Rockwell Medical reports Q3 2025 results with improved adjusted EBITDA, maintaining guidance despite ongoing customer transition and strategic restructuring efforts.

Good morning and welcome to Rockwell Medical's third quarter 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 Dr. Mark Strobek, Rockwell Medical's President and Chief Executive Officer, and Jesse Neary, Rockwell Medical's Chief Financial Officer. 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 10K and our subsequent periodic reports filed with the SEC. 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. Rockwell Medical's Quarterly Report on Form 10Q for the three months ended September 30, 2025 was filed prior to this call and provides a full analysis of the Company's business strategy as well as the company's third quarter 2025 results. The reconciliation of non GAAP measures we discussed on today's call can also be found in today's press Release. Our Form 10Q and other reports filed with the SEC along with today's press release, Our updated investor presentation and a replay of today's conference call and webcast can be found on Rockwell Medical's website under the Investors section. Now I would like to turn the conference call over to Rockwell Medical's President and CEO Dr. Mark Strobek.

Thank you Heather, Good morning and thank you for joining us today for Rockwell Medical's third quarter 2025 earnings conference call and webcast. As we approach the end of the year, I want to provide you with an update on what has truly been a year of resilience, transformation and growth for Rockwell. We are effectively managing the transition of our largest customer away from us while securing our base business through multi year contracts, right-sizing our organization to enhance operational efficiency and adding new customers, all while continuing to meet strong customer demand with high-quality products supported by exceptional customer service. I am proud to say that we have made substantial progress. We continue to fundamentally strengthen our contract portfolio with over 80% of our customers operating under long term agreements. This provides stability and revenue visibility that positions us well for the future. We continue to optimize our organizational structure to align with our current scale while maintaining our operational excellence and customer service standards. This right sizing effort has been executed thoughtfully ensuring we retain the capabilities and capacity needed to serve our customers and capitalize on growth opportunities as they emerge, and most importantly, we have demonstrated our ability to successfully manage through this transition period while maintaining our market position and building momentum for future growth. The strategic decisions we made earlier in the year are now translating into tangible results and we remain confident in our ability to achieve our full year guidance targets. Looking at our third quarter financial performance, I am pleased to report several key achievements that demonstrate our continued progress through this year of transition. Most notably, we are pleased to report that we were profitable on an adjusted EBITDA basis for the third quarter. This continues to track in line with our full year guidance range. The trajectory we are seeing gives us confidence in our ability to achieve sustainable profitability as we move forward with our strengthened contract portfolio and further optimize cost structure. While our net sales of 15.9 million reflected the expected impact from our largest customers transition, our adjusted gross margin performance remained consistent and well within the range of well within our guidance range of 16 to 18%. This growing stability in our margin profile even during a period of customer transition speaks to the quality of our customer base and the value proposition we deliver in the hemodialysis concentrates market. We continue to make meaningful progress with both new and existing customers. Our pipeline has the potential to be transformational for Rockwell Medical. These discussions span various customer segments and geographic markets, and while we maintain our characteristically conservative approach to guidance, the breadth and quality of these opportunities reinforce our optimism about the company's growth trajectory in 2016 and beyond. During the third quarter we signed several new long term product purchasing agreements with university medical centers, kidney centers and hospital systems. One agreement worth highlighting is with a single dialysis center located in Southern Florida. This is a three year commitment with the option to renew for two additional one year periods that has the potential to generate approximately 1 million in annualized net sales for the company during the third quarter. We also expanded our product purchase segment agreement with the largest provider of dialysis in skilled nursing facilities in the United States. The agreement will be in effect for three years with the option to renew for one additional year and includes supply and purchasing minimums for our liquid and dry acid and bicarbonate concentrates, including our bicarbonate cartridge, which as a reminder, officially launched earlier this year. Discussions with our formerly largest customer are still ongoing. We continue to supply them through the third quarter and expect to supply them through the end of the year. As a reminder, this customer originally planned to complete their transition to a new supplier in the middle of this year. However, due to a Class 1 recall of this by this new supplier and other unforeseen circumstances, the customer continues to rely on Rockwell Medical for a portion of its hemodialysis concentrate supply. We believe that this speaks to both the quality of our products and the operational challenges inherent in switching suppliers for mission critical dialysis treatment. It's worth noting that this large customer represented 12% of our net sales in the third quarter of 2025, demonstrating that while this relationship remains meaningful to our business, our successful diversification efforts have significantly reduced our dependence on any single customer. We believe that this reduced concentration risk, combined with our strengthened contract portfolio across our broadened customer base, positions us well regardless of how our discussions with the largest customer ultimately end up. We will continue to approach these discussions with the same professionalism and customer centric focus that have characterized our long standing relationship with this large customer, while maintaining our disciplined approach to guidance and ensuring that any future commitments align with our strategic objectives and operational capabilities. Now I'll turn the call over to Jesse to review our third quarter 2025 financial results in further detail.

Thanks Mark Good morning everyone. Our focus in 2025 has been to adjust our cost structure to align with the changes to our customer base. While improving efficiency is an ongoing exercise, we have made progress over the last two quarters in restructuring the size of our operations and expect those efforts to be substantially completed by the end of this year. We measure our progress in this area by focusing on three key metrics gross margin, adjusted EBITDA and cash. We believe adjusted EBITDA is a good proxy for profitability because we remove noncash items, non operating items, restructuring costs and other items that are not part of the concentrates business. Since there have been so many changes over the past year, we believe the most meaningful comparison is against the previous quarter instead of the prior year. I will now review our financial results for the three and nine months ended September 30, 2025 in greater detail. Net sales for the third quarter were 15.9 million, which were in line with net sales for the second quarter and represent a 44% decrease over net sales of 28.3 million for the same period in 2024. The decrease in net sales was driven by the transition of our largest customer to another supplier. Net sales for the nine months ended September 30, 2025, or 50.9 million, which represents a 34% decrease over net sales of 76.8 million for the same period in 2024. Gross profit for the third quarter was 2.3 million, which was in line with the gross profit for the second quarter and represents a 64% decrease over 6.2 million for the same period in 2024. Gross profit for the nine months ended September 30 was 7.8 million, which represents a 44% decrease over 13.9 million for the same period in 2024. Gross margin for the third quarter 2025 was 14%, down from 16% in Q2 2025 and 22% for Q2 2024, excluding restructuring costs. Gross margin was 18% in Q3 2025 and improvement over the first and second quarters of 2025. Gross margin for the nine months ended September 30, 2025 was 15%, which represents a decrease from 18% for the same period in 2024. Gross margin in 2025 was 17%, excluding restructuring expenses. Net loss for the third quarter of 2025 was 1.8 million, which was consistent with the first and second quarters of 2025 but was down compared to net income of 1.7 million for the same period in 2024. Net loss for the nine months ended September 30th, 2025 was 4.8 million, compared to a net income of 300,000 for the same period in 2024. Adjusted EBITDA for Q3 2025 was $50,000, which represents an improvement over adjusted EBITDA of negative 200,000 in Q2 2025 and a negative 400,000 in Q1 2025. Adjusted EBITDA for the nine months ended September 30th, 2025 was a negative $600,000 compared with a positive adjusted EBITDA of 3.7 million for the same period In 2024. While this represents a significant year over year decline, the trajectory shows meaningful improvement when compared to the first half performance, indicating that our strategic initiatives and new customer relationships are beginning to generate positive momentum for our financial results. Cash Cash equivalents and investments available for sale at September 30, 2025 was $23.7 million, an increase from 18.4 million at the end of Q2, the increase in cash was primarily driven by the issuance of common stock in connection with our ATM facilities, partially offset by cash paid in connection with a Voqua asset acquisition. The increased cash position offers us the opportunity to continue to pursue business development opportunities and further invest in infrastructure enhancements, and modernization. Now we'll turn the call back over to Mark.

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

Thank you. If you would like to ask a question, please press star followed by the number one on your telephone keypad. Our first question comes from ram Selvaraju. From H.C. wainwright. Please go ahead. Your line is open.

Thanks very much for taking my questions. Firstly, I was wondering if you could give us some additional color on when you expect the situation with your former largest customer to be fully resolved. If you anticipate a final decision to be taken before the end of this year, or if you anticipate continuing to provide services to this customer into 2026.

Thank you. Yep. Thanks, Ram. We expect that to resolve this quarter. We are currently in contract discussions with them and we expect to be able to discuss that shortly.

Okay. And then with respect to 2026, can you you give us a sense of when. You believe you might be in a position to provide forward revenue guidance for the full year 2026? And also I wondered if you could elaborate on what types of business development activities you might look to undertake with your current balance sheet strength. Thank you.

Yeah, yeah. So, you know, typically, you know, we provide 2026 guidance, early in the year, so we expect to continue to do that. So our anticipation is as we release our fourth quarter earnings, we'll be able to provide visibility into the company's performance in 2026. As far as business development activities, we continue to be very active in that. There are, you know, now that we have a strong cash balance, you know, that we are now employing as growth capital, we are currently in discussions with multiple companies around acquisitions of their business and customer base. And, you know, assuming those continue to progress, we'll be able to announce shortly what the impact of those will be. Okay.

And then lastly, could you just talk a little bit about what you see as the key prospects near- and medium-term for the bicarbonate disposables business.

Yeah. So, you know, with the, with, you know, the introduction of our bicarbonate cartridge with, you know, earlier in the year and now with our first large customer now beginning to access that product, we think that there's an opportunity to grow, significantly beyond that. That's a much higher margin product opportunity for us. And, you know, you know, it's been a significant effort to, you know, put that in place in relatively short order, get that ready to go, having it, you know, again with the quality standards that we expect for all of our products leaving our organization. You know, it's taken us some time to put all of that in place, but we are now in a position, I think, to maximize that. And, you know, we expect more and more of our customer, existing customer base to begin to start purchasing that product from us.

Thank you.

Our next question comes from Nick Sherwood from Maxim Group. Please go ahead. Your line is open.

Hi. Good morning, everyone. My first question is, how are you balancing some of this organizational restructuring while also ensuring you're making proper investments in the business? I mean, you just mentioned potential acquisitions, but is there anything more internal that we're focusing on? Are you making new hires or is. Kind of a lot of that investment. Based on some of these potential acquisitions you just mentioned?

Yeah, so it's, you know, as you can imagine, it's been, you know, it's been a tricky algorithm for us to work through, which is, you know, decreasing certain, you know, obviously products and, you know, the single largest customer moving away from us while simultaneously, you know, adding new customers and making sure that we continue to supply product to our existing customer base at the quality standards and with the service that we've provided previously. What that has, you know, essentially amounted to a titration of resources within our organization, shifting of priorities, shifting of some of those resources to focus more on growth opportunities in those areas and winding down some of the activities and sort of operations in areas that are no longer going to be supported by our organization. So it's been a balance, and the team has done an incredibly good job of managing that difficult sort of titration exercise. You know, as Jesse pointed out in his section, you know, we're beginning to start to see the fruits of that and, you know, we expect to see more of that here in the fourth quarter coming up and through 26.

I appreciate the detail. And my second question is, where do you see the most kind of room to run with, you know, improving your gross margin? Is it material costs? Is it labor costs? Are there sort of efficiencies that you can develop in your distribution system where you can, you know, kind of get more product on fewer shipments, or is it packaging? Can you kind of just thinking about 2026, what are some of those early targets you're looking at that can make the biggest impact in improving margins.

So I think in the immediate term, labor cost is certainly an area where we can become more efficient. So I think that's number one. But over the long term, we definitely see upside in reducing our materials costs and distribution as well.

Okay, so labor and then some of the materials after that. And then my third and final question is there's. On the adjusted EBITDA reconciliation, there is a facility closure. Can you kind of just give any. A little bit of background to what. What was happening there and kind of. Yeah. Just any detail you can provide.

Yeah. So we have one of our facilities we've. We've now trimmed again, in part because it was. The lease for that facility was coming up. We were able to consolidate our manufacturing activities into our existing facilities. And so we were able, you know, essentially wind that down and begin to offload that expense. So that's what you're. You're going to begin to see here in the third quarter and then more specifically in the fourth quarter.

Okay, so we. We should see maybe a little bit of a similar impact on operating expenses in this. In the fourth quarter as well as compared to the third quarter.

That's correct.

Okay, thanks for answering all my questions. I'll return to the queue.

Absolutely.

Our last question comes from Anthony Vendetti from Maxim Group. Please go ahead. Your line is open.

Sure. Thanks. So, Mark, I just wanted you to give us an update on two things. One is the west coast expansion, and then just an update on the home dialysis business.

Yep. Yeah. So the west coast, you know, continues to be an area of opportunity for us. We are expanding our customer base now into the West Coast. We expect to have. We hope to have an announcement here shortly related to, you know, further customers that we are acquiring in that area. That's going to be an area of focus for us in 26, which will be how to maximize the opportunity there for Rockwell, whether that comes through, you know, continued customer acquisition or that comes by setting up a small facility in the West. I think we're. We're now beginning to build a critical mass of customers out there that likely warrants that. You know, as we've said previously, we. We've taken the approach of not building something, hoping folks would come, but waiting till we have a, you know, significant, you know, customer base out there to warrant the presence of a facility. And I think based on our assessment now and certainly through the fourth quarter, we're likely in a position of where we will contemplate that. So, you know, we believe that's a significant area of growth for us. Your second question.

What about at home?

So at home we continue to be a, you know, a very large supplier to that market. As you know, we supply one of the largest at home hemodialysis providers in the United States. Our new product configuration, which I think is more amenable for at home use, has begun to start to take off again. That is a higher margin product opportunity for us and we believe we'll continue to see that growth through the end of the year and into 2026 as more of the at home users begin to convert to that product configuration. You know, we think that there's a, you know, that will have a place within the overall hemodialysis market and those organizations that are working in there and using our product, I think are establishing that. So, you know, we continue to be excited about the prospects there, but are well positioned to support that market as it continues to develop.

Okay, maybe just a final question, just to get an understanding of the magnitude, what percent right now of your business is at home.

So, you know, right now it's a small percentage, you know, probably single digit percentage at this point. And you know, it's our, our anticipation that that will continue to grow. You know, we think the overall at home market is probably going to be about 10 to 15% here in the near term in the overall hemodialysis market.

Okay, great. Thank you so much. Appreciate it.

Thanks, Anthony.

There are no further questions. I will now turn the call back over to Dr. Strobek.

Thank you for joining us today for an update on Rockwell Medical and we look forward to providing you with more updates in the next quarter.

This concludes today's call. You may now disconnect.