Rockwell Medical Reports Record Second Quarter Results
Aug 5, 2010 (GlobeNewswire via COMTEX News Network) --
- Revenues Increase 19.2 %; Gross Profit Increases 49% -
- Conference Call at 8:30am ET to Discuss Results and Review Clinical
Development -
WIXOM, Mich., Aug. 5, 2010 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported second quarter 2010 results today.
Second Quarter Financial Highlights
-- Sales increased to $15.5 million, up 19.2% compared to the second
quarter of 2009.
-- Gross profit increased to $2.8 million, up 49% or $0.9 million compared
to the second quarter of 2009.
-- Gross profit margins increased to 17.9%, compared to 14.3% in the second
quarter of 2009.
-- R&D expense was $0.4 million, compared to $2.0 million in the second
quarter of 2009.
-- Net income was $.01 per share, compared to a loss of ($.12) per share in
the second quarter of 2009.
-- Net income was $0.1 million, compared to a loss of ($1.7) million in the
second quarter of 2009.
First Half 2010 Financial Highlights
-- Sales increased to $30.5 million, up 18.1% compared to the first half of
2009.
-- Gross profit increased to $5.1 million, up 67% or $2 million compared to
the first half of 2009.
-- Gross profit margins increased to 16.7%, compared to 11.8% in the first
half of 2009.
-- R&D expense was $1.0 million, compared to $3.3 million in the first half
of 2009.
-- Net loss was ($.02) per share, compared to a loss of ($.25) per share in
the first half of 2009.
-- Net loss was ($0.3) million, compared to a loss of ($3.4) million in the
first half of 2009.
-- Cash and cash equivalents were $24.2 million at June 30, 2010, an
increase of $1.2 million from December 31, 2009.
Second Quarter Drug Development and Corporate Progress
-- Successfully completed End of Phase II meeting with the FDA; confirmed
approvable Phase III primary endpoint.
-- Presented SFP Phase IIb study data at European Dialysis Conference.
-- Appointed Dr. Ajay Singh to Scientific Advisory Board.
"We are pleased with our strong second quarter earnings, reflecting our best quarterly results to date. Our performance was in line with our expectations and we expect that our operating business will continue to generate cash to support the funding of our Phase III clinical development," stated Mr. Robert L. Chioini, Chairman and CEO of Rockwell. "From our recent End of Phase II meeting with the FDA, we confirmed a change in hemoglobin as an approvable primary efficacy endpoint for our Phase III study design. We intend to use a primary efficacy endpoint in the Phase III study that is identical to a secondary efficacy endpoint we had in our Phase IIb study, which achieved a statistically significant p-value, demonstrating an excess of 0.5 g/dL difference in hemoglobin between placebo and the SFP 10 ug/dl dose group." Mr. Chioini further stated, "Our regulatory path for SFP is now clear and we expect to submit our Phase III protocol design to the FDA shortly. We remain on track to start the pivotal Phase III program later this year."
Conference Call Information:
Rockwell Medical will be hosting a conference call to review its 2010 second quarter results on Thursday, August 5, 2010 at 8:30am ET. Investors are encouraged to call in a few minutes in advance at (877) 383-7438. International participants can call in at (678) 894-3975. To listen to the call on the web or to the call replay, investors can visit: http://ir.rockwellmed.com/.
About SFP:
SFP is a novel, investigational, continuous iron therapy designed to treat iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal physiologic dietary iron intake. SFP is designed as a continuous replacement treatment delivering small doses of iron during every dialysis session in order to replenish iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP, delivered during each dialysis treatment via dialysate, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response to erythropoiesis-stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell Medical has licensed exclusive world-wide rights to manufacture and sell SFP and patents have issued for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $1 billion.
About Rockwell Medical:
Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 400,000 ESRD patients in the United States, a prevalence growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed 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 SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. 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 the Company 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.
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three and six months ended June 30, 2010 and June 30, 2009
(Unaudited)
Three Months Three Months
Six Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
2010 2009 2010 2009
------------ ------------ ------------ ------------
Sales $ 15,506,712 $ 13,013,012 $ 30,486,664 $ 25,809,784
Cost of Sales 12,735,047 11,153,086 25,401,470 22,756,911
------------ ------------ ------------ ------------
Gross Profit 2,771,665 1,859,926 5,085,194 3,052,873
Selling, General and Administrative 2,221,336 1,570,688 4,416,239 3,131,503
Research and Product Development 441,273 1,996,571 958,688 3,334,881
------------ ------------ ------------ ------------
Operating Income (Loss) 109,056 (1,707,333) (289,733) (3,413,511)
Interest Expense (Income), Net (7,861) 7,238 (12,970) 16,503
------------ ------------ ------------ ------------
Net Income (Loss) $ 116,917 $(1,714,571) $(276,763) $(3,430,014)
============ ============ ============ ============
Basic Earnings (Loss) per Share $ 0.01 ($ 0.12) ($ 0.02) ($ 0.25)
Diluted Earnings (Loss) per Share $ 0.01 ($ 0.12) ($ 0.02) ($ 0.25)
ROCKWELL MEDICAL TECHNOLOGIES,
INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of June 30, 2010 and
December 31, 2009
June 30, December 31,
ASSETS 2010 2009
----------------- -----------------
(unaudited)
Cash and Cash Equivalents $ 24,199,534 $ 23,038,095
Accounts Receivable, net of a
reserve of $30,000 in 2010 and
$31,000 in 2009 4,598,332 3,492,622
Inventory 2,863,461 3,088,352
Other Current Assets 451,158 329,876
----------------- -----------------
Total Current Assets 32,112,485 29,948,945
Property and Equipment, net 3,431,426 3,631,549
Intangible Assets 198,521 214,337
Goodwill 920,745 920,745
Other Non-current Assets 163,706 163,645
----------------- -----------------
Total Assets $ 36,826,883 $ 34,879,221
================= =================
LIABILITIES AND SHAREHOLDERS'
EQUITY
Capitalized Lease Obligations $ 27,280 $ 42,938
Accounts Payable 3,441,891 3,388,757
Accrued Liabilities 1,831,253 1,854,347
Customer Deposits 630,448 250,915
----------------- -----------------
Total Current Liabilities 5,930,872 5,536,957
Capitalized Lease Obligations 9,365 19,062
Shareholders' Equity:
Common Shares, no par value,
17,202,108 and 17,200,442
shares issued and outstanding 55,062,172 53,545,394
Common Share Purchase Warrants,
3,328,569 and 3,318,569
warrants issued and
outstanding 7,959,023 7,635,594
Accumulated Deficit (32,134,549) (31,857,786)
----------------- -----------------
Total Shareholders' Equity 30,886,646 29,323,202
----------------- -----------------
Total Liabilities and
Shareholders' Equity $ 36,826,883 $ 34,879,221
================= =================
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND
SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the six months ended June 30, 2010 and
June 30, 2009
(Unaudited)
2010 2009
-------------- --------------
Cash Flows From Operating Activities:
Net (Loss) $ (276,763) $ (3,430,014)
Adjustments To Reconcile Net Loss To Net
Cash Used In
Operating Activities:
Depreciation and Amortization 707,749 527,292
Loss (Gain) on Disposal of Assets 16,822 (5,120)
Share Based Compensation -- Non-employee
Warrant 323,429 256,362
Share Based Compensation -- Employees 1,511,630 773,833
Changes in Assets and Liabilities:
(Increase) Decrease in Accounts
Receivable (1,105,710) 484,707
Decrease in Inventory 224,891 348,313
(Increase) Decrease in Other Assets (121,343) 4,898
Increase (Decrease) in Accounts Payable 53,134 (191,036)
Increase (Decrease) in Other Liabilities 356,439 (492,749)
-------------- --------------
Changes in Assets and Liabilities (592,589) 154,133
-------------- --------------
Cash Provided by (Used) In Operating
Activities 1,690,278 (1,723,514)
Cash Flows From Investing Activities:
Purchase of Equipment (509,432) (589,008)
Proceeds on Sale of Assets 800 5,120
Purchase of Intangible Assets -- (10,257)
-------------- --------------
Cash (Used ) In Investing Activities (508,632) (594,145)
Cash Flows From Financing Activities:
Issuance of Common Shares and Purchase
Warrants 5,148 140,502
Payments on Notes Payable (25,355) (84,030)
-------------- --------------
Cash Provided (Used) By Financing
Activities (20,207) 56,472
Increase (Decrease) In Cash and Cash
Equivalents 1,161,439 (2,261,187)
Cash and Cash Equivalents at Beginning of
Period 23,038,095 5,596,645
-------------- --------------
Cash and Cash Equivalents at End of Period $ 24,199,534 $ 3,335,458
============== ==============
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SOURCE: Rockwell Medical Technologies, Inc.
CONTACT: LaVoie Group Media Contact: Lisa Rivero, Director, Media Relations (978)745-4200 ext. 106 The Trout Group LLC Investor Contact: Brian Korb, VP (646) 378-2923
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