Rockwell Medical, Inc. Reports First Quarter 2014 Results
Q1 2014 Highlights
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Sales were
$13.0 million , a 5.1% increase over Q1 2013. -
Gross profit was
$1.7 million , a 31% increase over Q1 2013. -
R&D expense was
$4.6 million , a 64% decrease compared to$12.8 million in Q1 2013. -
Cash and investments were
$14.7 million as ofMarch 31, 2014 .
Q1 2014 Drug Development Highlights
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Triferic New Drug Application submitted to
FDA . -
Triferic formulation patent issued for
Japan . - Triferic long-term safety studies completed.
-
KOL breakfast meeting held in
New York to examine anemia management and potential iron delivery advancements for CKD-HD patients. -
Triferic clinical study abstracts and oral presentations accepted and presented at key nephrology conferences including the
National Kidney Foundation Spring Clinical Meeting,Asia Pacific Congress on Nephrology and ISN Nexus Symposium .
For the quarter ended
"The submission of our Triferic NDA during the first quarter represents a major milestone for the Company," stated Mr.
Conference Call Information
About Triferic
Triferic 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 every dialysis treatment. Triferic is introduced into the sodium bicarbonate concentrate on-site at the dialysis clinic, which is subsequently mixed into dialysate. Once in the dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to apo-transferrin and is taken to the bone marrow to assist in new red blood cell formation, similar to how dietary iron is processed in the human body. In completed clinical trials to date, Triferic 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 Triferic is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic 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, Triferic 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. Triferic has completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic 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 Triferic 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.
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 Triferic® following
Triferic™ is a trademark of
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CONSOLIDATED INCOME STATEMENTS | ||
For the three months ended |
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(Unaudited) | ||
Three Months | Three Months | |
Ended | Ended | |
March 31, 2014 | March 31, 2013 | |
Sales | $ 12,963,652 | $ 12,336,374 |
Cost of Sales | 11,283,694 | 11,055,394 |
Gross |
1,679,958 | 1,280,980 |
Selling, General and Administrative | 4,090,199 | 3,916,783 |
Research and Product Development | 4,615,197 | 12,754,518 |
Operating Income (Loss) | (7,025,438) | (15,390,321) |
Interest and Investment Income, net | 74,215 | 10,672 |
Interest Expense | 854,303 | 75 |
Income (Loss) Before Income Taxes | (7,805,526) | (15,379,724) |
Income Tax Expense | -- | -- |
Net Income (Loss) | $ (7,805,526) | $ (15,379,724) |
Basic Earnings (Loss) per Share |
( |
( |
Diluted Earnings (Loss) per Share |
( |
( |
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CONSOLIDATED BALANCE SHEETS | ||
As of |
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(Unaudited) | ||
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ASSETS | 2014 | 2013 |
Cash and Cash Equivalents | $ 661,117 | $ 11,881,451 |
Investments Available for Sale | 14,068,482 | 12,034,622 |
Accounts Receivable, net of a reserve of |
4,100,453 | 4,578,319 |
Inventory | 2,909,828 | 2,799,648 |
Other Current Assets | 602,393 | 623,734 |
Total Current Assets | 22,342,273 | 31,917,774 |
Property and Equipment, net | 1,761,165 | 1,648,949 |
Intangible Assets | 457,958 | 499,715 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 1,311,411 | 1,374,941 |
Total Assets | $ 26,793,552 | $ 36,362,124 |
LIABILITIES AND SHAREHOLDERS' EQUITY |
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Note Payable Capitalized Lease Obligations | $ 4,113,013 | $ 2,308,145 |
Accounts Payable | 5,133,267 | 8,686,153 |
Accrued Liabilities | 4,605,573 | 6,647,828 |
Customer Deposits | 244,314 | 207,545 |
Total Current Liabilities | 14,096,167 | 17,849,671 |
Long Term Debt | 16,224,575 | 17,916,914 |
Shareholders' Equity: | ||
Common Shares, no par value, 40,759,976 and 40,110,661 shares issued and outstanding | 158,776,957 | 154,457,878 |
Common Share Purchase Warrants, 838,071 and 983,071 warrants issued and outstanding | 4,225,669 | 4,895,811 |
Accumulated Deficit | (166,596,095) | (158,790,569) |
Accumulated Other Comprehensive Income | 66,279 | 32,419 |
Total Shareholders' Equity (Deficit) | (3,527,190) | 595,539 |
Total Liabilities And Shareholders' Equity | $ 26,793,552 | $ 36,362,124 |
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CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the three months ended |
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(Unaudited) | ||
2014 | 2013 | |
Cash Flows From Operating Activities: | ||
Net (Loss) | $ (7,805,526) | $ (15,379,724) |
Adjustments To Reconcile Net Loss To Net Cash Used In | ||
Operating Activities: | ||
Depreciation and Amortization | 257,761 | 250,530 |
Share Based Compensation - Non-employee | -- | 966,227 |
Share Based Compensation- Employees | 2,174,212 | 1,350,959 |
Amortization of Debt Issuance Costs | 113,529 | -- |
Non-Cash Interest Expense | 112,529 | -- |
Loss on Disposal of Assets | 1,662 | 5,109 |
Changes in Assets and Liabilities: | ||
Decrease (Increase) in Accounts Receivable | 477,866 | (30,367) |
Increase in Inventory | (110,180) | (215,871) |
Decrease (Increase) in Other Assets | (243,936) | 257,464 |
Increase (Decrease) in Accounts Payable | (3,552,886) | 1,266,909 |
Increase (Decrease) in Other Liabilities | (1,790,208) | 220,809 |
Changes in Assets and Liabilities | (5,219,344) | 1,498,944 |
Cash Used In Operating Activities | (10,365,177) | (11,307,955) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available for Sale | (2,000,000) | -- |
Purchase of Equipment | (329,882) | (153,380) |
Proceeds on Sale of Assets | -- | 5,998 |
Cash Used In Investing Activities | (2,329,882) | (147,382) |
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Shares and Purchase Warrants | 1,474,725 | 12,518,733 |
Payments on Notes Payable and Capital Lease Obligations | -- | (829) |
Cash Provided By Financing Activities | 1,474,725 | 12,517,904 |
Increase (Decrease) In Cash | (11,220,334) | 1,062,567 |
Cash At Beginning Of Period | 11,881,451 | 4,711,730 |
Cash At End Of Period |
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CONTACT:Source:Michael Rice , Investor Relations; 646-597-6979
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