Rockwell Medical, Inc. Reports Third Quarter 2014 Results
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 millionin Q3 2013
Net loss decreased by
$9.2 millionor 70% compared to Q3 2013.
Cash and investments were
$12.0 millionas of September 30, 2014.
2014 Nine Months Highlights
$39.7 million, up 3.5% over the first nine months of 2013.
Gross profit was
$6.0 million, up $1.4 million29.8% 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 millionor 82% compared to the first nine months of 2013.
Net loss decreased
$25.5 millionor 63% to $14.9 millioncompared to the first nine months of 2013.
Loss per share improved by
$0.98per 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 millionper successful appeal to the Small Business Administration.
Received majority vote from
FDA Advisory Committeefor 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 millionin cash, comprised of
$20 millionfor granting Baxter exclusive rights commercialize Rockwell's dialysis concentrate products in the U.S. and select foreign markets.
$15 millionequity investment in RMTI Common Shares from Baxter at $11.39per share.
$8 millionfrom 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
Conference Call Information
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.
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.
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
CONSOLIDATED INCOME STATEMENTS
For the three and nine months ended
|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)||
||$ (14,943,510)||$ (40,451,207)|
|Basic Earnings (Loss) per Share||
|Diluted Earnings (Loss) per Share||
CONSOLIDATED BALANCE SHEETS
|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
|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|
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended
|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|
Michael Rice, Investor Relations; 646-597-6979
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