May 3, 2012

Rockwell Medical Reports First Quarter 2012 Results

Conference Call at 8:30am ET to Discuss Results

WIXOM, Mich., May 3, 2012 (GLOBE NEWSWIRE) -- Rockwell Medical (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 deficiency, secondary hyperparathyroidism and hemodialysis, announced today its results for the first quarter ended March 31, 2012.

First Quarter Financial Highlights

  • Sales were $12.0 million compared to $13.3 million first quarter 2011, primarily due to lower international sales.
  • Sales increased 1.1% sequentially over the fourth quarter 2011 and gross profit dollars increased 5.3%.
  • Gross profit margins improved 1.1 percentage points to 13.5% compared to 12.4% in the first quarter of 2011.
  • SG&A increased $0.7 million mainly due to higher non-cash charges for equity compensation.
  • R&D expense increased to $9.4 million compared to $2.4 million in first quarter of 2011, due to accelerated Phase III clinical development.
  • Net loss was ($10.6) million compared to a net loss of ($2.9) million in first quarter of 2011, due to higher R&D expense.
  • Successful equity capital raise in February 2012 netted proceeds of approximately $16.2 million.
  • Cash and investments aggregated $25.6 million as of March 31, 2012.

Current Drug Development Highlights

  • PRIME study designed to capture ESA-sparing data completed enrollment.
  • Phase III CRUISE efficacy studies nearing patient enrollment completion.
  • Data Safety Monitoring Board recommended continuation of studies with no modifications after 2nd review.
  • Preparation for Calcitriol (vitamin-D) launch on track.
  • Raymond D. Pratt, MD, hired as Chief Medical Officer.

Mr. Robert L. Chioini, Chairman and CEO, stated, "We are pleased to report to you our continued SFP clinical development progress, highlighted by the completion of enrollment in our PRIME study. We look forward to study completion in nine short months. Our Calcitriol product launch remains on target." Mr. Chioini also stated, "First quarter operating performance was in line with our expectations. Both sales and margins increased over last quarter, despite rising fuel and material costs."

Conference Call Information:

Rockwell Medical will be hosting a conference call to review its first quarter 2012 results on Thursday, May 3, 2012 at 8:30 am ET. Investors are encouraged to call a few minutes in advance at (877) 383-7438 or to listen to the call on the web at: http://ir.rockwellmed.com/

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 deficiency, secondary hyperparathyroidism and hemodialysis. Rockwell's lead drug candidate for iron therapy treatment is called SFP.  SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment.  SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. market.  Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism addresses a $350M U.S. 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. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream.  Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval. 

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 SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.

The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773

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 launch Calcitriol and SFP following FDA approval. 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.

ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
     
CONSOLIDATED INCOME STATEMENTS
     
For the three months ended March 31, 2012 and March 31, 2011
     
(Unaudited)
     
  Three Months Ended Three Months Ended
   March 31, 2012  March 31, 2011
Sales  $12,028,417 $13,290,787
Cost of Sales  10,401,941 11,639,242
 Gross Profit  1,626,476 1,651,545
Selling, General and Administrative  2,898,684 2,246,553
Research and Product Development  9,405,547 2,402,596
 Operating Income (Loss)  (10,677,755) (2,997,604)
Interest and Investment Income, net  111,097 85,968
Interest Expense  253 601
 Income (Loss) Before Income Taxes  (10,566,911) (2,912,237)
Income Tax Expense   --   -- 
 Net Income (Loss)   $ (10,566,911)  $ (2,912,237)
     
Basic Earnings (Loss) per Share   ($.54)  ($.17)
     
Diluted Earnings (Loss) per Share   ($.54)  ($.17)
 
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
     
CONSOLIDATED BALANCE SHEETS
     
As of March 31, 2012 and December 31, 2011 
     
  March 31, 2012 December 31,
 ASSETS  (Unaudited) 2011
Cash and Cash Equivalents  $13,639,404 $5,715,246
Investments Available for Sale  11,911,484 11,810,775
Accounts Receivable, net of a reserve of $47,000 in 2012 and $29,000 in 2011  4,215,075 4,222,816
Inventory  2,410,235 2,504,127
Other Current Assets  1,664,372 1,643,565
 Total Current Assets  33,840,570 25,896,529
     
Property and Equipment, net  2,132,831 2,290,476
Intangible Assets  792,016 833,773
Goodwill  920,745 920,745
Other Non-current Assets  1,736,431 1,998,076
 Total Assets  $39,422,593 $31,939,599
     
 LIABILITIES AND SHAREHOLDERS' EQUITY    
     
Capitalized Lease Obligations  $4,232 $6,470
Accounts Payable  4,661,925 5,364,537
Accrued Liabilities  9,043,022 8,225,015
Customer Deposits  126,521 96,329
 Total Current Liabilities  13,835,700 13,692,351
     
Capitalized Lease Obligations  1,451 2,280
     
 Shareholders' Equity:    
Common Shares, no par value, 20,707,886 and 18,710,002 shares issued and outstanding 85,193,308 67,407,847
Common Share Purchase Warrants, 2,596,440 and 2,607,440 warrants issued and outstanding 7,125,190 7,103,975
Accumulated Deficit  (66,552,653) (55,985,742)
Accumulated Other Comprehensive Loss  (180,403) (281,112)
 Total Shareholders' Equity 25,585,442 18,244,968
     
 Total Liabilities And Shareholders' Equity  $39,422,593 $31,939,599
 
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
     
CONSOLIDATED STATEMENTS OF CASH FLOWS
     
For the three months ended March 31, 2012 and March 31, 2011
     
(Unaudited)
     
  2012 2011
     
Cash Flows From Operating Activities:    
 Net (Loss)   $ (10,566,911)  $ (2,912,237)
 Adjustments To Reconcile Net Loss To Net Cash Used In    
 Operating Activities:    
 Depreciation and Amortization  277,200 329,955
 Share Based Compensation — Non-employee  285,568 2,993
 Share Based Compensation- Employees  1,203,821 1,054,838
 Loss (Gain) on Disposal of Assets  10,395 6,070
     
 Changes in Assets and Liabilities:    
 (Increase) Decrease in Accounts Receivable 7,741 (180,362)
 Decrease in Inventory  93,892 154,482
 (Increase) Decrease in Other Assets  240,838 (2,325,988)
 (Decrease) in Accounts Payable  (702,612) (958,142)
 Increase in Other Liabilities  848,199 266,825
 Changes in Assets and Liabilities  488,058 (3,043,185)
 Cash Provided By (Used) In Operating Activities  (8,301,869) (4,561,566)
     
Cash Flows From Investing Activities:    
Purchase of Equipment  (88,543) (121,082)
Proceeds on Sale of Assets  350 --   
(Purchase) of Investments Available for Sale   -- (81,686)
 Cash (Used) In Investing Activities  (88,193) (202,768)
     
Cash Flows From Financing Activities:    
 Proceeds from Issuance of Common Shares and Purchase Warrants 16,317,287 459,370
 Payments on Notes Payable and Capital Lease Obligations  (3,067) (6,083)
 Cash Provided By Financing Activities  16,314,220 453,287
     
Increase (Decrease) In Cash 7,924,158 (4,311,047)
Cash At Beginning Of Period  5,715,246 12,263,449
Cash At End Of Period  $13,639,404 $7,952,402
CONTACT: Michael Rice, Investor Relations

         (646) 597-6979

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Source: Rockwell Medical Technologies, Inc.

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