Rockwell Medical, Inc. (RMTI) Q4 2025 Earnings Call Transcript

Good morning, and welcome to Rockwell Medical's fourth quarter and full year 2025 results, conference call, and webcast. Please note, this event is being recorded. At this time, I would like to turn the conference call over to Heather Hunter, Chief Operating Officer at Rockwell Medical. Heather, please go ahead.

Good morning, and thank you for joining us for this update on Rockwell Medical. Joining me on today's conference call are Rockwell Medical's President and Chief Executive Officer, Dr. Mark Strobeck, and Rockwell Medical's Chief Financial Officer, Jesse Neary. Before we begin, I would like to remind you that this conference call will contain forward-looking statements about Rockwell Medical within the meaning of the federal securities laws, including but not limited to the types of statements identified as forward-looking in our annual report on Form 10-K and our subsequent periodic reports filed with the FCC. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions and expectations only as of today. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our periodic reports filed with the SEC. ROCCO Medical's annual report on Form 10-K for the year ended December 31, 2025, was filed prior to this call and provides a full analysis of the company's business strategy as well as the company's full year 2025 results. The reconciliation of non-GAAP measures we discuss on today's call can also be found in today's press release. Our Form 10-K and other reports filed with the SEC along with today's press release, our updated investor presentation, and a webcast replay of today's call can be found on our website under the Investors section. Now, I will turn the call over to Rockwell Medical's President and CEO, Dr. Mark Strobeck.

Thank you, Heather, and good morning, everyone. Thank you for joining us today on Rockwell Medical's fourth quarter and full year 2025 earnings conference call and webcast. 2025 represented a defining year for Rockwell Medical. We successfully navigated changes in our customer base, changes in our customer purchasing volumes, and changes in our distribution footprint, all while maintaining profitability on an adjusted EBITDA basis for the second consecutive year. We made significant operational changes to further align our infrastructure to match demand, the benefits of which began to be realized in the fourth quarter and delivered one of the highest quarterly gross margin in the company's history. Additionally, in the fourth quarter 2025, we generated positive cash flow from operations, resulting in a higher cash position at year end. We exited 2025 with a business that we expect to remain stable and well-positioned to deliver sustainable profitability for years to come. Now let me delve into the details of our operational results. A central focus of our strategy over the past several years, and especially throughout 2025, has been building a more durable business to reduce volatility, support more consistent margin performance, and enable us to plan our operations with greater confidence. Reducing customer concentration risk and improving revenue stability have been essential priorities for Rockwell, and we believe we have made significant progress on both fronts. Today, our customer mix is diverse. We serve approximately 300 customers throughout the United States, including all five of the leading dialysis providers in the U.S., along with university medical centers, community hospital systems, and other renal care organizations. In addition, we supply hemodialysis concentrates to more than 30 countries outside the United States. Let's start with Presenius, the largest provider of renal care solutions in the world. Based on the agreement we signed back in 2024, we consistently and reliably supplied them with our concentrate products throughout 2025, and based on their projections for 2026, we expect that business to grow. As for DaVita, the second largest provider of kidney care services in the world, while they originally intended to completely transition away from Rockwell by the middle of 2025, they did not. Instead, for a variety of reasons, including our reliability, consistency, and quality, DaVita ended up extending our agreement to the end of 26, during which product pricing will be increased. We are excited to continue to supply and support DaVita and look forward to finding ways to to reestablish a larger supply agreement with them. We expanded our relationship with Innovative Renal Care, the fourth largest dialysis service provider in the United States. We signed a multi-year agreement with IRC to support their goals to invest in high quality hemodialysis products, streamlined workflows, and help avoid potential supply chain disruptions. This multimillion dollar purchase agreement has utilization commitments and will remain in effect for three years with the option to an extend for an additional one-year period since announcing this transition in july of last year our partnership with irc continues to grow stronger and we now reliably supply 70 percent of their clinics with our hemodialysis concentrates efficient processes high quality products business continuity and supply chain reliability were key drivers for irc to expand their relationship with us we are excited to be a part of their mission Another customer to highlight is DCI, which is one of the top five dialysis providers in the U.S. and the nation's largest not-for-profit dialysis provider. Rockwell is currently under a long-term agreement with DCI through which we supply and deliver to over 80% of their clinics. In 2025, we also signed a product purchase agreement with Concerto Reno Services, the largest provider of dialysis and skilled nursing facilities in the United States. This three-year agreement has an option to renew for one additional year and includes supply and purchasing minimums for our liquid and dry acid bicarbonate concentrates, including our bicarbonate cartridges. We currently supply 100% of their facilities where Concerto provides dialysis services. Last year, there was a major hemodialysis concentrate supply chain disruption due to another concentrate supplier in the western part of the U.S. winding down operations due to regulatory and compliance related concerns to stabilize the market we move quickly to ensure product availability by rapidly scaling production and expanding our logistics infrastructure to address vital customer demand created by this disruption as a result we added 30 new customers in the west increasing the clinics we serve and opening the possibility for further expansion we also further diversified our hemodialysis concentrate product portfolio by adding a single-use bicarbonate cartridge that is 510k approved by the fda and comes in two sizes 720 and 900 grams interest in this disposable which is compatible with a range of dialysis machines continues to increase with our existing customer base as well as with prospective customers in 2026 we expect to generate approximately 1 million in net sales from our bicarbonate cartridges As we look ahead, our pipeline remains active and diversified across customer segments and geographies. We continue to see strong interest from customers who increasingly recognize the importance of quality and supply chain reliability for our hemodialysis products. While we remain disciplined, we believe our diverse customer mix positions us well for sustainable growth and expansion. As our customer mix evolved in 2025, we took a hard look at our operations, not just to reduce cost, but to strengthen the foundation of our business. Throughout the year, we executed a series of targeted actions across manufacturing, supply chain, logistics, and overhead. The objective was straightforward, operate more efficiently while continuing to meet the high expectations of our customers to ensure quality, safety, reliability, and top tier customer service as our business evolved we took the opportunity to further standardize processes and optimize how we deploy resources across the organization by reducing complexity improving planning and better aligning capacity with demand we were able to operate more predictably and with greater discipline these changes support our ability to respond more efficiently as volumes and customer needs shift the impact of which is clearly being reflected in our gross margin. It's important to emphasize that our margin expansion, especially in the fourth quarter of 2025, is not the result of temporary actions or one-time benefits. Instead, these changes reflect structural improvements in how we run our business, from how we manage production to how we align resources with demand. Our margin improvement is being driven by several factors. First, we are improving our pricing discipline across a more diversified customer base which is allowing us to better align contract economics with the value we provide second operational efficiencies are reducing costs and improving throughput third a more stable production and logistics environment is able is enabling better planning and execution as volume shift and customer needs evolved this disciplined operating model gives us flexibility to respond efficiently while maintaining high service levels. In the fourth quarter, we appointed a new head of manufacturing and operations, Rashad Brown, as vice president of manufacturing and supply chain. Rashad brings deep operational expertise and a strong track record in regulated manufacturing environments, specifically hemodialysis concentrates, having previously worked at Fresenius and other leading medical device manufacturers. His leadership is already having a significant impact on our operations through improved execution, consistency, and discipline. We expect further improvements in our manufacturing efficiencies in 2026 and beyond. Our financial performance in 2025 reflected an organization that was in transition, but also laser focused on maintaining profitability and stabilizing its business to ensure future growth. Revenue changes throughout the year reflected the combination of a change in our customer base and product mix, along with additional organic growth. Similarly, we made adjustments to our organizational and manufacturing infrastructure to match the changes in our customer base, which produced consistent improvements quarter over quarter. Gross margin expanded meaningfully, making the fourth quarter 2025 one of the strongest quarters of gross margin in Rockwell's history. Operating loss narrowed, the overall financial profile of our organization improved, and we delivered positive adjusted EBITDA for the full year 2025. We also generated cash in the fourth quarter supported by margin expansion and better working capital management. That progress further reinforces the strength of our underlying business. In short, we are doing more with less and doing it better. The business is becoming more focused and more predictable, and we believe it is increasingly well-positioned to generate sustainable returns over time. We initiated a strategic shift nearly four years ago to fundamentally revitalize Rockwell. Our main objective at the time was to reestablish credibility with all stakeholders, especially with the investment community. This is and remains incredibly important to our success. We are pleased to report for the third year in a row our annual performance was aligned with our annual guidance. We have strengthened the core fundamentals of this business and clarified the key drivers for its success, positioning it to become increasingly consistent, reliable, and repeatable over time. For our 2026 guidance, we believe we are well positioned to advance our strategy to drive sustainable revenue growth, expand our profitability, and further diversify our portfolio. As a result, we project our business operations in 2026 will generate adjusted EBITDA between $1 and $2 million and operating cash flow to be positive. Because we are currently in negotiations with several large customers, the outcome of which has the potential to positively impact both net sales and gross margin in 2026 we expect to provide guidance on those financial metrics in the near future bottom line in 2026 we believe that our business is projected to be profitable and generate cash as new opportunities arise we anticipate that these projections have the potential to strengthen reflecting our businesses ongoing adaptability and growth prospects looking ahead we continue to focus on long-term value creation for our shareholders our strategy over the next three years is centered on three core elements first we are focused on growing our profitable leading hemodialysis concentrates business serving dialysis centers in the united states and around the world this remains our core foundation our ability to deliver reliable supply consistent quality and strong service supported by a more efficient operating model enables us to be a dependable partner to our customers while sustaining margin performance and supporting shareholder returns second we are focused on building a broader portfolio of renal care products that integrate seamlessly into our existing commercial manufacturing and distribution infrastructure we see meaningful opportunity to leverage that platform we have built including our customer relationships operational capabilities and logistics network to support additional products that align with our expertise and enhance the overall offering we provide to customers. Third and longer term, we continue to seek the next advancement in renal care, innovations that can drive improved treatment options and outcomes for patients. While inherently deliberate and disciplined, this work reflects our commitment to remaining forward-looking and strategically positioned within an involving healthcare landscape. beyond these core areas of focus and based on what we see today we believe that over the next three years we have a path to meaningfully grow our business by 2029 we believe that we will be well positioned to generate annual net sales above 100 million dollars while continuing to broaden and diversify our portfolio so that a smaller share of revenue comes from our concentrates business as it exists today over that same period we expect gross margins to trend upward potentially approaching 30% range and our business to move toward annual profitability in the range of five to ten million dollars these are our goals and we see a path to achieve these goals of course I'd emphasize that these are longer-term directional views based on our current expectations and they are subject to a range of risks and uncertainties so actual results could differ now I will turn the call over to Jesse to review in further detail our fourth quarter in full year 2025 financial results thank you mark good morning everyone as you can see from this morning's press release we've presented our financial highlights as a quarterly trend from q4 2024

through q4 2025. we believe the most meaningful comparisons are quarter to quarter progression given the changes to our business over the past year as mark mentioned we remain focused on continuing to optimize our cost structure to match the changes in our customer base. We measure our progress against this objective by focusing on three metrics, cash, gross margin, and adjusted EBITDA. We have shown consistent improvement throughout the year in each of these areas. First, we increased our cash position from $17.3 million at the end of March 2025 to $25 million by the end of the year. Gross margin grew from 16% in Q1 to 21% in Q4. And adjusted EBITDA improved each quarter, starting at negative $400,000 in Q1 of 25 and ended with a positive $1 million in Q4. We believe adjusted EBITDA is the best indicator of profitability because we remove non-cash items, non-operating items, restructuring costs, and other items that are not part of our core concentrates business. Now, let me walk through our financial results for the fourth quarter and full year 2025. Net sales for the fourth quarter of 2025 were $18.3 million, which was 15% higher than net sales for the third quarter of 2025 and represents a 26% decrease over net sales of $24.7 million for the fourth quarter. Net sales for the full year 2025 were $69.3 million, which represents a 32% decrease over net sales of $101.5 million for the same period in 2024. The decrease in net sales was driven by the expected reduction in purchase volumes by one of our customers. Gross profit for the fourth quarter of 2025 was $3.9 million, which was 70% greater than gross profit for the third quarter of 2025 and in line with gross profit for the fourth quarter of 2024. Gross profit for the full year 2025 was $11.7 million, down from $17.5 million for the same period in 2024. The decrease in gross profit was driven by the reduction in purchase volumes by the customer mentioned earlier. Gross margin for the fourth quarter 2025 was 21%, which represents one of the strongest quarters of gross margin in Rockwell's history and represents a meaningful increase over 14% gross margin in Q3 and 15% gross margin in the fourth quarter of 2024. Gross margin for the full year of 2025 was 17%, which was in line with our 2025 annual guidance and in line with our gross margin in 2024. As Mark mentioned earlier, we made adjustments to our infrastructure and operations last year to better match demand, and the results of these activities began to be reflected in our fourth quarter numbers. Net loss for Q4 2025 was $600,000, which represents a three-fold improvement over our net loss of $1.8 million in Q3 of 2025 and a slight improvement over a net loss of $800,000 for Q4 of 2024. Net loss for the full year of 2025 was $5.3 million compared to a net loss of $500,000 in 2024. Net loss for 2025 includes $4 million of non-cash depreciation, amortization, and stock compensation expense, as well as $1.2 million of severance and other restructuring costs associated with facility transitions. Rockwell Medical was profitable on an adjusted EBITDA basis for the fourth quarter and full year 2025. Adjusted EBITDA for Q4 2025 was a positive $1 million, which represents a $900,000 increase over Q3 of 2025 and generally in line with Q4 of 2024. Adjusted EBITDA for the full year of 2025 was a positive $300,000 compared to a positive $5 million for the full year of 2024. Cash equivalents and investments available for sale at year-end 2025 was $25 million, an increase of $1.3 million from the end of Q3. During the fourth quarter, we generated positive of the cash flow from operations of $2.3 million, which was partially offset by cash paid in connection with our VOPA asset acquisition. Since the end of 2024, we increased our cash position by $3.4 million. Our $25 million cash balance not only provides a stable foundation for the business, but also provides the growth capital necessary to pursue the strategic activities Mark outlined earlier. Now we'll turn the call back over to Mark.

Thank you, Jesse. Operator, please open the phone lines for any questions.

We will now begin the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad now. To withdraw your question, press star 1 again. Please pick up your handset when asking a question. If you are muted locally, please remember to unmute your device. Now please stand by while we compile the Q&A roster. Your first question comes from the line of Anthony Vendetti with Maxim Group. Your line is open. Please go ahead.

Thank you. Mark, I was wondering if, you know, based on the current relationship with DaVita, since they continue to purchase in 2025, Have they given you any indication what volume levels or commitments for 26 they're considering, or do you have expectations for 26 from DaVita, or is that still up in the air, negotiation phase? Any color on that would be really helpful. Thanks, Anthony.

Yes. As part of the-our agreement with DaVita, they are obligated to provide us a forecast for the year, to which they have. At this point, they are purchasing at volumes that are, you know, consistent with and slightly above what they have projected for us. So I think that is a positive sign. And again, I think as we continue to work with them and create better ways in which to service them, we are hopeful that there is an opportunity here, not only in establishing a much longer term relationship, but also the possibility of securing additional business with them.

Okay, great. And then two other quick follow-ups on the West Coast expansion as well as at-home dialysis. So, you have 30 new accounts on the West Coast. Is there a particular goal for 26 in terms of expansion there, or is that on a case-by-case basis? And then maybe talk about the progression of the at home dialysis market where is that right now in terms of a proximate percentage of revenue and and what do you see as the uh growth trajectory interest fix yeah um so on the first question um you know we took over those customers are now in the process of putting those under long-term agreements with Rockwell.

Given the customer base that we already have in the West, with the addition of this group really puts us in a position to begin to start to expand further within the West. We're right now, you know, designing a commercial strategy to bring forward in part to do that. We'll also be looking to our work with B-Bron, if you recall the partnership that we had put in place, you know, two years ago, as they are heavily focused in the West. So I think collectively that's going to position us well to target dialysis centers that we otherwise haven't supported in the past. As it relates to the at-home market, you know, that market, I think, you know, continues to establish itself, you know, As an overall percentage of the dialysis, hemodialysis market, you know, it's probably trending towards what will be about 10%. You know, we work with some of the largest players in that space, and so we're continuing to support those.

As we, you know, as that market grows, I think we're well positioned to take advantage of that in part because we have configurations now of our products that work incredibly well at home okay great thanks very much i appreciate it i'll back in too again if you would like to ask a question please press star one on your telephone keypad now to withdraw your question press star one again remember to pick up your handset when asking a question if you are muted locally remember to unmute your device. Please stand by while I compile the Q&A roster. Your next call. Your next question comes from the line of Ram Salvaraju with H.C. Wainwright. Your line is open. Please go ahead.

Thanks very much for taking my questions and congrats on all the recent progress. I wanted to drill down a little bit more on the likely evolution of the relationship with DaVita and asked three questions on that front. Firstly, I was wondering if contribution from DaVita factors into your longer-term projections. If it does, to what extent? And if it doesn't, could you confirm that? Secondly, I was wondering, in the context of 2026 are there any factors that you see potentially driving davida to extend the relationship with rockwell past the end of 2026 in other words is that even an option or do you think that's definitively off the table and we shouldn't be uh assuming it in any way shape or form and then lastly i was wondering if you could talk a little bit about the broader markets and competitors with you for DaVita's business and how they might be looking to prize DaVita away. Is it primarily on price or are they able to compete on something else? And then I have a few others. Thank you. Great.

Thanks, Ram. Maybe the first one I'll let Jesse answer.

Yeah, so Ram, In terms of our longer term projections, we are assuming consistent volumes purchased from DeVita over the next few years. So consistent with essentially what they purchased the last three quarters of last year and going forward into this year. So no gigantic growth assumption there for DaVita.

And then on your next question, you know, we continue to have a very strong relationship with DaVita. I think it is their intent and it was their desire to want to put in place a long-term relationship with us. So, you know, it's our anticipation that if we continue to supply them um consistently over the course of the year with products that have the you know high of the highest quality um that there is a high probability that they will continue to work with us going forward um and you know depending on how the performance of others um continues I think may open the possibility for us to expand further and regain many of the clinics that transitioned away in the middle of next year. As to the third part of your question around competitors, this is really, you know, what I'll call a three-party market. and it's us, Fresenius, and Dnepro. We believe that Dnepro continues to struggle to bring products to the market given some of their recent historical issues around the quality of their products. We don't have much visibility into that, but all indications are but that still continues to present a challenge to them. And, you know, we continue to not only work with Fresenius, but also recognize that there are customers that continue to leave Fresenius in preference of Rockwell, not just our ability to, you know, provide products that are incredibly high quality, but our ability to distribute those through our Rockwell Transportation System helps reduce the third-party costs that other customers would see if they were to purchase products from Presenius. So our competitive advantage continues to be high-quality products. That means products that manufacturing facilities that um you know do not and haven't had significant issues related to you know fda inspections um and then secondly um because we you know transport our products largely on rockwell transportation which is a more cost effective way to get products to clinics um that those are the two areas that put us at competitive at a competitive advantage and the third is our customer service group. We have a dedicated customer service group that works exclusively with dialysis centers. As you can imagine, many of these are not set up as businesses per se. They're set up as treatment facilities really focused on delivering high-quality therapy to patients with end-stage renal disease. They're not sophisticated in procurement.

They're not sophisticated in transportation they're not sophisticated and we provide all of that through our customer service and you know that is continues to be an advantage for us so those are the areas that i think differentiate us and continue to you know generate uh very positive customer feedback thank you that's very helpful um i wanted to ask two other quick ones if i may Firstly, can you give us any additional granularity on how the Western expansion is going, what the prospects are for additional customer acquisition in 2026, and how you see that aspect of the business contributing to your longer-term forecast? And then was wondering if in the, let's call it late 2020s timeframe, you know, the outer years of your longer term forecast, you can give us any further commentary on where you expect gross margins to be trending at that point.

Yeah. So, you know, as we mentioned, we stepped in and took over the business of about 30 customers in the West. That is a multi-million dollar revenue base that we've now acquired and are beginning to support. support. That, you know, as I mentioned, you know, gives us an even stronger foothold in a region of the country that has largely been supplied by one manufacturer. So once we made that announcement and made it clear to folks that we are now able to provide products to dialysis centers in the west um we received a number of calls from customers that are are looking to transition away from their their current um supplier so we're in the process of prosecuting those um you know those can be you know smaller opportunities all the way up to multi-million dollar opportunities and we're just going to continue to prosecute those um throughout the but we certainly think that there's a you know a large opportunity to to secure more business out there um as it relates to you know our projections through 2029 um you know two things i would say um in an effort to answer that question the first is we are you know continue to be actively engaged in a number of business development discussions um around acquiring renal care products that fit very squarely into what we are doing whether that is additional concentrates whether that is um products that you know are used by dialysis centers blood tubing sets dialyzers etc um so we are we are now working with a couple of organizations to evaluate those, determine the prospects of bringing them to the United States for us to sell alongside our concentrates. All of those product opportunities that we're looking at are going to be higher margin opportunities than we are, you know, than our current business today, which is going to help, you know, sort of pull up our overall gross margin. And then, in addition, we're also looking at one or two very innovative therapies in the space that may require additional investment, you know, to get to the market. But all of that is what we believe we can successfully accomplish to get to the revenue projections that we provided. Thank you so much. Thanks, Ram.

There are no further questions. I would now like to turn the call back over to Dr. Strobeck.

Thank you for joining us today for an update on Rockwell Medical. We are proud of our achievements in 2025 to navigate changes in our customer base, purchase volumes, and distribution footprint, all while maintaining profitability. Our team has done a tremendous job aligning our infrastructure to match demand. In 2026, we remain focused on making Rockwell profitable for what would be the third year in a row and continuing to ensure that we are set up for long-term stability and success. Strengthening our top-line revenue, expanding our profitability profile, and further diversifying our portfolio through product acquisitions and business development opportunities requires significant ongoing effort. We believe we are getting close and we'll have more to share with more to share with you as we reach key milestones in the coming month.

This concludes today's call. Thank you for attending. You may now disconnect.