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Hansen Medical, Inc. (NASDAQ:HNSN)

Q1 2014 Earnings Conference Call

May 07, 2014 05:00 PM ET

Executives

Peter Mariani - CFO

Chris Lowe - Interim CEO

Analysts

Chris Hamblett - Cowen and Company

Jon Demchick - Morgan Stanley

Jeffrey Cohen - Ladenburg Thalmann

Operator

Good day, ladies and gentlemen, thank you for standing by. Welcome to the Hansen Medical 2014 First Quarter Results Conference Call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be open for questions. (Operator Instructions)

I would now like to turn the conference over to Mr. Peter Mariani, Chief Financial Officer. Please go ahead, sir.

Peter Mariani

Thank you, Daniel. Good afternoon, everyone. Welcome to Hansen Medical’s first quarter 2014 results conference call. My name is Pete Mariani and I am the Chief Financial Officer of Hansen Medical. With me today is Chris Lowe, Hansen Medical’s Interim CEO.

Before we begin, I would like to inform you that comments made on today’s call maybe deemed to contain forward-looking statements. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of certain risks and uncertainties. These risks and uncertainties are described and detail in the company’s most recent Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission on March 30, 2014 and other filings with the SEC. These filings can be found through our website or at the SEC’s EDGAR database. Prospective investors are cautioned not to place undue reliance on such forward-looking statements.

And with that, I will turn the call over the Chris.

Chris Lowe

Thank you, Pete. Good afternoon everyone and thank you for joining us today for our first quarter conference call. First, I’d like to say how pleased we are to welcome Cary Vance as Hansen Medicals new President and CEO and member of the Board of Directors.

Cary joins Hansen from Teleflex where he most recently served as President of anesthesia and respiratory. Prior to joining Teleflex Cary held Executive Leadership at Covidien most recently servicing as the Vice President of Interventional Oncology. From 1997 to 2007 prior to joining Covidien, Cary served in a series of roles with progressive responsibility at GE Healthcare including capital equipment and sales management.

Throughout his carrier Cary has delivered above average revenue growth were also driving margin expansion opportunities. Many of his experience are been with disruptive technology and I am confident that he’s commercial expertise and leadership will be a tremendous asset for Hansen as we evolve into this next stage of growth.

Cary’s first day on the job will be May 23rd and as you would expect he’s already diving into the business and will be well prepared to hit the ground running when he arrives. Our plan to remain on with the company until Mid June to ensure and effective transition before we turn into the Board of Directors,

I have enjoyed this transition period interim and remain very encourage by Hansen’s outstanding team who is clearly committed to the long term vision of advancing intravascular robotics. Our intravascular robotics platforms continue large global markets with very strong growth prospects.

Currently we believe our Magellan and Sensei robotic systems and related catheters can access more than 75% of the nearly 2 million peripheral and electrophysiology procedures occurring each year. Once fully developed we believe our expanded product line will have the potential to impact up to 4 million intravascular procedure performed annually including peripheral, EP, cardiovascular and neurovascular interventions.

We are committed to demonstrate the breadth of capabilities our robotics platforms provide and to further validating the clinical and economic benefits of our technologies. With the addition of Cary Vance as our new CEO I am confident of our ability to deliver on this vision.

Let me turn to the agenda for the rest of today’s call. First I’ll provide an update on the commercial slides our commercial results of the first quarter and how those results beat to the progress we are making on our key operating priorities for 2014. I’ll then turn the call back over to Pete who will review our financial results.

Pete and I will then take your questions at the conclusion of our remarks. In Q1, we commercialized two robotic systems one Magellan and one Sensei. Positions performed in estimated 829 procedures representing year-over-year growth of approximately 6%. We placed one additional system for the purpose of completing a single center clinical trial to study a variety of peripheral vascular ambulation procedures.

These specific systems commercialized and placed in the quarter demonstrate progress towards the lap the four key operating objectives we shared with you on last quarter’s call. These four objectives include increasing clinical experienced and published data, expanding position awareness of our robotic technologies, growing the installed sub-systems and continuing the broaden the product platform.

Each of these priorities focuses on expanding clinical and economical evidence because of broad market adoption of our robotic platforms. Let me cover each of these objectives in further detail now and update you on our progress towards these goals.

On April 29 of this year we announced the completion of the first procedures with our Magellan 6 French Robotic Catheter. These treatments are part of an ongoing study of peripheral vascular ambulation procedure at Pompidou hospital in Paris, where we placed the Magellan robot with Professor Marc Sapoval and Dr. Olivier Pellerin for our 25 patients study. The first three subjects were successfully treated approximately two weeks ago and the initial experiences were we reviewed at the guest conference in San Francisco this past week. These initial cases included Uterine Fibroid Embolization procedures and a Transarterial Chemoembolization or TACE procedure for liver metastasis of color cancer. These initial cases demonstrate new opportunities for the Magellan robotic system. The study is anticipated to continue through the third quarter with manuscripts results expected at the end of the year.

The ROVER registry continues as part of Hansen’s long-term data strategy to collect post-market surveillance of device performance. ROVER X is a database for the preparation of educational materials, abstracts, manuscripts or presentations that disseminate clinical information to the medical community. Its initial published results are anticipated for the end of this year. In the second half of this year, we will also begin three additional Magellan studies to collect additional targeted data.

Now looking to Sensei data, we previously discussed our success of converting our 300 patient dual arm IDE study to a single arm of the Sensei system in the three of atrial fibrillation. To-date this new study has enrolled 33 patients at five centers. This enrollment rate has not met our internal expectations therefore we recently outlined an acceleration plan for enrollment and our objective is to complete enrollment by early 2015.

Physician awareness of intravascular robotics is arriving as we expand our participation and important medical conferences. So far 2014, Magellan was the subject of approximately nine physician presentations at five global interventional meetings. We believe live cases and presentations effectively drive interest in adoption while influencing key opinion leaders to become advocates for robotic technology and community hospitals to become aware of our value proposition.

The recent introduction of the Magellan 6 French Catheter has allowed us to begin targeting interventional radiologist which has been demonstrated by our attendance at major vascular meetings focused on this specialty including SIR guest in [indiscernible]. Also in Q1, we equipped a mobile demonstration lab with both a Magellan and a Sensei system. This demo lab travels to hospitals across the country allowing physicians, administrators and other key decision makers to receive hands of experience with the robotic systems in a single day in the convenience of their own community. Bringing the robotic technology directly to hospitals principal decision makers both supports our physician customer base and potentially accelerates our sales process.

To-date the mobile demo lab has made 26 site visits and generated a diverse audience of over 500 guest that included physicians, executive level hospital administration, nursing staff, donors, local media, community leaders, and other interested parties. This mobile lab initiative also broadens community awareness of intravascular robotics. We expect the mobile demo lab will help to drive interest beyond KOLs and into community hospitals. Intravascular robotic has the potential to bolster the profile of a community hospital by offering advanced technology and topnotch care closer to home.

Let me share two recent examples. Miami Valley Hospital in Dayton, Ohio is an excellent case study of how community hospitals can utilize Magellan as a center piece to growth its vascular line. The Magellan system is a key focus in their current marketing activities. Local marketing has already resulted in a variety of news coverage and published articles. We are encouraged by their efforts and believe the combined with the performance of the Magellan system, they will result in increased patient traffic and referral patterns. We are very pleased to be partnering with Miami Valley.

Sierra Providence Hospital in El Paso, Texas is another example where Hansen robotics has the potential to provide wide program success in a community hospital setting. Sierra Providence has demonstrated a clear commitment to intravascular robotics by purchasing both the Sensei and Magellan systems that we commercialized in the first quarter. Sierra Providence also conducted a highly attended media in community awareness event that resulted in extensive media coverage.

In parallel, the hospital is conducting a comprehensive marketing effort, enhancing its working with Sierra Providence to measure the impact of both systems on incremental patients and to demonstrate the overall value proposition. As patient traffic increases at these health centers, we expect to see physicians expand their utilization of the Magellan platform. Our goal is to share with your in future quarters how referral pattern and utilization evolve with the Magellan intravascular program.

The continued expansion of our technology is a key focus for our organization including the development of a suite of catheters to broaden the clinical applications in which our technology can be utilized. The Magellan 6 French Robotic Catheter is the latest addition to the growing family of catheters for use with the Magellan robotic system. This is an important milestone for Hansen Medical.

The work of professor Sapoval and Dr. Pellerin will be followed by the site in the United States utilizing our 6 French Catheters in the coming weeks. And there are cumulative results will help to develop a body of evidence with this new Catheter. The Magellan 6 French Robotic Catheter will enable physician to apply the benefits of robotic procession control and procedural predictability to the treatment of many more vascular patients.

The next milestone for product development is the Magellan mobility platform. During the quarter, we completed the development of our initial units and their currently undergoing testing in Houston and Miami. The Magellan mobility platform will allow hospitals to easily move the robotic arm away from the table and will allow us the opportunity to market multi room installations at potentially higher price points.

We expect Hansen will be ready to market multi room installations in the second half of the year. We also continue to work on our larger profile Magellan 10 French Robotic Catheter. And continue to expect to complete regulatory submissions on this product later this year. This catheter will potentially assist physician and placement of covered stems, larger atherectomy devices and in other procedures where a larger diameter catheter is preferred.

Lastly speaking to our ET system, the Sensei X2 prototype is on display this week at the Heart Rhythm Society scientific session in San Francisco. This new prototype version feature faster processing enhanced image integration and a slimmer design. The improved processing and imaging capabilities of the Sensei X2 will also be available to users of the current Sensei X upon release.

We expect Hansen will be ready to commercialize the Sensei X2 in the second half of the year. We’re very pleased with the progress we are making on all of these priorities and we look forward to updating you on our progress next quarter. With that I’ll turn the call over to Pete for review of our financial results.

Peter Mariani

Thank you, Chris. First quarter revenue increased 25% to $3.7 million compared to revenue of $3 million in the prior year. We commercialize two systems in the quarter including one Magellan and one Sensei, compared to one Sensei in the prior year’s first quarter.

The company sold 685 catheters in the quarter representing a 60% increase over the prior year. We estimate the positions performed approximately 829 Hansen Robotic procedures during the first quarter, representing a year-over-year increase of 6%. Gross profit in the first quarter of 2014 was $400,000 or 11% in sales, compared to $500,000 or 16% of sales for the same period in 2013.

First quarter gross margin was negatively impacted by $256,000 of additional product testing cost required in the quarter partially offset by lower service costs compared to prior year. The additional testing costs were unique to the quarter and are not continuing in the second quarter.

Research and development expenses for the first quarter were $4.4 million compared to $4.1 million in the same period of 2013. The increase of $300,000 is primarily due to incremental cost associated with continued new product development in clinical program initiatives design 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 in the same period of 2013. The increase of $1.8 million is primarily due to cost related to the development of our global sales organization and marketing activities in the quarter and incremental costs primarily related to the CEO transition.

Net loss for the quarter was $14.4 million or $0.42 per share based on average weighted shares outstanding of $103.3 million, compares to net income of $17.2 million or $0.26 per share based on 67.3 million weighted average shares outstanding during the same period of last year. Net loss for the first quarter of fiscal of 2013 also included $4.5 million loss on the settlement of litigation.

Turning to the balance sheet, cash, cash equivalents, short-term investments and restricted cash as of March 31 was approximately $38.4 million and increase $3.1 million compared to $35.3 million at December 31. During the quarter, the company received $40 million of cash from holders of Series A warrants to purchase 11.4 million shares of common stock that were issued as part of our August 2013 private placement transaction.

Under the terms of the private placement transaction the exercise of the Series A Warrants was trigged by the February FDA clearance of the Magellan 6 French Robotic Catheter excluding the impact of this $40 million of Warrant proceeds the company incurred negative cash flow of $10.8 million in Q1 compared to $11.8 million in Q4 2013 and $9.8 million in Q1 of 2013.

Warrant holders from the private placement transaction continue to hold 11.4 million Series B Warrants with an exercise price of $50 per share of common stock and 11.4 million Series C warrants with an exercise price of $2 per share of common stock. These warrants expired in August 2015 and are not tied to a product development milestone or any other milestone. Total proceeds from the Series D warrants, if fully exercised, would be approximately $17 million and from the Series C warrants, if fully exercised, would be an additional $23 million.

We anticipate filing our quarterly report for Q1 on Form 10-Q not later than Monday, May 12. This quarterly report will include going concern disclosures. These disclosures will note the Company will need to raise additional capital in order to meet our operating projections over the next 12 months. The Company continues to evaluate the form and timing of opportunities to raise additional capital including potential equity transactions which could include the exercise of Series B and C warrants as I discussed a moment ago; debt transactions or strategic financing transactions. Although we believe we will be able to raise the required funds. We cannot predict the form, timing, or terms under which the financing will be acquired and therefore our Form 10-Q will include additional disclosures regarding these risks.

Now in closing we continue to be encouraged by our progress and we believe we have a solid foundation which we will drive our commercialization efforts in 2014 and the future. We believe we have the right pieces in place to demonstrate the clinical and economic value of our platforms and to achieve our goal of making our solution the standard of care in intravascular procedures. We continue to see growing momentum in the business and in the quality of our system pipeline continues to improve. However, given our current CEO transition, we will not be providing formal financial system placement or procedure guidance at this time however we would note that we continue to expect growth in 2014 across many metrics in our business including the number of systems commercialized, procedure volumes and revenues.

And with that, I would like to open the call up to questions. Daniel.

Question-and-Answer Session

Operator

Thank you, Mr. Mariani. Ladies and gentlemen, we will now begin the question and answer season. (Operator Instructions) Our first question is from the line of Chris Hamblett with Cowen and Company. Please go ahead.

Chris Hamblett - Cowen and Company

Thanks for taking the question. With regard to Magellan in terms of outlook for the near term, what kind of drives net growth and adoption specific to the maybe the datasets are going to see in the Q3 and Q4, is it time we should look specifically in the ROVER study or other clinical studies you’re going to start kind of maybe outlined the details of the studies specific in Magellan? And I’ll ask one follow-up.

Chris Lowe

Sure, thanks Chris. Over the near-term when we think that the momentum that we continue to see in the maturing of this pipeline in conversations with hospitals is going to drive the growth of the system placements. We do believe that as Dr. Sapoval and others continue to perform and report on 6 French cases in an anecdote but that will continue to drive additional growth as well and when they get to the point where they can publish the results of the 25-patient study that will certainly be a driver. But again, we expect to see this additional data that you’re specifically asking to being reported on and published toward the back half of the year.

Chris Hamblett - Cowen and Company

Okay and anything specific we should look for in that data?

Chris Lowe

First by just the successful use of the 6 French in the smaller vessel procedures and including what we consider very exciting possibility in these embolization type of procedures. These are very unique procedures that are being to uterine fibroid embolization cases carry tremendous potential. If we continue to see good results from that, the embolization procedure for cancer treatment is also a very exciting opportunity and we’ll the results coming of out these -- this work is being done now and the additional work is going to be done by U.S. physicians beginning here in the next several weeks.

Chris Hamblett - Cowen and Company

Thanks and the three additional studies you’ve spoke to those already decided or there are going to be three new ones from Magellan?

Chris Lowe

The three new studies single center-type studies targeted towards specific research that we would like to do in coordination with physicians that we’re working on it really speaks to anything from the clinical utilization of the product to the economic benefits of the product and workflow within the hospital radiation reduction and things like that we’re very interested in getting focused targeted 20 to 30 cases done and reported on as quickly as we can -- as quick as we get that achieved.

Chris Hamblett - Cowen and Company

Okay so we’ll see potential C data in 2015 from that or little bit lighter?

Chris Lowe

Yes, certainly in 2015 and again how the way that we look at here is we’re trying to get as much of this work done as quickly as we can so that these physicians who are typically on podium in the large competencies toward the back half of the year we’ll be able to report on their experiences in those conferences.

Chris Hamblett - Cowen and Company

Okay. Thank you. And then just one follow up, in addition to the 6th and 10 trench catheters in the pipeline kind of what else is in the work through the pipeline opportunity near term and maybe if you could provide a little bit of color on you’ve mentioned neurovascular opportunities and kind of the time frame for what you might be looking to do in the neurovascular space?

Chris Lowe

Yes, great question and I think we’ve outlined for you the 6 and the 10 are really the key near term catheter developments that we work on. We really do emphasize also this Magellan mobility platform and ability to create more mobility across several different labs within the hospital that’s a development that we are very excited about here and look to continue to development that here in the back-half of the year. The Sensei work that is going on right now and potentially we’re going to commercial the Sensei X2 in the back half of the year that’s also the potential business driving there. And when we look to the future we haven’t given timing but we certainly do look towards a potentially a much larger catheter for structural hard type work and we do look towards a 4 trench or smaller device in one form or another that can assist again we have smaller vessels and potentially reach up into the neurovascular but we have not put timing together on those projects yet.

Operator

Our next question is from the line of David Lewis with Morgan Stanley. Please go ahead.

Jon Demchick - Morgan Stanley

Hi so Pete on today’s call you discussed a lot about plans discussed a lot about plans to build both clinical evidence and then efforts to kind of broaden up sales and while clearly the benefits won’t be seen overnight we did see I guess a step up in SG&A and R&D this quarter. Are these kind of the levels that we’d expected to be seeing moving forward to drive system placements and adoption or would we expect these to moderate throughout the year?

Chris Lowe

Yeah, good question Jon. We have talked about before even in the fourth quarter call we talked about how we more than doubled the U.S. capital sales force last year significant turnover in sales globally last year. And we talked about back then that that would be moderating this year and we would continue to add sales force through the first quarter which we have done. But beyond that, it would moderate. Because that we do think, we’ve got a good sales leadership team in place. We think we’ve got some great sales reps who have excellent experiences selling capital in the past, they have existing relationships with physicians and the say suit and hospitals and we think we do have a core sales group that could lead us to the future sales growth and placements.

And on the R&D side, we have made significant investments in addition to that I think we’ve proven that we can get some products out of that pipeline. So we don’t see the need to grow expenses dramatically from where we are. We think we can moderate around this level as we continue to sell more units and improve utilization across the pipeline.

Jon Demchick - Morgan Stanley

Thank you, very clear. And I just had a quick follow up on I guess guidance that there was no formal guidance but you did mention that you’ve expect I guess systems to grow year-over-year. I guess we’re ahead of the pace from last year but clearly last year was a bit back half loaded. Have you guys give any thoughts on where the pipeline stands right now and whether your expect is for the next few quarters to be a bit more balanced or are into a similar I guess trajectory from last year?

Chris Lowe

What we’ve always said that this is a -- the sales process is nine to 18 months with these different hospitals we have matured several conversations with many hospitals and to that nine to 18 month window and we’re having good conversations with these accounts. I think certainly all of us would have liked to see a few more systems in this quarter, but what we can say is we really haven’t lost deals we continue to work with these accounts. Those accounts are working through their internal approval process and this is what’s have including multiple layers. And what we’ve seen is several hospitals are utilizing donor funds to come in and help support these purchases. And all of those many things are coming together. We, like we said in the prepared remarks, we do expect growth over last year and so we certainly would expect to see more units being sold.

Whether that but I’ll continue to caution you as I’ve done before this is going to be up in there. This is new technology we’re going to have some strong quarters, some weaker quarters but in general as we’re trying to communicate here on this call underlying the financial results and the top line results is really an improving quality of pipeline and growing momentum across the business and as you’ve heard us talk about that with the work that we’re doing on the clinical activity, the R&D activity, the work we’re doing with the mobile demonstration lab, many good things happening that are continuing to improve the prospects and mature the pipeline.

Operator

(Operator Instructions) Our next question is from the line of Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen – Ladenburg Thalmann

I wondered if you could emphasize about the 6 French Robotic Catheter and at what percent of the compensation of the Catheter used for Magellan could had encompass over the as two quarters?

Peter Mariani

Great question. I think I have look at this one way first and that is the fact that many of disposition who do peripheral vascular procedures, actually preferred to use 6 and 7 French size devices in their day-to-day practice. So when we got a portfolio of products that includes a large 9 French device and a 6 French device, I think the general physician out there might be drawn toward the 6 French as the lead, the product for their practice. And reserved the 9 French for some of these larger more complex PV type procedures, so we may see a developed such whatever 6 French becomes the lead product. But again we need more experienced with that before we see that come to probation or not.

Jeffrey Cohen – Ladenburg Thalmann

And you saw pricing differential that you anticipate?

Peter Mariani

No, not at current time.

Jeffrey Cohen – Ladenburg Thalmann

Okay. So same pricing, okay. And as far -- so in 2013 you placed the total, there’s how many Magellan is out there now including the one from Q1 there’s 10?

Peter Mariani

No, we commercialized 14 in total as of last year and then an additional one in this quarter.

Jeffrey Cohen – Ladenburg Thalmann

So it’s 15 out in the market place being used?

Peter Mariani

Yes. Well, again Jeff, there’s difference how many are actually performing cases versus once that are set up in training centers and I think what we’ve talked about before as we got about 7 to 9 of those that are actually perform in cases. Some of those are in training centers, some of those are in the process of being installed either one tier in U.S. that has been shift but not quite installed yet or we have a few in international distributors that in the process of being installed. So we’re still a low number of actual systems that are performing cases on a day-to-day basis.

Jeffrey Cohen – Ladenburg Thalmann

Okay. And one more if I may could you talk a little bit about the Sensei X2 for existing Sensei users is there a software upgrade that is available and what is the cost of that?

Peter Mariani

Yeah. There is a software upgrade that will upgrade their existing systems and for those who account that under a service contract we will offer that to them as part of that service current track. So it is an backward compatible upgrade that we can make available to our existing customers.

Jeffrey Cohen – Ladenburg Thalmann

Okay. And for folks not under service agreement what’s the lease price?

Peter Mariani

We haven’t settled on that yet. We’ll established that when we head closer to the launch.

Jeffrey Cohen – Ladenburg Thalmann

Okay. And you expect to launch when?

Peter Mariani

In the back half of the year?

Operator

Our next question is a follow-up question from the line of Chris Hamblett with Cowen and Company. Please go ahead.

Chris Hamblett – Cowen and Company

Thanks for taking the follow-up just one, quick one on your mobility system, what do you expect, who do you expect to be the earlier adopter of that system if you have any commentary at this time, as you already to project that?

Peter Mariani

Well, we had handful of systems are being utilize on regular basis right now; we’re testing of the two of those pieces in the U.S. right now. And I would expect many of users, many of our current users are talking to us about or they wish they could move it from longer room. And I think in some accounts are going to have it locked in one room and they won’t care about the mobility and other are going to launch the flexibility of little but around. And another they want to settled up in a Hybrid OR and if have been in this Hybrid OR they typically have you on the table in the middle and lots of equipment around the side. And they want to free them to be able to bring equipment in their procedure will moving out. And this allows us to get into this Hybrid OR environments and be as flexible as we need to be with those customers.

Operator

Mr. Lowe, there are no further questions at this time. Please continue with any closing remarks.

Chris Lowe

Great. Thank you all for joining us today, we appreciate your interest in Hansen Medical. It was truly a privilege to service Hansen Medical’s Interim CEO for this transition of months. We look forward to Cary Vance coming on Board as Hansen’s new CEO and updating you on our progress throughout 2014. I know Cary looks forward to working with each and every one of you. Thanks very everybody have a great day.

Operator

Ladies and gentlemen, this concludes the Hansen Medical 2014 first quarter results conference call. Thank you for your participation you may now disconnect.

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