Full Press Release Details
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 |