WIXOM, Mich., Nov. 10, 2014 (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 third quarter ended September 30, 2014.
2014 Q3 Highlights
- Q3 sales were $13.7 million, a 5.0% increase over Q3 2013.
- Q2 gross profit was $2.3 million, a 39.0% increase over Q3 2013.
- Q2 gross profit margins improved by 4.0 percentage points to 16.5%, compared to 12.5% in Q3 2013.
- R&D expense was $1.3 million, an 87.7% decrease compared to $10.6 million in Q3 2013
- Net loss decreased by $9.2 million or 70% compared to Q3 2013.
- Cash and investments were $12.0 million as of September 30, 2014.
2014 Nine Months Highlights
- Sales were $39.7 million, up 3.5% over the first nine months of 2013.
- Gross profit was $6.0 million, up $1.4 million 29.8% over the first nine months of 2013.
- Gross profit margins increased by 3.0 percentage points to 15.0%, compared to the first nine months of 2013.
- R&D spending decreased $27.5 million or 82% compared to the first nine months of 2013.
- Net loss decreased $25.5 million or 63% to $14.9 million compared to the first nine months of 2013.
- Loss per share improved by $0.98 per share with a year-to-date loss of ($0.34) compared to a loss of ($1.32) in the first nine months of 2013.
Q3 and Recent 2014 Drug Development Highlights
- Received PDUFA fee refund of $2.2 million per successful appeal to the Small Business Administration.
- Received majority vote from FDA Advisory Committee for approval of Triferic as a therapy to treat iron loss and maintain hemoglobin in hemodialysis patients.
Recent Business Development Highlights
- Strengthened balance sheet in early October with $43 million in cash, comprised of
- $20 million for granting Baxter exclusive rights commercialize Rockwell's dialysis concentrate products in the U.S. and select foreign markets.
- $15 million equity investment in RMTI Common Shares from Baxter at $11.39 per share.
- $8 million from the exercise of Common Share Purchase Warrants.
"We achieved a strong 3rd quarter and then two significant accomplishments; our successful confirmatory vote on Triferic from the FDA Advisory Committee and our commercialization agreement with Baxter," stated Mr. Robert L. Chioini, Founder, Chairman and CEO of Rockwell Medical. "The Advisory Committee's majority vote recommending Triferic as a therapy to treat iron loss and maintain hemoglobin in hemodialysis patients adds to our conviction that this drug can make a positive difference for ESRD patients in addressing this unmet need. We remain committed to working with the FDA on completing its review for marketing approval of Triferic. Our exclusive distribution agreement with Baxter, a global leader in selling dialysis products, enabled us to monetize a valuable asset and strengthen our balance sheet while also providing dialysis patients and service providers expanded access to our market leading products in new territories. These two recent milestone events, in addition to our strong sales and margin improvements in the third quarter, give us great momentum moving forward."
Conference Call Information
Rockwell Medical will be hosting a conference call to review its third quarter 2014 results on Monday, November 10, 2014 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 # 28319994 or to listen to the call via webcast at the Rockwell Medical IR web page: http://ir.rockwellmed.com.
Triferic is a unique iron compound that is delivered to hemodialysis patients via dialysate, replacing approximately 5-7 mg of iron during their dialysis treatment. Triferic is introduced into 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 transferrin and is taken to the bone marrow, similar to how dietary iron binds in the 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 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 lead investigational drug Triferic is currently under NDA review by the FDA for the treatment of iron replacement and hemoglobin maintenance in dialysis patients, with a PDUFA date of January 24, 2015. Triferic delivers iron to dialysis patients during their regular dialysis treatment, using dialysate as the delivery mechanism. 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. Triferic has successfully completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2).
Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat 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. For a demonstration of the Triferic unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
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. / CitraPure® is a registered trademark of Rockwell Medical, Inc.
| ROCKWELL MEDICAL, INC. AND SUBSIDIARY |
CONSOLIDATED INCOME STATEMENTS
For the three and nine months ended September 30, 2014 and September 30, 2013
| Three Months |
| Three Months |
| Nine months |
| Nine Months |
|September 30,||September 30,||September 30,||September 30,|
|Sales||$ 13,743,778||$ 13,094,381||$ 39,740,791||$ 38,414,919|
|Cost of Sales||11,473,961||11,461,100||33,772,125||33,815,593|
|Selling, General and Administrative||4,098,835||3,386,367||12,403,240||10,541,124|
|Research and Product Development||1,301,824||10,611,219||6,103,716||33,588,458|
|Operating Income (Loss)||(3,130,842)||(12,364,305)||(12,538,290)||(39,530,256)|
|Interest and Investment Income, net||55,263||13,546||199,113||28,784|
|Income (Loss) Before Income Taxes||(3,967,606)||(13,208,264)||(14,943,510)||(40,451,207)|
|Income Tax Expense||--||--||--||--|
|Net Income (Loss)||$ (3,967,606)||$ (13,208,264)||$ (14,943,510)||$ (40,451,207)|
|Basic Earnings (Loss) per Share||($ 0.10)||($ 0.34)||($ 0.37)||($ 1.32)|
|Diluted Earnings (Loss) per Share||($ 0.10)||($ 0.34)||($ 0.37)||($ 1.32)|
| ROCKWELL MEDICAL, INC. AND SUBSIDIARY |
CONSOLIDATED BALANCE SHEETS
As of September 30, 2014 and December 31, 2013
| September 30, |
| December 31, |
|Cash and Cash Equivalents||$ 3,016,837||$ 11,881,451|
|Investments Available for Sale||9,017,395||12,034,622|
|Accounts Receivable, net of a reserve of $52,000 in 2014 and $37,000 in 2013||4,189,666||4,578,319|
|Other Current Assets||688,475||623,734|
|Total Current Assets||19,893,879||31,917,774|
|Property and Equipment, net||1,615,320||1,648,949|
|Other Non-current Assets||1,067,800||1,374,941|
|Total Assets||$ 23,872,187||$ 36,362,124|
| LIABILITIES AND SHAREHOLDERS' EQUITY |
|Note Payable Capitalized Lease Obligations||$ 7,962,819||$ 2,308,145|
|Total Current Liabilities||17,280,211||17,849,671|
|Long Term Debt||12,051,824||17,916,914|
|Common Shares, no par value, 41,015,392 and 40,110,661 shares issued and outstanding||164,056,146||154,457,878|
|Common Share Purchase Warrants, 838,071 and 983,071 warrants issued and outstanding||4,225,669||4,895,811|
|Accumulated Other Comprehensive Income||(7,584)||32,419|
|Total Shareholders' Equity (Deficit)||(5,459,848)||595,539|
|Total Liabilities And Shareholders' Equity||$ 23,872,187||$ 36,362,124|
| ROCKWELL MEDICAL, INC. AND SUBSIDIARY |
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended September 30, 2014 and September 30, 2013
|Cash Flows From Operating Activities:|
|Net (Loss)||$ (14,943,510)||$ (40,451,207)|
|Adjustments To Reconcile Net Loss To Net Cash Used In|
|Depreciation and Amortization||767,386||752,360|
|Share Based Compensation – Non-employee||--||1,435,344|
|Share Based Compensation – Employees||6,293,250||4,449,110|
|Amortization of Debt Issuance Costs||357,140||--|
|Non-Cash Interest Expense||353,994||426,938|
|Loss on Disposal of Assets||4,827||15,500|
|Loss on Sale of Investments, net||1,223||--|
|Changes in Assets and Liabilities:|
|Decrease in Accounts Receivable||388,653||209,521|
|(Increase) in Inventory||(181,858)||(164,526)|
|Decrease (Increase) in Other Assets||(317,194)||606,263|
|(Decrease) in Accounts Payable||(3,514,762)||(7,722,004)|
|(Decrease) in Other Liabilities||(2,506,918)||(2,079,489)|
|Changes in Assets and Liabilities||(6,132,079)||(9,150,235)|
|Cash Used In Operating Activities||(13,297,769)||(42,522,190)|
|Cash Flows From Investing Activities:|
|Purchase of Investments Available for Sale||(2,000,000)||(10,000,611)|
|Sale of Investments Available for Sale||4,976,000||--|
|Purchase of Equipment||(613,311)||(496,302)|
|Proceeds on Sale of Assets||--||6,898|
|Cash Provided By (Used) In Investing Activities||2,362,689||(10,490,015)|
|Cash Flows From Financing Activities:|
|Proceeds from the Issuance of Common Shares and Purchase Warrants||2,634,876||50,625,357|
|Proceeds from the Issuance of Notes Payable||--||20,000,000|
|Debt Issuance Costs||--||(1,109,776)|
|Payments on Notes Payable and Capital Lease Obligations||(564,410)||(2,280)|
|Cash Provided By Financing Activities||2,070,466||69,513,301|
|Increase (Decrease) In Cash||(8,864,614)||16,501,096|
|Cash At Beginning Of Period||11,881,451||4,711,730|
|Cash At End Of Period||$ 3,016,837||$ 21,212,826|
CONTACT: Michael Rice, Investor Relations; 646-597-6979Source:Rockwell Medical, Inc.