Ferric Pyrophosphate Citrate

Turkish Medicines and Medical Devices Agency assigns priority review status for Drogsan's Marketing Authorization application and high priority status for Drogsan's GMP application for Triferic AVNU WIXOM, Mich.--(BUSINESS WIRE)-- Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that its international partner, Drogsan Pharmaceuticals, submitted a Marketing Authorization application and GMP application for Triferic® AVNU to the Turkish Medicines and Medical Devices Agency ("TMMDA"), for which Drogsan received priority status and high priority status, respectively. Triferic AVNU (ferric pyrophosphate citrate injection) is an iron replacement product indicated to maintain hemoglobin in adult patients undergoing hemodialysis. In June 2021, Rockwell entered into license and supply agreements with Drogsan, one of the leading pharmaceutical companies in Turkey, for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. Under the terms of the agreements, Drogsan will be the exclusive commercialization partner for Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, Rockwell received an upfront payment and will be eligible for milestone payment and royalties on net sales. Drogsan will be responsible for all regulatory approval and commercialization activities, and the Company will supply the product to Drogsan for Turkey. "Rockwell’s international partnerships have the potential to generate near- and long-term revenue for Rockwell. We continue to work diligently with our international partners to bring Triferic to market in their respective territories. We are excited that Drogsan is making great strides in its plan to register and commercialize Triferic AVNU in Turkey," said Mark Strobeck, Ph.D., Rockwell Medical’s President and CEO. "Taking into consideration that Drogsan was granted an accelerated review for Triferic AVNU with the Turkish regulatory authority, we anticipate approval for Triferic AVNU in 2024." About Rockwell Medical Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Rockwell Medical is the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States and has the vision of becoming the leading global supplier of hemodialysis concentrates. Certified as a Great Place to Work® in 2023, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis SolutionsTM. For more information, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident," “are determined,” “are on track,” “are resolute in our vision,” "work to," "drive towards," or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. There can be no assurance that Rockwell’s international partnerships will generate near- and long-term revenue for Rockwell; that Triferic will be brought to market in territories where Rockwell has partnerships; or that Triferic AVNU will be approved in Turkey in 2024 or at all. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2022, as such description may be amended or updated in any future reports we the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law. View source version on businesswire.com: Contacts Heather R. Hunter SVP, Chief Corporate Affairs Officer (248) 432-1362 IR@RockwellMed.com Source: Rockwell Medical, Inc. View this news release online at:

Achieved third consecutive quarter of revenue growth with new high of $19.3 million in the fourth quarter 2022, representing a 26.0% increase over same period in 2021 Exceeded annual revenue guidance generating $72.8 million in 2022, representing a 17.6% increase year-over-year and the highest full-year revenue to date for the Company Reduced debt to $10.0 million at December 31, 2022, representing a significant decrease from $21.6 million at December 31, 2021 WIXOM, Mich.--(BUSINESS WIRE)-- Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced financial and operational results for the three months and full-year ended December 31, 2022. "In 2022, Rockwell delivered on its new business strategy, achieving three consecutive quarters of improved financial performance that culminated in the highest full-year revenue to-date for the Company," said Mark Strobeck, Ph.D., Rockwell Medical’s President and CEO. "Over the course of the year, we significantly reduced our expenses and paid down our debt. We continue to focus on enhancing efficiencies within our business as we drive towards profitability, all with the goal of benefiting patients and increasing stockholder value.” Fourth Quarter and Full-Year 2022 Financial Highlights Revenue for the three months ended December 31, 2022 was $19.3 million, which represents a 26.0% increase over $15.3 million for the three months ended December 31, 2021. Revenue for the twelve months ended December 31, 2022 was $72.8 million, which represents a 17.6% increase year-over-year compared to $61.9 million for the comparable period in 2021. For the three months ended December 31, 2022, cash used in operating activities was $594,000 compared to cash used in operating activities of $9.0 million for the same period in 2021. Cash used in operating activities for the twelve months ended December 31, 2022 was $17.4 million compared to $33.5 million for the same period in 2021. For the three months ended December 31, 2022, Rockwell's net loss was $2.4 million, or $0.20 per share, compared with a net loss of $8.9 million, or $1.05 per share for the same period in 2021. For the full-year ended December 31, 2022, Rockwell's net loss was $18.7 million, or $1.89 per share, compared with a net loss of $32.7 million, or $3.83 per share in 2021. Cash and cash equivalents at December 31, 2022 was $21.5 million compared to cash and cash equivalents of $27.6 million at September 30, 2022. The variance was largely driven by the Company's $5.0 million pre-payment of its long-term debt during the fourth quarter of 2022. The Company's outstanding debt at December 31, 2022 was $10.0 million, compared to $21.6 million at December 31, 2022. At December 31, 2022, Rockwell Medical had 18.5 million common shares and prefunded warrants outstanding. Three Months Ended (In Thousands, Except Per Share Amounts) December 31, 2021 March 31, 2022 June 30, 2022 September 30, 2022 December 31, 2022 Net Sales $ 15,333 $ 16,124 $ 18,682 $ 18,691 $ 19,313 Operating Cash Flow $ (9,026 ) $ (9,812 ) $ (5,906 ) $ (1,101 ) $ (594 ) Net Loss $ (8,941 ) $ (7,162 ) $ (4,967 ) $ (4,190 ) $ (2,360 ) Basic and Diluted Net Loss per Share $ (1.05 ) $ (0.84 ) $ (0.56 ) $ (0.40 ) $ (0.20 ) Twelve Months Ended December 31, (In Thousands, Except Per Share Amounts) 2022 2021 Net Sales $ 72,810 $ 61,931 Operating Cash Flow $ (17,413 ) $ (33,534 ) Net Loss $ (18,679 ) $ (32,674 ) Basic and Diluted Net Loss per Share $ (1.89 ) $ (3.83 ) Fourth Quarter and Full-Year 2022 Operating Highlights In December 2022, we expanded our hemodialysis concentrates distribution capabilities westward into Minnesota. In November 2022, we announced a new business strategy focused on growing our revenue-generating businesses and exiting our non-profitable businesses. This included the reacquisition of our distribution rights for our hemodialysis concentrates business from Baxter, comprising more than 700 hemodialysis concentrates customers including hospitals, medical centers, dialysis centers, and health systems. Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022. Rockwell agreed to provide certain services to a group of Baxter customers until March 31, 2023. Following the reacquisition of these rights, Rockwell is now able to sell its hemodialysis concentrates products directly to dialysis clinics throughout the United States and around the world. In July 2022, Jeil Pharmaceutical commercially launched Triferic® in South Korea. In July 2022, Mark Strobeck, Ph.D. joined Rockwell as President and Chief Executive Officer and as a member of the Company's Board of Directors. In June 2022, we closed a $15 million financing that consisted of $12 million in a Registered Direct Offering and $3 million in a private investment in public equity, both priced at-market, with Armistice Master Fund Ltd. In April 2022, we expanded our partnership with DaVita through an amended supply agreement. DaVita entered into a stock purchase agreement under which DaVita initially invested $7.5 million in Rockwell Medical in April 2022 and then an additional $7.5 million in June 2022. In April 2022, we announced that our partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical, completed enrollment with over 400 patients for its pivotal phase 3 clinical trial of Triferic in China. 2023 Guidance “For 2023, we plan to continue to focus on growing our hemodialysis concentrates business by enhancing the economics within our current customer agreements, adding new long-term supply agreements with new customers, continuing to reduce expenses, lowering our debt, and driving our business to profitability,” Dr. Strobeck concluded. Rockwell projects its 2023 guidance as follows: Net Sales $78.0 Million to $82.0 Million Gross Profit $7.0 Million to $9.0 Million CONFERENCE CALL AND WEBCAST DETAILS Date: Thursday, March 30, 2023 Time: 8:00am ET Webcast: Live Number: (888) 660-6347 // (International) 1 (929) 201-6594 Replay Number: (800) 770-2030 // (International) 1 (647) 362-9199 A replay will be available via the replay number and webcast through April 29, 2023. Access Code: 4944610 Speakers: Mark Strobeck, Ph.D. — President and Chief Executive Officer; Paul McGarry, CPA — SVP, Finance and Chief Accounting Officer; and Tim Chole — SVP, Sales and Marketing Format: Discussion of fourth quarter and full-year 2022 operational and financial results followed by Q&A. About Rockwell Medical Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Rockwell Medical is the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States and has the vision of becoming the leading global supplier of hemodialysis concentrates. Certified as a Great Place to Work® in 2023, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis SolutionsTM. For more information, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident," or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. There can be no assurance that: Rockwell Medical will grow its hemodialysis concentrates business; Rockwell Medical will be able to enhance the economics in its current customer agreements; Rockwell Medical will add new long-term supply agreements with new customers; Rockwell Medical will continue to lower its debt: Rockwell Medical will achieve its projected total net product sales and gross profit for 2023; Rockwell Medical will be able to achieve planned cost savings to operate its concentrates business profitability or achieve the other components of its strategy; Rockwell Medical will achieve profitability; or Rockwell Medical’s future cash balance will be sufficient to fund operations going forward. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2021, as such description may be amended or updated in any subsequent reports filed with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law. Financial Tables Follow ROCKWELL MEDICAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Dollars In Thousands) December 31, December 31, 2022 2021 (Unaudited) Cash and Cash Equivalents $ 21,492 $ 22,438 Total Assets $ 46,635 $ 48,574 Total Liabilities $ 32,529 $ 46,039 Total Stockholders’ Equity $ 14,106 $ 2,535 Common Stock Outstanding 12,163,673 8,544,225 Common stock and common stock equivalents* 19,192,700 2,967,441 *Common stock and common stock equivalents: Common stock 12,163,673 8,544,225 Common stock warrants (pre-funded) 6,300,000 — Common stock and pre-funded stock warrants 18,463,673 8,544,225 Preferred stock converted 1,363,636 — Options to purchase common stock 1,206,905 528,591 Restricted stock awards 891 7,118 Restricted stock units 125,000 29,289 Common stock warrants 10,196,268 2,402,442 Total common stock and common stock equivalents 31,356,373 11,511,666 ROCKWELL MEDICAL, INC. AND SUBSIDIARIES UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (In Thousands, Except Shares and Per Share Amounts) Three Months Ended December 31, 2022 Three Months Ended December 31, 2021 Twelve Months Ended December 31, 2022 Twelve Months Ended December 31, 2021 Net Sales $ 19,313 $ 15,333 $ 72,810 $ 61,931 Cost of Sales 16,973 17,563 68,733 64,351 Gross Profit (Loss) 2,340 (2,230 ) 4,077 (2,420 ) Research and Product Development 156 1,391 3,119 6,835 Selling and Marketing 352 873 2,094 5,733 General and Administrative 3,798 3,865 15,644 15,348 Operating Loss (1,966 ) (8,359 ) (16,780 ) (30,336 ) Other (Expense) Income Realized Gain on Investments — — 4 — Interest Expense (439 ) (588 ) (1,936 ) (2,360 ) Interest Income 45 6 33 22 Total Other Expense (394 ) (582 ) (1,899 ) (2,338 ) Net Loss $ (2,360 ) $ (8,941 ) $ (18,679 ) $ (32,674 ) Basic and Diluted Net Loss per Share $ (0.20 ) $ (1.05 ) $ (1.89 ) $ (3.83 ) Basic and Diluted Weighted Average Shares Outstanding 11,549,521 8,542,756 9,866,844 8,526,186 View source version on businesswire.com: Contacts Heather R. Hunter SVP, Chief Corporate Affairs Officer (248) 432-1362 IR@RockwellMed.com Source: Rockwell Medical, Inc. View this news release online at: