Hemosense (AMEX:HEM)
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From Jan 2020 to Jan 2025
HemoSense, Inc. (AMEX:HEM) – a medical device
company that develops, manufactures and sells easy-to-use, handheld
blood coagulation monitoring systems for use by patients and healthcare
professionals in the management of warfarin medication –
today reported financial results for the three months and year ended
September 30, 2006.
Total revenue for the fiscal 2006 fourth quarter was $4.2 million, an
increase of 45% from total revenue of $2.9 million in the fiscal 2005
fourth quarter. Domestic revenue was $3.4 million and international
revenue was $773,000, representing increases of 58% and 8%,
respectively, compared with the fiscal 2005 fourth quarter. Total
revenue included $813,000 in revenue for INRatio®
meters and accessories, a 35% decline from the fiscal 2005 fourth
quarter, and $3.4 million in revenue for INRatio test strips, an
increase of 105% from the fiscal 2005 fourth quarter. Total revenue
for the fourth quarter of fiscal 2006 was negatively impacted by the
timing of significant orders, seasonality in Europe, and temporary
supplier issues, which caused some orders to be delayed, but which
have since been resolved.
HemoSense reported a gross profit of $1.2 million for the quarter, or
28% of total revenue, up from a gross profit of $352,000, or 12% of
total revenue, for the fiscal 2005 fourth quarter. The improvement
from the prior year was due primarily to higher unit sales and
production volumes of test strips, and to process efficiencies. Gross
margin improved five percentage points on a sequential quarter basis,
reflecting a modification of the meter placement promotional programs
that took place during the second and third quarters of fiscal 2006.
These programs contributed to HemoSense achieving double digit market
share and being firmly established as the No. 2 player in the domestic
point-of-care PT/INR market.
Operating expenses for the quarter were $3.6 million, up from $3.0
million for the fiscal 2005 fourth quarter, and down from $4.0 million
in the fiscal 2006 third quarter.
The net loss for the fiscal 2006 fourth quarter decreased to $2.5
million from $2.8 million for the fiscal 2005 fourth quarter and $3.1
million in the fiscal 2006 third quarter. The net loss per common
share was $0.23 for the quarter on 11.2 million weighted-average
shares outstanding, compared with $0.30 for the fiscal 2005 fourth
quarter on 9.6 million weighted-average shares outstanding. Included
in the net loss and the net loss per share for the fourth quarter of
fiscal 2006 is a charge of $98,000, or approximately $0.01,
respectively, related to stock-based compensation expense pursuant to
SFAS No. 123(R).
“Overall product demand remains strong and we
are confident in our ability to grow revenue and continue to gain market
share in the rapidly growing PT/INR market,”
said Jim Merselis, President and CEO of HemoSense. “In
fact, the market demand level to-date in the first quarter of fiscal
2007, meaning shipments made so far in the quarter and orders in-house
for shipment later, is ahead of the revenue for the entire fourth
quarter of fiscal 2006. We are also encouraged with our progress and
recent developments. In October, we signed an agreement to supply our
INRatio system to all CheckUps medical clinics located in Wal-Mart
stores. We also made two new additions to our senior management team,
including the appointment of Gordon Sangster as CFO, and Bill Dippel as
EVP of Operations and Research & Development.
“Additionally, the FDA has required the
manufacturer of Coumadin to add a label alerting patients to the
potential health risks associated with warfarin when dosage levels are
not properly managed,” Mr. Merselis added. “This
new labeling further highlights the importance of frequent PT/INR
testing to manage dosage levels to ensure warfarin patients’
blood coagulation levels are maintained within their therapeutic range.
We continue to work with our manufacturers and distributors to offer
warfarin patients convenient and accurate PT/INR testing through our
easy-to-use INRatio system.”
HemoSense reported cash, cash equivalents and short-term investments of
$9.7 million as of September 30, 2006.
Year-to-Date Financial Results
For the fiscal year ended September 30, 2006, total revenue was $16.3
million, an increase of 85% from $8.8 million in fiscal 2005. Fiscal
2006 domestic revenue was $13.3 million, an increase of 105% over fiscal
2005, and international revenue was $3.0 million, an increase of 30%
over the prior fiscal year. Total revenue for fiscal 2006 included $4.7
million in meters and accessories revenue and $11.6 million in test
strip revenue, up 23% and 134%, respectively, from fiscal 2005.
Gross profit for fiscal 2006 was $4.4 million, up from a gross loss of
$603,000 in fiscal 2005. Operating expenses were $14.6 million, an
increase of 47% compared with operating expenses of $10.0 million in
fiscal 2005. The net loss was $10.9 million, compared with $11.7 million
for fiscal 2005.
Fiscal Year 2007 Financial Guidance
HemoSense today introduced financial guidance for its fiscal year ending
September 30, 2007. The Company anticipates fiscal 2007 total revenue to
be in the range of $23.0 million to $25.0 million, representing growth
of 41% to 54%. HemoSense also expects the fiscal 2007 net loss to be in
the range of $5.6 million to $6.6 million, which includes $420,000 in
stock-based compensation expense. The net loss per common share is
expected to be $0.50 to $0.59 based on approximately 11.2 million
average common shares outstanding.
Conference Call Information
Management will host an investment community conference call beginning
today at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this
announcement and to answer questions.
Individuals interested in listening to the conference call may do so by
dialing (877) 815-7177 for domestic callers, or (706) 634-1178 for
international callers. A telephone replay will be available for 48 hours
following the conclusion of the call by dialing (800) 642-1687 for
domestic callers, or (706) 645-9291 for international callers, and
entering reservation code 9167445.
The live conference call will also be available via the Internet on the
Investor Relations section of the Company’s
Web site at www.hemosense.com. A
recording of the call will be available on the Company’s
Web site for 30 days following the completion of the call.
About HemoSense
HemoSense develops, manufactures and markets easy-to-use, handheld blood
coagulation systems for monitoring patients taking warfarin. The
HemoSense INRatio® system, used by healthcare
professionals and patients themselves, consists of a small monitor and
disposable test strips. It provides accurate and convenient measurement
of blood clotting time, or PT/INR values. Routine measurements of PT/INR
are necessary for the safe and effective management of the patient’s
warfarin dosing. INRatio is sold in the United States and
internationally. For more information, visit www.hemosense.com.
This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Statements in this press release regarding the Company's business that
are not historical facts may be "forward-looking statements" that
involve risks and uncertainties. Specifically, forward-looking
statements include those relating to executing the Company’s
business strategy to increase market penetration and improve revenue,
and financial guidance for fiscal 2007, are forward looking statements
within the meaning of the Safe Harbor. Forward-looking statements are
based on management's current, preliminary, expectations and are subject
to risks and uncertainties which may cause the actual results to differ
materially from the statements contained herein. The Company’s
fiscal 2006 fourth quarter financial results are preliminary and
unaudited, and are subject to adjustment. Further information on the
Company's business, prior financial results and risk factors are
detailed in its filings with the SEC, including its including its Form
10-Q for the quarter ended June 30, 2006 filed on August 11, 2006. Undue
reliance should not be placed on these forward-looking statements, which
speak only as of the date they are made. The Company undertakes no
obligation to update publicly any forward-looking statements to reflect
new information, events or circumstances after the date they were made,
or to reflect the occurrence of unanticipated events.
HemoSense® and INRatio®
are registered trademarks of HemoSense, Inc.
HemoSense, Inc.
Statements of Operations
(Unaudited)
(In thousands, except per share data)
Three Months Ended
Year Ended
September 30,
September 30,
2006
2005
2006
2005
Revenue
$ 4,208
$ 2,897
$ 16,257
$ 8,768
Cost of goods sold
3,026
2,545
11,906
9,371
Gross profit (loss)
1,182
352
4,351
(603)
Operating expenses:
Research and development
815
453
2,728
1,259
Sales and marketing
1,945
1,856
7,899
6,733
General and administrative
815
641
3,996
1,962
Total operating expenses
3,575
2,950
14,623
9,954
Loss from operations
(2,393)
(2,598)
(10,272)
(10,557)
Interest income
130
112
580
130
Interest and other expense, net
(260)
(348)
(1,193)
(1,319)
Net loss
$ (2,523)
$ (2,834)
$ (10,885)
$ (11,746)
Net loss per share:
Basic and diluted
$(0.23)
$(0.30)
$(0.99)
$(4.26)
Shares used to compute loss per share:
Basic and diluted
11,205
9,594
11,030
2,758
HemoSense, Inc.
Balance Sheets
(In thousands)
September 30, 2006
September 30, 2005
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 1,789
$ 3,598
Short term investments
7,939
7,943
Accounts receivable
3,148
2,087
Prepaid expenses and other current assets
371
714
Inventories
2,731
2,744
Total current assets
15,978
17,086
Property and equipment, net
501
512
Technology licenses and prepaid royalties
245
1,179
Other assets
126
226
Total assets
$ 16,850
$ 19,003
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
$ 1,142
$ 1,029
Accrued expenses and other liabilities
1,751
1,159
Capital lease, current portion
37
37
Borrowings, current portion
2,353
2,000
Total current liabilities
5,283
4,225
Capital lease, net of current portion
16
52
Borrowings, net of current portion
2,476
4,714
Other liabilities
398
—
Total liabilities
8,173
8,991
Shareholders' equity:
Common stock
11
10
Additional paid-in capital
66,739
57,191
Unrealized loss on investments
(2)
(3)
Accumulated deficit
(58,071)
(47,186)
Total shareholders’ equity
8,677
10,012
Total liabilities and shareholders’ equity
$ 16,850
$ 19,003
HemoSense, Inc. (AMEX:HEM) - a medical device company that
develops, manufactures and sells easy-to-use, handheld blood
coagulation monitoring systems for use by patients and healthcare
professionals in the management of warfarin medication - today
reported financial results for the three months and year ended
September 30, 2006.
-- Total revenue for the fiscal 2006 fourth quarter was $4.2
million, an increase of 45% from total revenue of $2.9 million
in the fiscal 2005 fourth quarter. Domestic revenue was $3.4
million and international revenue was $773,000, representing
increases of 58% and 8%, respectively, compared with the
fiscal 2005 fourth quarter. Total revenue included $813,000 in
revenue for INRatio(R) meters and accessories, a 35% decline
from the fiscal 2005 fourth quarter, and $3.4 million in
revenue for INRatio test strips, an increase of 105% from the
fiscal 2005 fourth quarter. Total revenue for the fourth
quarter of fiscal 2006 was negatively impacted by the timing
of significant orders, seasonality in Europe, and temporary
supplier issues, which caused some orders to be delayed, but
which have since been resolved.
-- HemoSense reported a gross profit of $1.2 million for the
quarter, or 28% of total revenue, up from a gross profit of
$352,000, or 12% of total revenue, for the fiscal 2005 fourth
quarter. The improvement from the prior year was due primarily
to higher unit sales and production volumes of test strips,
and to process efficiencies. Gross margin improved five
percentage points on a sequential quarter basis, reflecting a
modification of the meter placement promotional programs that
took place during the second and third quarters of fiscal
2006. These programs contributed to HemoSense achieving double
digit market share and being firmly established as the No. 2
player in the domestic point-of-care PT/INR market.
-- Operating expenses for the quarter were $3.6 million, up from
$3.0 million for the fiscal 2005 fourth quarter, and down from
$4.0 million in the fiscal 2006 third quarter.
-- The net loss for the fiscal 2006 fourth quarter decreased to
$2.5 million from $2.8 million for the fiscal 2005 fourth
quarter and $3.1 million in the fiscal 2006 third quarter. The
net loss per common share was $0.23 for the quarter on 11.2
million weighted-average shares outstanding, compared with
$0.30 for the fiscal 2005 fourth quarter on 9.6 million
weighted-average shares outstanding. Included in the net loss
and the net loss per share for the fourth quarter of fiscal
2006 is a charge of $98,000, or approximately $0.01,
respectively, related to stock-based compensation expense
pursuant to SFAS No. 123(R).
"Overall product demand remains strong and we are confident in our
ability to grow revenue and continue to gain market share in the
rapidly growing PT/INR market," said Jim Merselis, President and CEO
of HemoSense. "In fact, the market demand level to-date in the first
quarter of fiscal 2007, meaning shipments made so far in the quarter
and orders in-house for shipment later, is ahead of the revenue for
the entire fourth quarter of fiscal 2006. We are also encouraged with
our progress and recent developments. In October, we signed an
agreement to supply our INRatio system to all CheckUps medical clinics
located in Wal-Mart stores. We also made two new additions to our
senior management team, including the appointment of Gordon Sangster
as CFO, and Bill Dippel as EVP of Operations and Research &
Development.
"Additionally, the FDA has required the manufacturer of Coumadin
to add a label alerting patients to the potential health risks
associated with warfarin when dosage levels are not properly managed,"
Mr. Merselis added. "This new labeling further highlights the
importance of frequent PT/INR testing to manage dosage levels to
ensure warfarin patients' blood coagulation levels are maintained
within their therapeutic range. We continue to work with our
manufacturers and distributors to offer warfarin patients convenient
and accurate PT/INR testing through our easy-to-use INRatio system."
HemoSense reported cash, cash equivalents and short-term
investments of $9.7 million as of September 30, 2006.
Year-to-Date Financial Results
For the fiscal year ended September 30, 2006, total revenue was
$16.3 million, an increase of 85% from $8.8 million in fiscal 2005.
Fiscal 2006 domestic revenue was $13.3 million, an increase of 105%
over fiscal 2005, and international revenue was $3.0 million, an
increase of 30% over the prior fiscal year. Total revenue for fiscal
2006 included $4.7 million in meters and accessories revenue and $11.6
million in test strip revenue, up 23% and 134%, respectively, from
fiscal 2005.
Gross profit for fiscal 2006 was $4.4 million, up from a gross
loss of $603,000 in fiscal 2005. Operating expenses were $14.6
million, an increase of 47% compared with operating expenses of $10.0
million in fiscal 2005. The net loss was $10.9 million, compared with
$11.7 million for fiscal 2005.
Fiscal Year 2007 Financial Guidance
HemoSense today introduced financial guidance for its fiscal year
ending September 30, 2007. The Company anticipates fiscal 2007 total
revenue to be in the range of $23.0 million to $25.0 million,
representing growth of 41% to 54%. HemoSense also expects the fiscal
2007 net loss to be in the range of $5.6 million to $6.6 million,
which includes $420,000 in stock-based compensation expense. The net
loss per common share is expected to be $0.50 to $0.59 based on
approximately 11.2 million average common shares outstanding.
Conference Call Information
Management will host an investment community conference call
beginning today at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to
discuss this announcement and to answer questions.
Individuals interested in listening to the conference call may do
so by dialing (877) 815-7177 for domestic callers, or (706) 634-1178
for international callers. A telephone replay will be available for 48
hours following the conclusion of the call by dialing (800) 642-1687
for domestic callers, or (706) 645-9291 for international callers, and
entering reservation code 9167445.
The live conference call will also be available via the Internet
on the Investor Relations section of the Company's Web site at
www.hemosense.com. A recording of the call will be available on the
Company's Web site for 30 days following the completion of the call.
About HemoSense
HemoSense develops, manufactures and markets easy-to-use, handheld
blood coagulation systems for monitoring patients taking warfarin. The
HemoSense INRatio(R) system, used by healthcare professionals and
patients themselves, consists of a small monitor and disposable test
strips. It provides accurate and convenient measurement of blood
clotting time, or PT/INR values. Routine measurements of PT/INR are
necessary for the safe and effective management of the patient's
warfarin dosing. INRatio is sold in the United States and
internationally. For more information, visit www.hemosense.com.
This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Statements in this press release regarding the Company's business that
are not historical facts may be "forward-looking statements" that
involve risks and uncertainties. Specifically, forward-looking
statements include those relating to executing the Company's business
strategy to increase market penetration and improve revenue, and
financial guidance for fiscal 2007, are forward looking statements
within the meaning of the Safe Harbor. Forward-looking statements are
based on management's current, preliminary, expectations and are
subject to risks and uncertainties which may cause the actual results
to differ materially from the statements contained herein. The
Company's fiscal 2006 fourth quarter financial results are preliminary
and unaudited, and are subject to adjustment. Further information on
the Company's business, prior financial results and risk factors are
detailed in its filings with the SEC, including its including its Form
10-Q for the quarter ended June 30, 2006 filed on August 11, 2006.
Undue reliance should not be placed on these forward-looking
statements, which speak only as of the date they are made. The Company
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events or circumstances after
the date they were made, or to reflect the occurrence of unanticipated
events.
HemoSense(R) and INRatio(R) are registered trademarks of
HemoSense, Inc.
-0-
*T
HemoSense, Inc.
Statements of Operations
(Unaudited)
(In thousands, except per share data)
Three Months Ended Year Ended
-------------------------------------
September 30, September 30,
-------------------------------------
2006 2005 2006 2005
-------------------------------------
Revenue $4,208 $2,897 $16,257 $8,768
Cost of goods sold 3,026 2,545 11,906 9,371
-------------------------------------
Gross profit (loss) 1,182 352 4,351 (603)
-------------------------------------
Operating expenses:
Research and development 815 453 2,728 1,259
Sales and marketing 1,945 1,856 7,899 6,733
General and administrative 815 641 3,996 1,962
-------------------------------------
Total operating expenses 3,575 2,950 14,623 9,954
-------------------------------------
Loss from operations (2,393) (2,598) (10,272) (10,557)
Interest income 130 112 580 130
Interest and other expense, net (260) (348) (1,193) (1,319)
-------------------------------------
Net loss $(2,523)$(2,834) $(10,885)$(11,746)
=====================================
Net loss per share:
Basic and diluted $(0.23) $(0.30) $(0.99) $(4.26)
=====================================
Shares used to compute loss per
share:
Basic and diluted 11,205 9,594 11,030 2,758
*T
-0-
*T
HemoSense, Inc.
Balance Sheets
(In thousands)
September 30, 2006 September 30, 2005
------------------ ------------------
(unaudited)
Assets
Current assets:
Cash and cash equivalents $1,789 $3,598
Short term investments 7,939 7,943
Accounts receivable 3,148 2,087
Prepaid expenses and other
current assets 371 714
Inventories 2,731 2,744
------------------ ------------------
Total current assets 15,978 17,086
Property and equipment, net 501 512
Technology licenses and prepaid
royalties 245 1,179
Other assets 126 226
------------------ ------------------
Total assets $16,850 $19,003
================== ==================
Liabilities and Shareholders'
Equity
Current liabilities:
Accounts payable $1,142 $1,029
Accrued expenses and other
liabilities 1,751 1,159
Capital lease, current portion 37 37
Borrowings, current portion 2,353 2,000
------------------ ------------------
Total current liabilities 5,283 4,225
Capital lease, net of current
portion 16 52
Borrowings, net of current
portion 2,476 4,714
Other liabilities 398 --
------------------ ------------------
Total liabilities 8,173 8,991
------------------ ------------------
Shareholders' equity:
Common stock 11 10
Additional paid-in capital 66,739 57,191
Unrealized loss on investments (2) (3)
Accumulated deficit (58,071) (47,186)
------------------ ------------------
Total shareholders' equity 8,677 10,012
------------------ ------------------
Total liabilities and
shareholders' equity $16,850 $19,003
================== ==================
*T