Rockwell Medical Reports Second Quarter 2013 Results
- Successful Top Line Data from Phase 3
- Conference Call at
Q2 2013 Highlights
-
Sales were
$13.0 million , a 7.1% increase over Q2 2012. - Sales increased 5.3% sequentially from Q1 2013.
- CitraPure® product line highlighted increased sales growth.
- Gross profit was equivalent to Q2 2012.
- Multi-year contract with DaVita calls for increased business.
-
R&D cost was
$10.2 million vs.$10.9 million in Q2 2012; down$2.5 million from Q1 2013. -
Completed
$57.7 million combined debt and equity financing. -
Cash and investments of
$41 million as ofJune 30, 2013 .
Drug Development Highlights
- SFP Phase 3 CRUISE-1 efficacy trial met primary and key secondary endpoints, achieved statistical significance and delivered excellent safety results.
- CRUISE-2 trial results expected in September.
-
PRIME clinical data, demonstrating SFP significantly reduced ESA 35%, was presented at the ERA-EDTA in
Istanbul, Turkey . -
FDA -approved Calcitriol (active vitamin D) injection underFDA review for manufacturing approval.
For the quarter, Rockwell reported a loss of
For the six months ending
"During the second quarter and early July we achieved several major clinical milestones," stated
Conference Call Information
About SFP
SFP is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7 mg of iron that is lost during a dialysis treatment. SFP is introduced into the sodium bicarbonate concentrate on-site at the dialysis clinic and subsequently mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane and enters the blood where it immediately binds to apo-transferrin and is taken to the bone marrow, similar to how dietary iron is processed in the human body. In completed clinical trials to date, SFP has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose.
About
Rockwell's lead drug candidate in late-stage clinical development is for the treatment of iron replacement 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 during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, SFP has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. SFP has completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). SFP 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/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 and six months ended |
||||
(Unaudited) | ||||
Three Months Ended |
Three Months Ended |
Six Months Ended |
Six Months Ended |
|
June 30, 2013 | June 30, 2012 | June 30, 2013 | June 30, 2012 | |
Sales | $ 12,984,164 | $ 12,124,790 | $ 25,320,538 | $ 24,153,207 |
Cost of Sales | 11,299,099 | 10,405,991 | 22,354,493 | 20,807,932 |
Gross Profit | 1,685,065 | 1,718,799 | 2,966,045 | 3,345,275 |
Selling, General and Administrative | 3,237,974 | 2,824,379 | 7,154,757 | 5,723,063 |
Research and Product Development | 10,222,721 | 10,876,396 | 22,977,239 | 20,281,943 |
Operating Income (Loss) | (11,775,630) | (11,981,976) | (27,165,951) | (22,659,731) |
Interest and Investment Income, net | 4,566 | 77,091 | 15,238 | 188,188 |
Interest Expense | 92,155 | 456 | 92,230 | 709 |
Income (Loss) Before Income Taxes | (11,863,219) | (11,905,341) | (27,242,943) | (22,472,252) |
Income Tax Expense | -- | -- | -- | -- |
Net Income (Loss) |
|
|
$ (27,242,943) | $ (22,472,252) |
Basic Earnings (Loss) per Share |
( |
( |
( |
( |
Diluted Earnings (Loss) per Share |
( |
( |
( |
( |
|
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CONSOLIDATED BALANCE SHEETS | ||
As of |
||
ASSETS |
2013 (Unaudited) |
2012 |
Cash and Cash Equivalents | $ 40,952,067 | $ 4,711,730 |
Accounts Receivable, net of a reserve of |
4,576,492 | 4,431,932 |
Inventory | 2,916,599 | 2,649,639 |
Other Current Assets | 814,765 | 1,356,131 |
Total Current Assets | 49,259,923 | 13,149,432 |
Property and Equipment, net | 1,740,379 | 1,858,442 |
Intangible Assets | 583,229 | 666,744 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 1,523,502 | 429,723 |
Total Assets | $ 54,027,778 | $ 17,025,086 |
LIABILITIES AND SHAREHOLDERS' EQUITY |
||
Capitalized Lease Obligations | $ 592 | $ 2,280 |
Accounts Payable | 8,303,965 | 14,833,565 |
Accrued Liabilities | 8,455,508 | 12,015,978 |
Customer Deposits | 29,007 | 135,133 |
Total Current Liabilities | 16,789,072 | 26,986,956 |
Long Term Debt | 20,000,000 | -- |
Shareholders' Equity: | ||
Common Shares, no par value, 39,916,961 and 21,494,696 shares issued and outstanding | 146,702,432 | 92,866,458 |
Common Share Purchase Warrants, 2,071,407 and 2,233,240 warrants issued and outstanding | 7,786,474 | 7,178,929 |
Accumulated Deficit | (137,250,200) | (110,007,257) |
Accumulated Other Comprehensive Loss | -- | -- |
Total Shareholders' Equity (Deficit) | 17,238,706 | (9,961,870) |
Total Liabilities And Shareholders' Equity | $ 54,027,778 | $ 17,025,086 |
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CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the six months ended |
||
(Unaudited) | ||
2013 | 2012 | |
Cash Flows From Operating Activities: | ||
Net (Loss) | $ (27,242,943) | $ (22,472,252) |
Adjustments To Reconcile Net Loss To Net Cash Used In | ||
Operating Activities: | ||
Depreciation and Amortization | 502,178 | 555,182 |
Share Based Compensation — Non-employee | 1,200,785 | 614,762 |
Share Based Compensation- Employees | 2,779,121 | 2,393,609 |
Loss (Gain) on Disposal of Assets | 5,516 | 25,340 |
Changes in Assets and Liabilities: | ||
(Increase) in Accounts Receivable | (144,560) | (133,189) |
(Increase) in Inventory | (266,960) | (257,962) |
Decrease in Other Assets | 528,866 | 759,966 |
Increase (Decrease) in Accounts Payable | (6,529,600) | 1,046,470 |
Increase (Decrease) in Other Liabilities | (3,666,596) | 2,682,643 |
Changes in Assets and Liabilities | (10,078,850) | 4,097,928 |
Cash Provided By (Used In) Operating Activities | (32,834,193) | (14,785,431) |
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Cash Flows From Investing Activities: | ||
Purchase of Equipment | (313,014) | (242,495) |
Proceeds on Sale of Assets | 6,898 | 1,578 |
(Purchase) of Investments Available for Sale | -- | (2,000,000) |
Cash (Used In) Investing Activities | (306,116) | (2,240,917) |
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Shares and Purchase Warrants | 50,463,613 | 17,785,640 |
Proceeds from the Issuance of Notes Payable | 20,000,000 | -- |
Debt Issuance Costs | (1,081,279) | -- |
Payments on Capital Lease Obligations | (1,688) | (4,626) |
Cash Provided By Financing Activities | 69,380,646 | 17,781,014 |
Increase (Decrease) In Cash | 36,240,337 | 754,666 |
Cash At Beginning Of Period | 4,711,730 | 5,715,246 |
Cash At End Of Period | $ 40,952,067 | $ 6,469,912 |
CONTACT:Source:Michael Rice , Investor Relations; 646-597-6979David Connolly , Media Contact; 617-374-8800
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