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 business
highlights and financial results for the fourth quarter and full
year ended December 31, 2010.
Fourth Quarter Summary and Recent Business
Highlights
- New Agreements with Philips on Fiber Optic Shape Sensing and
Localization (FOSSL) technology: Upfront payment of $29 million
received February 3, 2011, and up to an additional $78 million in
future payments, for non-robotic rights
- Sensei® Robotic Catheter Systems: Shipped 3 systems (2 U.S. and
1 internationally); recognized revenue on 2 systems
- Growth in Catheter Sales: Record 666 catheters, up 15%
sequentially and 24% over fourth quarter 2009
- Growth in Procedures: Record 647 procedures, up 3% sequentially
and 34% over fourth quarter 2009
- New Product: Commercial launch of Lynx® Irrigated Ablation
Catheter in Europe
- U.S. Clinical Trial Approval: Unconditional IDE approval from
FDA for ARTISAN™ clinical trial
- Strengthened Leadership Team: Vice Presidents for US Commercial
Sales (announced January 25, 2011), Engineering, and Training and
Clinical Affairs
- Unveiled New Flexible Catheter Vascular Robotic System:
VEITHsymposium™ panel presentation
- New Facility in London: Opened new European headquarters and
clinical education center to accelerate adoption of Lynx Catheter
and support expected launch of flexible catheter vascular
system
- Reduced Operating Expenses and Use of Cash: Operating expenses
decreased $3.0 million vs. fourth quarter of 2009; Cash used in
operations decreased $5.0 million vs. fourth quarter of 2009
Full Year 2010 Summary
- Sensei Robotic Catheter Systems: Shipped 16 systems (U.S. 9,
International 7); recognized revenue on 12 systems (U.S. 7,
International 5). 16 systems in deferred revenue. Since commercial
launch in mid-2007, shipped 97 systems worldwide
- Growth in Catheter Sales: Record 2,439 catheters, up 9% year
over year
- Growth in Procedures: Record 2,474 procedures performed, up 50%
year over year and more procedures than all of 2007, 2008 and 2009
combined
- New Products: Lynx Irrigated Ablation Catheter in Europe and
integration with St. Jude Medical's next generation EnSite Velocity
Cardiac Mapping System™
- Growing Body of Published Clinical Data in Electrophysiology
(EP): Multiple clinical studies on-going, with nearly 5,000
arrhythmia procedures performed since first commercial launch
- New Flexible Catheter Vascular Robotic System: Successful
completion of first-in-man clinical study
- Reduced Operating Expenses and Use of Cash: Operating expenses
decreased $20.4 million vs. 2009; Cash used in operations decreased
$10.1 million vs. 2009
- Reduced Net Loss: $37.9 million in 2010 vs. $52.4 million in
2009, down 28%
"2010 was a transformational year for Hansen Medical, as we
delivered on the foundational elements that we believe are
necessary to reach commercial excellence in the coming year and
beyond," said Bruce Barclay, president and chief executive officer
of Hansen Medical. "In fulfillment of several commitments made
early in my tenure, we launched new products, including our new
Lynx irrigated ablation catheter, received unconditional approval
for an IDE study for Atrial Fibrillation (AF), completed a
first-in-man clinical study with our flexible catheter vascular
system, expanded our relationship with key business partners that
included deepening our relationship with Philips, expanded our
intellectual property portfolio, and appointed talented industry
executives to execute on our strategic initiatives. We are
beginning 2011 with positive momentum and a strengthened balance
sheet, excited about the approaching commercial launch of our
flexible catheter vascular system which we expect will accelerate
market adoption of flexible robotics and expand our customer base
over the coming 12 months."
2010 Fourth Quarter Financial Results
Total revenue for the fourth quarter ended December 31, 2010 was
$3.5 million compared to revenue of $7.2 million in the same period
in 2009. Procedures performed in the period with company products
grew to a record 647 worldwide. During the fourth quarter, the
company recognized revenue on two Sensei Robotic Systems as well as
shipment of 666 catheters. The company shipped a total of three
systems all of which will be recognized as revenue as they are
installed and physicians are trained. As of December 31, 2010, the
company had a total deferred revenue balance of $11.6 million that
includes shipment of 16 Sensei systems that have not been
recognized as revenue.
Cost of revenues for this year's fourth quarter was $3.5 million
and included non-cash stock compensation expense of $202,000. As a
result, gross profit for the quarter was $(59,000) and gross margin
was negative 1.7 percent. This compares to gross profit of $2.4
million and gross margin of 33.2 percent for the same period in
2009, which included non-cash stock compensation expense of
$170,000.
Research and development expenses for the fourth quarter 2010,
including non-cash stock compensation expense of $401,000, were
$3.2 million, compared to $4.3 million for the same period in 2009,
which included non-cash stock compensation expense of $503,000. 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
a product development milestone payment under the joint development
agreement with Philips.
Selling, general and administrative expenses for the fourth
quarter of 2010, including non-cash stock compensation expense of
$807,000, were $7.6 million, compared to $9.4 million for the same
period in 2009, which included non-cash stock compensation expense
of $577,000. 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.
Net loss for the fourth quarter 2010, including total non-cash
stock compensation expense of $1.4 million, was $11.0 million, or
$0.20 loss per share, based on average shares outstanding of 53.8
million shares. This compares favorably with a net loss for the
fourth quarter of 2009, including non-cash stock compensation
expense of $1.3 million, of $11.7 million, or $0.31 loss per share,
based on average shares outstanding of 37.5 million shares.
Cash, cash equivalents and short-term investments as of December
31, 2010 were $28.0 million, compared to $28.3 million as of
December 31, 2009. The flat cash balance is due primarily to the
net proceeds of approximately $29.8 million raised from the public
offering completed in April 2010 largely offset by the expenses of
the company's operations during 2010.
2010 Full-Year Financial Results
Total revenue for the year ended December 31, 2010 was $16.6
million, compared to $22.2 million for 2009. The company shipped 16
Sensei Robotic Catheter Systems, 2,439 catheters and recorded 2,474
Sensei procedures in 2010 compared to 26 Sensei Robotic Catheter
Systems, 2,243 catheters and 1,652 Sensei procedures in 2009. The
company's net loss for 2010, including non-cash stock compensation
expense of $5.0 million, was $37.9 million, or $0.78 loss per basic
and diluted share, based on an average basic and diluted shares
outstanding of 48.9 million. This compares favorably to a net loss
of $52.4 million, or $1.55 loss per basic and diluted share, based
on an average basic and diluted shares outstanding of 33.9 million,
for 2009, which included non-cash stock compensation expense of
$7.4 million.
Full Year 2011 Outlook
The company will continue to focus on its three strategic
initiatives in 2011: growing the electrophysiology (EP) business,
developing and launching the vascular platform, and achieving
operational excellence. The company has already delivered on one of
its previously communicated 2011 outlook items, namely the
execution of new agreements with Philips for the FOSSL technology.
While the company anticipates Sensei system shipments in 2011,
given the uncertainty of timing of those shipments, the company
will not currently be providing specific guidance. The company
expects continued good growth in catheter shipments and procedures
in 2011, continuing the positive trends shown in the prior year.
Overall operating expense levels are not expected to change
significantly in 2011 from the prior year. The company expects to
receive regulatory clearance in the U.S. and Europe for the
flexible catheter vascular robotic system and to offer the system
for commercial sale in the second half of 2011. Finally, the
current cash position, including anticipated cash flows from the
company's last milestone payment under its joint development
agreement with Philips, is expected to be sufficient to fund the
Company's operations through the launch of the next generation
flexible catheter vascular robotic technology in 2012.
"We are very encouraged about our EP procedural growth as it
testifies to the continued market adoption, safety and clinical
relevance of our Sensei system and the value that it delivers to
patients, physicians, hospitals and payors," said Barclay. "Our
2011 business plan is focused on achieving key strategic
initiatives, and establishing a unique and differentiated value
proposition for our vascular system that we believe represents a
ten-fold increase in market opportunity from our currently
addressable market and includes a new set of physician
customers."
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2010 fourth quarter and year-end results today, February 23, 2011,
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 877-941-2322 or 480-629-9715. An audio replay will be
available approximately one hour after the completion of the
conference call through March 2, 2011, by calling 877-870-5176 or
858-384-5517, and entering access code 4409948.
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 EP procedures. This robotic catheter system is
compatible with fluoroscopy, ultrasound, 3D surface map and patient
electrocardiogram data. In the United States, the Sensei System is
not approved for use in guiding ablation procedures; this use
remains experimental. The U.S. product labeling therefore provides
that 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 during EP procedures, such as guiding catheters in
the treatment of AF. 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 and the Lynx® robotic
catheter is cleared for the treatment of AF. The flexible catheter
vascular robotic system requires regulatory filings and approval
and is not commercially available. 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
expectations for commercializing our vascular robotic system and
the FOSSL technology, expectations regarding procedure and shipment
trends, expectations around operating expense levels and the
sufficiency of cash to support the launch of a second generation
flexible catheter robotic system. Important factors that could
cause actual results to differ materially from those indicated by
forward-looking statements include, among others, that the
development of new products and applications of technology are
subject to design, engineering and manufacturing challenges that
could delay clinical studies, regulatory filings and
commercialization, potential safety and regulatory issues that
could delay, suspend or terminate clinical studies, regulatory
approvals or sales, 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 November 9,
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,
Sensei, and Lynx are registered trademarks, and Artisan is a
trademark of Hansen Medical, Inc. in the United States and other
countries.
EnSite Velocity is a trademark of St. Jude Medical.
TABLES FOLLOW
HANSEN MEDICAL
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
Three months ended Year ended
December 31, December 31,
---------------------- ----------------------
2010 2009 2010 2009
---------- ---------- ---------- ----------
Revenues $ 3,474 $ 7,234 $ 16,634 $ 22,203
Cost of revenues 3,533 4,834 14,736 16,147
---------- ---------- ---------- ----------
Gross profit (59) 2,400 1,898 6,056
---------- ---------- ---------- ----------
Operating expenses:
Research and development 3,154 4,347 18,170 19,828
Selling, general and
administrative 7,585 9,356 28,736 37,524
Gain on settlement of
litigation -- -- (10,003) --
---------- ---------- ---------- ----------
Total operating expenses 10,739 13,703 36,903 57,352
---------- ---------- ---------- ----------
Loss from operations (10,798) (11,303) (35,005) (51,296)
Other income (expense), net (194) (399) (2,890) (1,153)
---------- ---------- ---------- ----------
Net loss $ (10,992) $ (11,702) $ (37,895) $ (52,449)
========== ========== ========== ==========
Basic and diluted net loss
per share $ (0.20) $ (0.31) $ (0.78) $ (1.55)
========== ========== ========== ==========
Shares used to compute basic
and diluted net loss per
share 53,832 37,461 48,881 33,892
========== ========== ========== ==========
HANSEN MEDICAL
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
December 31, December 31,
2010 2009
------------- -------------
Assets
Cash, cash equivalents and short-term
investments $ 28,033 $ 28,279
Accounts receivable 4,207 6,888
Inventories, net 6,232 7,406
Deferred cost of revenues 3,277 2,535
Prepaids and other current assets 1,796 1,929
Property and equipment, net 10,145 13,460
Note receivable 3,818 --
Other assets 436 244
------------- -------------
Total assets $ 57,944 $ 60,741
============= =============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 3,157 $ 2,068
Deferred revenues 11,637 9,463
Debt 6,238 9,803
Other liabilities 6,140 5,654
------------- -------------
Total liabilities 27,175 26,988
------------- -------------
Stockholders' equity 30,772 33,753
------------- -------------
Total Liabilities and Stockholders' Equity $ 57,944 $ 60,741
============= =============
Investor Contacts: Peter Osborne Interim CFO Hansen
Medical 650.404.5800 Matt Clawson Allen & Caron Inc
949.474.4300 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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