Rockwell Medical, Inc. Reports Second Quarter 2014 Results
Q2 2014 Highlights
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Q2 sales were
$13.0 million , a 0.4% increase over Q2 2013. -
Q2 gross profit was
$2.0 million , a 19.8% increase over Q2 2013. - Q2 gross profit margins improved by 2.5 percentage points to 15.5%, compared to 13.0% in Q2 2013.
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R&D expense was
$0.2 million , a 98% decrease compared to$10.2 million in Q2 2013. -
Net loss decreased by
$8.7 million or 73% compared to Q2 2013. -
Cash and investments were
$11.9 million as ofJune 30, 2014 .
1H 2014 Highlights
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Sales were
$26 million , up 2.7% over the first half of 2013. -
Gross profit was
$3.7 million , up 24.7% over the first half of 2013. - Gross profit margins increased by 2.5 percentage points to 14.2%, compared to the first half of 2013.
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R&D spending decreased
$18.2 million or 79% compared to the first half of 2013. -
Net loss decreased
$16.3 million or 60% to$11.0 million compared to the first half of 2013. -
Loss per share improved by
$0.76 per share with a year-to-date loss of ($0.28 ) compared to a loss of ($1.04 ) in the first half of 2013.
Q2 2014 Drug Development Highlights
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Triferic New Drug Application (NDA) was accepted for review by the
FDA . -
Triferic was given a Prescription Drug User Fee Act (PDUFA) action date of
January 24, 2015 by theFDA . -
Triferic clinical study abstracts and oral presentations accepted and presented at key nephrology conferences including the
National Kidney Foundation Spring Clinical Meeting inDallas , theERA-EDTA Congress inthe Netherlands and at theAsian Pacific Congress of Nephrology inJapan . -
Rockwell won its
Small Business Administration appeal for the PDUFA fee waiver, resulting in a$2.2 million refund to the Company. -
Rockwell received
FDA manufacturing approval for Calcitriol, the Company's low-cost, generic active vitamin D injection.
"We are pleased with our achievements and continued execution," 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, similar to how dietary iron is processed in the human body. In completed clinical trials to date, Triferic has demonstrated that it may 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 investigational drug Triferic is currently under NDA review by the
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 product 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 and six months ended |
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(Unaudited) | ||||
Three Months Ended |
Three Months Ended |
Six Months Ended |
Six Months Ended |
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Sales |
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Cost of Sales | 11,014,469 | 11,299,099 | 22,298,163 | 22,354,493 |
Gross Profit | 2,018,892 | 1,685,065 | 3,698,850 | 2,966,045 |
Selling, General and Administrative | 4,214,205 | 3,237,974 | 8,304,404 | 7,154,757 |
Research and Product Development | 186,695 | 10,222,721 | 4,801,892 | 22,977,239 |
Operating Income (Loss) | (2,382,008) | (11,775,630) | (9,407,446) | (27,165,951) |
Interest and Investment Income, net | 69,633 | 4,566 | 143,848 | 15,238 |
Interest Expense | 858,003 | 92,155 | 1,712,306 | 92,230 |
Income (Loss) Before Income Taxes | (3,170,378) | (11,863,219) | (10,975,904) | (27,242,943) |
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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(Unaudited) | ||
ASSETS |
2014 |
2013 |
Cash and Cash Equivalents |
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Investments Available for Sale | 9,076,243 | 12,034,622 |
Accounts Receivable, net of a reserve of |
4,218,917 | 4,578,319 |
Other Receivable | 2,169,883 | -- |
Inventory | 2,784,142 | 2,799,648 |
Other Current Assets | 589,074 | 623,734 |
Total Current Assets | 21,696,983 | 31,917,774 |
Property and Equipment, net | 1,650,003 | 1,648,949 |
Intangible Assets | 416,200 | 499,715 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 1,197,882 | 1,374,941 |
Total Assets |
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LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Note Payable |
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Accounts Payable | 6,276,561 | 8,686,153 |
Accrued Liabilities | 2,784,711 | 6,647,828 |
Customer Deposits | 284,105 | 207,545 |
Total Current Liabilities | 15,314,888 | 17,849,671 |
Long Term Debt | 14,480,606 | 17,916,914 |
Shareholders' Equity: | ||
Common Shares, no par value, 40,895,726 and 40,110,661 shares issued and outstanding | 161,575,859 | 154,457,878 |
Common Share Purchase Warrants, 838,071 and 983,071 warrants issued and outstanding | 4,225,669 | 4,895,811 |
Accumulated Deficit | (169,766,473) | (158,790,569) |
Accumulated Other Comprehensive Income | 51,264 | 32,419 |
Total Shareholders' Equity (Deficit) | (3,913,681) | 595,539 |
Total Liabilities And Shareholders' Equity |
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CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the six months ended |
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(Unaudited) | ||
2014 | 2013 | |
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 | 506,465 | 502,178 |
Share Based Compensation - Non-employee | -- | 1,200,785 |
Share Based Compensation- Employees | 4,406,012 | 2,779,121 |
Amortization of Debt Issuance Costs | 227,058 | -- |
Non-Cash Interest Expense | 225,058 | -- |
Loss on Disposal of Assets | 4,827 | 5,516 |
Loss on Sale of Investments, net | 1,223 | -- |
Changes in Assets and Liabilities: | ||
Decrease (Increase) in Accounts Receivable | 359,402 | (144,560) |
Decrease (Increase) in Inventory | 15,506 | (266,960) |
Decrease (Increase) in Other Assets | (2,393,555) | 528,866 |
(Decrease) in Accounts Payable | (2,409,592) | (6,529,600) |
(Decrease) in Other Liabilities | (3,578,224) | (3,666,596) |
Changes in Assets and Liabilities | (8,006,463) | (10,078,850) |
Cash Used In Operating Activities | (13,611,724) | (32,834,193) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available for Sale | (2,000,000) | -- |
Sale of Investments Available for Sale | 4,976,000 | -- |
Purchase of Equipment | (428,831) | (313,014) |
Proceeds on Sale of Assets | -- | 6,898 |
Cash Provided By (Used) In Investing Activities | 2,547,169 | (306,116) |
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Shares and Purchase Warrants | 2,041,828 | 50,463,613 |
Proceeds from the Issuance of Notes Payable | -- | 20,000,000 |
Debt Issuance Costs | -- | (1,081,279) |
Payments on Notes Payable and Capital Lease Obligations | -- | (1,688) |
Cash Provided By Financing Activities | 2,041,828 | 69,380,646 |
Increase (Decrease) In Cash | (9,022,727) | 36,240,337 |
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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