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 first quarter ended March
31, 2008.
Recent Business Highlights
-- System Sales: The company recognized revenue on eight Sensei? Robotic
Catheter Systems sold during the first quarter, which brings the total
worldwide system placements to 23, including 14 in the United States and
nine in Europe.
-- Catheter Sales: 401 Artisan? Control Catheters were shipped in the
first quarter, which exceeds the number of catheters shipped during all of
2007.
-- Collaboration with St. Jude Medical: The company's CoHesion? 3D
Visualization Module -- a module integrating the 3D movement of the Sensei
system with the 3D visualization of the Ensite? system from St. Jude
Medical -- has been configured in six systems in Europe. Clearance for the
integrated system by the U.S. Food & Drug Administration (FDA) is expected
by mid-2008.
-- Enhanced Manufacturing Capabilities: Previous and ongoing investments
made to improve the company's manufacturing capabilities are proving to be
effective as the manufacturing capacity of the Sensei system increased to
an average of three systems per month during the first quarter, and
manufacturing yields of the Artisan control catheter were approximately 90%
at the end of the period.
-- Secondary Financing: In April 2008, the company completed a successful
secondary public offering of common stock, selling three million shares
with net proceeds to the company of approximately $39.4 million.
"I am pleased to report that since commercialization, we have
achieved four consecutive quarters of increases in the number of
systems placed," said Frederic Moll, M.D., co-founder and chief
executive officer of Hansen Medical. "In this past quarter, we
recorded revenue on eight Sensei Robotic Catheter Systems, bringing
the number of units we have recognized revenue on -- which we refer
to as our installed base -- to 23 systems in our first 10 months of
commercialization. First quarter shipments represent more than a
50% increase in our installed base, which now includes 14 systems
in the United States and nine in Europe. Additionally, the 401
catheters sold in the first quarter exceeded the number shipped
during all of 2007 and is nearly double the prior quarter's
catheter shipments.
"As the demand for our platform continues to grow, the
investments we have made to increase manufacturing capacity and
improve catheter yields will allow us to meet customer expectations
and expand our worldwide market presence more efficiently,"
concluded Dr. Moll.
2008 First Quarter Financial Results
Total revenue for the three months ended March 31, 2008 was $6.2
million. During the quarter, the company recorded revenue on the
sale of eight Sensei systems (including five in the United States
and three Sensei systems in Europe), shipments of 401 Artisan
control catheters and one CoHesion module. No revenues were
recorded in the same period in 2007.
Cost of goods sold for the three months ended March 31, 2008 was
$4.9 million and included non-cash stock compensation expense of
$161,000. Gross profit for the quarter was $1.3 million yielding in
a gross margin of 21%. There were no costs of goods sold, gross
profit or gross margin recorded in the same period in 2007. The
company expects that cost of goods sold, both as a percentage of
revenue and on a dollar basis for the remainder of 2008, will
continue to fluctuate from quarter to quarter as revenue grows,
manufacturing levels change, scale up of both in-house and contract
manufacturing processes to full commercial levels is achieved, and
as the company transitions into a new manufacturing facility.
Research and development expenses for the three months ended
March 31, 2008, including non-cash stock compensation expense of
$570,000, were $5.2 million, compared to $5.1 million for the same
period in 2007, which included non-cash stock compensation expense
of $720,000. 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 March 31, 2007 included
development-stage manufacturing expenses of $1.0 million. The
remaining change in research and development expenses was due
primarily to increased compensation expenses related to higher
headcount necessary for the development of our Sensei system and
the disposable Artisan catheters for the EP market, percutaneous
valve replacement application and other future applications.
Selling, general and administrative expenses for the three
months ended March 31, 2008, including non-cash stock compensation
expense of $1.3 million, were $8.1 million, compared to $4.5
million for the same period in 2007, which included non-cash stock
compensation expense of $1.1 million. The increase in selling,
general and administrative expenses was due primarily to increased
compensation expenses related to higher headcount necessary to
support continued growth, legal costs for the development of the
company's intellectual property portfolio and other IP and
litigation-related legal costs, lease costs for the new facility
and increased non-cash stock compensation expenses. The company
expects selling, general and administrative expenses to increase
during the remainder of this year due to the continued growth of
its sales and clinical support groups and the expansion of its
intellectual property portfolio.
Other income, net, for the three months ended March 31, 2008 was
$352,000, compared to $982,000 for the same period in 2007. The
decrease was primarily due to lower interest income related to
lower average cash, cash equivalents and short-term investments as
a result of cash used in operations and the acquisition of
AorTx.
Net loss for the three months ended March 31, 2008, including
non-cash stock compensation expense of $2.0 million, was $11.6
million, or $(0.53) per basic and diluted share, based on an
average basic and diluted shares outstanding of 21.8 million. This
compares to a net loss of $8.6 million, or $(0.40) per basic and
diluted share, based on an average basic and diluted shares
outstanding of 21.4 million, for the same period in 2007, which
included non-cash stock compensation expense of $1.8 million.
Cash, cash equivalents and short-term investments as of March
31, 2008 were $32.8 million, compared to $48.6 million as of
December 31, 2007. The decrease is due mainly to the company's
normal operating expenses and $2.3 million in capital expenditures
primarily related to the build out of the new facility. Subsequent
to the end of the first quarter, in April 2008, the company
successfully completed a secondary public offering of common stock,
selling three million shares with net proceeds to the company of
approximately $39.4 million.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2008 first quarter results and provide a business update today, May
1, 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 800-218-0204 or 303-275-2170. An audio replay will
be available approximately one hour after the completion of the
conference call through May 9, 2008, by calling 800-405-2236 or
303-590-3000, and entering passcode 11112640.
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 Annual Report on Form 10-K filed with the
SEC on February 28, 2008. 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.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three Months Ended
March 31,
--------------------
2008 2007
--------- ---------
Revenues $ 6,244 $ -
Cost of goods sold 4,937 -
--------- ---------
Gross profit 1,307 -
Operating expenses
Research and development 5,214 5,072
Selling, general and administrative 8,077 4,526
--------- ---------
Total operating expenses 13,291 9,598
Loss from operations (11,984) (9,598)
Other income, net 352 982
--------- ---------
Net loss $ (11,632) $ (8,616)
========= =========
Basic and diluted net loss per share $ (0.53) $ (0.40)
========= =========
Shares used to compute basic and diluted net loss per
share 21,806 21,443
========= =========
Condensed Consolidated Balance Sheets (unaudited)
(in thousands)
March 31, December
2008 31, 2007
--------- ---------
Assets
Cash, cash equivalents and short-term investments $ 32,849 $ 48,552
Accounts receivable 6,780 4,003
Inventories, net 3,501 2,982
Prepaids and other current assets 1,773 1,397
Property and equipment, net 6,583 2,672
Other assets 904 295
--------- ---------
Total assets $ 52,390 $ 59,901
--------- ---------
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 2,149 $ 2,956
Deferred revenues 343 368
Debt 2,802 3,309
Other liabilities 6,915 4,204
--------- ---------
Total liabilities 12,209 10,837
--------- ---------
Stockholders' equity 40,181 49,064
--------- ---------
Total Liabilities and Stockholders' Equity $ 52,390 $ 59,901
========= =========
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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