Rockwell Medical, Inc. (NASDAQ:RMTI) Q3 2018 Earnings Conference Call November 9, 2018 8:30 AM ET
Stuart Paul - President and Chief Executive Officer
David Bouchey - IFS Securities
Casey Zimmerman - Private Investor
John Crowley - Private Investor
Good morning. And welcome to the Rockwell Medical Third Quarter 2018 Results Conference Call.
Before we begin, I wanted to note that certain matters we will discuss may be forward-looking statements intended to qualify for the Safe Harbors from liability established by the Private Securities Litigation Reform Act of 1995.
These forward-looking statements can be identified as such because the context of the statement will include words such as we believe, anticipate, expect or words of similar import. Similarly, statements that describe our future plans, objectives, strategies or goals are also forward-looking statements.
These forward-looking statements are subject to certain risks and uncertainties that may materially adversely affect our anticipated results. Risks and uncertainties included but are not limited to, risks relating to plans around the development of commercialization of Triferic are projected cash runaway [ph] the timing and success of our planned NDA submission for IV Triferic and the pricing and reimbursement status of our products including IV Triferic. Forward-looking statements are subject to numerous factors that could cause actual results to differ from our anticipated results. These includes the factors described in our Form 10-K for fiscal 2017 and is updated in our periodic reports including our most recently quarterly report on Form 10-Q. Copies of our Form 10-K are available on the SEC's website, which is www.sec.gov and through a link on our website located at www.rockwellmed.com.
The forward-looking statements made on this call are made as of the date of this call. As we disclaim any intent to publicly update these forward-looking statements to reflect subsequent events or circumstances.
This conference call includes the slides presentation which can be at Rockwell Medical Investor Relations webpage. This call is being recorded for audio rebroadcast and can also be accessed on the same webpage. The call will be followed by a question-and-answer session.
At this time, I would like to turn the conference call over to Stuart Paul, President and Chief Executive Officer of Rockwell Medical. Please go ahead sir.
Thank you, Christy [ph]. And good morning, thanks to everyone for joining us today. This is my first quarterly results call with all of you since becoming President and CEO of Rockwell Medical and while I look forward to meeting with investors and covering all aspects of the business overtime. Today I'm going to focus on several key topics including the market opportunity at hand and the final payment roll out of CMS rule out of CMS which provides us with much needed clarity around pricing and timing for US commercialization of Triferic.
Over the last 70 days or so I've spent time getting to know our team, doing a top to bottom review of our business. And while this review remains ongoing I'd like to share with you what I found. First dialysate Triferic, the only FDA approved drug indicated to replace iron and maintain hemoglobin in hemodialysis patients suffering from anemia and the IV version of Triferic. If FDA approved have significant potential to change the way anemia is managed. Second, we have a great group of employees at Rockwell Medical. However I found that there were really no viable business plans in place for commercializing our therapies nor any marketing or performance target set therefore impacting our commercial launch readiness. And what's more there was need for additional capital.
Third, Calcitriol while it may be an important patient need it is a challenging product to manufacture, it may not offer sufficient profitability based on our preliminary review of potential pricing and costs. And frankly, we'll require further study to determine if there is real potential for profitability. And fourth, despite the fact that Rockwell Medical serves more than a quarter of the US Concentrates market. We need to improve the profitability of this business as pricing and transportation expenses of challenged our margins.
These are the areas that are key to the business, so I want to focus here and I do not plan to do a deep dive into company's financial performance this morning. For an overview of our financial performance from the third quarter of 2018, I refer you to the press release which we just issued in our Form 10-Q for the third quarter. And since this is my first quarterly call, I'd like to tell you a little bit about my background. First [indiscernible] my 25-year career I served in leadership positions at several global companies including Baxter International, Gambro AB, Quest Diagnostics and Abbott Laboratories.
I'm very familiar with the global renal space and bring significant expertise in developing and executing commercialization strategies in the dialysis markets and that includes North America, Latin America and Asia Pacific. And although my prior experience capitalizing on international opportunities will be used for Rockwell Medical I plan to focus today's call on US opportunities only. As CEO, my primary objectives are to realize the full potential of Rockwell Medical's valuable assets to improve patient outcomes and to enhance shareholder value. And what I've learned since coming on board has only confirmed to me the fundamental opportunity at hand with the FDA approved dialysate version of Triferic and if approved, the IV version of Triferic.
This therapy and its potential to drive overall better patients in economic outcomes is what attracted to me to Rockwell Medical. No other therapy is FDA approved to solve the problem of replacing iron and maintaining hemoglobin levels in dialysis patients while also showing great promise to reduce the need and the costs of administering ESAs and IV iron. So to give you some sense of the opportunity in front of us, here's what I can tell you about the dialysis market. Today there are more than 500,000 dialysis patients in the US most of whom received hemodialysis and these patients are receiving treatments approximately three times per week or roughly 150 or so treatments a year and as most of you are aware, the US market is concentrated with two major players that cover more than 70% of the market.
Several of our new hires and I'll touch on this later on the call bring to Rockwell great business relationships including with these key large players as well as other corporate players in the renal space. Globally there are millions of dialysis patients and I previously had the opportunity to manage and develop several of these key regional markets outside the US with my prior employment relationships. Forecasting suggest a continued 6% annual increase in the global dialysis patient population. There are significant opportunity internationally for IV Triferic not only due to the size of the patient population, but also the market having already evolved through the use of dry bicarbonate cartridges and trends in the US are also moving towards the use of dry bicarb cartridges which aligns with a product like IV Triferic as the next steps in the evolution of anemia management.
Although the final CMS rule was only published last week I know what the cover - what I know and discuss how it provides a clearer picture around commercial pricing for both IV Triferic if approved and the dialysate formulation of Triferic. When I started at Rockwell Medical, we knew that a decision at CMS was expected in the near term and we also knew that we had to be able to move quickly once it came out to capitalize on the US market opportunity and as such, one of the first things I did was make sure that we had the right team of advisors assembled and that we had scenario plans in place.
With respect to IV Triferic, CMS ruled on the new Transitional Drug Add-on Pricing Adjustment Program or TDAPA which starts in 2020. And we believe that newly approved FDA therapies on or after January 1, 2020 are eligible for separate payments for two-year timeframe and because the NDA filing for IV Triferic will be under a 505(b)1 pathway and therefore considered a new drug. This should allow for separate payment and a separate unique building code. And therefore, it's important that we optimize the NDA filing in 2019 and plan for a PDUFA action date in order to realize an approval on or after January 1, 2020. And with the assistance of the regulatory and reimbursement experts that I brought on, we are currently assessing our NDA plans and separate payment opportunity to ensure we optimize our position to successfully launch IV Triferic in the US in the first half of 2020 subject of course to FDA approval and in light of the January 1, 2020 start date for newly approved therapies to be eligible for this add-on reimbursement we may elect to delay and that's right, to delay our planned IV Triferic NDA submission into 2019 in order to ensure a PDUFA action date in 2020.
Further ruling, TDAPA payment would last for two years following launch after which time IV Triferic would likely go into the bundle. However, given the potential for this therapy to improve both health outcomes and overall economics. We believe this two-year window would provide us with an adequate opportunity to establish this innovative therapy on the market. And in addition, we had met with CMS to seek out on reimbursement for dialysate Triferic and to gain clarity around the expected reimbursement levels and this meeting took place in my very first week as CEO. And I can tell you, it was a productive meeting last week's final rule out of CMS means that Rockwell Medical's dialysates formulation of Triferic will definitely be priced inside the bundle.
In other words, the current version of Triferic will not be a separately paid therapy in the ESRD setting. And given that our pricing and reimbursement experts helped us mapped out all potential CMS outcomes. We were prepared for this possibility. So we carefully analyzed the November 1, CMS ruling with the assistance of these outside experts and we have determined to move ahead with a US commercial launch inside the bundle for dialysates Triferic. We are working now to finalize our commercialization, our manufacturing scale up and implementation plans and we're targeting launch in the first half of 2019 or as soon as practical. And this includes making sure, we have the right marketing and sales team in place. We're in the final stages of a market study, guiding us on optimal pricing and uptake of the 5 ML and the powder pack versions of our product inside the bundle. And upon launch, we expect dialysates Triferic to be bundled as part of the base rates to providers.
We are also assessing our inventory of dialysates Triferic and our expected ability to use existing inventory for our commercial launch. While today's focus is on our US commercialization plans for Triferic. I'm working on our business development plans including how best to capture the significant international opportunity and we'll provide and update on our next quarterly earnings call about international. By taking advantage of the US opportunity which is the maintain opportunity directly in front of us, the company will be able to drive better patient outcomes in the near term while also gathering insights that will inform our eventual international launch.
In order to capture, the dialysis US market opportunity that's directly in front of us it's essential that the company is well capitalized in order to execute in our commercial plans. And one of my first priorities as CEO was to assess the cash situation. I determined to raise additional capital given that we ended the third quarter with approximately $17.7 million of cash in investments. Our cash loss for the third quarter was approximately $4.8 million and the net cash burn for the same period was approximately $5 million. As such, we recently closed on $22 million private placement which lowers the risk to our balance sheet and allows us to continue funding, working capital needs relating to the commercialization of dialysates Triferic and IV Triferic and this includes engaging a third party firm to help us collect, consolidate and harness the data from our sample program for dialysates Triferic as we prepare sites for our initial launch phase.
Continuing to build out our commercial strategic counts in sales team. Scaling manufacturing and enhancing our supply chain through distribution partnerships. Building out our marketing efforts by creating a medical education initiative which includes bringing on KOLs and getting our data into scientific and medical publications and securing the IP rights related to IV Triferic, thereby de-risking our IP. This has been our recent focus as all of this is necessary for a successful commercial launch whether in the US or internationally.
And on a pro forma basis, I can tell you we started the fourth quarter with $39.7 million in capital which we believe is sufficient to fund our business plans in 2020. Let us now turn to the other areas of our business and since I joined the company a number of shareholders have asked us about our plans for Calcitriol. I've done a preliminary analysis and assessment and here's what I learned. Calcitriol is a synthetic version of Item D [ph] used to treat calcium deficiency with hyperparathyroidism which is essentially the decreased function of parathyroid gland and metabolic bone disease and patients with chronic kidney failure.
And although there may be an important patient need Calcitriol is challenging to manufacture and furthermore given that there are major pharmaceutical companies in this very competitive space, we have to consider downward pressure on pricing. Given all of this, we need to spend time carefully examining Calcitriol potential and intent to share an update regarding our commercialization plans in the first quarter of 2019. The other area that I want to touch on is our concentrate product. Concentrates are acid and bicarbonate liquids and powders used in the hemodialysis treatment to enable removal of toxins. And Rockwell Medical is currently the second largest supplier of concentrates in the US, supplying more than 25% of the market. Although these products contribute significant revenue there are challenges with pricing and profitability and based on my preliminary assessment I believe we should be able to earn a reasonable return from these products. Thus we're currently in discussions with potential partners regarding ways in which we can improve upon the economics.
These products need to generate acceptable operating margins, provide free cash flow and capture customer and patient synergies. And I'll be working with the team to determine how we best improve the profitability of our concentrate products and intend to provide a further update in the first quarter of 2019. We've accomplished a lot in my first 70 days and I firmly believe the future is very bright for Rockwell Medical. However all of this work had to be done given that there were no viable business plans or targets in place when I came on board. Fortunately we have a fantastic group of employees and we are further strengthening our team with key senior hires, expert advisors and regulatory, clinical, scientific and reimbursement areas and together these individuals bring essential experience in the renal therapy and or the specialty pharmaceutical space I would say to recap some of our recent hires.
In September we appointed Jim McCarthy to the newly formed role of Senior Vice President, Corporate and Business Development. Jim has extensive knowledge in business development, planning and product marketing. He brings a record of successfully executing upon commercialization strategies in a wide range of therapeutic areas as well as significant expertise leading corporate development activities both in the US and internationally. And last month, we welcomed Anne Boardman to Rockwell Medical's; Vice President, Strategic Accounts. I've longed been impressed by Anne's ability to build, improve and manage critical business relationships. Anne also has significant experience in the renal space and brings a proven record in contracting and executing, deployment strategies and also deep understanding of the reimbursement landscape. And just last week, we appointed Angus Smith as Chief Financial Officer and he will be joining Rockwell Medical later this month. His deep financial expertise including with debt and equity financing, internal controls and operational performance along with his background advising speciality pharmaceutical and healthcare companies are a great fit for Rockwell Medical. And additionally, Angus' experience in Investor Relations will be valuable as we continue to uphold our commitment to increasing transparency with our shareholders. I look forward to having Angus play a key role in our future calls.
I can also tell you that in the fourth quarter of 2018 we expect to complete the hiring of the rest of the senior management team which includes marketing, launch, operational leadership as well as other key launch and professional resources. I hope it's clear to you that we have a significant opportunity in front of us with dialysates Triferic and also IV Triferic and it's important that we get that right because this is only the start. We believe the Triferic has the potential to drive better patient outcomes in a global anemia market not just for dialysis patients. So before I open up the call to Q&A, I want to thank all of our stakeholders who have supported Rockwell Medical I understand that there is a lot of work that still needs to be done to position Rockwell Medical for success, but I want to assure you that we're working tirelessly to re-establish the company's credibility with employees, customers, patients and yes investors.
And today we provided with a number of upcoming milestones from which you can measure our success and this includes the plan to launch our dialysates Triferic formulation of Triferic in the US, inside the bundle in the first half of 2019 or as soon as practical and if approved launch IV Triferic in the US outside the bundle in the first half of 2020. Our work is cut out for us but we're committed to getting this done and I truly believe we have great opportunities ahead.
I'll now turn the call back over to the operator to open the call for Q&A. Christy [ph]?
[Operator Instructions] and you do have a question from David Bouchey of IFS Securities.
First of I've got to say I'm not used to seeing this level of effort and detail going into a quarterly conference call from Rockwell Medical. Congratulations on that.
Thanks, Dave. Great to hear from you.
Yes, I would also like to say congratulations this was a pretty good quarter financial. You certainly did manage to beat the consensus analysts' expectations for the estimates for the quarter, so congratulations on that.
Yes, let me move into real briefly Calcitriol and I know you've got a lot of work to do to decide exactly what your strategy is going to be there. Do you believe you have enough manufacturing capacity to handle whatever the demand is in the US as well as whatever your demand might be internationally when you start to commercialize Calcitriol, if you internationally.
Great, Dave. That's a great question. And what I want to focus on around this is, not so much the capacity. I'm not concerned about the capacity but I'm really more concerned about the competitiveness of the space and the nature, the challenging nature to drive the manufacturing profitably. We have a significant opportunity here, but we need to carefully examine the potential for profitability around this product. There were assumptions in place previously that we've challenged and I feel right now, that the jury is out on this product. So I'll be back in the first quarter with more on this. The main opportunity obviously in front of us is IV Triferic and that's really where we need to be placing our initial focus and efforts. I'll be back on Calcitriol in the first quarter to you.
Well you do have some commitments to partner such as Langbank in China, I believe in places like Canada, Peru and Chile. Will you be going ahead with launches there and do you have an update on when the Chinese launch for Triferic and Calcitriol might occur?
Sure. I can give you a little bit more color on that. So things are going well internationally again that's not our primary focus right now, IV Triferic and dialysates Triferic are the keys to really exploding the value of the company. I think things with Langbank [indiscernible] are moving nicely clinical trials are moving forward. If things go well, we may see some news on that in the back half of 2019, that's all I'm going to say about China right now. And we're moving forward with and some of the French international markets potential to get the products approved somewhere in the back half of 2019. So more to come in international, but I think you know you have to understand my position as to really pivot the focus to the company onto the US opportunity directly in front of us.
Okay, so there are clinical trials going on in China for Triferic.
Okay, let me ask you a question that I have been a little confused about. How will the initial price for IV Triferic be determined, what is that process?
For IV? Okay, so it's a good question I think as you know when I came in the door there were a lot of pushes from all sides to get the NDA and IV Triferic filed. I did not think that was a prudent move and decided to delay the filing. We clearly now think that was a good decision and the key for pricing around IV Triferic in terms of optimizing will be to see a PDUFA action as I mentioned on or post 01/01/2020. So with that in mind and the 505(b)1 pathway basically giving us a new drug classification for IV Triferic puts us in a great position where CMD policy and TDAPA should make this product eligible for separate billing code, separate J-code and with that in mind, I think we also have the next year to really focus leading up to the IV launch. The great opportunities develop data that are going to be critical in supporting the price points we envisioned for this therapeutic.
Well that's really kind of what I'm getting after is, it's too early I think for you to be giving us guidance about what the initial price for IV Triferic would be, but is this determined will you make contract negotiations with people like [indiscernible] and some of the independent clinics to determine what the initial price will be, is that how it eventually you'll get to ASP. Is that how that is, actually determined?
I'm a classic business guy, right? And I've got a marketing background and the way you want to do, this is you want to get some primary research in-house. So number one, we're working on that okay. That was not something that was in place previously so once we get through some of the initial market studies I mentioned which is targeted toward understanding the pricing optimization. Well I'll be able to comment more on that clearly we're inside the bundle, clearly it's not going to be at price points that might have been envisioned in some people's models at much higher level, but I can tell you that even within the bundle this is a profitable product. I'm excited about it and again it just points me right back to immediate opportunity in front of us, which is to get in market. This product has been on the shelf for three years and it's time, it really is time for action. This is a significant product and therapeutic that means a significant unmet patient need in hemodialysis.
Thank you. Your next question is from Casey Zimmerman, Private Investor.
I've been a shareholder since about 2002. My share price is about the same as it is in the 2002. We've been promised all sorts of things or told different things. I realize you've only been on the job for 70 days so I'll cut you some slack, but is this ever going to be a company?
Okay, Casey I think what the real question that you're asking is, why would I come to Rockwell Medical, perhaps right? I left the great world at Abbott Labs and what really struck me about this opportunity is the opportunity to focus on realizing the full potential of the assets of this company. I think we were falling short in prior years clearly and I sympathize with the frustration you've been around 15, 16 years. But improving patient outcomes, creating shareholder value is what I've done my whole career. I love working in turnaround situations. I've had one after the next, after the next at Gambro AB in the renal space was a clear example of that. And spent time out in Asia Pacific, in the US. My top priorities in the last 70 days have been to really get to know the team, understand the products, the operations. I'm really energized by this opportunity. I think I made a great decision, but I have to tell you. There is a lot to do.
I've been doing my top to bottom review of the business. It remains on ongoing, this doesn't happen just in 70 days given the history of what we've been through here and I'm working to re-establish credibility with all stakeholders. So hopefully, that answers your questions and which I really do appreciate and sympathize.
Thank you. Your next question comes from Joey [ph] Moss [ph], Private Investor.
Welcome, Mr. Paul. Appreciate the call and the information. I too am a very long-term investor and to be honest with you I never invested in Rockwell. I invested in Triferic and so the commercialization of Triferic is what's most important to me as well as it sounds like to you. My question is simply this, dialysates and IV Triferic are molecularly exactly the same. The view that the IV Triferic when approved by the FDA in 2020 is would be a new J-code classification as a new drug. Can you say that for sure knowing that they're molecularly identical or not?
Thanks for the question. I mean I think the key here is the CMS ruling providing clarity. Our experts that I brought in and I and the team have gone through this over and over the past week. We're positioned to move quickly to capitalize on the US market with respect to 2020 and J-codes we think we are in an outstanding position to achieve that success. I do want to mention the margins and profitability for this product are good at most price points. So even inside the bundle of dialysates we're going to be able to drive profitability and that's important. The 505(b)1 pathway provides us a new drug designation, consistent with their policy despite the fact that the molecular structures maybe similar we have a new drug and I think the eligibility again is only for two-year period right.
We have the next year to build our data. We have the next year to build experience with the dialysates version of the product and establish its credibility and that's what's most important about the opportunity in front of us and it should bode well. There are no guarantees obviously, but I think we're in very good position.
Thank you. Your next question is from John Crowley, Private Investor.
I have two brief questions. The first is, what will be the status of the free dialysates Triferic program and is there any plan to bring that to an end in the near term. And secondly is, Raymond Pratt, MD is still working for Rockwell as the Scientific Director?
Okay, great. Let me take the second question first. So I've got great respect for Dr. Pratt. He's done a lot of amazing things in his career and I think his position Rockwell. Obviously he's wearing multiple hats. We do have a Chief Science Officer and Dr. Ajay Gupta and I would say Ray and Ajay can benefit from working together more intensively than they have in the past. I've great respect for both of them. I would not to say the scientific and R&D part solely falls into Ray's area. I think Ray has done a great job over the years. This is kind of an all hands on deck. We need to breakdown the silos, get the team working together better around our key R&D and scientific and clinical strategies and that's exactly what I'm doing turning down silos, bringing team together. Great respect for both these gentlemen in terms of their contributions to the company and to the field.
Regarding the sample program, which is your first question? What we've done is we've engaged a third party firm to help collect and consolidate and harness the data as we prepare sites for the initial launch phase. This was a bit of surprise to me that we did not have a very prospective focus around data, coming out of that program, right. That program is been in effect for three years, so one of the most surprising elements or components of what I found coming in was the lack of prospected design and focus to get the data out of the sample sites. I've now addressed that. I put an external team in place. We want it done properly. But for the most part right now, we have a retrospective review. I intent to bring that to a conclusion at some point in the fourth quarter and we'll share more in the first quarter about that, in the next call.
Thank you. Your next question is from Greg [indiscernible], Private Investor.
Couple of quick questions. It seems a like common theme here of - lot of private investors who have been in the company for a while and have seen the share price unfortunately dwindle down to the price of Happy Meal right now which is obviously where not you need to be. I got into the company with the launch of C and it seems like we've had C approved for over three years, but for whatever one or reason or another, whether it's manufacturing or not, it hasn't been launched. I appreciate your comments regarding C currently and if you were a betting man, would you say 50-50, 60-40. We start selling it and in the next three to four months.
Okay, well again. I appreciate the frustration about Calcitriol and what you may have heard in the past. I can tell you this, as I mentioned earlier we need to do a fairly rigorous deep dive here to ensure pricing, cost, manufacture ability all work out. This is a very competitive market space. I do think there is an opportunity here. I haven't come to a conclusion on it yet, but I can tell you perhaps assumptions that have been made in the past about pricing could use a lot of sharpening and we're carefully examining the potentials. So I'll be back in the first quarter with more on this. Thanks for the question.
Appreciate the comment. And if I may, you mentioned that we've had the powder form of T on the shelf for three years just sitting there and hopefully we're moving quickly to bring that to market. If everything goes according to plan, how soon do you think we'll be cash flow positive. One quarter, two quarters.
I'll tell you this, again top to bottom review underway. Building a significant business plan for the company. On cash, we secured sufficient capital to fund the business into 2020, we're in excellent position. The company has not had a formal business plan in place previously. I'm calling this our Grade A business plan and it will certainly map out our ability to remain strong into the future and that's why I'm here is to basically take this now and turn it to a positive P&L trajectory that will drive cash. I mean for me it's all about improving. We're going to focus on improving the patient outcomes and creating shareholder value. So I'm here to build value.
Thank you. Your next question is from Richard Maleno [ph], Private Investor.
Just wanted to ask you, I heard a comment about cash flow and that we had enough. And I don't know if I misunderstood you to get all the way through the year 2020 or up to the year 2020? And if nothing change then our cash flow did not approve. Are we thinking ahead, that then we have to another cash rate, what are your thoughts on that?
To be clear in my comment. We have sufficient cash on hand to go into 2020, not up to 2020 but into 2020. There are no immediate plans to raise additional cash.
Thank you sir and I appreciate. I've listened to a lot of these conference calls been a long time holder of the stock. I appreciate to me, I just feel this is the first time I've heard a call with a plan. And I thank you for that.
You're welcome. I think it's been long overdue and do sympathize with all the investors and shareholders.
Thank you. We have reached our allotted time for questions-and-answers. I will turn the call back over to Stuart Paul for any additional or closing remarks.
Thank you, Christy [ph]. So in closing we have innovative products that have the potential to drive medical advancements for patients and create value for our shareholders and on behalf of everyone at Rockwell Medical, we appreciate your investments and continued interest. Christy [ph] we can end the call now.
Thank you. This concludes today's Rockwell Medical conference call. You may now disconnect.