0001041024FALSE00010410242024-05-142024-05-14

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  May 14, 2024
 
ROCKWELL MEDICAL, INC.
(Exact name of registrant as specified in its charter)
 
Delaware000-2366138-3317208
(State or other jurisdiction
of incorporation)		(Commission File Number)(IRS Employer
Identification No.)
 
30142 S. Wixom Road, Wixom, Michigan 48393
(Address of principal executive offices, including zip code)
 
(248) 960-9009
(Registrant’s telephone number, including area code)
 
N/A
(Former name or former address, if changed since last report)
  
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each Class Trading Symbol Name of Each exchange on which registered
Common Stock, par value $0.0001 RMTI 
Nasdaq Capital Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐


 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 




Item 2.02        Results of Operations and Financial Condition.

On May 14, 2024, Rockwell Medical, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2024. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8‑K.

As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 incorporated in this Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01        Financial Statements and Exhibits.

(d) Exhibits        The following exhibit is being furnished herewith:

EXHIBIT INDEX
 
Exhibit No. Description
   
99.1 
104Cover Page Interactive Data File, formatted in INline XBRL and included as Exhibit 101.



SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 ROCKWELL MEDICAL, INC.
   
Date: May 14, 2024By: /s/ Mark Strobeck
  Mark Strobeck
  Chief Executive Officer

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Rockwell Medical Announces First Quarter 2024 Results, Raises 2024 Guidance
•Reports record net sales of $22.7 million for the first quarter of 2024, an increase of 25% over net product sales and a 15% increase over net sales for the same period in 2023.
•Reports record gross profit of $3.1 million for the first quarter of 2024, an increase of 18% over the same period in 2023.
•Raises guidance for net sales, gross profit, and profitability on an adjusted EBITDA basis for the full-year 2024.

Wixom, Michigan, May 14, 2024 – 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 ended March 31, 2024.

"We continue to see increasing interest in, and market demand for, our hemodialysis portfolio of products from medical equipment suppliers and distributors, along with health systems, dialysis centers, and skilled nursing facilities, domestically and internationally, all of which advances our vision to expand our global footprint and become the leading global supplier of all hemodialysis concentrates," said Mark Strobeck, Ph.D., Rockwell Medical’s President and CEO. "Taking into account our first quarter 2024 financial and operating results, we are pleased to announce that we have revised our guidance for 2024 upward and believe we are well-positioned to deliver on that guidance."

FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS

Net sales for the three months ended March 31, 2024 consisted solely of concentrates products sales. Net sales for the three months ended March 31, 2023 consisted of sales of concentrates products and the recognition of $1.5 million of deferred license revenue related to the termination of the Baxter distribution agreement. The following first quarter year-over-year financial highlights illustrate the organic growth driven exclusively by the Company's hemodialysis concentrates products, particularly after excluding the impact of deferred revenue recognized in the first quarter of 2023.
•Net sales for the three months ended March 31, 2024 were $22.7 million, the highest quarterly concentrates products sales generated to date for the Company. This represents a 15% increase over net sales of $19.7 million for the same period in 2023. Excluding deferred revenue, net sales for the first quarter of 2024 increased 25% over the same period in 2023.
•Gross profit for the three months ended March 31, 2024 was $3.1 million, representing an 18% increase over $2.6 million for the same period in 2023. Excluding deferred revenue, gross profit of $3.1 million in the first quarter of 2024 nearly tripled from $1.1 million over the same period in 2023.
•Gross margin for the three months ended March 31, 2024 was 14%, representing an increase from 13% for the same period in 2023. Excluding deferred revenue, gross margin for the first quarter of 2024 approximately doubled from gross margin of 6% for the same period in 2023.
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•Net loss for the three months ended March 31, 2024 was $1.7 million, representing a slight improvement over a net loss of $1.8 million for the same period in 2023. Excluding deferred revenue, net loss for the first quarter of 2024 improved by $1.5 million over a net loss of $3.2 million for the same period in 2023.
•Adjusted EBITDA for the three months ended March 31, 2024 was ($0.5) million. Seasonal items related to audit, payroll tax, and other public-company related expenses historically incurred in the first quarter drove the Company's Adjusted EBITDA to be slightly negative. The Company expects expenses to normalize for the remainder of 2024.
•Cash and cash equivalents and investments available-for-sale at March 31, 2023 was $8.6 million compared to cash and cash equivalents and investments available-for-sale of $10.9 million at December 31, 2023. The decrease in cash of approximately $2.3 million was driven by changes in working capital. At close-of-business May 9, 2024, our cash and cash equivalents and investments available for sale was $10.2 million.
•During the first quarter of 2024, the Company amended its Loan and Security Agreement with Innovatus Life Sciences Lending Fund I, LP. Under the terms of the amendment, Rockwell Medical reduced the interest rate on the $8.0 million remaining balance of the loan and extended the loan maturity date from March 2025 to January 2029. The Company will now make interest-only payments through September 2026 and may extend the interest-only period through March 2027 if certain conditions are met.
Three Months Ended
March 31
(In Millions, Except Per Share Amounts)2024   2023*
Net Sales$ 22.7    $ 19.7    
Gross Profit3.1    2.6    
Operating Loss(1.3)(1.4)
Net Loss(1.7)(1.8)
Adjusted EBITDA*
(0.5)
(1.0)
Basic and Diluted Net Loss per Share **$ (0.06)$ (0.10)
Adjusted EPS ***$ (0.02)$ (0.05)

* Includes $1.5 million of deferred license revenue related to the termination of the Baxter distribution agreement.
** See Note 3 for more details related to Basic and Diluted Weighted Average Shares Outstanding on Form 10-Q filed May 14, 2024.
*** See reconciliation to GAAP financial measures in the tables below.




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FIRST QUARTER 2024 OPERATING HIGHLIGHTS
•Rockwell Medical was certified as a Great Place to Work® for the second year in a row. This accreditation reflects the continued positive changes the Company has made over the last two years.
•Rockwell Medical entered into new and expanded distribution agreements with BioNuclear and Atlantic Medical International ("AMI"), respectively. In the aggregate, these agreements are expected to generate approximately $1 million in annual revenues for the Company. BioNuclear specializes in the marketing of reagents, equipment and furniture for clinical laboratories, medical equipment and devices, vaccines for human consumption and supplies for hemodialysis and peritoneal dialysis. AMI is Bermuda's leading supplier of medical products and equipment for the acute and continuing care markets.
•Rockwell Medical entered into a product purchase agreement with one of the largest health systems in the Mountain West region of the United States. Under the terms of the agreement, Rockwell Medical will supply this health system with the Company's liquid and dry acid and bicarbonate hemodialysis concentrates, cleaning agents, hemodialysis concentrates mixers and any additional products offered by Rockwell Medical.

GUIDANCE
Rockwell updates its guidance as follows:

Initial 2024 GuidanceUpdated 2024 GuidanceUpdated Expected
Improvement (%) over 2023
Net Sales$84.0M to $88.0M $90.0M to $94.0M 13% to 18% increase over $79.8 million in net product sales for 2023
Gross Profit $12.0M to $14.0M $13.0M to $15.0M49% to 72% increase over $8.7 million in gross profit for 2023
Gross Margin 14% to 16%unchanged4 to 6 percentage point increase over 10% in gross margin for 2023
Adjusted EBITDAnill to $0.5M$0.5M to $1.0M 113% to 126% increase over ($3.9) million in adjusted EBITDA for 2023

Rockwell Medical projects net sales to grow in the mid-to-high single digits in 2025 and beyond. Rockwell Medical projects gross margin in 2025 to be approximately 20% and reaching above 25% in 2026 and beyond.


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CONFERENCE CALL AND WEBCAST DETAILS

Date: Tuesday, May 14, 2024
Time: 8:00am ET
Live Number: (888) 660-6347 // (International) 1 (929) 201-6594
Conference Call ID: 4944610
Webcast and Replay: www.RockwellMed.com/Results
Speakers:
•Mark Strobeck, Ph.D. — President and Chief Executive Officer; and
•Jesse Neri — SVP, Finance.
Format: Discussion of first quarter 2024 financial and operational results followed by Q&A.

NON-GAAP FINANCIAL MEASURES
To supplement Rockwell Medical’s unaudited condensed consolidated statements of operations and unaudited condensed consolidated balance sheets, which are prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”), this press release also includes references to Adjusted EBITDA, a non-GAAP financial measure that is defined as net income (loss) before net interest income (expense), net other income (expense), income tax expenses (benefit), depreciation and amortization, impairment charges, stock-based compensation expense, and other items that are considered unusual or not representative of underlying trends of our business, including but not limited to one-time severance costs, deferred revenue and inventory reserve amounts, if applicable for the periods presented. The Company has provided a reconciliation of net loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA at the end of this press release. In addition, the Company has excluded deferred revenue from first quarter calculations of net sales, gross profit, gross margin and net loss. Each of these adjusted measures is a non-GAAP financial measure. The Company has provided reconciliations to the GAAP measures at the end of this press release.

Adjusted EBITDA is a key measure used by Rockwell Medical to understand and evaluate operating performance and trends, to prepare and approve its annual budget and to develop short- and long-term operating plans. The Company provides Adjusted EBITDA because it believes the metric is helpful in highlighting trends in its operating results because it excludes items that are not indicative of Rockwell Medical’s core operating performance. In particular, the Company believes that the exclusion of the items eliminated in calculating Adjusted EBITDA provides useful measures for period-to-period comparisons of Rockwell Medical’s business. Adjusted net sales, gross profit, gross margin and net loss is used by Rockwell Medical to understand growth within its hemodialysis concentrates business by excluding a one-time item that is not indicative of its core operating performance.

Adjusted EBITDA and adjusted net sales, gross profit, gross margin and net loss should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. Other companies, including companies in the same industry, may calculate similarly titled non-GAAP financial measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of Adjusted EBITDA and adjusted net sales, gross profit, gross margin and net loss as tools for comparison. There are a number of limitations related to the use of these non-GAAP financial measures rather than the most directly comparable financial measures calculated in accordance with GAAP. When evaluating the Company’s performance, you should consider Adjusted EBITDA and adjusted net sales, gross profit, gross margin and net loss alongside other financial performance measures, including net loss
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and other GAAP results. Adjusted EBITDA is our best proxy for cash burn. Adjusted net sales, gross profit, gross margin and net loss enable us to understand growth within our hemodialysis concentrates business by excluding a one-time item that is not indicative of our core operating performance.

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 largest supplier of liquid bicarbonate concentrates and the second largest supplier of acid and dry bicarbonate concentrates for dialysis patients in the United States and has the vision of becoming the leading global supplier of all hemodialysis concentrates. Certified as a Great Place to Work® in 2023 and 2024, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis SolutionsTM. For more information, visit www.RockwellMed.com.

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," “feel confident,” “guidance,” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements include (without limitation) statements regarding: plans to expand our global footprint; our expectations regarding normalizing our expenses; the impact of our strategy on our top and bottom line; growth in the hemodialysis concentrates market; the growth of our business; guidance for net sales, gross profit, gross margin and adjusted EBITDA. 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, 2023, 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.
###
CONTACT:
Heather R. Hunter,
SVP, Chief Corporate Affairs Officer
IR@RockwellMed.com

Financial Tables Follow
###
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ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars In Thousands)
March 31,March 31,
20242023
Cash, Cash Equivalents & Investments available-for-sale$8,619 $16,833 
Total Assets$50,723 $40,472 
Total Liabilities$30,080 $27,930 
Total Stockholders’ Equity $20,643 $12,542 
Common Stock Outstanding29,556,47418,463,673
Common stock and common stock equivalents*37,222,73431,343,670
*Common stock and common stock equivalents:
Common stock29,556,47412,552,673
Common stock warrants (pre-funded)— 5,911,000
Common stock and pre-funded stock warrants29,556,47418,463,673
Preferred stock converted1,363,6361,363,636
Options to purchase common stock1,876,0311,194,202
Restricted stock awards891891
Restricted stock units441,218125,000
Common stock warrants3,984,48410,196,268
Total common stock and common stock equivalents37,222,73431,343,670
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ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In Thousands, Except Shares and Per Share Amounts)
    Three Months Ended March 31, 2024Three Months Ended March 31, 2023
Net Sales$22,676 $19,668 
Cost of Sales19,612 17,069 
Gross Profit3,064 2,599 
Research and Product Development18 278 
Selling and Marketing594 498 
General and Administrative3,776 3,250 
Operating Loss(1,325)(1,427)
Other (Expense) Income
Interest Expense(431)(387)
Interest Income24 64 
Total Other Expense(406)(323)
 
Net Loss$(1,731)$(1,750)
Basic and Diluted Net Loss per Share$(0.06)$(0.10)
Basic and Diluted Weighted Average Shares Outstanding29,327,20418,359,940
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Reconciliation to GAAP Financial Measures
(In Thousands, Except Shares and Per Share Amounts)
Three Months Ended
March 31
20242023
Net Loss$(1,731)$(1,750)
Income taxes
Interest expense431 387 
Depreciation and amortization544 159 
EBITDA(757)(1,205)
Severance costs— 29 
Stock-based compensation251 193 
Adjusted EBITDA$(506)$(982)
Adjusted EPS$(0.02)$(0.05)
Basic and Diluted Weighted Average Shares Outstanding29,327,20418,359,940
Reconciliation to GAAP Financial Measures
(Dollars in Thousands)
Three Months Ended
March 31
20242023
Net Sales$22,676 $19,668 
Deferred Revenue— (1,472)
Net Sales excluding Deferred Revenue22,676 18,197 
Gross Profit3,064 2,599 
Deferred Revenue— (1,472)
Gross Profit excluding Deferred Revenue$3,064 $1,128 
Net Loss(1,731)(1,750)
Deferred Revenue0(1,472)
Net Loss excluding Deferred Revenue$(1,731)$(3,222)
v3.24.1.1.u2
Cover
May 14, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 14, 2024
Entity Registrant Name ROCKWELL MEDICAL, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 000-23661
Entity Tax Identification Number 38-3317208
Entity Address, Address Line One 30142 S. Wixom Road
Entity Address, City or Town Wixom
Entity Address, State or Province MI
Entity Address, Postal Zip Code 48393
City Area Code 248
Local Phone Number 960-9009
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001
Trading Symbol RMTI
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001041024
Amendment Flag false
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