November 8, 2017

Rockwell Medical Reports Third Quarter Results

Conference Call and Webcast Today at 4:30 p.m. EST.

WIXOM, Mich., Nov. 08, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), reported results for the three and nine months ended Sept. 30, 2017.

Q3 2017 Financial Highlights

  • Sales were $14.6 million, an increase of 14.1% or $1.8 million over third quarter of 2016.
  • Gross profit was $1.1 million, compared to $1.6 million in Q3 2016.  
  • SG&A expense was $4.8 million, compared $5.1 million in Q3 2016.
  • R&D expense was $1.3 million, same as Q3 2016.
  • Net loss was $5.1 million or ($0.10) per share compared to a $4.6 million loss or ($0.09) per share in Q3 2016.
  • Cash and investments were $38.9 million as of September 30, 2017.
  • Net working capital was $53.6 million as of September 30, 2017 compared to $56.1 million at June 30, 2017.

Q3 YTD 2017 Financial Highlights

  • Sales were $42.5 million, an increase of 6.4% or $2.6 million over first nine months of 2016.
  • Gross profit was $4.9 million, compared to $4.8 million in first nine months of 2016.
  • SG&A expense was $17.4 million compared to $15.1 million in first nine months of 2016.
  • R&D expense was $4.2 million compared to $4.6 million in first nine months of 2016.
  • Net Loss was $16.9 million or ($0.33) per share compared to $14.7 million or ($0.29) per share in first nine months of 2016.

Mr. Robert L. Chioini, Chairman and Chief executive Officer of Rockwell, stated, "Our operating business results were in-line with our expectations. Regarding our progress on gaining separate reimbursement for Triferic, we have had further productive interaction with the Centers for Medicare and Medicaid Services (CMS) and with the Center for Medicare and Medicaid Innovation (CMMI). As requested, we have provided a comprehensive package of information that highlights the clinical benefits and cost savings advantages for separate reimbursement for Triferic.  We believe we are well positioned to gain a favorable decision."

Conference Call Information
Rockwell Medical will be hosting a conference call to review its 2017 third quarter and year to date results today Wednesday, Nov. 8, 2017 at 4:30 p.m. EST.  Investors are encouraged to call a few minutes in advance at (888) 282-4591, or for international callers (719) 325-2491, Conference ID #8182379. 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
Rockwell Medical 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 recent FDA approved drug Triferic is 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 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.

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," "predict," "forecast," "project," "plan", "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. 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. Thus, actual results could be materially different. Rockwell Medical 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

 
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
 
CONSOLIDATED INCOME STATEMENTS
 
For the three and nine months ended September 30, 2017 and September 30, 2016
 
(Unaudited)
             
  Three Months Ended
September 30, 2017
 Three Months Ended
September 30, 2016
 Nine Months Ended
September 30, 2017
 Nine Months Ended
September 30, 2016
Sales $14,626,904  $12,814,815  $42,462,265  $39,894,380 
Cost of Sales  13,555,853   11,234,934   37,535,454   35,130,045 
Gross Profit  1,071,051   1,579,881   4,926,811   4,764,335 
Selling, General and Administrative  4,791,636   5,070,127   17,433,530   15,071,238 
Research and Product Development  1,304,658   1,261,863   4,195,003   4,639,617 
Operating Income (Loss)  (5,025,243)  (4,752,109)   (16,701,722)  (14,946,520)
Interest and Investment Income  (31,751)  188,847   (180,279)  602,429  
Income (Loss) Before Income Taxes  (5,056,994)  (4,563,262)  (16,882,001)  (14,344,091)
Income Tax Expense            (404,527)
Net Income (Loss) $(5,056,994) $(4,563,262) $(16,882,001) $(14,748,618)
             
Basic Earnings (Loss) per Share  $(0.10) $(0.09) $(0.33) $(0.29)
             
Diluted Earnings (Loss) per Share $(0.10) $(0.09) $(0.33) $(0.29)
             


 
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
 
CONSOLIDATED BALANCE SHEETS
 
As of September 30, 2017 and December 31, 2016
 
(Unaudited)
       
  September 30 December 31
  2017
 2016
ASSETS      
Cash and Cash Equivalents $3,887,923  $17,180,594 
Investments Available for Sale  35,028,841   40,759,703 
Accounts Receivable, net of a reserve of $6,000 in 2017 and $5,000 in 2016  5,374,390   6,393,228 
Inventory  14,864,642   12,141,072 
Other Current Assets  2,032,095   2,034,598 
Total Current Assets  61,187,891   78,509,195 
Property and Equipment, net  1,708,817   1,391,575 
Inventory, Non-Current  1,494,175   1,826,554 
Intangible Assets  4,117   4,382 
Goodwill  920,745   920,745 
Other Non-current Assets  490,655   501,187 
Total Assets $65,806,400  $83,153,638 
LIABILITIES AND SHAREHOLDERS' EQUITY      
Accounts Payable $4,188,677  $5,858,234 
Accrued Liabilities  3,231,789   4,210,151 
Customer Deposits  199,407   77,217 
Total Current Liabilities  7,619,873   10,145,602 
       
Deferred License Revenue  17,396,167   20,051,737 
       
Shareholders' Equity:      
Common Shares, no par value, 51,761,040 and 51,527,711 shares issued and outstanding  272,055,391   268,199,939 
Accumulated Deficit  (231,223,093)  (214,341,092)
Accumulated Other Comprehensive Income  (41,938)  (902,548)
Total Shareholders' Equity  40,790,360   52,956,299 
Total Liabilities And Shareholders' Equity $65,806,400  $83,153,638 
         


 
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the nine months ended September 30, 2017 and September 30, 2016
 
(Unaudited)
       
  2017
 2016
Cash Flows From Operating Activities:      
Net (Loss)  $ (16,882,001) $ (14,748,618)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:      
Depreciation and Amortization  384,835   583,501  
Share Based Compensation—Non-employee  158,667    
Share Based Compensation—Employees  5,874,769   7,794,690 
Loss on Disposal of Assets  4,084   7,340 
Loss on Sale of Investments Available for Sale  704,695   26,820  
Changes in Assets and Liabilities:      
(Increase) in Accounts Receivable  (149,429)  (2,984,463)
(Increase) in Inventory  (2,391,191)  (3,888,489)
Decrease (Increase) in Other Assets  224,635   (1,376,042)
(Decrease) in Accounts Payable  (1,669,651)  (598,427)
(Decrease) in Other Liabilities  (863,034)   (179,856)
(Decrease) in Deferred License Revenue  (1,494,360)  (1,445,058)
(Decrease) Increase in Deferred Drug License Revenue  (204,543)  3,818,184 
Changes in Assets and Liabilities  (6,547,573)  (6,654,151)
Cash (Used In) Operating Activities   (16,302,524)   (12,990,418)
Cash Flows From Investing Activities:       
Purchase of Investments Available for Sale  (34,235,347)  (23,158,809)
Sale of Investments Available for Sale  40,122,266   24,491,678 
Purchase of Equipment  (706,346)  (328,322)
Proceeds on Sale of Assets  450   1,000 
Cash Provided by Investing Activities   5,181,023    1,005,547 
Cash Flows From Financing Activities:      
Proceeds from Issuance of Common Shares  116,105   80,161 
Restricted Stock Retained in Satisfaction of Tax Liabilities  (2,287,231)   
Cash (Used In) Provided By Financing Activities   (2,171,126)   80,161 
       
Effects of exchange rate changes  (44)  (18)
(Decrease) In Cash  (13,292,671)  (11,904,728)
Cash At Beginning Of Period  17,180,594   31,198,182 
Cash At End Of Period $ 3,887,923  $ 19,293,454 
         

Source: Rockwell Medical, Inc.

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