MOUNTAIN VIEW, CA , a developer of new generation robotic
technology for accurate and stable control of catheter movement in
3D during cardiac procedures, today reported its business
highlights and financial results for the fourth quarter and
full-year ended December 31, 2007.
Recent Business Highlights
-- System Sales: Recognized revenue on six Sensei? Robotic Catheter
Systems sold during the fourth quarter, bringing total worldwide system
placements to fifteen, including nine in the United States and six in
Europe.
-- Clinical Case Count: Clinical cases performed during the fourth
quarter increased approximately 50% compared to cases performed during the
third quarter, bringing total case count, including pre-commercial
experience, to approximately 350 cases.
-- Engineering Milestones: The company's CoHesion? 3D Visualization
Module -- a module integrating the Sensei system with the Ensite? system
from St. Jude Medical -- has been installed on a limited release basis in
Europe; clearance for the integrated system is currently under review by
the U.S. Food & Drug Administration (FDA).
-- Investing to Execute a Full Commercial Release in 2008: The company
instituted internal and external measures to help meet future demand,
including investments in process improvements and capacity expansion and
agreements with contract manufacturers to assist in the production of the
Sensei system and Artisan control catheter. The company has also
significantly increased headcount in its sales, marketing, clinical and
service organizations.
"I am pleased with our performance in the fourth quarter and
throughout all of 2007," said Frederic Moll, M.D., founder and
chief executive officer of Hansen Medical. "Since receiving
regulatory approval for the Sensei system in May of 2007, I have
been encouraged by the demand for our technology. Clinical
experience with the Sensei system is ramping quickly and we are
looking forward to commencing studies to further validate the
efficacy of our platform. We believe the investments initiated
during this past year to expand our manufacturing capabilities will
enable us to transition to a full-scale commercial release and to
expand our market presence in 2008 and beyond," concluded Dr.
Moll.
2007 Fourth Quarter Financial Results
Total revenue for the three months ended December 31, 2007 was
$4.2 million. During the quarter, the company recorded revenue on
the sale of four Sensei systems in the United States and two Sensei
systems in Europe in addition to shipments of Artisan control
catheters.
Cost of goods sold for the three months ended December 31, 2007
was $4.2 million and included non-cash stock compensation expense
of $139,000. Gross profit for the quarter was nearly break-even.
During the fourth quarter of 2007 cost of goods sold was impacted
by higher direct labor costs, yield losses and costs to increase
capacity and improve yields. The company expects gross profit to
improve significantly during 2008 as revenue grows and the company
realizes improvements in operating efficiencies.
Research and development expenses for the three months ended
December 31, 2007, including non-cash stock compensation expense of
$494,000, were $5.1 million, compared to $4.4 million for the same
period in 2006, which included non-cash stock compensation expense
of $289,000. Prior to the second quarter of 2007, the company was
in the development stage and all manufacturing expenses, including
provisions for inventory valuation, were included in research and
development expenses. Beginning with commercialization in the
second quarter of 2007, the company's manufacturing expenses were
included in cost of goods sold. Research and development expenses
for the three months ended December 31, 2006 included
development-stage manufacturing expenses of $0.7 million and a
credit to adjust inventory valuation of $0.4 million. The remaining
change in research and development expenses was due primarily to
increased prototype and material expenses and increased
compensation expenses related to higher headcount necessary for the
development of our Sensei system, and the disposable Artisan
catheters for the EP market and other future applications in
addition to increased non-cash stock compensation expense.
Selling, general and administrative expenses for the three
months ended December 31, 2007, including non-cash stock
compensation expense of $1.4 million, were $7.9 million, compared
to $3.7 million for the same period in 2006, which included
non-cash stock compensation expense of $853,000. The increase in
selling, general and administrative expenses was due primarily to
investments made to execute the company's commercialization
strategy and included increased compensation expenses related to
higher headcount necessary to support our continued growth, legal
costs for the development of our intellectual property portfolio
and other IP and litigation-related legal costs, costs associated
with being a public company and increased non-cash stock
compensation expenses.
In-process research and development expenses for the three
months ended December 31, 2007 were $11.4 million. There were no
comparable expenses incurred during the same period in 2006. In
November 2007, the company completed its acquisition of AorTx,
Inc., an early stage company developing heart valves which may be
delivered minimally invasively through the skin and blood vessels.
The acquisition was accounted for as an acquisition of assets since
the operations of AorTx did not meet the definition of a business
as defined by the prevailing accounting standards. As such, the
assets acquired and liabilities assumed were recorded at their
estimated fair values during the fourth quarter. In addition, all
of the acquisition costs were allocated among the relative fair
values of the assets acquired and no goodwill was recorded as part
of the transaction. The transaction included the acquisition of
in-process research and development costs of $11.4 million, which
were expensed immediately.
Other income, net, for the three months ended December 31, 2007
was $545,000, compared to $410,000 for the same period in 2006. The
increase was primarily due to higher interest income related to
higher average cash, cash equivalents and short-term investments as
a result of the completion of the company's initial public offering
on November 15, 2006.
Net loss for the three months ended December 31, 2007, including
non-cash stock compensation expense of $2.0 million, was $23.9
million, or $(1.10) per basic and diluted share, based on an
average basic and diluted shares outstanding of 21.7 million. This
compares to a net loss of $7.7 million, or $(0.76) per basic and
diluted share, based on an average basic and diluted shares
outstanding of 10.2 million, for the same period in 2006, which
included non-cash stock compensation expense of $1.1 million.
Included in the net loss for the three months ended December 31,
2007 were expenses associated with the acquisition of AorTx
totaling $11.4 million, or $(0.52) per basic and diluted share.
Cash, cash equivalents and short-term investments as of December
31, 2007 were $48.6 million, compared to $89.9 million as of
December 31, 2006. The decrease is due mainly to the company's
normal operating expenses and $5.1 million related to the AorTx
acquisition.
2007 Full-Year Financial Results
Total revenue for the year ended December 31, 2007 was $10.1
million. The company's net loss for the year ended December 31,
2007, including non-cash stock compensation expense of $8.0
million, was $50.4 million, or $(2.33) per basic and diluted share,
based on an average basic and diluted shares outstanding of 21.6
million. This compares to a net loss of $26.0 million, or $(7.09)
per basic and diluted share, based on an average basic and diluted
shares outstanding of 3.7 million, for the same period last year,
which included non-cash stock compensation expense of $2.7 million.
Included in the net loss for the year ended December 31, 2007 were
expenses associated with the acquisition of AorTx totaling $11.4
million, or $(0.53) per basic and diluted share.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2007 fourth quarter and year-end results and provide a business
update today, February 19, 2008 at 2:00 p.m. Pacific (5:00 p.m.
Eastern). Investors are invited to listen to the call live via the
Internet using the link available within the "Investor Relations"
section of Hansen Medical's website at www.hansenmedical.com.
Please go to the Website at least 15 minutes early to register,
download and install any necessary audio software. A replay of the
webcast will be available approximately one hour after the
completion of the live call. Additionally, participants can dial
into the live conference call by calling 800-240-5318 or
303-262-2004. An audio replay will be available approximately one
hour after the completion of the conference call through February
26, 2008, by calling 800-405-2236 or 303-590-3000, and entering
passcode 11108667.
About Hansen Medical, Inc.
Hansen Medical, based in Mountain View, Calif., was founded in
2002 to develop products and technology using robotics for the
accurate positioning, manipulation and stable control of catheters
and catheter-based technologies. Additional information can be
found at www.hansenmedical.com.
Forward-Looking Statements
This press release contains forward-looking statements
regarding, among other things, statements relating to expectations,
goals, plans, objectives and future events. We intend such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Exchange Act and the Private Securities Litigation Reform
Act of 1995. Examples of such statements include statements about
the expected numbers, locations and timing of placements of the
company's Sensei' systems, our expected operational and financial
results, expectations regarding regulatory approvals, plans for
future clinical studies, plans for increasing manufacturing
capacity and efficiency, and plans for the timing of future
products. These statements are based on the current estimates and
assumptions of our management as of the date of this press release
and the conference call and are subject to risks, uncertainties,
changes in circumstances, assumptions and other factors that may
cause actual results to differ materially from those indicated by
forward-looking statements. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, among others, the risks and
uncertainties inherent in our business, including potential safety
and regulatory issues that could slow or suspend our sales; our
ability to effectively sell, service and support our products; our
ability to effectively train, manage and retain new employees; the
rate of adoption of our systems and the rate of use of our
catheters at customers that have purchased our systems; our ability
to successfully move and scale our manufacturing capabilities; our
reliance on third-party manufacturers and suppliers that could
adversely affect our ability to manufacture products on a timely
basis; the scope and validity of intellectual property rights
applicable to our products; competition from other companies; and
our ability to obtain additional financing to support our
operations . These and other risks are described in greater detail
under the heading "Risk Factors" contained in our periodic SEC
filings, including our Current Report on Form 8-K filed with the
SEC on January 23, 2008 and our Registration Statement on Form S-3
filed on February 11, 2008 in connection with the shares we issued
our recently completed acquisition of AorTx, Inc. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. We undertake no obligation to revise or
update information herein to reflect events or circumstances in the
future, even if new information becomes available.
"Hansen Medical," "Sensei," "Artisan," "Hansen Artisan," as well
as the Hansen Medical "heart design" are trademarks of Hansen
Medical, Inc.
EnSite is a trademark of St. Jude Medical.
Financial Tables to Follow
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three months ended Year ended
December 31, December 31,
-------------------- --------------------
2007 2006 2007 2006
--------- --------- --------- ---------
Revenues $ 4,196 $ - $ 10,085 $ -
Cost of goods sold 4,219 - 9,138 -
--------- --------- --------- ---------
Gross (loss) profit (23) - 947 -
--------- --------- --------- ---------
Operating expenses:
Research and development 5,134 4,441 19,020 16,561
General and administrative 7,938 3,677 24,179 10,122
In-process research and
development 11,350 - 11,350 -
--------- --------- --------- ---------
Total operating expenses 24,422 8,118 54,549 26,683
--------- --------- --------- ---------
Loss from operations (24,445) (8,118) (53,602) (26,683)
Interest and other expense 545 410 3,181 679
--------- --------- --------- ---------
Net loss $ (23,900) $ (7,708) $ (50,421) $ (26,004)
========= ========= ========= =========
Basic and diluted net loss per
share $ (1.10) $ (0.76) $ (2.33) $ (7.09)
========= ========= ========= =========
Shares used to compute basic
and diluted net loss per share 21,708 10,184 21,603 3,670
========= ========= ========= =========
Condensed Consolidated Balance Sheets (unaudited)
(in thousands)
December December
31, 2007 31, 2006
----------- -----------
Assets
Cash, cash equivalents and short-term investments $ 48,552 $ 89,900
Accounts receivable 4,003 -
Inventories, net 2,982 290
Prepaids and other current assets 1,397 754
Property and equipment, net 2,672 1,706
Other assets 295 140
----------- -----------
Total assets $ 59,901 $ 92,790
=========== ===========
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 2,956 $ 1,163
Deferred revenues 368 -
Debt 3,309 5,223
Other liabilities 4,204 1,632
----------- -----------
Total liabilities 10,837 8,018
----------- -----------
Total stockholders' equity 49,064 84,772
----------- -----------
Total liabilities and stockholders' equity $ 59,901 $ 92,790
=========== ===========
Investor Contact: Steven Van Dick 650.404.5800 Email Contact
Kathy Waller Financial Relations Board 312.640.6696 Email Contact
News Media Contact: Amy Cook 925.552.7893 Email Contact
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