Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible
medical robotics and the developer of robotic technology for
accurate 3D control of catheter movement, today reported its recent
business highlights and financial results for the third quarter
ended September 30, 2010.
Recent Business Highlights
-- Systems: The company shipped three Sensei(R) Robotic Catheter Systems
during the third quarter and recognized revenue on two systems. The
company has shipped a cumulative total of 94 Sensei systems worldwide.
-- Procedures: Sensei procedures during the quarter increased 42% to a
record 629 as compared to the third quarter of 2009 and 48% year to
date over the first nine months of 2009. Strong procedure trends are
expected to continue in Q4.
-- New Flexible Catheter Vascular Robotic System: The company announced
the successful completion of its first-in-man clinical study. Based on
this success, the company is expecting a Philips milestone payment in
Q1 of 2011 and anticipates commercialization in mid-2011.
-- New Products: The company announced the first sale of the Lynx(TM)
Irrigated Ablation Catheter in Europe and its first successful use
treating patients with atrial fibrillation (AF). The company also
launched enhancements to its Sensei X Robotic System with the
introduction of compatibility with St. Jude Medical's next generation
Ensite Velocity Cardiac Mapping System(TM) to improve clinical
efficiency and ease of use.
-- Clinical Trials: Unconditional IDE approval was received from the FDA
for the clinical trial evaluating use of the Sensei Robotic Catheter
System and the Artisan(TM) Control Catheter in patients with AF.
-- Operating Expenses: Operating expenses for the quarter decreased
$2.9 million from the second quarter of 2010 and $2.6 million from
Q3 2009.
"The entire organization has re-focused on commercial
execution," said Bruce Barclay, president and chief executive
officer of Hansen Medical. "There are a series of clinical and
operational achievements that will combine to create marketplace
traction and expansion over the coming 12 months, and we are ahead
of schedule on many of these elements. Especially significant is
the recent successful first-in-man experience with our vascular
robotic system -- an important step towards entering a market
approximately 10 times the size of our current opportunity."
Barclay added, "In addition, we are very encouraged by the record
number of EP procedures during the quarter demonstrating the
continued market acceptance, safety and clinical relevance of our
products."
2010 Third Quarter Financial Results
Total revenue for the third quarter ended September 30, 2010 was
$3.5 million compared to revenue of $4.6 million in the same period
in 2009. Procedures performed in the period grew to a record 629
worldwide. During the third quarter, the company recognized revenue
on two Sensei Robotic Systems as well as shipment of 581 catheters.
The company shipped a total of three systems during the quarter;
one of which was recognized as revenue and two of which will be
recognized as revenue as they are installed and physicians are
trained. In addition, one system from deferred revenue that had
been shipped in a prior quarter was recognized as revenue in the
third quarter of 2010. As of September 30, 2010, the company had a
total deferred revenue balance of $10.4 million. The company has
shipped 15 Sensei systems that have not been recognized as
revenue.
Cost of goods sold for this year's third quarter was $3.2
million and included non-cash stock compensation expense of
$201,000. As a result, gross profit for the quarter was $338,000
and gross margin was 9.7 percent. This compares to gross profit of
$1.3 million and gross margin of 28.4 percent for the same period
in 2009, which included non-cash stock compensation expense of
$180,000. Looking ahead for the remainder of 2010, the company
expects that cost of goods sold, both as a percentage of revenue
and on a dollar basis, will continue to vary from quarter to
quarter as manufacturing levels change and as revenues fluctuate
due to changes in system and catheter sales volumes, the timing of
revenue recognition on shipped systems, product mix and average
sales prices of systems and catheters.
Research and development expenses for the 2010 third quarter,
including non-cash stock compensation expense of $388,000, were
$4.2 million, compared to $4.9 million for the same period in 2009,
which included non-cash stock compensation expense of $592,000. The
decrease in research and development expenses was primarily the
result of an offset to the company's research and development costs
arising from the financial accounting for the company's receipt of
product development milestone payments under the company's joint
development agreement with Philips. During the remainder of 2010,
the company expects research and development expenses to be flat
compared to 2009 principally due to the on-going development and
commercialization activities of the vascular system platform, the
atrial fibrillation clinical trial sponsored by the company,
engineering activities to support the fiber optic shape sensing and
localization technology under the company's Luna Innovations
development agreement, offset by funded development costs from
Philips.
Selling, general and administrative expenses for the third
quarter of 2010, including non-cash stock compensation expense of
$679,000, were $6.2 million, compared to $8.2 million for the same
period in 2009, which included non-cash stock compensation expense
of $794,000. The decrease in selling, general and administrative
expenses was primarily due to decreased employee-related expenses
and a decrease in legal costs primarily associated with the Luna
litigation in 2009. During the remainder of 2010, the company
expects selling, general and administrative expenses to decline
from 2009 levels primarily as a result of a decrease in legal and
accounting expenses.
Other expense, net, for this year's third quarter was $2.1
million, compared to other expense, net, of $194,000 for the same
period in 2009. The increase was primarily due to a $1.9 million
write-down of the company's equity investment in Luna as the
impairment of its value was considered other than temporary.
Net loss for the 2010 third quarter, including total non-cash
stock compensation expense of $1.3 million, was $12.1 million, or
$0.23 loss per share, based on average shares outstanding of 53.8
million shares. Net loss for the third quarter of 2009, including
non-cash stock compensation expense of $1.6 million, was $11.9
million, or $0.32 loss per share, based on average shares
outstanding of 37.4 million shares.
Cash, cash equivalents and short-term investments as of
September 30, 2010 were $35.3 million, compared to $28.3 million as
of December 31, 2009. The higher cash, cash equivalents and
short-term investments balance is primarily due to the successful
completion of a secondary public offering of common stock in the
second quarter of 2010, which included the sale of approximately
16.1 million shares with net proceeds to the company, after
expenses, of approximately $29.8 million offset by $22.8 million
used to finance operations.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2010 third quarter results today, November 3, 2010, 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 877-941-2321 or 480-629-9714. An audio replay will be
available approximately one hour after the completion of the
conference call through November 10, 2010, by calling 877-870-5176
or 858-384-5517, and entering access code 4379093.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California,
develops products and technology using robotics for the accurate
positioning, manipulation and control of catheters and
catheter-based technologies. The company's Sensei® system and its
Sensei X Robotic Catheter System were cleared by the U.S. Food and
Drug Administration for manipulation and control of certain mapping
catheters in electrophysiology (EP) procedures. The flexible
robotic platform is compatible with fluoroscopy, ultrasound, 3D
surface map and patient electrocardiogram data. The safety and
effectiveness of the Sensei and Sensei X systems 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 and the Sensei X systems are 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 that
involve risks, uncertainties, assumptions and other factors which,
if they do not materialize or prove correct, could cause Hansen's
results to differ materially from those expressed or implied by
such forward-looking statements. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including statements containing the
words "plan," "expects," "believes," "goal," "estimate," and
similar words. Hansen Medical intends 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
timing of commercializing our vascular robotic system, expectations
regarding procedure and shipment trends, and the planned impact of
planned clinical and operating actions. Important factors that
could cause actual results to differ materially from those
indicated by forward-looking statements include, among others,
potential safety and regulatory issues that could delay, suspend or
terminate clinical studies, regulatory approvals or sales,
challenges in designing, engineering and manufacturing systems to
function as intended, uncertain timelines, costs and results of
clinical trials and development new products, our ability to plan
and manage cost-reduction or operational efficiency initiatives,
the scope and validity of intellectual property rights applicable
to products being developed, and our ability to remediate material
weaknesses in internal controls over financial reporting. 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 August 6, 2010.
Given these uncertainties, you should not place undue reliance on
the forward-looking statements in this press release. 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, Heart Design, Hansen Medical & Heart Design,
are registered trademarks, and Artisan and Lynx are trademarks of
Hansen Medical, Inc. in the United States and other countries.
EnSite Velocity is a trademark of St. Jude Medical.
HANSEN MEDICAL
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
Three months ended Nine months ended
September 30, September 30,
-------------------- --------------------
2010 2009 2010 2009
--------- --------- --------- ---------
Revenues $ 3,499 $ 4,565 $ 13,160 $ 14,969
Cost of goods sold 3,161 3,268 11,203 11,313
--------- --------- --------- ---------
Gross profit 338 1,297 1,957 3,656
--------- --------- --------- ---------
Operating expenses:
Research and development 4,176 4,879 15,016 15,481
Selling, general and
administrative 6,231 8,153 21,151 28,168
Gain on settlement of
litigation -- -- (10,003) --
--------- --------- --------- ---------
Total operating expenses 10,407 13,032 26,164 43,649
--------- --------- --------- ---------
Loss from operations (10,069) (11,735) (24,207) (39,993)
Other expense, net (2,073) (194) (2,696) (754)
--------- --------- --------- ---------
Net loss $ (12,142) $ (11,929) $ (26,903) $ (40,747)
========= ========= ========= =========
Basic and diluted net loss per
share $ (0.23) $ (0.32) $ (0.57) $ (1.25)
========= ========= ========= =========
Shares used to compute basic
and diluted net loss per share 53,784 37,418 47,213 32,693
========= ========= ========= =========
HANSEN MEDICAL
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
September 30, December 31,
2010 2009
------------- -------------
Assets
Cash, cash equivalents and short-term
investments $ 35,312 $ 28,279
Accounts receivable 4,429 6,888
Inventories, net 6,273 7,406
Deferred cost of goods sold 2,803 2,535
Prepaids and other current assets 1,725 1,929
Property and equipment, net 10,947 13,460
Note receivable 4,171 --
Other assets 363 244
------------- -------------
Total assets $ 66,023 $ 60,741
============= =============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 1,847 $ 2,068
Deferred revenues 10,414 9,463
Debt 7,130 9,803
Other liabilities 6,005 5,654
------------- -------------
Total liabilities 25,396 26,988
------------- -------------
Stockholders' equity 40,627 33,753
------------- -------------
Total Liabilities and Stockholders' Equity $ 66,023 $ 60,741
============= =============
Investor Contacts: Peter Osborne Interim CFO Hansen Medical
650.404.5800 Matt Clawson Allen & Caron Inc 949.474.4300 Email
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