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Edited Transcript of RMTI.OQ earnings conference call or presentation 9-Nov-20 9:30pm GMT

·30 min read

Q3 2020 Rockwell Medical Inc Earnings Call Nov 21, 2020 (Thomson StreetEvents) -- Edited Transcript of Rockwell Medical Inc earnings conference call or presentation Monday, November 9, 2020 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Marc L. Hoffman Rockwell Medical, Inc. - Chief Medical Officer * Russell H. Ellison Rockwell Medical, Inc. - President, CEO & Director * Russell L. Skibsted Rockwell Medical, Inc. - Executive VP, CFO & Chief Business Officer * Tim Chole Rockwell Medical, Inc. - VP of Marketing ================================================================================ Conference Call Participants ================================================================================ * Brandon Richard Folkes Cantor Fitzgerald & Co., Research Division - Analyst * Raghuram Selvaraju H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst * Claudia Styslinger Argot Partners, LLC - IR Associate ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical 2020 Q3 Results Call. As a reminder, this conference call is being recorded. At this time, I would like to introduce Claudia Styslinger, Investor Relations. Please go ahead. -------------------------------------------------------------------------------- Claudia Styslinger, Argot Partners, LLC - IR Associate [2] -------------------------------------------------------------------------------- Welcome to Rockwell Medical's Third Quarter 2020 Earnings Results Call. This is Claudia Styslinger of Argot Partners, the Investor Relations representative for Rockwell Medical. Joining me from Rockwell Medical on today's call are Dr. Russell Ellison, President and Chief Executive Officer; Russell Skibsted, Executive Vice President, Chief Financial Officer and Chief Business Officer; Tim Chole, Vice President of Marketing; and Dr. Marc Hoffman, Chief Medical Officer, who will be joining us for Q&A. Before we begin, I wanted to note that certain matters we will discuss may constitute forward-looking statements within the meaning of the federal securities laws, including, but not limited to, Rockwell Medical's intention to commercialize Triferic Dialysate, Triferic AVNU and any future products based upon Rockwell's pyrophosphate platform. Words such as may, might, will, should, believe, expect, anticipate, estimate, continue, could, potential, predict, forecast, project, plan, intend or similar expressions or statements regarding intent, belief or current expectations are forward-looking statements. While Rockwell Medical 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, 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 Medical's SEC filings many of which are beyond our control and subject to change. Actual results could be materially different. Accordingly, you should not place undue reliance on these forward-looking statements. Rockwell Medical 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 web page. This call is being recorded on November 9, 2020, for audio rebroadcast and can also be accessed on the same web page. At this time, I would like to turn the conference call over to Rockwell Medical's Chief Executive Officer, Dr. Russell Ellison. Russell? -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Claudia. Good afternoon, everyone, and thank you for your time today. On today's call, we will address our vision and our strategy to build value for the company, 2 new potential indications for our FPC platform and our next steps for each, continued progress on the commercialization of our first FDA approved product, Triferic Dialysate. Our preparations for the upcoming launch of our second FDA approved product, Triferic AVNU, an update on our international partnering activities and other pertinent corporate updates and a review of our financials. And then we'll take questions from covering analysts, and we'll answer some of the questions we've received by email. Rockwell Medical is focused on transforming the treatment of iron deficiency in anemia around the world to improve outcomes for patients. Our vision is to establish a new standard of care for patients suffering with iron deficiency and iron-deficiency anemia. Iron deficiency anemia afflicts a subset of 2 billion people worldwide who are nutritionally iron deficient and in the United States alone, approximately 10 million people are iron deficient, including 5 million who have iron deficiency anemia. Patients suffering from iron deficiency anemia can experience extreme fatigue, dizziness, and reduced cardiac function. Current treatment options have limitations. Because elemental iron is toxic and iron absorption and availability to cells is tightly regulated by the body via the hormone hepcidin, iron deficiency is challenging to effectively manage orally due to poor absorption and side effects, and intravenous iron is often required in many situations. However, current IV forms of iron or IONPs, release iron into white blood cells and then to the liver, which slowly releases iron to the transport protein transferrin, which makes the iron available to cells. This release can be substantially reduced by hepcidin in inflammatory situations such as dialysis. Our company's ferric pyrophosphate citrate or FPC technology platform has potentially transformative attributes. FPC releases iron directly and immediately to the transport protein, transferrin, and thus, the iron is immediately available to tissue independent of inflammation. To unlock the value of this platform, we are focused on transforming the way anemia is managed for hemodialysis patients and developing FPC to treat other medical conditions with unmet medical needs where iron can be important, such as for patients with iron deficiency anemia, receiving home infusions and potentially in hospitalized patients with congestive heart failure to improve their cardiac function. We believe that we now have a management team that has the relevant experience in hemodialysis, sales and marketing to dialysis clinics, commercial strategy, drug development, clinical trials, and public biopharma company management. We strongly believe that we put our company on a track that we anticipate will build significant value over the next several years. We have a solid core business that generates over $60 million annually and gives us a presence in dialysis clinics across the country where we have an excellent reputation for reliability and service. We have one branded product in the market, Triferic; and the second one about to be launched Triferic AVNU. We have international partnerships that we expect to generate significant growth over time. We have a pipeline of new uses for FPC being developed that we expect will not only help us grow sales in the future but will also provide us with multiple potentially value-enhancing milestones well before they are launched. Those of you that are familiar with the biopharma sector already understand the significant value that can come from achieving certain milestones, such as commencing clinical trials, attaining full enrollment in and completing the trials, data readouts and FDA interactions, all of which occur well before these new uses actually generate sales. I'm delighted to welcome Russell Skibsted to Rockwell in his new position as CFO and Chief Business Officer. Russell joined us in September from the BioTime family of companies and has extensive experience in the management of small-cap public biopharma companies, financing, partnering, drug development, and M&A. And thanks to his efforts on joining, we are now well capitalized to meet our goals. With our recent capital raise, we have sufficient resources to drive value creation for our company. Now, early next year and into the future across 3 concurrent tracks. Maximizing U.S. sales of Triferic Dialysate and soon to be launched Triferic AVNU. Expanding the global commercial reach of Triferic through our key partners and strategically developing our FPC platform for new indications, beginning with our home infusion program. In the United States, we continue to build momentum for the sales of Triferic Dialysate and are prepared to launch Triferic AVNU, the IV formulations, to dialysis centers nationally in the first quarter of 2021. Our global efforts are progressing on many fronts: India, China, Korea, and Latin America. For new indications, we believe there is potential for important value creation, both near and long term. Through the development of the FPC platform for indications outside of the hemodialysis setting where there are significant needs to transform the way iron deficiency and iron deficiency anemia is managed and where we will leverage the clinical and medical experiences to date of 2 FDA approved products. Our top priority, new indication to pursue is FPC for the treatment of iron deficiency anemia in patients undergoing home infusion therapy. Currently, iron requirements can only be met with either an oral iron supplement, which is often not well tolerated or is suboptimal because of the inflammatory conditions, or by IV iron infusion, which requires an office visit due to the hypersensitivity risk with these products. However, we believe FPC could be safely administered through the already available IV line at home. Home infusion therapy is a rapidly growing area of medicine with over 3.2 million patients served every year. In a large subset of patients treated with home infusion, the incidence of iron deficiency anemia is estimated to be as high as 60%. The growth trend of home infusion therapy is likely to continue. Driven by cost savings versus office-based or hospital care and improving reimbursement landscape under Medicare and emerging standards, resulting from the global pandemic. We estimate that the market access for FPC will be favorable, largely because payers want to reduce costly hospitalization and office visits for the administration of these drugs or nutrients with approximately 50% of patients covered by commercial payers and Medicare coverage currently available through a specific part B home infusion benefit. We intend to submit our clinical development plan to FDA and to hold the Type C meeting in the first quarter of 2021. Pending this discussion next quarter, we currently estimate that Phase II studies could commence in the second half of 2021. The second opportunity under consideration is FPC for patients with congestive heart failure. More than 1 million patients are hospitalized each year with decompensated heart failure, and we feel that FPC may be able to address some significant unmet clinical needs in this patient population. A growing body of evidence exists to support the use of IVR as replacement therapy. The current therapeutic options are IONPs, which are limited in iron uptake and clinical benefit because of the relative bioavailability, particularly in an inflamed patient population such as patients with heart failure. However, studies with older forms of parental iron have consistently demonstrated meaningful benefit with heart failure patients in the outpatient setting. But with these products, the release of iron from the liver is likely to be too slow to produce a health benefit in the acute hospital setting. The Triferic Dialysate and AVNU, expanding global commercial reach of Triferic through key partners and strategically developing new indications for our FPC platform and includes numerous milestones starting in Q1 2021 and throughout the following 24 months and beyond. These milestones include a U.S. product launch AVNU, consultation with FDA and active U.S. clinical development of FPC for home infusion, consultation with FDA regarding the regulatory pathway for FPC for heart failure, and multiple clinical development milestones and expected product approvals as well as product launches throughout Asia, North America and Latin America. We are the #2 supplier of concentrate products in the U.S., from which we generate more than $60 million in annual revenue through nearly 20 million life-saving treatments each year. And we continue to reliably supply concentrates to our customers. While our pharmaceutical business is clearly the growth and profit driver for our business going forward, the concentrate business allows us to develop and harvest relationships with key customers in the industry and facilitates discussions we have with current and prospective Triferic customers. Regrettably, the COVID-19 pandemic has not yet abated and continues to impact countries around the world and states within the United States. The dialysis industry faces a unique challenge from the pandemic because many patients are already carrying multiple comorbidities and patients' lives are quite literally dependent on the treatment that they receive 3 times per week. In addition, one of the downstream impacts of COVID-19 can be multiple organ failure, including kidney failure, and this has put further stress on both acute and outpatient dialysis clinics. Our role in supporting health care providers and patients is absolutely critical. And I am pleased to share that we continue to see no disruption to our supply chain for either concentrates or Triferic. This is a testament to our hard-working employees who adapted to the challenges posed by the pandemic. As we have mentioned in prior earnings calls this year, dialysis clinics have restricted access to facilities by nonessential workers, including our sales representatives and nurse educators, and they have paused any significant change in clinical protocols to focus on managing the crisis. This has impacted our ability to continue the promotion of and medical educations for Triferic so we have been working to continue our efforts virtually where possible. With the resurgence of COVID-19 in many states, it is unclear for how long these restrictions will continue. In the states that have reopened, we have taken measured steps to resume in-person clinic visits taking necessary safety precautions. We are in close contact with our global partners to evaluate the potential impact of COVID-19 on these partners' timelines for clinical development and commercialization. I'll now hand over the call to Tim Chole to discuss commercial metrics and the Triferic AVNU launch plan. Tim? -------------------------------------------------------------------------------- Tim Chole, Rockwell Medical, Inc. - VP of Marketing [4] -------------------------------------------------------------------------------- Thank you, Russell. In the third quarter, we continue to make important progress in the commercialization of Triferic Dialysate despite the challenges of the COVID-19 pandemic. As of the end of the third quarter, we increased the number of contracted patients to approximately 3,400, which translates to an annualized treatment volume of approximately $500,000, a meaningful increase compared to last quarter. The overall growth in Triferic sales was lower than expected, primarily due to the restrictions dialysis clinics have levied on in-person visits from our field staff. However, we are pleased with the results our sales and clinical nurse educator teams have produced by leveraging virtual engagement tactics to complete training programs and close contracts. In the quarter, certain U.S. geographies continued to relax restrictions, which has allowed us to reengage with more clinics and get back on track with planned in-person training programs. We are continuing to monitor the increase in COVID-19 cases happening this fall, and we will adapt as needed. With real-world data on hand and experience from the first year of the Triferic launch, we have instituted a number of new initiatives in the third quarter. First, we're encouraging clinics to move straight to purchase contracts and bypass the evaluation process when possible. Second, we have adopted a more aggressive pricing strategy. While these combined efforts are recent and implementation has been slowed by COVID-19, they have allowed us to shorten the overall sales cycle for Triferic in some cases. Third, we have introduced new promotional and educational programs to jump-start a much-needed increase in broader awareness of Triferic and its place in the management of anemia in dialysis. New programs include a non-branded disease awareness education campaign for both nephrologists and dialysis nurses, a refreshed Triferic promotional speakers program series, and a clinical level Triferic value analysis toolkit. Fourth, we've upped our presence in scientific congresses, including the recently concluded American Society of Nephrology Congress, where we sponsored a virtual exhibit booth, posted a scientific symposium, and submitted 3 scientific abstracts that were accepted as posters. Lastly, we have increased our presence on social media to highlight Rockwell's key activities and dedication to the dialysis community. The execution and culmination of these programs that we believe will drive the long-term adoption of our groundbreaking product. Once the COVID pandemic moves towards resolution, we expect to see a reacceleration of adoption of Triferic. This is importantly, specifically important for Triferic as the sales process is a high touch, high support, hands-on approach by our field personnel, which yields us the best results. So next, I'll turn to Triferic AVNU, which is our IV formulation of Triferic. Triferic AVNU is a line extension of our Triferic portfolio and it joins Triferic dialysis as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Triferic AVNU is designed for intravenous administration and enhances the Triferic platform by providing patients with greater access to Triferic by expanding administration options for clinics. The therapy allows dialysis centers to administer Triferic to patients regardless of the mode of bicarbonate delivery being used. And thus, it's more appropriate in cases where the hemodialysis clinic is using drive bicarbonate technology and our Triferic Dialysate product is not an option. Now, our outreach to prospective customers to increase awareness of the upcoming commercial launch of Triferic AVNU started in the second quarter of 2020 and is ongoing. Currently, this includes reaching out to customers who have already expressed interest in Triferic in the past but have been unable to adopt it due to their use of dry bicarbonate technology. We're also in discussions with current Triferic customers about adding Triferic AVNU to existing agreements in order to pave the way for adoption once the product is commercially available. We have started to generate excitement in the market for Triferic AVNU and included an introduction to Triferic AVNU as part of our exhibitor spotlight program at the recent ASN Annual Congress, while promoting our evaluation program, at our virtual exhibit booth. In parallel, we are now finalizing the integrated marketing communications and educational programs that will signal commercial availability of the product expected in Q1 of next year. Originally, we had planned for the commercial release of Triferic AVNU in the fourth quarter of this year. But the time line has been extended due to a minor scheduling delay in the production of packaging for salable product. We initiated the first Triferic AVNU evaluation programs in early October. These programs provide samples of Triferic AVNU to clinics at no cost to trial the product. While it's too early to report comprehensive results, customers have shown interest in the program and have selected patients that they feel will benefit from treatment with Triferic AVNU. Our experienced field team of nurse educators schedule regular lab and medication use reviews to help them evaluate the impact of Triferic while also assuring proper training and education of the field staff. We believe these evaluation programs afford an important marketplace introduction for Triferic AVNU and will support our commercial efforts when saleable product is available in the first quarter of 2021. We look forward to continuing to provide updates regarding the commercialization of Triferic AVNU in future reports. In terms of reimbursement, Triferic AVNU will be reimbursed within the ESRD bundle payment that has been established for Medicare patients. But importantly, we believe the cost structure for Triferic AVNU enables us to make an attractive gross margin while ensuring that the product is price competitive and provides clinical and financial value to dialysis clinics. Now lastly, I would like to touch upon the anticipated introduction of an entirely new class of anemia management agents, the HIF-PHIs, which are expected to change the management of anemia in hemodialysis. We plan to strategically position Triferic alongside the HIF-PHIs to provide a reliable and physiologic treatment of anemia in hemodialysis patients. We expect that the introduction of the HIF-PHI agents, the first of which, roxadustat, is expected to come to market in early 2021, present an important opportunity for Triferic. The mean IV iron requirement in the patients in the roxadustat Phase III dialysis trials was presented at this year's ASN. The requirement is well within the range that can be achieved with Triferic, given with each dialysis session, such that Triferic could be a sufficient source of iron in patients managed with roxadustat. We look forward to providing further updates on our strategy related to HIF-PHIs in the coming months. So with that, I'll turn the call over to Russell Skibsted to discuss Triferic international updates and our Q3 financial results. Russell? -------------------------------------------------------------------------------- Russell L. Skibsted, Rockwell Medical, Inc. - Executive VP, CFO & Chief Business Officer [5] -------------------------------------------------------------------------------- Thanks, Tim. As Dr. Ellison mentioned earlier, our partner, Wanbang Biopharmaceutical is making great progress in China. We hope to soon announce the first patient has been enrolled in the pivotal study once some logistical issues with shipping have been resolved. Access to hemodialysis in China has been continuing to increase at a rapid rate in recent years, with over 600,000 hemodialysis patients in China. It is the largest single market in the world. Earlier this year, we entered into a partnership with Sun Pharma for the rights to commercialize Triferic in India. India is also an attractive market with over 120,000 hemodialysis patients. Sun is working to get regulatory approval for launch from the Indian Central Drugs Standard Control Organization's Technical Committee. We entered into an exclusive license agreement with Jeil Pharmaceutical Company in the third quarter for the rights to commercialize Triferic in South Korea. South Korea represents a sizable and growing market opportunity, with over 78,000 patients receiving hemodialysis annually. We believe that Jeil is an ideal partner. They will be responsible for all regulatory and commercialization activities. Jeil advised us that it will not require a clinical trial in advance of approval. So we anticipate sales to begin in early 2022. And of course, this is subject to regulatory approval in Korea. We are also making progress in discussions with potential partners in other key markets like Japan, Europe, and Latin America. Now, turning to our third quarter results. We ended the third quarter with a strong liquidity position. In anticipation of uncertainty and increased volatility in the capital markets due to the elections, COVID-19, the economy, we had the foresight to raise capital in September. This raise allows us to continue to execute on our growth strategy without worrying about having to raise cash during a volatile and potentially closed capital market. We ended the quarter with cash, cash equivalents, and investments of more than $67 million. Cash used in operating activities for the 9 months ended September 30 was approximately $21 million, which is comparable to the same period last year. Net sales for the third quarter were $15.3 million, which is comparable to the same period last year. Triferic net sales for the 3 months ended September 30, 2020, were approximately $284,000. But since Triferic was launched in the second quarter of 2019, there were only nominal revenues during the third quarter of last year. Cost of sales for the third quarter of 2020 was approximately $14.9 million, resulting in a gross profit of approximately $350,000. This compared to cost of sales of $15.4 million and a nominal gross loss during the third quarter of 2019. Finally, net loss for the third quarter of 2020 improved to approximately $7.4 million from $7.9 million in the third quarter of last year. The improvement in operating loss compared to the prior year was driven primarily by reductions in both commercial and G&A spending, which was partially offset by an increase in R&D spending and interest expense. I will now turn the call back to Russell Ellison for his closing remarks. -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [6] -------------------------------------------------------------------------------- Thanks, Russell. We've made significant progress in the third quarter across many fronts, and we continue to drive value creation for our company now, early next year, and into the future across 3 concurrent tracks, maximizing U.S. sales of Triferic and soon to be launched Triferic AVNU, expanding the global commercial reach of Triferic through our key partners, and strategically developing new indications for our FPC platform, beginning with patients requiring home infusion therapy. In the U.S., we continue to drive adoption of Triferic Dialysate despite COVID-19 headwinds and we expect to see a reacceleration of adoption of Triferic when the COVID-19 pandemic begins to resolve. And we are making final preparations for the commercial launch of Triferic AVNU, expected soon. In China, our partner, Wanbang Pharmaceuticals is about to enroll the first patient in its pivotal Phase III trial of Triferic. In India, our partner, Sun Pharma, submitted all regulatory appeal process documents for its approval for marketing. Sun Pharma is navigating the next steps due to the country's temporary suspension of regulatory review due to COVID-19. And in South Korea, we entered into an exclusive license agreement with Jeil Pharmaceutical Company in the third quarter for the rights to commercialize Triferic in that country, where a clinical trial is not expected to be required prior to marketing. We're progressing home infusion as a priority new indication for our FPC platform with submission of our clinical development plan to FDA expected in Q4 2020, and a Type C meeting expected in Q1 2021. We ended the quarter in a strong financial position to enable our execution of our 3 parallel strategies for value creation. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [1] -------------------------------------------------------------------------------- With that, we'd now like to address some questions that we've received by email. The first set of questions were regarding the stock price performance and whether we believe it reflects the value of the company. Now I can't really talk about stock price, but we can talk about value. We're driving, as I said, value creation across 3 concurrent tracks. Maximizing U.S. sales of Triferic Dialysate and soon to be launched Triferic AVNU, expanding the commercial -- the global commercial reach of Triferic through our key partners, and strategically developing new indications for our FPC platform. And we're confident that our strategy will build value as we move through these milestones that we have laid out. And most programs do have potentially multiple value-driven milestones. Another set of questions address the performance of Triferic Dialysate in the quarter, and the progress we are making in face of headwinds from the COVID-19 pandemic. I mean, I think Tim has addressed this already, but perhaps, Tim, you have more comments on this. -------------------------------------------------------------------------------- Tim Chole, Rockwell Medical, Inc. - VP of Marketing [2] -------------------------------------------------------------------------------- Yes. Thanks, Russell. Just to reiterate, certainly, Q3 growth for Triferic was lower than we expected, and that was primarily due to the restrictions from COVID in dialysis clinics, not only restricting in person visits but also being resistant to making protocol changes during this time. But we have implemented virtual engagement tactics, and we have been pleased with our field force embrace of these tactics, and it is helping us to continue making progress. And as I mentioned, as geographies relax restrictions, and they did relax restrictions in quarter 3 that allowed us to reengage in many cases. And the real-world data we have on hand allows us to encourage clinics to move straight to purchase contracts. In some cases, where they see the data and do not need an evaluation process and along with a more aggressive pricing strategy, we see a shortened overall sales cycle for Triferic. Definitely once COVID starts to move towards resolution, which is an uncertainty. But at that time, we do expect the trajectory of Triferic sales to improve. -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thanks, Tim. Now I'll turn the line over to the operator for questions. -------------------------------------------------------------------------------- Operator [4] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from Brandon Folkes of Cantor Fitzgerald. -------------------------------------------------------------------------------- Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [5] -------------------------------------------------------------------------------- Ahead of the NRU full commercial launch in 1Q '21, can you talk about any gating factors that are still required or needed to get through before launch or that may sort of have an impact on the timing of the launch. In terms of the Home Infusion Type C meeting, can you provide any additional -- or are you able to provide any additional color in terms of when in 1Q we could expect this? And then lastly, gross margin in the quarter seemed to be a lot better than we've seen in the past. Any color on that? -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [6] -------------------------------------------------------------------------------- Okay. So Tim, maybe you want to -- Brandon, sorry. Let me take the Type C meeting question. That's pretty straightforward. We expect this probably in the late February, early March. That would be our estimate. Tim, do you want to address another one of those questions? -------------------------------------------------------------------------------- Tim Chole, Rockwell Medical, Inc. - VP of Marketing [7] -------------------------------------------------------------------------------- Yes, I can speak to the AVNU launch. So the delay that we saw was minor. It was related to, as I mentioned, scheduling of the production of packaging with our supplier in Europe. Certainly, there could always be further delays. But for the moment, we do not anticipate any further manufacturing issues. And there are no other, I would say, barriers to introduction. And on that basis, we're comfortable with the expectation of commercial delivery in the first quarter. -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [8] -------------------------------------------------------------------------------- Okay. Brandon, I think you had one other question. -------------------------------------------------------------------------------- Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [9] -------------------------------------------------------------------------------- Yes. Just on the gross margin, just looking at it, it seems to be a lot higher than we experienced last year. So if you can share any color in terms of that? Or is it just product mix from… -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [10] -------------------------------------------------------------------------------- It's mostly product mix. But Russell, do you have any further comments on that? -------------------------------------------------------------------------------- Russell L. Skibsted, Rockwell Medical, Inc. - Executive VP, CFO & Chief Business Officer [11] -------------------------------------------------------------------------------- Well, I would say that the one thing is we are trying to make our processes more efficient and cost-effective. So hopefully, the early stages of that were being seen here. But I think it's one of the focuses we're going to be taking going forward as well to hopefully try to have not only a gross margin but also net margin that is as efficient as possible. So where we can take excess costs out of it. So stay tuned for that. That is a process that we're going at very heavily right now. -------------------------------------------------------------------------------- Operator [12] -------------------------------------------------------------------------------- Our next question comes from Raghuram Selvaraju of H.C. Wainwright. -------------------------------------------------------------------------------- Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [13] -------------------------------------------------------------------------------- Just to start with a few questions on the international development of Triferic. Can you give us a sense of how long Wanbang expected to take to reach full enrollment in the pivotal Triferic trial in China? Or if they haven't given you any real guidance regarding that time line? -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [14] -------------------------------------------------------------------------------- Marc, can you talk about this? Maybe give some more detail about the product itself. -------------------------------------------------------------------------------- Marc L. Hoffman, Rockwell Medical, Inc. - Chief Medical Officer [15] -------------------------------------------------------------------------------- Sure. And thank you for the question. So as you heard from Russell, we are anticipating a start of the study sometime early next year. And depending on the speed of enrollment, we should have a fully subscribed study sometime in the first half of 2023. -------------------------------------------------------------------------------- Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [16] -------------------------------------------------------------------------------- And then with respect to the situation in India, do you have any sense of what the Indian regulators are looking for with regard to when they would rescind the suspension of regulatory review due to COVID-19? Or that's likely to persist indefinitely. -------------------------------------------------------------------------------- Marc L. Hoffman, Rockwell Medical, Inc. - Chief Medical Officer [17] -------------------------------------------------------------------------------- That's a very good question and I wish I really had a firm answer for that, but I don't. This seemed to be very much related to the incidence rate of cases, which, as you know, in India was really bad. And I haven't -- we haven't certainly got any guidance about what sort of incidence rate would allow regulatory meetings to happen and that sort of thing. So we really don't know. The good news is, we don't know that it's going to be a very long time, but the bad news is we don't know that it's going to be a short time either. So we're just waiting to hear from the authorities in Sun Pharma, which is a pretty major company in India, is really very connected with the authorities. And I'm sure that as soon as they open up, or start to open up, we should be able to get a meeting. -------------------------------------------------------------------------------- Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [18] -------------------------------------------------------------------------------- Okay. And then can you just very quickly provide us with any kind of update metrics regarding A, the evaluation programs on Triferic AVNU? And when you expect those evaluation programs to effectively close following the formal rollout of the product? And then secondly, if you can comment on what the status is of the real-world data program with dialysis? -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [19] -------------------------------------------------------------------------------- Okay. Tim, do you want to take the first 2 questions, and I'll answer the second -- the last one. -------------------------------------------------------------------------------- Tim Chole, Rockwell Medical, Inc. - VP of Marketing [20] -------------------------------------------------------------------------------- Yes, absolutely. So thanks for the question. Our first valuation programs started only in early October. So for now, it's too early for us to really report comprehensively on how this is going to go and how many clinics are going to adopt. But we have the heavy promotion of the program among eligible customers in our target segments. In various channels, I have mentioned as well through our ASN, American Society Nephrology Congress, which occurred in October, to increase awareness of the program. The length of the evaluations vary based on what I explained to earlier, which is our negotiation with clinics about evaluation program length versus cost of the product. So we're trying to accelerate the sales cycle there. But early to say what the results are there. But we certainly will apply learnings from the evaluation program to our commercial launch in the first quarter. -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [21] -------------------------------------------------------------------------------- And the real-world data question is a good one. We've been -- we've contracted a firm to do an in-depth dive on the United States renal disease service data set as provided by [RES DAC], which is current. And we've very recently received that data set. It takes a while to get it. And so we'll be evaluating multiple clinics with about a 9-month to 12-month tenure of using the product. So we should have a -- and the information in the RES DAC data set is pretty comprehensive and includes also outcomes data such as hospitalizations and deaths and so on, as well as dialysis drug and device inputs. So we should have a very nice data set, we hope, certainly in the first quarter next year as we're analyzing it now. I would hope that that would be earlier in the first quarter than not. -------------------------------------------------------------------------------- Operator [22] -------------------------------------------------------------------------------- This concludes our question-and-answer session. I'll now pass the call back to Russell Ellison for closing remarks. -------------------------------------------------------------------------------- Russell H. Ellison, Rockwell Medical, Inc. - President, CEO & Director [23] -------------------------------------------------------------------------------- Well, thank you all for joining us this afternoon, in these interesting times for taking the time to be on this call. And we look forward to following up with many of you in the coming days or weeks. So thanks very much. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- Ladies and gentlemen, this does conclude the conference. You may now disconnect. Everyone, have a great day.