Chad Therapeutics (AMEX:CTU)
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CHAD Therapeutics, Inc. (AMEX:CTU) today reported financial
results for the second quarter and first half of fiscal 2007, commented
on the recent decision by the Centers for Medicare & Medicaid Services
(CMS) to establish a new reimbursement rate for oxygen transfilling
systems such as CHAD's proprietary TOTAL O2®
home oxygen filing system, and provided an update on products the
Company is developing for the sleep disorder market.
Second Quarter and First Half Results
For the three months ended September 30, 2006, revenue declined to
$4,983,000 from $5,375,000 for the second quarter of fiscal 2006. The
net loss for the second quarter of fiscal 2007 was $307,000, or $0.03
per diluted share, compared to a net loss for the second quarter of
fiscal 2006 of $210,000, or $0.02 per diluted share.
For the six months ended September 30, 2006, revenue declined to
$10,459,000 from $11,270,000 for last year's period. The net loss for
the first six months of fiscal 2007 was $423,000, or $0.04 per diluted
share, compared to a net loss for the first six months of fiscal 2006 of
$252,000 or $0.02 per diluted share.
Sales of oxygen conservers and therapeutic devices declined 4% during
the first six months of fiscal 2007 compared to the prior year,
reflecting a 14% decline in sales to domestic customers and a 44%
increase in international sales. The decline in domestic sales was
primarily due to pricing pressure as unit sales declined by 4%.
"We remain focused on reducing costs and have achieved significant
savings by sourcing several products and components in Asia. We are
analyzing additional outsourcing opportunities to improve our product
margins and are developing new, low-cost conservers which may enhance
our competitive position in the domestic market. Conserver sales are
improving in Europe, and there are opportunities for growth in other
markets this fiscal year for products we are developing based on
specific requests from our distributors," said President and CEO Earl
Yager.
Sales of CHAD's TOTAL O2 home oxygen filing
system decreased 29% during the first six months of fiscal 2007 compared
to the same period of fiscal 2006. "We believe that uncertainty among
homecare providers in advance of the CMS ruling on November 1, 2006,
contributed to lower demand for our TOTAL O2
system in the first half of this fiscal year. International sales of our
TOTAL O2 system remain small, although we are
beginning to see some improvement in markets that do not have an
infrastructure to support traditional oxygen delivery systems, such as
Turkey and Indonesia," Yager said.
Working capital was approximately $9.5 million at September 30, 2006,
including cash and cash equivalents of $1,777,000 versus $935,000 at
March 31, 2006. The Company has no debt.
Management Comments on CMS Ruling
On November 1, 2006, CMS posted the final rule to implement oxygen and
capped rental provisions of the Deficit Reduction Act of 2005. "By
establishing an entirely new payment class for portable oxygen
transfilling equipment such as CHAD's TOTAL O2
home oxygen filling system, CMS is strongly encouraging homecare
providers to invest in advanced technology solutions that will improve
the quality of life for patients while reducing the cost of delivering
oxygen therapy," Yager said. He added that the CMS ruling also clarified
issues regarding maintenance and servicing of oxygen equipment in the
period following the transfer of title to the patient after 36 months.
"While we continue to believe that proposals to reduce the current
36-month reimbursement period to 13 months remain an impediment to our
customers' purchase decisions, we are happy to report that we now are
seeing a significant increase in interest and pricing requests for TOTAL
O2. We remain convinced that the most
cost-effective products will prevail in the long run. As we have said
ever since we launched the TOTAL O2 system more
than six years ago, we believe CHAD's system is the most cost-effective
means to provide both stationary and portable oxygen to a home oxygen
patient."
Yager added that the Company is developing a new transfilling device
that addresses the large installed base of approximately 1 million
traditional oxygen concentrators in the U.S. "This new device is
designed to allow homecare providers to benefit from the new
reimbursement category for transfilling devices without having to write
off their investment in traditional concentrators," he said.
Sleep Product Update
Yager added, "We are finalizing product designs and plan to initiate the
FDA approval process for our initial products for the sleep disorder
market. We hope to launch our first commercial product for this market
in the summer of 2007," he said.
"Our diagnostic device targeted at sleep laboratories has proprietary,
patentable features to independently monitor left and right nasal
airflow, oral airflow and snoring. The device is designed to provide
constant baseline airflow volumetric sleep scoring and to evaluate the
effects of nasal resistance and nasal cycling. We believe these features
should provide a competitive advantage over products currently in the
market, which treat the nasal passages as one airway when in fact they
are two airways," Yager explained.
CHAD also is developing a diagnostic device for performing unattended
sleep studies, including at-home studies. This device is intended to
enable ear, nose & throat specialists (ENTs), pediatricians and primary
care physicians to diagnose sleep disorders for the first time. "More
than 10 million people in the U.S. alone are estimated to have an
undiagnosed sleep disorder, and the waiting time for testing at many
sleep labs -- which is the most common way to diagnose the problem today
-- is now up to eight weeks," Yager noted. Both of CHAD's diagnostic
products will use proprietary and patented nasal cannula test kits,
which will be required for each patient tested.
"Our therapeutic device has been designed to monitor and control the
left and right nasal airflows individually to create a comfortable
equalizing of airflows throughout respiration. This allows for lower
operating pressures, as we proved in the initial clinical trial that we
reported on last year, as well as greater airway support and less
drying, all of which we believe will contribute to better compliance by
patients with our device than with devices currently on the market. Our
device unilaterally compensates for nasal resistance, which we believe
may be a competitive advantage once our products are introduced. The
system will use a proprietary and patented mask and hose system that
will need to be replaced at regular intervals, typically twice a year,"
Yager added.
The products for the sleep disorder market discussed above have not yet
been commercially introduced. The ability of the Company to successfully
introduce these products will depend upon obtaining necessary regulatory
approvals and demonstrating the efficacy and reliability of the products
to the health care community. As with any new products, the Company
cannot know if the products will perform as expected after they have
been commercially introduced. The sleep disorder market is a new market
for the Company, and the Company will be competing with several
well-established and much larger competitors in this market. These
competitors may offer more attractive prices for their products and may
introduce new products that have technological capabilities equal or
superior to the Company's products. As a result, the Company cannot
predict the level of success, if any, that it will achieve with its
products for the sleep disorder market.
About CHAD Therapeutics
CHAD Therapeutics, Inc. is in the business of developing, producing and
marketing respiratory care devices designed to improve the efficiency of
oxygen delivery systems for home health care and hospital treatment of
patients suffering from pulmonary diseases. For more information, visit www.CHADtherapeutics.com.
Safe Harbor Statements under the Private Securities Litigation
Reform Act of 1995.
The foregoing statements regarding prospects for future earnings and
revenues, future sales trends and the introduction of products under
development are forward-looking statements that involve certain risks
and uncertainties. A number of important factors could cause
actual results to differ materially from those contemplated by such
forward-looking statements. These include the potential loss of
one of our major customers upon whom we depend for a material portion of
our business, increased competition and continuing downward pressure on
prices for certain of our products, the potential introduction of new
products with perceived competitive advantages over the Company's
products, changes or proposed changes in health care reimbursement which
affect homecare providers, the terms of any distribution agreement which
may be negotiated with respect to our TOTAL O2 system or our sleep
products, and CHAD's ability to anticipate and respond to technological
and economic changes in the home oxygen market. The projected
timing for the introduction of new products may be delayed as a result
of unforeseen difficulties encountered in the design, manufacture and
quality testing for such products. The Company has limited design
and manufacturing resources and it relies to a significant extent upon
independent contractors for the development of products for the sleep
disorder market. As a result, the Company may have more
difficulty ensuring adherence to projected timetables for the
introduction of such products. Moreover, the success of the
Company's products and products under development will depend on their
efficacy, reliability and the health care community's perception of the
products' capabilities and benefits, the degree of acceptance the
products achieve among homecare providers and, with respect to products
under development, obtaining timely regulatory approval. Additional
factors that could cause actual results to differ materially from those
contemplated in this press release can be found in the Company's annual
and quarterly reports filed with the Securities and Exchange Commission
under the caption "Risk Factors."
CHAD THERAPEUTICS, INC.CONDENSED STATEMENTS OF
OPERATIONS(Unaudited)
Three Months EndedSeptember 30,
Six Months EndedSeptember 30,
2006
2005
2006
2005
Net sales
$ 4,983,000
$ 5,375,000
$ 10,459,000
$ 11,270,000
Cost of sales
3,366,000
3,594,000
7,028,000
7,388,000
Gross profit
1,617,000
1,781,000
3,431,000
3,882,000
Costs and expenses:
Selling, general and administrative
1,682,000
1,699,000
3,384,000
3,543,000
Research and development
322,000
435,000
657,000
767,000
Total costs and expenses
2,004,000
2,134,000
4,041,000
4,310,000
Operating (loss)
(387,000)
(353,000)
(610,000)
(428,000)
Other income, net
16,000
13,000
39,000
19,000
Loss before income taxes
(371,000)
(340,000)
(571,000)
(409,000)
Income tax benefit
(64,000)
(130,000)
(148,000)
(157,000)
Net loss
$ (307,000)
$ (210,000)
$ (423,000)
$ (252,000)
Loss per share:
Basic
$ (0.03)
$ (0.02)
$ (0.04)
$ (0.02)
Diluted
$ (0.03)
$ (0.02)
$ (0.04)
$ (0.02)
Weighted shares outstanding:
Basic
10,169,000
10,141,000
10,169,000
10,137,000
Diluted
10,169,000
10,141,000
10,169,000
10,137,000
CHAD THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(Unaudited)
September 30,
2006
2005
Assets
Current assets:
Cash
$ 1,777,000
$ 434,000
Accounts receivable, net
2,568,000
3,013,000
Income taxes refundable
182,000
--
Inventories, net
6,303,000
8,118,000
Prepaid expenses and other assets
146,000
472,000
Deferred income taxes
640,000
518,000
Total current assets
11,616,000
12,555,000
Property, plant and equipment, net
818,000
1,124,000
Intangible assets, net
1,073,000
863,000
Deferred income taxes
610,000
568,000
Other assets
44,000
65,000
Total Assets
$ 14,161,000
$ 15,175,000
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
$ 923,000
$ 1,210,000
Accrued expenses
1,206,000
1,176,000
Income taxes payable
--
--
Total current liabilities
2,129,000
2,386,000
Capital lease obligation, net of current portion
--
7,000
Total liabilities
2,129,000
2,393,000
Shareholders' equity:
Common shares, .01 par value, authorized 40,000,000 shares,
10,144,000 and 10,022,000 issued and outstanding
13,473,000
13,379,000
Accumulated deficit
(1,441,000)
(597,000)
Net shareholders' equity
12,032,000
12,782,000
Total Liabilities and Shareholders' Equity
$ 14,161,000
$ 15,175,000
CHAD Therapeutics, Inc. (AMEX:CTU) today reported financial
results for the second quarter and first half of fiscal 2007,
commented on the recent decision by the Centers for Medicare &
Medicaid Services (CMS) to establish a new reimbursement rate for
oxygen transfilling systems such as CHAD's proprietary TOTAL O(2)(R)
home oxygen filing system, and provided an update on products the
Company is developing for the sleep disorder market.
Second Quarter and First Half Results
For the three months ended September 30, 2006, revenue declined to
$4,983,000 from $5,375,000 for the second quarter of fiscal 2006. The
net loss for the second quarter of fiscal 2007 was $307,000, or $0.03
per diluted share, compared to a net loss for the second quarter of
fiscal 2006 of $210,000, or $0.02 per diluted share.
For the six months ended September 30, 2006, revenue declined to
$10,459,000 from $11,270,000 for last year's period. The net loss for
the first six months of fiscal 2007 was $423,000, or $0.04 per diluted
share, compared to a net loss for the first six months of fiscal 2006
of $252,000 or $0.02 per diluted share.
Sales of oxygen conservers and therapeutic devices declined 4%
during the first six months of fiscal 2007 compared to the prior year,
reflecting a 14% decline in sales to domestic customers and a 44%
increase in international sales. The decline in domestic sales was
primarily due to pricing pressure as unit sales declined by 4%.
"We remain focused on reducing costs and have achieved significant
savings by sourcing several products and components in Asia. We are
analyzing additional outsourcing opportunities to improve our product
margins and are developing new, low-cost conservers which may enhance
our competitive position in the domestic market. Conserver sales are
improving in Europe, and there are opportunities for growth in other
markets this fiscal year for products we are developing based on
specific requests from our distributors," said President and CEO Earl
Yager.
Sales of CHAD's TOTAL O(2) home oxygen filing system decreased 29%
during the first six months of fiscal 2007 compared to the same period
of fiscal 2006. "We believe that uncertainty among homecare providers
in advance of the CMS ruling on November 1, 2006, contributed to lower
demand for our TOTAL O(2) system in the first half of this fiscal
year. International sales of our TOTAL O(2) system remain small,
although we are beginning to see some improvement in markets that do
not have an infrastructure to support traditional oxygen delivery
systems, such as Turkey and Indonesia," Yager said.
Working capital was approximately $9.5 million at September 30,
2006, including cash and cash equivalents of $1,777,000 versus
$935,000 at March 31, 2006. The Company has no debt.
Management Comments on CMS Ruling
On November 1, 2006, CMS posted the final rule to implement oxygen
and capped rental provisions of the Deficit Reduction Act of 2005. "By
establishing an entirely new payment class for portable oxygen
transfilling equipment such as CHAD's TOTAL O(2) home oxygen filling
system, CMS is strongly encouraging homecare providers to invest in
advanced technology solutions that will improve the quality of life
for patients while reducing the cost of delivering oxygen therapy,"
Yager said. He added that the CMS ruling also clarified issues
regarding maintenance and servicing of oxygen equipment in the period
following the transfer of title to the patient after 36 months.
"While we continue to believe that proposals to reduce the current
36-month reimbursement period to 13 months remain an impediment to our
customers' purchase decisions, we are happy to report that we now are
seeing a significant increase in interest and pricing requests for
TOTAL O(2). We remain convinced that the most cost-effective products
will prevail in the long run. As we have said ever since we launched
the TOTAL O(2) system more than six years ago, we believe CHAD's
system is the most cost-effective means to provide both stationary and
portable oxygen to a home oxygen patient."
Yager added that the Company is developing a new transfilling
device that addresses the large installed base of approximately 1
million traditional oxygen concentrators in the U.S. "This new device
is designed to allow homecare providers to benefit from the new
reimbursement category for transfilling devices without having to
write off their investment in traditional concentrators," he said.
Sleep Product Update
Yager added, "We are finalizing product designs and plan to
initiate the FDA approval process for our initial products for the
sleep disorder market. We hope to launch our first commercial product
for this market in the summer of 2007," he said.
"Our diagnostic device targeted at sleep laboratories has
proprietary, patentable features to independently monitor left and
right nasal airflow, oral airflow and snoring. The device is designed
to provide constant baseline airflow volumetric sleep scoring and to
evaluate the effects of nasal resistance and nasal cycling. We believe
these features should provide a competitive advantage over products
currently in the market, which treat the nasal passages as one airway
when in fact they are two airways," Yager explained.
CHAD also is developing a diagnostic device for performing
unattended sleep studies, including at-home studies. This device is
intended to enable ear, nose & throat specialists (ENTs),
pediatricians and primary care physicians to diagnose sleep disorders
for the first time. "More than 10 million people in the U.S. alone are
estimated to have an undiagnosed sleep disorder, and the waiting time
for testing at many sleep labs -- which is the most common way to
diagnose the problem today -- is now up to eight weeks," Yager noted.
Both of CHAD's diagnostic products will use proprietary and patented
nasal cannula test kits, which will be required for each patient
tested.
"Our therapeutic device has been designed to monitor and control
the left and right nasal airflows individually to create a comfortable
equalizing of airflows throughout respiration. This allows for lower
operating pressures, as we proved in the initial clinical trial that
we reported on last year, as well as greater airway support and less
drying, all of which we believe will contribute to better compliance
by patients with our device than with devices currently on the market.
Our device unilaterally compensates for nasal resistance, which we
believe may be a competitive advantage once our products are
introduced. The system will use a proprietary and patented mask and
hose system that will need to be replaced at regular intervals,
typically twice a year," Yager added.
The products for the sleep disorder market discussed above have
not yet been commercially introduced. The ability of the Company to
successfully introduce these products will depend upon obtaining
necessary regulatory approvals and demonstrating the efficacy and
reliability of the products to the health care community. As with any
new products, the Company cannot know if the products will perform as
expected after they have been commercially introduced. The sleep
disorder market is a new market for the Company, and the Company will
be competing with several well-established and much larger competitors
in this market. These competitors may offer more attractive prices for
their products and may introduce new products that have technological
capabilities equal or superior to the Company's products. As a result,
the Company cannot predict the level of success, if any, that it will
achieve with its products for the sleep disorder market.
About CHAD Therapeutics
CHAD Therapeutics, Inc. is in the business of developing,
producing and marketing respiratory care devices designed to improve
the efficiency of oxygen delivery systems for home health care and
hospital treatment of patients suffering from pulmonary diseases. For
more information, visit www.CHADtherapeutics.com.
Safe Harbor Statements under the Private Securities Litigation
Reform Act of 1995.
The foregoing statements regarding prospects for future earnings
and revenues, future sales trends and the introduction of products
under development are forward-looking statements that involve certain
risks and uncertainties. A number of important factors could cause
actual results to differ materially from those contemplated by such
forward-looking statements. These include the potential loss of one of
our major customers upon whom we depend for a material portion of our
business, increased competition and continuing downward pressure on
prices for certain of our products, the potential introduction of new
products with perceived competitive advantages over the Company's
products, changes or proposed changes in health care reimbursement
which affect homecare providers, the terms of any distribution
agreement which may be negotiated with respect to our TOTAL O2 system
or our sleep products, and CHAD's ability to anticipate and respond to
technological and economic changes in the home oxygen market. The
projected timing for the introduction of new products may be delayed
as a result of unforeseen difficulties encountered in the design,
manufacture and quality testing for such products. The Company has
limited design and manufacturing resources and it relies to a
significant extent upon independent contractors for the development of
products for the sleep disorder market. As a result, the Company may
have more difficulty ensuring adherence to projected timetables for
the introduction of such products. Moreover, the success of the
Company's products and products under development will depend on their
efficacy, reliability and the health care community's perception of
the products' capabilities and benefits, the degree of acceptance the
products achieve among homecare providers and, with respect to
products under development, obtaining timely regulatory approval.
Additional factors that could cause actual results to differ
materially from those contemplated in this press release can be found
in the Company's annual and quarterly reports filed with the
Securities and Exchange Commission under the caption "Risk Factors."
-0-
*T
CHAD THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended
September 30, September 30,
2006 2005 2006 2005
----------- ----------- ------------ ------------
Net sales $4,983,000 $5,375,000 $10,459,000 $11,270,000
Cost of sales 3,366,000 3,594,000 7,028,000 7,388,000
----------- ----------- ------------ ------------
Gross profit 1,617,000 1,781,000 3,431,000 3,882,000
----------- ----------- ------------ ------------
Costs and expenses:
Selling, general and
administrative 1,682,000 1,699,000 3,384,000 3,543,000
Research and
development 322,000 435,000 657,000 767,000
----------- ----------- ------------ ------------
Total costs and
expenses 2,004,000 2,134,000 4,041,000 4,310,000
----------- ----------- ------------ ------------
Operating (loss) (387,000) (353,000) (610,000) (428,000)
Other income, net 16,000 13,000 39,000 19,000
----------- ----------- ------------ ------------
Loss before income
taxes (371,000) (340,000) (571,000) (409,000)
Income tax benefit (64,000) (130,000) (148,000) (157,000)
----------- ----------- ------------ ------------
Net loss $(307,000) $(210,000) $(423,000) $(252,000)
=========== =========== ============ ============
Loss per share:
Basic $(0.03) $(0.02) $(0.04) $(0.02)
Diluted $(0.03) $(0.02) $(0.04) $(0.02)
=========== =========== ============ ============
Weighted shares
outstanding:
Basic 10,169,000 10,141,000 10,169,000 10,137,000
Diluted 10,169,000 10,141,000 10,169,000 10,137,000
*T
-0-
*T
CHAD THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(Unaudited)
September 30,
2006 2005
------------ ------------
Assets
Current assets:
Cash $1,777,000 $434,000
Accounts receivable, net 2,568,000 3,013,000
Income taxes refundable 182,000 --
Inventories, net 6,303,000 8,118,000
Prepaid expenses and other assets 146,000 472,000
Deferred income taxes 640,000 518,000
------------ ------------
Total current assets 11,616,000 12,555,000
------------ ------------
Property, plant and equipment, net 818,000 1,124,000
Intangible assets, net 1,073,000 863,000
Deferred income taxes 610,000 568,000
Other assets 44,000 65,000
------------ ------------
Total Assets $14,161,000 $15,175,000
============ ============
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $923,000 $1,210,000
Accrued expenses 1,206,000 1,176,000
Income taxes payable -- --
------------ ------------
Total current liabilities 2,129,000 2,386,000
Capital lease obligation, net of current
portion -- 7,000
------------ ------------
Total liabilities 2,129,000 2,393,000
Shareholders' equity:
Common shares, .01 par value, authorized
40,000,000 shares, 10,144,000 and
10,022,000 issued and outstanding 13,473,000 13,379,000
Accumulated deficit (1,441,000) (597,000)
------------ ------------
Net shareholders' equity 12,032,000 12,782,000
------------ ------------
Total Liabilities and Shareholders' Equity $14,161,000 $15,175,000
============ ============
*T