11/12/2025

speaker
Heather
Conference Call Moderator

and Jesse Neary, Rockwell Medical's Chief Financial Officer. Before we begin, I would like to remind you that this conference call will contain forward-looking statements about Rockwell Medical within the meaning of the federal securities laws, including but not limited to the types of statements identified as forward-looking in our annual report on Form 10-K and our subsequent periodic reports filed with the FDC. 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 three months ended September 30th, 2025 was filed prior to this call and provides a full analysis of the company's business strategy as well as the company's third quarter 2025 results. The reconciliation of non-GAAP measures we discussed on today's call can also be found in today's press release. Our Form 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 investor section. Now I would like to turn the conference call over to Rockwell Medical's president and CEO, Dr. Mark Strobeck.

speaker
Dr. Mark Strobeck
President and CEO

Thank you, Heather. Good morning, and thank you for joining us today for Rockwell Medical's third quarter 2025 earnings conference call and webcast. As we approach the end of the year, I want to provide you with an update on what has truly been a year of resilience, transformation, and growth for Rockwell. We are effectively managing the transition of our largest customer away from us while securing our base business through multi-year contracts, right-sizing our organization to enhance operational efficiency, and adding new customers, all while continuing to meet strong customer demand with high-quality products supported by exceptional customer service. I am proud to say that we have made substantial progress. We continue to fundamentally strengthen our contract portfolio with over 80% of our customers operating under long-term agreements. This provides stability and revenue visibility that positions us well for the future. We continue to optimize our organizational structure to align with our current scale while maintaining our operational excellence and customer service standards. This right-sizing effort has been executed thoughtfully ensuring we retain the capabilities and capacity needed to serve our customers and capitalize on growth opportunities as they emerge. And most importantly, we have demonstrated our ability to successfully manage through this transition period while maintaining our market position and building momentum for future growth. The strategic decisions we made earlier in the year are now translating into tangible results and we remain competent 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 optimized cost structure. While our net sales of $15.9 million reflected the expected impact from our largest customer's transition, our adjusted gross margin performance remained consistent and 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 with a single dialysis center located in southern Florida. This is a three-year commitment with the option to renew for two additional one-year periods that has the potential to generate approximately one million in annualized net sales for the company. During the third quarter, we also expanded our product purchase segment agreement with the largest provider of dialysis in skilled nursing facilities in the United States. The agreement will be in effect for three years with the option to renew for one additional year. and includes supply and purchasing minimums for our liquid and dry acid and bicarbonate concentrates, including our bicarbonate cartridge, which, as a reminder, officially launched earlier this year. Discussions with our formerly largest customer are still ongoing. We continue to supply them through the third quarter and expect to supply them through the end of the year. As a reminder, this customer originally planned to complete their transition to a new supplier in the middle of this year, However, due to a Class I recall 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.

speaker
Jesse Neary
Chief Financial Officer, Rockwell Medical

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

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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