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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): November 14, 2023
Rockwell
Medical, Inc.
(Exact name of registrant as specified in its
charter)
Delaware |
000-23661 |
38-3317208 |
(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 November 14, 2023, Rockwell Medical, Inc. issued
a press release and earnings presentation announcing its financial results for the quarter ended September 30, 2023. The press release
and earnings presentation are 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
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: November 14, 2023 |
By: |
/s/ Mark Strobeck |
|
|
Mark Strobeck |
|
|
Chief Executive Officer |
Exhibit 99.1
Rockwell Medical
Announces Third Quarter 2023 Results
| · | Net
sales for the third quarter of 2023 were $23.8 million, including concentrates product sales
of $21.6 million, both of which were the highest sales generated to-date for the Company. |
| · | Gross
profit for the third quarter of 2023 increased 183% over the same period in 2022. Gross margin
for the third quarter of 2023 was 9%, an increase from 4% for the same period in 2022. |
| · | Operating
loss for the third quarter of 2023 was $1.7 million, a 41% improvement over the second quarter
of 2023 and a 53% improvement over the same period in 2022. |
| · | Rockwell
Medical reiterates projected 2023 net sales to be between $82.0 million and $86.0 million,
an increase of 17% to 18% year-over-year, and projected 2023 gross profit to between $8.0
million and $10.0 million, an increase of 95% to 144% year-over-year. |
| | |
| · | Rockwell
Medical expects to achieve profitability on an adjusted EBITDA basis in the fourth quarter
of 2023. |
Wixom,
Michigan, November 14, 2023 – 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 September 30, 2023.
"Since
we started implementing our new focused business strategy a little over a year ago, we have successfully completed two acquisitions,
aligned our cost structure, and are on track to meet our revenue and profitability expectations for this year," said
Mark Strobeck, Ph.D.,
Rockwell Medical’s President and CEO. "During the third quarter of 2023, Rockwell Medical became the leading supplier of liquid
bicarbonate hemodialysis concentrates in the United States and now services approximately one-third of all purchasing facilities, including
outpatient dialysis clinics and hospitals. Additionally, Rockwell Medical continues to evaluate potential business development opportunities
that could continue to strengthen our existing hemodialysis concentrates business and potentially enable Rockwell Medical to expand into
new product categories and markets."
Third Quarter 2023 Operating Highlights
| · | Rockwell
Medical completed its second acquisition during the third quarter of 2023, acquiring the
hemodialysis concentrates assets from Evoqua Water Technologies. Evoqua's operations are
fully automated and afford Rockwell Medical the potential to manufacture its hemodialysis
concentrates products at a lower cost and add significant capacity to the Company's production
line. By assuming responsibility for Evoqua’s concentrates customer contracts, Rockwell
Medical has further expanded its footprint in the United States and assumed a larger share
of the already growing hemodialysis concentrates market. Additionally, the Company is now
the leading supplier of liquid bicarbonate products to dialysis centers in the United States. |
|
|
| · | Rockwell
Medical entered into an amended and restated products purchase agreement with its largest
customer. Under the agreement, Rockwell Medical and the customer agreed to an increase in
product pricing, effective September 1, 2023 and continuing until December 31, 2024, and
a one-time payment to Rockwell Medical on or after December 1, 2023. The customer has the
option to further extend the term through December 31, 2025. In the event of such an extension,
product pricing will be increased for the extended term. |
| · | Rockwell
Medical entered into several three-year product purchase agreements with new and existing
customers including Centers for Dialysis Care, Houston Methodist, and Sanderling Renal Services. |
| · | Rockwell
Medical appointed Joan Lau, Ph.D. to the Company's Board of Directors. Dr. Lau has more than
20 years’ experience in executive leadership of R&D focused biopharma as an entrepreneur
scientist, CEO, operator, investor, and board member of public and private biopharmaceutical
companies. |
| · | Rockwell
Medical named Jesse Neri as Senior Vice President, Finance. Mr. Neri has more than 20 years’
experience leading finance functions at both public and private companies. |
Third Quarter 2023 Financial Highlights
| · | Net sales for the three months
ended September 30, 2023 were $23.8 million, representing a 31% increase over the second quarter of 2023 and a 27% increase over $18.7
million for the same period in 2022. Concentrates product sales for the three months ended September 30, 2023 were $21.6 million, the
highest quarterly concentrates product sales generated to-date for the Company. Net sales for the nine months ended September 30, 2023
were $61.5 million, representing a 15% increase over the same period in 2022. |
| · | Gross profit for the three months
ended September 30, 2023 was $2.2 million, representing an increase of $1.2 million over the second quarter of 2023 and a 183% increase
over the same period in 2022. Gross profit for the nine months ended September 30, 2023 was $5.8 million, representing a 236% increase
over the same period in 2022. |
| · | Gross margin for the three months
ended September 30, 2023 was 9%, representing an increase from 6% in the second quarter of 2023 and 4% for the same period in 2022. Gross
margin for the nine months ended September 30, 2023 was 9%, compared with 3% for the same period in 2022. |
| · | Rockwell
Medical undertook workforce and cost reductions as part of its continued business restructuring.
Operating loss for the three months ended September 30, 2023 was $1.7 million, representing
a 53% decrease from an operating loss of $3.7 million for the same period in 2022. Operating
loss for the nine months ended September 30, 2023 was $6.1 million, representing a 59% decrease
from an operating loss of $14.8 million for the same period in 2022. |
| · | Cash
and cash equivalents and investments available-for-sale at September 30, 2023 was $11.7 million
compared to cash and cash equivalents and investments available-for-sale of $14.9 million
at June 30, 2023. The decrease in cash for the third quarter of 2023 included a $0.5 million
principal payment to reduce the Company's outstanding debt and a $4 million increase in the
Company's accounts receivable primarily related to the Evoqua asset acquisition. The Company
anticipates collection of these receivables in the fourth quarter of 2023. |
| · | Rockwell
Medical's outstanding debt at the end of the third quarter of 2023 was $9.5 million. The
Company projects its outstanding debt at year-end 2023 will be $8.0 million. |
Financial Highlights
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
(In Thousands, Except Per Share Amounts) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net Sales | |
$ | 23,771 | | |
$ | 18,691 | | |
$ | 61,519 | | |
$ | 53,497 | |
| |
| | | |
| | | |
| | | |
| | |
Gross Profit | |
| 2,202 | | |
| 777 | | |
| 5,834 | | |
| 1,737 | |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| (1,872 | ) | |
| (4,189 | ) | |
| (6,927 | ) | |
| (16,318 | ) |
| |
| | | |
| | | |
| | | |
| | |
Adjusted EBITDA* | |
| (1,347 | ) | |
| (3,208 | ) | |
| (4,581 | ) | |
| (13,237 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and Diluted Net Loss per Share ** | |
$ | (0.07 | ) | |
$ | (0.23 | ) | |
$ | (0.32 | ) | |
$ | (1.26 | ) |
* See reconciliation to GAAP financial measures in the tables below.
**
See Note 3 for more details related to Basic and Diluted Weighted Average Shares Outstanding
on Form 10-Q filed November 14, 2023.
2023 GUIDANCE
The
Company expects net sales for 2023 to be between $82.0 million and $86.0 million, which represents an increase of 17% to 18% year-over-year.
The Company expects gross profit for 2023 to be between $8.0 million and $10.0 million, which represents an increase of 95% to 144% year-over-year.
Since Rockwell Medical announced its updated business strategy in November 2022, the Company provided
guidance that it expected to achieve profitability in 2024. Rockwell Medical now expects to be profitable on an adjusted EBITDA basis
in the fourth quarter of 2023.
CONFERENCE CALL AND WEBCAST DETAILS
Date: Tuesday,
November 14, 2023
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 third quarter 2023 operational and financial 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.
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 EBITDA 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 as a tool for comparison. There are a number of limitations related to the
use of these non-GAAP financial measures rather than net loss, which is the most directly comparable financial measure calculated in
accordance with GAAP. When evaluating the Company’s performance, you should consider Adjusted EBITDA alongside other financial
performance measures, including net loss and other GAAP results. Adjusted EBITDA is our best proxy for cash burn.
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 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," “guidance,” 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 be profitable
in the fourth quarter of 2023, will achieve its expected net sales or gross profit for the full year 2023, or that the hemodialysis
concentrates market will continue to grow and that Rockwell Medical will grow its market share.
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 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
(248) 432-1362
IR@RockwellMed.com
Financial Tables
Follow
###
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars In Thousands)
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
| (Unaudited) | | |
| | |
Cash, Cash Equivalents & Investments available-for-sale | |
$ | 11,730 | | |
$ | 21,492 | |
Total Assets | |
$ | 52,607 | | |
$ | 46,635 | |
Total Liabilities | |
$ | 31,088 | | |
$ | 32,529 | |
Total Stockholders’ Equity | |
$ | 21,519 | | |
$ | 14,106 | |
| |
| | | |
| | |
Common Stock Outstanding | |
| 28,489,663 | | |
| 12,163,673 | |
Common stock and common stock equivalents* | |
| 35,554,361 | | |
| 31,356,373 | |
| |
| | | |
| | |
*Common stock and common stock equivalents: | |
| | | |
| | |
Common stock | |
| 28,489,663 | | |
| 12,163,673 | |
Common stock warrants (pre-funded) | |
| - | | |
| 6,300,000 | |
Common stock and pre-funded stock warrants | |
| 28,489,663 | | |
| 18,463,673 | |
Preferred stock converted | |
| 1,363,636 | | |
| 1,363,636 | |
Options to purchase common stock | |
| 1,367,493 | | |
| 1,206,905 | |
Restricted stock awards | |
| 891 | | |
| 891 | |
Restricted stock units | |
| 287,400 | | |
| 125,000 | |
Common stock warrants | |
| 4,045,278 | | |
| 10,196,268 | |
Total common stock and common stock equivalents | |
| 35,554,361 | | |
| 31,356,373 | |
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In Thousands, Except Shares and Per Share Amounts)
| |
Three Months
Ended September
30, 2023 | | |
Three Months
Ended September
30, 2022 | | |
Nine Months
Ended September
30, 2023 | | |
Nine Months
Ended September
30, 2022 | |
Net Sales | |
$ | 23,771 | | |
$ | 18,691 | | |
$ | 61,519 | | |
$ | 53,497 | |
Cost of Sales | |
| 21,569 | | |
| 17,914 | | |
| 55,685 | | |
| 51,760 | |
Gross Profit (Loss) | |
| 2,202 | | |
| 777 | | |
| 5,834 | | |
| 1,737 | |
Research and Product Development | |
| 495 | | |
| 469 | | |
| 939 | | |
| 2,963 | |
Selling and Marketing | |
| 556 | | |
| 762 | | |
| 1,584 | | |
| 1,743 | |
General and Administrative | |
| 2,889 | | |
| 3,253 | | |
| 9,434 | | |
| 11,845 | |
Operating Loss | |
| (1,737 | ) | |
| (3,707 | ) | |
| (6,123 | ) | |
| (14,814 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other (Expense) Income | |
| | | |
| | | |
| | | |
| | |
Realized Gain on Investments | |
| 220 | | |
| - | | |
| 220 | | |
| 4 | |
Interest Expense | |
| (410 | ) | |
| (476 | ) | |
| (1,193 | ) | |
| (1,497 | ) |
Interest Income | |
| 56 | | |
| (6 | ) | |
| 169 | | |
| (10 | ) |
Total Other Expense | |
| (134 | ) | |
| (482 | ) | |
| (804 | ) | |
| (1,503 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (1,872 | ) | |
$ | (4,189 | ) | |
$ | (6,927 | ) | |
$ | (16,318 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and Diluted Net Loss per Share | |
$ | (0.07 | ) | |
$ | (0.23 | ) | |
$ | (0.32 | ) | |
$ | (1.26 | ) |
Basic and Diluted Weighted Average Shares Outstanding | |
| 27,521,088 | | |
| 18,463,673 | | |
| 21,526,978 | | |
| 12,902,890 | |
Reconciliation to GAAP Financial Measures
Adjusted EBITDA
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net Loss | |
$ | (1,872 | ) | |
$ | (4,189 | ) | |
$ | (6,927 | ) | |
$ | (16,318 | ) |
Income taxes | |
| — | | |
| — | | |
| — | | |
| — | |
Interest expense, net | |
| 318 | | |
| 382 | | |
| 921 | | |
| 1,219 | |
Depreciation and amortization | |
| 518 | | |
| 234 | | |
| 1,030 | | |
| 696 | |
| |
| | | |
| | | |
| | | |
| | |
EBITDA | |
| (1,036 | ) | |
| (3,573 | ) | |
| (4,976 | ) | |
| (14,403 | ) |
| |
| | | |
| | | |
| | | |
| | |
One time severance costs | |
| 576 | | |
| 188 | | |
| 777 | | |
| 1,072 | |
Stock-based compensation | |
| 212 | | |
| 177 | | |
| 717 | | |
| 94 | |
Wanbang deferred revenue | |
| (2,197 | ) | |
| - | | |
| (2,197 | ) | |
| - | |
Wanbang inventory reserve | |
| 1,098 | | |
| - | | |
| 1,098 | | |
| - | |
Adjusted EBITDA | |
$ | (1,347 | ) | |
$ | (3,208 | ) | |
$ | (4,581 | ) | |
$ | (13,237 | ) |
v3.23.3
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Nov. 14, 2023 |
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