Rockwell Medical, Inc. Reports Fourth Quarter 2013 Results
Q4 2013 Highlights
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Sales were
$14.0 million , a 7.4% increase over Q4 2012. -
Gross profit was
$2.1 million , a 21% increase over Q4 2012. -
R&D expense was
$5.8 million , a 51% decrease compared to$11.8 million in Q4 2012 -
Cash was
$23.9 million as ofDecember 31, 2013 .
2013 Highlights
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Sales were
$52.4 million , a 5.1% increase over 2012. -
Gross profit was
$6.7 million , about the same as 2012. -
R&D expense was
$39.4 million , an 18.4% decrease compared to$48.3 million in 2012.
2013 Drug Development Highlights
- Three, large-scale, long-term clinical studies for investigational iron replacement drug Triferic® successfully met primary and key secondary endpoints.
- PRIME clinical marketing study results demonstrated significant 35% ESA reduction overall and 74.4% in hypo-responsive patients.
- CRUISE-1 and CRUISE-2 Phase 3 efficacy studies met primary and key secondary endpoints, achieved statistical significance, and delivered excellent safety results showing no acute safety signal or anaphylactic reaction in over 100,000 doses.
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Triferic® accepted as brand name for marketing upon
FDA approval. -
Multiple Triferic® clinical study abstracts were presented at numerous kidney conferences, including the
American Society of Nephrology (ASN) Annual Meeting,November 7-9, 2013 . -
Calcitriol (active vitamin D injection) chemistry data submitted to
FDA for manufacturing approval.
For the quarter ended
For the year ended
"We had a very productive and successful 2013," stated,
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, 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
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CONSOLIDATED INCOME STATEMENTS | ||||
For the three and twelve months ended |
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Three Months | Three Months | Twelve Months | Twelve Months | |
Ended | Ended | Ended | Ended | |
December 31, | December 31, | December 31, |
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2013 | 2012 | 2013 | 2012 | |
Sales |
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Cost of Sales | 11,904,730 | 11,297,621 | 45,720,323 | 43,148,965 |
Gross Profit | 2,059,894 | 1,702,225 | 6,659,220 | 6,693,427 |
Selling, General and Administrative | 3,795,325 | 3,635,386 | 14,336,449 | 12,683,860 |
Research and Product Development | 5,793,579 | 11,751,256 | 39,382,037 | 48,271,649 |
Operating Income (Loss) | (7,529,010) | (13,684,417) | (47,059,266) | (54,262,082) |
Interest and Investment Income, net | 69,317 | 11,034 | 98,101 | 241,518 |
Interest Expense | 872,412 | 105 | 1,822,147 | 951 |
Income (Loss) Before Income Taxes | (8,332,105) | (13,673,488) | (48,783,312) | (54,021,515) |
Income Tax Expense | -- | -- | -- | -- |
Net Income (Loss) |
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Basic Earnings (Loss) per Share |
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Diluted Earnings (Loss) per Share |
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CONSOLIDATED BALANCE SHEETS | ||
As of |
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ASSETS | 2013 | 2012 |
Cash and Cash Equivalents |
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Investments Available for Sale | 12,034,622 | -- |
Accounts Receivable, net of a reserve of |
4,578,319 | 4,431,932 |
Inventory | 2,799,648 | 2,649,639 |
Other Current Assets | 623,734 | 1,356,131 |
Total Current Assets | 31,917,774 | 13,149,432 |
Property and Equipment, net | 1,648,949 | 1,858,442 |
Intangible Assets | 499,715 | 666,744 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 1,374,941 | 429,723 |
Total Assets |
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LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Note Payable Capitalized Lease Obligations |
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$ -- |
Capitalized Lease Obligations Capitalized Lease Obligations | -- | 2,280 |
Accounts Payable | 8,686,153 | 14,833,565 |
Accrued Liabilities | 6,647,828 | 12,015,978 |
Customer Deposits | 207,545 | 135,133 |
Total Current Liabilities | 17,849,671 | 26,986,956 |
Long Term Debt | 17,916,914 | -- |
Shareholders' Equity: | ||
Common Shares, no par value, 40,110,661 and 21,494,696 shares issued and outstanding | 154,457,878 | 92,866,458 |
Common Share Purchase Warrants, 983,071 and 2,233,240 warrants issued and outstanding | 4,895,811 | 7,178,929 |
Accumulated Deficit | (158,790,569) | (110,007,257) |
Accumulated Other Comprehensive Income | 32,419 | -- |
Total Shareholders' Equity (Deficit) | 595,539 | (9,961,870) |
Total Liabilities And Shareholders' Equity |
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CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the years ended |
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2013 | 2012 | |
Cash Flows From Operating Activities: | ||
Net (Loss) |
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Adjustments To Reconcile Net Loss To Net Cash Used In | ||
Operating Activities: | ||
Depreciation and Amortization | 1,007,411 | 1,087,397 |
Share Based Compensation - Non-employee | 1,862,874 | 2,322,417 |
Share Based Compensation- Employees | 5,849,196 | 4,979,724 |
Loss (Gain) on Disposal of Assets | 16,410 | 17,876 |
Loss on Sale of Investments Available for Sale | -- | 67,303 |
Amortization of Debt Issuance Costs | 227,059 | -- |
Non-Cash Interest Expense | 225,059 | -- |
Changes in Assets and Liabilities: | ||
(Increase) Decrease in Accounts Receivable | (146,387) | (209,116) |
(Increase) Decrease in Inventory | (150,009) | (145,512) |
(Increase) Decrease in Other Assets | 669,896 | 1,855,787 |
Increase (Decrease) in Accounts Payable | (6,147,412) | 9,469,028 |
Increase (Decrease) in Other Liabilities | (5,295,738) | 3,829,767 |
Changes in Assets and Liabilities | (11,069,650) | 14,799,954 |
Cash (Used In) Operating Activities | (50,664,953) | (30,746,844) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available for Sale | (12,002,203) | (2,012,671) |
Sale of Investments Available for Sale | -- | 14,037,255 |
Purchase of Equipment | (654,197) | (507,788) |
Proceeds on Sale of Assets | 6,898 | 1,578 |
Purchase of Intangible Assets | -- | -- |
Cash Provided By (Used In) Investing Activities | (12,649,502) | 11,518,374 |
Cash Flows From Financing Activities: | ||
Proceeds from Issuance of Common Shares and Purchase Warrants | 51,596,232 | 18,231,424 |
Proceeds from the Issuance of Notes Payable | 20,000,000 | -- |
Debt Issuance Costs | (1,109,776) | -- |
Payments on Notes Payable and Capital Lease Obligations | (2,280) | (6,470) |
Cash Provided By Financing Activities | 70,484,176 | 18,224,954 |
Increase (Decrease) In Cash | 7,169,721 | (1,003,516) |
Cash At Beginning Of Period | 4,711,730 | 5,715,246 |
Cash At End Of Period |
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CONTACT:Source:Michael Rice Investor Relations 646-597-6979
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