Rockwell Medical Q1 2026 Earnings Report

Rockwell Medical EPS Results

• Actual EPS: -$0.04
• Consensus EPS: -$0.01
• Beat/Miss: Missed by -$0.03
• One Year Ago EPS: N/A

Rockwell Medical Revenue Results

• Actual Revenue: $17.34 million
• Expected Revenue: $17.95 million
• Beat/Miss: Missed by -$618.00 thousand
• YoY Revenue Growth: N/A

Rockwell Medical Announcement Details

• Quarter: Q1 2026
• Date: 5/7/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, May 7, 2026
• Conference Call Time: 8:00AM ET

Rockwell Medical (NASDAQ:RMTI) is a Delaware‐domiciled biopharmaceutical company focused on the development and commercialization of therapies for patients with chronic kidney disease (CKD). The company’s mission centers on addressing common complications in CKD—namely iron deficiency and secondary hyperparathyroidism—through innovative treatment approaches designed for dialysis settings.

The company’s lead product, TRIFERIC®, is an iron replacement therapy approved by the U.S. Food and Drug Administration for use in hemodialysis patients. TRIFERIC is delivered via dialysate and is intended to replace iron losses that occur during the dialysis process, helping to maintain hemoglobin levels without the need for intravenous iron supplements. In addition to TRIFERIC, Rockwell Medical offers a generic injectable formulation of calcitriol, a form of vitamin D used to manage secondary hyperparathyroidism in CKD patients.

Since its founding in 1991, Rockwell Medical has conducted research, clinical development, and regulatory activities primarily in the United States. The company collaborates with specialty distributors and dialysis providers to commercialize its products and is exploring further innovations, including oral formulations of its iron therapy. Rockwell Medical’s operations are led by an experienced management team with backgrounds in nephrology, pharmaceutical development, and health-care commercialization, reflecting its commitment to improving patient outcomes in the CKD community.

Rockwell Medical Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Rockwell raised 2026 guidance to $70–75M in net sales, projects 18–22% gross margin, expects $1–2M Adjusted EBITDA, positive operating cash flow, and targets positive net income in H2 2026.
• Positive Sentiment: Operational changes — including activation of two automated liquid lines expected to boost output ~50% — should materially lower manufacturing cost per bottle and are estimated to add ~$3M of gross profit (roughly half realizable in 2026).
• Neutral Sentiment: Q1 results showed $17.3M in sales (down 8% YoY due to a large customer's volume decline), gross profit of $2.9M and 17% gross margin (up from 16%); Adjusted EBITDA improved slightly to a negative $0.3M, and cash was $23.9M at quarter end.
• Positive Sentiment: Customer diversification and commercial traction strengthened — ~300 customers covering 1,400+ facilities (including all five leading U.S. dialysis providers), sales in 30+ countries, and recent contract renewals/new wins with improved pricing and product mix.
• Neutral Sentiment: Management reiterated long-term targets (by 2029: >$100M sales, gross margin approaching 30%, and annual profitability of $5–10M), but these remain forward‑looking goals subject to execution and risks.

Presentation

[Operator]

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 Med. Heather, please go ahead.

[Heather Hunter, COO at Rockwell Medical]

Good morning. 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.

[Heather Hunter, COO at Rockwell Medical]

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 three months ended March 31, 2026 was filed prior to this call and provides a 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, our updated investor presentation, and a replay of today's call can be found on our website under the investor section. I will turn the call over to Rockwell Medical's President and CEO, Dr. Mark Strobeck.

[Mark Strobeck, President and CEO at Rockwell Medical]

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 non-cash items, non-operating items, restructuring costs, and other items that are not part of our core concentrates business.

[Mark Strobeck, President and CEO at Rockwell Medical]

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.

[Mark Strobeck, President and CEO at Rockwell Medical]

Net sales were higher than expected in Q1. Although net sales were lower compared to the same period in 2025, that reduction was due to our then largest customer's 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 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%.

[Mark Strobeck, President and CEO at Rockwell Medical]

Rockwell currently serves approximately 300 customers, which represents more than 1,400 facilities, highlighted by all five of the leading dialysis providers in the U.S., along with university medical centers, community hospital systems, and other renal care organizations. In addition, we supply hemodialysis concentrates to more than 30 countries outside the U.S. 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.

[Mark Strobeck, President and CEO at Rockwell Medical]

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.

[Mark Strobeck, President and CEO at Rockwell Medical]

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 projects 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 expectation each of those three years.

[Mark Strobeck, President and CEO at Rockwell Medical]

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 U.S. 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.

[Mark Strobeck, President and CEO at Rockwell Medical]

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-$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.

[Jesse Neri, CFO at Rockwell Medical]

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-$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 16% 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%.

[Jesse Neri, CFO at Rockwell Medical]

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.

[Jesse Neri, CFO at Rockwell Medical]

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 growth capital to pursue strategic objectives. Now I will turn the call back over to Mark.

[Mark Strobeck, President and CEO at Rockwell Medical]

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

[Operator]

Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star and the number one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Now, please stand by while we compile the Q&A roster. Your first question comes from the line of Jeremy Pearlman with Maxim Group. Your line is open. Please go ahead.

[Jeremy Pearlman, Analyst at Maxim Group]

Good morning. Thank you for taking the question. Yeah, just a couple questions from us. 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 ex-expansion opportunities are there, and what does the margin profile look like outside of the U.S. versus in the U.S.?

[Mark Strobeck, President and CEO at Rockwell Medical]

Thanks, Jeremy. We continue to see strong demand for our products outside of the U.S., particularly, you know, 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. Our margins are typically higher in that product category. We don't, you know, we don't provide the details around that. It's a very attractive business for us.

[Jeremy Pearlman, Analyst at Maxim Group]

Okay. That's great. Maybe while we're also talking about expansion, on the last call you mentioned that you had 30 new customers, I think, or 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 any new customer wins? 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?

[Mark Strobeck, President and CEO at Rockwell Medical]

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 docks out in that area. Once we're able to do that, you know, 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, you know, organizations that are in the West that are now looking to access products as they were otherwise unable to do so previously. Yeah, we're very happy with the progress we're making, you know, in that expansion.

[Jeremy Pearlman, Analyst at Maxim Group]

Okay. Great. I know you mentioned you took some pricing. Is that just on new customer wins or is that gonna be across your entire customer Rolodex? Has there been any, you know, while you're renegotiating the prices, has there been any pushback or maybe, you know, it's accepted at this point?

[Mark Strobeck, President and CEO at Rockwell Medical]

Yeah. You know, we constantly evaluate the value of our products, and the price that we charge, for those, you know, given the importance that those products have in the treatment of patients with end-stage renal disease. Yes, we are, you know, with new customers, I mean, certainly we are very focused on making sure that we, you know, receive the value of what we produce. For existing customers, you know, we are working with them to again, adjust pricing that may be reflective of, you know, a more current and contemporary framework. You know, we're very interested in making sure, you know, customers are making sure that they receive the value that they're interested in purchasing. At this point, we've not received, you know, any pushback on that.

[Mark Strobeck, President and CEO at Rockwell Medical]

I think, you know, we'll continue to, you know, try to maximize that going forward.

[Jeremy Pearlman, Analyst at Maxim Group]

Okay. That's great. Just last question from us, you know, you still I don't know if you're still in ongoing negotiations with DaVita, you know, your probably largest customer. Is there any update on that or you've locked in for 2026? Is there any opportunity, possibility, you know, that that contract gets expanded or moved on into 2027 or too early to tell yet?

[Mark Strobeck, President and CEO at Rockwell Medical]

Yeah. 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. I feel very strongly that, you know, that we'll be able to continue to do that going forward. DaVita did make a one-time large purchase this quarter or in the second quarter. You know, again, which indicates for us that they are, you know, very interested in continuing to work with us to supply them.

[Jeremy Pearlman, Analyst at Maxim Group]

Okay. That's great. Thank you so much for the update and for taking my questions. I'll hop back in the queue. Have a nice day.

[Mark Strobeck, President and CEO at Rockwell Medical]

Thank you.

[Operator]

Just a reminder that if you would like to ask a question, please press star one on your telephone keypad now. There appears to be no further questions at this time, I will turn the call back over to Dr. Strobeck.

[Mark Strobeck, President and CEO at Rockwell Medical]

Thank you for joining us today for an update on Rockwell Medical. What's that?

[Heather Hunter, COO at Rockwell Medical]

Hey, Tracy. We'll take the call if it's still coming through for the questions.

[Operator]

Oh, yes. Thank you. 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.

[Heather Hunter, COO at Rockwell Medical]

Great. Thank you for trying.

[Mark Strobeck, President and CEO at Rockwell Medical]

All right. 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 on 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.

[Operator]

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

Participants

Executives

• Heather Hunter, COO
• Jesse Neri, CFO
• Mark Strobeck, President and CEO

Analysts

• Jeremy Pearlman, Analyst at Maxim Group