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 second quarter
ended June 30, 2010.
Recent Business Highlights
- System Sales: The company recognized revenue on seven Sensei®
Robotic Catheter Systems and shipped three systems during the
second quarter. Second quarter revenue consisted of one system that
was shipped in the quarter and six systems from deferred revenue
that had been shipped in prior quarters. From commercial launch in
2007 through June 30, 2010, the company has shipped a cumulative
total of 91 Sensei systems worldwide and recognized revenue on a
total of 77 systems.
- Catheter Sales: The company recognized revenue on 555 Artisan™
Control Catheters shipped during the second quarter.
- Procedures: Electrophysiology procedures performed with Hansen
Sensei systems increased over 50% in the first half of 2010 as
compared to such procedures performed in the first half of
2009.
- Vascular Platform: The company announced the successful
completion of a pre-clinical in-vivo study evaluating its new
vascular robot, which demonstrated improvements in catheter
navigation, reduction in vessel trauma during catheter
manipulation, and improvements in access time for some vessels, as
compared to manual catheter manipulation during endovascular
procedures. Results also showed that the company's vascular robot
has the potential to standardize catheter navigation, which may
lead to more predictable procedures. The early, but encouraging
results were presented June 12, 2010 at the Society of Vascular
Surgery's 2010 Vascular Annual Meeting in Boston.
- Electrophysiology: The company announced a joint development
and cooperation agreement with Siemens Healthcare to co-develop
integrated products designed to help simplify complex cardiac
procedures for the diagnosis and treatment of cardiac arrhythmias,
or irregular heartbeats. The agreements will enable the creation of
integrated product solutions by combining Siemens' Artis zee®
family of angiography systems and the syngo® DynaCT Cardiac
(angiographic computed tomography) with Hansen Medical's Sensei® X
Robotic Catheter System. The integrated products are being designed
to enable electrophysiologists to perform complex cardiac
procedures with greater confidence and improved efficiency.
- Clinical Trial Update: During the second quarter, enrollment
began in the company's conditional IDE clinical trial evaluating
use of the Sensei® Robotic Catheter System and the Artisan™ Control
Catheter in patients with Atrial Fibrillation (AF).
- On June 9, 2010 veteran medical device industry executive Bruce
J Barclay joined the company as president and chief executive
officer, and a member of the Board of Directors. In addition,
Frederic H. Moll, M.D. became executive chairman of the Board and
Russell C. Hirsch, M.D., Ph.D., transitioned from his former role
as chairman of the Board to lead outside director.
"The company is making important progress on several fronts that
include key initiatives in growing our EP business, developing and
commercializing our vascular platform and improving our operating
efficiency," said Bruce Barclay, president and chief executive
officer of Hansen Medical. "During the second quarter, we commenced
a previously announced conditional IDE clinical trial using our
Sensei Robotic Catheter System for the treatment of patients with
AF and results from a recently completed pre-clinical in-vivo study
evaluating our new vascular robot validate the important progress
of our vascular platform in addressing significant new markets for
the company. Finally, while the company successfully raised $29.8
million of capital early in the second quarter, we are continuing
to take a hard look at operating expenses while maintaining our
focus on our strategic key initiatives."
2010 Second Quarter Financial Results
Total revenue for the three months ended June 30, 2010 was $7.0
million compared to revenue of $2.9 million in the same period in
2009. During the second quarter, the company recognized revenue on
seven Sensei Robotic Systems as well as on shipments of 555 Artisan
control catheters. During the quarter the company shipped a total
of three systems; one of which was recognized as revenue and two of
which will be recognized as revenue as they are installed and
physicians are trained, which the company expects will occur during
2010. In addition, six systems from deferred revenue that had been
shipped in prior quarters were recognized as revenue in the second
quarter of 2010. As of June 30, 2010 the company had a total
deferred revenue balance of $10.3 million. The company has shipped
14 Sensei systems that have not been recognized as revenue.
Cost of goods sold for the three months ended June 30, 2010 was
$4.5 million and included non-cash stock compensation expense of
$156,000. As a result, gross profit for the quarter was $2.5
million and gross margin was 35.7%. This compares to gross profit
of $0.3 million and gross margin of 9.7% for the same period in
2009, which included non-cash stock compensation expense of
$214,000. 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 fluctuate 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 per system and per catheter.
Research and development expenses for the three months ended
June 30, 2010, including non-cash stock compensation expense of
$372,000, were $6.1 million, compared to $5.0 million for the same
period in 2009, which included non-cash stock compensation expense
of $688,000. The increase in research and development expenses was
primarily the result of development of the company's vascular
system platform. During the remainder of 2010, the company expects
research and development expenses to increase from 2009 levels
principally due to the on-going vascular system platform
development, the atrial fibrillation clinical trial sponsored by
the company and engineering activities to support the fiber optic
shape sensing and localization technology under our Luna
Innovations development agreement.
Selling, general and administrative expenses for the three
months ended June 30, 2010, including non-cash stock compensation
expense of $504,000, were $7.2 million, compared to $9.9 million
for the same period in 2009, which included non-cash stock
compensation expense of $1.0 million. The decrease in selling,
general and administrative expenses was primarily due to decreased
employee-related expenses, related primarily to lower average
headcount and a decrease in non-cash stock compensation expense.
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 restatement-related
expenses.
Other expense, net, for the three months ended June 30, 2010 was
$131,000, compared to other expense, net, of $115,000 for the same
period in 2009.
Net loss for the three months ended June 30, 2010, including
total non-cash stock compensation expense of $1.0 million, was
$10.9 million, or $(0.22) per basic and diluted share, based on
average basic and diluted shares outstanding of 50.1 million
shares. Net loss for the second quarter of 2009, including non-cash
stock compensation expense of $1.9 million, was $14.7 million, or
$(0.42) per basic and diluted share, based on average basic and
diluted shares outstanding of 35.2 million shares.
Cash, cash equivalents and short-term investments as of June 30,
2010 were $44.2 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.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2010 second quarter results today, August 4, 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 888-549-7750 or 480-629-9867. An audio replay will be
available approximately one hour after the completion of the
conference call through August 11, 2010, by calling 800-406-7325 or
303-590-3030, and entering access code 4333050.
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 robotic navigation
system 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. Hansen Medical's Sensei® system and its Sensei X
Robotic Catheter System are compatible with fluoroscopy,
ultrasound, 3D surface map and patient electrocardiogram data. The
remote navigation platform was cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in Electrophysiology (EP) procedures. 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," "enable"
and similar words. Hansen 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. Actual results
may differ materially from those projected in such statements due
to various factors, including but not limited to: the effect of
credit, financial and general economic conditions on capital
spending by our potential customers; risks and uncertainties
inherent in our business, including potential safety and regulatory
issues that could delay, slow or suspend our clinical trial or our
sale efforts, uncertain timelines, costs and results of clinical
trials and of developing new products, 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 plan
and manage cost-reduction or operational efficiency initiatives,
the scope and validity of intellectual property rights applicable
to our products and competition from other companies; additional
costs and resources necessary to address existing shareholder
litigation regarding the restatement of our financial statements;
potential claims and proceedings relating to our restatement, such
as additional shareholder litigation and any action by the SEC,
U.S. Attorney's Office or other governmental agency which could
result in civil or criminal sanctions against the company and/or
current or former officers, directors or employees; our ability to
remediate material weaknesses in internal controls over financial
reporting; and other risks more fully described in the "Risk
Factors" section contained in Hansen's periodic SEC filings,
including its Quarterly Report on Form 10-Q filed with the SEC on
May 10, 2010.
"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.
Artis zee and syngo are registered trademarks of Siemens AG.
Condensed Consolidated Statements of Operations
(unaudited) (in thousands, except per share data)
Three months ended Six months ended
June 30, June 30,
---------------------- -------------------
2010 2009 2010 2009
----------- --------- --------- --------
Revenues $ 6,950 $ 2,949 $ 9,661 $ 10,404
Cost of goods sold 4,472 2,664 8,042 8,045
----------- --------- --------- --------
Gross profit 2,478 285 1,619 2,359
----------- --------- --------- --------
Operating expenses:
Research and development 6,073 4,951 10,840 10,602
Selling, general and
administrative 7,189 9,904 14,920 20,015
Gain on settlement of
litigation -- -- (10,003) --
----------- --------- --------- --------
Total operating expenses 13,262 14,855 15,757 30,617
----------- --------- --------- --------
Loss from operations (10,784) (14,570) (14,138) (28,258)
Other income, net (131) (115) (623) (560)
----------- --------- --------- --------
Net loss $ (10,915) $ (14,685) $ (14,761) $(28,818)
=========== ========= ========= ========
Basic and diluted net loss per
share $ (0.22) $ (0.42) $ (0.34) $ (0.95)
=========== ========= ========= ========
Shares used to compute basic and
diluted net loss per share 50,136 35,187 43,873 30,293
=========== ========= ========= ========
Condensed Consolidated Balance Sheets
(unaudited) (in thousands)
December 31,
June 30, 2010 2009
--------------- ---------------
Assets
Cash, cash equivalents and short-term
investments $ 44,190 $ 28,279
Accounts receivable 4,438 6,888
Inventories, net 6,284 7,406
Deferred cost of goods sold 2,625 2,535
Prepaids and other current assets 1,945 1,929
Property and equipment, net 11,787 13,460
Note receivable 4,556 --
Other assets 400 244
--------------- ---------------
Total assets $ 76,225 $ 60,741
=============== ===============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 2,251 $ 2,068
Deferred revenues 10,273 9,463
Debt 8,021 9,803
Other liabilities 6,298 5,654
--------------- ---------------
Total liabilities 26,843 26,988
--------------- ---------------
Stockholders' equity 49,382 33,753
--------------- ---------------
Total Liabilities and Stockholders' Equity $ 76,225 $ 60,741
=============== ===============
Investor Contacts: Peter Osborne 650.404.5800
peter_osborne@hansenmedical.com News Media Contact: Amy
Cook 925.552.7893 Email Contact Lasse Glassen
Financial Relations Board 213.486.6546 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024
