Rockwell Medical Reports 2013 First Quarter Results; Signs Long-Term, National Supply Agreement With DaVita
- Compelling PRIME Data, Calcitriol Manufacturing Submission Highlight Q1-
- Company to expand business with
Q1 2013 Highlights
-
Sales were
$12.3 million , an increase of 2.6% over Q1 2012. - Domestic sales increased 5.5% over Q1 2012.
-
Gross profit decreased
$300,000 , primarily due to higher material and operational costs. -
Cash and investments aggregated
$5.8 million as ofMarch 31, 2013 .
Drug Development Highlights
-
Calcitriol (active vitamin D) injection data was submitted to
FDA for manufacturing approval. -
PRIME clinical data showing 35% ESA reduction to be presented at upcoming ERA-EDTA,
Istanbul, Turkey . - CRUISE-1 top-line data projected Q3 2013; CRUISE-2 top-line data projected Q4 2013.
For the quarter, Rockwell reported a loss of
"We achieved two very important clinical goals in Q1," stated
Conference Call Information
About SFP
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 processed 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 an increase in iron stores.
About
Rockwell's lead drug candidate in late-stage clinical development is for the treatment of iron deficiency in dialysis patients 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 completed clinical trials to date, SFP has demonstrated that it can safely deliver sufficient iron to the bone marrow. SFP is nearing completion of its Phase 3 clinical studies (CRUISE-1 and CRUISE-2) and is expected to address an estimated
Rockwell is preparing to launch its
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. As one of the two major suppliers in the U.S., Rockwell's products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell has three manufacturing and distribution facilities located in the U.S. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol 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.
The
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
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CONSOLIDATED INCOME STATEMENTS | ||
For the three months ended |
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(Unaudited) | ||
Three Months Ended | Three Months Ended | |
March 31, 2013 | March 31, 2012 | |
Sales | $ 12,336,374 | $ 12,028,417 |
Cost of Sales | 11,055,394 | 10,401,941 |
Gross Profit | 1,280,980 | 1,626,476 |
Selling, General and Administrative | 3,916,783 | 2,898,684 |
Research and Product Development | 12,754,518 | 9,405,547 |
Operating Income (Loss) | (15,390,321) | (10,677,755) |
Interest and Investment Income, net | 10,672 | 111,097 |
Interest Expense | 75 | 253 |
Income (Loss) Before Income Taxes | (15,379,724) | (10,566,911) |
Income Tax Expense | -- | -- |
Net Income (Loss) | $ (15,379,724) | $ (10,566,911) |
Basic Earnings (Loss) per Share |
( |
( |
Diluted Earnings (Loss) per Share |
( |
( |
|
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CONSOLIDATED BALANCE SHEETS | ||
As of |
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ASSETS |
2013 (Unaudited) |
2012 |
Cash and Cash Equivalents | $ 5,774,297 | $ 4,711,730 |
Accounts Receivable, net of a reserve of |
4,462,299 | 4,431,932 |
Inventory | 2,865,510 | 2,649,639 |
Other Current Assets | 1,086,167 | 1,356,131 |
Total Current Assets | 14,188,273 | 13,149,432 |
Property and Equipment, net | 1,791,942 | 1,858,442 |
Intangible Assets | 624,987 | 666,744 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 442,223 | 429,723 |
Total Assets | $ 17,968,170 | $ 17,025,086 |
LIABILITIES AND SHAREHOLDERS' EQUITY |
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Capitalized Lease Obligations | $ 1,451 | $ 2,280 |
Accounts Payable | 16,100,474 | 14,833,565 |
Accrued Liabilities | 12,288,923 | 12,015,978 |
Customer Deposits | 82,997 | 135,133 |
Total Current Liabilities | 28,473,845 | 26,986,956 |
Capitalized Lease Obligations | -- | -- |
Shareholders' Equity: | ||
Common Shares, no par value, 25,859,138 and 21,494,696 shares issued and outstanding | 106,884,342 | 92,866,458 |
Common Share Purchase Warrants, 2,175,407 and 2,233,240 warrants issued and outstanding | 7,996,964 | 7,178,929 |
Accumulated Deficit | (125,386,981) | (110,007,257) |
Accumulated Other Comprehensive Loss | -- | -- |
Total Shareholders' Equity (Deficit) | (10,505,675) | (9,961,870) |
Total Liabilities And Shareholders' Equity | $ 17,968,170 | $ 17,025,086 |
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CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the three months ended |
||
(Unaudited) | ||
2013 | 2012 | |
Cash Flows From Operating Activities: | ||
Net (Loss) | $ (15,379,724) | $ (10,566,911) |
Adjustments To Reconcile Net Loss To Net Cash Used In | ||
Operating Activities: | ||
Depreciation and Amortization | 250,530 | 277,200 |
Share Based Compensation — Non-employee | 966,227 | 285,568 |
Share Based Compensation- Employees | 1,350,959 | 1,203,821 |
Loss (Gain) on Disposal of Assets | 5,109 | 10,395 |
Changes in Assets and Liabilities: | ||
Decrease (Increase) in Accounts Receivable | (30,367) | 7,741 |
Decrease (Increase) in Inventory | (215,871) | 93,892 |
Decrease in Other Assets | 257,464 | 240,838 |
Increase (Decrease) in Accounts Payable | 1,266,909 | (702,612) |
Increase in Other Liabilities | 220,809 | 848,199 |
Changes in Assets and Liabilities | 1,498,944 | 488,058 |
Cash Provided By (Used) In Operating Activities | (11,307,955) | (8,301,869) |
Cash Flows From Investing Activities: | ||
Purchase of Equipment | (153,380) | (88,543) |
Proceeds on Sale of Assets | 5,998 | 350 |
Cash (Used) In Investing Activities | (147,382) | (88,193) |
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Shares and Purchase Warrants | 12,518,733 | 16,317,287 |
Payments on Notes Payable and Capital Lease Obligations | (829) | (3,067) |
Cash Provided By Financing Activities | 12,517,904 | 16,314,220 |
Increase (Decrease) In Cash | 1,062,567 | 7,924,158 |
Cash At Beginning Of Period | 4,711,730 | 5,715,246 |
Cash At End Of Period | $ 5,774,297 | $ 13,639,404 |
CONTACT:Source:Michael Rice , Investor Relations; (646) 597-6979David Connolly , Media Contact; (617) 374-8800
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