March 10, 2010

Rockwell Medical Reports Excellent Fourth Quarter and Full Year 2009 Business Results

Mar 10, 2010 (GlobeNewswire via COMTEX News Network) --

Gross Profit Increases $2.25 million in Q4; Gross Profit up 215% for the
                                  Year


  Conference Call at 4:15pm ET to Discuss Results and Review Clinical
                              Development


WIXOM, Mich., March 10, 2010 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq: RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported today fourth quarter and full-year 2009 results.

Fourth Quarter Financial Highlights

  --  Sales were $14.8 million, an increase of 9.0% compared to the fourth
      quarter of 2008.
  --  Sales increased 4.3% sequentially or $0.6 million over the third quarter
      of 2009.
  --  Gross profit increased $2.25 million to $2.4 million compared to $0.2
      million in the fourth quarter of 2008.
  --  Gross profit margins were 16.4%, an increase of 15.1% compared to gross
      profit margin of 1.3% in 2008.
  --  R&D expense was $1.1 million compared to $1.3 million in the fourth
      quarter 2008.
  --  Loss of ($0.5) million compared to a loss of ($3.0) million in the
      fourth quarter 2008.


2009 Financial Highlights

  --  Improved profitability of core business operations (excluding R&D
      expense).
  --  Sales were $54.7 million, an increase of $3.1 million or 5.9% compared
      to 2008.
  --  Gross profit margins were 14.4%, an increase of 9.5% compared to gross
      profit margin of 4.9% in 2008.
  --  Gross profit increased 215% to $7.9 million compared to $2.5 million in
      2008.
  --  R&D expense was $6.5 million compared to $3.8 million in 2008.
  --  Loss of ($5.5) million compared to a loss of ($7.9) million in 2008.
  --  $23 million year-end cash position.


2009 Drug Development and Corporate Progress

  --  Raised $20.4 million in net proceeds from a registered direct offering
      that closed in October 2009.
  --  Completed SFP Phase IIb dose range, safety and exploratory study in
      October 2009.
  --  Added senior expertise to the drug development team with the addition of
      Dr. Richard Yocum and Dr. Ajay Gupta.
  --  Enhanced regulatory expertise with the addition of Dr. Jur Strobos M.D.
      to Scientific Advisory Board.
  --  Presented new in vitro iron-binding data on proprietary iron-delivery
      drug SFP at the American Society of Nephrology (ASN) annual meeting in
      San Diego, CA.
  --  Unveiled rebranded Company with new name, logo and website to better
      reflect the Company's strategic focus towards bio-pharma
      (www.rockwellmed.com) at the American Society of Nephrology (ASN) annual
      meeting in San Diego, CA.
  --  Included into the Russell 2000, 3000 and Global Indices.


Mr. Robert L. Chioini, Chairman and CEO stated, "We made great progress in 2009, showing improvements in both our operating business and our drug development business. Our operating margins increased significantly, due in part to higher end-user prices and our continued effort to improve internal efficiencies, thereby contributing cash flow to our drug development efforts. Our recently released Phase IIb study data demonstrated SFP is well-tolerated and safe, confirmed dosing for Phase III and provided valuable data for us to design a thoughtful and carefully planned Phase III trial protocol. We are planning our end-of-Phase II meeting with the FDA in order to review our Phase III clinical design and we anticipate commencing SFP's Phase III clinical program in the second-half of the year."

About SFP:

SFP is a novel, investigational, continuous iron therapy designed to treat iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal physiologic dietary iron intake. SFP is designed as a continuous replacement treatment delivering small doses of iron during every dialysis session in order to replenish iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP, delivered during each dialysis treatment via dialysate, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response to erythropoiesis-stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell Medical has licensed exclusive world-wide rights to manufacture and sell SFP and patents have issued for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $850 million.

About Rockwell Medical:

Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 400,000 ESRD patients in the United States, a prevalence growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed 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.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. 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 the Company 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 the 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.

                                   CONSOLIDATED INCOME STATEMENTS

            For the three and twelve months ended December 31, 2009 and December 31, 2008

                                          Three Months   Three Months
                                             Ended          Ended       Year Ended     Year Ended

                                          December 31,   December 31,
                                              2009           2008       December 31,   December 31,
                                          (unaudited)    (unaudited)        2009           2008
                                         -------------  -------------  -------------  -------------
  Sales                                   $ 14,761,487   $ 13,537,674   $ 54,729,505   $ 51,666,033

  Cost of Sales                             12,333,924     13,360,807     46,842,334     49,159,478
                                         -------------  -------------  -------------  -------------
   Gross Profit                              2,427,563        176,867      7,887,171      2,506,555
  Selling, General and Administrative        1,836,125      1,975,942      6,914,198      6,761,617

  Research and Product Development           1,141,853      1,272,416      6,454,352      3,830,134
                                         -------------  -------------  -------------  -------------
   Operating (Loss)                          (550,415)    (3,071,491)    (5,481,379)    (8,085,196)

  Interest Expense (Income), Net                 (634)       (38,657)         19,859      (221,139)
                                         -------------  -------------  -------------  -------------

   Net (Loss)                             $  (549,781)  $ (3,032,834)  $ (5,501,238)  $ (7,864,057)
                                         =============  =============  =============  =============

  Basic Earnings (Loss) per Share           $ (0.03)       $ (0.22)       $ (0.37)       $ (0.57)

  Diluted Earnings (Loss) per Share         $ (0.03)      $  (0.22)       $ (0.37)       $ (0.57)

Note:

In the Consolidated Income Statements the Company reclassified specific quality assurance and operations management expenses totaling $112,000 to "cost of sales" from "selling, general and administrative expense" for the fourth quarter of 2008 and $510,000 for 2008 to maintain comparability of prior year results with the current year presentation.

           ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY

                       CONSOLIDATED BALANCE SHEETS

                    As of December 31, 2009 and 2008


                                  December 31, 2009  December 31, 2008
                                  -----------------  -----------------
   ASSETS
  Cash and Cash Equivalents            $ 23,038,095        $ 5,596,645
  Accounts Receivable, net of a
   reserve of $31,000 in 2009
   and $97,000 in 2008                    3,492,622          5,229,656
  Inventory                               3,088,352          3,161,625

  Other Current Assets                      329,876            440,765
                                  -----------------  -----------------
   Total Current Assets                  29,948,945         14,428,691

  Property and Equipment, net             3,631,549          3,249,003
  Intangible Assets                         214,337            240,656
  Goodwill                                  920,745            920,745

  Other Non-current Assets                  163,645            120,887
                                  -----------------  -----------------

   Total Assets                        $ 34,879,221       $ 18,959,982
                                  =================  =================

   LIABILITIES AND SHAREHOLDERS'
    EQUITY

  Capitalized Lease Obligations            $ 42,938          $ 176,850
  Accounts Payable                        3,388,757          5,210,972
  Accrued Liabilities                     1,854,347          1,464,828

  Customer Deposits                         250,915            245,186
                                  -----------------  -----------------
   Total Current Liabilities              5,536,957          7,097,836

  Capitalized Lease Obligations              19,062             41,203

   Shareholders' Equity:
  Common Shares, no par value,
   17,200,442 and 14,104,690
   shares issued and outstanding         53,545,394         34,799,093
  Common Share Purchase
   Warrants, 3,318,569 and
   2,114,169 warrants issued and
   outstanding                            7,635,594          3,378,398

  Accumulated Deficit                  (31,857,786)       (26,356,548)
                                  -----------------  -----------------

   Total Shareholders' Equity            29,323,202         11,820,943
                                  -----------------  -----------------

   Total Liabilities And
    Shareholders' Equity               $ 34,879,221       $ 18,959,982
                                  =================  =================

             ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY

                   CONSOLIDATED STATEMENTS OF CASH FLOWS

               For the years ended December 31, 2009 and 2008


                                                  2009           2008
                                             -------------  -------------

  Cash Flows From Operating Activities:
   Net (Loss)                                $ (5,501,238)  $ (7,864,057)
   Adjustments To Reconcile Net Loss To Net
    Cash Used In
    Operating Activities:
    Depreciation and Amortization                1,233,706        911,718
    Share Based Compensation --
     Non-employee warrants                         403,203        339,987
    Share Based Compensation- Employees          1,949,684      1,115,231
    Loss (Gain) on Disposal of Assets               36,415        (7,534)


    Changes in Assets and Liabilities:
     (Increase) Decrease in Accounts
      Receivable                                 1,737,034      (542,427)
     (Increase) Decrease in Inventory               73,273      (602,574)
     (Increase) Decrease in Other Assets            68,131      (133,412)
     Increase (Decrease)in Accounts Payable    (1,822,215)      2,228,073

     Increase in Other Liabilities                 395,248        286,497
                                             -------------  -------------

     Changes in Assets and Liabilities             451,471      1,236,157
                                             -------------  -------------
     Cash (Used) In Operating Activities       (1,426,759)    (4,268,498)

  Cash Flows From Investing Activities:
   Purchase of Equipment                       (1,595,999)    (1,268,498)
   Proceeds on Sale of Assets                           --          9,555

   Purchase of Intangible Assets                   (4,949)          (903)
                                             -------------  -------------
    Cash (Used ) In Investing Activities       (1,600,948)    (1,259,846)

  Cash Flows From Financing Activities:
   Proceeds from Issuance of Common Shares
    and Purchase Warrants                       20,650,610        232,140
   Payments on Notes Payable and Capital
    Lease Obligations                            (181,453)      (204,243)
                                             -------------  -------------
    Cash Provided By Financing Activities       20,469,157         27,897

  Increase (Decrease) In Cash                   17,441,450    (5,500,447)

  Cash At Beginning Of Period                    5,596,645     11,097,092
                                             -------------  -------------

  Cash At End Of Period                      $  23,038,095    $ 5,596,645
                                             =============  =============

Conference Call Information:

Rockwell Medical will be hosting a conference call to review its 2009 fourth quarter results on Wednesday, March 10, 2010 at 4:15 pm ET. Investors are encouraged to call a few minutes in advance at (877) 383-7438 or to listen to the call or on the web at:

http://ir.rockwellmed.com/

The call will be available for replay at the same link above.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Rockwell Medical Technologies, Inc.

CONTACT:  LaVoie Group
Media Contact:
Lisa Rivero, Director, Media Relations
(978)745-4200 ext. 106
The Trout Group LLC
Investor Contact:
Brian Korb, VP
(646) 378-2923

(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.

News Provided by COMTEX


Close window | Back to top


Copyright 2017 Rockwell Medical