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): March 15, 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 March 15, 2018, the Company issued the press release attached hereto as Exhibit 99.1, announcing its financial results for the quarter ended December 31, 2017.

 

Item 9.01. Financial Statements and Exhibits.

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

Exhibit   Description
   
99.1 Press Release dated March 15, 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: March 15, 2018By: /s/ Thomas E. Klema        
  Thomas E. Klema
  Its: Chief Financial Officer
  


EXHIBIT INDEX

 

Exhibit   Description
   
99.1 Press Release dated March 15, 2018.

EdgarFiling

EXHIBIT 99.1

Rockwell Medical Reports Fourth Quarter and Year End 2017 Results

Conference call at 4:30 p.m. EDT today

WIXOM, Mich., March 15, 2018 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical 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 fourth quarter and year ending December 31, 2017.

Q4 2017 Financial Highlights

2017 Financial Highlights                                                                                                                                                                      

2017 Corporate Highlights

Mr. Robert L. Chioini, Chief Executive Officer of Rockwell stated, “We are pleased and excited with the substantial progress we have made working with policy makers in Washington D.C. to ensure hemodialysis patients across the U.S. will have access to our new, innovative anemia therapy Triferic. There is a timely emphasis on spurring innovation in the U.S. renal market to provide new therapies, like Triferic, that can improve patients’ lives and lower healthcare costs. Based on our progress to date, we remain optimistic that Triferic will receive the proper reimbursement soon. Our marketing and education efforts for Triferic continue, and have been well received by the dialysis community. Data reported via our drug sample program has shown positive patient outcomes and cost-saving benefits, giving us further confidence that Triferic should be widely adopted if separate reimbursement is granted.”

Conference Call Information
Rockwell Medical will be hosting a conference call to review its 2017 fourth quarter and year end results today, Thursday, March 15, 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 #8976030. 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 biopharmaceutical 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.

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 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 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 prospects of obtaining the approval from CMS for separate reimbursement for Triferic and its intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “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 Medical’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 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 and twelve months ended December 31, 2017 and December 31, 2016
 
  Three Months Ended
December 31, 2017
  Three Months Ended
December 31, 2016
 
Year Ended
December 31, 2017
 Year Ended
December 31, 2016 
Sales$ 14,838,016  $ 13,389,786 $ 57,300,281  $ 53,284,166 
Cost of Sales  16,062,936    11,401,603   53,598,390    46,531,648 
Gross Profit (Loss)  (1,224,920)   1,988,183   3,701,891    6,752,518 
Selling, General and Administrative  5,869,879    6,049,663   23,303,409    21,120,901 
Research and Product Development  2,126,397    1,200,729   6,321,400    5,840,346 
Operating (Loss) (9,221,196)  (5,262,209) (25,922,918)  (20,208,729)
Interest and Investment Income  181,171    207,911   892    810,340 
Foreign Currency Gain (Loss) 742      742    — 
Income (Loss) Before Income Taxes (9,039,283)  (5,054,298) (25,921,284)  (19,398,389)
Income Tax Expense       —    (404,527)
Net (Loss)$(9,039,283 $(5,054,298)$ (25,921,284) $ (19,802,916)
           
  Basic Earnings (Loss) per Share$(0.18) $(0.10)$ (0.51) $ (0.39)
           
  Diluted Earnings (Loss) per Share$(0.18) $(0.10)$ (0.51) $ (0.39)
           



ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
 
CONSOLIDATED BALANCE SHEETS
 
As of December 31, 2017 and 2016
 
  December 31,  December 31,  
  2017 2016
 
ASSETS       
Cash and Cash Equivalents $ 8,406,917  $ 17,180,594  
Investments Available for Sale   24,648,459    40,759,703  
Accounts Receivable, net of a reserve of $11,000 in 2017 and $5,000 in 2016   6,355,566    6,393,228  
Inventory   7,637,384    12,141,072  
Other Current Assets   1,779,992    2,034,598  
Total Current Assets   48,828,318    78,509,195  
Property and Equipment, net   2,548,978    1,391,575  
Inventory, Non-Current   5,986,752    1,826,554  
Intangible Assets   4,028    4,382  
Goodwill   920,745    920,745  
Other Non-current Assets   490,819    501,187  
Total Assets $ 58,779,640  $ 83,153,638  
LIABILITIES AND SHAREHOLDERS’ EQUITY       
Accounts Payable $ 4,222,159  $ 5,858,234  
Accrued Liabilities   4,715,712    4,210,151  
Customer Deposits   205,303    77,217  
Total Current Liabilities   9,143,174    10,145,602  
        
Deferred License Revenue   16,723,318    20,051,737  
        
Shareholders’ Equity:       
Common Shares, no par value, 51,768,424 and 51,527,711 shares issued and outstanding   273,210,907    268,199,939  
Accumulated Deficit   (240,262,376)   (214,341,092) 
Accumulated Other Comprehensive Income   (35,383)   (902,548) 
Total Shareholders’ Equity   32,913,148    52,956,299  
Total Liabilities And Shareholders’ Equity $ 58,779,640  $ 83,153,638  



ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the years ended December 31, 2017 and 2016
 
 
  2017 2016  
Cash Flows From Operating Activities:        
Net (Loss) $ (25,921,284) $ (19,802,916)  
Adjustments To Reconcile Net Loss To Net Cash Used In Operating
Activities:
        
Depreciation and Amortization   514,362    762,368   
Share Based Compensation—Non-employee   228,847    —   
Share Based Compensation—Employees   6,945,749    10,346,284   
Loss on Disposal of Assets   10,777    8,168   
Loss on Sale of Investments Available for Sale   792,207    26,820   
Changes in Assets and Liabilities:        
(Increase) in Accounts Receivable   (962,338)   (1,162,469)  
(Increase) in Inventory   343,490    (6,095,846)  
(Increase) in Other Assets   264,975    (1,230,084)  
(Decrease) Increase in Accounts Payable   (1,636,840)   1,863,018   
(Decrease) Increase in Other Liabilities   634,238    191,134   
(Decrease) in Deferred License Revenue   (2,099,028)   (2,065,785)  
(Decrease) Increase in Deferred Drug License Revenue   (229,390)   4,706,670   
Changes in Assets and Liabilities   (3,684,893)   (3,793,362)  
Cash (Used In) Operating Activities   (21,114,235)   (12,452,638)  
Cash Flows From Investing Activities:        
Purchase of Investments Available for Sale   (35,733,677)   (25,781,853)  
Sale of Investments Available for Sale   51,918,745    24,491,677   
Purchase of Equipment   (1,682,913)   (355,264)  
Proceeds on Sale of Assets   725    1,000   
Cash Provided by (Used In) Investing Activities   14,502,880    (1,644,440)  
Cash Flows From Financing Activities:        
Proceeds from Issuance of Common Shares   123,603    80,161   
Restricted Stock Retained in Satisfaction of Tax Liabilities    (2,287,231)   —   
Cash (Used In) Provided By Financing Activities   (2,163,628)   80,161   
         
Effects of exchange rate changes   1,306    (671)  
(Decrease) In Cash   (8,773,677)   (14,017,588)  
Cash At Beginning Of Period   17,180,594    31,198,182   
Cash At End Of Period $ 8,406,917  $ 17,180,594