data collection and analysis for Triferric, an increase in headcount to support medical education efforts for Triferric, and potential investments in developing Triferric for new clinical indications. Net loss for the Q4 of 2019 was $7.3 million, or $0.11 per basic and diluted share, compared to a net loss of $9.4 million, or $0.17 per basic and diluted share in the Q4 of 2018.

We expect our research and product development expenses will increase in the future due to additional clinical development of dialysate, an Ivy triferic, including the pediatric clinical trial for Triferic expenses associated with real World data collection and analysis for Triferic, an increase in headcount to support medical education efforts for Triferic and potential investments in developing try.

Thanks, Eric for new clinical indications.

Net loss for the fourth quarter of 2019 was $7.3 million or 11 cents per basic and diluted share compared to a net loss of $9.4 million or 17 cents per basic and diluted share in the fourth quarter of 2018.

As of 31 December 2019, the company had approximately $26 million of cash, cash equivalents, and investments available for sale. Net cash used in operating activities for the Q4 of 2019 was approximately $5.3 million. In February 2020, we completed the public offering of common stock for gross proceeds of $8.1 million. This was the first step in our broader financing strategy for 2020. As we look forward, we continue to believe that our valuable assets provide us with financial flexibility, including non-dilutive financing alternatives.

As of December 30, Onest 2019, the company had approximately $26 million of cash cash equivalents in investments available for sale.

Net cash used in operating activities for the fourth quarter of 2019 with approximately $5.3 million.

Judy DiClemente: In February 2020, we completed the public offering of common stock for gross proceeds of $8.1 million. This was the first step in our broader financing strategy for 2020. As we look forward, we continue to believe that our valuable assets provide us with financial flexibility, including non-dilutive financing alternatives. Finally, as many of you are aware, we received correspondence from Medical Resource Acquisition Group, or MRAG, recently regarding potential director nominations for our upcoming annual meeting. Our board has determined that the director nominations failed to comply with our bylaws, and therefore MRAG's directors will not stand for election at our annual meeting. We will not be taking any further questions on this matter today so that we can focus on our business update and quarterly earnings results. I will now turn the call back to Stuart. Thank you, Angus.

In February 2020, we completed the public offering of common stock for gross proceeds of $8.1 million. This was the first step in our broader financing strategy for 2020.

As we look forward. We continue to believe that are valuable assets provide us with the financial flexibility, including non dilutive financing alternatives.

Finally, as many of you are aware, we received correspondence from Medical Resource Acquisition Group, or MRAG, recently regarding potential director nominations for our upcoming annual meeting. Our board has determined that the director nominations failed to comply with our bylaws, and therefore MRAG's directors will not stand for election at our annual meeting. We will not be taking any further questions on this matter today so that we can focus on our business update and quarterly earnings results. I will now turn the call back to Stuart.

Finally, as many of you are aware, we receive correspondence from medical resource acquisition group or M. Rag recently regarding potential director nominations for our upcoming annual meeting.

Our board has determined that the director nominations failed to comply with our bylaws and therefore Emirates directors will not stand for reelection at our annual meeting.

We will not be taking any further questions on this matter today said that we can focus on our business update and quarterly earnings results I will now turn the call back to Stewart.

Stuart Paul: Thank you, Angus. We have a lot to look forward to in the next weeks and months. We'll continue to work to bring this innovative and much-needed therapeutic to the hemodialysis patients who can benefit today, as well as to address anemia in a wider variety of disease states in the future. Our goal remains to establish a new standard of care for anemia management over the course of the next three to five years. We're proud of our two very valuable assets, our Triferric platform and our concentrates business, that we believe offer multiple opportunities to drive the long-term value of Rockwell Medical. We'll now open the call to questions. Operator?

Thank you Angus.

We have a lot to looks forward to in the next weeks and months, we'll continue to work to bring this innovative and much needed therapeutic to the human dialysis patients who can benefit today.

Judy DiClemente: We have a lot to look forward to in the next weeks and months. We'll continue to work to bring this innovative and much-needed therapeutic to the hemodialysis patients who can benefit today, as well as to address anemia in a wider variety of disease states in the future. Our goal remains to establish a new standard of care for anemia management over the course of the next three to five years. We're proud of our two very valuable assets, our Triferric platform and our concentrates business, that we believe offer multiple opportunities to drive the long-term value of Rockwell Medical. We'll now open the call to questions. Operator? Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone.

As well as to address anemia in a wider variety of disease states in the future and our goal remains to establish a new standard of care for anemia management over the course of the next three to five years. We're proud of our two very valuable assets are triferic platform in our concentrates business that we believe offer.

Multiple opportunities to drive the long term value of Rockwell medical.

We'll now open the call the questions operator.

Ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your touched on telephone. If your question have you been answered are you wish to remove yourself from the Q. Please press the pound.

Operator: Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We have our first question from the line of Raghuram Selvaraju. Also, Raghuram, your line is now open.

Judy DiClemente: If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We have our first question from the line of Raghuram Selvaraju. Also, Raghuram, your line is now open. Good afternoon, guys. This is Edward Marks on for Ram. I appreciate you guys taking the questions. A few questions on the MDOs. For those that have inked a purchase agreement, how many of the 160 clinics do you anticipate using Triferric by the end of this year? And how many more might sign purchase agreements over this year, versus how many are you currently targeting? Great to talk with you. Thanks for the question.

We have our first question from the line of Robert.

You also very I heard your line is now open.

[Analyst]: Good afternoon, guys. This is Edward Marks on for Ram. I appreciate you guys taking the questions. A few questions on the MDOs. For those that have inked a purchase agreement, how many of the 160 clinics do you anticipate using Triferric by the end of this year? And how many more might sign purchase agreements over this year, versus how many are you currently targeting?

Good afternoon, guys. This is Ed remarks on for Rob I appreciate guys, taking the questions.

Few questions on the Amnios.

For those.

That having to purchase agreement how many of 160 clinics do you anticipate using triferic by the end of this year.

And how many more might signed purchase agreements over this year versus how many are you currently targeting.

Stuart Paul: Great to talk with you. Thanks for the question. So I'm not going to give specific numbers of clinics, but I mean, I can tell you we've got access to 160 where we have an evaluation program in place for most of the types of single or independent accounts that we pick up, which are more of like on a one-by-one basis. In an MDO setting, you have the ability to go after bigger chunks of clinics at a time and not necessarily with the need for the evaluation program. So there is a bit of a process to work through together to drive these forward successfully.

No great too.

To talk with you. Thanks for the question so.

Judy DiClemente: So I'm not going to give specific numbers of clinics, but I mean, I can tell you we've got access to 160 where we have an evaluation program in place for most of the types of single or independent accounts that we pick up, which are more of like on a one-by-one basis. In an MDO setting, you have the ability to go after bigger chunks of clinics at a time and not necessarily with the need for the evaluation program. So there is a bit of a process to work through together to drive these forward successfully. We're in active dialogue with this MDO as well as other MDOs, and large regional clusters of clinics regarding evaluation programs as well. As you move into these chunkier types of accounts, things have a tendency to pick up faster.

I'm not going to give specific numbers of clinics, but I can tell you we got access to 160.

Where we have an evaluation program in place for.

Most of the types of single or independent accounts that we pick up which are more of like on a one by one basis.

And then MTO setting you have the ability to go after bigger chunks of clinics at a time and not necessarily with the need for the evaluation program. So.

There is a there was a bit of a process to work through together.

To drive these forward successfully we're in active dialogue with.

We're in active dialogue with this MDO as well as other MDOs, and large regional clusters of clinics regarding evaluation programs as well. As you move into these chunkier types of accounts, things have a tendency to pick up faster. So our expectation is that we'll be able to significantly accelerate the pace that you've seen today. But that's all I'll say on that.

This MTO as well as other Ngos and and large regional clusters.

Have a clinics regarding evaluation programs as well.

And.

As you move into these chunky or types of accounts things have a tendency to pick up faster. So our expectation is that we'll be able to significantly accelerate the pace.

Judy DiClemente: So our expectation is that we'll be able to significantly accelerate the pace that you've seen today. But that's all I'll say on that. Okay. Understood. And if you could provide a little more detail on the timeline for conversion of these LDOs, and just wondering if any are likely to come online this year, or is that more of a capture that you're expecting to take place next year? What I can tell you is we're obviously engaged with the LDOs in discussions, and when we have more to report there, we'll let you know. All right. Sounds good. Three more quick ones then here. Just wondering if there are any recent requests from the FDA regarding the NDA for IV Triferric. I would just say we're very excited about the process and being so close to the PDUFA.

That you've seen to date, but but thats all small mostly on that.

[Analyst]: Okay. Understood. And if you could provide a little more detail on the timeline for conversion of these LDOs, and just wondering if any are likely to come online this year, or is that more of a capture that you're expecting to take place next year?

Okay understood.

And if you could provide a little more detail on the timeline for conversion of these.

LDL and just wondering if any are likely to come online this year or is that more of a capture that you're expecting to take place next year.

Stuart Paul: What I can tell you is we're obviously engaged with the LDOs in discussions, and when we have more to report there, we'll let you know.

Well what I can tell you is no. We're obviously engaged with the LDR discussions and.

When we have more to report there, we'll we'll let you know.

[Analyst]: All right. Sounds good. Three more quick ones then here. Just wondering if there are any recent requests from the FDA regarding the NDA for IV Triferric.

Okay. That's good.

A quick ones than here just wondering if there any recent request from the FDA regarding the India for I'd be triferic.

Stuart Paul: I would just say we're very excited about the process and being so close to the PDUFA. We've had the normal correspondence you would expect ahead of the PDUFA date with the FDA over the last several weeks, and we're looking forward to their decision later this month.

I would just say, we're very excited about the process of being so close to the PDUFA. We've had the normal correspondents you would expect ahead of the PDUFA date with the FDA over the last several weeks and we're looking forward to their decision later this month.

Judy DiClemente: We've had the normal correspondence you would expect ahead of the PDUFA date with the FDA over the last several weeks, and we're looking forward to their decision later this month. So are we. And then the two final questions, just if you could provide any timeline updates for regulatory approvals in Chile, and just wondering whether the matter regarding the web page warning letter from the FDA has been addressed and officially closed. Yeah. Angus, do you want to take these ones? Sure. Yeah. So as it relates to Chile, we were originally expecting to get approval in Chile last year. There was some civil unrest down there that had delayed it. I think we're back on track there and expecting to have approval later this year. So we're pleased with that.

[Analyst]: So are we. And then the two final questions, just if you could provide any timeline updates for regulatory approvals in Chile, and just wondering whether the matter regarding the web page warning letter from the FDA has been addressed and officially closed.

Sorry.

So in the two final question just if you could provide any timeline updates for regulatory approvals in Chile.

And just wondering whether the matter regarding the web page warning letter from the FDA has been a true.

And officially closed.

Stuart Paul: Yeah. Angus, do you want to take these ones?

Yeah. Thanks, you want take these ones sure, yes, so as it relates to Chile.

Angus Smith: Sure. Yeah. So as it relates to Chile, we were originally expecting to get approval in Chile last year. There was some civil unrest down there that had delayed it. I think we're back on track there and expecting to have approval later this year. So we're pleased with that. And then as it relates to the FDA untitled letter and the website, we've removed certain references on the website and had a dialogue with the FDA about some of their comments. So from our perspective, we've resolved some of them, and we look forward to continuing the dialogue with them as we go forward.

We were originally expecting to get approval in Chile last year. There was some civil unrest down there that had to later I.

I think we're back on track there and expecting tend to have approval. Later later this year.

So so we're pleased with that.

And then.

Judy DiClemente: And then as it relates to the FDA untitled letter and the website, we've removed certain references on the website and had a dialogue with the FDA about some of their comments. So from our perspective, we've resolved some of them, and we look forward to continuing the dialogue with them as we go forward. Excellent. I appreciate all the detail. Thank you, guys. Thank you. Again, ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone. At this time, I would like to turn it back to the speakers for any further comments. Well, thank you again for joining us for this Q4 earnings call, and we look forward to staying in touch with you at future business updates and earnings calls in the near future. Thanks so much.

As it relates to that to the FDA untitled letter in the website weve.

We removed certain references on the website and had dialogue with with the FDA. That's some of their comments so from our perspective, we've resolved some of them and we look forward to continuing the dialogue with them as we go forward.

[Analyst]: Excellent. I appreciate all the detail. Thank you, guys.

Excellent I appreciate all the detail. Thank you guys.

Angus Smith: Thank you.

Thank you.

Operator: Again, ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone. At this time, I would like to turn it back to the speakers for any further comments.

Again, ladies and gentlemen, if you if you have a question at this time discretion as part of that that number one key on your touched on telephone.

At this time I would like to turn it back to the speakers for any further comments.

Stuart Paul: Well, thank you again for joining us for this Q4 earnings call, and we look forward to staying in touch with you at future business updates and earnings calls in the near future. Thanks so much.

Well. Thank you again for joining us for this.

The fourth quarter earnings call and.

We look forward to staying in touch with you with future business updates and earnings calls.

In the near future.

Thanks, so much.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and have a wonderful day present SBC for the first one thing.

Judy DiClemente: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. Presenters, please stay for the post-conference.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. Presenters, please stay for the post-conference.

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