November 7, 2016

Rockwell Medical Reports Third Quarter Results

WIXOM, Mich., Nov. 07, 2016 (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 third quarter of 2016.

Q3 2016 Financial Highlights

  • Sales were $12.8 million, or $1.6 million lower than Q3 2015, primarily due to lower contract manufacturing sales.
  • Gross profit was $1.6 million compared to $2.5 million in Q3 2015, due to lower contract manufacturing revenue and due to an increase in manufacturing and costs related to our drug products.   
  • SG&A expense was $5.1 million compared $3.8 million in Q3 2015.
  • R&D expense was $1.3 million and at the same level as in Q3 2015.
  • Net loss was $4.5 million or ($0.09) per share compared to a $2.4 million loss or ( $0.05) per share in Q3 2015.
  • Net loss in Q3 was lower sequentially by $0.8 million compared to Q2 2016 due to lower R&D expenses.
  • Cash and investments were $57.7 million as of September 30, 2016.
  • Net working capital was $72.5 million as of September 30, 2016.

YTD 2016 Financial Highlights

  • Sales were $39.9 million, compared to $41.2 million in the first nine months of 2015.
  • Gross profit was $4.8 million compared to $6.9 million in the first nine months of 2015.
  • Gross profit was impacted by higher drug manufacturing costs, a value add tax paid on the $4.0 million payment received from Wanbang Biopharma and lower third party contract manufacturing revenue.
  • SG&A expense was $15.1 million compared $13.0 million in the first nine months of 2015.
  • R&D expense was $4.6 million compared to $2.9 million in the first nine months of 2015.
  • Net loss was $14.7 million or ($0.29) per share versus $8.7 million or ($0.17) per share in 2015.

YTD Corporate Highlights

  • Triferic Phase-1 Healthy Volunteer Intravenous (IV) Pharmacokinetic Study published in the September 2016 edition of the Journal of Clinical Pharmacology.
  • Entered into license agreement with ARAM Medical to market Triferic in Saudi Arabia and other middle eastern countries.
  • Received FDA approval to market Triferic powder packet.
  • Partnered with Wanbang Biopharma to commercialize Triferic and Calcitriol in the People's Republic of China, receiving up to $39 million in milestone payments and ongoing profit on commercial product sales in China.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell stated, "We continue to make solid progress in our efforts to obtain transitional add-on reimbursement for Triferic. We believe we are moving closer to our goal of securing it. Multiple stakeholders have aided us and support add-on reimbursement for Triferic. Concurrently, we have been educating our customers and patients about Triferic and its unique benefits. We also have advanced Triferic clinical development work for the renal application outside the U.S. as well as additional therapeutic indications. Overall, we are pleased with our progress, which includes ensuring we have redundancy in our manufacturing and supply capability."

Conference Call Information
Rockwell Medical will be hosting a conference call to review its second quarter 2016 results on Monday, November 7, 2016 at 4:30 pm ET.  Investors are encouraged to call a few minutes in advance at (877)-857-6150, or for international callers (719)325-4825, passcode # 8926063 or to listen to the call via webcast at 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.

  
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES 
CONSOLIDATED INCOME STATEMENTS 
For the three and nine months ended September 30, 2016 and September 30, 2015 
(Unaudited) 
  
  Three Months Ended
September 30, 2016
 Three Months Ended
September 30, 2015
 Nine Months Ended
September 30, 2016
 Nine Months Ended
September 30, 2015
 
Sales $ 12,814,815  $ 14,378,528  $ 39,894,380  $ 41,218,065  
Rebates                 
Cost of Sales   11,234,934    11,875,122    35,130,045    34,336,359  
Gross Profit   1,579,881    2,503,406    4,764,335    6,881,706  
Selling, General and Administrative   5,070,127    3,827,904    15,071,238    12,989,261  
Research and Product Development   1,261,863    1,246,727    4,639,617    2,931,577  
Operating Income (Loss)   (4,752,109)   (2,571,225)   (14,946,520)   (9,039,132) 
Interest and Investment Income   188,847    156,672    602,429    388,638  
Interest (Expense)                 
Income (Loss) Before Income Taxes   (4,563,262)   (2,414,553)   (14,344,091)   (8,650,494) 
Income Tax Expense           (404,527)     
Net Income (Loss) $ (4,563,262) $ (2,414,553) $ (14,748,618) $ (8,650,494) 
              
Basic Earnings (Loss) per Share $ (0.09) $ (0.05) $ (0.29) $ (0.17) 
              
Diluted Earnings (Loss) per Share $ (0.09 ) $ (0.05) $ (0.29) $ (0.17) 
                      


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES 
CONSOLIDATED BALANCE SHEETS 
As of September 30, 2016 and December 31, 2015 
(Unaudited) 
  
  September 30 December 31 
  2016 2015 
ASSETS       
Cash and Cash Equivalents $ 19,293,454  $ 31,198,182  
Investments Available for Sale   38,434,312    39,482,732  
Accounts Receivable, net of a reserve of $39,000 in 2016 and $75,000 in 2015   8,031,196    5,046,733  
Inventory   11,760,269    7,871,780  
Other Current Assets   2,264,583    1,026,889  
Total Current Assets    79,783,814    84,626,316  
Property and Equipment, net   1,506,155    1,646,568  
Intangible Assets   42,555    165,657  
Goodwill   920,745    920,745  
Other Non-current Assets   601,187    462,839  
Total Assets $ 82,854,456  $ 87,822,125  
LIABILITIES AND SHAREHOLDERS' EQUITY       
Accounts Payable $ 3,396,789  $ 3,995,216  
Accrued Liabilities   3,825,374    3,831,356  
Customer Deposits   91,005    264,879  
Total Current Liabilities   7,313,168    8,091,451  
        
Deferred License Revenue   19,783,978    17,410,852  
        
Shareholders' Equity:       
Common Shares, no par value, 51,527,711 and 51,501,877 shares issued and outstanding   265,648,345    257,773,494  
Accumulated Deficit   (209,286,794)   (194,538,176) 
Accumulated Other Comprehensive Income   (604,241)   (915,496) 
Total Shareholders' Equity   55,757,310    62,319,822  
Total Liabilities And Shareholders' Equity $ 82,854,456  $ 87,822,125  
            


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES 
CONSOLIDATED STATEMENTS OF CASH FLOWS 
For the nine months ended September 30, 2016 and September 30, 2015 
(Unaudited) 
  
  2016 2015 
Cash Flows From Operating Activities:       
Net (Loss) $  (14,748,618) $  (8,650,494) 
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:       
Depreciation and Amortization   583,501    608,152  
Share Based Compensation—Employees   7,794,690    6,097,122  
Restricted Stock Retained in Satisfaction of Tax Liabilities       (2,912,859) 
Loss on Disposal of Assets   7,340    4,292  
Loss on Sale of Investments Available for Sale   26,820    58,095  
Changes in Assets and Liabilities:       
(Increase) in Accounts Receivable   (2,984,463)   (1,424,485) 
(Increase) in Inventory   (3,888,489)   (3,495,096) 
(Increase) in Other Assets   (1,376,042)   (1,014,009) 
(Decrease) in Accounts Payable   (598,427)   (71,121) 
(Decrease) in Other Liabilities   (179,856)   (1,259,560) 
Increase (decrease) in Deferred License Revenue   2,373,126    (1,479,681) 
Changes in Assets and Liabilities   (6,654,151)   (8,743,952)  
Cash (Used) In Provided By Operating Activities    (12,990,418)    (13,539,644) 
Cash Flows From Investing Activities:       
Purchase of Investments Available for Sale   (23,158,809)   (21,800,000) 
Sale of Investments Available for Sale   24,491,678    1,468,656  
Purchase of Equipment   (328,322)   (336,856) 
Proceeds on Sale of Assets   1,000    4,800  
Cash (Used In) Investing Activities    1,005,547      (20,663,400) 
Cash Flows From Financing Activities:       
Proceeds from Issuance of Common Shares and Purchase Warrants   80,161    1,575,333   
Cash Provided By Financing Activities    80,161     1,575,333  
Effects of exchange rate changes   (18)     
(Decrease) Increase In Cash   (11,904,728)    (32,627,711) 
Cash At Beginning Of Period   31,198,182    65,800,451  
Cash At End Of Period $  19,293,454  $  33,172,740  
            

 

Michael Rice,

Investor Relations;

646-597-6979

Primary Logo

Source: Rockwell Medical, Inc.

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