|
Index of
Rockwell News
2006
Click on underlined dates to view complete story
Nov. 8, 2006 - RMTI Reports
Q3; Increased Sales Projected for Q4
Oct. 26, 2006 - Rockwell
Medical Schedules Investor Conference Call
Oct. 25, 2006 - Rockwell
Receives Canadian Patent for Dri-Sate® System
Oct. 18, 2006 - RMTI Submits
SFP Dose-Ranging Study Protocol to FFDA
Sep. 28, 2006 - Rockwell's
Proprietary SFP Iron-Delivery Receives
Patent Grant for
Poland
Aug. 9, 2006 - Rockwell Q2
Report; Increased R&D Spending
for SFP Drug
Approval
Aug. 1, 2006 - Rockwell
Schedules Investor Conference Call
July 20, 2006 - WIRB Approves
NIH Protocol for Proprietary SFP
June 27, 2006 - Rockwell
Receives Hong Kong Patent Grant
for Proprietary
SFP
May 24, 2006 - Rockwell
Medical Signs Concentrate Distribution
Agreement for
European Market
May 16, 2006 - RMTI Signs
Supply Contract with Renal Advantage
May 11, 2006 - Rockwell
Reports First Quarter Sales Up 10%
May 3, 2006 - RMTI Schedules
Q1 Investor Conference Call
Apr 20, 2006 - Rockwell
Submits SFP Pre-IND Package to FDA
Apr 19, 2006 - Rockwell
Receives European Patent Issuance for
Proprietary
Iron-Delivery Technology
Mar. 1, 2006 - RMTI Reports Q4
and Year-End Sales Increase;
Spendng for FDA
Drug Approval Increases
Feb 21, 2006 - Rockwell
Schedules Investor Conference Call
Feb 06, 2006 - RMTI Raises
$9.25 Million from Warrant Exercise
Jan 31, 2006 - Rockwell Signs
Distribution Agreement with Genpharm, Inc.
of Toronto,
Canada
Jan 18, 2006 - RMTI Signs
Exclusive Licensing Agreement to Market
Dialysate
Containing Vitamins and Carnitine
Jan 12, 2006 - Rockwell
Medical Receives $13 Million Supply Order
Jan 11, 2006 - RMTI Finalizes
Phase III Clinical Trial Protocol; Begins
Features
Nov 2005 - Rockwell
Predicted as "Future Pharma" by "Crain's Detroit Business"
June 2005 - Rockwell CEO
Receives Entrepreneur of the Year Award
Oct 2001 - Chioini chosen for
"Forty under Forty" by "Crain's Detroit
Business"
Most Recent News
News
Archives
2005 2004 2003 2002 2001 2000
(return to News
Index)
Wednesday, November 8, 2006
Rockwell Medical Reports Third Quarter;
Projects Increased Sales in Q4
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer of hemodialysis products and developer of
specialty pharmaceuticals focused on the end-stage-renal-disease (ESRD) market,
reported its third quarter and nine month results today which included
increased spending on product development and drug approval costs for soluble
ferric pyrophosphate (SFP).
Business and Financial Highlights for the quarter and year to date included:
Third Quarter Financial Highlights
- Sales were $7,379,200; $449,000 lower than the third quarter of 2005.
- International sales were $1.5 million lower compared to the third quarter
of 2005.
- Domestic sales increased by over $1 million or 20% over the third quarter
of 2005.
- Sales increased 25.7% sequentially from the second quarter of 2006.
- Net loss was ($1,621,669) which included $1,621,821 in R&D costs.
- Net loss per share was ($.14), which included R&D costs of $.14 per
share for SFP, vs. EPS of $.02 last year.
Nine Month Financial Highlights
- Sales were $19.4 million; $1.8 million or 8.6% lower than the first nine
months of 2005.
- International sales were $4.5 million lower than in the first nine months
of 2005.
- Domestic sales increased $2.7 million or 17.3%.
- Increased market share of independent and smaller chain accounts grew
35.8% over the first nine months of 2005; and represented over 53% of total
sales.
- Net loss was ($3,419,944) which included $3,381,643 in R&D costs.
- Net loss per share was ($.31) which included R&D costs of $.31 per
share for SFP vs. 2005 EPS of $.04.
SFP DevelopmentHighlights
- Non-clinical testing program for toxicity and safety pharmacology studies
progressing toward completion.
- Favorable SFP safety profile demonstrated in both completed and interim
reports from non-clinical testing.
- Submitted protocol to FDA to begin dose ranging study; on track to begin
study in the fourth quarter.
- Modified National Institutes of Health (NIH) study protocol; on track to
begin study in the fourth quarter.
- Western Institutional Review Board (WIRB) approved modified protocol to
begin NIH SFP study.
Mr. Robert L. Chioini, Chairman and Chief Executive Officer
of Rockwell Medical Technologies, Inc. stated, Our third quarter results
reflected dynamic changes in our market and business. The continuing withdrawal
of a major competitor from the concentrate market is creating significant
opportunity for us to expand our business. In addition, our international
distributors have substantially increased their order volumes over their orders
in the first half of 2006. We anticipate sequentially increasing sales and
gross profit margins in the fourth quarter.
Mr. Chioini also said, We are actively working towards FDA market
approval of our SFP product. We met with the FDA in the second quarter and
carefully evaluated their feedback. We have made adjustments to our clinical
plan and to the NIH funded study protocol in order to capture additional data
to facilitate the FDA approval process. We anticipate beginning human clinical
trials before the end of this year.
Rockwell is actively working towards FDA market approval for its proprietary
iron-delivery product SFP, which is designed to provide physiological iron
maintenance therapy for hemodialysis patients with end stage renal disease. The
U.S. market for intravenous iron products is estimated to be approximately
$450,000,000 while the global market is believed to be over $750,000,000. The
Company anticipates that human clinical studies will commence this year. SFP
was successfully tested in an FDA Phase II clinical trial and was shown to be
safe and effective at maintaining iron stores at targeted levels. Non-clinical
safety, pharmacology and toxicology testing throughout the first nine months of
2006 have shown a safety profile both consistent with earlier human testing and
with the Company's expectations.
Rockwell will be hosting a conference call to review its results and business
developments on Wednesday, November 8, 2006 at 11:00 am EST. Investors are
encouraged to dial in a few minutes in advance of the call at 866-406-5369 or
may listen on the web at
http://orion.calleci.com/servlet/estreamgetevent?id=7301&folder=default
using Windows Media Player. See www.rockwellmed.com for more details and
playback options.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 3-5% on average each year over the last five years. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding status and
timing of Rockwell's efforts to obtain FDA approval of SFP, the potential of
Rockwell's proprietary Soluble Ferric Pyrophosphate (SFP) to capture market
share, potential for sales growth, expected customer orders, etc. constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements
reflect management's expectations and are based upon currently available
information. Management of Rockwell believes the expectations reflected in the
forward-looking statements made in this press release are based upon reasonable
assumptions. However, certain factors could occur that might cause actual
results to vary. These include, but are not limited to, delays or failure to
obtain FDA approval of SFP, failure to obtain Medicare or private insurance
reimbursement approval, cancellation of an existing purchase order from a major
international distributor of our products or failure of such international
distributor to order anticipated level of products in the fourth quarter of
2006, delay or failure to be awarded expected new business from a major
customer or distributor, general economic conditions, economic conditions in
the hemodialysis industry, modified regulatory requirements, competitive
factors, and other factors discussed in Rockwell's reports filed with the
Securities and Exchange Commission. These forward-looking statements should be
considered in light of these risks and uncertainties.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and nine months ended
September 30, 2006 and September 30, 2005
(Whole dollars)
(Unaudited)
|
| |
3 Months ended Sept 30, 2006 |
3 Months ended Sept 30, 2005 |
9 Months ended Sept 30, 2006 |
9 Months ended Sept 30, 2005 |
| Sales |
$ 7,379,201 |
$ 7,828,262 |
$ 19,410,357 |
$ 21,238,803 |
| Cost of Sales |
6,785,796 |
6,868,274 |
17,568,497 |
18,798,954 |
| Gross Profit |
593,405 |
959,988 |
1,841,860 |
2,439,849 |
| Selling, General, Admin |
592,767 |
684,809 |
1,912,544 |
1,935,114 |
| Research & Product Devel. |
1,621,821 |
74,010 |
3,381,643 |
159,831 |
| Operating Income (Loss) |
(1,621,183) |
201,169 |
(3,452,327) |
344,904 |
| Other Income |
- |
- |
137,468 |
- |
| Interest Expense (Expense), net |
(486) |
(44,992) |
32,383 |
(131,524) |
| Net Income |
($1,621,669) |
$ 156,177 |
($ 3,419,944) |
$ 350,848 |
| Basic Earnings (Loss) per share |
$ (0.14) |
$ 0.02 |
$ (0.31) |
$ 0.04 |
| Diluted Earnings (Loss)per share |
$ (0.14) |
$ 0.02 |
$ (0.31) |
$ 0.04 |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
September 30, 2006 and December 31, 2005
(Whole dollars)
(Unaudited)
|
| |
Sept. 30, 2006 |
Dec. 31, 2005 |
| Assets |
| Cash and Cash Equivalents |
$ 4,034,516 |
$ 299,031 |
Accounts Receivable,
net of a reserve of $92,000 in 2006 and $70,000
in 2005 |
2,748,827 |
2,836,072 |
| Inventory |
2,547,135 |
2,051,819 |
| Other Current Assets |
257,776 |
193,158 |
| Total Current Assets |
9,588,254 |
5,380,080 |
| Property and Equipment, net |
2,486,943 |
2,430,222 |
| Intangible Assets |
467,957 |
394,819 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
129,584 |
134,794 |
| Total Assets |
$13,593,483 |
$ 9,260,660 |
Liabilities and Shareholders' Equity
|
| Short Term Borrowings |
$ - |
$ 1,800,000 |
| Notes Payable & Capitalized Lease Obligations |
444,634 |
522,439 |
| Accounts Payable |
2,425,081 |
1,795,393 |
| Accrued Liabilities |
488,741 |
530,749 |
| Customer Deposits |
386,682 |
33,558 |
| Total Current Liabilities |
3,745,138 |
4,682,139 |
Long Term Notes Payable & Capitalized Lease Obligations
|
414,632 |
733,723 |
| Shareholders' Equity: |
Common Shares, no par value,
11,475,749 and 8,886,948 shares issued and
outstanding |
23,052,274 |
12,628,539 |
Common Share Purchase Warrants,
-0- and 3,591,385 shares issued and
outstanding |
- |
1,414,876 |
| Accumulated Deficit |
(13,618,561) |
(10,198,617) |
| Total Shareholders' Equity |
9,433,713 |
3,844,798 |
| Total Liabilities and Shareholders'
Equity |
$13,593,483 |
$ 9,260,660 |
(return to News
Index)
Thursday, October 26, 2006
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Wednesday,
November 8, 2006 at 11:00AM EST to discuss its third quarter results and to
provide investors with a business update. The Company intends to release
results before the market opens on the same date. Robert Chioini, Chairman and
CEO, and Thomas Klema, CFO, will be hosting the call to review Rockwell's
results and answer questions from investors.
The conference will be held on:
Wednesday, November 8, 2006
Starting Time 11:00 AM Eastern
Dial in Number: 866-406-5369
Conference ID#: 8046813
When calling in please refer to Conference ID# 8046813 for the Rockwell Medical
Technologies Third Quarter Investor Conference Call and provide the operator
with your name and company affiliation.
Investors who prefer to participate using the internet may access the following
link for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7302&folder=default.
Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7301&folder=default
International Investors may dial in directly on 973-582-2847.
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at http://www.rockwellmed.com
.
We appreciate your interest in Rockwell.
(return to News
Index)
 |
Wednesday, October 25, 2006
Rockwell Receives Canadian Patent for
Dri-Sate® Dry Acid Concentrate Mix System
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of concentrates and specialty
pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported
today that it has received notice from the Canadian Patent Office that its
application for its Dri-Sate® Dry Acid Concentrate Mix System has been
allowed.
Rockwell's proprietary Dri-Sate® Dry Acid Concentrate Mix System provides
an efficient method for dialysis providers to prepare and distribute the
dialysate solution needed for dialysis treatment. Dri-Sate® Powder is a
better alternative to pre-mixed liquid concentrate solutions that are currently
delivered. Dri-Sate® is packaged as a lightweight, condensed powder that is
mixed on-site by the technician at the dialysis center, which enables the
dialysis center to better utilize storage space that was previously restricted
to liquid concentrate storage. Once mixed, the product is equivalent to the
acid concentrate provided to the dialysis center in liquid form.
The Dri-Sate® technology provides an automated system designed to work
exclusively with the Dri-Sate® Powder. It is compact, easy to operate and
requires no additional plumbing installation. All that is required is an
electrical outlet and a water source able to produce AAMI quality water, which
all dialysis centers in Canada have. For the dialysis provider, the advantages
for using the Dri-Sate® Dry Acid Concentrate Mix System include lower cost
per treatment, increased storage space, fewer deliveries and greater
flexibility.
On January 31, 2006, Rockwell signed an exclusive distribution agreement with
Genpharm, Inc., of Toronto, Canada wherein Rockwell will manufacture its dry
dialysis concentrate products for Genpharm's Renal Care Products Division.
Genpharm will market and distribute both Rockwell's Dri-Sate® Dry Acid
Concentrate Mix System and RenalPure® Powder Bicarbonate in Canada under
the Rockwell label following regulatory approval. Both Rockwell and Genpharm
estimate the Canadian dialysis market for concentrate to be approximately U.S.
$24 million annually.
Mr. Rob Chioini, Chairman, CEO and President of Rockwell stated, This
patent is an important step in our business development in Canada. The superior
packaging and mixing technology of the Dri-Sate® System, coupled with
Genpharm's aggressive Renal Care distribution arm, should position us to
develop a strong presence in Canada. We anticipate regulatory approval sometime
within the next two quarters.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to the
estimated size of the Canadian dialysis market and prospective sales constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements
reflect management's expectations and are based upon currently available
information. Management of Rockwell believes the expectations reflected in the
forward-looking statements made in this press release are based upon reasonable
assumptions. However, certain factors could occur that might cause actual
results to vary. These include, but are not limited to, delay or failure to
receive regulatory approval in Canada, general economic conditions, economic
conditions in the hemodialysis industry, competitive factors and other factors
discussed in Rockwell's reports filed with the Securities and Exchange
Commission. The forward-looking statements should be considered in light of
these risks and uncertainties.
(return to News
Index)
 |
Wednesday, October 18, 2006
Rockwell Submits SFP Dose-Ranging Study Protocol to FDA
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of concentrates and specialty
pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported
today that it submitted its Soluble Ferric Pyrophosphate (SFP) Dose Ranging
Study protocol to the FDA.
The SFP Dose Ranging Study design is a double-blinded, randomized,
multi-center, parallel groups, placebo controlled study. Subjects will undergo
hemodialysis treatment three times per week for 36 weeks followed by a one week
treatment-free follow-up. Rockwell is currently on schedule to begin enrollment
for the study in the fourth quarter of this year.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, We
are encouraged by the solid progress we continue to make towards obtaining FDA
approval for our proprietary SFP product. This study will enable us to define
the optimal dose for iron maintenance therapy for a majority of ESRD patients,
as well as determine the minimum and maximum dose limits for those special ESRD
patients who may need more or less iron.
Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron
called Ferric Pyrophosphate. SFP is designed to provide physiological iron
maintenance therapy in ESRD patients by delivering iron via dialysate during
dialysis treatment. Rockwell has licensed the exclusive world-wide rights to
the SFP patent and is in the process of seeking FDA approval to market the
product.
Compared to intravenous (IV) iron administration, early clinical study results
have shown that delivering iron via dialysate is a safe and effective method
for maintaining iron balance in dialysis patients, while at the same time
eliminating associated nursing and pharmaceutical IV iron administration costs.
Rockwell has licensed the exclusive rights to the patents for the SFP
technology which grant the Company the right to manufacture and market the
combination drug/device. Rockwell estimates that the U.S. dialysis market for
IV-iron delivery represents approximately $450 million annually while the
global market potential is approximately $750 million annually. Upon FDA market
approval, Rockwell expects SFP to compete aggressively in those markets. For
more information on SFP visit Rockwell's website at
www.rockwellmed.com/ironnews.htm.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release including statements
regarding FDA approval to market SFP, the market potential for iron
supplementation and the ability of SFP to compete for market share once
approved by the FDA constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, general economic conditions, economic conditions in the
hemodialysis industry, modified regulatory requirements, competitive factors,
and other factors discussed in Rockwell's reports filed with the Securities and
Exchange Commission. The forward-looking statements should be considered in
light of these risks and uncertainties.
(return to News
Index)
 |
Thursday, September 28, 2006
Rockwell's Proprietary SFP Iron-Delivery
Receives Patent Grant for Poland
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of concentrates and specialty
pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported
that the Polish patent was granted for its proprietary drug, Soluble Ferric
Pyrophosphate (SFP). The patent covers the "Method and Pharmaceutical
Composition for Iron Delivery administered via Dialysate in Hemodialysis and
Peritoneal Dialysis Patients".
Rockwell's proprietary iron-delivery product SFP is a soluble form of iron
designed to provide physiological iron maintenance therapy in ESRD patients by
delivering iron via dialysate during a dialysis treatment. Rockwell has
licensed the exclusive rights to SFP and its patents and is in the process of
seeking FDA approval to market the product.
Compared to intravenous (IV) iron administration, early clinical study results
have shown that delivering iron via dialysate is a safe and effective method
for maintaining iron balance in dialysis patients, while at the same time
eliminating associated nursing and pharmaceutical IV iron administration costs.
Rockwell estimates that the U.S. market for IV iron delivery is as much as $450
million annually while the global market potential is approximately $750
million annually. Upon FDA market approval, Rockwell expects SFP to compete
aggressively for those markets. Visit Rockwell's website at
www.rockwellmed.com/ironnews.htm
for more information on SFP.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated,
This patent approval is another important step for protecting our
proprietary drug-delivery delivery technology internationally.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release including statements
regarding FDA approval to market SFP, the market potential for iron
supplementation and the ability of SFP to compete for market share once
approved by the FDA constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, general economic conditions, economic conditions in the
hemodialysis industry, modified regulatory requirements, competitive factors,
and other factors discussed in Rockwell's reports filed with the Securities and
Exchange Commission. The forward-looking statements should be considered in
light of these risks and uncertainties.
(return to News
Index)
 |
Wednesday August 9, 2006
Rockwell Reports Q2;
Increased R&D Spending for SFP Drug Approval
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer of hemodialysis products and developer of
specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD),
reported its second quarter and six month results today which included
increased spending on product development and drug approval costs for soluble
ferric pyrophosphate (SFP). Second quarter 2006 loss per share was ($.13) with
$.12 per share spending on SFP. First half 2006 loss per share was ($.16) which
included $.16 per share spending on SFP.
Business and Financial Highlights for the quarter and year to date included:
Second Quarter Financial Highlights:
- Sales of $5.9 million were $1.9 million lower than second quarter 2005.
- Sales
decreased primarily due to a delay in filling an international order
for dialysis kits.
- Domestic
sales increased 9.1% in the second quarter compared to the second
quarter of 2005.
- Dri-Sate
Dry
Acid Concentrate volume increased 10% sequentially over the first quarter of
2006.
- Net loss
was
($1,509,057) which included $1,311,085 in R&D costs.
- Net loss
per
share was ($.13), which included R&D costs of $.12 per share for SFP, vs.
EPS of $.01 last year.
SFP Development Highlights - 2006 to date:
- Successfully completed financing to begin funding FDA approval process for
SFP.
- Commenced
non-clinical testing program consisting of 19 toxicity and safety
pharmacology studies.
- Met with
FDA
to discuss plans for commercialization of SFP.
- Received
FDA
feedback on SFP product development plans in June.
- Advanced
clinical plan, incorporating FDA recommendations.
- Continued
preparation to commence pivotal studies in late 2006.
- National
Institutes of Health (NIH) study protocol filed with FDA.
- Manufactured
SFP concentrate for use in NIH funded $500.000 study.
- Western
Institutional Review Board approved protocol for NIH SFP study.
- NIH nine-month
SFP study on track
to begin enrollment in third quarter of 2006.
First Half 2006 Financial Highlights:
- Sales of $12.0 million were $1.4 million or 10.3% lower than the first half
of 2005.
- Sales to
our
major international distributor were $3 million lower in the first half of
2006.
- Domestic
sales increased 16.1% over the first half of 2005.
- Independent
and smaller chain account sales increased 28.7% over the first half
of 2005.
- Net loss
per
share was ($.16) which included R&D costs of $.16 per share for SFP vs.
first half 2005 EPS of $.02.
Mr. Robert L. Chioini, Chairman and Chief Executive Officer
of Rockwell Medical Technologies, Inc. stated, Regarding our SFP
progress, we are on schedule and actively working towards FDA market approval.
Our second quarter and year-to-date results were consistent with our
expectations for both our SFP development progress and our financial investment
to accomplish that objective. Our timeline for commencing our final clinical
studies remains on schedule. We are also pleased with the progress of our
on-going non-clinical testing program for SFP.
With respect to first half sales results, Mr. Chioini stated, Our
domestic concentrate business is progressing as we anticipated. Our independent
and regional chain volume increased 29% in the first half of the year. In the
near term, we are encouraged by the developments in our competitive marketplace
as we continue to secure additional concentrate business at higher prices than
in the past. Regarding our international business, our sales results were
impacted by the order pattern of our major international distributor which
serves a single customer for us and which ordered $3 million less in the first
half of 2006 compared to 2005. We are advised that orders from this distributor
will increase in the second half of 2006.
Rockwell is actively working towards FDA market approval for its proprietary
iron-delivery product SFP, which is designed to provide physiological iron
maintenance therapy for hemodialysis patients with end stage renal disease. The
U.S. market for intravenous iron products is estimated to be approximately
$400,000,000 while the global market is believed to be over $750,000,000. The
Company anticipates that pivotal studies will commence in the fourth quarter of
2006. SFP was successfully tested in an FDA Phase 2 clinical trial and was
shown to be safe and effective at maintaining iron stores at targeted levels.
Non-clinical safety, pharmacology and toxicity testing continuing throughout
2006 have had favorable results and been in line with expectations.
Rockwell will be hosting a conference call to review its results and business
developments on Wednesday, August 9, 2006 at 11:00 am EST. Investors are
encouraged to dial in a few minutes in advance of the call at 888-896-0862 or
may listen on the web at
http://orion.calleci.com/servlet/estreamgetevent?id=7067&folder=default
using Windows Media Player. See www.rockwellmed.com for more details and
playback options.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 3-5% on average each year over the last five years. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding FDA
approval, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate
(SFP) to capture market share, potential for sales growth, expected customer
orders, etc. constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, delays or failure to obtain FDA approval of SFP, failure to obtain
medicare or private insurance reimbursement approval, general economic
conditions, economic conditions in the hemodialysis industry, modified
regulatory requirements, competitive factors, and other factors discussed in
Rockwell's reports filed with the Securities and Exchange Commission. These
forward-looking statements should be considered in light of these risks and
uncertainties.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and six months ended
June 30, 2006 and June 30, 2005
(Whole dollars)
(Unaudited)
|
| |
3 Months ended June 30, 2006 |
3 Months ended June 30, 2005 |
6 Months ended June 30, 2006 |
6 Months ended June 30, 2005 |
| Sales |
$ 5,869,253 |
$ 7,791,033 |
$ 12,031,156 |
$ 13,410,541 |
| Cost of Sales |
5,404,107 |
6,980,588 |
10,782,701 |
11,930,680 |
| Gross Profit |
465,146 |
810,445 |
1,248,455 |
1,479,861 |
| Selling, General, Admin |
693,935 |
652,045 |
1,319,777 |
1,250,305 |
| Research & Product Devel. |
1,311,085 |
36,422 |
1,759,822 |
85,821 |
| Operating Income (Loss) |
(1,539,874) |
121,978 |
(1,831,144) |
143,735 |
| Other Income |
- |
- |
- |
137,468 |
| Interest Income (Expense), net |
30,817 |
(36,522) |
32,869 |
(86,532) |
| Net Income (Loss) |
($ 1,509,057) |
$ 85,456 |
($ 1,798,275) |
$ 194,671 |
| Basic Earnings (Loss) per share |
$ (0.13) |
$ 0.01 |
$ (0.16) |
$ 0.02 |
| Diluted Earnings (Loss) per share |
$ (0.13) |
$ 0 .01 |
$ (0.16) |
$ 0.02 |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of June 30, 2006 and December 31, 2005
(Whole dollars)
(Unaudited)
|
| |
June 30, 2006 |
Dec. 31, 2005 |
| Assets |
| Cash and Cash Equivalents |
$ 4,748,427 |
$ 299,031 |
Accounts Receivable,
net of a reserve of $86,000 in 2006 and $70,000
in 2005 |
2,476,690 |
2,836,072 |
| Inventory |
2,544,896 |
2,051,819 |
| Other Current Assets |
472,883 |
193,158 |
| Total Current Assets |
10,242,896 |
5,380,080 |
| Property and Equipment, net |
2,375,080 |
2,430,222 |
| Intangible Assets |
450,295 |
394,819 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
131,542 |
134,794 |
| Total Assets |
$ 9,260,660 |
$ 9,260,660 |
Liabilities and Shareholders' Equity
|
| Short Term Borrowings |
$ - |
$ 1,800,000 |
| Notes Payable & Capitalized Lease Obligations |
498,800 |
522,439 |
| Accounts Payable |
1,566,277 |
1,795,393 |
| Accrued Liabilities |
560,714 |
530,749 |
| Customer Deposits |
80,916 |
33,558 |
| Total Current Liabilities |
2,706,707 |
4,682,139 |
Long Term Notes Payable & Capitalized Lease Obligations
|
443,220 |
733,723 |
| Shareholders' Equity: |
Common Shares, no par value,
11,455,583 and 8,886,948 shares issued and
outstanding |
22,967,523 |
12,628,539 |
Common Share Purchase Warrants,
-0- and 3,591,385 shares issued and
outstanding |
- |
1,414,876 |
| Accumulated Deficit |
(11,996,892) |
(10,198,617) |
| Total Shareholders' Equity |
10,970,631 |
3,844,798 |
| Total Liabilities and Shareholders'
Equity |
$ 14,120,558 |
$ 9,260,660 |
(return to News
Index)
Tuesday, August 1, 2006
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Wednesday,
August 9, 2006 at 11:00 AM ET to discuss its second quarter results and to
provide investors with a business update. The Company intends to release
results before the market opens on the same date. Robert Chioini, Chairman and
CEO, and Thomas Klema, CFO, will be hosting the call to review Rockwell's
results and answer questions from investors.
The call will be held on:
Wednesday, August 9, 2006
Starting Time 11:00 AM Eastern Time
Dial in Number: 888-896-0862
Conference ID#: 7684014
When calling in please refer to Conference ID# 7684014 for the Rockwell Medical
Technologies Second Quarter Investor Conference Call and provide the operator
with your name and company affiliation.
Investors who prefer to participate using the internet may access the following
link for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7068&folder=default.
Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7067&folder=default
International Investors may dial in directly on 973-935-8597.
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at http://www.rockwellmed.com
.
We appreciate your interest in Rockwell.
(return to News
Index)
 |
Thursday, July 20, 2006
WIRB Approves NIH Protocol for Proprietary SFP
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of concentrates and specialty
pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported
that the Western Institutional Review Board (WIRB) has approved the Company's
National Institutes of Health (NIH) sponsored study protocol for examining the
prospective advantages of soluble ferric pyrophosphate (SFP) delivery via
dialysate in hemodialysis patients. The nine-month study is expected to begin
in the third quarter of 2006.
The WIRB provides review services for more than 100 institutions (academic
centers, hospitals, networks and in-house biotech research), as well as for
individual investigators in all 50 states and internationally. The WIRB has
worked with all major pharmaceutical and device manufacturers, CRO's and the
biotech industry.
The National Institutes of Health (NIH), a part of the U.S. Department of
Health and Human Services, is the primary Federal agency for conducting and
supporting medical research. Helping to lead the way toward important medical
discoveries that improve people's health and save lives, NIH scientists
investigate ways to prevent disease as well as the causes, treatments, and even
cures for common and rare diseases.
Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron
called Ferric Pyrophosphate. SFP is designed to provide physiological iron
maintenance for hemodialysis patients by delivery of SFP via dialysate.
Compared to intravenous (IV) iron administration, early clinical study results
for SFP have shown that delivering iron via dialysate is a safe and effective
method for maintaining iron balance in dialysis patients, while at the same
time eliminating associated nursing and pharmaceutical IV iron administration
costs.
Rockwell has licensed the exclusive rights to the patents for the SFP
technology which grant the Company the right to manufacture and market the
combination drug/device. Rockwell is seeking FDA approval to market the product
and estimates that the U.S. dialysis market for IV-iron delivery represents
$400 million annually, while the global market potential is approximately $750
million annually. Upon FDA market approval, Rockwell expects SFP to compete
aggressively in those markets. For more information on SFP visit
www.rockwellmed.com/ironnews.htm.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's anticipated sales revenue and earnings constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements
reflect management's expectations and are based upon currently available
information. Management of Rockwell believes the expectations reflected in the
forward-looking statements made in this press release are based upon reasonable
assumptions. However, certain factors could occur that might cause actual
results to vary. These include, but are not limited to, general economic
conditions, economic conditions in the hemodialysis industry, any breach of a
contract by a major customer, competitive factors and other factors discussed
in Rockwell's reports filed with the Securities and Exchange Commission. The
forward-looking statements should be considered in light of these risks and
uncertainties.
(return to News
Index)
 |
Tuesday, June 27, 2006
RMTI Receives Hong Kong Patent Grant for Proprietary SFP
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of concentrates and specialty
pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported
that the Hong Kong Patent and Trademark Office has issued a patent for
Rockwell's proprietary SFP product. The patent covers the "Method and
Pharmaceutical Composition for Iron Delivery administered via Dialysate in
Hemodialysis and Peritoneal Dialysis Patients".
Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron
called Ferric Pyrophosphate. SFP is designed to provide physiological iron
maintenance therapy in ESRD patients by delivering iron via dialysate during a
dialysis treatment. Rockwell has licensed the exclusive rights to the SFP
patent and is in the process of seeking FDA approval to market the product.
Compared to intravenous (IV) iron administration, early clinical study results
have shown that delivering iron via dialysate is a safe and effective method
for maintaining iron balance in dialysis patients, while at the same time
eliminating associated nursing and pharmaceutical IV iron administration costs.
Rockwell estimates that the U.S. market for IV iron delivery is as much as $450
million annually while the global market potential is approximately $750
million annually. Upon FDA market approval, Rockwell expects SFP to compete
aggressively for those markets. Visit Rockwell's website at
www.rockwellmed.com/ironnews.htm for more information on SFP.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We
believe the markets along the pacific rim hold tremendous potential for SFP.
This patent approval in Hong Kong is a significant step toward commercial
realization of SFP in an important market. Overall, we are pleased with our
progress toward FDA approval."
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release including statements
regarding FDA approval to market SFP, the market potential for iron
supplementation and the ability of SFP to compete for market share once
approved by the FDA constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, general economic conditions, economic conditions in the
hemodialysis industry, modified regulatory requirements, competitive factors,
and other factors discussed in Rockwell's reports filed with the Securities and
Exchange Commission. The forward-looking statements should be considered in
light of these risks and uncertainties.
(return to News
Index)
 |
Wednesday, May 24, 2006
Rockwell Medical Signs Concentrate Distribution
Agreement for European Market
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of concentrates and specialty
pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported
today that it has signed an exclusive distribution agreement with a specialty
pharma distributor to supply its dialysis concentrate products in Europe.
The Agreement calls for the purchase of Rockwell's Dri-Sate Dry Acid
Concentrate Mixing System for distribution into Europe. Under the terms of the
Agreement, minimum volumes of Rockwell's Dri-Sate Dry Acid Concentrate are
required to be purchased. The product will be marketed under the Rockwell label
following European CE regulatory approval. The European dialysis market is the
third largest following the U.S. and Japan.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, We
are pleased to have secured this distribution channel into Europe. Our
distributor is active in the European dialysis market and we anticipate our
Dri-Sate Dry Acid Concentrate Mixing System will sell very well. Much like our
Canadian distribution agreement we announced earlier this year, this agreement
enables Rockwell to enter the European dialysis market without having to make
capital investments for production and distribution facilities in the
region.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of concentrates and specialty pharmaceuticals focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
properly and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis
patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell
manufactures, markets and delivers high-quality dialysis solutions, powders and
ancillary products that are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell's proprietary formulations for
iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the
delivery mechanism, are designed to provide replacement therapy with
unprecedented patient safety and efficacy while eliminating nursing time and
supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to the
estimated size of the European dialysis market and prospective sales constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements
reflect management's expectations and are based upon currently available
information. Management of Rockwell believes the expectations reflected in the
forward-looking statements made in this press release are based upon reasonable
assumptions. However, certain factors could occur that might cause actual
results to vary. These include, but are not limited to, delay or failure to
receive regulatory approval in Canada, general economic conditions, economic
conditions in the hemodialysis industry, competitive factors and other factors
discussed in Rockwell's reports filed with the Securities and Exchange
Commission. The forward-looking statements should be considered in light of
these risks and uncertainties.
(return to News
Index)
 |
Tuesday, May 16, 2006
Rockwell Medical Signs Concentrate Supply Contract
with Renal Advantage Inc.
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative hemodialysis concentrate manufacturer serving the
healthcare industry, announced today that it has signed a supply contract with
Renal Advantage Inc. (RAI).
RAI is headquartered in Brentwood, TN and is the fourth largest provider of
dialysis services in the United States. RAI currently operates more than 70
freestanding renal dialysis centers in 10 states serving approximately 7,000
patients suffering from chronic kidney failure. RAI acquired the centers as a
result of DaVita Inc.'s acquisition of Gambro Healthcare US. For more
information on RAI visit www.renaladvantage.com.
At the start of the contract, Rockwell will service approximately half of the
RAI centers. The general terms of the supply contract call for RAI to purchase
concentrate and other products from Rockwell over a 24-month period. The
contract is renewable upon mutual consent thereafter. The RAI centers initially
serviced by Rockwell are expected to generate more than $1 million in annual
sales revenue.
Mr. Rob Chioini, Chairman, CEO and President of Rockwell said, We are
pleased to have the opportunity to supply RAI with our product. The majority of
the centers that we will service will utilize our Dri-Sate Dry Acid Concentrate
Mixing System, which will benefit both RAI and Rockwell.
Ms. Angela Newman, Vice President of Supply Chain for RAI stated, We are
very pleased to have Rockwell as a dialysate supplier for our centers. Rockwell
has exceptional customer and delivery service and we are confident that having
Rockwell as our dialysate provider will benefit RAI as we continue to
streamline and consolidate our supply chain functions.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing,
marketing and delivering high-quality dialysis solutions, powders and ancillary
products that improve the quality of care for dialysis patients. Dialysis is a
process that duplicates kidney function for those patients whose kidneys have
failed to work properly and suffer from chronic kidney failure, a condition
also known as end stage renal disease (ESRD). There are an estimated 350,000
dialysis patients in the United States and the incidence of ESRD has increased
approximately 6% on average each year over the last decade. Rockwell's products
are used to cleanse the ESRD patient's blood and replace nutrients in the
bloodstream. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's anticipated sales revenue constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect management's expectations
and are based upon currently available information. Management of Rockwell
believes the expectations reflected in the forward-looking statements made in
this press release are based upon reasonable assumptions. However, certain
factors could occur that might cause actual results to vary. These include, but
are not limited to, general economic conditions, economic conditions in the
hemodialysis industry, competitive factors and other factors discussed in
Rockwell's reports filed with the Securities and Exchange Commission. The
forward-looking statements should be considered in light of these risks and
uncertainties.
(return to News
Index)
 |
Thursday May 11, 2006
Rockwell Medical Reports First Quarter Sales Up 10%;
Increased R&D Spending for Proprietary Drug
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative hemodialysis products manufacturer in the healthcare
sector, reported its first quarter results today which included a 10% sales
increase over the first quarter last year. Earnings per Share was a loss of
($.03). Increased R&D spending for FDA approval of Rockwell's proprietary
iron-delivery drug, Soluble Ferric Pyrophosphate (SFP), reduced earnings per
share $.04 in the first quarter.
First Quarter Financial Highlights
- Sales increased 10% over the first quarter of 2005 to $6,161,903
- Net Loss was ($289,218) which included $448,737 in R&D costs.
- Loss per Share was ($.03) which included R&D costs of $.04 per share
for SFP.
- Loss per Share was ($.03) compared to first quarter 2005's EPS of $.01.
- Raised $9.1 million in gross capital from successful warrant exercise in
January.
- Increased Equity Capital to $11,900,000.
- Renewed Credit Line of $2.75 million.
SFP Highlights
- Successfully completed financing to begin funding FDA approval process for
SFP.
- Commenced non-clinical testing program consisting of 19 toxicity and
safety pharmacology studies.
- Eleven studies have been completed to date, five studies are on-going and
the final three studies are scheduled to begin in May of this year.
- Completed designing test protocols for the final 3 non-clinical studies to
commence in second quarter.
- Manufactured commercial batch of SFP concentrate for use in upcoming NIH
Study.
- NIH study design completed and submitted to Institutional Review Board
(IRB).
- Submitted Pre-IND package to FDA containing Phase 3 Protocol in April.
Mr. Robert L. Chioini, Chairman and Chief Executive Officer
of Rockwell Medical Technologies, Inc. stated, "Our first quarter marked
several important milestones in our history. First, we completed a successful
warrant offering which provides us with the resources to aggressively work
towards gaining FDA market approval of SFP, a top priority for us. Second, we
are well underway with our non-clinical SFP testing program, which is
progressing as planned. Finally, our project team completed the SFP Phase 3
protocol which was submitted to the FDA in April. In addition, to achieving
these milestones, we were pleased to see our share price appreciate which we
attribute to increasing investor recognition of SFP's potential value."
Mr. Chioini also said, "Our strategic initiatives encompass both building
our concentrate business and gaining FDA market approval for SFP, but clearly
our top priority will be getting SFP, our proprietary iron-delivery drug, to
the market as fast as possible. We expect to spend as much as $4 million for
SFP testing and development in 2006. We are truly excited about this
innovative, proprietary product and its potential to capture market share in
what we think will grow to be a billion dollar global market by the end of this
decade."
Rockwell is actively working towards FDA market approval for its SFP, its
iron-delivery product, which is designed to be a physiological iron replacement
therapy for hemodialysis patients with end stage renal disease. The Company
anticipates that Phase 3 clinical studies will commence in late 2006. SFP was
successfully tested in a Phase 2 clinical trial and was shown to be effective
at maintaining iron stores at targeted levels. Safety and pharmacology testing
is planned to continue throughout 2006 has had favorable results so far.
Rockwell will be hosting a conference call to review its first quarter
developments on Thursday, May 11, 2006 at 11:00 am EST. Investors are
encouraged to dial in a few minutes in advance of the call at 888-896-0862 or
may listen on the web at
http://orion.calleci.com/servlet/estreamgetevent?id=6827&folder=default
using Windows Media Player. See www.rockwellmed.com for more details and
playback options.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing,
marketing and delivering high-quality dialysis solutions, powders and ancillary
products that improve the quality of care for dialysis patients. Dialysis is a
process that duplicates kidney function for those patients whose kidneys have
failed to work properly and suffer from chronic kidney failure, a condition
also known as end stage renal disease (ESRD). There are an estimated 350,000
dialysis patients in the United States and the incidence of ESRD has increased
approximately 4-6% on average over the last decade. Rockwell's products are
used to cleanse the ESRD patient's blood and replace nutrients in the
bloodstream. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate
Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid
Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood
Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding FDA
approval, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate
(SFP) to capture market share, etc. constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect management's expectations
and are based upon currently available information. Management of Rockwell
believes the expectations reflected in the forward-looking statements made in
this press release are based upon reasonable assumptions. However, certain
factors could occur that might cause actual results to vary. These include, but
are not limited to, delays or failure to obtain FDA approval of SFP, failure to
obtain medicare or private insurance reimbursement approval, general economic
conditions, economic conditions in the hemodialysis industry, modified
regulatory requirements, competitive factors, and other factors discussed in
Rockwell's reports filed with the Securities and Exchange Commission. These
forward-looking statements should be considered in light of these risks and
uncertainties.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three months ended
March 31, 2006 and March 31, 2005
(Whole dollars)
(Unaudited)
|
| |
3 Months ended March 31, 2006 |
3 Months ended March 31, 2005 |
| Sales |
$ 6,161,903 |
$ 5,619,50 |
| Cost of Sales |
5,378,594 |
4,950,092 |
| Gross Profit |
783,309 |
669,416 |
| Selling, General, Admin |
625,842 |
598,260 |
| Operating Income (Loss) |
(291,270) |
21,757 |
| Other Income |
- |
137,468 |
| Interest Expense (Income), net |
(2,052) |
50,010 |
| Net Income (Loss) |
$ (289,218) |
$ 109,215 |
| Basic Earnings (Loss) per share |
( $ .03) |
$ .01 |
| Diluted Earnings (Loss) per share |
( $ .03) |
$ .01 |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of March 31, 2006 and December 31, 2005
(Whole dollars)
(Unaudited)
|
| |
Mar. 31, 2006 |
Dec. 31, 2005 |
| ASSETS |
| Cash and Cash Equivalents |
$ 5,694,893 |
$ 299,031 |
Accounts Receivable,
net of a reserve of $85,227 in 2006 and $70,000
in 2005 |
3,064,293 |
2,836,072 |
| Inventory |
2,211,945 |
2,051,819 |
| Other Current Assets |
309,463 |
193,158 |
| Total Current Assets |
5,893,711 |
4,241,037 |
| Property and Equipment, net |
2,068,157 |
2,048,665 |
| Intangible Assets |
400,499 |
369,508 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
128,742 |
120,597 |
| Total Assets |
$ 11,280,594 |
$ 9,260,660 |
LIABILITIES AND SHAREHOLDERS' EQUITY
|
| Short Term Borrowings |
$ - |
$ 1,800,000 |
| Notes Payable & Capitalized Lease Obligations |
516,647 |
522,439 |
| Accounts Payable |
1,617,959 |
1,795,393 |
| Customer Deposits |
145,307 |
33,558 |
| Accrued Liabilities |
384,695 |
530,749 |
| Total Current Liabilities |
2,664,608 |
4,682,139 |
Long Term Notes Payable & Capitalized Lease Obligations
|
606,856 |
733,723 |
| Shareholders' Equity: |
Common Shares, no par value,
11,283,188 and 8,886,948 shares issued and
outstanding |
22,392,249 |
12,628,539 |
Common Share Purchase Warrants,
25,000 and 3,591,385 shares issued and
outstanding |
14,042 |
1,414,876 |
| Accumulated Deficit |
(10,487,835) |
(10,198,617) |
| Total Shareholders' Equity |
11,918,456 |
3,844,798 |
| Total Liabilities and Shareholders'
Equity |
$ 15,189,920 |
$ 9,260,660 |
(return to News
Index)
Wednesday, May 3, 2006
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies,
Inc.announced today that it will hold an investor conference call on Thursday,
May 11, 2006 at 11:00AM EST to discuss its first quarter results and to provide
investors with a business update. The Company intends to release results before
the market opens on the same date. Robert Chioini, Chairman and CEO, and Thomas
Klema, CFO, will be hosting the call to review Rockwell's results and answer
questions from investors.
The call will be held on:
Thursday, May 11, 2006
Starting Time 11:00AM Eastern Time
Dial in Number: 888-896-0862
When calling in please refer to Conference ID#7360306 for the Rockwell Medical
Technologies First Quarter Investor Conference Call and provide the operator
with your name and company affiliation.
Investors who prefer to participate using the internet may access the following
link for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6826&folder=default
Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6827&folder=default
International Investors may dial in directly on 973-935-8597
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at www.rockwellmed.com.
We appreciate your interest in Rockwell.
(return to News
Index)
 |
Wednesday, April 20, 2006
Rockwell Medical Submits SFP Pre-IND Package Containing
Phase III Clinical Protocol to FDA
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative dialysis products manufacturer serving the healthcare
industry, reported today that it has submitted a pre-IND package to the FDA for
their review. This pre-IND package contains Rockwell's Phase III clinical trial
protocol for its proprietary iron-delivery product Soluble Ferric Pyrophosphate
(SFP). Rockwell's SFP is designed to provide physiological iron replacement in
ESRD patients by delivering iron via dialysate during hemodialysis. Pending FDA
approval of its IND development plan, the Company anticipates initiating the
Phase III clinical trial during the fourth quarter of 2006.
Rockwell has non-clinical safety studies ongoing in support of the SFP product
development. Out of a total of 19 non-clinical safety studies, eleven studies
have been completed to date, five studies are on-going and the final three
studies are scheduled to begin in May of this year. The final three studies are
projected to conclude in the first quarter of 2007.
Based on the results of an FDA approved Phase II study, delivering SFP via
dialysate has shown to be a safer and more effective method for maintaining
iron balance in dialysis patients, as compared to intravenous iron (IV-iron)
administration. Also demonstrated during the study, SFP delivered via dialysate
appeared to have a distinct safety advantage for patients in that it
transferred the iron load directly from dialysate into the blood plasma,
thereby avoiding liver toxicity that may occur during IV-iron administration.
The study results also appeared to demonstrate a reduction in the amount of
Epoetin-alfa (EPO) needed during the dialysis treatment.
In addition, as compared to IV-iron administration, SFP delivered via dialysate
is expected to produce substantial cost savings for dialysis providers by
eliminating the nursing time and the medical supplies needed for current
IV-iron administration. Cost and liability due to a potential needle-stick is
expected to be eliminated as well.
Rockwell has licensed the exclusive rights to the patents for the SFP
technology which grant the Company the right to manufacture and market the
combination drug/device. Rockwell estimates that the U.S. dialysis market for
IV-iron delivery represents $450 million annually while the global market
potential is approximately $750 million annually. Upon FDA market approval,
Rockwell expects SFP to compete aggressively for those markets. For more
information on SFP visit Rockwell's website at www.rockwellmed.com/ironnews.htm
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, We
are pleased to have submitted our pre-IND package to the FDA. This submission,
including the Phase III protocol, should enable us to save valuable time on our
development plan for SFP. Our overall goal is to attain FDA market approval of
SFP as quickly as possible so that we can provide a safe and effective delivery
method for patients undergoing hemodialysis who require physiological iron
replacement.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing,
marketing, and delivering high-quality dialysis solutions, powders, and
ancillary products that improve the quality of care for dialysis patients.
Dialysis is a process that duplicates kidney function for those patients whose
kidneys have failed to work properly and suffer from chronic kidney failure, a
condition also known as end stage renal disease (ESRD). There are an estimated
350,000 dialysis patients in the United States and the incidence of ESRD has
increased approximately 6%-8% on average each year over the last decade.
Rockwell's products are used to cleanse the ESRD patient's blood and replace
nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry
Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate,
SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder
Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of
ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding an
anticipated commencement on the Company's Phase III clinical trial,
non-clinical study timelines, FDA approval, the potential of Rockwell's
proprietary SFP, etc., constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, general economic conditions, economic conditions in the
hemodialysis industry, modified regulatory requirements, competitive factors,
and other factors discussed in Rockwell's reports filed with the Securities and
Exchange Commission. The forward-looking statements should be considered in
light of these risks and uncertainties.
(return to News
Index)
 |
Wednesday, April 19, 2006
Rockwell Medical Receives European Patent Issuance for
Proprietary Iron-Delivery Technology
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative hemodialysis products manufacturer in the healthcare
industry, reported that the European Patent and Trademark Office has issued a
patent for Rockwell's proprietary iron-delivery product SFP, which covers the
"Method and Pharmaceutical Composition for Iron Delivery in Hemodialysis
and Peritoneal Dialysis Patients". Rockwell reported on August 10, 2005
that the EPTO had allowed its claims for the proprietary drug/device.
Rockwell's proprietary product SFP is designed to provide physiological iron
replacement in ESRD patients by delivering iron via dialysate during
hemodialysis and peritoneal dialysis treatment. Rockwell has licensed the
exclusive rights to the SFP patent and is in the process of seeking FDA
approval to market the product.
The countries the patent grant will effect are Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.
Compared to intravenous (IV) iron administration, results based on an FDA
approved Phase II Study have shown that delivering iron via dialysate is a
safer and more effective method for maintaining iron balance in dialysis
patients, while at the same time eliminating associated nursing and
pharmaceutical IV iron administration costs. Rockwell estimates that the U.S.
dialysis market for IV iron delivery represents $450 million annually while the
global market potential is approximately $750 million annually. Upon FDA market
approval, Rockwell expects SFP to compete aggressively for those markets. Visit
Rockwell's website at www.rockwellmed.com/ironnews.htm for more information
on SFP.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated,
This European patent issuance was expected based on the allowance
we had previously received. It is a significant step for Rockwell as it enables
us to protect our proprietary technology in a major market. Currently, we are
making solid progress in our FDA development process and we expect to achieve
several more significant milestones as we work towards market approval.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing,
marketing, and delivering high-quality dialysis solutions, powders, and
ancillary products that improve the quality of care for dialysis patients.
Dialysis is a process that duplicates kidney function for those patients whose
kidneys have failed to work properly and suffer from chronic kidney failure, a
condition also known as end stage renal disease (ESRD). There are an estimated
350,000 dialysis patients in the United States and the incidence of ESRD has
increased approximately 6%-8% on average each year over the last decade.
Rockwell's products are used to cleanse the ESRD patient's blood and replace
nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry
Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate,
SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder
Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of
ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding an
anticipated response from the FDA on the Company's Phase III Clinical Trial
proposal, non-clinical study timelines, FDA approval, the potential of
Rockwell's proprietary Soluble FePPi, etc., and the Company's ability to raise
additional capital constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, general economic conditions, economic conditions in the
hemodialysis industry, modified regulatory requirements, competitive factors,
and other factors discussed in Rockwell's reports filed with the Securities and
Exchange Commission. The forward-looking statements should be considered in
light of these risks and uncertainties.
(return to News
Index)
 |
Wednesday March 1, 2006
Rockwell Reports Q4 and 2005 Year-End Sales Increase;
Spending for FDA Drug Approval Increases
WIXOM, Mich. -- Rockwell Medical Technologies, Inc. a
leading, innovative hemodialysis products manufacturer in the healthcare
sector, reported its fourth quarter and year-end results today. Sales increased
35% in the fourth quarter over last year's fourth quarter and 2005 revenue
increased 54% over 2004. Sales increased to $27.7 million in 2005 compared to
$18 million in 2004. Spending on FDA drug approval for Rockwell's proprietary
iron-delivery product, Soluble Ferric Pyrophosphate (SFP), reduced earnings
$.04 per share in 2005.
Fourth quarter 2005 earnings per share was a loss of ($.03) as compared to
breakeven in the fourth quarter of 2004. Net loss of ($274,040) in the fourth
quarter included $186,000 of drug product spending for SFP related expenses.
Earnings per share for 2005 were $.01 as compared to $.02 in 2004. Investments
in FDA approval costs for SFP during 2005 totaled $.04 per share. 2005 profit
of $76,808 was reduced by $350,000 for SFP related expenses.
Fourth Quarter Highlights:
- Sales increased 35% over the fourth quarter of 2004 to $6,456,000.
- Appointed
Scientific Advisory Board (SAB) to advise on the development and FDA
approval of SFP.
- Commenced
Safety Pharmacology Tests for the development and approval of SFP.
- Completed
warrant exchange resulting in successful exercise and gross capital
raise of $9.25 million.
- Net loss
was
($.03) per share and included $.02 per share of SFP development costs.
2005 Highlights:
- Sales increased $9.75 million, or 54%, to $27.7 million in 2005 as compared
to 2004.
- Significantly
increased market penetration both domestically and internationally.
- Expanded
national production and distribution footprint with third
manufacturing facility in the Southeast.
- Received
European Patent allowance for Rockwell's proprietary iron delivery
product SFP.
- Completed
commercial SFP manufacturing and testing procedures.
- Net
Income was
$.01 per share and included $.04 of SFP development costs.
Mr. Robert L. Chioini, Chairman and Chief Executive Officer
of Rockwell Medical Technologies, Inc. stated, We are extremely pleased
with the progress we made during 2005. Our strategic initiatives encompass both
building our core concentrate business and gaining FDA market approval for our
proprietary iron-delivery product (SFP), but clearly our top priority will be
getting SFP to the market as fast as possible. The fourth quarter was the
beginning of accelerated spending on SFP product testing and resulted in
increased product development expense for Rockwell; we anticipate that expense
will increase substantially going forward. We expect to spend at least $3-4
million for FDA testing and development in 2006 which will be funded from the
proceeds from the exercise of our warrants. We are very excited about this
innovative, proprietary product and its potential to capture market
share.
Rockwell is seeking FDA approval for its Soluble Ferric Pyrophosphate (SFP)
iron-delivery product used to treat dialysis patients with iron deficiency. The
Company plans to submit its Phase III protocol for FDA review in the second
quarter of 2006 and anticipates that Phase III clinical studies will commence
in late 2006. Safety and pharmacology testing commenced in the fourth quarter
of 2005 and will run throughout 2006. Safety and pharmacology testing so far
has demonstrated favorable results. SFP was successfully tested in its Phase II
clinical trial. An independent National Institutes of Health Study is expected
to commence treating patients with SFP in May.
Rockwell will be hosting a conference call to review its year end and fourth
quarter results on Wednesday, March 1, 2006 at 11:00 am EST. Investors are
encouraged to call in five minutes in advance of the call at 888-896-0862 or
may listen on the web at:
http://orion.calleci.com/servlet/estreamgetevent?id=6516&folder=default
using Windows Media Player. See www.rockwellmed.com for more details and
playback options.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing,
marketing and delivering high-quality dialysis solutions, powders and ancillary
products that improve the quality of care for dialysis patients. Dialysis is a
process that duplicates kidney function for those patients whose kidneys have
failed to work properly and suffer from chronic kidney failure, a condition
also known as end stage renal disease (ESRD). There are an estimated 350,000
dialysis patients in the United States and the incidence of ESRD has increased
approximately 4-6% on average each year over the last decade. Rockwell's
products are used to cleanse the ESRD patient's blood and replace nutrients in
the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry Acid
Concentrate Mixing System, RenalPure® Liquid Acid Concentrate,
SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder
Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of
ancillary dialysis items.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding FDA
approval, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate
(SFP) to capture market share, etc. constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect management's expectations
and are based upon currently available information. Management of Rockwell
believes the expectations reflected in the forward-looking statements made in
this press release are based upon reasonable assumptions. However, certain
factors could occur that might cause actual results to vary. These include, but
are not limited to, delays or failure to obtain FDA approval of SFP, failure to
obtain medicare or private insurance reimbursement approval, general economic
conditions, economic conditions in the hemodialysis industry, modified
regulatory requirements, competitive factors, and other factors discussed in
Rockwell's reports filed with the Securities and Exchange Commission. These
forward-looking statements should be considered in light of these risks and
uncertainties.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and twelve months ended
December 31, 2005 and December 31, 2004
(Whole dollars)
|
| |
3 Months ended Dec 31, 2005 |
3 Months ended Dec 31, 2004 |
9 Months ended Dec 31, 2005 |
9 Months ended Dec 31, 2004 |
| Sales |
$ 6,456,152 |
$ 4,780,070 |
$ 27,694,955 |
$ 17,944,710 |
| Cost of Sales |
5,890,958 |
4,072,467 |
24,689,912 |
15,139,215 |
| Gross Profit |
565,194 |
707,603 |
3,005,043 |
2,805,495 |
| Selling, General, Admin |
772,663 |
636,623 |
2,867,608 |
2,396,315 |
| Operating Income |
(207,469) |
70,980 |
137,435 |
409,180 |
| Other Income |
- |
- |
137,468 |
- |
| Interest Expense, net |
66,571 |
59,576 |
198,095 |
197,658 |
| Net Income |
$ (274,040) |
$ 11,404 |
$ 76,808 |
$ 211,522 |
| Basic Shares Outstanding |
8,795,057 |
8,553,527 |
8,674,651 |
8,546,302 |
| Basic Earnings per share |
$ (0.03) |
$ 0.00 |
$ 0.01 |
$ 0.02 |
| Fully Diluted Shares Outstanding |
9,891,521 |
9,199,505 |
9,356,990 |
9,305,123 |
| Fully Diluted Earnings per share |
$ (0.03) |
$ 0 .00 |
$ 0.01 |
$ 0.02 |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of December 31, 2005 and December 31, 2004
(Whole dollars)
|
| |
Dec. 31, 2005 |
Dec. 31, 2004 |
| Assets |
| Cash and Cash Equivalents |
$ 299,031 |
$ 166,195 |
| Restricted Cash and Cash Equivalents |
- |
8,662 |
Accounts Receivable,
net of a reserve of $70,000 in 2005 and $44,500
in 2004 |
2,836,072 |
2,302,093 |
| Inventory |
2,051,819 |
1,652,457 |
| Other Current Assets |
193,158 |
111,630 |
| Total Current Assets |
5,380,080 |
4,241,037 |
| Property and Equipment, net |
2,430,222 |
2,048,665 |
| Intangible Assets |
394,819 |
369,508 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
134,794 |
120,597 |
| Total Assets |
$ 9,260,660 |
$ 7,700,552 |
Liabilities and Shareholders' Equity
|
| Short Term Borrowings |
$ 1,800,000 |
$ 452,682 |
| Notes Payable & Capitalized Lease Obligations |
522,439 |
389,602 |
| Accounts Payable |
1,795,393 |
2,124,679 |
| Accrued Liabilities |
530,749 |
481,587 |
| Customer Deposits |
33,558 |
11,005 |
| Total Current Liabilities |
4,682,139 |
3,459,555 |
Long Term Notes Payable & Capitalized Lease Obligations
|
733,723 |
818,678 |
| Shareholders' Equity: |
Common Shares, no par value,
8,886,948 and 8,556,531 shares issued and
outstanding |
12,628,539 |
11,870,909 |
Common Share Purchase Warrants,
3,591,385 and 3,761,071 shares issued and
outstanding |
1,414,876 |
320,150 |
| Accumulated Deficit |
(10,198,617) |
(8,768,740) |
| Total Shareholders' Equity |
3,844,798 |
3,422,319 |
| Total Liabilities and Shareholders'
Equity |
$ 9,260,660 |
$ 7,000,552 |
(return to News
Index)
Tuesday, February 21, 2006
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Wednesday,
March 1, 2006 at 11:00AM EST to discuss its 2005 results. The Company intends
to release its fourth quarter and year end results before the market opens on
the same date. Robert Chioini, Chairman and CEO, and Thomas Klema, CFO, will be
hosting the call to review Rockwell's results and answer questions from
investors.
The call will be held on:
Wednesday, March 1, 2006
Starting Time 11:00AM Eastern Time
Dial in Number: 888-896-0862
When calling in please refer to the Rockwell Medical Technologies, 2005 Year
End Investor Conference Call and provide the operator with your name and
company affiliation.
Investors who prefer to participate using the internet may access the following
link for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6514&folder=default
Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6516&folder=default
International Investors may dial in directly on 973-935-8597
Investors who are unable to listen to the Rockwell investor conference call
will be able to access a replay via our web site at www.rockwellmed.com. There
will be no telephone replay.
We appreciate your interest in Rockwell.
(return to News
Index)
 |
Monday, February 6, 2006
Rockwell Medical Raises $9.25 Million from Warrant Exercise
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
dialysis products manufacturer serving the healthcare industry, reported today
that it has raised $9.25 million in gross proceeds from the exercise of
warrants. Rockwell will have 11.3 million shares outstanding after the exercise
of approximately 2.4 million warrants at $3.90 each.
Rockwell intends to utilize the majority of the proceeds to fund its efforts to
obtain FDA approval for its proprietary iron-delivery product, Soluble Ferric
Pyrophosphate (FePPi). Soluble FePPi is a physiological iron replacement
therapy for end stage renal disease patients via dialysis. Rockwell's Phase III
Clinical Trial protocol has been finalized and is scheduled to be submitted to
the FDA during the second quarter of 2006. Pending FDA approval of its
development plan, the Company anticipates initiating the Phase III Clinical
Trial in late 2006. Rockwell expects its proprietary iron-delivery product to
aggressively compete in the $300,000,000 U.S. iron market and the overall
$500,000,000-plus global iron market if Rockwell is successful in obtaining
governmental and other regulatory approvals.
Thomas E. Klema, Vice President and Chief Financial Officer stated, We
are very pleased with successful completion of this offering. We accomplished
our primary objective to raise funds needed for the testing of our drug
product. This is a significant infusion of capital for us and permits us to
aggressively execute our business development plans.
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing,
marketing and delivering high-quality dialysis solutions, powders and ancillary
products that improve the quality of care for dialysis patients. Dialysis is a
process that duplicates kidney function for those patients whose kidneys have
failed to work properly and suffer from chronic kidney failure, a condition
also known as end stage renal disease (ESRD). There are an estimated 350,000
dialysis patients in the United States and the incidence of ESRD has
experienced an average annual increase of approximately 6% over the last
decade. Rockwell's products are used to cleanse the ESRD patient's blood and
replace nutrients in the bloodstream. Rockwell offers the proprietary
Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid
Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure®
Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide
range of ancillary dialysis items. Rockwell is currently in the process of
developing and gaining FDA approval of a proprietary iron-delivery product
which will be administered to dialysis patients via dialysate.
Certain statements in this press release with respect to
Rockwell's business and operations, including statements regarding FDA
approval, the potential of Rockwell's proprietary Soluble FePPi, adequacy of
capital raised, etc. constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect management's expectations and are based upon
currently available information. Management of Rockwell believes the
expectations reflected in the forward-looking statements made in this press
release are based upon reasonable assumptions. However, certain factors could
occur that might cause actual results to vary. These include, but are not
limited to, delays or failure to obtain FDA approval of Soluble FePPi, failure
to obtain medicare or private insurance reimbursement approval, general
economic conditions, economic conditions in the hemodialysis industry, modified
regulatory requirements, competitive factors, and other factors discussed in
Rockwell's reports filed with the Securities and Exchange Commission. The
forward-looking statements should be considered in light of these risks and
uncertainties.
(return to News
Index)
 |
Tuesday, January 31, 2006
Rockwell Signs Distribution Agreement with
Genpharm, Inc. of Toronto, Canada
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative dialysis products manufacturer serving the healthcare
industry, reported today that it has signed an exclusive distribution agreement
with Genpharm, Inc., of Toronto, Canada
The Distribution Agreement calls for Genpharm to purchase Rockwell's
Dri-Sate® Dry Acid Concentrate Mixing System along with RenalPure®
Powder Bicarbonate, as well as SteriLyte® Liquid Bicarbonate and
RenalPure® Liquid Acid Concentrate. Rockwell will manufacture its dialysis
concentrate products for Genpharm's Renal Care Products Division located in
Toronto, Canada. Genpharm will market and distribute Rockwell's product in
Canada under the Rockwell label following regulatory approval. Both Rockwell
and Genpharm estimate the Canadian dialysis market for concentrate to be
approximately U.S. $24 million annually.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, We
are very pleased to have Genpharm as our distributor in Canada. Their
aggressive marketing practices and strong relationships with many of the large
dialysis providers make them an ideal partner to service the 20,000-plus
dialysis patients in Canada. Due to the fact that there are only two major
concentrate manufacturers in Canada both supplying mostly liquids, coupled with
Genpharm's ability to offer Rockwell's dry concentrates along with their
substantial product offering, we believe we can capture significant market
share in Canada. This distribution agreement enables Rockwell to enter the
Canadian dialysis market without the expense of purchasing and operating an
additional manufacturing plant as well as the infrastructure that goes along
with it.
Mr. Denis Carrier, Director of Genpharm Renal Care said, We are excited
about our new partnership with Rockwell Medical Technologies, as it allows us
to continue in our mandate to bring the Canadian dialysis community the most
innovative medical technologies and pharmaceuticals in the world today. Adding
Rockwell's products to our portfolio provides us not only with gre |