Rockwell Medical, Inc. Stock

Good morning, and welcome to Rockwell Medical's Third Quarter 2026 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 Laura Guerrant, Rockwell Medical's newly appointed Executive Director of Investor Relations. Laura, please go ahead.

Good morning, everyone, and thank you for joining us for this update on Rockwell Medical. I'm thrilled to be joining you today as Rockwell Medical's new Executive Director of Investor Relations. I look forward to working closely with our investment community and partnering with you moving forward.

Joining me on today's conference call are Dr. Mark Strobeck, Rockwell Medical's President and CEO; and Jesse Neri, 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 10-K 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 10-Q for the 3 months ended September 30, 2026, was filed prior to this call. The reconciliation of non-GAAP measures we discuss on today's call can be found in today's press release. Our Form 10-Q and other reports filed with the SEC, along with today's press release and a replay of today's conference call, can be found on Rockwell Medical's website under the Investors section.

And with that, I will turn the call over to Rockwell Medical's President and CEO, Dr. Mark Strobeck. Mark?

Thank you, Laura, and good morning, everyone. Thank you for joining us today for Rockwell Medical's Third Quarter 2026 Earnings Conference Call and Webcast. We are excited to welcome Laura, who recently joined us as our new Executive Director of Investor Relations. Laura brings to Rockwell more than 30 years' experience in Investor Relations and capital markets, especially within the healthcare sector. Laura now leads our Investor Relations function and will serve as a key liaison between Rockwell Medical and our shareholders, analysts, prospective investors and the broader investment community.

This morning, our remarks are organized around 3 key topics: 1, the continued execution of our plan for our core hemodialysis business; 2, the future impact of our pending acquisition of Vantive's global hemodialysis business; and 3, the potential opportunity inherent in the new U.S. Health and Human Services Kidney Care National Plan.

During the third quarter 2026, we continued to grow our core hemodialysis concentrates business through customer acquisition, geographic expansion, enhanced customer retention and disciplined pricing. This resulted in net sales of $19.1 million for the third quarter 2026, which represented a 20% increase over the same period in 2025. During his remarks, Jesse will review our third quarter 2026 financial results in greater detail. The hemodialysis market continues to evolve as several industry participants adjust their product portfolios and operations.

Additionally, there have been publicly disclosed FDA recalls involving certain dialysis products manufactured by other suppliers. Against that backdrop, we continue to focus on being a reliable supplier and delivering high-quality products. We believe this focus on quality and reliability continue to support our customer relationships and net sales growth. It's how we win business and how we keep it.

During the third quarter, we saw increased demand from our existing customers, including the top 5 major dialysis providers in the United States. As a result, we maintained solid upward momentum across our business, driven by robust market demand and disciplined execution. Today, we serve approximately 300 customers while also supplying products to more than 30 international markets through third-party distributors. We continue to have productive discussions with some of our largest customers regarding opportunities to expand our existing relationships and increase product volumes. We will provide updates when appropriate.

The second topic we would like to discuss is the Vantive acquisition. Last week, we announced that we entered into an equity and asset purchase agreement with Vantive Limited, under which we will acquire Vantive's hemodialysis concentrates, hemodialysis machines, water treatment systems and related consumables and technical services business. In addition, we will acquire Vantive's state-of-the-art 1 million square foot manufacturing campus in Medolla, Italy. This acquisition will broaden our portfolio within the hemodialysis sector beyond concentrates and will also add established international customer relationships, distribution capabilities, technical expertise and a global manufacturing footprint.

Together, these capabilities will expand the scale, scope and strategic reach of Rockwell Medical, creating a more diversified global hemodialysis platform with the ability to serve customers across a broad range of products and geographies. This acquisition is transformational for us. By bringing these 2 businesses together, we have the opportunity to form one of the world's leading hemodialysis medical device manufacturers and suppliers with a scale and global presence that would otherwise take years to build organically.

Upon closing, we estimate that the combined business will bring together a global workforce of more than 1,000 employees across more than 36 countries. Based on the current revenue profile of the 2 businesses, we expect the combined business to generate annual revenue between $400 million and $450 million, approximately 90% of which is expected to be reoccurring.

Between signing and closing, which remains subject to customary closing conditions and regulatory approvals and is currently expected to occur in mid-2027, our priorities are clear. The transaction contemplates a transition services agreement and manufacturing and supply agreement with Vantive to support the orderly transition of the business, especially with respect to employees, customers, systems, processes, manufacturing, product registrations and distribution.

We plan to work closely with Vantive and focus on continuity of supply along with support for customers, patients and employees throughout the transition. At the same time, we will be preparing Rockwell Medical to operate as a larger, more global organization following closing. We look forward to keeping you updated as we continue to make progress.

Lastly, I want to touch on the Kidney Care National Plan announced last month by HHS. The plan is built around 3 priorities: 1, preventing kidney failure; 2, improving dialysis care and expanding patient choice; and 3, reforming transplantation. Specifically citing the announcement, the plan identifies where federal action can improve kidney care across the entire spectrum of kidney disease, eliminate regulatory barriers to support innovation in a well-functioning kidney market and deliver greater choice and superior outcomes to patients in the United States.

For Rockwell, the most compelling aspect of this announcement is the plan's continued focus on restoring competition in dialysis care. HHS describes a market weakened by decades of regulation that too often protects incumbents rather than patients. And the plan sets out to remove barriers that inhibit competition and innovation, and to reduce barriers to entry for new providers and treatments. The plan emphasizes innovation, patient choice and access to dialysis care, including home-based care. We view this as a positive step for both patients and providers.

Additionally, we believe this presents a long-term opportunity for Rockwell Medical as the care model evolves because our products support hemodialysis wherever patients receive care, whether in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities or a patient's home. Our goal within this ecosystem is straightforward: be where the patients are, whether that is at home or in the clinic. We provide reliable service, high-quality products and continuity of supply to the customers and patients who depend on us for our life-saving hemodialysis products so that patients have more choices in how and where they receive care.

Our core concentrates business, together with the broader capabilities we expect to add through Vantive transaction present an opportunity to strengthen our ability to fulfill that role across a larger and more diverse hemodialysis sector. This initiative leverages our core strength, and we fully support HHS in the endeavor to revitalize American Kidney Care.

With that, I'll now turn the call over to Jesse.

Thank you, and good morning, everyone. Net sales for the 3 months ended September 30, 2026, were $19.1 million, representing a 20% increase over net sales for the same period in 2025. The increase was primarily driven by sales to new customers in the West and larger purchasing volumes from existing customers, particularly the top 5 dialysis providers in the U.S., all of which are current Rockwell customers. For the 9 months ended September 30, 2026, net sales were $54.2 million, which represents a 7% increase over net sales for the same period in 2025.

Gross profit for the third quarter was $3.1 million, which represents a 37% increase over gross profit for the same period in 2025. Gross profit for the 9 months ended September 30, 2026, was $9.3 million, which represents an 18% increase over gross profit for the same period in 2025. Gross margin for the third quarter was 16%, which represents an increase from 14% for the same period in 2025. Gross margin for the 9 months ended September 30, 2026, was 17%, which represents an increase over 15% for the same period in '25.

It's important to note that the gross margin was also negatively impacted during the third quarter by higher freight, material and supply costs, all of which were driven in part by increased diesel costs. We continue to optimize our supply chain to mitigate the impact of these cost pressure variables on our operating performance.

Moving down the income statement, our net loss for the third quarter was $2.3 million, which was driven by approximately $800,000 in acquisition-related expenses compared to a net loss of $1.8 million for the same period in 2025. For the 9 months ended September 30, 2026, net loss was $5.1 million compared to $4.8 million for the same period in 2025. Adjusted EBITDA for the third quarter 2026 was a negative $300,000 compared to adjusted EBITDA of $50,000 for the same period in 2025. For the 9-month period of 2026, adjusted EBITDA was negative $700,000 compared to a negative $600,000 for the same period in 2025.

Cash, cash equivalents and investments available for sale at September 30, 2026, was $22.5 million, which represents a decrease from $24.8 million at June 30, 2026. The decrease in cash was primarily driven by normal increases in accounts receivable and prepaid expenses as well as equipment purchases to further automate our production lines.

We have withdrawn all full year 2026 guidance, including net sales, gross margin, adjusted EBITDA and operating cash flow in consideration of the pending Vantive HD business acquisition and related expenses incurred during the third quarter and related expenses expected to be incurred during the fourth quarter of 2026.

Now I'll turn the call back over to Mark.

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

[Operator Instructions] Your first question comes from the line of Ram Selvaraju with H.C. Wainwright.

Congratulations on all the recent progress. I was wondering if you could just provide us with some additional clarity regarding the integration of the Vantive organization and, in particular, what initiatives you expect to be able to take to accomplish the following 3 objectives. Firstly, maintain organizational efficiency across the combined infrastructure; secondly, ensure maximal retention of existing customers for that business; and thirdly, optimize any potential cross-selling and synergies that might be extractable or achievable over the course of the coming months and quarters once the acquisition has been finalized.

Thank you, Ram. So, the integration activities that we've already begun are going to be critical for us to not only integrate the business into the Rockwell platform, but then also to maintain continuity of supply to both existing sets of customers, those that are at Rockwell and those that are currently being serviced today with Vantive.

Vantive has been a tremendous partner to us through this process. We are going to continue to work alongside them hand-in-hand over the course of the next 6 to 9 months until we're able to close the transaction, building a plan that I, think, efficiently and effectively allows us to integrate their business into ours making sure that we continue to maintain that important supply that patients now across the globe rely upon.

We are going to continue to look at both of our businesses as a way in which to identify not only areas of synergies, but then also areas of efficiency that we're going to look to capitalize on. I think the benefit of being in a smaller organization now looking at a bigger organization is that we've been able to build into our system significant efficiencies that we think we can apply into that larger organization, which I think will ultimately benefit the combined business.

Now that the announcement has been made around the transaction, we are getting a number of calls from our existing customers, looking at ways in which they can access the broader now portfolio of products that we will now have under one roof. And whether that is additional access to concentrates in the bicarb cartridge up to machines and blood tubing sets and some of the other consumables that are coming along with this transaction, we think there's a rich opportunity for us to take advantage of that. And we've already begun the process of talking to customers about those, that combined product portfolio.

And then with respect to the possibility of revamped guidance across the combined organization, can you give us a sense of the timing with which you anticipate being able to provide such guidance? And what additional metrics, if any, you expect to be able to provide given the changes that are envisaged?

Thanks, Ram. We expect to give guidance for full company after the 10-K is released, and we do that end-of-the-year announcement. So sometime in March, we'll provide an estimate typically the same sort of guidance we've been given.

[Operator Instructions] There are no further questions. I will now turn the call back over to Dr. Strobeck.

Thanks. As we conclude today's call, I want to leave you with 2 thoughts. First, our core hemodialysis concentrates business continues to perform well. We are growing sales, maintaining a sound balance sheet and executing every day for the customers and patients who rely on us for our high-quality products and dependable supply. Second, the pending acquisition of Vantive's global hemodialysis business marks an exciting new chapter for Rockwell Medical. The transaction has the potential to accelerate our growth by building on our core hemodialysis concentrates business, expanding our global portfolio of hemodialysis products and creating new opportunities for innovation in renal care.

We believe these capabilities will position Rockwell Medical to become a leading global hemodialysis company. We look forward to updating you when we have more to share about the Vantive acquisition and our progress towards closing. Thank you for your continued support.

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

Good morning, and welcome to Rockwell Medical's conference call and webcast. Please note, this event is being recorded. At this time, I would like to turn the conference call over Heather Hunter; Senior Vice President and 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 is Rockwell Medical's President and CEO, Dr. Mark Strobeck; and Jesse Neri, Rockwell'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 10-K and our subsequent periodic reports filed at the SEC.

These statements are subject to risks and uncertainties that could cause actual results to differ materially. 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 subsequent periodic and current reports filed with the SEC, including the current report on Form 8-K filed in connection with the transaction and the exhibits thereto and the press release relating to the transaction. Our reports filed with the SEC, along with today's press release and a replay of today's conference call and webcast can be found on Rockwell Medical's website under the Investors section. Now I will turn the call over to Mark Strobeck, Rockwell Medical's President and CEO.

Thank you, Heather, and good morning, everyone. This morning, we announced that Rockwell Medical has entered into an equity and asset purchase agreement with Vantive Limited to acquire Vantive's global hemodialysis concentrates, hemodialysis machines, including the AK98, water treatment systems, related consumables and technical services business. Based on the current projections, we estimate that the combined business could generate annual revenue between $400 million and $450 million, 90% of which we expect would be recurring.

In addition, Rockwell expects to acquire Vantive's 1 million square foot state-of-the-art manufacturing campus in Modola, Italy and additional assets around the globe. This is a transformational transaction for Rockwell Medical, and we are incredibly excited to bring these 2 businesses together to form one of the world's leading hemodialysis medical device manufacturers and suppliers. This acquisition is expected to close in the middle of 2027, subject to receipt of required regulatory approvals and the satisfaction or waiver of the other closing conditions set forth in the agreement. Four years ago, we initiated a turnaround of Rockwell Medical's business. When we set out on this mission, we highlighted 3 critical phases of company development that would frame our long-term strategy. First, eliminate non-core activities and refocus Rockwell on its core expertise in manufacturing and distributing hemodialysis products to grow the core business and develop Rockwell into a sustainably profitable platform. We successfully completed this first phase in the second half of 2024 and have maintained the underlying profitability profile of our core operations, excluding transaction-related expenses associated with the acquisition.

Next, our plan calls for us to leverage our more stable platform to expand into new HD product opportunities in global markets and build a larger global renal care portfolio. And then finally, once we are a larger globally recognized leader in the renal care space, we plan to turn our attention to more novel, innovative technologies and therapies that drive higher margins and seek to have a meaningful impact on patient care. Our acquisition of Vantive's hemodialysis business is expected to accelerate the second phase of our development in a single transaction and rapidly accelerate our development into a leading global renal care company.

I want to walk you through why we believe this transaction is truly transformational for Rockwell Medical. This transaction fundamentally changes the scale, scope and strategic profile of our company. It transforms Rockwell Medical from a primarily U.S.-based hemodialysis concentrates business into a vertically integrated globally scaled hemodialysis platform with a broader product portfolio and international manufacturing and distribution footprint, a larger installed base and multiple streams of recurring revenue.

First, the transaction substantially broadens the hemodialysis solutions we can offer dialysis providers. In addition to our core liquid and dry concentrates business, Rockwell Medical will add additional dry concentrate cartridges and additional concentrate formulations. We will add hemodialysis machines, including the AK 98, related parts and consumables, water treatment systems, including the CWP-100 and CWP-800 and a global technical services team. These are highly complementary products and capabilities that have the potential to expand our role within the hemodialysis treatment ecosystem and deepen the value we can deliver to customers.

This product portfolio also changes the nature of our revenue base. We will no longer be principally dependent on the sale of hemodialysis concentrates alone. The acquired hemodialysis machine installed base of approximately 100,000 machines creates ongoing demand for related consumables, replacement parts, technical services and other aftermarket support. Together with our concentrates business, these offerings are expected to provide a larger and more durable base of recurring revenue tied to the ongoing delivery of hemodialysis treatments.

Second, the transaction gives Rockwell Medical a global operating platform that would take years to replicate organically. Rockwell is already 1 of 2 major U.S. manufacturers and suppliers with the production capacity, scale and transportation infrastructure required to serve the hemodialysis concentrate needs of the U.S. dialysis market. Through this acquisition, we have the opportunity to combine our strong domestic position with established international products, customer relationships, distribution capabilities and technical expertise into Canada, Europe and Asian Pacific area.

A central component of that global platform is Vantive's manufacturing campus in Modola, Italy. Subject to the terms and conditions of the agreement, we expect to acquire this 1 million square foot state-of-the-art campus, which is located within the Mirandola Biomedical District, the third largest med tech region in the world. This site currently manufactures dry concentrate cartridges, hemodialysis machines, related parts and consumables and water treatment systems supporting the broader hemodialysis portfolio. The Modola campus provides us with an immediate European operating presence, specialized manufacturing and distribution capabilities, established technical expertise and infrastructure supporting a broader global customer base. When combined with the continued ramp-up of our fully automated concentrate production lines in the United States, we believe the expanded manufacturing network will enhance our scale, operating efficiency and ability to compete as a reliable global supplier.

Third, this transaction brings together complementary products, customer relationships, operating capabilities and technical expertise under one organization. The result will be a more diversified and scalable renal care company with a stronger ability to support customers across products, geographies and stages of the hemodialysis treatment process. It will also strengthen our ability to provide the quality, reliability, technical support and continuity of supply that dialysis providers and patients depend on every day. Importantly, this is not diversification away from our core. It's an expansion of our core.

Hemodialysis concentrates are our foundation, and this transaction allows us to build outward from that position into complementary products and services that are sold to many of the same customers used within the same treatment environment and supported by many of the same commercial and operational capabilities. The combined businesses will, therefore, have greater product breadth, significantly expanded international reach and a more diversified mix of recurring revenue streams. We believe this creates a stronger platform for profitable growth, innovation and long-term shareholder value. Finally, continuity will be critical priority throughout this transition. We are committed to working closely with Vantive to support customers, patients and employees and to maintain reliable access to the products, services and technical support on which care providers depend.

In summary, this transaction is transformational because it changes Rockwell's scale, geographic reach, product breadth, manufacturing footprint and revenue profile, all while remaining firmly centered on the hemodialysis market we know well. It positions us to move from being a leading U.S. concentrate supplier to becoming a broader, vertically integrated and globally relevant hemodialysis company. I'm now going to turn the call over to Jesse to walk through the financial terms of this transaction.

Under the terms of the agreement, the aggregate base purchase price is $125 million, subject to customary adjustments. Vantive will provide financing through two $50 million term loans plus a $25 million convertible note. Vantive may also receive up to $45 million in contingent consideration tied to specified revenue and EBITDA milestones. If achieved, these payments will be made over several years. Tranche A, the first of the 2 seller finance notes has a 6-year term and an initial interest rate of SOFR plus 550 basis points. The rate increases by 75 basis points annually. Tranche B also has a 6-year term with an initial interest rate of SOFR plus 700 basis points. This rate also increases by 75 basis points per year.

Neither term loan carries a prepayment penalty, and we believe the seller finance structure helps align Rockwell and Vantive's objectives. The $25 million convertible note will have an initial conversion price set at a 100% premium to the 15-day volume weighted average price or VWAP of our common stock at the time of signing. We believe this premium reflects the underlying value of Rockwell Medical. As Mark mentioned, we expect the combined enterprise to generate annual sales of $400 million to $450 million with approximately 90% forecasted to be recurring revenue. We expect the combined business will generate sufficient cash to meet its financing obligations. As disclosed in this morning's press release, we are withdrawing our 2026 guidance for net sales, gross margin, adjusted EBITDA and operating cash flow due to transaction-related expenses expected in the third and fourth quarters.

I will now turn the call back over to Mark for closing remarks before we open up the call for questions.

Thank you, Jesse. With today's announcement, we embarked on an exciting new chapter for Rockwell Medical. This transaction has the potential to significantly accelerate the next phase of our growth by adding product breadth, global distribution, manufacturing, research and development infrastructure, technical services and a broader, more diversified customer base. Between signing and closing of this transaction, Rockwell Medical will work in partnership with the Vantive team to build and successfully execute an integration plan and support an orderly transition and continuity of supply at close and beyond. It is important to note that we will have transition services agreements and manufacturing and supply agreements in place with Vantive to support the transition of the business, including with respect to employees, customers, systems, processes, manufacturing, product registrations and distribution.

Following the closing, we believe the complementary products, capabilities and expertise of these hemodialysis businesses can create a stronger, more scalable global renal care platform with a broad product portfolio, greater international reach and enhanced opportunities to serve dialysis providers and patients. We look forward to keeping you updated in the coming months as we move towards closing this transaction. With that, I'll conclude the formal remarks and turn the call over to our operator to open the line for questions.

[Operator Instructions] please note that Rockwell Medical will only be taking questions specific to today's announcement. The company will not answer questions related to Rockwell Medical's financial performance for the 3 and 9 months ended September 30, 2026. The company will address those questions on its earnings call, which is scheduled for Thursday, November 12. Your first question comes from the line of Ram Selvaraju with H.C. Wainwright.

This is [indiscernible] sitting in for Ram.

I have 3. The first is, given the seller finance structure and the expectation that the combined business is going to generate sufficient cash to meet its financing obligations, how should we think about Rockwell's pro forma liquidity position and cash runway? And do you anticipate needing additional capital to support integration or ongoing operations?

Yes. So as of right now, we do not need additional cash to support operations between signing and close. We are contemplating financing structures that could be beneficial here for us post close. But as of right now, we are sufficiently funded to get through this period of time.

Got it. And beyond the transition period, do you anticipate maintaining an ongoing commercial relationship with Vantive? And do you think Vantive for example, might remain a customer of Rockwell's hemodialysis business following this transaction?

Yes. The plan is that post closing that we will both be a customer of theirs and [ vice versa ] they will be -- and we will be a supplier of theirs as well.

Got it. This is my last one. And you mentioned that the acquired products serve many of the same customers and significantly expand your international reach. Do you see an opportunity to introduce Rockwell's legacy concentrate products into Vantive's existing customer base, particularly with respect to international markets? And how significant could that opportunity become you think?

Yes. I actually think it's -- for us, they manufacture a set of concentrate products that are very similar to the ones that we manufacture here in the United States. So I think where the opportunity lies is actually introducing the other components of the Vantive portfolio into our existing customer base here in the United States. And I think that is a pretty significant opportunity. We haven't -- we're not releasing that information yet, but we think the cross-selling opportunities within our existing customer base is significant, and I think can provide an opportunity for growth.

[Operator Instructions] your next question comes from the line of Jeremy Pearlman with Maxim Group.

Maybe just first, how does the acquired Vantive business or the potential acquired business, how does maybe the gross margins and the EBITDA margins compare to Rockwell currently? Will they be accretive from the get-go? Or there's going to be some time to bring them up to levels or above what Rockwell is seeing at?

Thanks for the question. The acquired product groups have similar margins to what Rockwell is currently at, although we do think there is some upside there once we take over the business.

Okay. Understood. And also maybe what's the competitive landscape like globally? We've been focused -- you've been focused pretty much predominantly in the U.S. So we're familiar with that market and the big players there. And who are some of Vantive's top competitors? What are the regions that their largest customer base is from or that they sell to? And where do you see the biggest potential for expansion beyond that?

Yes. So in the regions outside of the United States, there are a number of large players that service and complete hemodialysis procedures, such as the companies that we are current competitors of ours. And so you've got big suppliers like B-Braun, you've got big suppliers like Nipro. So those are all present within the global market. In a number of the countries outside of the United States, those treatments are provided through government tenders.

And so Vantive brings a number of tenders that are in place within the 35-plus territories that we are acquiring that are contracts that cover all of the products that we currently -- well, will currently manufacture and sell. In addition, the they have a machine installed base of 100,000 machines that I think has an opportunity for us to grow that installed base as well as to leverage off of that installed base to continue to grow the opportunity.

And so we're looking to access that and enhance the HD products we sell within those centers that have machines that are currently installed. So we think there's -- overall, we think there's a tremendous opportunity to grow this business. And we think with the expertise that we have, the resources that we intend to provide to support this business that we'll be able to grow it beyond what our current projections are.

Okay. Understood. And then just last question from us. What do you think maybe the biggest operational challenges you can anticipate integrating these businesses together? And then will you -- I think you mentioned -- I'm not sure just a follow-up. Did you mention earlier in the call that you will be keeping the existing Vantive management team? Or is there any other management capabilities and infrastructure that you'll have to build out post the close?

Yes. So where we're focused right now is working with Vantive to build a comprehensive integration plan and strategy. That's where all of our attention and focus is going to be making sure that at the time of close in day 1 that we are in a position to be able to take on that business. So our teams are working and we'll work with Vantive quite closely to help us to do that. As it relates to particularly the manufacturing site in Modola, we think this is a great opportunity to make that site a center of excellence for us as we look to continue to develop the products that we have, add new products and expand into the territories that we are currently supporting. It's a state-of-the-art manufacturing facility with a tremendous team of experienced professionals that are joining Rockwell and going to become part of the Rockwell family. We're super excited to have them be a part of the organization and to discuss ways in which to build and enhance that facility. to support our global operations. So it's a super exciting addition for us.

We have reached the end of our Q&A session, and this concludes today's call. Thank you for attending. You may now disconnect.

Thank you. Good morning and welcome to Rockwell Medical's second quarter 2026 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, everyone, and thank you for joining us for this update on Rockwell Medical. Joining me on today's conference call are Dr.Mark Strobeck, Rockwell Medical's President and CEO, and Jesse Neri, Rockwell Medical's CFO. 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 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 this concept is 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 10-Q for the 3 months ended June 30, 2026, was filed prior to this call and provides a full analysis of the company's business strategy, as well as the company's second quarter 2026 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-Q and other reports filed with the SEC along with today's press release, our updated investor presentation, and a replay of today's call can be found on our website under the investor 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 second quarter 2026 earnings conference call and webcast. The second quarter was another important step forward for Rockwell Medical. We delivered strong year-over-year growth, continued to expand gross margin, generated positive operating cash flow, strengthened our customer portfolio, and advanced the operational initiatives that we believe will continue to drive long-term shareholder value.

As a result, we remain on track to achieve our full-year 2026 guidance while continuing to execute against our strategy for further growth in the years ahead. When I think about where Rockwell is today compared to just a few years ago, the difference is significant. Our focus over the last several years has been straightforward: to build a strong business, improve profitability, generate cash, diversify our customer base, increase operational efficiency, and establish a foundation capable of supporting long-term growth.

Those objectives have driven nearly every strategic and operational decision we have made. Today we are seeing tangible evidence that those efforts are working. During the second quarter, net sales increased 11% compared to the prior year period, driven by continued customer growth, increased purchase activity from existing customers, and the impact of pricing actions implemented across portions of our portfolio. Gross profit increased and gross margin expanded to 18%, reflecting higher volumes and improved operating efficiency.

We also generated positive cash flow from operations and ended the quarter with a strong cash position. These results demonstrate continued progress in the execution of our strategy and further improvement in our financial performance. Perhaps equally important, these results are not driven by 1 single customer, a 1-time initiative, or a short-term event. They're being generated through disciplined execution across the organization. A key component of our strategy has been creating a more diversified and durable revenue base.

We currently serve approximately 300 customers, including all 5 major U.S. dialysis providers, while also supplying products to more than 30 international markets. Over time, we have worked deliberately to reduce customer concentration and increase the percentage of business conducted under longer-term agreements that provide greater visibility and predictability. The second quarter included additional progress on this front. We announced a new agreement with Heritage Dialysis, the renewal of our long-standing relationship with Aqua Dialysis.

Both agreements reinforce our position as a trusted supplier and further strengthen the recurring nature of our revenue base. Importantly, these agreements also include annual pricing provisions that better align our products with the value we provide our customers. Our commercial momentum also continues to build in regions where we are investing significant effort. As a result, we continue to see meaningful growth in the western United States, as recently onboarded customers continue to transition business to Rockwell.

These wins are particularly important because they demonstrate our ability to compete successfully in new geographies while leveraging existing manufacturing and distribution infrastructure. We continue to remain the leading supplier of liquid bicarbonate concentrates and 1 of the largest overall providers of hemodialysis concentrates in the United States. We believe our products and services provide meaningful value, and our customers continue to depend on us to deliver high-quality products reliably and consistently in an environment where supply continuity is critical.

Another area where we are seeing encouraging progress is operational efficiency. We have invested substantial time and resources into improving our manufacturing footprint, streamlining operations, optimizing distribution, and implementing automation initiatives. Many of these projects required upfront investment and significant organizational focus. While they were designed to create long-term benefits, we are now beginning to see those benefits reflected in our financial results.

One of the clearest examples is the successful activation of two new automated liquid production lines which increase our manufacturing capacity, improve efficiency, reduce labor intensity, and lower production costs. As utilization continues to grow, we expect these and future investments to continue to contribute to margin expansion and profitability improvements over the coming years. Our objective is not simply to improve margins for a quarter or 2.

We are focused on creating structural advantages that support sustainable profitability over the long term. When we discuss our goal of achieving approximately 30% gross margins by 2029, that target is not based on a single initiative. It reflects multiple drivers working together, including higher volume, pricing discipline, increased automation, improved manufacturing efficiency, distribution optimization, and continued growth, operating leverage as the business grows. We believe the progress we delivered during the second quarter demonstrates that these initiatives are moving in the right direction.

Beyond our core concentrates business, we are also focused on creating future growth opportunities that are closely aligned with our existing renal care platform. During the second quarter, we incurred a modest amount of expense related to the evaluation and development of a new medical device opportunity that we believe complements our current product portfolio and leverages the commercial relationships, manufacturing expertise, and market knowledge we have built over many years.

Importantly, this is a measured investment that is being funded within our existing operating plan and does not alter our commitment to maintaining a strong balance sheet and positive operating cash flow. While it is still early in the process, we believe this opportunity offers an attractive way to expand our offerings while remaining focused on disciplined capital allocation and creating long-term shareholder value. We will provide additional updates as they become available. Looking ahead, our long-term growth strategy remains centered around 3 core pillars.

First, we will continue growing our core hemodialysis concentrates business through customer acquisition, geographic expansion, enhanced customer retention, and disciplined pricing. Second, we intend to broaden our portfolio with complementary renal care products that can leverage our existing infrastructure. Third, we will continue to evaluate innovations that improve the patient experience and expand our portfolio within the broader renal care ecosystem. Together, these initiatives support our goal of generating annual net sales in excess of $100 million by 2029 while continuing to improve profitability and cash generation.

Before I turn the call over to Jesse, I'd like to address our recently completed reverse stock split. We recognize that some investors may naturally compare this reverse stock split to actions taken during prior periods in the company's history, particularly those who have followed Rockwell for many years. However, it is important to recognize that the circumstances surrounding this reverse split are fundamentally different. The reverse stock split completed this year was undertaken to regain compliance with Nasdaq's minimum bid price requirement to increase interest from institutional investors and reassure customers' confidence in Rockwell.

While market conditions and trading dynamics contributed to Rockwell's share price performance, the reverse split was not driven by the need to raise capital, the deterioration in our operating performance, liquidity concerns, financial concerns, or change in our business outlook. Unlike prior periods, this reverse split was not undertaken in connection with nor will be followed by a capital raise. At the time of the split, Rockwell has demonstrated continued revenue growth, improving profitability, positive operating cash flow, expanded margins, and a strengthened balance sheet.

Since completing the reverse split, we have regained compliance with Nasdaq's listing requirements, and the matter has been closed. More importantly, today Rockwell is fundamentally stronger than it was several years ago. We have strengthened our balance sheet, improved profitability, expanded margins, diversified our customer base, generated positive operating cash flow, invested in automation, and established a clear strategic roadmap for future growth. We believe these accomplishments are what should define Rockwell Medical's, should be, or what should define today's Rockwell Medical.

We also continue to believe there is a meaningful disconnect between our current market valuation and the progress being made within the business. While markets ultimately determine value, our responsibility is straightforward. Execute our strategy, meet our commitments, communicate transparently, and continue to build a business that generates sustainable long-term returns.

We believe the best way to close that gap is through continued execution, and our team remains intensely focused on delivering results. As the second half of 2026 gets fully underway, we are encouraged by the momentum in the business. We believe our company is stronger operationally, healthier financially, and better positioned strategically than it has been in recent years. While there is still work to do, we are confident that the actions we have taken, combined with the opportunities ahead of us, position Rockwell Medical for continued growth and value creation. With that, I'll turn the call over to Jesse to review our second quarter 2026 financial results in more detail.

Thank you, Mark. Good morning, everyone. Net sales for the 3 months ended June 30, 2026, were $17.8 million, representing an 11% increase compared to net sales of $16.1 million for the same period in 2025. The increase was primarily driven by sales to new customers in the western United States, increased purchasing from existing customers, and annual pricing actions implemented across our portfolio. For the 6 months ended June 30, 2026, net sales were $35.1 million, which was in line with net sales for the same period in 2025.

While net sales for the 6-month comparative periods were consistent year-over-year, it is important to point out that the first half of 2025 sales included higher purchasing volumes from DaVita. Including DaVita, first half 2026 sales grew by more than 10% over the prior year. We also delivered sequential growth with Q2 2026 sales exceeding Q1, driven by increased purchases from existing customers. We believe that this trend provides a stronger indication of the direction of the business than the 6-month comparison alone.

Turning to profitability, gross profit for the second quarter was $3.2 million compared to $2.5 million in the second quarter of 2025, representing a 30% year-over-year improvement. Gross margin increased to 18% compared to 16% during the same period last year and 17% in the first quarter of this year. For the 6 months ended June 30, 2026, gross profit was $6.1 million compared to $5.5 million during the prior year period. Gross margin improved to 17% compared to approximately 16% during the first half of 2025.

We believe these results continue the positive margin trajectory we have discussed over the last several quarters and represent another step toward our full-year gross margin target of 18% to 22%. The increase in gross profit and gross margin reflects the benefit of lower manufacturing costs and operational efficiency initiatives implemented throughout the organization, including our most recent automation investments. These improvements are designed to create a more efficient cost structure and support long-term profitability.

As production volumes increase and asset utilization continues to improve, we believe there remains additional opportunity for margin expansion over time. Moving down the income statement, our net loss for the second quarter was $1.2 million compared to a net loss of $1.5 million during the second quarter of 2025 and $1.6 million for the first quarter of 2026. For the first 6 months of 2026, net loss was $2.8 million compared to $3 million during the same period in 2025. While we are not yet at our ultimate profitability objectives, these results demonstrate continued progress toward improving overall operating performance.

Adjusted EBITDA for the second quarter was a negative $200,000, consistent with the prior year period. For the 6-month period, adjusted EBITDA improved $200,000 compared to the first half of '25, the benefits of higher gross profit. As additional revenue and margin improvement initiatives take hold throughout the remainder of the year, we continue to expect adjusted EBITDA to improve and remain within our previously issued guidance range of $1 million to $2 million for the full year of 2026. Now let's discuss cash flow and liquidity.

One of the most encouraging aspects of our second quarter performance was the continued strength of our balance sheet and the ability to generate cash from operations. During the second quarter, the company generated approximately $2.1 million of cash from operations. This performance contributed to a quarter-end balance of $24.8 million in cash, cash equivalents, and investments available for sale. Importantly, this cash balance increased from $23.9 million at the end of the first quarter and remained generally consistent with our year-end 2025 position, despite continued investments in the business and the final payments associated with the Evoqua acquisition.

We have consistently stated that our primary financial objective is to achieve operating cash flow and position the business to fund its operations organically. The second quarter represents another important step toward that objective. We believe our strong cash position provides flexibility to support our growth initiatives, invest in operational improvements, pursue strategic opportunities, and continue to build long-term shareholder value. Based on our performance through the first half of the year and current business trends, we are reiterating our full year 2026 guidance.

We continue to expect net sales between $70 million and $75 million, gross margin between 18% and 22%, and adjusted EBITDA between $1 million and $2 million, and positive operating cash flow. As Mark noted earlier, we have met or exceeded our stated expectations for 3 consecutive years. While we remain mindful of the dynamic environment in which we operate, we are encouraged by the momentum we are seeing across the business and remain focused on disciplined execution during the second half of the year. In closing, our financial performance this quarter reflects a business that is becoming stronger, more efficient, and more predictable.

Net sales increased, margin expanded, operating cash flow strengthened, and our balance sheet remains healthy. We believe these results reinforce the effectiveness of our strategy and positions us well for continued progress as we move through the remainder of 2026. Now I will 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. [Operator Instructions] Please stand by while we compile the roster. Your first question comes from Nicholas Sherwood with Maxim Group. Please go ahead.

Good morning. Nick, I think we lost you. No, we can't hear you.

Hello?

Hello, we can hear you now. Go ahead.

So in the past you've spoken about expanding more into the West Coast. Can you talk about how it's been going building up your operations in that market?

Yes. So I think as we've spoken about previously, it's been a strategic objective of ours to expand our operations more directly in the West Coast as you know as of right now there is really primarily one supplier of concentrates in the West and we think there is a significant market opportunity for us to access as we announced at the beginning of the year, we had begun to take over a customer base that existed out in the West platform, and have now begun to supply those on a consistent and regular basis.

What that's doing is really opening up the opportunity for us and our sales force to go out and begin to start to talk to other customers in the West, letting them know that Rockwell is now present in that region, has a full suite of concentrates, that we manufacture and distribute and can now begin to start to supply them. We're seeing a lot of positive interactions out there. And we expect that business, that part of the business, to continue to grow.

Thank you for that detail. And then talking about contracts you've been signing with your partners, what do the renewal structures look like? Are these things that you'll be 2 to 3 year contracts? Will you be revisiting them with your partners well before they end a year before the end or like 6 months before the end? And like some of these renewal option mechanisms, when can these be triggered just so you can maybe have even more idea of consistent revenue timeline?

Yes. Our standard sort of supply agreement is approximately 3 years in length. It carries with it a set amount of prices for the products that they are purchasing. It has in it standard price escalators, depending on the products, depending on the volumes that they are purchasing and the increases that they expect over those years. And then typically, we begin discussing with those partners about 6 months in advance of the end of those agreements, you know, renewing those agreements, and, you know, given our performance, given their needs, you know, that's usually the right time for us to begin those discussions and then have translated into extensions of those agreements for longer periods.

Okay, understood. And then I know you said you'd provide more forthcoming details, but I'm going to ask a question about the medical device opportunity you mentioned earlier. Anyway, how should we think about how it's going to settle and, you know, compare with your current portfolio of products? Is this going to be something that's going to be easily bundled with your current products? Either enhance their efficacy or efficiency, or is this more of something where it's going to be depending on your partner? This is going to be something that's going to be applicable to them, and it'll also be able to be used with your current product base.

Yes, so as we've spoken about previously, we've been looking for opportunities for us to in particular fold into our existing product portfolio that we think targets a large enough market opportunity to make it worth the investment for us to develop, ultimately register, and begin to start to sell and distribute a product. We've looked at a number of different opportunities. And this is 1 that we feel very strongly about that the data supports that if we are able to develop this product, register it, and begin to distribute it, really targets a large opportunity, folds directly into the current portfolio of products that we make. We would be potentially the only other supplier of this type of product in the United States.

And I think that offers a pretty significant opportunity for us. So with all of that analysis behind it, we took the decision to begin the process of developing that product. And as I mentioned in the discussion, this will be entirely funded by our balance sheet. We don't need to go out and raise additional funding to support this. We think we can do it based on our current operating plan. And that also makes it equally attractive to us.

Okay, yes, great. Thank you for all those details. I'll return to the queue.

Your next question comes from Ram Selvaraju with H.C. Wainwright. Please go ahead.

Good morning. This is [ Katie ] on for Ram. Beyond the manufacturing costs and volume drivers you've called out, is there a product mix component to the West Coast growth and to your path towards the high end of the 18% to 22% margin guide? On top of that, what's the plan to keep growing that Western business from here?

So in terms of the product mix, I could help that. The Western product is more skewed towards our liquid products, which as you know we are the leading manufacturer of. So that's generally, it's a higher margin profile, but in terms of customers, I'll turn it over to Mark.

Yes. And then I think as far as, you know, continuing to expand our customer base out in the West, you know part of that is you know I think educating you know dialysis centers that are present in the West that Rockwell is you know now present now manufacturing products and has a path to distribute those products in that region. So it's really us going out and starting to more aggressively meet with those clinics, whether it's a large clinic or it's a medium dialysis organization letting them know that there is an alternative out there to the single provider that they've been largely locked into having to buy products from, and that's our path to continue to grow.

Obviously the success of our supply and the customers that we currently have is also starting to ripple through the marketplace. And so the combination of those 2, I think are going to be incredibly important and helpful for us to drive growth further in the West.

Great. If I could, 1 quick follow-on. For that incremental volume growth, I think you sort of alluded to it, does that carry a margin similar to the corporate average, or are you seeing any kind of dilution by the freight onboarding costs as this business matures?

So for the incremental growth that we've seen over the quarter, that is consistently higher than the corporate average.

Great. Thank you. We have reached the end of the Q&A session. I will now turn the call back over to Dr. Strobeck for closing remarks.

As we conclude today's call, I want to reiterate that our focus remains unchanged. Growing revenue, expanding margins, generating positive cash flow, and creating long-term value for our shareholders. The results we've reported today reflect the progress we are making against those objectives, including revenue growth, improved profitability, and improved performance. continued operational efficiencies, and a strong cash position.

While we remain focused on executing our strategy, we are confident that the actions we have taken combined with the opportunities ahead of us position Rockwell Medical for continued growth and value creation. We appreciate the continued dedication of our employees, the trust of our customers, and the support of our shareholders. We look forward to updating you on our progress in the quarters ahead.

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

Hello, everyone. Thank you for joining us and welcome to Rockwell Medical's First Quarter 2026 Results Conference Call and Webcast. Please note, this event is being recorded. At this time, I would like to turn the conference 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 Strobeck, Rockwell Medical's President and Chief Executive Officer; and Jesse Neri, 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 10-K 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 10-Q for the 3 months ended March 31, 2026, was filed prior to this call and provide the full analysis of our business strategy as well as the company's first quarter 2026 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-Q and other reports filed with the SEC along with today's press release are updated in investor presentation and a 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 for Rockwell Medical's First Quarter 2026 Earnings Conference Call and Webcast. When we set out to transform Rockwell nearly four years ago, our goal was to establish Rockwell as a financially sound, profitable, well-capitalized company that was well positioned for future growth.

We believed Rockwell could consistently generate cash. And with that cash, make investments in new product categories that would diversify our portfolio, further growing Rockwell. While it hasn't been a straight line over those four years, we have consistently grown our gross margin and gross profit, and in the last two years, we achieved profitability on an adjusted EBITDA basis, an important proxy on profitability for Rockwell as it removes noncash items, nonoperating items, restructuring costs and other items that are not part of our core concentrates business.

Fast forward to today, Rockwell is a sustainably profitable, stable company. As we work to further expand our efforts around improved gross margin and profitability, we announced this morning that we are making additional changes to our operations, which I will expand upon shortly. With these additional changes, our goal is to achieve positive net income in the second half of 2026, subject to customary risks and uncertainties that could cause actual results to differ materially.

Now let's review our financial and operational performance for the first quarter 2026. We continue to experience high demand for our products, particularly for our liquid bicarbonate concentrates as we have now become the primary supplier of liquid bicarbonate in the United States. Net sales were higher than expected in Q1. And although net sales were lower compared to the same period in 2025, that reduction was due to our then largest customers' volumes declining.

In addition, we demonstrated gross margin improvement over the same period last year with comparable gross profit. We believe that this demonstrates improved efficiency in our manufacturing and distribution of our hemodialysis products. In fact, we experienced sequential growth each month during the first quarter of this year in gross margin, gross profit, adjusted EBITDA and net income.

We expect that trend to continue in the coming months. During the first quarter, we added several new customers and renewed contracts with existing customers, improving price and product mix. Today, our customer mix is diverse with most customer sales concentrations under 10%.

Rockwell currently serves approximately 300 customers, which represents more than 1,400 facilities, highlighted by all five of the leading dialysis providers in the United States, 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. 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 their hemodialysis products. We believe our diverse customer mix positions us well for sustainable growth and expansion.

During the first quarter, we spent a considerable amount of effort setting into motion operational changes that we believe will further streamline and enhance our manufacturing and distribution efficiencies. These changes are designed to enhance profitability by further reducing the overall cost to make and distribute our products.

For example, we are activating two new automated liquid lines this quarter, which we anticipate will generate an approximate 50% increase in our output and a significant reduction in our manufacturing cost per bottle. We have also made adjustments in our pricing, which reflect the value of our products.

All of these changes will be in place and be reflected in our results starting in the second quarter, positively impacting our performance in 2026. In fact, we estimate that these modifications will result in an additional $3 million of gross profit, approximately half of which we expect to realize in 2026. For 2026, we continue to be focused on growing our business.

We plan to grow revenue by adding new customers and expanding contracts with existing customers, improving our operational efficiencies and further enhancing our profitability. Today, we announced additional guidance beyond what we provided several weeks ago during our last earnings call.

Rockwell Medical projected that our 2026 annual guidance will be as follows: Net sales will be between $70 million and $75 million. Gross margin will be between 18% and 22%. Our business will be profitable. We estimate adjusted EBITDA will be between $1 million and $2 million, and operating cash flow will be positive, meaning we will generate cash and eliminate our need to raise additional capital to fund our operations.

As a reminder, we started issuing guidance three years ago and have met or exceeded expectations each of those three years. For 2026, as new opportunities arise, we anticipate that our projections have the potential to strengthen, reflecting Rockwell's 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: growing our profitable hemodialysis concentrates business, serving dialysis centers in the United States and around the world, building a broader portfolio of renal care products that integrate seamlessly into our existing commercial, manufacturing and distribution infrastructure, expanding our foothold within the renal space by pursuing innovations that can drive improved treatment options and outcomes for patients.

By 2029, we believe that we will be well positioned to generate annual net sales above $100 million. Gross margin will continue to trend upward potentially approaching 30%, and our business will be profitable on an annual basis in the range of $5 million to $10 million. These are our goals, and we believe we have a clear path to achieve them.

Now I will turn the call over to Jesse to review our first quarter 2026 financial results in more detail.

Thank you, Mark. Good morning, everyone. Net sales for the first quarter were $17.3 million. While this represents an 8% decrease over net sales for the same period in 2025, our Q1 results exceeded our expectations and track toward our full year 2026 estimate of $70 million to $75 million. Gross profit for the first quarter 2026 was $2.9 million, in line with gross profit for the same period in 2025. Gross margin for the first quarter 2026 was 17%, representing a slight improvement over gross margin of 15% for the same period in 2025.

This demonstrates that we continue to become more efficient at manufacturing our products. We expect gross margin for the full year 2026 to be between 18% and 22%. Net loss for Q1 2026 was $1.6 million, representing a slight increase over a net loss of $1.5 million for the same period in 2025. Adjusted EBITDA for the Q1 2026 was a negative $300,000, which was a slight improvement over adjusted EBITDA of negative $400,000 for the same period in 2025. Seasonal items associated with payroll tax and other public company-related expenses incurred in Q1 historically drive our adjusted EBITDA to be slightly negative. Cash, cash equivalents and investments available for sale at March 31, 2026, was $23.9 million compared to $25 million at year-end.

The decrease in cash of approximately $1.1 million was driven by seasonal items historically incurred in the first quarter as well as a $500,000 payment associated with our Evoqua acquisition. The final Evoqua payment was made in April.

Our cash balance continues to provide a stable foundation for our business while providing growing capital to pursue strategic objectives.

Now I'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. [Operator Instructions] Your first question comes from the line of Jeremy Pearlman with Maxim Group.

Just a couple of questions from us. Meaning you mentioned on the call that you had -- you were selling in 30 countries outside the U.S. Maybe talk a little bit about what other expansion opportunities are there? And what does the margin profile look like outside of the U.S. versus in the U.S.

Yes. Thanks, Jeremy. Yes, we continue to see strong demand for our products outside of the United States particularly in areas of Latin America and South America. For us, that product category is very attractive in part because we sell our products through distributors who are primarily responsible for the distribution or the cost of the distribution of those products. So our margins are typically higher in that product category. We don't -- we don't provide the details around that, but it's a very attractive business for us.

Okay. That's great. And then maybe while we're also talking about expansion, I know on the last call, you mentioned that you had 30 new customers, I think, roughly 30 new customers out West. I know that's also been on the radar for a while. Maybe any update on how that's going, if there's been any new customer wins, how -- at what point -- what inflection point do you think it'd be worthwhile to have its own distribution point or maybe even a factory out there?

Yes. So yes, we transitioned those 30 customers into the Rockwell platform. We are currently supplying those successfully. We're also in the process now of hiring drivers and establishing cross-dock out in that area. Once we're able to do that, we'll be in a position to be able to expand that business in the West. Now that we're out there, we're also receiving calls from organizations that are in the West, that are now looking to access products as they were otherwise unable to do so previously So yes, we're very happy with the progress we're making in that expansion.

Okay. Great. And then I know you mentioned that you took some pricing. Is that just on new customer wins? Or is that going to be across your entire customer [indiscernible]? And has there been any -- while you're renegotiating the prices, has there been any pushback or discussed at this point?

Yes. So we constantly evaluate the value of our products and the price that we charge for those, given the importance of those products have in the treatment of patients with end-stage renal disease. Yes, we are with new customers, I mean, certainly, we are very focused on making sure that we receive the value of what we produce.

For existing customers, we are working with them to, again, adjust pricing that may be reflective of a more current and contemporary framework. We're very interested in making sure customers are making sure that they receive the value that they are interested in purchasing.

And at this point, we've not achieved any pushback on that, and I think we'll continue to try to maximize that going forward.

Okay. That's great. And then just last question from us. You still -- I don't know if you're still in ongoing negotiations with DaVita, your prior largest customer. Is there any update on that? Or are you locked in for 2026? Or is there any opportunity or possibility that contract gets expanded or moved on into '27 or too early to tell?

Yes. So we continue to maintain a very good relationship with DaVita. We are continuing to supply the facilities that they've asked us to supply at the end of last year, and I feel very strongly that, that we'll be able to continue to do that going forward. DaVita did make a onetime large purchase this quarter -- in the second quarter, again, which indicates for us that they are very interested in continuing to work with us to supply them.

[Operator Instructions] There appear to be no further questions at this time. I will turn the call back over to Dr. Strobeck.

Thank you for joining us today for an update on Rockwell Medical.

Tracey, we'll take the call if it's still coming through, the question?

I see that we do have Ram Selvaraju sitting here in the queue, he has disconnected. But if he comes back, we can put him back on.

Thank you for joining us today for an update on Rockwell Medical. We continue to drive increased efficiencies in our manufacturing processes and distribution network, driving down our operating costs. We continue to onboard new customers while renewing contracts with existing customers at favorable terms to Rockwell.

We continue to pursue product diversification and business development opportunities that we believe have the potential to have a significant impact on our organization. For 2026 and beyond, we remain focused on increasing our revenue, expanding our gross margin and generating sustainable profitability on an adjusted EBITDA and cash flow basis.

We are focused on growth that positively impacts our bottom line. We look forward to sharing more in the months to come. Thank you.

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

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 Neri.

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 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 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 5 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 Fresenius, 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 through 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 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 multiyear 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 3 years with the option to extend for an additional 1-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% 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 1 of the top 5 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 Renal Services, the largest provider of dialysis and skilled nursing facilities in the United States. This 3-year agreement has an option to renew for 1 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 510(k) approved by the FDA and comes in 2 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 need 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 onetime 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 enabling better planning and execution. As volume shift in 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 with 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 4 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 million 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 business' ongoing adaptability and growth prospects.

Looking ahead, we continue to focus on long-term value creation for our shareholders. Our strategy over the next 3 years is centered on 3 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 discipline, this work reflects our commitment to remaining forward-looking and strategically positioned within an evolving health care landscape. Beyond these core areas of focus and based on what we see today, we believe that over the next 3 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 while continuing to broaden and diversify our portfolio 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 $5 million to $10 million. 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 and full year 2025 financial results.

Thank you, Mark. Good morning, everyone. As you can see from this morning's press release, we 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 3 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 removed noncash items, nonoperating 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 of 2024. 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 result of these activities began to be reflected in our fourth quarter numbers. Net loss for Q4 2025 was $600,000, which represents a threefold 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 noncash, 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, 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 cash flow from operations of $2.3 million, which was partially offset by cash paid in connection with our Evoqua 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 I will turn the call back over to Mark.

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

[Operator Instructions] Your first question comes from the line of Anthony Vendetti with Maxim Group.

Mark, I was wondering if based on the current relationship with DaVita, as 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 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 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 2 other quick follow-ups on the West Coast expansion as well 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 approximate percentage of revenue? And what do you see as the growth trajectory in '26?

Yes. So on the first question, 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 had 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 designing a commercial strategy to bring forward in part to do that. We'll also be looking to our work with B.Braun, if you recall, the partnership that we have put in place, 2 years ago as they are heavily focused in the West. So 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, that market, I think, continues to establish itself as an overall percentage, of the dialysis, hemodialysis market, it's probably trending towards what will be about 10%. We worked with some of the largest players in that space. And so we're continuing to support those. As we -- 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.

[Operator Instructions] Your next question comes from the line of Ram Selvaraju with HC Wainwright.

I wanted to drill down a little bit more on the likely evolution of the relationship with DaVita and ask 3 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 DaVita to extend the relationship with Rockwell past the end of 2026. In other words, is that even an option? Or do you think that definitively off the table, and we shouldn't be 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 drive DaVita away? Is it primarily on price? Or are they able to compete on something else? And then I have a few others.

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

Yes. So Ram, in terms of our longer-term projections, we are assuming consistent volumes purchased from DaVita over the next few years. So consistent with essentially what they purchased the last 3 quarters of last year and going forward into this year. So no gigantic growth assumption there for DaVita.

And then on your next question, 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 it's our anticipation that if we continue to supply them consistently over the course of the year with products that have -- of the highest quality that there is a high probability that they will continue to work with us going forward. And depending on how the performance of others continues, I think, may open the possibility for us to expand further and we gain 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 what I'll call a 3-party market. And it's us, Fresenius and Nipro. We believe that Nipro 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 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 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 Fresenius.

So our competitive advantage continues to be high-quality products. That means products that are manufacturing facilities that do not and haven't had significant issues related to FDA inspections. And then secondly, because we transport our products largely on Rockwell transportation, which is a more cost-effective way to get products to clinics. Those are the 2 areas that put us 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 that is continues to be an advantage for us. So those are the areas that I think differentiate us and continue to generate very positive customer feedback.

That's very helpful. I wanted to ask 2 other quick ones, if I may. Firstly, can you give us any additional granularity on how the Western expansion is growing? What's the prospects are for additional customer acquisitions in 2026? And how you see that aspect of the business contributing to your longer-term forecast? And then I was wondering if in the, let's call it, late 2020s time frame, 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?

Yes. So as we mentioned, we stepped in and took over the business of about 30 customers in the West, that is a multimillion dollar revenue base that we've now acquired, and are beginning to support. That, as I mentioned, 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, we received a number of calls from customers that are looking to transition away from their current supplier. So we're in the process of prosecuting those, those can be smaller opportunities all the way up to multimillion dollar opportunities, and we're just going to continue to prosecute those throughout the year, but we certainly think that there's a large opportunity to secure more business out there.

As it relates to our projections through 2029, 2 things I would say in an effort to answer that question. The first is we are -- continue to be actively engaged in a number of business development discussions around acquiring renal care products that fit very squarely into what we are doing, whether that is additional concentrates, whether that is products that are used by dialysis centers, blood tubing sets, dialyzers, et cetera. So 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 -- than our current business today, which is going to help sort of pull up our overall gross margin. And then in addition, we're also looking at 1 or 2 very innovative therapies in the space that may require additional investment 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.

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 require significant ongoing effort. We believe we are getting close and we'll have more to share with you as we reach key milestones in the coming months.

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

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 Strobeck, Rockwell Medical's President and Chief Executive Officer; and Jesse Neri, 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 10-K 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 10-Q for the 3 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 discuss on today's call can also be found in today's press release. Our Form 10-Q 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 Strobeck.

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 multiyear contracts, rightsizing 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 rightsizing 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 -- 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 '26 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 the -- is with a single dialysis center located in Southern Florida. This is a 3-year commitment with the option to renew for 2 additional 1-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 and skilled nursing facilities in the United States. The agreement will be in effect for 3 years with the option to renew for 1 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 treatments.

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 2 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 3 key metrics: gross margin, adjusted EBITDA and cash.

We believe adjusted EBITDA is a good proxy for profitability because we remove noncash items, nonoperating 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 3 and 9 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 9 months ended September 30, 2025, were $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 9 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, an improvement over the first and second quarters of 2025. Gross margin for the 9 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 9 months ended September 30, 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 of 2025. Adjusted EBITDA for the 9 months ended September 30, 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 facility, partially offset by cash paid in connection with the Evoqua asset acquisition.

The increased cash position offers us the opportunity to continue to preserve, 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.

[Operator Instructions]

Our first question comes from Ram Selvaraju from H.C. Wainwright.

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?

Yes. Thanks, Ram. We expect that to resolve this quarter. We are currently in a contract discussion with them, and we expect to be able to discuss that shortly.

Okay. And then with respect to 2026, can 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 given your current balance sheet strength?

Yes. Yes. So typically, we provide 2026 guidance early in the year. So we expect to continue to do that. So our anticipation is that 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 -- now that we have a strong cash balance 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 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?

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

Our next question comes from Nick Sherwood from Maxim Group.

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 you'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 mentioned?

Yes. So it's -- as you can imagine, it's been a sort of a tricky algorithm for us to work through, which is decreasing certain obviously, products and the single largest customer moving away from us while simultaneously adding new customers and making sure that we continue to supply product to our existing customer base with the quality standards and with the service that we've provided previously.

What that has essentially amounted to is 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.

And as Jesse pointed out in his section, we're beginning to start to see the fruits of that. And we expect more -- to see more of that here in the fourth quarter coming up and through '26.

Understood. I appreciate the detail. And my second question is, where do you see the most kind of room to run with 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 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 aspect of 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 a little bit of background to what was happening there and kind of just any detail you can provide?

Yes. So we have -- one of our facilities 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 to essentially wind that down and begin to start to offload that expense. So that's what you're going to begin to see here in the third quarter and then more specifically in the fourth quarter.

Okay. So we should see maybe a little bit of a similar impact on the operating expenses in the fourth quarter as well as compared to the third quarter?

That's correct.

Our last question comes from Anthony Vendetti from Maxim Group.

Sure. So Mark, I was wondering if you could give us an update on 2 things, one is the West Coast expansion and then just an update on the home dialysis business.

Yes. Yes. So the West Coast 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 sort of 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 continued customer acquisition or that comes through setting up a small facility in the West.

I think we're now beginning to build a critical mass of customers out there that likely warrants that. As we've said previously, we've taken the approach of not building something hoping folks would come, but waiting until we have a significant 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 we believe that's a significant area of growth for us.

Your second question -- so at home, we continue to be 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.

We think that there's a -- 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 we continue to be excited about the prospects there, but are well positioned to support that market as it continues to develop.

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

So right now, it's a small percentage, probably single-digit percentage at this point. And it's our anticipation that, that will continue to grow. 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.

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

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.