Rockwell Medical Reports Third Quarter 2013 Results
— Successful Triferic™ Phase 3
- Conference Call
Q3 2013 Highlights
-
Sales were
$13.1 million , a 3.2% increase over Q3 2012. -
Gross profit was
$1.6 million , equivalent to Q3 2012. -
R&D expense was
$10.6 million , a reduction of 35% compared to$16.2 million in Q3 2012. -
Cash and investments of
$31.2 million as ofSeptember 30, 2013 .
Drug Development Highlights
- Phase 3 CRUISE-2 clinical study for investigational iron replacement drug Triferic™ met primary and key secondary endpoints, achieved statistical significance and delivered excellent safety results.
- Phase 3 CRUISE-1 and CRUISE-2 clinical studies achieved identical positive efficacy results, demonstrating effective iron delivery to the bone marrow while maintaining hemoglobin.
- Phase 3 CRUISE-1 and CRUISE-2 clinical studies demonstrated clean safety profile with over 100,000 accumulated administrations to date without a single acute safety signal or anaphylactic reaction.
-
Triferic™ accepted as brand name for marketing upon
FDA approval. -
(4) Triferic™ poster presentations and (1) oral presentation demonstrating clinical study results are accepted for presentation at the
American Society of Nephrology (ASN) Annual Meeting,November 7-9, 2013 . -
Triferic™ selected to be showcased at the ASN Kidney Week "
Innovators Place " which highlights innovative investigational drugs and devices to the nephrology community.
For the quarter, Rockwell reported a loss of
For the nine months ending
"During the third quarter we achieved several major clinical milestones that have the potential to transform Rockwell," 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 nine months ended |
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(Unaudited) | ||||
Three Months | Three Months | Nine Months | Nine Months | |
Ended | Ended | Ended | Ended | |
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2013 | 2012 | 2013 | 2012 | |
Sales |
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Cost of Sales | 11,461,100 | 11,043,412 | 33,815,593 | 31,851,344 |
Gross Profit | 1,633,281 | 1,645,927 | 4,599,326 | 4,991,202 |
Selling, General and Administrative | 3,386,367 | 3,325,411 | 10,541,124 | 9,048,474 |
Research and Product Development | 10,611,219 | 16,238,450 | 33,588,458 | 36,520,393 |
Operating Income (Loss) | (12,364,305) | (17,917,934) | (39,530,256) | (40,577,665) |
Interest and Investment Income, net | 13,546 | 42,296 | 28,784 | 230,484 |
Interest Expense | 857,505 | 137 | 949,735 | 846 |
Income (Loss) Before Income Taxes | (13,208,264) | (17,875,775) | (40,451,207) | (40,348,027) |
Income Tax Expense | -- | -- | -- | -- |
Net Income (Loss) |
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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 |
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Investments Available for Sale | 10,004,943 | -- |
Accounts Receivable, net of a reserve of |
4,222,411 | 4,431,932 |
Inventory | 2,814,165 | 2,649,639 |
Other Current Assets | 687,367 | 1,356,131 |
Total Current Assets | 38,941,712 | 13,149,432 |
Property and Equipment, net | 1,705,258 | 1,858,442 |
Intangible Assets | 541,472 | 666,744 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 1,492,214 | 429,723 |
Total Assets |
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LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Loan Payable |
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$ -- |
Capitalized Lease Obligations | -- | 2,280 |
Accounts Payable | 7,111,561 | 14,833,565 |
Accrued Liabilities | 10,124,949 | 12,015,978 |
Customer Deposits | 263,825 | 135,133 |
Total Current Liabilities | 18,071,690 | 26,986,956 |
Long Term Debt | 19,428,645 | -- |
Shareholders' Equity: | ||
Common Shares, no par value, 39,997,961 and 21,494,696 shares issued and outstanding | 151,396,640 | 92,866,458 |
Common Share Purchase Warrants, 1,063,071 and 2,233,240 warrants issued and outstanding | 5,158,558 | 7,178,929 |
Accumulated Deficit | (150,458,464) | (110,007,257) |
Accumulated Other Comprehensive Income | 4,332 | -- |
Total Shareholders' Equity (Deficit) | 6,101,066 | (9,961,870) |
Total Liabilities And Shareholders' Equity |
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CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the nine months ended |
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(Unaudited) | ||
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 | 752,360 | 828,676 |
Share Based Compensation — Non-employee | 1,435,344 | 1,309,502 |
Share Based Compensation- Employees | 4,449,110 | 3,727,224 |
Non-cash Interest Expense | 426,938 | -- |
Loss (Gain) on Disposal of Assets | 15,500 | 26,340 |
Changes in Assets and Liabilities: | ||
(Increase) Decrease in Accounts Receivable | 209,521 | (95,917) |
(Increase) in Inventory | (164,526) | (167,940) |
Decrease in Other Assets | 606,263 | 1,233,592 |
Increase (Decrease) in Accounts Payable | (7,722,004) | 2,726,145 |
Increase (Decrease) in Other Liabilities | (2,079,489) | 7,184,330 |
Changes in Assets and Liabilities | (9,150,235) | 10,880,210 |
Cash Provided By (Used In) Operating Activities | (42,522,190) | (23,576,075) |
Cash Flows From Investing Activities: | ||
Purchase of Equipment | (496,302) | (381,400) |
Proceeds on Sale of Assets | 6,898 | 1,578 |
Purchase of Intangible Assets | -- | (550,000) |
Sale of Investments Available for Sale | -- | 3,986,750 |
(Purchase) of Investments Available for Sale | (10,000,611) | (2,000,000) |
Cash (Used In) Investing Activities | (10,490,015) | 1,056,928 |
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Shares and Purchase Warrants | 50,625,357 | 17,983,844 |
Proceeds from the Issuance of Notes Payable | 20,000,000 | -- |
Debt Issuance Costs | (1,109,776) | -- |
Payments on Capital Lease Obligations | (2,280) | (5,672) |
Cash Provided By Financing Activities | 69,513,301 | 17,978,172 |
Increase (Decrease) In Cash | 16,501,096 | (4,540,975) |
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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