Diomed Holdings, Inc. (AMEX: DIO), a leading developer and marketer
of minimally invasive medical technologies, including its patented
EVLT� laser treatment for varicose veins, today announced results
for the third quarter ended September 30, 2006. Significant
accomplishments during the third quarter of 2006 included: Diomed�s
third highest quarterly revenue performance, at $5.3 million; EVLT�
revenue, 22% above the third quarter of 2005; EVLT� disposable
revenue, 44% over the third quarter of 2005; EVLT� installed base
exceeds 1,000 laser systems; Nearly 80,000 EVLT� procedures
successfully performed; Close of $10 million preferred stock
financing, increasing cash and short term investments to $13.4
million. Summary Judgment ruling that �777 patent is valid and
enforceable, eliminating two of the three defenses and allowing
trial on infringement action to proceed; "We are pleased with our
third quarter accomplishments," commented James A. Wylie, CEO and
President of Diomed Holdings, Inc. "The Company drove significant
year-over-year growth in what is traditionally our softest quarter
due to seasonality in our key North American EVLT� market.
Additionally, Diomed delivered revenue for the nine months ended
September 30, 2006 of $16 million, an increase of $2.5 million, or
18%, over the first nine months of 2005, while EVLT� sales
increased a solid 23%." �Of particular note is our continued growth
in laser market share. During the three-month period ending August
2006, Diomed sold over three times the number of lasers sold by our
largest competitor, strengthening our belief that Diomed�s
installed base exceeds the installed base of all of our laser
competitors combined.� Wylie further commented. Gross profit for
the third quarter of 2006 was $2.3 million, representing an
increase of $208,000, or 10%, over the third quarter of 2005. Gross
profit as a percentage of sales of 43% decreased 2.4 percentage
points against the third quarter of 2005, as a less favorable
product mix and lower overhead absorption offset favorable pricing
variances. The Company has targeted continued improvement in gross
profit levels to the 60% level and higher, consistent with other
proprietary medical device companies, as the EVLT� product line
grows. Selling and marketing expenses for the third quarter of 2006
were $2.7 million, an increase of $606,000, or 29%, over the third
quarter of 2005. The increase was driven by an expansion of our
sales force, higher sales commissions resulting from the increased
sales volume and increased marketing expenditures in support of our
sales initiatives to drive the growing commercialization of EVLT�.
For the nine months ended September 30, 2006, selling and marketing
expenses were $8.5 million, an increase of $1.8 million, or 27%,
over the same period of 2005. General and administrative expenses
for the third quarter of 2006 of $1.9 million increased $95,000, or
5%, compared to the third quarter of 2005, and were relatively flat
sequentially. Total third quarter legal costs of $694,000 decreased
$16,000 from the second quarter of 2006, with a reduction in the
continuing cost of litigation against our primary laser competitors
offset by the cost of litigation in the action brought by our
radio-frequency competitor. For the nine months ended September 30,
2006, general and administrative expenses were $5.9 million, an
increase of $390,000, or 7%, over the same period in 2005. Losses
from operations for the third quarter of 2006 of approximately $2.7
million increased $513,000 from the third quarter of 2005, as gains
from incremental revenue were offset by increased selling and
marketing costs and $126,000 in SFAS 123R compensation costs.
Losses from operations for the nine months ended September 30, 2006
were $8.3 million, compared with $7.2 million for the same period
in 2005, and included $444,000 in SFAS 123R stock based
compensation charges. Net loss for the third quarter of 2006 of
$3.0 million increased by $620,000, or 26%, from the third quarter
of 2005. Net loss for the third quarter of 2006 includes a $69,000
non-cash, non-operating loss for the increase in the fair value of
the warrant obligation entered into on September 30, 2005, as the
market price of the Company�s stock increased from $1.11 at June
30, 2006 to $1.20 at September 30, 2006. As a result of the
financing which closed on September 29, 2006, the Company marked to
market the warrant obligation for a final time and reclassified its
mezzanine level preferred stock and warrant liability to permanent
equity. Upon completion of the 2006 preferred stock financing, the
Company recorded a one-time, non-cash, non-operating beneficial
conversion feature charge of $469,938, since the market price of
the Company�s common stock on September 29, 2006 of $1.20 was above
the $1.15 effective conversion price of the immediately convertible
preferred stock. The Company also recorded a one-time, non-cash,
non-operating deemed dividend of $3.0 million on the exchange of
the 2005 preferred stock for the 2006 preferred stock. Net loss
applicable to common stockholders for the third quarter of 2006 was
$6.7 million, or $0.35 per share, compared to $3.1 million, or
$0.16 per share, for the third quarter of 2005. Net loss applicable
to common stockholders for the third quarter of 2006 includes
$167,000 of non-cash preferred stock dividends accreted for future
increasing rate dividends and $149,000 of preferred stock cash
dividends earned during the third quarter on the 2005 preferred
stock. As noted above, the 2005 preferred stock was exchanged for
the 2006 preferred stock under the 2006 financing, which does not
accrue dividends unless a future dilutive financing is completed
within certain terms. The Company ended the third quarter of 2006
with a cash and short term investment balance of $13.4 million,
compared to a cash and short term investment balance of $7.0
million at the end of the second quarter of 2006. The cash balance
includes approximately, $9.3 million in net proceeds received from
the 2006 preferred stock financing. Conference Call Information
Diomed will hold a conference call to review its third quarter 2006
financial results on Thursday, October 26, 2006, at 10:00 a.m.
(ET). The call will be hosted by James A. Wylie, Jr., President and
Chief Executive Officer, and David B. Swank, Chief Financial
Officer. Interested parties may access the conference call by
dialing 866-831-6162 (domestic) or 617-213-8852 (international),
participant pass code 146644724. The call will also be available
via web cast at www.diomedinc.com. If you are unable to
participate, an audio digital replay of the call will be available
from Thursday, October 26, 2006, 12:00 p.m. ET, until Thursday,
November 2, 2006, 12:00 p.m. ET. The digital replay can be accessed
by dialing 1-888-286-8010, (domestic) or 1-617-801-6888 -
(international), using pass code 92289158. A web archive will also
be available during this time period at www.diomedinc.com. About
Diomed Diomed develops and commercializes minimal and
micro-invasive medical procedures that use its proprietary laser
technologies and disposable products. Diomed�s EVLT� laser vein
ablation procedure is used in varicose vein treatments. Diomed also
provides photodynamic therapy (PDT) for use in cancer treatments,
and dental and general surgical applications. The EVLT� procedure
and the Company�s related products were cleared by the United
States FDA in January of 2002. Along with lasers and single-use
procedure kits for its EVLT� laser vein treatment, the Company
provides its customers with state of the art physician training and
practice development support. Additional information is available
on the Company�s website: www.evlt.com. EVLT� is a registered
trademark of Diomed Inc., Andover, MA. Safe Harbor Safe Harbor
statements under the Private Securities Litigation Reform Act of
1995: Statements in this news release looking forward in time
involve risks and uncertainties, including the risks associated
with trends in the products markets, reliance on third party
distributors in various countries outside the United States,
reoccurring orders under OEM contracts, market acceptance risks,
technical development risks and other risk factors. These
statements relate to our future plans, objectives, expectations and
intentions. These statements may be identified by the use of words
such as "may," "will," "should," "potential," "expects,"
"anticipates," "intends," "plans," "believes" and similar
expressions. These statements are based on our current beliefs,
expectations and assumptions and are subject to a number of risks
and uncertainties. Our actual results could differ materially from
those discussed in these statements. Our Annual Report on Form SEC
10-KSB/A (the "Annual Report") contains a discussion of certain of
the risks and uncertainties that affect our business. We refer you
to the "Risk Factors" on pages 23 through 38 of the Annual Report
for a discussion of certain risks, including those relating to our
business as a medical device company without a significant
operating record and with operating losses, our risks relating to
our commercialization of our current and future products and
applications and risks relating to our common stock and its market
value. Diomed disclaims any obligation or duty to update or correct
any of its forward-looking statements. Diomed Holdings, Inc.
(Unaudited) Condensed Consolidated Statements of Operations Three
Months and Nine Months Ended September 30, 2006 and 2005 � Three
Months Three Months Nine Months Nine Months Ended Ended Ended Ended
September 30, September 30, September 30, September 30, 2006� 2005�
2006� 2005� � Revenues $ 5,321,080� $ 4,582,840� $ 15,972,476� $
13,488,120� � Cost of revenues 3,042,223� 2,511,536� 8,786,487�
7,325,127� � Gross profit 2,278,857� 2,071,304� 7,185,989�
6,162,993� � Operating expenses: Research and development 422,596�
403,498� 1,140,170� 1,150,712� Selling and marketing 2,687,000�
2,080,723� 8,490,263� 6,693,660� General and administrative
1,906,886� 1,811,921� 5,865,439� 5,475,535� � Total operating
expenses 5,016,482� 4,296,142� 15,495,872� 13,319,907� � Loss from
operations (2,737,625) (2,224,838) (8,309,883) (7,156,914) � Other
(income) expense Gain (Loss) on fair value adjustment on warrant
liability 68,995� -� (971,442) -� Interest expense, non-cash
96,078� 98,904� 288,229� 1,502,760� Interest expense, net and other
(income) 76,480� 35,405� (958) 187,773� Total other (income)
expense, net 241,553� 134,309� (684,171) 1,690,533� � � Net loss
(2,979,178) (2,359,147) (7,625,712) (8,847,447) � Less preferred
stock cash dividends (149,063) -� (447,353) -� Less preferred stock
non-cash dividends (167,480) (762,656) (483,586) (762,656) Less
beneficial conversion feature on 2006 preferred stock (469,938) -�
(469,938) -� Less deemed dividend on the exchange of 2005 preferred
stock (2,980,439) -� (2,980,439) -� � Net loss applicable to common
stockholders $ (6,746,098) $ (3,121,803) $ (12,007,028) $
(9,610,103) � Basic and diluted net loss per share applicable to
common stockholders $ (0.35) $ (0.16) $ (0.62) $ (0.50) � Basic and
diluted weighted average common shares outstanding 19,448,728�
19,423,728� 19,447,812� 19,143,276� Diomed Holdings, Inc. Condensed
Consolidated Balance Sheets As of September 30, 2006 (unaudited)
and December 31, 2005 � ASSETS September 30, 2006 December 31, 2005
Current assets: Cash and cash equivalents $ 12,941,840� $
9,562,087� Short term investments 498,595� 3,566,454� Accounts
receivable, net 2,629,923� 2,824,717� Inventories 3,874,721�
3,059,886� Prepaid expenses and other current assets 713,820�
444,453� � Total current assets 20,658,899� 19,457,597� � Property,
plant and equipment, net 1,272,790� 1,171,703� Intangible assets,
net 4,125,294� 4,302,915� Investment 1,000,000� 500,000� Other
assets 229,014� 294,810� � Total assets $ 27,285,997� $ 25,727,025�
� LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS� EQUITY Current
liabilities: Accounts payable $ 4,180,333� $ 3,561,786� Accrued
expenses 2,104,597� 2,298,823� Current portion of deferred revenue
260,625� 257,889� Bank loan 420,519� 53,924� Current maturities of
capital lease obligations 1,389� 2,047� EVLT technology payable
(zero face value at September 30, 2006 and $250,000 face value, net
of $4,902 debt discount at December 31, 2005) -� 245,098� Warrant
liability -� 1,898,213� � Total current liabilities 6,967,463�
8,317,780� � Deferred revenue, net of current portion 108,527�
144,428� Capital lease obligation, net of current maturities 2,778�
4,094� Convertible notes payable ($3,712,000 face value, net of
$3,712,000 debt discount at September 30, 2006 and $3,712,000 face
value, net of $1,081,727 debt discount at December 31, 2005) -�
2,630,273� � Total liabilities 7,078,768� 11,096,575� � Preferred
Stock -� 7,819,658� Stockholders� equity 20,207,229� 6,810,792� �
Total liabilities, preferred stock and stockholders� equity $
27,285,997� $ 25,727,025� Diomed Holdings, Inc. (AMEX: DIO), a
leading developer and marketer of minimally invasive medical
technologies, including its patented EVLT(R) laser treatment for
varicose veins, today announced results for the third quarter ended
September 30, 2006. Significant accomplishments during the third
quarter of 2006 included: -- Diomed's third highest quarterly
revenue performance, at $5.3 million; -- EVLT(R) revenue, 22% above
the third quarter of 2005; -- EVLT(R) disposable revenue, 44% over
the third quarter of 2005; -- EVLT(R) installed base exceeds 1,000
laser systems; -- Nearly 80,000 EVLT(R) procedures successfully
performed; -- Close of $10 million preferred stock financing,
increasing cash and short term investments to $13.4 million. --
Summary Judgment ruling that '777 patent is valid and enforceable,
eliminating two of the three defenses and allowing trial on
infringement action to proceed; "We are pleased with our third
quarter accomplishments," commented James A. Wylie, CEO and
President of Diomed Holdings, Inc. "The Company drove significant
year-over-year growth in what is traditionally our softest quarter
due to seasonality in our key North American EVLT(R) market.
Additionally, Diomed delivered revenue for the nine months ended
September 30, 2006 of $16 million, an increase of $2.5 million, or
18%, over the first nine months of 2005, while EVLT(R) sales
increased a solid 23%." "Of particular note is our continued growth
in laser market share. During the three-month period ending August
2006, Diomed sold over three times the number of lasers sold by our
largest competitor, strengthening our belief that Diomed's
installed base exceeds the installed base of all of our laser
competitors combined." Wylie further commented. Gross profit for
the third quarter of 2006 was $2.3 million, representing an
increase of $208,000, or 10%, over the third quarter of 2005. Gross
profit as a percentage of sales of 43% decreased 2.4 percentage
points against the third quarter of 2005, as a less favorable
product mix and lower overhead absorption offset favorable pricing
variances. The Company has targeted continued improvement in gross
profit levels to the 60% level and higher, consistent with other
proprietary medical device companies, as the EVLT(R) product line
grows. Selling and marketing expenses for the third quarter of 2006
were $2.7 million, an increase of $606,000, or 29%, over the third
quarter of 2005. The increase was driven by an expansion of our
sales force, higher sales commissions resulting from the increased
sales volume and increased marketing expenditures in support of our
sales initiatives to drive the growing commercialization of
EVLT(R). For the nine months ended September 30, 2006, selling and
marketing expenses were $8.5 million, an increase of $1.8 million,
or 27%, over the same period of 2005. General and administrative
expenses for the third quarter of 2006 of $1.9 million increased
$95,000, or 5%, compared to the third quarter of 2005, and were
relatively flat sequentially. Total third quarter legal costs of
$694,000 decreased $16,000 from the second quarter of 2006, with a
reduction in the continuing cost of litigation against our primary
laser competitors offset by the cost of litigation in the action
brought by our radio-frequency competitor. For the nine months
ended September 30, 2006, general and administrative expenses were
$5.9 million, an increase of $390,000, or 7%, over the same period
in 2005. Losses from operations for the third quarter of 2006 of
approximately $2.7 million increased $513,000 from the third
quarter of 2005, as gains from incremental revenue were offset by
increased selling and marketing costs and $126,000 in SFAS 123R
compensation costs. Losses from operations for the nine months
ended September 30, 2006 were $8.3 million, compared with $7.2
million for the same period in 2005, and included $444,000 in SFAS
123R stock based compensation charges. Net loss for the third
quarter of 2006 of $3.0 million increased by $620,000, or 26%, from
the third quarter of 2005. Net loss for the third quarter of 2006
includes a $69,000 non-cash, non-operating loss for the increase in
the fair value of the warrant obligation entered into on September
30, 2005, as the market price of the Company's stock increased from
$1.11 at June 30, 2006 to $1.20 at September 30, 2006. As a result
of the financing which closed on September 29, 2006, the Company
marked to market the warrant obligation for a final time and
reclassified its mezzanine level preferred stock and warrant
liability to permanent equity. Upon completion of the 2006
preferred stock financing, the Company recorded a one-time,
non-cash, non-operating beneficial conversion feature charge of
$469,938, since the market price of the Company's common stock on
September 29, 2006 of $1.20 was above the $1.15 effective
conversion price of the immediately convertible preferred stock.
The Company also recorded a one-time, non-cash, non-operating
deemed dividend of $3.0 million on the exchange of the 2005
preferred stock for the 2006 preferred stock. Net loss applicable
to common stockholders for the third quarter of 2006 was $6.7
million, or $0.35 per share, compared to $3.1 million, or $0.16 per
share, for the third quarter of 2005. Net loss applicable to common
stockholders for the third quarter of 2006 includes $167,000 of
non-cash preferred stock dividends accreted for future increasing
rate dividends and $149,000 of preferred stock cash dividends
earned during the third quarter on the 2005 preferred stock. As
noted above, the 2005 preferred stock was exchanged for the 2006
preferred stock under the 2006 financing, which does not accrue
dividends unless a future dilutive financing is completed within
certain terms. The Company ended the third quarter of 2006 with a
cash and short term investment balance of $13.4 million, compared
to a cash and short term investment balance of $7.0 million at the
end of the second quarter of 2006. The cash balance includes
approximately, $9.3 million in net proceeds received from the 2006
preferred stock financing. Conference Call Information Diomed will
hold a conference call to review its third quarter 2006 financial
results on Thursday, October 26, 2006, at 10:00 a.m. (ET). The call
will be hosted by James A. Wylie, Jr., President and Chief
Executive Officer, and David B. Swank, Chief Financial Officer.
Interested parties may access the conference call by dialing
866-831-6162 (domestic) or 617-213-8852 (international),
participant pass code 146644724. The call will also be available
via web cast at www.diomedinc.com. If you are unable to
participate, an audio digital replay of the call will be available
from Thursday, October 26, 2006, 12:00 p.m. ET, until Thursday,
November 2, 2006, 12:00 p.m. ET. The digital replay can be accessed
by dialing 1-888-286-8010, (domestic) or 1-617-801-6888 -
(international), using pass code 92289158. A web archive will also
be available during this time period at www.diomedinc.com. About
Diomed Diomed develops and commercializes minimal and
micro-invasive medical procedures that use its proprietary laser
technologies and disposable products. Diomed's EVLT(R) laser vein
ablation procedure is used in varicose vein treatments. Diomed also
provides photodynamic therapy (PDT) for use in cancer treatments,
and dental and general surgical applications. The EVLT(R) procedure
and the Company's related products were cleared by the United
States FDA in January of 2002. Along with lasers and single-use
procedure kits for its EVLT(R) laser vein treatment, the Company
provides its customers with state of the art physician training and
practice development support. Additional information is available
on the Company's website: www.evlt.com. EVLT(R) is a registered
trademark of Diomed Inc., Andover, MA. Safe Harbor Safe Harbor
statements under the Private Securities Litigation Reform Act of
1995: Statements in this news release looking forward in time
involve risks and uncertainties, including the risks associated
with trends in the products markets, reliance on third party
distributors in various countries outside the United States,
reoccurring orders under OEM contracts, market acceptance risks,
technical development risks and other risk factors. These
statements relate to our future plans, objectives, expectations and
intentions. These statements may be identified by the use of words
such as "may," "will," "should," "potential," "expects,"
"anticipates," "intends," "plans," "believes" and similar
expressions. These statements are based on our current beliefs,
expectations and assumptions and are subject to a number of risks
and uncertainties. Our actual results could differ materially from
those discussed in these statements. Our Annual Report on Form SEC
10-KSB/A (the "Annual Report") contains a discussion of certain of
the risks and uncertainties that affect our business. We refer you
to the "Risk Factors" on pages 23 through 38 of the Annual Report
for a discussion of certain risks, including those relating to our
business as a medical device company without a significant
operating record and with operating losses, our risks relating to
our commercialization of our current and future products and
applications and risks relating to our common stock and its market
value. Diomed disclaims any obligation or duty to update or correct
any of its forward-looking statements. -0- *T Diomed Holdings, Inc.
(Unaudited) Condensed Consolidated Statements of Operations Three
Months and Nine Months Ended September 30, 2006 and 2005 Three
Months Three Months Nine Months Nine Months Ended Ended Ended Ended
September September September September 30, 30, 30, 30, 2006 2005
2006 2005 ------------ ------------ ------------- ------------
Revenues $5,321,080 $4,582,840 $15,972,476 $13,488,120 Cost of
revenues 3,042,223 2,511,536 8,786,487 7,325,127 ------------
------------ ------------- ------------ Gross profit 2,278,857
2,071,304 7,185,989 6,162,993 ------------ ------------
------------- ------------ Operating expenses: Research and
development 422,596 403,498 1,140,170 1,150,712 Selling and
marketing 2,687,000 2,080,723 8,490,263 6,693,660 General and
administrative 1,906,886 1,811,921 5,865,439 5,475,535 ------------
------------ ------------- ------------ Total operating expenses
5,016,482 4,296,142 15,495,872 13,319,907 ------------ ------------
------------- ------------ Loss from operations (2,737,625)
(2,224,838) (8,309,883) (7,156,914) ------------ ------------
------------- ------------ Other (income) expense Gain (Loss) on
fair value adjustment on warrant liability 68,995 - (971,442) -
Interest expense, non-cash 96,078 98,904 288,229 1,502,760 Interest
expense, net and other (income) 76,480 35,405 (958) 187,773
------------ ------------ ------------- ------------ Total other
(income) expense, net 241,553 134,309 (684,171) 1,690,533
------------ ------------ ------------- ------------ Net loss
(2,979,178) (2,359,147) (7,625,712) (8,847,447) Less preferred
stock cash dividends (149,063) - (447,353) - Less preferred stock
non-cash dividends (167,480) (762,656) (483,586) (762,656) Less
beneficial conversion feature on 2006 preferred stock (469,938) -
(469,938) - Less deemed dividend on the exchange of 2005 preferred
stock (2,980,439) - (2,980,439) - ------------ ------------
------------- ------------ Net loss applicable to common
stockholders $(6,746,098) $(3,121,803) $(12,007,028) $(9,610,103)
============ ============ ============= ============ Basic and
diluted net loss per share applicable to common stockholders
$(0.35) $(0.16) $(0.62) $(0.50) ============ ============
============= ============ Basic and diluted weighted average
common shares outstanding 19,448,728 19,423,728 19,447,812
19,143,276 ============ ============ ============= ============ *T
-0- *T Diomed Holdings, Inc. Condensed Consolidated Balance Sheets
As of September 30, 2006 (unaudited) and December 31, 2005
September December 31, ASSETS 30, 2006 2005 ------------
------------ Current assets: Cash and cash equivalents $12,941,840
$9,562,087 Short term investments 498,595 3,566,454 Accounts
receivable, net 2,629,923 2,824,717 Inventories 3,874,721 3,059,886
Prepaid expenses and other current assets 713,820 444,453
------------ ------------ Total current assets 20,658,899
19,457,597 Property, plant and equipment, net 1,272,790 1,171,703
Intangible assets, net 4,125,294 4,302,915 Investment 1,000,000
500,000 Other assets 229,014 294,810 ------------ ------------
Total assets $27,285,997 $25,727,025 ============ ============
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable $4,180,333 $3,561,786 Accrued
expenses 2,104,597 2,298,823 Current portion of deferred revenue
260,625 257,889 Bank loan 420,519 53,924 Current maturities of
capital lease obligations 1,389 2,047 EVLT technology payable (zero
face value at September 30, 2006 and $250,000 face value, net of
$4,902 debt discount at December 31, 2005) - 245,098 Warrant
liability - 1,898,213 ------------ ------------ Total current
liabilities 6,967,463 8,317,780 Deferred revenue, net of current
portion 108,527 144,428 Capital lease obligation, net of current
maturities 2,778 4,094 Convertible notes payable ($3,712,000 face
value, net of $3,712,000 debt discount at September 30, 2006 and
$3,712,000 face value, net of $1,081,727 debt discount at December
31, 2005) - 2,630,273 ------------ ------------ Total liabilities
7,078,768 11,096,575 Preferred Stock - 7,819,658 Stockholders'
equity 20,207,229 6,810,792 ------------ ------------ Total
liabilities, preferred stock and stockholders' equity $27,285,997
$25,727,025 ============ ============ *T
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