WIXOM, Mich., March 1 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. , a leading, innovative hemodialysis products manufacturer in the healthcare sector, reported its fourth quarter and year- end results today. Sales increased 35% in the fourth quarter over last year’s fourth quarter and 2005 revenue increased 54% over 2004. Sales increased to $27.7 million in 2005 compared to $18 million in 2004. Spending on FDA drug approval for Rockwell’s proprietary iron-delivery product, Soluble Ferric Pyrophosphate (SFP), reduced earnings $.04 per share in 2005.
Fourth quarter 2005 earnings per share was a loss of ($.03) as compared to breakeven in the fourth quarter of 2004. Net loss of ($274,040) in the fourth quarter included $186,000 of drug product spending for SFP related expenses. Earnings per share for 2005 were $.01 as compared to $.02 in 2004. Investments in FDA approval costs for SFP during 2005 totaled $.04 per share. 2005 profit of $76,808 was reduced by $350,000 for SFP related expenses.
Fourth Quarter Highlights: * Sales increased 35% over the fourth quarter of 2004 to $6,456,000. * Appointed Scientific Advisory Board (SAB) to advise on the development and FDA approval of SFP. * Commenced Safety Pharmacology Tests for the development and approval of SFP. * Completed warrant exchange resulting in successful exercise and gross capital raise of $9.25 million. * Net loss was ($.03) per share and included $.02 per share of SFP development costs. 2005 Highlights: * Sales increased $9.75 million, or 54%, to $27.7 million in 2005 as compared to 2004. * Significantly increased market penetration both domestically and internationally. * Expanded national production and distribution footprint with third manufacturing facility in the Southeast. * Received European Patent allowance for Rockwell’s proprietary iron delivery product - SFP. * Completed commercial SFP manufacturing and testing procedures. * Net Income was $.01 per share and included $.04 of SFP development costs.
Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell Medical Technologies, Inc. stated, “We are extremely pleased with the progress we made during 2005. Our strategic initiatives encompass both building our core concentrate business and gaining FDA market approval for our proprietary iron-delivery product (SFP), but clearly our top priority will be getting SFP to the market as fast as possible. The fourth quarter was the beginning of accelerated spending on SFP product testing and resulted in increased product development expense for Rockwell; we anticipate that expense will increase substantially going forward. We expect to spend at least $3-4 million for FDA testing and development in 2006 which will be funded from the proceeds from the exercise of our warrants. We are very excited about this innovative, proprietary product and its potential to capture market share.”
Rockwell is seeking FDA approval for its Soluble Ferric Pyrophosphate (SFP) iron-delivery product used to treat dialysis patients with iron deficiency. The Company plans to submit its Phase III protocol for FDA review in the second quarter of 2006 and anticipates that Phase III clinical studies will commence in late 2006. Safety and pharmacology testing commenced in the fourth quarter of 2005 and will run throughout 2006. Safety and pharmacology testing so far has demonstrated favorable results. SFP was successfully tested in its Phase II clinical trial. An independent National Institutes of Health Study is expected to commence treating patients with SFP in May.
Rockwell will be hosting a conference call to review its year end and fourth quarter results on Wednesday, March 1, 2006 at 11:00 am EST. Investors are encouraged to call in five minutes in advance of the call at 888-896-0862 or may listen on the web at: http://orion.calleci.com/servlet/estreamgetevent?id=6516&folder=default using Windows Media Player. See http://www.rockwellmed.com for more details and playback options.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing and delivering high-quality dialysis solutions, powders and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 4-6% on average each year over the last decade. Rockwell’s products are used to cleanse the ESRD patient’s blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate(R) Dry Acid Concentrate Mixing System, RenalPure(R) Liquid Acid Concentrate, SteriLyte(R) Liquid Bicarbonate Concentrate, RenalPure(R) Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell’s website at http://www.rockwellmed.com for more information.
Certain statements in this press release with respect to Rockwell’s business and operations, including statements regarding FDA approval, the potential of Rockwell’s proprietary Soluble Ferric Pyrophosphate (SFP) to capture market share, etc. constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management’s expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delays or failure to obtain FDA approval of SFP, failure to obtain medicare or private insurance reimbursement approval, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell’s reports filed with the Securities and Exchange Commission. These forward-looking statements should be considered in light of these risks and uncertainties.
Rockwell Medical Technologies, Inc. and Subsidiary Consolidated Income Statements For the three and twelve months ended December 31, 2005 and December 31, 2004
(Whole dollars) Three Months Three Months Twelve Months Twelve Months Ended Ended Ended Ended Dec. 31, 2005 Dec. 31, 2004 Dec. 31, 2005 Dec. 31, 2004 Sales $6,456,152 $4,780,070 $27,694,955 $17,944,710 Cost of Sales 5,890,958 4,072,467 24,689,912 15,139,215 Gross Profit 565,194 707,603 3,005,043 2,805,495 Selling, General and Administrative 772,663 636,623 2,867,608 2,396,315 Operating Income (207,469) 70,980 137,435 409,180 Other Income - - 137,468 - Interest Expense, net 66,571 59,576 198,095 197,658 Net Income $(274,040) $11,404 $76,808 $211,522 Basic Shares Outstanding 8,795,057 8,553,527 8,674,651 8,546,302 Basic Earnings Per Share $(0.03) $ 0.00 $0.01 $0.02 Fully Diluted Shares Outstanding 9,891,521 9,199,505 9,356,990 9,305,123 Fully Diluted Earnings Per Share $(0.03) $ 0.00 $0.01 $0.02 Rockwell Medical Technologies, Inc. And Subsidiary Consolidated Balance Sheets As of December 31, 2005 and December 31, 2004 (Whole Dollars) DECEMBER 31, DECEMBER 31, 2005 2004 ASSETS Cash and Cash Equivalents $299,031 $166,195 Restricted Cash Equivalents - 8,662 Accounts Receivable, net of a reserve of $70,000 in 2005 and $44,500 in 2004 2,836,072 2,302,093 Inventory 2,051,819 1,652,457 Other Current Assets 193,158 111,630 Total Current Assets 5,380,080 4,241,037 Property and Equipment, net 2,430,222 2,048,665 Intangible Assets 394,819 369,508 Goodwill 920,745 920,745 Other Non-current Assets 134,794 120,597 Total Assets $9,260,660 $7,700,552 LIABILITIES AND SHAREHOLDERS’ EQUITY Short Term Borrowings $1,800,000 $452,682 Notes Payable & Capitalized Lease Obligations 522,439 389,602 Accounts Payable 1,795,393 2,124,679 Accrued Liabilities 530,749 481,587 Customer Deposits 33,558 11,005 Total Current Liabilities 4,682,139 3,459,555 Long Term Notes Payable & Capitalized Lease Obligations 733,723 818,678 Shareholders’ Equity: Common Share, no par value, 8,886,948 and 8,556,531 shares issued and outstanding 12,628,539 11,870,909 Common Share Purchase Warrants, 3,591,385 and 3,761,071 shares issued and outstanding 1,414,876 320,150 Accumulated Deficit (10,198,617) (8,768,740) Total Shareholders’ Equity 3,844,798 3,422,319 Total Liabilities And Shareholders’ Equity $9,260,660 $7,700,552
Rockwell Medical Technologies, Inc.
CONTACT: Thomas Klema, CFO, +1-248-960-9009, or Ronald J. Aubrey, InvestorRelations, +1-866-565-6139, both for Rockwell Medical Technologies, Inc.
Web site: http://rockwellmed.com/
