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 10, 2018  

Rockwell Medical, Inc.
(Exact Name of Registrant as Specified in Charter)

Michigan000-2366138-3317208
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)

 

30142 Wixom Road, Wixom, Michigan 48393
(Address of Principal Executive Offices) (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:

 [   ]  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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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 10, 2018, the Company issued the press release attached hereto as Exhibit 99.1, announcing its financial results for the quarter ended March 31, 2018.

 

Item 9.01. Financial Statements and Exhibits.

The following exhibit is furnished with this Form 8-K:

Exhibit Description
   
99.1 Press Release dated May 10, 2018.

 


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 10, 2018By: /s/ Thomas E. Klema        
  Thomas E. Klema
  Its: Chief Financial Officer
  


EXHIBIT INDEX

Exhibit Description
   
99.1 Press Release dated May 10, 2018.

EdgarFiling

EXHIBIT 99.1

Rockwell Medical Reports First Quarter 2018 Results

Conference call at 4:30 p.m. EDT today, May 10

WIXOM, Mich., May 10, 2018 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated specialty pharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the first quarter ended March 31, 2018.

Q1 2018 Financial Highlights

Corporate Highlights

Mr. Robert L. Chioini, Chief Executive Officer of Rockwell stated, “We continue to work with federal policymakers to obtain separate reimbursement for Triferic. Our work with policy makers in Washington D.C. to ensure hemodialysis patients across the U.S. will have access to new, innovative therapies like Triferic continues to move in the right direction. There has been recent emphasis on spurring innovation in the U.S. renal market by those in Washington and we have strong support from key members of Congress and from senior officials within the Administration to make our innovative therapy accessible to the estimated 500,000 hemodialysis patients in the United States. Although we cannot be certain, based on our progress to date, we believe that Triferic has the potential to be granted separate reimbursement.”

Conference Call Information
Rockwell Medical will be hosting a conference call to review its 2018 first quarter today, Thursday, May 10, 2018 at 4:30 p.m. EDT.  Investors are encouraged to call a few minutes in advance at (866) 548-4713, or for international callers (323) 794-2093, Conference ID #3644040. To listen to the call via webcast, please go to the Rockwell Medical IR web page:  http://ir.rockwellmed.com/

About Triferic
Triferic is the only FDA approved drug indicated to replace iron and maintain hemoglobin in hemodialysis patients suffering from anemia. Via dialysate during each dialysis treatment, Triferic replaces the 5-7 mg iron loss that occurs in all patients, effectively maintaining their iron balance. Unlike IV iron products, Triferic binds iron immediately and completely to transferrin (carrier of iron in the body) upon entering the blood and it is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no anaphylaxis, addressing a significant unmet need in overcoming Functional Iron Deficiency (FID) in ESRD patients. Please visit www.triferic.com to view the Triferic mode-of-action (MOA) video and for more information.

About Rockwell Medical, Inc.
Rockwell Medical, Inc. (“Rockwell”) is a fully-integrated pharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.

Rockwell’s FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients suffering from anemia. 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 globally.

Rockwell’s FDA approved generic drug Calcitriol is indicated 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 dialysis concentrate 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 novel 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 has also obtained licenses for certain dialysis related drugs which we are developing and planning to market globally. Please visit www.rockwellmed.com for more information.

Forward-Looking Statement Disclaimer
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. 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, actual results could be materially different. 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.

Triferic® is a registered trademark of Rockwell Medical, Inc.
Investor Contact:
Michael Rice
LifeSci Advisors
(646) 597-6979
mrice@lifesciadvisors.com

Media Contact:
Matt Middleman
LifeSci Public Relations
(646) 627-8384
matt@lifescipublicrelations.com

Source: Rockwell Medical, Inc.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED INCOME STATEMENTS

For the three months ended March 31, 2018 and March 31, 2017

(Unaudited)

        
  Three Months
Ended
March 31, 2018
 Three Months
Ended
March 31, 2017
 
Sales $ 14,948,579  $ 14,592,254  
Cost of Sales  14,919,072   12,234,782  
Gross Profit  29,507   2,357,472  
Selling, General and Administrative  5,061,955   6,100,715  
Research and Product Development  1,666,356   1,214,851  
Operating Income (Loss)  (6,698,804)  (4,958,094) 
Interest and Investment Income  169,283   216,071  
Income (Loss) Before Income Taxes  (6,529,521)  (4,742,023) 
Income Tax Expense       
Net Income (Loss) $ (6,529,521) $ (4,742,023) 
        
Basic Earnings (Loss) per Share $ (0.13) $ (0.09) 
        
Diluted Earnings (Loss) per Share $ (0.13) $ (0.09) 
          

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

As of March 31, 2018 and December 31, 2017

(Unaudited)

        
  March 31,  December 31,  
  2018
 2017
 
ASSETS       
Cash and Cash Equivalents $3,278,087  $8,406,917  
Investments Available for Sale  24,821,682   24,648,459  
Accounts Receivable, net of a reserve of $3,400 in 2018 and $11,000 in 2017  5,993,708   6,355,566  
Inventory  8,544,854   7,637,384  
Other Current Assets  1,607,440   1,779,992  
Total Current Assets   44,245,771    48,828,318  
Property and Equipment, net  2,572,619   2,548,978  
Inventory, Non-Current  3,722,901   5,986,752  
Intangible Assets  3,940   4,028  
Goodwill  920,745   920,745  
Other Non-current Assets  490,703   490,819  
Total Assets $ 51,956,679  $ 58,779,640  
LIABILITIES AND SHAREHOLDERS’ EQUITY       
Accounts Payable $4,012,341  $4,222,159  
Accrued Liabilities  4,191,501   4,715,712  
Customer Deposits  235,078   205,303  
Total Current Liabilities   8,438,920    9,143,174  
        
Deferred License Revenue  16,150,609   16,723,318  
        
Shareholders’ Equity:       
Common Shares, no par value, 51,768,424 and 51,768,424 shares issued and outstanding  274,386,910   273,210,907  
Accumulated Deficit  (246,791,897)  (240,262,376) 
Accumulated Other Comprehensive Income  (227,863)  (35,383) 
Total Shareholders’ Equity    27,367,150    32,913,148  
Total Liabilities And Shareholders’ Equity $ 51,956,679  $ 58,779,640  
          


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

For the three months ended March 31, 2018 and March 31, 2017

(Unaudited)

        
  2018  2017  
Cash Flows From Operating Activities:       
Net (Loss) $ (6,529,521) $ (4,742,023) 
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:       
Depreciation and Amortization  129,076   130,215  
Share Based Compensation—Non-employee  68,654   19,071  
Share Based Compensation—Employees  1,107,349   2,259,316  
Increase in Inventory Reserves  1,296,954     
Loss on Disposal of Assets  3,083   3,350  
Loss on Sale of Investments Available for Sale  2,892     
Changes in Assets and Liabilities:       
Decrease (Increase) in Accounts Receivable  295,973   (344,500) 
Decrease (Increase) in Inventory  59,427   (2,291,108) 
Decrease in Other Assets  238,438   160,406  
(Decrease) in Accounts Payable  (209,208)  (1,914,780) 
(Decrease) Increase in Other Liabilities  (494,969)  2,160,268  
(Decrease) in Deferred License Revenue  (504,528)  (498,120) 
(Decrease) in Deferred Drug License Revenue  (68,181)  (93,181) 
Changes in Assets and Liabilities  (685,666)  (2,821,015) 
Cash (Used In) Operating Activities   (4,604,561)   (5,151,086) 
Cash Flows From Investing Activities:       
Purchase of Investments Available for Sale  (1,416,665)    
Sale of Investments Available for Sale  1,050,554   31,123  
Purchase of Equipment  (155,712)  (162,003) 
Proceeds on Sale of Assets     450  
Cash (Used In) Investing Activities   (521,823)   (130,430) 
Cash Flows From Financing Activities:       
Cash (Used In) Provided By Financing Activities   —    —  
        
Effects of exchange rate changes  (2,446)  632  
(Decrease) In Cash  (5,128,830)  (5,280,884) 
Cash At Beginning Of Period  8,406,917   17,180,594  
Cash At End Of Period $ 3,278,087  $ 11,899,710