WIXOM, Mich., Feb. 26, 2015 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the fourth quarter and year ended December 31, 2014.
Q4 2014 Financial Highlights
- Sales were $14.4 million, a 3.5% increase over Q4 2013.
- Gross profit was $2.6 million, a 25% increase over Q4 2013.
- R&D expense was $1.7 million, a 71% decrease compared to $5.8 million in Q4 2013.
- Cash and investments were $85.7 million at December 31, 2014.
Q4 2014 Corporate Highlights
- Received $20 million in cash from Baxter Healthcare Corporation upon executing exclusive concentrate product commercialization agreement; additionally cash potential of $17.5 million for meeting milestones.
- Received $15 million in cash from Baxter for equity investment for RMTI common stock at $11.39 per share.
- Received $8.4 million in cash from warrant conversion.
- Raised $55 million in cash from equity financing with Bank of America Merrill Lynch.
- Paid off long-term debt of $20 million.
- Received FDA Advisory Committee majority vote to approve Triferic for iron replacement and maintenance of hemoglobin in hemodialysis patients.
2014 Financial Highlights
- Sales were $54.2 million, a 3.5% increase over 2013.
- Gross profit was $8.5 million, an increase of 28.3% over 2013.
- R&D expense was $7.8 million, an 80% decrease compared to $39.4 million in 2013.
- Loss for the year was $21.3 million, a 56% decrease compared to $48.8 million loss in 2013.
Recent Corporate Highlights
- Received U.S. FDA market approval for Triferic for iron replacement and maintenance of hemoglobin in hemodialysis patients.
- Presented two Triferic posters at Annual Dialysis Conference in New Orleans, Louisiana.
“We had a very eventful active year,” stated Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell. “Our fourth quarter was exceptional and included three major milestone accomplishments. First, we monetized and de-risked our operating business and positioned it for future growth through our new partnership with Baxter. Then, we conducted a successful FDA advisory committee meeting, achieving a majority vote to approve Triferic as the only iron replacement and hemoglobin maintenance drug for hemodialysis patients. Additionally, we completed a successful financing, strengthening our cash and liquidity position resulting in a strong balance sheet with no debt.”
Mr. Chioini further commented, “Recently, we received FDA approval to commercially market Triferic in the U.S., where we are confident that this new drug will improve the lives of hemodialysis patients and create value for the dialysis providers in the renal community. We are now working diligently towards the commercial launch of both Triferic and Calcitriol, as well as expanding our operating business. Overall, we accomplished significant, strategic milestones and as we continue to execute we are focused and well prepared to offer patients and physicians clinically beneficial products while building Rockwell into a leading biotech company.”
Conference Call Information
Rockwell Medical will be hosting a conference call to review its fourth quarter and 2014 year end results on Thursday, February 26, 2015 at 4:30 pm ET. Investors are encouraged to call a few minutes in advance at (877) 383-7438, or for international callers (678) 894-3975, passcode #89813322 or to listen to the call via webcast at the Rockwell Medical IR web page: http://ir.rockwellmed.com/
About Triferic
Triferic is a unique iron compound that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow and maintain hemoglobin, without increasing iron stores (ferritin). Please visit www.triferic.com for more information.
About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell’s recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials, Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market.
Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market.
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.
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 Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
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 FDA approval. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical’s SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Triferic™ is a trademark of Rockwell Medical, Inc.
| ROCKWELL MEDICAL, INC. AND SUBSIDIARY | ||||
| CONSOLIDATED INCOME STATEMENTS | ||||
| For the three and twelve months ended December 31, 2014 and December 31, 2013 | ||||
| Three Months Ended | Three Months Ended | Twelve Months Ended | Twelve Months Ended | |
| December 31, 2014 | December 31, 2013 | December 31, 2014 | December 31, 2013 | |
| Sales | $14,447,653 | $13,964,624 | $54,188,444 | $52,379,543 |
| Cost of Sales | 11,871,106 | 11,904,730 | 45,643,231 | 45,720,323 |
| Gross Profit | 2,576,547 | 2,059,894 | 8,545,213 | 6,659,220 |
| Selling, General and Administrative | 5,917,480 | 3,795,325 | 18,320,720 | 14,336,449 |
| Research and Product Development | 1,679,878 | 5,793,579 | 7,783,594 | 39,382,037 |
| Operating Income (Loss) | (5,020,811) | (7,529,010) | (17,559,101) | (47,059,266) |
| Interest and Investment Income, net | 187,144 | 69,317 | 386,257 | 98,101 |
| Interest Expense | 1,549,980 | 872,412 | 4,154,313 | 1,822,147 |
| Income (Loss) Before Income Taxes | (6,383,647) | (8,332,105) | (21,327,157) | (48,783,312) |
| Income Tax Expense | -- | -- | -- | -- |
| Net Income (Loss) | $ (6,383,647) | $ (8,332,105) | $ (21,327,157) | $ (48,783,312) |
| Basic Earnings (Loss) per Share | ($0.14) | ($0.21) | ($0.52) | ($1.48) |
| Diluted Earnings (Loss) per Share | ($0.14) | ($0.21) | ($0.52) | ($1.48) |
| ROCKWELL MEDICAL, INC. AND SUBSIDIARY | ||
| CONSOLIDATED BALANCE SHEETS | ||
| As of December 31, 2014 and 2013 | ||
| December 31, | December 31, | |
| ASSETS | 2014 | 2013 |
| Cash and Cash Equivalents | $65,800,451 | $11,881,451 |
| Investments Available for Sale | 19,927,310 | 12,034,622 |
| Accounts Receivable, net of a reserve of $52,000 in 2014 and $37,000 in 2013 | 4,472,002 | 4,578,319 |
| Inventory | 3,920,185 | 2,799,648 |
| Other Current Assets | 587,201 | 623,734 |
| Total Current Assets | 94,707,149 | 31,917,774 |
| Property and Equipment, net | 1,496,912 | 1,648,949 |
| Intangible Assets | 332,686 | 499,715 |
| Goodwill | 920,745 | 920,745 |
| Other Non-current Assets | 542,224 | 1,374,941 |
| Total Assets | $97,999,716 | $36,362,124 |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||
| Note Payable Capitalized Lease Obligations | $ -- | $2,308,145 |
| Accounts Payable | 5,294,515 | 8,686,153 |
| Accrued Liabilities | 4,325,997 | 6,647,828 |
| Customer Deposits | 183,890 | 207,545 |
| Total Current Liabilities | 9,804,402 | 17,849,671 |
| Deferred License Revenue | 19,492,520 | -- |
| Long Term Debt | -- | 17,916,914 |
| Shareholders’ Equity: | ||
| Common Shares, no par value, 50,284,007 and 40,110,661 shares issued and outstanding | 249,018,189 | 154,457,878 |
| Common Share Purchase Warrants, none and 983,071 warrants issued and outstanding | -- | 4,895,811 |
| Accumulated Deficit | (180,117,726) | (158,790,569) |
| Accumulated Other Comprehensive Income | (197,669) | 32,419 |
| Total Shareholders’ Equity | 68,702,794 | 595,539 |
| Total Liabilities And Shareholders’ Equity | $97,999,716 | $36,362,124 |
| ROCKWELL MEDICAL, INC. AND SUBSIDIARY | ||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
| For the years ended December 31, 2014 and 2013 | ||
| 2014 | 2013 | |
| Cash Flows From Operating Activities: | ||
| Net (Loss) | $ (21,327,157) | $ (48,783,312) |
| Adjustments To Reconcile Net Loss To Net Cash Used In | ||
| Operating Activities: | ||
| Depreciation and Amortization | 996,321 | 1,007,411 |
| Share Based Compensation – Non-employee | -- | 1,862,874 |
| Share Based Compensation- Employees | 10,094,685 | 5,849,196 |
| Loss (Gain) on Disposal of Assets | 7,338 | 16,410 |
| Loss on Sale of Investments Available for Sale | 1,223 | -- |
| Amortization of Debt Issuance Costs | 882,716 | 227,059 |
| Non-Cash Interest Expense | 874,942 | 225,059 |
| Changes in Assets and Liabilities: | ||
| (Increase) Decrease in Accounts Receivable | 106,317 | (146,387) |
| (Increase) in Inventory | (1,120,537) | (150,009) |
| (Increase) Decrease in Other Assets | (13,466) | 669,896 |
| Increase (Decrease) in Accounts Payable | (3,391,638) | (6,147,412) |
| Increase (Decrease) in Other Liabilities | (2,345,486) | (5,295,738) |
| Deferred Distribution Agreement Income | 20,000,000 | -- |
| Recognized Distribution Agreement Income | (507,480) | -- |
| Changes in Assets and Liabilities | 12,727,710 | (11,069,650) |
| Cash Provided By (Used In) Operating Activities | 4,257,778 | (50,664,953) |
| Cash Flows From Investing Activities: | ||
| Purchase of Investments Available for Sale | (13,100,000) | (12,002,203) |
| Sale of Investments Available for Sale | 4,976,000 | -- |
| Purchase of Equipment | (684,593) | (654,197) |
| Proceeds on Sale of Assets | -- | 6,898 |
| Cash Provided By (Used In) Investing Activities | (8,808,593) | (12,649,502) |
| Cash Flows From Financing Activities: | ||
| Proceeds from Issuance of Common Shares and Purchase Warrants | 79,569,815 | 51,596,232 |
| Proceeds from the Issuance of Notes Payable | -- | 20,000,000 |
| Debt Issuance Costs | -- | (1,109,776) |
| Payments on Notes Payable and Capital Lease Obligations | (21,100,000) | (2,280) |
| Cash Provided By Financing Activities | 58,469,815 | 70,484,176 |
| Increase (Decrease) In Cash | 53,919,000 | 7,169,721 |
| Cash At Beginning Of Period | 11,881,451 | 4,711,730 |
| Cash At End Of Period | $65,800,451 | $11,881,451 |
CONTACT: Michael Rice, Investor Relations; 646-597-6979
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