Rockwell Medical Reports 2011 and Fourth Quarter Results
Fourth Quarter Financial Highlights
$11.9 million; $2.4 millionless than fourth quarter 2010 primarily due to lower international sales.
- Sales were comparable with the third quarter 2011 and gross profit margins increased 1.5 percentage points.
Gross profit was
$1.5 million; $0.8 millionless than fourth quarter of 2010 due to lower sales volumes and inflationary cost increases.
- SG&A increased 7.0% from the fourth quarter of 2010 due to higher non-cash charges for equity compensation.
R&D expense increased to
$7.9 million, compared to $1.7 millionin fourth quarter of 2010.
Net loss was
($9.0) million, compared to a net loss of ($1.7) millionin fourth quarter of 2010.
Net loss increased sequentially from the third quarter of 2011 by
$3.9 millionwhile R&D increased $3.6 million.
2011 Financial Highlights
$49.0 million; $10.6 millionless than 2010 primarily due to lower international sales.
- Completed a multi-year supply agreement with our largest customer through 2013.
Gross profit was
$5.6 million; $4.2 millionless than 2010 due to lower sales volumes and higher material and fuel costs.
- SG&A increased 2.3% compared to 2010 largely due to higher non-cash equity charges for compensation.
R&D expense increased significantly to
$17.8 million, compared to $3.4 millionin 2010, reflecting spending on the SFP Phase III clinical development program in 2011.
Net loss was
($21.4) million, compared to a net loss of ($2.7) millionin 2010.
Cash and short-term investments aggregated
$17.5 millionat December 31, 2011; an additional $16.2 millionwas netted from a common stock offering in February 2012.
Drug Development Highlights
- Two Phase III CRUISE efficacy studies nearing patient enrollment completion.
- PRIME study to capture ESA-sparing data nearing patient enrollment completion.
- Data Safety Monitoring Board, upon review of safety data from Phase III CRUISE studies, recommended continuation of studies with no modifications.
Annamaria Kausz, M.D. as Vice President of Drug Development & Medical Affairs.
ANDAfor Calcitriol (Active Vitamin-D) injection.
Conference Call Information:
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 for its drug products into the commercial markets, Calcitriol in 2012 and SFP upon
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.
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 during 2012. 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
|CONSOLIDATED INCOME STATEMENTS|
For the three and twelve months ended
|(unaudited)||(unaudited)||Dec. 31, 2011||
|Sales||$ 11,896,808||$ 14,322,514||$ 48,966,231||$ 59,554,592|
|Cost of Sales||10,352,677||11,947,062||43,323,321||49,693,753|
|Selling, General and Administrative||2,631,805||2,460,015||9,522,305||9,307,621|
|Research and Product Development||7,867,886||1,735,468||17,805,362||3,422,134|
|Operating Income (Loss)||(8,955,560)||(1,820,031)||(21,684,757)||(2,868,916)|
|Interest and Investment Income, net||3,432||157,577||244,049||195,218|
|Income (Loss) Before Income Taxes||(8,952,459)||(1,663,279)||(21,442,552)||(2,683,399)|
|Income Tax Expense||47||--||2,005||--|
|Net Income (Loss)||$ (8,952,506)||$ (1,663,279)||$ (21,444,557)||
|Basic Earnings (Loss) per Share||
|Diluted Earnings (Loss) per Share||
|CONSOLIDATED BALANCE SHEETS|
|Cash and Cash Equivalents||$ 5,715,246||$ 12,263,449|
|Investments Available for Sale||11,810,775||11,938,098|
Accounts Receivable, net of a reserve of
|Other Current Assets||1,643,565||1,020,647|
|Total Current Assets||25,896,529||32,666,368|
|Property and Equipment, net||2,290,476||3,049,513|
|Other Non-current Assets||1,998,076||163,624|
|Total Assets||$ 31,939,599||$ 36,966,907|
LIABILITIES AND SHAREHOLDERS' EQUITY
|Capitalized Lease Obligations||$ 6,470||$ 18,215|
|Total Current Liabilities||13,692,351||6,420,220|
|Capitalized Lease Obligations||2,280||8,750|
|Common Shares, no par value, 18,710,002 and 17,513,608 shares issued and outstanding||67,407,847||57,017,236|
|Common Share Purchase Warrants, 2,607,440 and 3,338,569 warrants issued and outstanding||7,103,975||8,275,509|
|Accumulated Other Comprehensive Loss||(281,112)||(213,623)|
|Total Shareholders' Equity||18,244,968||30,537,937|
|Total Liabilities And Shareholders' Equity||$ 31,939,599||$ 36,966,907|
|CONSOLIDATED STATEMENTS OF CASH FLOWS|
For the years ended
|Cash Flows From Operating Activities:|
|Net (Loss)||$ (21,444,557)||$ (2,683,399)||$ (5,501,238)|
|Adjustments To Reconcile Net Loss To Net Cash Used In|
|Depreciation and Amortization||1,176,007||1,389,152||1,233,706|
|Share Based Compensation — Non-employee warrants||312,325||639,915||403,203|
|Share Based Compensation- Employees||4,065,703||3,381,394||1,949,684|
|Loss (Gain) on Disposal of Assets||29,093||19,816||36,415|
|Loss on Sale of Investments Available for Sale||84,590||--||--|
|Changes in Assets and Liabilities:|
|(Increase) Decrease in Accounts Receivable||284,480||(1,014,674)||1,737,034|
|Decrease in Inventory||432,751||151,474||73,273|
|(Increase) Decrease in Other Assets||(2,457,370)||(690,750)||68,131|
|Increase (Decrease)in Accounts Payable||1,705,030||270,750||(1,822,215)|
|Increase in Other Liabilities||5,028,846||637,236||395,248|
|Changes in Assets and Liabilities||4,993,737||(645,964)||451,471|
|Cash Provided By (Used) In Operating Activities||(10,783,102)||2,100,914||(1,426,759)|
|Cash Flows From Investing Activities:|
|(Purchase) of Investments Available for Sale||(2,000,000)||(12,151,721)||--|
|Sale of Investments Available for Sale||1,975,244||--||--|
|Purchase of Equipment||(421,043)||(772,364)||(1,595,999)|
|Proceeds on Sale of Assets||2,985||1,800|
|Purchase of Intangible Assets||(145,121)||--||(4,949)|
|Cash (Used) In Investing Activities||(587,935)||(12,922,285)||(1,600,948)|
|Cash Flows From Financing Activities:|
|Proceeds from Issuance of Common Shares and Purchase Warrants||4,841,049||90,448||20,650,610|
|Payments on Notes Payable and Capital Lease Obligations||(18,215)||(43,723)||(181,453)|
|Cash Provided By Financing Activities||4,822,834||46,725||20,469,157|
|Increase (Decrease) In Cash||(6,548,203)||(10,774,646)||17,441,450|
|Cash At Beginning Of Period||12,263,449||23,038,095||5,596,645|
|Cash At End Of Period||$ 5,715,246||$ 12,263,449||
Michael Rice, Investor Relations, (646) 597-6979
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