Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in flexible
robotics and the developer of robotic technology for accurate 3D
control of catheter movement, today reported its business
highlights and financial results for the fourth quarter and
full-year ended December 31, 2008.
Recent Business Highlights
-- System Sales: During the fourth quarter, the company recognized
revenue on 10 Sensei Robotic Systems and shipped one additional system for
which revenue is expected to be recognized in the first quarter of 2009.
For the full year of 2008, the company recognized revenue on 40 systems.
Through December 31, 2008, the company has recognized revenue on a total of
55 systems (which the company refers to as its installed base), including
36 in the United States and 19 in Europe.
-- Catheter Sales: The company shipped and recognized revenue on 520
ArtisanTM Control Catheters in the fourth quarter, a record for a single
quarter.
-- Revenue Growth: The company generated fourth quarter revenues of $7.3
million, a 74% year-over-year increase. Full-year 2008 revenues are $30.2
million.
-- CoHesion Adoption: Of the 10 systems sold in the fourth quarter,
seven were configured with CoHesion modules, and two additional CoHesion
modules were sold to the existing installed base.
-- Philips Partnership: The company recently announced joint development
and cooperation agreements with Royal Philips Electronics to co-develop
integrated products for the electrophysiology (EP) market targeting
applications to enhance visualization capabilities.
"I am pleased with our progress and accomplishments during this
past year," said Frederic Moll, M.D., co-founder and chief
executive officer of Hansen Medical. "Adoption rates for our
technology have been strong, with an installed base of 55 systems
worldwide since we began commercial shipments in May 2007. In
addition, we made important investments in our business and
established partnerships that we believe put us in a position to
significantly expand our technology in the years ahead. We are also
encouraged by the progress we are making in markets outside EP and
believe that this success provides evidence of the opportunity to
leverage the Sensei platform into a variety of other interventional
applications," concluded Dr. Moll.
2008 Fourth Quarter Financial Results
Total revenue for the three months ended December 31, 2008 was
$7.3 million, a 74% increase compared to revenue of $4.2 million in
the same period in 2007. The company recognized revenue on 10
Sensei Robotic Systems, including seven systems configured with the
CoHesionTM module, as well as on shipments of 520 Artisan control
catheters.
Cost of goods sold for the three months ended December 31, 2008
was $5.2 million and included non-cash stock compensation expense
of $210,000. Gross profit for the quarter was $2.1 million,
yielding a gross margin of 28.7%. This compares to gross profit of
negative $23,000 and negative gross margin of 0.5% for the same
period in 2007, which included non-cash stock compensation expense
of $139,000. The company expects that cost of goods sold for 2009,
both as a percentage of revenue and on a dollar basis, will
continue to vary from quarter to quarter as manufacturing levels
fluctuate and as revenues fluctuate due to changes in system sales
volumes, product mix and average sales prices per system.
Research and development expenses for the three months ended
December 31, 2008, including non-cash stock compensation expense of
$741,000, were $6.8 million, compared to $5.1 million for the same
period in 2007, which included non-cash stock compensation expense
of $494,000. The increase in research and development expenses was
primarily due to increased employee-related expenses due primarily
to higher average headcount, increased outside services, materials
and overhead expenses, along with higher non-cash stock
compensation expenses. In 2009, the company expects research and
development expenses to decline modestly from levels in 2008 as it
carefully manages expenses related to development efforts for the
EP market and other applications and realizes savings from the
company's recently completed reduction in force.
Selling, general and administrative expenses for the three
months ended December 31, 2008, including non-cash stock
compensation expense of $2.7 million, were $10.1 million, compared
to $7.9 million for the same period in 2007, which included
non-cash stock compensation expense of $1.4 million. The increase
in selling, general and administrative expenses was primarily due
to increased employee-related expenses related to higher average
headcount necessary to support continued growth, legal costs
related to procuring and protecting the company's intellectual
property, separation costs for two executives and increased
non-cash stock compensation expenses. In 2009, the company expects
selling, general and administrative expenses to decline slightly
from 2008 levels as a result of careful expense management and
savings realized from the recently completed reduction in
force.
Other loss, net, for the three months ended December 31, 2008
was $102,000, compared to other income, net, of $545,000 for the
same period in 2007. The change was primarily due to higher
interest expense due to the company's borrowings under its new
equipment line of credit, in addition to lower interest income
related to lower balances of average cash, cash equivalents and
short-term investments.
Net loss for the three months ended December 31, 2008, including
total non-cash stock compensation expense of $3.6 million, was
$14.9 million, or $(0.59) per basic and diluted share, based on
average basic and diluted shares outstanding of 25.2 million
shares. Net loss for the fourth quarter of 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 average basic and
diluted shares outstanding of 21.7 million shares.
Cash, cash equivalents and short-term investments as of December
31, 2008 were $35.2 million, compared to $48.6 million as of
December 31, 2007. The lower cash balance is due to the company's
operating expenses and $18.4 million in capital expenditures during
2008, primarily related to the build-out of the company's new
facility, partially offset by capital raised from financing
activities during the year.
2008 Full-Year Financial Results
Total revenue for the year ended December 31, 2008 was $30.2
million, compared to $10.1 million for the same period last year.
The company's net loss for 2008, including non-cash stock
compensation expense of $11.2 million, was $53.4 million, or
$(2.21) per basic and diluted share, based on an average basic and
diluted shares outstanding of 24.2 million. This compares to a net
loss of $50.4 million, or $(2.33) per basic and diluted share,
based on an average basic and diluted shares outstanding of 21.6
million, for 2007, which included non-cash stock compensation
expense of $8.0 million.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2008 fourth quarter and full year results and provide a business
update today, February 12, 2009 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. 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 800-754-1053 or
303-262-2053. An audio replay will be available approximately one
hour after the completion of the conference call through February
19, 2009, by calling 800-405-2236 or 303-590-3000, and entering
passcode 11125891.
About Hansen Medical, Inc.
Hansen Medical Inc., based in Mountain View, Calif., develops
products and technology using robotics for the accurate
positioning, manipulation and control of catheters and
catheter-based technologies. Its first product, the Sensei(TM)
Robotic Catheter system, is a robotic navigation system that
enables clinicians to place mapping catheters in hard-to-reach
anatomical locations within the heart easily, accurately and with
stability during complex cardiac arrhythmia procedures. The Sensei
system is compatible with fluoroscopy, ultrasound, 3D surface map
and patient electrocardiogram data and was cleared by the U.S. Food
and Drug Administration (FDA) in May 2007 for manipulation and
control of certain mapping catheters in Electrophysiology (EP)
procedures. The safety and effectiveness of the Sensei system for
use with cardiac ablation catheters in the treatment of cardiac
arrhythmias, including atrial fibrillation (AF), have not been
established. In the European Union, the Sensei system is cleared
for use during EP procedures, such as guiding catheters in the
treatment of AF. 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 company's anticipated operational and financial results and
expectations regarding new applications for the company's products
and technology. 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; 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 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; the
effect of credit, financial and general economic conditions on
potential purchasers of our systems; 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
Quarterly Report on Form 10-Q filed with the SEC on November 5,
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.
"Sensei," "Artisan," and "CoHesion" are trademarks of Hansen
Medical, Inc., and "Hansen Medical," "Hansen Medical and Heart
Logo," and "Hansen Medical Heart Logo" are registered trademarks of
Hansen Medical, Inc. in the United States and other countries.
--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,
-------------------- --------------------
2008 2007 2008 2007
--------- --------- --------- ---------
Revenues $ 7,312 $ 4,196 $ 30,233 $ 10,085
Cost of goods sold 5,213 4,219 21,528 9,138
--------- --------- --------- ---------
Gross profit (loss) 2,099 (23) 8,705 947
--------- --------- --------- ---------
Operating expenses:
Research and development 6,819 5,134 25,582 19,020
Selling, general and
administrative 10,097 7,938 37,112 24,179
Acquired in-process research
and development -- 11,350 -- 11,350
--------- --------- --------- ---------
Total operating expenses 16,916 24,422 62,694 54,549
--------- --------- --------- ---------
Loss from operations (14,817) (24,445) (53,989) (53,602)
Other income and expense, net (102) 545 545 3,181
--------- --------- --------- ---------
Net loss $ (14,919) $ (23,900) $ (53,444) $ (50,421)
========= ========= ========= =========
Basic and diluted net loss per
share $ (0.59) $ (1.10) $ (2.21) $ (2.33)
========= ========= ========= =========
Shares used to compute basic
and diluted net loss per share 25,196 21,708 24,232 21,603
========= ========= ========= =========
Condensed Consolidated Balance Sheets (unaudited)
(in thousands)
December 31, December 31,
2008 2007
------------- -------------
Assets
Cash, cash equivalents and short-term
investments $ 35,223 $ 48,552
Accounts receivable 9,506 4,003
Inventories, net 6,674 2,982
Prepaids and other current assets 2,136 1,397
Property and equipment, net 18,195 2,672
Other assets 284 295
------------- -------------
Total assets $ 72,018 $ 59,901
============= =============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 3,081 $ 2,956
Deferred revenues 1,575 368
Debt 12,476 3,309
Other liabilities 7,181 4,204
------------- -------------
Total liabilities 24,313 10,837
------------- -------------
Stockholders' equity 47,705 49,064
------------- -------------
Total Liabilities and Stockholders' Equity $ 72,018 $ 59,901
============= =============
Investor Contact: Steven Van Dick 650.404.5800 Email Contact
News Media Contact: Amy Cook 925.552.7893 Email Contact Lasse
Glassen Financial Relations Board 213.486.6546 Email Contact
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