Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, today reported business highlights and
financial results for the second quarter and six months ended June
30, 2012.
Second Quarter Summary and Recent Business
Highlights
- Received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for the Magellan™ Robotic System and
immediately commenced initial launch in the U.S.
- Generated total revenue of $3.5 million; shipped one Sensei
System and recognized revenue on two Sensei Systems during the
quarter
- Sold 704 catheters in the second quarter, up 23% sequentially
and 3% year over year, as hospitals returned to growing their
inventories
- Physicians performed an estimated 637 procedures in the second
quarter, flat sequentially and up 7% year over year
- Drove sequential reduction in cash burn rate to $9.1 million
for second quarter, down $4.6 million from the first quarter
- Held cash, cash equivalents and short-term investments of $29.4
million at June 30, 2012
- Appointed two new directors, bringing additional operational
and commercial expertise from the hospital and medical device
industries to the Board
Six Months 2012 Financial Summary
- Shipped 4 robotic systems (3 Sensei Systems and 1 Magellan
System); recognized revenue on 6 robotic systems (4 Sensei Systems
and 2 Magellan Systems).
- Sold 1,278 catheters year to date, down 7% year over year
- Physicians performed an estimated 1,273 procedures year to
date, flat year over year
- Generated year to date total revenue of $8.2 million, down 23%
year over year
"In June, we achieved one of the most significant milestones in
the Company's history with the receipt of 510(k) clearance and
subsequent initial U.S. launch of the Magellan Robotic System,"
said Bruce Barclay, Hansen Medical's President and Chief Executive
Officer. "While we are still in the very early days of the launch,
we are pleased with the clinical interest for the Magellan System.
We currently have several quotes outstanding to potential customers
and expect to ship multiple Magellan Systems this year. With
growing clinical experience and our strengthened commercial
capabilities across key geographies, we believe we are well
positioned for long-term commercial success."
Mr. Barclay continued, "Additionally during the quarter, we
further realigned resources allowing us flexibility to bring
additional focus to our sales and commercialization efforts as
needed, while lowering total expenses and reducing our cash burn.
This initiative contributed to the improved cash burn in the
quarter, and we expect further improvement through the remainder of
the year. Importantly, we continue to believe that we have
sufficient cash to support our initial U.S. launch of the Magellan
Robotic System."
2012 Second Quarter Financial Results
Total revenue for the second quarter ended June 30, 2012 was
$3.5 million compared to revenue of $5.3 million in the same period
in 2011. During the second quarter, the Company shipped one Sensei
Robotic System and recognized revenue on two Sensei Robotic
Systems, as well as the shipment of 704 catheters. Catheter sales
were up 3% over the second quarter of 2011, and up 23%
sequentially, as hospitals returned to growing their inventory
levels of Company catheters. Further, an estimated 637 procedures
were performed in the period with Company products, an increase of
7% compared to the same quarter of the prior year, and flat
sequentially. As of June 30, 2012, the Company had a total deferred
revenue balance of $4.8 million, which includes prior shipment of 4
systems that have not been recognized as revenue.
Cost of revenues for the second quarter was $2.8 million. As a
result, gross profit for the quarter was $753,000, or 21% of
revenue, compared to gross profit of $1.4 million, or 26% of
revenue for the same period in 2011. The decrease in gross profit
in the current quarter is primarily the result of lower system
sales, partially offset by improved manufacturing efficiencies.
Research and development expenses for the second quarter were
$4.6 million, compared to $2.6 million for the same period in 2011,
which included $2.8 million of funded research and development
credits (recorded as a reduction of expense) from our now completed
work under our joint development agreement with Philips. Excluding
these research and development credits in the second 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 second
quarter were $6.8 million, compared to $7.2 million for the same
period of 2011. The net decrease in the current quarter is
primarily due to a reduction in legal and non-cash stock
compensation expenses partially offset by increases in sales and
marketing expenses.
Net loss for the second quarter was $11.5 million, or $0.19 loss
per share, based on average shares outstanding of 61.2 million.
This compares with a net loss for the second quarter of 2011 of
$8.8 million or $0.16 per share, based on average shares
outstanding of 54.7 million. Net loss for the second quarter of
2012 included total non-cash stock compensation expenses of $1.0
million compared to $1.4 million in the second quarter of 2011. The
reduction is primarily the result of lower equity awards in the
quarter compared to the prior year.
Cash burn in the quarter improved to $9.1 million compared to
$13.7 million in first quarter of 2012, due primarily to improved
collection of receivables and operating efficiencies. Cash, cash
equivalents and short-term investments as of June 30, 2012 were
$29.4 million, compared to $38.5 million as of March 31, 2012, and
$52.2 million as of December 31, 2011.
Hansen Medical Conference Call
Company management will hold a conference call to discuss its
2012 second quarter results today, August 8, 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 1-877-941-8416 or 1-480-629-9808.
An audio replay of the webcast will be available approximately one
hour after the completion of the conference call through August 15,
2012, by calling 1-877-870-5176 or 1-858-384-5517, and entering
access code 4552153.
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 US 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," 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 benefits of our Magellan Robotic System on vascular
procedures, expectations of shipments of our Magellan Robotic
System, the company's ability to improve margins, lower expenses
and improve cash burn, and the sufficiency of the company's cash
resources for supporting the initial launch of the Magellan 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, 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 maintain our remedial actions over
previously reported material weaknesses in internal controls over
financial reporting; 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 March 31, 2012 filed with the SEC
on May 7, 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), Sensei and Lynx are registered trademarks, and Magellan
and NorthStar are 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 Six months ended
June 30, June 30,
-------------------- --------------------
2012 2011 2012 2011
--------- --------- --------- ---------
Revenues $ 3,535 $ 5,320 $ 8,189 $ 10,599
Cost of goods sold 2,782 3,945 6,704 8,407
--------- --------- --------- ---------
Gross profit 753 1,375 1,485 2,192
--------- --------- --------- ---------
Operating expenses:
Research and development 4,562 2,615 8,860 6,800
Selling, general and
administrative 6,769 7,151 14,128 15,195
--------- --------- --------- ---------
Total operating expenses 11,331 9,766 22,988 21,995
Gain on sale of intellectual
property -- -- -- 23,000
--------- --------- --------- ---------
Gain (loss) from operations (10,578) (8,391) (21,503) 3,197
Other income, net (898) (367) (1,784) (278)
--------- --------- --------- ---------
Net income (loss) $ (11,476) $ (8,758) $ (23,287) $ 2,919
========= ========= ========= =========
Net income (loss) per share:
Basic $ (0.19) $ (0.16) $ (0.38) $ 0.05
========= ========= ========= =========
Diluted $ (0.19) $ (0.16) $ (0.38) $ 0.05
========= ========= ========= =========
Shares used to computed net
income (loss) per share:
Basic 61,209 54,675 60,853 54,388
========= ========= ========= =========
Diluted 61,209 54,675 60,853 56,508
========= ========= ========= =========
Condensed Consolidated Balance Sheets (unaudited)
(in thousands)
June 30, December 31,
2012 2011
------------ ------------
Assets
Cash, cash equivalents and short-term
investments $ 29,402 $ 52,210
Accounts receivable 4,713 5,493
Inventories, net 8,112 6,617
Deferred cost of revenues 922 1,573
Prepaids and other current assets 1,393 1,829
Property and equipment, net 7,222 8,300
Other assets 672 737
------------ ------------
Total assets $ 52,436 $ 76,759
============ ============
Liabilities and Stockholders' Equity
Liabilities
Accounts payable $ 2,664 $ 2,944
Deferred revenues 4,808 6,438
Debt 29,277 29,147
Other liabilities 4,071 4,749
------------ ------------
Total liabilities 40,820 43,278
------------ ------------
Stockholders' equity 11,616 33,481
------------ ------------
Total Liabilities and Stockholders' Equity $ 52,436 $ 76,759
============ ============
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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