Rockwell Medical Reports 2012 Fourth Quarter and Full Year Results
Q4' 2012 Highlights
$13.0 million, increasing 9.3% over Q4 2011.
Gross profit increased 10.2% or
$0.2 millionover Q4 2011.
Cash and investments aggregated
$4.7million December 31, 2012.
Full-year 2012 Financial Highlights
$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
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
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.
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
Rockwell is also preparing to launch a
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
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 and SFP following
CONSOLIDATED INCOME STATEMENTS
For the three and twelve months ended
||Year Ended||Year Ended|
|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|
|Selling, General and Administrative||3,635,386||2,631,805||12,683,860||9,522,305|
|Research and Product Development||11,751,256||7,867,886||48,271,649||17,805,362|
|Operating Income (Loss)||(13,684,417)||(8,995,560)||(54,262,082)||(21,684,757)|
|Interest and Investment Income, net||11,034||3,432||241,518||244,049|
|Income (Loss) Before Income Taxes||(13,673,488)||(8,952,459)||(54,021,515)||(21,442,552)|
|Income Tax Expense||--||47||--||2,005|
|Net Income (Loss)||
|Basic Earnings (Loss) per Share||
|Diluted Earnings (Loss) per Share||
CONSOLIDATED BALANCE SHEETS
|Cash and Cash Equivalents||$ 4,711,730||$ 5,715,246|
|Investments Available for Sale||--||11,810,775|
Accounts Receivable, net of a reserve of
|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|
|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|
|Total Current Liabilities||26,986,956||13,692,351|
|Capitalized Lease Obligations||--||2,280|
|Common Shares, no par value, 21,494,696 and 18,710,002 shares issued and outstanding||
|Common Share Purchase Warrants, 2,233,240 and 2,607,440 warrants issued and outstanding||
|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|
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the years ended
|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|
|Depreciation and Amortization||1,087,397||1,176,007||1,389,152|
|Share Based Compensation — Non-employee||2,322,417||312,325||639,915|
|Share Based Compensation- Employees||4,979,724||4,065,703||3,381,394|
|Loss (Gain) on Disposal of Assets||17,876||29,093||19,816|
|Loss on Sale of Investments Available for Sale||67,303||84,590||--|
|Changes in Assets and Liabilities:|
|(Increase) Decrease in Accounts Receivable||(209,116)||284,480||(1,014,674)|
|(Increase) Decrease in Inventory||(145,512)||432,751||151,474|
|(Increase) Decrease in Other Assets||1,855,787||(2,457,370)||(690,750)|
|Increase (Decrease)in Accounts Payable||9,469,028||1,705,030||270,750|
|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 Operating Activities||(30,746,844)||(10,783,102)||2,100,914|
|Cash Flows From Investing Activities:|
|(Purchase) of Investments Available for Sale||(2,012,671)||(2,000,000)||(12,151,721)|
|Sale of Investments Available for Sale||14,037,255||1,975,244||--|
|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 Activities||11,518,374||(587,935)||(12,922,285)|
|Cash Flows From Financing Activities:|
|Proceeds from Issuance of Common Shares and Purchase Warrants||
|Payments on Notes Payable and Capital Lease Obligations||(6,470)||(18,215)||(43,723)|
|Cash Provided By Financing Activities||18,224,954||4,822,834||46,725|
|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|
Michael Rice, Investor Relations; (646) 597-6979 David Connolly, Media Contact; (617) 374-8800
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