Rockwell Medical, Inc. (NASDAQ:RMTI) Q1 2023 Earnings Conference Call May 15, 2023 8:00 AM ET Company Participants Heather Hunter - Senior Vice President and Chief Corporate Affairs Officer Mark Strobeck - President and Chief Executive Officer Paul McGarry - Senior Vice President, Finance and Chief Accounting Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Operator Good morning and welcome to Rockwell Medical's First Quarter 2023 Results Conference Call and Webcast. Please note this ...

United States SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q __________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-23661 ROCKWELL MEDICAL, INC. (Exact name of registrant as specified in its c ...

Financial Data and Key Metrics Changes - For Q4 2022, the company reported revenue of $19.3 million, a 26% increase compared to Q4 2021 [32] - Full-year 2022 revenue reached $72.8 million, representing a 17.6% increase from 2021, marking the highest full-year revenue to date [20][32] - Net cash used in operating activities decreased to $594,000 in Q4 2022 from $9 million in Q4 2021, and for the full year, it reduced to $17.4 million from $33.5 million, a 48% year-over-year reduction [33] - The net loss for Q4 2022 was $2.4 million or $0.20 per share, down from a net loss of $8.9 million or $1.05 per share in Q4 2021 [34] Business Line Data and Key Metrics Changes - The company is transitioning over 700 former Baxter customers to Rockwell, focusing on establishing new agreements with preferred terms [25][27] - The hemodialysis concentrate market is experiencing a shift towards growth as patient census levels off post-COVID, which is expected to increase demand for concentrates [2][3] Market Data and Key Metrics Changes - The U.S. hemodialysis market is currently valued at approximately $380 million and is projected to grow to around $500 million by 2026 [14] - The company anticipates generating revenue between $78 million and $82 million in 2023, reflecting a potential 13% increase over 2022 [57] Company Strategy and Development Direction - The company aims to become the leading global supplier of hemodialysis concentrates, focusing on expanding into new geographies and optimizing agreements with existing customers [21][29] - The strategic decision to terminate the Baxter agreement allows the company to control its own distribution and establish long-term supply agreements [16][51] - The company plans to enhance its financial condition and reduce debt, with a goal of achieving profitability by 2024 [50][62] Management's Comments on Operating Environment and Future Outlook - Management noted that the dialysis market is beginning to recover from a contraction experienced during COVID, with expectations for growth in 2023 [2][3] - The company is focused on reducing expenses and operating more efficiently, with a commitment to finding ways to decrease operational costs [8][21] Other Important Information - The company has successfully completed a $5 million prepayment of its existing loan, reducing long-term debt to $10 million as of December 31, 2022 [56][61] - The company has entered into new supply agreements with major dialysis providers, which include multi-year purchase commitments [59][60] Q&A Session Summary Question: Potential drivers of upside to current 2023 top line guidance - Management highlighted a shift in the dialysis market towards growth and the leveling off of patient census as key drivers for potential revenue increase [2][3] Question: Expectations for fee spending and debt management in 2023 - Management emphasized a focus on operational efficiency and a commitment to reducing expenses while looking for ways to accelerate debt repayment [7][9] Question: Overview of the updated business model and strategy - Management reiterated the goal of becoming a leading supplier in the hemodialysis market and the importance of transitioning former Baxter customers to Rockwell [13][27]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 000-23661 ROCKWELL MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 30142 S. Wixom Road, Wixom, Michigan 48393 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE S ...

Rockwell Medical, Inc. (NASDAQ:RMTI) Q3 2022 Earnings Conference Call November 14, 2022 8:00 AM ET Company Participants Heather Hunter - SVP & Chief Affairs Officer Mark Strobeck - President, CEO & Director Paul McGarry - Senior Vice President, Finance and Chief Accounting Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Raghuram Selvaraju - HC Wainwright & Co. Operator Good morning, and welcome to Rockwell Medical's Third Quarter 2022 Results Conference Call and Webcast. Please ...

United States SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q __________________________________________________ (Mark One) Commission File Number: 000-23661 ROCKWELL MEDICAL, INC. (Exact name of registrant as specified in its charter) Delaware 38-3317208 (State or other jurisdiction of incorporation or organization) 30142 S. Wixom Road, Wixom, Michigan 48393 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September ...

United States SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q __________________________________________________ (Mark One) Commission File Number: 000-23661 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ROCKWELL MEDICAL, INC. (Exact name of registrant as specified in its ch ...

Rockwell Medical, Inc. (NASDAQ:RMTI) Q2 2022 Earnings Conference Call August 15, 2022 8:00 AM ET Company Participants Heather Hunter - SVP & Chief Affairs Officer Mark Strobeck - President, CEO & Director Russell Skibsted - EVP, CFO & Chief Business Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Operator Good morning, and welcome to Rockwell Medical's Second Quarter 2022 Results Conference Call and Webcast. Please note, this event is being recorded. At this time, I would like ...

Rockwell Medical, Inc. (NASDAQ:RMTI) Q1 2022 Earnings Conference Call May 16, 2022 4:15 PM ET Company Participants Jason Finkelstein - Investor Relations Russell Ellison - President and Chief Executive Officer Russell Skibsted - Executive Vice President, Chief Financial Officer and Chief Business Officer Marc Hoffman - Chief Medical Officer Tim Chole - Senior Vice President, Sales and Marketing Conference Call Participants Brandon Folkes - Cantor Fitzgerald Operator Good afternoon, ladies and gentlemen and ...

Part I — Financial Information [Item 1. Financial Statements](index=4&type=section&id=Item%201%20-%20Financial%20Statements) Unaudited Q1 2022 financials show a $7.2 million net loss, $4.8 million stockholders' deficit, and decreased assets [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2022, total assets decreased to $37.4 million, resulting in a $4.8 million stockholders' deficit Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and Cash Equivalents | $9,914 | $13,280 | | Investments Available-for-Sale | $0 | $9,158 | | Total Current Assets | $24,797 | $35,288 | | Total Assets | $37,436 | $48,574 | | **Liabilities and Stockholders' (Deficit) Equity** | | | | Total Current Liabilities | $19,595 | $20,966 | | Total Liabilities | $42,243 | $46,039 | | Total Stockholders' (Deficit) Equity | $(4,807) | $2,535 | | Total Liabilities and Stockholders' Equity | $37,436 | $48,574 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2022 net sales increased to $16.1 million, but higher costs resulted in a $0.8 million gross loss and $7.2 million net loss Q1 2022 vs Q1 2021 Statement of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net Sales | $16,124 | $15,473 | | Cost of Sales | $16,910 | $15,072 | | Gross (Loss) Profit | $(786) | $401 | | Operating Loss | $(6,626) | $(7,182) | | Net Loss | $(7,162) | $(7,752) | | Basic and Diluted Net Loss per Share | $(0.84) | $(0.91) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2022 net cash used in operations was $9.8 million, with $9.1 million from investing, resulting in a $3.4 million net decrease Q1 2022 vs Q1 2021 Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Cash Used In Operating Activities | $(9,812) | $(12,495) | | Cash Provided By (Used In) Investing Activities | $9,133 | $(512) | | Cash Used In Financing Activities | $(2,687) | $0 | | **Decrease in Cash and Cash Equivalents** | **$(3,366)** | **$(13,007)** | | Cash and Cash Equivalents at End of Period | $9,914 | $35,675 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight liquidity challenges, going concern doubt, and management's plans including a DaVita agreement and reverse stock split - The company is a commercial-stage biopharmaceutical firm with two main business lines: its proprietary FPC iron deficiency platform (Triferic, Triferic AVNU) and being the second-largest supplier of hemodialysis concentrates in the U.S[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - Significant net losses, an accumulated deficit of **$377.2 million**, and inflationary pressures on its concentrates business raise substantial doubt about the company's ability to continue as a going concern[28](index=28&type=chunk)[29](index=29&type=chunk) - To address liquidity issues, the company amended a supply agreement with DaVita for better pricing, secured a **$15 million** equity investment commitment from DaVita (first **$7.5M** tranche funded post-quarter), and initiated an 'at-the-market' offering of up to **$12.2 million**[30](index=30&type=chunk)[31](index=31&type=chunk)[129](index=129&type=chunk) - A **1-for-11 reverse stock split** was effected on May 13, 2022, to regain compliance with Nasdaq's minimum bid price requirement. All share and per-share data have been retroactively adjusted[46](index=46&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) - The company has a **$35.0 million** term loan facility with Innovatus, with **$18.4 million** outstanding as of March 31, 2022. The loan is subject to financial covenants, including minimum liquidity and Triferic sales thresholds, with which the company was in compliance[117](index=117&type=chunk)[122](index=122&type=chunk)[125](index=125&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202%20-%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses FPC platform expansion and concentrates profitability, addressing Q1 2022 results and ongoing 'going concern' risks [Overview and Recent Developments](index=30&type=section&id=Overview%20and%20Recent%20Developments) Strategy focuses on FPC platform expansion and concentrates business improvement, supported by a DaVita agreement and reverse stock split - The company's strategy is to expand its FPC technology platform into new therapeutic areas, such as home infusion and acute heart failure, while improving the efficiency and profitability of its legacy concentrates business[147](index=147&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) - On April 6, 2022, the company entered into a strategic arrangement with DaVita to stabilize its concentrates business through better pricing, cost-sharing, and a commitment from DaVita to invest up to **$15 million** in preferred stock[157](index=157&type=chunk) - A **1-for-11 reverse stock split** was effected on May 13, 2022, to address non-compliance with Nasdaq's minimum bid price rule[146](index=146&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Q1 2022 net sales rose **4.2%** to **$16.1 million**, but inflation led to a **$0.8 million** gross loss despite reduced operating expenses Q1 2022 vs Q1 2021 Operating Results (in thousands) | | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | % Change | | :--- | :--- | :--- | :--- | | Net Sales | $16,124 | $15,473 | 4.2% | | Gross (Loss) Profit | $(786) | $401 | (296.0)% | | Research and Product Development | $1,567 | $1,809 | (13.4)% | | Selling and Marketing | $455 | $1,851 | (75.4)% | | General and Administrative | $3,818 | $3,923 | (2.7)% | | **Operating Loss** | **$(6,626)** | **$(7,182)** | **(7.7)%** | - Gross profit decreased by **$1.2 million** to a gross loss, primarily due to significant inflationary pressures impacting the concentrates business. The company expects margins to improve following the renegotiated contract with DaVita[162](index=162&type=chunk) - Selling and marketing expenses decreased by **$1.4 million (75.4%)** due to reduced marketing spend for Triferic products and a reduction in headcount[164](index=164&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Substantial doubt exists about the company's going concern ability due to losses, with management's plans including a DaVita agreement and capital raising - The company's history of significant net losses and an accelerated operating loss in its concentrates business due to inflation raise substantial doubt about its ability to continue as a going concern[168](index=168&type=chunk)[169](index=169&type=chunk) - Management's plan to address the going concern issue includes the amended DaVita agreement, a **$15M** equity investment from DaVita (contingent on raising an additional **$15M** by June 30, 2022), a **$12.2M** 'at-the-market' stock offering, and cost-cutting measures[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - Net cash used in operating activities was **$9.8 million** for Q1 2022. Cash was provided by investing activities (**$9.1 million**) through the liquidation of all available-for-sale investments[180](index=180&type=chunk)[181](index=181&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=38&type=section&id=Item%203%20-%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a Smaller Reporting Company, Rockwell Medical, Inc. is not required to provide disclosure for this item - The Company is designated a Smaller Reporting Company and is not required to provide the disclosure required by this Item[189](index=189&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204%20-%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal controls - Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2022[191](index=191&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[192](index=192&type=chunk) Part II — Other Information [Item 1. Legal Proceedings](index=39&type=section&id=Item%201%20-%20Legal%20Proceedings) No legal proceedings are expected to materially affect the company's financial condition or operations - The company is not involved in any legal proceedings expected to have a material effect on its financial condition or operations[194](index=194&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A%20-%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K - There have been no material changes to the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021[195](index=195&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202%20-%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) None - None[196](index=196&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206%20-%20Exhibits) Exhibits filed include the Certificate of Amendment for the reverse stock split and the DaVita Securities Purchase Agreement - Exhibits filed include amendments to the Certificate of Incorporation for the reverse stock split, the Securities Purchase Agreement with DaVita, and CEO/CFO certifications[200](index=200&type=chunk)[201](index=201&type=chunk)