Hansen Medical Reports Recent Business Highlights and First Quarter
2014 Results
MOUNTAIN VIEW, CA--(Marketwired - May 7, 2014) - Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics,
today reported recent business highlights and financial results for
the first quarter of fiscal year 2014 ended March 31, 2014.
Recent Business Highlights:
- On May 6, the Company's Board of Directors announced the
appointment of Cary Vance to the position of President and Chief
Executive Officer and a member of the Board of Directors. Mr. Vance
will join the Company on May 23, 2014.
- On April 29, the Company announced successful completion of the
world's first clinical procedures using the Magellan™ 6Fr Robotic
Catheter. The cases included two Uterine Fibroid Embolizations and
a Transarterial Chemoembolization (TACE) procedure for colon cancer
with liver metastasis.
First Quarter 2014 Highlights:
- First quarter revenue of $3.7 million, up 25%
year-over-year.
- Commercialized two robotic systems (1 Magellan™ Robotic System
and 1 Sensei® X Robotic Catheter System) in the first quarter of
fiscal year 2014 compared to one robotic system in the first
quarter of 2013.
- Placed one additional Magellan System for the purpose of
completing a single center clinical study with the new Magellan™
6Fr Robotic Catheter in a variety of embolization procedures.
- Physicians performed an estimated 827 robotic procedures in the
first quarter of fiscal year 2014, up 6% year-over-year.
"We are pleased to welcome Cary Vance as President and Chief
Executive Officer and look forward to his leading Hansen through
the next stage of growth," said Christopher P. Lowe, Hansen
Medical's interim Chief Executive Officer. "Throughout his career,
Cary has delivered above average revenue growth while also driving
margin expansion opportunities; and I am confident that his
commercial expertise and leadership will be a tremendous asset for
the Company. During this interim transition, the Company has
remained focused on achieving our stated objectives for fiscal 2014
and we are particularly pleased to have recently announced the
first-in-human clinical cases performed with the 6Fr Robotic
Catheter as part of a clinical study to evaluate the use of the
Magellan in a variety of peripheral vascular embolization
procedures."
First Quarter of 2014 Financial Results
Total revenue for the first quarter ended March 31, 2014
increased 25% to $3.7 million, compared to revenue of $3.0 million
in the same period in 2013. The Company commercialized two robotic
systems in the quarter (1 Magellan System and 1 Sensei System). The
Company uses the term "commercialized" to refer to
revenue-generating system transactions, including rental
transactions. The Company sold 685 catheters in the first
quarter of fiscal 2014, up 16% year-over-year. Physicians
performed an estimated 827 robotic procedures in the first quarter
of 2014, up 6% year-over-year.
Gross profit in the first quarter of fiscal 2014 decreased 15%
to $0.4 million, or 11% of sales, compared to $0.5 million, or 16%
of sales, last year. First quarter gross margin was negatively
impacted by $256,000 of costs associated with additional product
testing required in the quarter, partially offset by lower service
costs in the quarter.
Research and development expenses for the first quarter were
$4.4 million, compared to $4.1 million for same period in 2013. The
increase of $0.3 million is primarily due to incremental costs
associated with new product development and clinical program
initiatives designed to expand the utilization of our platform.
Selling, general and administrative expenses for the first
quarter were $9.2 million, compared to $7.4 million for the same
period of 2013. The increase of $1.8 million year-over-year is
primarily due to costs related to the expansion of our global sales
organization and certain administrative expenses in the
quarter.
Net loss for the first quarter of 2014 was $14.4 million, or
$0.14 per share, compared to a net loss of $17.2 million, or $0.26
per share, in the first quarter of 2013. Net loss for the first
quarter of 2014 included total non-cash stock compensation expense
of $0.8 million compared to $1.1 million in the first quarter of
2013. Net loss in the first quarter of 2013 included a pre-tax
loss of $4.5 million related to a litigation settlement. Weighted
average shares outstanding used to compute diluted net loss per
share were 103.3 million for the first quarter of fiscal 2014,
compared to 67.3 million in the first quarter of fiscal
2013.
Cash, cash equivalents, short-term investments and restricted
cash totaled $38.4 million as of March 31, 2014, up $3.1 million
quarter-over-quarter, compared to a total of $35.3 million as of
December 31, 2013.
Hansen Medical Earnings Release and Conference Call
Hansen Medical is scheduled to report the first quarter 2014
results and host a conference call on May 7, at 5:00 p.m. ET (2:00
p.m. PT) at which point the Company will discuss in more detail the
results of the quarter and other recent business
highlights. 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 888-846-5003 (480-629-9808
for international callers) and referencing the participant code
4681413. An audio replay of the webcast will be available
approximately one hour after the completion of the conference call
through May 14, 2014 by calling 877-870-5176 (858-384-5517 for
international callers) and entering the access code
4681413.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a
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, 9Fr Magellan™
Robotic Catheter, Magellan™ 6Fr Robotic Catheter, and related
accessories are intended to facilitate navigation to anatomical
targets in the peripheral vasculature and subsequently provide a
conduit for manual placement of therapeutic devices. The Magellan
9Fr Robotic Catheter has undergone both CE marking and 510(k)
clearance and is commercially available in the European Union, and
the U.S. The Magellan 6Fr Robotic Catheter has undergone 510(k)
clearance in the U.S. and is in limited release for the next
several months in anticipation of more wide-scale commercial
availability later in 2014. In the European Union, the
Company's Sensei® X Robotic Catheter System and Artisan® and
Artisan Extend® Control Catheters 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 and Artisan
Extend Control Catheters are cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in EP procedures. In the U.S., the Sensei X Robotic
Catheter 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 Robotic Catheter System and Artisan and Artisan Extend
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," 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. An example of such statements include our statement
regarding expectations for the timing of the more wide-scale
commercial availability of the Magellan 6Fr Robotic Catheter.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include, among others: factors relating to engineering, regulatory,
manufacturing, sales and customer service challenges in developing
new products and entering new markets; potential safety and
regulatory issues that could slow or suspend our sales; the effect
of credit, financial and economic conditions on capital spending by
our potential customers; the uncertain timelines for the sales
cycle for newly introduced products; 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 manage expenses and cash
flow, 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, 2013 filed with the SEC
on March 13, 2014 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.
"Artisan Extend," "Hansen Medical," "Hansen Medical (with Heart
Design)," "Heart Design (Logo)," "Sensei," "Lynx," "Artisan,"
"Instinctive Motion," "Fine Force Technology," "IntelliSense" are
registered trademarks, and "Magellan" and "Hansen Medical Magellan"
are trademarks of Hansen Medical, Inc. in the U.S. and other
countries.
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HANSEN MEDICAL, INC. |
|
Condensed Consolidated Statements of Operations |
|
(In thousands, except per share data) |
|
(Unaudited) |
|
|
|
|
Three Months Ended March 31, |
|
|
2014 |
|
|
2013 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product |
$ |
2,352 |
|
|
$ |
1,626 |
|
|
Service |
|
1,347 |
|
|
|
1,325 |
|
|
|
Total
revenues |
|
3,699 |
|
|
|
2,951 |
|
Cost of revenues: |
|
|
|
|
|
|
|
|
Product |
|
2,744 |
|
|
|
1,859 |
|
|
Service |
|
557 |
|
|
|
623 |
|
|
|
Total
cost of revenues |
|
3,301 |
|
|
|
2,482 |
|
Gross profit |
|
398 |
|
|
|
469 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
4,415 |
|
|
|
4,112 |
|
|
Selling, general and administrative |
|
9,161 |
|
|
|
7,418 |
|
|
Loss on settlement of litigation |
|
-- |
|
|
|
4,500 |
|
Total operating expenses |
|
13,576 |
|
|
|
16,030 |
|
Loss from operations |
|
(13,178 |
) |
|
|
(15,561 |
) |
Other expense, net |
|
(1,249 |
) |
|
|
(1,588 |
) |
Loss before income taxes |
|
(14,427 |
) |
|
|
(17,149 |
) |
Income tax expense |
|
(18 |
) |
|
|
(38 |
) |
Net loss |
$ |
(14,445 |
) |
|
$ |
(17,187 |
) |
Basic and diluted net loss per share |
$ |
(0.14 |
) |
|
$ |
(0.26 |
) |
Shares used to compute basic and diluted net loss per
share |
|
103,334 |
|
|
|
67,296 |
|
|
|
|
|
|
|
|
|
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HANSEN MEDICAL, INC. |
Condensed Consolidated Balance Sheets |
(In thousands) |
(Unaudited) |
|
|
March 31, 2014 |
|
December 31, 2013 |
ASSETS |
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
33,004 |
|
$ |
29,940 |
|
Accounts receivable, net |
|
4,395 |
|
|
5,114 |
|
Inventories |
|
12,028 |
|
|
12,203 |
|
Prepaids and other current assets |
|
1,629 |
|
|
1,914 |
|
Property and equipment, net |
|
3,882 |
|
|
3,641 |
|
Restricted cash |
|
5,394 |
|
|
5,394 |
|
Other assets |
|
1,582 |
|
|
2,953 |
|
|
Total
assets |
$ |
61,914 |
|
$ |
61,159 |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
Accounts payable |
$ |
3,174 |
|
$ |
3,337 |
|
Deferred revenue |
|
3,180 |
|
|
3,115 |
|
Debt |
|
33,608 |
|
|
33,358 |
|
Other liabilities |
|
4,820 |
|
|
4,473 |
|
|
Total
liabilities |
|
44,782 |
|
|
44,283 |
|
|
Total
stockholders' equity |
|
17,132 |
|
|
16,876 |
|
|
Total
liabilities and stockholders' equity |
$ |
61,914 |
|
$ |
61,159 |
|
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|
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Investor Contacts: Peter J. Mariani Chief Financial Officer
Hansen Medical, Inc. 650.404.5800 Westwicke Partners, LLC. Mark
Klausner or Mike Piccinino, CFA 443.213.0500 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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