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):

 

July 26, 2018

 

ROCKWELL MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

Michigan

 

000-23661

 

38-3317208

(State or other
jurisdiction of
incorporation)

 

(Commission File
Number)

 

(IRS Employer
Identification No.)

 

30142 Wixom Road, Wixom, Michigan 48393

(Address of principal executive offices, including zip code)

 

(248) 960-9009

(Registrant’s telephone number, including area code)

 

Not Applicable

(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:

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

 

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                                              o

 

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.   o

 

 

 



 

Item 4.01                                           Changes in Registrant’s Certifying Accountant.

 

On July 26, 2018, the Audit Committee of the Board of Directors of Rockwell Medical, Inc. (the “Company”) engaged Marcum LLP (“Marcum”) as the Company’s new independent registered public accounting firm. The engagement of Marcum comes after the resignation of the Company’s former independent registered public accounting firm, Plante & Moran, PLLC (“Plante”), on June 22, 2018.

 

During the two years ended December 31, 2017 and 2016 and the subsequent interim periods through July 26, 2018, neither the Company, nor anyone on its behalf, has consulted with Marcum regarding: (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company’s financial statements or the effectiveness of internal control over financial reporting, and neither a written report or oral advice was provided to the Company that Marcum concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing or financial reporting issue; (ii) any matter that was the subject of a disagreement within the meaning of Item 304(a)(1)(iv) of Regulation S-K or (iii) any reportable event within the meaning of Item 304(a)(1)(v) of Regulation S-K, other than informing Marcum of the material weakness in the Company’s internal control over financial reporting and the inability to rely on management representations identified by Plante as described in the Company’s Current Report on Form 8-K filed on June 27, 2018.

 

The Audit Committee discussed the subject matter of the reportable events described in the Company’s Current Report on Form 8-K filed on June 27, 2018 with Plante. The Company has authorized Plante to respond fully to all inquiries of Marcum concerning all matters related to the periods audited by Plante, including with respect to the subject matter of these reportable events.

 

Item 8.01                                           Other Events.

 

On July 30, 2018, the Company issued a press release announcing the engagement of Marcum. Attached hereto as Exhibit 99.1 and incorporated herein by reference, is a copy of the press release.

 

Item 9.01                                           Financial Statements and Exhibits.

 

(d) Exhibits.                              The following exhibits are being filed herewith:

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release, dated July 30, 2018.

 

2



 

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: July 30, 2018

By:

/s/ Benjamin Wolin

 

 

Benjamin Wolin

 

 

Chairman of the Board

 

3


Exhibit 99.1

 

Rockwell Medical Announces Engagement of Marcum LLP as New Independent Auditor

 

WIXOM, Mich., July 30, 2018 — Rockwell Medical, Inc. (NASDAQ:RMTI) (the “Company”) today announced  that the Audit Committee of its Board of Directors has engaged Marcum LLP as Rockwell Medical’s new independent registered public accounting firm.

 

The Audit Committee of the Rockwell Medical Board engaged Marcum LLP following a month-long search and evaluation of several audit firms.

 

The Company has also filed a Form 8-K with the Securities and Exchange Commission noting the engagement of Marcum LLP.

 

About Rockwell Medical, Inc.

 

Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.

 

Rockwell’s anemia drug Triferic is the only FDA-approved product indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and other major markets globally.

 

Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.  Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market.

 

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities.

 

Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.

 

Forward-Looking Statement

 

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to bring to market Triferic and Calcitriol. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,”

 



 

“anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “project,” “plan”, “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell 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’s SEC filings), many of which are beyond our control and subject to change Actual results could be materially different. Risks and uncertainties include: the ongoing litigation with Rockwell’s former Chief Executive Officer, Chief Financial Officer and certain current and former directors; the timing for the appointment of a successor Chief Executive Officer, Chief Financial Officer; Rockwell’s ability to maintain compliance with SEC and NASDAQ rules and requests; and whether Rockwell can successfully execute on its business strategy. Rockwell expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

 

Contacts

 

Dan Katcher / Kelly Sullivan / Arielle Rothstein

Joele Frank, Wilkinson Brimmer Katcher

212-355-4449