Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible
catheter robotics and the developer of robotic technology for
accurate 3D control of catheter movement, today reported business
highlights and financial results for the third quarter and nine
months ended September 30, 2011.
Third Quarter Summary and Recent Business Highlights
- Installed first Magellan™ Robotic System at St Mary's Hospital,
London in October
- Several physicians and their staff have completed training
- First cases are expected to be performed in the coming
weeks
- Allows for $3.0 million payment to the Company of final Philips
milestone under joint development agreement
- Secured CE Mark for the Magellan Robotic System, NorthStar™
Robotic Catheter and accessories
- Received an initial response from the FDA regarding the
Magellan Robotic System 510(k) application
- FDA requested additional information but did not request
additional clinical cases
- No questions were raised by the FDA regarding the 510(k)
pathway for the device
- Third quarter total revenue of $5.4 million, up 53% year over
year and 1% sequentially
- Sensei® Robotic Catheter Systems: Shipped 2 systems (1 U.S. and
1 internationally); recognized revenue on 5 systems
- Record Catheter Sales: 698 catheters, up 20% year over year and
2% sequentially
- Procedures: 598 procedures, down 5% year over year and flat
sequentially
- Cash, cash equivalents and short-term investments: $26.0
million at September 30, 2011
Nine Months 2011 Summary
- Year to date total revenue of $16.0 million, up 21% year over
year
- Sensei Robotic Catheter Systems: Shipped 7 systems (3 U.S. and
4 internationally); recognized revenue on 15 systems
- Since commercial launch in mid-2007, shipped 104 systems
worldwide
- Record Catheter Sales: 2,073 catheters, up 17% year over
year
- Record Procedures: 1,865 procedures performed in first nine
months, up 2% year over year
- New Product: Full launch of Lynx® Irrigated Ablation Catheter
for the treatment of atrial fibrillation in Europe
"Hansen Medical delivered a solid third quarter as we continued
to execute on our strategy of growing our EP business and
developing and launching our vascular robotic platform," said Bruce
Barclay, Hansen Medical's President and Chief Executive Officer.
"In support of our focus on launching our vascular platform, I am
pleased to announce that we secured CE Mark for the Magellan
Robotic System and the NorthStar Robotic Catheter and related
accessories, and we have just installed the first Magellan Robotic
System at St. Mary's Hospital in London. Several of the hospital's
physicians and their staff have completed our extensive training
program on the System and we are expecting the first clinical cases
to be performed in the coming weeks. We are also driving momentum
with our electrophysiology business, having recognized revenue from
15 systems over the first nine months of the year, compared to 12
in all of 2010. As we close out the year, we remain steadfastly
focused on continuing to gain traction with our electrophysiology
business while making significant inroads towards the
commercialization of our robotic technology for vascular
applications."
As previously reported, the Company, on September 7, 2011,
received a letter from the U.S. Food and Drug Administration (FDA)
responding to the Company's April 2011 submission of a 510(k)
pre-market notification application for its Magellan Robotic System
and NorthStar Robotic Catheter. The FDA's initial response
requested additional information but did not request additional
clinical cases. No questions were raised by the FDA regarding the
510(k) pathway for the device. The Company will respond to the
FDA's questions which will include the results of additional
pre-clinical testing. We believe that the FDA clearance for the
Magellan and NorthStar products can be expected in the second
quarter of 2012.
First Magellan™ Robotic System
Hansen installed its first Magellan™ Robotic System at St Mary's
Hospital, London, a pioneer of robotic surgical technology. The
Magellan System accesses peripheral vessels with a proprietary
technology that delivers independent distal tip control of a
catheter and a sheath, as well as robotic manipulation of a
standard guidewire from a centralized, remote workstation. This
system has the potential to transform the way endovascular
treatments are performed for patients with Peripheral Vascular
Disease (PVD). The System was designed to assist physicians to
effectively and efficiently treat a variety of peripheral diseases,
while reducing procedure time, lessening radiation exposure and
enabling new procedures.
2011 Third Quarter Financial Results
Total revenue for the third quarter ended September 30, 2011 was
$5.4 million, an increase of 53 percent compared to revenue of $3.5
million in the same period in 2010. During the third quarter, the
Company recognized revenue on five Sensei Robotic Systems as well
as shipment of a record 698 catheters. The Company shipped a total
of two systems, both of which were recognized as revenue in the
quarter. Further, 598 electrophysiology procedures were performed
in the period with Company products. As of September 30, 2011, the
Company had a total deferred revenue balance of $7.2 million, which
includes prior shipment of eight Sensei systems that have not been
recognized as revenue.
Cost of revenues for the third quarter was $4.3 million and
included non-cash stock compensation expense of $169,000 and
charges recorded in connection with the build of vascular inventory
of $524,000. As a result, gross profit for the quarter was $1.1
million and gross margin was 20.2 percent. This compares to gross
profit of $338,000 and gross margin of 9.7 percent for the same
period in 2010.
Research and development expenses for the third quarter,
including non-cash stock compensation expense of $274,000, were
$3.5 million, compared to $4.2 million for the same period in 2010,
which included non-cash stock compensation expense of $388,000. The
decrease in research and development expenses was primarily the
result of a $1.0 million increase in the financial accounting
offset arising from the recognition of funded development costs
under the joint development agreement with Philips which totaled
$2.1 million in the third quarter. Additionally, research and
development expenses in the current quarter also include a $367,000
non-cash charge associated with the acquisition of certain
technology rights in exchange for Company stock.
Selling, general and administrative expenses for the third
quarter, including non-cash stock compensation expense of $1.4
million, were $7.6 million, compared to $6.2 million for the same
period in 2010, which included non-cash stock compensation expense
of $679,000. The increase in non-cash stock compensation is
primarily due to a one-time charge of $623,000 to record the
vesting of the unvested stock options held by the Company's
Chairman as he transitioned to non-employee status. Selling,
general and administrative expenses also increased in the quarter
due to growth in employee-related expenses and outside service
costs.
Net loss for the third quarter, including total non-cash stock
compensation expense of $1.8 million, was $10.1 million, or $0.18
per share, based on average shares outstanding of 55.1 million.
This compares favorably with a net loss for the third quarter of
2010, including non-cash stock compensation expense of $1.3
million, of $12.1 million, or $0.23 per share, based on average
shares outstanding of 53.8 million.
Cash, cash equivalents and short-term investments as of
September 30, 2011 were $26.0 million, compared to $37.2 million as
of June 30, 2011, and $28.0 million as of December 31, 2010.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2011 third quarter results today, November 2, 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. Additionally, participants can dial into the
live conference call by calling 877-941-2069 or 480-629-9713. An
audio replay of the webcast will be available approximately one
hour after the completion of the conference call through November
11, 2011, by calling 877-870-5176 or 858-384-5517, and entering
access code 4485113.
About the Magellan™ Robotic System Hansen
Medical's Magellan Robotic System is based upon the flexible
robotic technology incorporated in the Sensei-X® Robotic Catheter
System currently sold in the U.S. and Europe, which has been used
in nearly 7,000 patients with cardiac arrhythmia, but includes a
number of key enhancements. In particular, the Magellan Robotic
System:
- Allows for independent, individual robotic control of the
distal tips of both the outer sheath and the inner leader catheter,
as well as robotic manipulation of standard guidewires.
- Is designed to allow for sufficient extension inside the body
to better access hard to reach peripheral anatomy.
- Preserves the open architecture featured in the Sensei System
to allow for the subsequent use with most 6F therapeutic devices on
the market today.
- Employs a catheter that is expected to be available in multiple
lengths and has a low profile with significant flexibility to be
compatible with most 6F treatment catheters currently used
today.
Last year, the Company announced the completion of its
First-in-Man study in Europe during which 20 endovascular
procedures were successfully performed in patients with an earlier
version of the Magellan Robotic System, demonstrating its potential
to allow physicians to effectively treat peripheral vascular
disease, while lessening radiation exposure.
In Europe, the Magellan Robotic System, including the NorthStar
Robotic Catheter and related accessories, are CE marked. In the
U.S., the Magellan Robotic System requires U.S. Food & Drug
Administration (FDA) clearance, and a 510(k) application is
currently pending. As such, the products are not commercially
available in the U.S.
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® X Robotic Catheter System and
Artisan Control Catheter were cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in electrophysiology (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 X System and Artisan Control Catheter
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 X System and Artisan
Control Catheter are cleared for use during EP procedures, such as
guiding catheters in the treatment of AF, and the Lynx® Robotic
Ablation Catheter is cleared for the treatment of AF. The Company's
Magellan™ Robotic System, NorthStar™ Robotic Catheter and related
accessories, which are intended to facilitate navigation to
anatomical targets in the peripheral vasculature and subsequently
provide a conduit for manual placement of therapeutic devices, have
undergone conformity assessment and CE marking and are commercially
available in the European Union. In the U.S., the Magellan™ Robotic
System, the NorthStar™ Robotic Catheter and accessories are the
subject of a current filing with the FDA and are not commercially
available. 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 goals, plans, objectives, milestones
and future events. All statements, other than statements of
historical fact, are statements that could be deemed
forward-looking statements, including statements containing the
words "plan," "expects," "potential," "believes," goal,"
"estimate," and similar words. These statements are based on the
current estimates and assumptions of our management as of the date
of this press release and are subject to risks, uncertainties,
changes in circumstances and other factors that may cause actual
results to differ materially from the information expressed or
implied by forward-looking statements made in this press release.
Examples of such statements include statements about the potential
timing of FDA clearance of our vascular robotic system in the US,
the timing of first cases to be performed with the Magellan System,
the potential benefits of our vascular robotic system on the
vascular procedures and the timing of commercializing our vascular
robotic system. Important factors that could cause actual results
to differ materially from those indicated by such forward-looking
statements include, among others: engineering, regulatory and sales
challenges in developing new products and entering new markets;
potential safety and regulatory issues that could slow or suspend
our sales; the uncertain timelines, costs and results of
pre-clinical and clinical trials; the rate of adoption of our
systems and the rate of use of our catheters; the scope and
validity of intellectual property rights applicable to our
products; competition from other companies; our ability to recruit
and retain key personnel; our ability to maintain our remedial
actions over previously reported material weaknesses in internal
controls over financial reporting; the effect of credit, financial
and economic conditions on capital spending by our potential
customers; our ability to manage expenses and obtain additional
financing; and other risks more fully described in the "Risk
Factors" section of our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2011 filed with the SEC on August 8, 2011
and the risks discussed in our other reports filed with the SEC.
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 (Logo), Hansen Medical (with Heart
Design), and Sensei are registered trademarks of Hansen Medical,
Inc. in the United States and other countries.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three months ended Nine months ended
September 30, September 30,
-------------------- --------------------
2011 2010 2011 2010
--------- --------- --------- ---------
Revenues $ 5,360 $ 3,499 $ 15,959 $ 13,160
Cost of goods sold 4,278 3,161 12,685 11,203
--------- --------- --------- ---------
Gross profit 1,082 338 3,274 1,957
--------- --------- --------- ---------
Operating expenses:
Research and development 3,458 4,176 10,258 15,016
Selling, general and
administrative 7,621 6,231 22,816 21,151
Gain on settlement of
litigation -- -- -- (10,003)
--------- --------- --------- ---------
Total operating expenses 11,079 10,407 33,074 26,164
Gain on sale of intellectual
property -- -- 23,000 --
--------- --------- --------- ---------
Loss from operations (9,997) (10,069) (6,800) (24,207)
Other income, net (148) (2,073) (426) (2,696)
--------- --------- --------- ---------
Net loss $ (10,145) $ (12,142) $ (7,226) $ (26,903)
========= ========= ========= =========
Basic and diluted net loss per
share $ (0.18) $ (0.23) $ (0.13) $ (0.57)
========= ========= ========= =========
Shares used to compute basic and
diluted net loss per share 55,094 53,784 54,626 47,213
========= ========= ========= =========
Condensed Consolidated Balance Sheets (unaudited)
(in thousands)
September 30, December 31,
2011 2010
-------------- --------------
Assets
Cash, cash equivalents and short-term
investments $ 26,022 $ 28,033
Accounts receivable 3,953 4,207
Inventories, net 6,466 6,232
Deferred cost of revenues 1,577 3,277
Prepaids and other current assets 1,310 1,796
Property and equipment, net 8,608 10,145
Note receivable -- 3,818
Other assets 562 436
-------------- --------------
Total assets $ 48,498 $ 57,944
============== ==============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 2,620 $ 3,157
Deferred revenues 7,260 11,637
Debt 3,565 6,238
Other liabilities 5,453 6,140
-------------- --------------
Total liabilities 18,898 27,172
-------------- --------------
Stockholders' equity 29,600 30,772
-------------- --------------
Total Liabilities and Stockholders' Equity $ 48,498 $ 57,944
============== ==============
Investor Contacts: Peter J. Mariani Chief Financial
Officer Hansen Medical, Inc. 650.404.5800 FTI Consulting,
Inc. Sharrifah Al-Salem, CFA 415.293.4414 Email Contact John
Capodanno 212.850.5705 Email Contact
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