Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, today reported recent business highlights
and financial results for the first quarter ended March 31, 2013.
Recent Business Highlights
- Shipped four systems (3 Magellan™ Systems and 1 Sensei® System)
in the first quarter
- Of the four systems shipped, the Sensei System was sold, and
the three Magellan Systems were shipped as part of the Company's
commercial evaluation program; the commercial evaluation program
allows certain strategic accounts to install and utilize Hansen
Medical robotic systems for a trial period while the purchase
opportunity is being evaluated by the hospital
- Continuing to develop strong pipeline of potential system sales
- Anticipating the commercialization of 14 to 17 Magellan and
Sensei Systems in 2013
- Agreed to convert one evaluation system to a monthly payment
program effective April 1 through a potential purchase date in
Q4
- In advanced discussions with multiple institutions in both the
U.S. and Europe to become regional training and reference
centers
- Nine Magellan systems are installed and in clinical use at
March 31. Approximately 150 vascular cases have now been performed
to date using the Magellan System, demonstrating broad clinical
applications in the peripheral vasculature
- Physicians performed an estimated record 781 Hansen robotic
procedures in the first quarter, up 23% year over year and 3%
sequentially. This is the seventh consecutive quarter of procedure
growth; providing outlook of total estimated procedures of between
3,100 and 3,400 in 2013, which would represent growth of
approximately 15% to 25% compared to 2012.
- Exhibited the Magellan System at the 2013 Charing Cross
Symposium in London, which included five separate presentations
from industry leading physicians discussing the benefits of the
System
- Two live endovascular aortic aneurysm repair (EVAR) cases
successfully performed by Dr. Barry Katzen at the 25th Annual
International Symposium on Endovascular Therapy ISET25 in Miami,
FL, in January; additional live cases are anticipated at the
European Association for Percutaneous Cardiovascular Interventions
(EuroPCR) congress to be held in Paris, France, on May 21 - 24
- Filed 30 new patent applications relating to flexible medical
robotics during the first quarter
- Hansen Medical owns or has exclusive rights to approximately
250 issued patents and pending patent applications relating to
medical robotics, in addition to hundreds of other patents and
patent applications which the Company has shared rights to use
under various third-party license agreements
- Strengthened Leadership Team: In newly created positions, hired
Will Sutton as Chief Operating Officer, and Bob Cathcart as Senior
Vice President, Global Sales, to build further operational and
commercial expertise
- Continued building the Company's sales organization through
hiring of sales representatives with significant capital equipment
experience
- Filling important positions in clinical support and management,
marketing and sales operations
- First Quarter 2013 Financial Summary
- Generated revenue of $2.9 million in the first quarter, down
37% year-over-year
- Recognized revenue on 1 Sensei system during the first
quarter
- Sold 592 catheters in the first quarter, up 3% year-over-year
and down 30% sequentially. Consistent with the prior year,
hospitals reduced the level of catheter inventory held in the first
quarter compared to year-end, resulting in a sequential decrease in
catheter sales.
- Held cash, cash equivalents and short-term investments of $31.3
million at March 31, 2013, representing a quarterly cash burn of
$9.9 million
- The Company has not sold any shares of its common stock under
its recently executed 'at-the-market' agreement
"In a little over two quarters, the Company has gone from having
just one installed clinical Magellan Robotic System to nine total
clinical installations that are involved in treating patients and
generating data, as of March 31," said Bruce Barclay, Hansen
Medical's President and Chief Executive Officer. "I am encouraged
by the breadth of clinical applications in the peripheral
vasculature and the positive experiences that are being generated
at these hospitals. These varied applications are demonstrating the
real-world medical utility of Hansen Medical's systems, and helping
to drive further interest and adoption of our technology. Today, we
are reporting another quarter of record procedures, marking the
seventh consecutive quarter of procedure growth. This is further
evidence of the value we believe physicians and hospitals can, and
are, experiencing with our intravascular robotic systems. We are
particularly encouraged by recent in vitro data and clinical
experiences regarding the potential benefits of endovascular
robotics in the treatment of carotid artery disease."
Mr. Barclay continued, "As noted above, we have a strong and
growing pipeline of potential commercial transactions and are in
advanced discussions with several accounts regarding the potential
purchase of systems. Additionally, we are in advanced discussions
with multiple institutions in both the U.S. and Europe to become
regional training and reference centers for the Magellan System.
Given the number of positive indicators we are seeing, including
the status of our discussions with various accounts, we can now
update our 2013 outlook to anticipate the commercialization of 14
to 17 robotic systems in 2013. While there is no guarantee that
these hospitals will ultimately purchase a system this year, we are
excited about the direction of these ongoing discussions and remain
optimistic about the potential of these sales opportunities."
2013 First Quarter Financial Results
Total revenue for the first quarter ended March 31, 2013 was
$2.9 million compared to revenue of $4.7 million in the same period
in 2012. During the first quarter, the Company recognized revenue
on one Sensei system, as well as the shipment of 592 catheters.
Catheter sales were up 3% compared to the first quarter of 2012 and
down 30% sequentially. Further, an estimated record 781 Hansen
robotic procedures were performed in the quarter, an increase of
23% compared to the same quarter of the prior year, and up 3%
sequentially.
Cost of revenues for the first quarter was $2.5 million. As a
result, gross profit for the quarter was $469,000 or 16% of
revenue, compared to gross profit of $732,000 or 16% of revenue,
for the same period in 2012.
Research and development expenses for the first quarter were
$4.1 million, compared to $4.3 million for the same period in 2012.
Prior year research and development expenses were higher primarily
due to additional costs associated with the Company's Magellan
System and other product development initiatives, partially offset
by an increase in non-cash stock compensation.
Selling, general and administrative expenses for the first
quarter were $7.4 million, flat with $7.4 million for the same
period of 2012. Decreases in commissions due to lower sales volume
and other employee-related costs were offset by increases in
professional fees, primarily legal fees due to increased patent
applications activities, and an increase in non-cash stock
compensation.
The Company has reached an agreement in principle to settle all
claims related to the class action suit regarding the restatement
of Hansen Medical's financial statements that was first reported in
October 2009. The settlement is subject to execution of final
documents and to final court approval, which the Company expects to
receive within approximately six months. As a result, the Company
recorded a loss on settlement of litigation of $4.5 million in the
first quarter. The loss represents the Company's portion of the
total $8.5 million settlement amount, whereby the Company's
insurance provider and another third party will fund $4.0 million
of the settlement in cash, and the Company will fund the remaining
portion by issuing $4.25 million worth of shares of common stock,
the number of shares to be determined based on the average closing
price of the Company's stock for the 10 trading days preceding
final court approval of the settlement of the Class Action, and
paying $250,000 in cash.
Net loss for the first quarter was $17.2 million, or $0.26 per
share, based on average shares outstanding of 67.3 million. This
compares with a net loss for the first quarter of 2012 of $11.8
million, or $0.20 per share, based on average shares outstanding of
60.5 million. Net loss for the first quarter of 2013 included total
non-cash stock compensation expenses of $1.1 million compared to
$279,000 in the first quarter of 2012. The first quarter of 2012
included a one-time adjustment of $740,000 related to previously
recorded expenses for the Company's employee stock purchase program
affecting all expense categories.
Cash, cash equivalents and short-term investments as of March
31, 2013 were $31.3 million, compared to $41.2 million as of
December 31, 2012. Cash burn in the quarter was $9.9 million
compared to a cash gain of $19.5 million in the fourth quarter of
2012.
Updated Full-Year 2013 Outlook
Hansen Medical anticipates the commercialization of 14 to 17
total robotic catheter systems in 2013, as well as total estimated
procedures of between 3,100 and 3,400 during the year. The Company
continues to expect improvement in gross margins over 2012 levels
based on current volume assumptions of product sales and increased
efficiency from cost savings initiatives. Hansen Medical also
continues to anticipate that operating expenses will increase
moderately, as the Company expects to add resources to support the
commercial launch of the Magellan System and the continuing
adoption of the Sensei System. Hansen Medical will continue to
invest in new products in 2013, and the Company anticipates the
commercial launch of its 6F vascular catheter for use in smaller
vessel, peripheral applications by the end of 2013. For purposes of
the Company's 2013 outlook, the term "commercialize" refers to
revenue-generating transactions, including the conversion of
evaluation units.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
first quarter 2013 results today, May 8, 2013 at 5:00 p.m. ET (2:00
p.m. PT). 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 877-941-1428 (480-629-9665 for international callers).
An audio replay of the webcast will be available approximately one
hour after the completion of the conference call through May 15,
2013, by calling 877-870-5176 (858-384-5517 for international
callers) and entering the access code 4617017.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the
global leader in intravascular robotics, developing products and
technology designed to enable the accurate positioning,
manipulation and control of catheters and catheter-based
technologies. 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 both CE marking and 510(k)
clearance and are commercially available in the European Union, and
the U.S. In the European Union, the Company's Sensei® X Robotic
Catheter System and Artisan Control Catheter are cleared for use
during electrophysiology (EP) procedures, such as guiding catheters
in the treatment of atrial fibrillation (AF), and the Lynx® Robotic
Ablation Catheter is cleared for the treatment of AF. This robotic
catheter system is compatible with fluoroscopy, ultrasound, 3D
surface map and patient electrocardiogram data. In the U.S. 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 EP
procedures. 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 AF, have not been established.
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," "anticipates," "outlook," and similar words. These
statements are based on the current estimates and assumptions of
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 benefits of the Magellan Robotic
System for hospitals, patients and physicians, the anticipated
range of the commercialization of the Company's robotic systems and
the range of estimated procedure for 2013, expectations of gross
margins and operating expenses for 2013, and the anticipated timing
of commercially launching a 6F vascular catheter. Important factors
that could cause actual results to differ materially from those
indicated by such forward-looking statements include, among others:
engineering, regulatory, manufacturing, sales and customer service
challenges in developing new products and entering new markets; the
commercial viability of the Company's products in the vascular
markets; potential safety and regulatory issues that could slow or
suspend sales; the effect of economic conditions on capital
spending by potential customers; the uncertain timelines for the
sales cycle for newly introduced products and the resulting
difficulties in forecasting the timing of sales; failures to close
system sales with interested prospects; the rate of adoption of
systems and the rate of use of systems by hospitals and physicians;
the scope and validity of intellectual property rights applicable
to our products; competition from other companies; the ability to
recruit and retain key personnel; the ability to maintain adequate
internal controls over financial reporting; the ability to manage
expenses and cash flow, and obtain additional financing; possible
failure of the parties to execute final settlement documents
relating to the class action lawsuit, or to obtain court approval
of the settlement, or delays in final court approval of the
proposed settlement ; and other risks more fully described in the
"Risk Factors" section of our Annual Report on Form 10-K for the
year ended December 31, 2012 filed with the SEC on March 18, 2013
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. The Company
undertakes 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), Sensei and Lynx are registered trademarks, and Magellan
and NorthStar are trademarks of Hansen Medical, Inc. in the United
States and other countries.
HANSEN MEDICAL
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
Three months ended
March 31,
------------------------
2013 2012
----------- -----------
Revenues: $ 2,951 $ 4,654
Cost of revenues 2,482 3,922
----------- -----------
Gross profit 469 732
----------- -----------
Operating expenses:
Research and development 4,112 4,298
Selling, general and administrative 7,418 7,359
Loss on settlement of litigation 4,500 --
----------- -----------
Total operating expenses 16,030 11,657
Loss from operations (15,561) (10,925)
Other expense, net (1,588) (886)
----------- -----------
Loss before income taxes (17,149) (11,811)
Income tax expense (38) --
----------- -----------
Net loss $ (17,187) $ (11,811)
=========== ===========
Basic and diluted net loss per share $ (0.26) $ (0.20)
=========== ===========
Shares used to compute basic and diluted net loss
per share 67,296 60,497
=========== ===========
HANSEN MEDICAL
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
December 31,
March 31, 2013 2012
-------------- --------------
Assets
Cash, cash equivalents and short-term
investments $ 31,320 $ 41,173
Accounts receivable 3,377 5,235
Inventories, net 10,740 9,134
Deferred cost of revenues 238 167
Prepaids and other current assets 1,704 1,765
Property and equipment, net 5,299 6,040
Other assets 542 578
-------------- --------------
Total assets $ 53,220 $ 64,092
============== ==============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 3,022 $ 3,056
Deferred revenues 2,446 2,770
Debt 29,491 29,417
Other liabilities 8,818 4,110
-------------- --------------
Total liabilities 43,777 39,353
-------------- --------------
Stockholders' equity 9,443 24,739
-------------- --------------
Total liabilities and stockholders' equity $ 53,220 $ 64,092
============== ==============
Investor Contacts: Peter J. Mariani Chief Financial
Officer Hansen Medical, Inc. 650.404.5800 FTI Consulting,
Inc. Brian Ritchie 212.850.5683 Email Contact John Capodanno
212.850.5705 Email Contact
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