|By Marketwired .||
|May 7, 2014 04:05 PM EDT||
MOUNTAIN VIEW, CA -- (Marketwired) -- 05/07/14 -- 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.
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.
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 ============= ============= HANSEN MEDICAL, INC. Condensed Consolidated Balance Sheets (In thousands) (Unaudited) March 31, December 31, 2014 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 ============= =============
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
Westwicke Partners, LLC.
Mark Klausner or Mike Piccinino, CFA
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to th...
Dec. 26, 2014 04:15 AM EST Reads: 2,659
SYS-CON Media announced that Centrify, a provider of unified identity management across cloud, mobile and data center environments that delivers single sign-on (SSO) for users and a simplified identity infrastructure for IT, has launched an ad campaign on Cloud Computing Journal. The ads focus on security: how an organization can successfully control privilege for all of the organization’s identities to mitigate identity-related risk without slowing down the business, and how Centrify provides ...
Dec. 26, 2014 04:00 AM EST Reads: 1,717
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!
Dec. 26, 2014 04:00 AM EST Reads: 1,972
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Dec. 26, 2014 02:45 AM EST Reads: 2,102
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Dec. 26, 2014 01:45 AM EST Reads: 1,589
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, focused on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud platfo...
Dec. 26, 2014 01:00 AM EST Reads: 2,422
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 26, 2014 12:00 AM EST Reads: 2,828
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
Dec. 25, 2014 04:00 PM EST Reads: 1,789
This builds on Puppet Labs' first class Windows support, including native .MSI packages for x32 and x64 operating systems, modules to extend common Windows server management tools, including Powershell, and integrations with Microsoft Azure and Visual Studio. By automating common Windows administration tasks, Puppet Labs is enabling users to adopt DevOps practices, thereby reducing the time needed to deploy applications from weeks to hours.
Dec. 25, 2014 04:00 PM EST Reads: 1,080
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
Dec. 25, 2014 02:00 PM EST Reads: 2,470
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
Dec. 25, 2014 12:30 PM EST Reads: 1,837
There's Big Data, then there's really Big Data from the Internet of Things. IoT is evolving to include many data possibilities like new types of event, log and network data. The volumes are enormous, generating tens of billions of logs per day, which raise data challenges. Early IoT deployments are relying heavily on both the cloud and managed service providers to navigate these challenges. In her session at Big Data Expo®, Hannah Smalltree, Director at Treasure Data, discussed how IoT, Big D...
Dec. 25, 2014 11:00 AM EST Reads: 2,207
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Dec. 25, 2014 11:00 AM EST Reads: 1,893
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
Dec. 25, 2014 11:00 AM EST Reads: 2,054
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 25, 2014 11:00 AM EST Reads: 1,743