Breaking News

Tweet TWEET

Hansen Medical Reports Full Year 2012 and Fourth Quarter Results

Hansen Medical Reports Full Year 2012 and Fourth Quarter Results 
Record Annual Procedures and Catheter Sales; Six Consecutive Quarters
of Procedure Growth Through Q4; Over 10,000 Patients Have Now Been
Treated With Intravascular Robotics; Shipped Three Robotic Systems in
Q4 and Three additional Robotic Systems in February 2013; At Least 9
Magellan Systems Expected to Be Installed in Hospitals by the End of
Q1 2013; Strengthened Cash Position Through Expanded License
Agreement With, and Stock Sale to Intuitive Surgical 
MOUNTAIN VIEW, CA -- (Marketwire) -- 02/27/13 --  Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today
reported recent business highlights and financial results for the
full year and fourth quarter ended December 31, 2012.  
Full Year 2012 Summary and Recent Business Highlights  


 
--  Full Year 2012 Results:
    --  Shipped 12 robotic catheter systems: 6 Magellan(TM) Robotic
        Systems (4 U.S. and 2 internationally) and 6 Sensei(R) X
        Robotic Catheter Systems (3 U.S. and 3 internationally)
        --  3 of the shipped Magellan Robotic Systems and one of the
            shipped Sensei Robotic Systems were shipped under the
            company's commercial evaluation program
        --  Shipped a total of 122 robotic systems worldwide since first
            commercial launch
            
            
    --  Recognized revenue on 13 robotic systems (5 U.S. and 8
        internationally)
        --  8 of the systems recognized as revenue were shipped in 2012
            and 5 were shipped in previous years
            
            
    --  We estimate a record 2,688 procedures performed, up 8% year over
        year
        
        
    --  Sold a record 2,807 catheters, up 1% year over year
        
        
    --  Generated revenue of $17.6 million, down 20% compared to 2011.
        2011 revenue was higher than 2012 primarily due to the inclusion
        of 12 systems in 2011 revenue which had been shipped in 2010 and
        prior, compared to only 5 systems in 2012 revenue which had been
        shipped in previous years.
        
        
--  Shipped three additional Magellan Robotic Systems in February of 2013
    to hospitals in Europe under the company's commerci
al 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
    
    
--  New Products:
    --  Received U.S. regulatory clearance and launched our Magellan
        Robotic System including catheters and related accessories for
        peripheral vascular interventions
        --  First Magellan System sold and clinical cases performed in the
            U.S.
        --  Artisan(R) Extend Control Catheter cleared in the US and
            Europe, to improve clinical workflow and reduce manufacturing
            costs
        --  Sensei X 4.1 software upgrade cleared in the US and Europe
            which provides enhanced visualization and clinical utility
            through improved third party product integration
            
            
--  Growing body of clinical data and physician presentations
    demonstrating clinical value of intravascular robotics
    --  More than 10,000 patients have now been treated with Hansen
        Medical intravascular robotics
    --  Four live cases successfully performed with Magellan Robotic
        System by Dr. Barry Katzen, founder and Medical Director of the
        Baptist Cardiac & Vascular Institute (Baptist Hospital of
        Miami), at Transcatheter Cardiovascular Therapeutics (TCT)
        conference and 25th Annual International Symposium on Endovascular
        Therapy (ISET)
        
        
--  Operational Excellence:
    --  Lowered product costs through improved design, and productivity
        gains through lean manufacturing initiatives
    --  Reduced operating expenses $11.9 million, or 22%, compared to
        2011, excluding the $10.5 million impact of funded R&D credits
        received in 2011, as the company drove efficiencies across the
        organization and even though it added resources to commercial
        operations
        
        
--  Capital Raising Activities: Received $30 million from Intuitive
    Surgical (NASDAQ: ISRG) in the fourth quarter through a $20 million
    fee for an expanded license agreement and a $10 million private
    placement of Hansen Medical common stock at a 5% premium, with an 18
    month lock-up
    
    
--  Expanded our broad and deep intellectual property portfolio for
    medical robotics through the issuance of 15 additional U.S. patents in
    2012
    
    
--  Strengthened Leadership Team: Created new positions of Chief Operating
    Officer and Senior Vice President, Global Sales, and appointed new
    Vice President to oversee Global Marketing and Business Development
    initiatives, all intended to build further operational and commercial
    expertise
    
    
--  Board of Director Changes: Appointed four new directors in 2012,
    recruited to bring additional industry, operational and commercial
    expertise to the Board

  
Fourth Quarter 2012 Financial Summary  


 
--  Shipped three systems (1 Magellan system and 2 Sensei systems)
    --  Of the three systems shipped in the fourth quarter, one Sensei
        system was part of our commercial evaluation program
        
        
--  Generated revenue of $4.3 million in the fourth quarter, down 30% year
    over year
    --  Recognized revenue on 2 systems during the fourth quarter,
        including 1 Magellan system and 1 Sensei system
    --  Sold a record 840 catheters in the fourth quarter, up 22%
        sequentially and 18% year over year
        
        
--  We estimate physicians performed a record 755 Hansen robotic
    procedures in the fourth quarter, up 15% sequentially and 19% year
    over year. This is the sixth consecutive quarter of estimated
    procedure growth.
    
    
--  Held cash, cash equivalents and short-term investments of $41.2
    million at December 31, 2012, representing a quarterly cash gain of
    $19.5 million. The current quarter cash position was positively
    impacted by the receipt of $30 million from the expanded licensing
    agreement with and stock purchase by Intuitive Surgical, and
    negatively impacted by a $620,000 negative valuation adjustment of a
    short-term investment. Excluding these items, cash burn in the quarter
    would have been $9.9 million.

  
"2012 was a strong year for Hansen Medical, as we achieved one of the
most significant milestones in the Company's history with the receipt
of FDA clearance for our Magellan Robotic System, and the subsequent
first system sale and clinical cases in the U.S.," said Bruce
Barclay, Hansen Medical's President and Chief Executive Officer. "The
Magellan System has the potential to be a significant growth driver
for our business and to transform the way endovascular procedures are
performed. Since commencing the initial U.S. launch of the Magellan
System in June, we have generated a large and growing pipeline of
clinical interest in our robotic technology through live case
demonstrations and multiple presentations by leading physicians at
prominent industry conferences. While the difficult macroeconomic
environment has caused hospitals to prolong their evaluation period
for new technologies, we
 anticipate that at least nine Magellan
Systems will be installed in hospitals by the end of the first
quarter, and I expect that the adoption of our technology will grow
as physicians generate additional clinical data." 
"I am also pleased to announce that we have delivered annual records
for catheters sold and procedures performed by our customers, as well
as six consecutive quarters of procedure growth. The strong procedure
rates and catheter sales seen in recent quarters, driven primarily by
our base electrophysiology business and to a lesser extent by the
introduction of our Magellan System, are indicative of the
significant value we believe physicians and hospitals can, and are,
deriving from our intravascular robotic systems. More than 10,000
patients have now received the benefits of intravascular robotics
from Hansen Medical, and this is a testament to the innovation and
hard work of all of our employees." 
Mr. Barclay continued, "Finally, our expanded licensing agreement
with Intuitive Surgical is a validation of our technology from the
global leader in medical robotics and has further bolstered our
balance sheet and provided us with capital to continue to support the
initial global launch of the Magellan System." 
2012 Fourth Quarter Financial Results  
Total revenue for the fourth quarter ended December 31, 2012 was $4.3
million compared to revenue of $6.2 million in the same period in
2011. During the fourth quarter, the Company shipped 3 systems (2
Sensei systems and 1 Magellan system) and recognized revenue on 2
systems (1 Magellan system and 1 Sensei system), as well as shipment
of a record 840 catheters. Catheter sales were up 22% compared to the
fourth quarter of 2011 and up 18% sequentially. Further, an estimated
record 755 Hansen robotic procedures were performed in the period, an
increase of 19% compared to the same quarter of the prior year, and
up 15% sequentially.  
Cost of revenues for the fourth quarter was $3.5 million. As a
result, gross profit for the quarter was $868,000 or 20% of revenue,
compared to gross profit of $1.6 million, or 27% of revenue for the
same period in 2011. The decrease in gross profit in the current
quarter is primarily the result of fewer system sales, partially
offset by continued improvement in catheter and service margins.  
Research and development expenses for the fourth quarter were $3.5
million, compared to $1.9 million for the same period in 2011. The
2011 amount included $3.7 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 fourth quarter of 2011,
prior year research and development expenses were higher primarily
due to additional development costs associated with the Company's
Magellan System and higher employee related costs.  
Selling, general and administrative expenses for the fourth quarter
were $6.9 million, compared to $8.6 million for the same period of
2011. The net decrease in the current quarter is primarily due to
lower legal fees and stock based compensation.  
Net income for the fourth quarter was $9.6 million, or $0.15 per
share, based on average shares outstanding of 65.3 million. This
compares with a net loss for the fourth quarter of 2011 of $9.5
million or $0.16 per share, based on average shares outstanding of
57.9 million. Net income for the fourth quarter of 2012 included
total non-cash stock compensation expenses of $0.6 million compared
to $1.2 million in the fourth quarter of 2011.  
Cash, cash equivalents and short-term investments as of December 31,
2012 were $41.2 million, compared to $21.6 million as of September
30, 2012, and $52.2 million as of December 31, 2011.  
Cash gain in the quarter was $19.5 million compared to a cash burn of
$7.8 million in the third quarter of 2012. The current quarter cash
position was positively impacted by the receipt of $30 million from
the expanded licensing agreement with and stock purchase by Intuitive
Surgical, and negatively impacted by a $620,000 valuation adjustment
of a short-term investment. Excluding these two items, cash burn in
the quarter would have been $9.9 million. The third quarter cash burn
was positively impacted by a $1.5 million insurance reimbursement.
Excluding this item, third quarter cash burn would have been
approximately $9.3 million.  
2012 Full Year Financial Results  
Total revenue for the year ended December 31, 2012 was $17.6 million,
compared to $22.1 million for 2011, a decrease of 20%. In 2012, the
Company shipped 12 robotic catheter systems, recorded revenue on 13
systems, sold a record 2,807 catheters, and physicians performed a
record 2,688 estimated procedures. These results compare to 2011
shipments of 13 robotic catheter systems, revenue on 23 systems,
catheter sales of 2,787 and estimated procedures performed by
physicians of 2,498. 2011 revenue was higher than 2012 primarily due
to the inclusion of 12 systems in 2011 revenue which had been shipped
in 2010 and prior, compared to only 5 systems in 2012 revenue which
had been shipped in previous years. 
Total operating expenses for 2012 were $42.1 million, compared to
2011 operating expenses of $43.5 million which included $10.6 million
of funded research and development credits from the Philips agreement
(which were recorded as a reduction of expense in 2011). Excluding
these research and development credits, 2011 operating expenses were
22.0% higher than 2012 operating expenses primarily due to additional
development costs associated with the Company's Magellan System and
higher employee related costs.  
The Company's net loss for 2012, including non-cash stock
compensation expense of $2.9 million, and a gain on the licensing of
intellectual property of $20.0 million, was $22.1 million, or $0.35
loss per basic and diluted share, based on average basic and diluted
shares outstanding of 62.5 million. The Company's net loss in 2011,
including non-cash stock compensation expense of $6.7 million, and a
gain on the sale of intellectual property of $23.0 million, was $16.7
million, or $0.30 loss per basic and diluted share, based on average
basic and diluted shares outstanding of 55.4 million. 
Full Year 2013 Outlook  
Hansen Medical will continue to focus on its three strategic
initiatives of launching the Magellan Robotic system, driving EP
procedure adoption, and achieving operational excellence. The company
anticipates growth in total robotic system shipments in 2013 compared
to 2012, as well as growth in procedures and catheter sales. However,
given the uncertainty of the timing of system shipments, the company
is not in a position to provide specific financial guidance. 
We expect continued improvement in gross margins over 2012 levels
based on our current volume assumptions of product sales and
increased efficiency from our cost savings initiatives. We also
expect that operating expenses will increase moderately as we
anticipate adding resources to support the commercial launch of our
Magellan System and the continuing adoption of our Sensei System. We
will continue to invest in new products in 2013, and the company
anticipates the commercial launch of our 6F vascular catheter for use
in smaller vessel, peripheral applications by the end of 2013.  
Finally, the 
Company's year-end cash position of $41.2 million is
expected to be sufficient to fund the Company's operations for at
least the next twelve months as we continue to execute on our
strategy. 
"Hansen Medical is shifting the focus of its resources towards sales
and marketing in order to further support the global launch of our
Magellan System. We will continue to leverage the positive data being
generated by physicians with our technology in order to drive further
adoption of intravascular robotics around the world," concluded Mr.
Barclay.  
Hansen Medical Conference Call  
Company management will hold a conference call to discuss its 2012
full year and fourth quarter results today, February 27, 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 877-941-1427 or 480-629-9664
(international callers). An audio replay of the webcast will be
available approximately one hour after the completion of the
conference call through March 6, 2013, by calling 877-870-5176 or
858-384-5517 (international callers), and entering access code
4593337.  
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(TM) Robotic System, NorthStar(TM) 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(R) 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(R) 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," 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 for hospitals, patients and physicians,
expectations of shipments and installations of our robotic systems,
catheter sales, and procedures, expectations of gross margins and
operating expenses for 2013, the sufficiency of the company's cash
resources for supporting the Company's operations, expected
efficiencies from cost saving initiatives, 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 our products in the vascular markets;
potential safety and regulatory issues that could slow or suspend our
sales; the effect of 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 September 30, 2012 filed with the SEC on
November 9, 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. 


 
                                                                            
                               HANSEN MEDICAL                               
                                                                            
              Condensed Consolidated Statements of Operations               
                                (unaudited)                                 
                   (in thousands, except per share data)                    
                                                                            
                                  Three months ended        Year ended      
                                     December 31,          December 31,     
                                 --------------------  -------------------- 
                                    2012       2011       2012
       2011   
                                 ---------  ---------  ---------  --------- 
Revenues                         $   4,344  $   6,170  $  17,636  $  22,129 
Cost of revenues                     3,476      4,526     14,026     17,211 
                                 ---------  ---------  ---------  --------- 
Gross profit                           868      1,644      3,610      4,918 
                                 ---------  ---------  ---------  --------- 
Operating expenses:                                                         
  Research and development           3,494      1,898     16,126     12,156 
  Selling, general and                                                      
   administrative                    6,801      8,612     25,987     31,428 
                                 ---------  ---------  ---------  --------- 
Total operating expenses            10,295     10,510     42,113     43,584 
Gain on licensing of                                                        
 intellectual property              20,000         --     20,000         -- 
Gain on sale of intellectual                                                
 property                               --         --         --     23,000 
                                 ---------  ---------  ---------  --------- 
Gain (loss) from operations         10,573     (8,866)   (18,503)   (15,666)
Other income (expense), net           (886)      (620)    (3,528)    (1,046)
                                 ---------  ---------  ---------  --------- 
Net income (loss) before income                                             
 taxes                               9,687     (9,486)   (22,031)   (16,712)
Income tax expense                     114         --        114         -- 
                                 ---------  ---------  ---------  --------- 
Net income (loss)                $   9,573  $  (9,486) $ (22,145) $ (16,712)
                                 =========  =========  =========  ========= 
Basic net income (loss) per                                                 
 share                           $    0.15  $   (0.16) $   (0.35) $   (0.30)
                                 =========  =========  =========  ========= 
Diluted net income (loss) per                                               
 share                           $    0.15  $   (0.16) $   (0.35) $   (0.30)
                                 =========  =========  =========  ========= 
Shares used to compute basic net                                            
 income (loss) per share            65,336     57,881     62,472     55,362 
                                 =========  =========  =========  ========= 
Shares used to compute diluted                                              
 net income (loss) per share        65,890     57,881     62,472     55,362 
                                 =========  =========  =========  ========= 
                                                                            
                                                                            
                               HANSEN MEDICAL                               
                                                                            
                    Condensed Consolidated Balance Sheets                   
                                 (unaudited)                                
                               (in thousands)                               
                                                                            
                                                  December 31,  December 31,
                                                      2012          2011    
                                                 ------------- -------------
                                   Assets                                   
                                                                            
  Cash, cash equivalents and short-term                                     
   investments                                   $      41,173 $      52,210
  Accounts receivable                                    5,235         5,493
  Inventories, net                                       9,134         6,617
  Deferred cost of revenues                                167         1,573
  Prepaids and other current assets                      1,765         1,829
  Property and equipment, net                            6,040         8,300
  Note receivable                                           --            --
  Other assets                                             578           737
                                                 ------------- -------------
                                                                            
Total assets                                     $      64,092 $      76,759
                                                 ============= =============
                                                                            
                    Liabilities and Stockholders' Equity                    
                                                                            
Liabilities                                                                 
  Accounts payable                               $       3,056 $       2,944
  Deferred revenues                                      2,770         6,438
  Debt                                                  29,417        29,147
  Other liabilities                                      4,110         4,749
                                                 ------------- -------------
                                                                            
Total liabilities                                       39,353        43,278
                                                 ------------- -------------
                                                                            
Stockholders' equity                                    24,739        33,481
                                                 ------------- -------------
                                                                            
Total Liabilities and Stockholders' Equity       $      64,092 $      76,759
                                                 ============= =============

  
Investor Contacts:
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800 
FTI Consulting, Inc.
Brian Ritchie
212.850.5683
brian.ritchie@fticonsulting.com  
John Capodanno
212.850.5705
John.capodanno@fticonsulting.com