Rockwell Medical (RMTI) Q1 2025 Earnings Call May 12, 2025 08:00 AM ET Company Participants Heather Hunter - Senior VP & Chief Corporate Affairs OfficerMark Strobeck - President & CEOJesse Neri - SVP & CFORaghuram Selvaraju - Managing Director, Healthcare Equity Research Conference Call Participants Jeremy Pearlman - Equity Analyst Operator Good morning, and welcome to Rockwell Medical's First Quarter twenty twenty five Results Conference Call and Webcast. Please note that this event is being recorded. At t ...

Rockwell Medical (RMTI) Q1 2025 Earnings Call May 12, 2025 08:00 AM ET Speaker0 Good morning, and welcome to Rockwell Medical's First Quarter twenty twenty five Results Conference Call and Webcast. Please note that this event is being recorded. At this time, I would like to turn the conference call over to Heather Hunter, Senior Vice President, Chief Corporate Affairs Officer at Rockwell Medical. Heather, please go ahead. Speaker1 Good morning, and thank you for joining us for this update on Rockwell Medica ...

Financial Performance - Net sales for the three months ended March 31, 2025, were $18.914 million, a decrease of 16.5% compared to $22.676 million for the same period in 2024[14]. - Gross profit for Q1 2025 was $3.042 million, slightly down from $3.064 million in Q1 2024, resulting in a gross margin of 16.1%[14]. - The net loss for the three months ended March 31, 2025, was $1.515 million, compared to a net loss of $1.731 million for the same period in 2024, reflecting a 12.5% improvement[14]. - Basic and diluted net loss per share improved to $0.04 in Q1 2025 from $0.06 in Q1 2024[14]. - Comprehensive loss for Q1 2025 was $1,509 million, slightly improved from $1,706 million in Q1 2024, showing a reduction of approximately 11.5%[16]. - For the three months ended March 31, 2025, Rockwell Medical reported a net loss of $1.515 million, an improvement from a net loss of $1.731 million in the same period of 2024, representing a decrease of approximately 12.5%[23]. Assets and Liabilities - Total assets decreased to $53.961 million as of March 31, 2025, down from $59.208 million as of December 31, 2024[10]. - Total liabilities decreased to $22.439 million as of March 31, 2025, compared to $26.622 million as of December 31, 2024, indicating a reduction of 15.8%[10]. - Stockholders' equity decreased to $31.522 million as of March 31, 2025, from $32.586 million as of December 31, 2024[11]. - Total current liabilities decreased from $14,091 million as of December 31, 2024, to $11,205 million as of March 31, 2025, a reduction of approximately 20.5%[10]. - Total accrued liabilities decreased to $4.6 million as of March 31, 2025, from $6.3 million as of December 31, 2024, representing a reduction of approximately 26.9%[80]. Cash Flow and Liquidity - Cash and cash equivalents were $11.391 million as of March 31, 2025, down from $15.662 million as of December 31, 2024[10]. - Net cash used in operating activities for the three months ended March 31, 2025 was approximately $3.487 million, an increase of 46.5% compared to $2.380 million for the same period in 2024[23]. - Rockwell's net decrease in cash and cash equivalents for the three months ended March 31, 2025 was $4.271 million, compared to a decrease of $2.341 million for the same period in 2024[23]. - As of March 31, 2025, Rockwell had approximately $17.3 million in cash, cash equivalents, and investments available-for-sale, with working capital of $21.8 million[30]. - The company continues to explore capital-raising options, with $21.1 million available under its at-the-market facility[31]. Revenue Sources - Revenue from DaVita accounted for approximately 27% of total revenues for the three months ended March 31, 2025, down from 44% in the same period of 2024[49]. - Revenue from drug products was $0.325 million, while concentrate product sales were $18.589 million, with U.S. sales accounting for $16.436 million and international sales $2.153 million[57]. - The company recognized $0.3 million of revenue from deferred license agreements during the three months ended March 31, 2025, as all remaining deferred revenue related to these agreements was recognized[54]. - A one-time, non-refundable payment of $0.9 million from DaVita was recorded as revenue during the three months ended March 31, 2025, to ensure supply continuity[55]. Expenses - The company incurred $711,000 in selling and marketing expenses for Q1 2025, up from $594,000 in Q1 2024, reflecting a 19.7% increase[14]. - Research and product development expenses were $0 for Q1 2025, down from $18 million in Q1 2024, indicating a strategic shift in R&D spending[14]. - Stock-based compensation expense for the three months ended March 31, 2025, was $0.445 million, compared to $0.251 million for the same period in 2024, reflecting an increase of 77%[92]. Stock and Equity - The weighted average number of shares of common stock outstanding increased to 34,107,640 for the three months ended March 31, 2025, compared to 29,327,204 for the same period in 2024, reflecting a 16.5% increase[40]. - The number of common stock equivalents increased to 41,902,125 as of March 31, 2025, compared to 37,222 in 2024[86]. - The Series X Preferred Stock accreted a total of $0.3 million as of March 31, 2025, reflecting ongoing financial obligations related to this equity[82]. - The company issued a warrant to purchase 191,096 shares of common stock at an exercise price of $1.83 per share, with a fair value of approximately $0.2 million at issuance[90]. Compliance and Agreements - The company is currently in compliance with all covenants under its Loan Agreement with Innovatus, which includes an interest-only payment period for 36 months[32]. - The Company is required to maintain consolidated revenue from hemodialysis products at not less than 85.0% of projections for the trailing six-month period[112]. - The company has a Technology License Agreement with Charak for TPN products, which continues until at least February 1, 2034, with royalties based on net sales[103]. Market and Operations - Rockwell Medical operates in the hemodialysis market, manufacturing and distributing a range of hemodialysis products[48]. - The company operates in a single segment focused on the hemodialysis market, providing a range of products for dialysis providers worldwide[25].

Financial Performance - Rockwell Medical reported net sales of $18.9 million for Q1 2025, a 17% decrease from $22.7 million in Q1 2024[5] - Gross profit for Q1 2025 was $3.0 million, consistent with the same period in 2024, resulting in a gross margin of 16%, up from 14% in Q1 2024[6] - The net loss for Q1 2025 was $1.5 million, representing a 12% improvement over the net loss of $1.7 million in Q1 2024[6] - Adjusted EBITDA for Q1 2025 was ($0.4) million, slightly negative due to seasonal payroll tax and public company expenses[6] - Cash and cash equivalents decreased to $17.3 million as of March 31, 2025, down from $21.6 million at the end of 2024[6] - Total stockholders' equity increased to $31.5 million as of March 31, 2025, compared to $20.6 million in the same period in 2024[22] Future Guidance - Rockwell Medical confirmed its 2025 annual guidance, projecting net sales between $65.0 million and $70.0 million, with a gross margin of 16% to 18%[11] Product Development - The company added a single-use bicarbonate cartridge to its product portfolio through a distribution agreement with a leading medical equipment manufacturer[12] Company Recognition - Rockwell Medical was recognized as a Great Place to Work for the third consecutive year, highlighting its commitment to fostering a supportive workplace[12] Customer Impact - The largest customer transition to another supplier contributed to the decrease in net sales, although a one-time payment of $0.9 million was received to ensure product supply continuity[6]

Rockwell Medical, Inc. (NASDAQ:RMTI) Q4 2024 Earnings Conference Call March 20, 2025 8:00 AM ET Company Participants Heather Hunter - Senior Vice President, Chief Corporate Affairs Officer Mark Strobeck - President & Chief Executive Officer Tim Chole - Chief Commercial Officer Jesse Neri - Chief Financial Officer Conference Call Participants Brandon Folkes - Rodman & Renshaw Ram Selvaraju - H.C. Wainwright Anthony Vendetti - Maxim Group Operator Good morning, and welcome to Rockwell Medical's Fourth Quarter ...

Rockwell Medical (RMTI) Q4 2024 Earnings Call March 20, 2025 08:00 AM ET Company Participants Heather Hunter - Senior VP & Chief Corporate Affairs OfficerMark Strobeck - President & CEOTim Chole - Senior VP & Chief Commercial OfficerJesse Neri - SVP & CFOBrandon Folkes - Managing Director - Equity ResearchRaghuram Selvaraju - Managing Director, Healthcare Equity ResearchAnthony Vendetti - Executive Managing Director Operator Good morning, and welcome to Rockwell Medical's Fourth Quarter and Full Year twenty ...

Core Insights - Rockwell Medical reported a quarterly loss of $0.02 per share, matching the Zacks Consensus Estimate, compared to earnings of $0.02 per share a year ago [1] - The company posted revenues of $24.67 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 9.09% and up from $22.09 million year-over-year [3] Financial Performance - The quarterly report reflects an earnings surprise of -200%, following a previous quarter where the company had a positive surprise of 400% [2] - Over the last four quarters, Rockwell Medical has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2][3] Stock Performance - Rockwell Medical shares have declined approximately 13.7% since the beginning of the year, while the S&P 500 has decreased by 3.5% [4] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $20.2 million, and -$0.03 on revenues of $87.63 million for the current fiscal year [8] Industry Outlook - The Medical - Products industry, to which Rockwell Medical belongs, is currently ranked in the bottom 49% of over 250 Zacks industries, indicating potential challenges ahead [9] - The performance of Rockwell Medical's stock may be influenced by the overall outlook for the industry [9]

Rockwell Medical (RMTI) Q4 2024 Earnings Call March 20, 2025 08:00 AM ET Company Participants Heather Hunter - Senior VP & Chief Corporate Affairs OfficerMark Strobeck - President & CEOTim Chole - Senior VP & Chief Commercial OfficerJesse Neri - SVP & CFOBrandon Folkes - Managing Director - Equity ResearchRaghuram Selvaraju - Managing Director, Healthcare Equity ResearchAnthony Vendetti - Executive Managing Director Operator Good morning, and welcome to Rockwell Medical's Fourth Quarter and Full Year twenty ...

Acquisition and Partnerships - Rockwell Medical's total consideration for the acquisition of customer relationships, equipment, and inventory from Evoqua was $17.4 million, including a cash payment of $12.4 million at closing [31]. - In July 2023, the Company acquired the hemodialysis concentrates business from Evoqua, including all contracts and FDA clearances, with a transition to Rockwell Medical's products effective December 31, 2024 [45]. - The company entered into a distribution agreement with Nephro Group Dialysis Centers, becoming the exclusive supplier for all dry hemodialysis concentrates products in the Philippines [26]. - A distribution agreement with Nipro was established in August 2024, allowing Nipro to distribute the Company's products globally, excluding the U.S. [56]. - The Company entered into a product purchase agreement with Fresenius Medical Care NA in December 2024 to supply liquid bicarbonate hemodialysis concentrates for three years [55]. - The Company executed an Asset Purchase Agreement with Evoqua Water Technologies for $17.4 million, including a cash payment of $12.4 million and two deferred payments of $2.5 million each [212]. - A product purchase agreement with Fresenius Medical Care NA was signed for the supply of liquid bicarbonate hemodialysis concentrates, effective for three years with renewal options [217]. - The Company entered into several multi-year product purchase agreements with various parties, including HydroCare and Nephro Group Dialysis Centers [218]. Market and Product Development - In 2024, Rockwell Medical expanded its distribution capabilities in the western U.S. and entered new markets, including the Dominican Republic and Bermuda [26]. - The company launched a convenience pack in August 2024, which includes two 1-gallon pre-mixed containers of hemodialysis concentrate products, aimed at home patients and acute facilities [26]. - The U.S. hemodialysis concentrates market is projected to grow from $450 million in 2024 to approximately $560 million by 2028, driven by an increasing number of patients with end-stage kidney disease [48]. - Dialysate concentrates accounted for 100% of the Company's revenue for the year ended December 31, 2024, with approximately 90.9% of sales to U.S. distributors and customers [51]. - Rockwell Medical is a leading supplier of hemodialysis products, with a strong market position in the U.S. and international markets [208]. - The Company manufactures hemodialysis concentrates at facilities in Michigan, South Carolina, and Texas, ensuring quality and reliability [209]. - Rockwell Medical's products are regulated by the FDA and adhere to ISO 13485 and cGMP standards, ensuring high-quality manufacturing practices [210]. Financial Performance and Risks - The company expects to lose approximately 50% of its sales volume and $34 million in revenue compared to 2024 due to the transition of its largest customer to another supplier by mid-2025 [115]. - The company has a cumulative deficit of approximately $397.7 million since inception and may incur further losses [122]. - The company faces risks related to the loss of its largest customer, which could negatively impact revenue [113]. - The company may need to raise additional capital to operate and expand its business, which could be dilutive to existing shareholders [126]. - The company faces significant competition in the concentrates market from larger competitors like Fresenius and Nipro, which have substantial resources [130]. - The company has been adversely affected by rising raw material, labor, and transportation costs, which are expected to continue increasing in the future [134]. - The company anticipates that limitations on price increases in contracts may continue to negatively impact profit margins and financial position [136]. - The company faces risks from unfavorable weather, economic conditions, and supply shortages that could adversely affect operations and financial results [138]. Regulatory Compliance and Quality Assurance - The company operates under FDA regulations and has established a Quality Management System to ensure product quality and compliance [63]. - The testing, manufacture, and sale of the Company's hemodialysis concentrates are subject to regulation by the FDA and other governmental authorities, with noncompliance potentially resulting in significant penalties [76]. - The company is required to report to the FDA if its device may have caused or contributed to a death or serious injury [95]. - The company is subject to unannounced inspections by the FDA to ensure compliance with quality system regulations [97]. - The company must comply with FDA regulations, including stringent quality assurance procedures during manufacturing processes [95]. Employee and Corporate Governance - The company had 244 employees, all of whom are full-time, and there are no collective bargaining agreements governing their arrangements [108]. - The company emphasizes a comprehensive benefits package to support employee health and wellness, including performance-based merit increases and cash bonuses [109]. - The company’s cybersecurity program is overseen by the Audit Committee, which regularly interacts with the Chief Corporate Affairs Officer [188]. - The company has implemented a comprehensive cybersecurity incident response plan, which is reviewed and updated annually [192]. Legal and Litigation Risks - The company has potential exposure to product liability litigation due to failure to comply with applicable regulations, which could adversely impact its financial condition [158]. - The company is subject to numerous commercial disputes and claims, which may divert management's attention and incur significant expenses [159]. - The company has faced litigation in the past, and future lawsuits could result in substantial damages and divert management's focus from business operations [160]. - The company maintains product liability insurance, but there is no assurance that it will be sufficient to cover potential liabilities [162]. Stock and Financial Management - The company has substantial net operating loss carryforwards, but their use may be limited by future ownership changes, potentially increasing tax liabilities [174]. - The company does not anticipate paying dividends in the foreseeable future, as it intends to retain earnings to finance operations [175]. - As of December 31, 2024, there are 5,870,731 shares issuable upon the exercise of stock options and warrants, which may depress the market price of the common stock [172]. - The company has experienced volatility in its common stock price, which could lead to litigation and significant costs [169].

Financial Performance - Rockwell Medical achieved profitability on an adjusted EBITDA basis for the full-year 2024, marking the first time in the company's history[5]. - The company reported record net sales of $101.5 million for 2024, a 21% increase from $83.6 million in 2023, with fourth-quarter net sales of $24.7 million, a 12% increase year-over-year[5][6]. - Gross profit for 2024 was $17.5 million, representing a 101% increase over $8.7 million in 2023, with a gross margin improvement to 17% from 10%[9][10]. - Adjusted EBITDA for 2024 was $5.2 million, a 232% improvement from a loss of $3.9 million in 2023[9][10]. - Rockwell Medical reported net sales of $24.665 million for Q4 2024, a 12% increase from $22.093 million in Q4 2023[29]. - Rockwell Medical achieved an adjusted EBITDA of $1.358 million for Q4 2024, compared to $530,000 in Q4 2023, marking a significant increase[31]. - The gross profit for the twelve months ended December 31, 2024, was $17.484 million, up from $8.704 million in 2023, representing a year-over-year growth of 100%[29]. - The net loss for the twelve months ended December 31, 2024, was $480,000, a significant improvement from a net loss of $8.439 million in 2023[29]. Customer and Market Developments - The largest customer is transitioning away from Rockwell Medical, which is expected to result in a revenue loss of approximately $34 million compared to 2024[16]. - Rockwell Medical plans to target additional customers representing an estimated 14.5 million gallons of potential business within its distribution footprint[13]. - The company continues to identify additional business development opportunities to diversify its customer base and support strategic objectives[24]. - A new single-use bicarbonate cartridge was added to the product portfolio, representing a market opportunity of approximately $100 million[14]. Future Projections - Rockwell Medical projects 2025 net sales guidance of $65.0 million to $70.0 million, with a gross margin of 16% to 18%[17]. - The company aims to achieve profitability on an adjusted EBITDA basis for the full year 2025[24]. Financial Position - Cash and cash equivalents increased to $21.6 million as of December 31, 2024, compared to $18.3 million at the end of Q3 2024[7]. - The company's total assets increased to $59.208 million in 2024, up from $52.173 million in 2023, reflecting a growth of approximately 13%[27]. - Rockwell Medical's total stockholders' equity rose to $32.586 million in 2024, a 53% increase from $21.291 million in 2023[27]. - Rockwell Medical's common stock outstanding increased to 34,056,920 shares in 2024, up from 29,130,607 shares in 2023[27]. Agreements and Contracts - The company entered into a product purchase agreement expected to generate upwards of $10 million in net sales in the first year[12].