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Rockwell Medical Reports 2012 Fourth Quarter and Full Year Results



Rockwell Medical Reports 2012 Fourth Quarter and Full Year Results

Fourth Quarter Sales Increase 9.3%

WIXOM, Mich., March 18, 2013 (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 deficiency,
secondary hyperparathyroidism and hemodialysis, reported financial results for
the three and twelve months ended December 31, 2012.

Q4' 2012 Highlights

  * Sales were $13.0 million, increasing 9.3% over Q4 2011.
  * Gross profit increased 10.2% or $0.2 million over Q4 2011.
  * Cash and investments aggregated $4.7 million December 31, 2012.

Full-year 2012 Financial Highlights

  * Sales were $49.8 million, up 1.8% over 2011.
  * Gross profit margins increased to 13.4%, compared to 11.5% in 2011.
  * Gross profit increased 18.6% or $1.1 million, compared to 2011.

Drug Development Highlights

  * PRIME study successfully demonstrated a statistically significant 37.1%
    reduction in ESA use.
  * PRIME study successfully met primary efficacy endpoint of % change in ESA
    from baseline.
  * CRUISE-1 top line results projected in Q3 2013 and CRUISE-2 results in
    early Q4 2013.
  * Four successful clinical safety reviews of Phase 3 CRUISE efficacy
    studies.
  * Calcitriol (active vitamin D) 90-day stability data period completed.

For the year ended December 31, 2012, Rockwell incurred a loss of ($54.0)
million vs. a loss of ($21.4) million in 2011, due primarily to clinical
development expense. Clinical development expense was $48.3 million compared
to $17.8 million in 2011

Mr. Robert L. Chioini, Founder, Chairman and CEO stated, "We achieved solid
operating performance and continue to make progress in areas that are
important to both our near and long term strategic plan. We believe Rockwell
is uniquely positioned for growth in its core operating business, and we
expect Calcitriol will generate significant additional sales and profit
revenue once launched into the commercial market."

In commenting on the Company's recent advancements in its clinical development
of its lead investigational drug SFP, Chioini stated, "We are extremely
pleased with the results of our PRIME study. Not only does the data
demonstrate use of SFP significantly reduces the need for ESA, it supports our
belief that SFP will meet the primary efficacy endpoint in the Phase 3 CRUISE
clinical studies."

Conference Call Information

Rockwell Medical will be hosting a conference call to review its fourth
quarter and 2012 year end results on Monday, March 18, 2013 at 4:30 pm 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 SFP

SFP is a unique iron compound that is delivered to the hemodialysis patient
via dialysate, replacing the 5-7mg of iron lost during a dialysis treatment.
SFP is introduced into the sodium bicarbonate concentrate that subsequently is
mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane
and enters the bloodstream where it immediately binds to apo-transferrin and
is taken to the bone marrow, mimicking the way dietary iron is handled in the
human body. In completed clinical trials to date, SFP has demonstrated that it
can safely deliver iron and maintain hemoglobin levels, while decreasing ESA
use without any increase in iron stores.

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 in late-stage clinical development is for the
treatment of iron deficiency and is called Soluble Ferric Pyrophosphate
(SFP).  SFP delivers iron to the bone marrow of dialysis patients in a
non-invasive, physiologic manner via dialysate during their regular dialysis
treatment. In order to prevent or treat anemia, sufficient availability of
iron and erythropoietin must be present in the bone marrow to generate healthy
red blood cells. In completed clinical trials to date, SFP has demonstrated
that it can safely deliver sufficient iron to the bone marrow. SFP is
currently in ongoing Phase 3 clinical studies (CRUISE-1 and CRUISE-2) to
address an estimated $600M U.S. and $1B global market. 

Rockwell is also preparing to launch a FDA approved generic drug called
Calcitriol. Calcitriol is active vitamin D injection and indicated for the
treatment of secondary hyperparathyroidism in dialysis patients. Rockwell
intends to enter the vitamin D market in 2013, addressing an estimated $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 has three manufacturing and distribution
facilities in the United States and its operating infrastructure is a
ready-made sales and distribution channel that is able 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, INC. AND SUBSIDIARY
 
CONSOLIDATED INCOME STATEMENTS
 
For the three and twelve months ended December 31, 2012 and December 31, 2011
                                                                  
                       Three Months  Three Months                 
                       Ended         Ended
                        December 31, December 31,  Year Ended    Year Ended
                       2012          2011
                        (Unaudited)  (Unaudited)  December 31,   December 31,
                                                  2012           2011 
Sales                  $ 12,999,846  $ 11,896,808 $ 49,842,392   $ 48,966,231
Cost of Sales          11,297,621    10,352,677   43,148,965     43,323,321
Gross Profit           1,702,225     1,544,131    6,693,427      5,642,910
Selling, General and   3,635,386     2,631,805    12,683,860     9,522,305
Administrative
Research and Product    11,751,256    7,867,886    48,271,649     17,805,362
Development
Operating Income       (13,684,417)  (8,995,560)  (54,262,082)   (21,684,757)
(Loss)
Interest and           11,034        3,432        241,518        244,049
Investment Income, net
Interest Expense        105           331          951            1,844
Income
(Loss) Before Income   (13,673,488)  (8,952,459)  (54,021,515)   (21,442,552)
Taxes
Income Tax Expense       --           47            --            2,005 
Net Income (Loss)      $(13,673,488) $            $ (54,021,515) $(21,444,557)
                                     (8,952,506)
                                                                  
Basic Earnings (Loss)  ($ .66)       ($ .48)      ($ 2.65)       ($ 1.21)
per Share 
                                                                  
Diluted Earnings       ($ .66)       ($ .48)      ($ 2.65)       ($ 1.21)
(Loss) per Share 

 
 
ROCKWELL MEDICAL, INC. AND SUBSIDIARY
 
CONSOLIDATED BALANCE SHEETS
 
As of December 31, 2012 and 2011
                                                                   
ASSETS                                              December 31,  December 31,
                                                    2012          2011
Cash and Cash Equivalents                           $ 4,711,730   $ 5,715,246
Investments Available for Sale                      --            11,810,775
Accounts Receivable, net of a reserve of $26,000 in 4,431,932     4,222,816
2012 and $29,000 in 2011
Inventory                                           2,649,639     2,504,127
Other Current Assets                                1,356,131     1,643,565
Total Current Assets                                13,149,432    25,896,529
                                                                   
Property and Equipment, net                         1,858,442     2,290,476
Intangible Assets                                   666,744       833,773
Goodwill                                            920,745       920,745
Other Non-current Assets                             429,723        1,998,076
Total Assets                                        $ 17,025,086  $ 31,939,599
                                                                   
                                                                   
LIABILITIES AND SHAREHOLDERS' EQUITY                               
Capitalized Lease Obligations                       $ 2,280       $ 6,470
Accounts Payable                                    14,833,565    5,364,537
Accrued Liabilities                                 12,015,978    8,225,015
Customer Deposits                                      135,133       96,329
Total Current Liabilities                            26,986,956    13,692,351
                                                                   
Capitalized Lease Obligations                       --            2,280
                                                                   
Shareholders' Equity:                                              
Common Shares, no par value, 21,494,696 and                        
18,710,002 shares issued and outstanding            92,866,458    67,407,847
Common Share Purchase Warrants, 2,233,240 and                      
2,607,440 warrants issued and outstanding            7,178,929     7,103,975
Accumulated Deficit                                 (110,007,257) (55,985,742)
Accumulated Other Comprehensive Loss                   --          (281,112)
Total Shareholders' Equity (Deficit)                 (9,961,870)   18,244,968
                                                                   
Total Liabilities And Shareholders' Equity          $ 17,025,086  $ 31,939,599

 
ROCKWELL MEDICAL, INC. AND SUBSIDIARY
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the years ended December 31, 2012, 2011 and 2010
                                                                  
                                   2012           2011           2010
                                                                  
Cash Flows From Operating                                         
Activities:
 Net (Loss)                        $ (54,021,515) $ (21,444,557) $ (2,683,399)
 Adjustments To Reconcile Net Loss                                
To Net Cash Used In
 Operating Activities:                                            
 Depreciation and Amortization     1,087,397      1,176,007      1,389,152
 Share Based Compensation –        2,322,417      312,325        639,915
Non-employee
 Share Based Compensation-         4,979,724      4,065,703      3,381,394
Employees
 Loss (Gain) on Disposal of Assets 17,876         29,093         19,816
 Loss on Sale of Investments       67,303         84,590         --
Available for Sale
                                                                  
 Changes in Assets and                                            
Liabilities:
 (Increase) Decrease in Accounts   (209,116)      284,480        (1,014,674)
Receivable
 (Increase) Decrease in Inventory  (145,512)      432,751        151,474
 (Increase) Decrease in Other      1,855,787      (2,457,370)    (690,750)
Assets
 Increase (Decrease)in Accounts    9,469,028      1,705,030      270,750
Payable
 Increase in Other Liabilities      3,829,767      5,028,846      637,236
 Changes in Assets and Liabilities  14,799,954     4,993,737      (645,964)
 Cash Provided By (Used) In        (30,746,844)   (10,783,102)   2,100,914
Operating Activities
                                                                  
Cash Flows From Investing                                         
Activities:
(Purchase) of Investments          (2,012,671)    (2,000,000)    (12,151,721)
Available for Sale
Sale of Investments Available for  14,037,255     1,975,244      --
Sale
Purchase of Equipment              (507,788)      (421,043)      (772,364)
Proceeds on Sale of Assets         1,578          2,985          1,800
Purchase of Intangible Assets       --             (145,121)      --
 Cash (Used) In Investing          11,518,374     (587,935)      (12,922,285)
Activities
                                                                  
Cash Flows From Financing                                         
Activities:
 Proceeds from Issuance of Common                                 
Shares and Purchase Warrants       18,231,424     4,841,049      90,448
 Payments on Notes Payable and      (6,470)        (18,215)       (43,723)
Capital Lease Obligations
 Cash Provided By Financing        18,224,954     4,822,834      46,725
Activities
                                                                  
Increase (Decrease) In Cash        (1,003,516)    (6,548,203)    (10,774,646)
Cash At Beginning Of Period         5,715,246      12,263,449     23,038,095
Cash At End Of Period              $  4,711,730   $  5,715,246   $ 12,263,449

CONTACT: Michael Rice, Investor Relations; (646) 597-6979
         David Connolly, Media Contact; (617) 374-8800

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