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 recent
business highlights and financial results for the quarter ended
March 31, 2012.
First Quarter Summary and Recent Business Highlights
- Response submitted to FDA for Magellan™ Robotic System in
February 2012; continue to anticipate second quarter 510(k)
clearance and U.S. launch
- Complex endovascular procedures performed with the Magellan
System at St. Mary's Hospital, London
- Shipped second vascular robotic system in the U.S. for the
purpose of conducting preclinical research
- Hartford Hospital selected as a center of excellence for the
Sensei X® Robotic Catheter Platform
- Strengthened leadership team with the addition of Joe Guido as
vice president of marketing and business development
- Added two new Board members, bringing additional operational,
commercial and manufacturing expertise
- First Quarter Financial Summary:
- Shipped 3 Robotic Catheter Systems in the US: 2 Sensei Systems,
1 vascular preclinical research system; recognized revenue on 4
robotic systems (3 U.S. and 1 internationally)
- 636 procedures performed, up 1% sequentially and down 5% year
over year; over 8,000 robotic system procedures performed in
patients since first commercialization
- 574 catheters sold, down 20% sequentially and 17% year over
year, as customers reduced inventory levels for the first time in 5
consecutive quarters
- First quarter total revenue of $4.7 million, down 25%
sequentially and 12% year over year
- Cash, cash equivalents and short-term investments: $38.5
million at March 31, 2012
"Interest and excitement continued to build in the first quarter
for our Magellan Robotic System as the result of the positive,
growing clinical experience in Europe and our February response to
the FDA regarding our pending 510(k) application," said Bruce
Barclay, Hansen Medical's President and Chief Executive Officer.
"We continue to advance our commercial capabilities across key
geographies as we anticipate 510(k) clearance of the Magellan
System in the US during the second quarter. While clinical interest
is strong, and the number of hospitals currently evaluating
Magellan System purchases is encouraging, our top-line growth in
the quarter was adversely affected by the weakened economic
environment in Europe."
2012 First Quarter Financial Results
Total revenue for the first quarter ended March 31, 2012 was
$4.7 million, a decrease of 12 percent compared to revenue of $5.3
million in the same period in 2011. During the first quarter, the
Company recognized revenue on four systems as well as shipment of
574 catheters. The Company shipped a total of three systems, all of
which were recognized as revenue in the quarter. Further, 636
procedures were performed in the period with Company products. As
of March 31, 2012, the Company had a total deferred revenue balance
of $5.9 million, which includes prior shipment of five systems that
have not been recognized as revenue.
Cost of revenues for the first quarter was $3.9 million. As a
result, gross profit for the quarter was $732,000 and gross margin
was 15.7 percent. This compares to gross profit of $817,000 and
gross margin of 15.5 percent for the same period in 2011.
Research and development expenses for the first quarter were
$4.3 million, compared to $4.2 million for the same period in 2011,
which included $2.0 million of funded research and development
credits (recorded as a reduction of expense) from our now completed
work under the joint development agreement with Philips. Excluding
these research and development credits in the first quarter of
2011, prior year research and development expenses were higher due
primarily to additional development costs associated with the
Company's Magellan System and higher non-cash stock compensation
expenses.
Selling, general and administrative expenses for the first
quarter were $7.4 million, compared to $8.0 million for the same
period in 2011. The net decrease in the current quarter is
primarily due to a reduction in stock compensation expense of $0.9
million partially offset by increases in sales and marketing
expenses.
Net loss for the first quarter was $11.8 million, or $0.20 per
diluted share, based on average shares outstanding of 60.5 million.
This compares with a net gain for the first quarter of 2011 of
$11.7 million, or $0.21 per diluted share, based on average shares
outstanding of 55.5 million. The net gain for the first quarter of
2011 included a $23 million gain on the sale of the non-robotic
rights associated with the Company's Fiber Optic Shape Sensing and
Localization (FOSSL) technology. Net loss for the first quarter of
2012 included total non-cash stock compensation expense of $279,000
compared to $2.3 million in the first quarter of 2011. The
reduction is primarily the result of lower equity awards in the
quarter compared to the prior year, and a one-time adjustment of
$740,000 related to previously recorded expenses for the Company's
employee stock purchase program.
Cash, cash equivalents and short-term investments as of March
31, 2012 were $38.5 million compared to $52.2 million as of
December 31, 2011. Cash used in the quarter was $13.7 million and
has been negatively impacted by lower system sales, inventory
builds in support of the anticipated US Magellan launch, and the
delayed collection of approximately $1.5 million of accounts
receivable which were due in the first quarter of 2012 but not
collected until April.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2012 first quarter results today, May 2, 2012, 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 877-941-8416 or 480-629-9808. An
audio replay of the webcast will be available approximately one
hour after the completion of the conference call through May 9,
2012, by calling 877-870-5176 or 858-384-5517, and entering access
code 4532840.
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, expectations,
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", 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 Magellan™ Robotic
System and NorthStar™ Robotic Catheters in the US, the potential
benefits of our Magellan Robotic System in vascular procedures and
the timing of commercializing our Magellan Robotic System, and
anticipated growth in the adoption of the Sensei platform for
electrophysiology procedures. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, among others: potential delays
or obstacles to achieving required regulatory clearances;
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 Annual Report on
Form 10-K for the year ended December 31, 2011 filed with the SEC
on March 15, 2012 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.
HANSEN MEDICAL
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three months ended
March 31,
---------------------------
2012 2011
------------ -------------
Revenues $ 4,654 $ 5,279
Cost of revenues 3,922 4,462
------------ -------------
Gross profit 732 817
------------ -------------
Operating expenses:
Research and development 4,298 4,185
Selling, general and administrative 7,359 8,044
------------ -------------
Total operating expenses 11,657 12,229
Gain on sale of intellectual property -- 23,000
------------ -------------
Income (loss) from operations (10,925) 11,588
Other income (expense), net (886) 89
------------ -------------
Net income (loss) $ (11,811) $ 11,677
============ =============
Net income (loss) per share:
Basic $ (0.20) $ 0.22
============ =============
Diluted $ (0.20) $ 0.21
============ =============
Shares used to compute net income (loss) per
share:
Basic 60,497 54,098
============ =============
Diluted 60,497 55,452
============ =============
Condensed Consolidated Balance Sheets (unaudited)
(in thousands)
March 31, December 31,
2012 2011
------------- -------------
Assets
Cash, cash equivalents and short-term
investments $ 38,537 $ 52,210
Accounts receivable 7,460 5,493
Inventories, net 7,368 6,617
Deferred cost of revenues 1,105 1,573
Prepaids and other current assets 1,682 1,829
Property and equipment, net 7,837 8,300
Other assets 693 737
------------- -------------
Total assets $ 64,682 $ 76,759
============= =============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 2,697 $ 2,944
Deferred revenues 5,885 6,438
Debt 29,219 29,147
Other liabilities 4,825 4,749
------------- -------------
Total liabilities 42,626 43,278
------------- -------------
Stockholders' equity 22,056 33,481
------------- -------------
Total Liabilities and Stockholders' Equity $ 64,682 $ 76,759
============= =============
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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