Hansen Medical Reports Fourth Quarter and Full-Year 2013 Results
MOUNTAIN VIEW, CA--(Marketwired - Feb 20, 2014) - Hansen
Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular
robotics, today reported recent business highlights and financial
results for the fourth quarter and full year ended December 31,
2013.
Fourth Quarter and Fiscal Year 2013 Highlights:
- Fourth quarter revenue of $5.6 million, up 29%
year-over-year.
- Commercialized six robotic systems in the fourth quarter and 14
robotic systems in fiscal year 2013.
- Physicians performed an estimated 815 procedures in the fourth
quarter and an estimated 3,210 procedures in fiscal year 2013, up
8% and 19%, respectively, year-over-year.
- Qualified two Magellan Centers of Excellence for the training
of physicians and medical staff in the U.S.: the Keck Medical
Center at the University of Southern California in Los Angeles, CA,
and Premier Health Miami Valley Hospital, in Dayton, OH.
Highlights Subsequent to the Quarter Include:
- The Board of Directors appointed Christopher P. Lowe, a current
board member, as our interim Chief Executive Officer.
- Received U.S. Food and Drug Administration (FDA) clearance of
the new, smaller diameter Magellan 6Fr Robotic Catheter, which
extends the clinical benefits of Intravascular Robotics to a
broader set of patients, physicians and procedures.
- The FDA clearance of the Magellan 6Fr Robotic Catheter triggers
the exercise of approximately $14 million of Series A warrants that
were issued as part of the private placement of stock and warrants
announced on July 31, 2013.
"We are pleased with our fourth quarter and second half 2013
performance including the continued placement of systems, the
broadening clinical experience, and the qualifying of new Magellan
centers of excellence," said Peter J. Mariani, Hansen Medical's
Chief Financial Officer. "These positive trends, together with
the recent FDA clearance of our new, smaller diameter Magellan 6Fr
Robotic Catheter demonstrate the expanding breadth of applications
of our platform across intravascular procedures."
"Hansen Medical's proprietary, intravascular robotic technology
offers improved procedure predictability and control,
potentially improving both clinical and economic outcomes in a
large and growing global intravascular market," said Christopher P.
Lowe, Hansen Medical's interim Chief Executive Officer. "We will
continue to develop the clinical experience and utilization of our
core technology, and expand our catheter and technology offerings
toward the long-term opportunity of making robotics the standard of
care for intravascular procedures. We have an exceptional team
focused on delivering innovation to these important markets."
Fourth Quarter of 2013 Financial Results
Total revenue for the fourth quarter ended December 31, 2013
increased 29% to $5.6 million, compared to revenue of $4.3 million
in the same period in 2012. The Company commercialized six systems
in the quarter (5 Magellan and 1 Sensei). The Company uses the term
"commercialized" to refer to revenue-generating system
transactions, including rental transactions. The Company sold
600 catheters in the fourth quarter of fiscal 2013, down 29%
year-over-year. The decrease was driven primarily by
hospitals' and distributors' intentions to manage inventory at
lower levels at the end of the calendar year, despite continued
growth in procedures. Physicians performed an estimated 815 robotic
procedures in the fourth quarter of 2013, up 8% year-over-year.
Gross profit in the fourth quarter of fiscal 2013 increased 29%
to $1.1 million, or 20% of sales, compared to $0.9 million, or 20%
of sales, last year. Fourth quarter gross margin was negatively
impacted by one time price discounts on the strategic sales of two
systems in two new international markets.
Research and development expenses for the fourth quarter were
$3.7 million, compared to $3.5 million for same period in 2012. The
increase of $0.2 million is primarily due to incremental costs
associated with continued new product development and clinical
program initiatives designed to expand the utilization of our
platform.
Selling, general and administrative expenses for the fourth
quarter were $8.0 million, compared to $6.8 million for the same
period of 2012. The increase of $1.2 million is primarily due
to costs related to the expansion of our global sales organization
and marketing activities in the quarter.
Net loss for the fourth quarter of 2013 was $11.9 million, or
$0.12 per share compared to net income of $9.6 million, or $0.15
per share, in the fourth quarter of 2012. Net loss for the fourth
quarter of 2013 included total non-cash stock compensation expenses
of $1.3 million compared to $0.6 million in the fourth quarter of
2012. Net income for the fourth quarter of 2012 included a
$20.0 million gain on licensing of intellectual property to
Intuitive Surgical. Weighted average shares outstanding to compute
diluted net income or loss per share were 96.8 million for the
fourth quarter compared to 65.9 million in the fourth quarter of
2012.
Cash, cash equivalents, short-term investments and restricted
cash were $35.3 million as of December 31, 2013, down $11.8 million
quarter-over-quarter from the $47.1 million balance as of September
30, 2013.
Fiscal Year 2013 Financial Results
Total revenue for the year ended December 31, 2013 was $17.0
million, a decrease of 4% compared to $17.6 million in fiscal year
2012. The Company commercialized 14 systems in 2013 (9
Magellan and 5 Sensei), including two rental systems, compared to
13 systems in the prior year period (4 Magellan and 9
Sensei). Revenue in fiscal year 2012 included approximately
$2.6 million on five systems that were sold prior to 2012 (1
Magellan and 4 Sensei). Catheter sales increased 2% to 2,857
in fiscal year 2013, compared to 2,807 in the prior year period,
and physicians performed an estimated 3,210 procedures in 2013, a
19% increase compared to estimated procedures of 2,688 in 2012.
Gross profit for fiscal year 2013 declined 3% to $3.5 million,
or 21% of sales, compared to gross profit of $3.6 million, or 21%
of sales in 2012. Gross profit for the year was negatively
impacted by one time price discounts on the strategic sales of two
systems in two new international markets, partially offset by
continuing efforts to lower product manufacturing costs.
Total operating expenses for 2013 were $52.4 million, which
included a $4.5 million loss on settlement of litigation compared
to 2012 operating expenses of $42.1 million. Excluding the
$4.5 million settlement charge, the $5.8 million increase over
prior year is due primarily to additional litigation and other
legal expenses in the current year of approximately $2.8 million,
additional costs associated with the Company's development of
global sales organization, and other marketing activities of
approximately $1.4 million, and $1.5 million of insurance
reimbursement proceeds received, and recorded as a reduction to
expense, in 2012.
The Company reported a net loss of $55.7 million, or $0.70 per
share, in fiscal year 2013, compared to a net loss of $22.1
million, or $0.35 per share in the prior year. Fiscal year
2013 results included $4.9 million of non-cash stock compensation
expense and a loss of $1.9 million on the extinguishment of debt.
The Company's net loss in 2012 included non-cash stock compensation
expense of $2.9 million, and a gain $20.0 million on the licensing
of intellectual property to Intuitive Surgical. Weighted average
shares outstanding used to compute diluted net loss were 79.1
million for fiscal year 2013 compared to 62.5 million for fiscal
year 2012.
Expected Exercise of Series A Warrants
The FDA clearance of the Magellan 6Fr Robotic Catheter triggered
the required exercise period for approximately $14 million of
Series A warrants that were issued as part of the private placement
of stock and warrants that was announced on July 31, 2013. The
Company issued Series A warrants to purchase approximately 11.4
million shares of common stock with a per share exercise price of
$1.23 as part of the private placement transaction. The
holders of these Series A warrants are required to exercise the
warrants, upon 15 days' notice of the FDA clearance of the 6Fr
catheter, which the Company provided to holders on February
11. Any Series A warrants not exercised by holders within the
15 day exercise period will be forfeited. The Company also
issued Series B warrants to purchase approximately 11.4 million
shares of common stock with a per share exercise price of
$1.50, and Series C warrants to purchase approximately 11.4 million
shares of common stock with a per share exercise price of $2.00 as
part of the private placement transaction. These warrants
expire in August of 2015 and are not subject to any other required
exercise trigger.
Hansen Medical Earnings Release and Conference Call
Hansen Medical is scheduled to report the final fourth quarter
2013 results and host a conference call on February 20, 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
4668716. An audio replay of the webcast will be available
approximately one hour after the completion of the conference call
through February 27, 2014, by calling 877-870-5176 (858-384-5517
for international callers) and entering the access code
4668716.
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 commercially
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. 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 Quarterly Report on
Form 10-Q for the quarter ended September 30, 2013 filed with the
SEC on November 8, 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. 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 December 31, |
|
|
Year Ended December 31, |
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
$ |
4,296 |
|
|
$ |
2,927 |
|
|
$ |
11,790 |
|
|
$ |
12,303 |
|
|
Service |
|
|
1,324 |
|
|
|
1,417 |
|
|
|
5,192 |
|
|
|
5,333 |
|
|
|
Total
revenues |
|
|
5,620 |
|
|
|
4,344 |
|
|
|
16,982 |
|
|
|
17,636 |
|
Cost of revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
|
3,957 |
|
|
|
2,922 |
|
|
|
11,150 |
|
|
|
11,990 |
|
|
Service |
|
|
547 |
|
|
|
554 |
|
|
|
2,331 |
|
|
|
2,036 |
|
|
|
Total
cost of revenues |
|
|
4,504 |
|
|
|
3,476 |
|
|
|
13,481 |
|
|
|
14,026 |
|
Gross profit |
|
|
1,116 |
|
|
|
868 |
|
|
|
3,501 |
|
|
|
3,610 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,722 |
|
|
|
3,494 |
|
|
|
16,139 |
|
|
|
16,126 |
|
|
Selling, general and administrative |
|
|
8,047 |
|
|
|
6,801 |
|
|
|
31,765 |
|
|
|
25,987 |
|
|
Loss on settlement of litigation |
|
|
-- |
|
|
|
-- |
|
|
|
4,500 |
|
|
|
-- |
|
Total operating expenses |
|
|
11,769 |
|
|
|
10,295 |
|
|
|
52,404 |
|
|
|
42,113 |
|
Gain on licensing of intellectual property |
|
|
-- |
|
|
|
20,000 |
|
|
|
-- |
|
|
|
20,000 |
|
Gain (loss) from operations |
|
|
(10,653 |
) |
|
|
10,573 |
|
|
|
(48,903 |
) |
|
|
(18,503 |
) |
Loss on extinguishment of debt |
|
|
-- |
|
|
|
-- |
|
|
|
(1,935 |
) |
|
|
-- |
|
Other expense, net |
|
|
(1,213 |
) |
|
|
(886 |
) |
|
|
(4,769 |
) |
|
|
(3,528 |
) |
Income (loss) before income taxes |
|
|
(11,866 |
) |
|
|
9,687 |
|
|
|
(55,607 |
) |
|
|
(22,031 |
) |
Income tax expense |
|
|
(22 |
) |
|
|
(114 |
) |
|
|
(115 |
) |
|
|
(114 |
) |
Net income (loss) |
|
$ |
(11,888 |
) |
|
$ |
9,573 |
|
|
$ |
(55,722 |
) |
|
$ |
(22,145 |
) |
Basic and diluted net income (loss) per share |
|
$ |
(0.12 |
) |
|
$ |
0.15 |
|
|
$ |
(0.70 |
) |
|
$ |
(0.35 |
) |
Shares used to compute basic net income (loss) per
share |
|
|
96,774 |
|
|
|
65,336 |
|
|
|
79,052 |
|
|
|
62,472 |
|
Shares used to compute diluted net income (loss) per
share |
|
|
96,774 |
|
|
|
65,890 |
|
|
|
79,052 |
|
|
|
62,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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HANSEN MEDICAL, INC. |
Condensed Consolidated Balance Sheets |
In thousands, except per share data) |
(Unaudited) |
|
|
|
December 31, 2013 |
|
December 31, 2012 |
ASSETS |
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
29,940 |
|
$ |
41,173 |
|
Accounts receivable, net |
|
|
5,114 |
|
|
5,235 |
|
Inventories |
|
|
12,203 |
|
|
9,134 |
|
Deferred cost of revenues |
|
|
149 |
|
|
167 |
|
Prepaids and other current assets |
|
|
1,765 |
|
|
1,765 |
|
Property and equipment, net |
|
|
3,641 |
|
|
6,040 |
|
Restricted cash |
|
|
5,394 |
|
|
-- |
|
Other assets |
|
|
2,953 |
|
|
578 |
|
|
Total
assets |
|
$ |
61,159 |
|
$ |
64,092 |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,337 |
|
$ |
3,056 |
|
Deferred revenue |
|
|
3,115 |
|
|
2,770 |
|
Debt |
|
|
33,358 |
|
|
29,417 |
|
Other liabilities |
|
|
4,473 |
|
|
4,110 |
|
|
Total
liabilities |
|
|
44,283 |
|
|
39,353 |
|
|
Total
stockholders' equity |
|
|
16,876 |
|
|
24,739 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
61,159 |
|
$ |
64,092 |
|
|
|
|
|
|
|
Investor Contacts: Peter J. Mariani Chief Financial Officer
Hansen Medical, Inc. 650.404.5800 Westwicke Partners, LLC. Mark
Klausner 443.213.0501 Email Contact Mike Piccinino, CFA
443.213.0509 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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