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Rockwell Medical Reports Fourth Quarter 2014 Results

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; 646-597-6979Source:Rockwell Medical, Inc.