Asensus Surgical, Inc.

Asensus Surgical, Inc.

ASXC
Asensus Surgical, Inc.US flagNew York Stock Exchange Arca
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94.92MMarket Cap

Q1 FY2015 · Earnings Call TranscriptMay 6, 2015

APIChatGPT

Executives

Mark Klausner - Westwood Partners Todd Pope - President and Chief Executive Officer Joseph Slattery - Executive Vice President and Chief Financial Officer

Analysts

Frederick Wise - Stifel Nicolaus & Co Inc. Lawrence Keusch - Raymond James & Associates Gregory Chodaczek - CRT Capital Group, LLC, Jeffrey Cohen - Ladenburg Thalmann & Co.

Inc.,

Operator

Good morning ladies and gentlemen and welcome to the TransEnterix Incorporated First Quarter 2015 Financial and Operating Results Conference Call. Today's conference is being recorded.

Now, I’ll turn the conference over to Mark Klausner of Westwood Partners. Please go ahead Mr.

Klausner.

Mark Klausner

Thank you. Good morning and thanks for joining us today for TransEnterix first quarter conference call.

Joining us on today's call are TransEnterix’s President and Chief Executive Officer, Todd Pope and its Executive Vice President and Chief Financial Officer Joe Slattery. I would like to remind you that this call is being webcast live and recorded, a replay of the event will be available following the call on our website.

To access the webcast please visit the events link of the IR section of our website transenterix.com. Before we begin, I would like caution listeners that certain information discussed by management during this conference call are Forward-Looking Statements covered under the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995.

Actual results could differ materially from those stated or implied by our Forward-Looking Statements due to risks and uncertainties associated with the company’s businesses. The company undertakes no obligation to update information provided on this call.

For a discussion of risks and uncertainties associated with TransEnterix businesses, I encourage you to review the company’s filings with the Securities and Exchange Commission, including the annual report on Form-10K for the year ended December 31, 2014 filed on February 20, 2015 and the Form-10Q for the quarter ended March 31, 2015 expected to be filed on or about May 6, 2015. With that it’s my pleasure to turn the call over to TransEnterix’s President and Chief Executive Officer, Todd Pope.

Todd Pope

Good morning and thank you for joining us today to discuss our operating and financial results for the first quarter. On today's call I’ll begin with an update regarding the development of the SurgiBot system and the operating progress we made in the first quarter before handing the call over to Joe who will review our financial results.

Then I will wrap up and open up the line to take any questions. I would like to start with an update regarding SurgiBot, we continue to be focused on completing our upcoming FDA submission ad I'm pleased to announce that we now anticipate filing our 510K in June.

Since our last quarterly call, we have successfully completed our good laboratory practice or GLP Studies, a key step that needed to be completed prior to the submission process. Our GLP Studies included multiple procedures performed by surgeons from bearing specialties to demonstrate the system’s ability to handle the critical task commonly performed in laparoscopy.

We have been encouraged with the feedback and response we receive from the operating surgeons who took part in these studies. We are now in the final stages of gathering data and pulling together the information needed to make our submission in June.

Following our anticipated filing, we will work closely with the FDA to support our submission and provide any additional information that maybe requested. We are excited and proud in the position to achieve this important milestone for our company, which is the reflection of the hard work and dedication of the entire TransEnterix team.

We also recently hosted a Surgeon Panel for the investment community; the panel included two general surgeons and one urologist and focused on those doctors discussing their preclinical experience with SurgiBot and their thoughts about how I could be incorporated into practice once available on the market. The slides from this presentation and the audio webcast are available on our website and I would like to remind that the SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other Regulatory Authorities for sale outside the United States.

The surgeons on this panel felt there were many potential applications for the SurgiBot in their practice areas of general surgery, bariatric surgery and urology. Each of the surgeons commented on their preference to be in the sterile field which the SurgiBot will allow them to do.

They also commented on the improved ergonomics due to the SurgiBot’s ability to clutch which allows them to reposition their arms and reduce fatigue. Finally each agreed that economic value and efficiency are critical in healthcare, they commented that the anticipated price point in parallel to laparoscopic surgery would make the SurgiBot appropriate for a wide variety of procedure performed in both hospitals and surgical centers.

As we look to the upcoming quarters, our focus will transition toward commercial activities. We have begun the recruiting for a senior sales leader and are highly focused on this process, after this person is on board; we will work collectively to refine our thinking our sales force structure and go-to-market strategy.

I would like to turn the call over the Joe to review our financial results.

Joseph Slattery

Thanks, Todd. We recognize no revenue or cost of goods sold in the first quarter of 2015, as a result of our discontinuation of the SPIDER Surgical System on December 31, 2014.

Research and development expense were $7.5 million in the first quarter of 2015 compared with $5 million in the first quarter of 2014. The increase in R&D spend resulted primarily from increased investment in SurgiBot development including increased costs of preclinical labs, increased contract engineering and consulting services, and increased supplies and personnel related expenses.

Sales and marketing expenses remain relatively flat at $375,000 for the first quarter in comparison to $406,000 in the prior year period. General and administrative expenses were $2 million in the first quarter of 2015 as compared to $1.6 million in the prior year period.

The increase in expenses was due primarily to increased stock based compensation costs. Net loss was $10.1 million in the first quarter of 2015 compared to a net loss of $7.5 million in the first quarter of 2014.

On a per share basis, the net loss was $0.16 in the first quarter of 2015 based on a fully diluted share count of 63.7 million shares compared to $0.15 in the prior year period based on a fully diluted share count of 48.9 million shares. Looking at the balance sheet, we finished the quarter with $28.4 million in cash and cash equivalents.

During the first quarter of 2015, our cash declined by $6.4 million reflecting $8.2 million in cash burn from operations and approximately $155,000 in property and equipment investment offset by the proceeds from the issuance of common stock of $1.8 million under the ATM facility and exercise of stock options of $196,000. Through today, under the ATM facility we have sold approximately $1.8 million shares four our proceeds of $5.7 million net of commissions.

I’ll now hand the call back to Todd.

Todd Pope

Thanks, Joe. We’re extremely pleased with our progress this past quarter and to be in position to complete our FDA submission in June.

During the review process, we will begin to transition our focus to our commercialization strategy for SurgiBot. These certainly exciting times to TransEnterix and we look forward to the next chapter for our company.

And with that I would like to turn it over to the operator and open up for questions.

Operator

[Operator Instructions] Our first question comes from Rick Wise with Stifel.

Frederick Wise

Hi, good morning, Todd. Good morning, Joe.

Could you talk Todd, if you would little more about the getting ready for launch the commercialization process? You talked about search for Senior Sales Leader, maybe just some perspective on the kind of individual you are looking for, what kind of experience or background and do you think we could - I mean is this something that you would hope to put in place or assume like this quarter or no you just once they come on board after the approval comes, how do we think about it?

Todd Pope

Sure. Good morning, Rick and thank you for the question.

Yes, right now we’ve always talked about with the capital product you would like to have sales leadership on hopefully two to three quarters prior to approval. So we’ve really started the process of the search now, .what we think about as far as the sales leader, we want someone that’s had experience in high growth Medtech areas and differentiated product and someone that’s is very customer focused.

That’s what we’re really looking at and we’ll certainly not wait till an approval to bring that person on, we’ve started that process now and we will have that person on here in the second half.

Frederick Wise

And just extending on that do you - actually you probably would or no you would wait to start hiring sales folks until that person is in place or is that process also underway and maybe Todd just to follow on that…

Todd Pope

Well, the first thing I do is - go ahead Rick.

Frederick Wise

Okay, maybe you can just talk to us about the kind of style sales force you are thinking about putting in place for year one of the launch?

Todd Pope

Yes. So as far the first part of your question, we think it is most important to get a sales leader on board, so we can really develop the go-to-market strategy and the size and the geographic placement of reps with that person, so we’ll start with that hire and we talked about that timing and then really develop from there.

My guess is we will have some sales leaders in place prior to the end of the year, but we really haven’t talked about specific numbers not at this point. We want to really develop that look further with our later that we’ll bring in.

Frederick Wise

Okay, couple more questions here.

Todd Pope

Okay sure.

Frederick Wise

Just observing what’s happened in other areas of Medtech, it just seems like my impression is that the FDA seems to be of late occasionally generous with approval timeline, so there is no hard hard-pressed rule obviously, but if you are look enough that the process goes smoothly and may be more quickly than would be the case in sort of the by the rule book approval timeline, if it came earlier how quickly could you actually be ready to launch, couldn’t accelerated approval lead to an accelerated launch trajectory?

Todd Pope

Well, I think the FDA has really take a stance to try to be is open and transparent as possible and things are moving in the right direction there, we feel like our timelines that we provided our adequate and we think we will have a thorough submission file, and six month to nine months are adequate. So the way we think about that approval coming in the first half of next year and then be ready to launch shortly thereafter.

Frederick Wise

I know you’re going to love this question, but so maybe I’ll ask Joe, let him answer it. Any sense how we could think should think about a first 12 months post approval revenue run rate, it’s not fair, I know this million moving pieces here, but I'll just speak to myself, I certainly want to start thinking about just directionally what numbers like that could be.

Joseph Slattery

Rick, this is Joe. Yes we’re not in a position to give any guidance and I look forward to seeing your thoughts on the subject.

Frederick Wise

Last from me for now, at stages we got another good close and personal look at intuitive surgical SP-99 the single port system may be Todd, just your latest thoughts on how it might - you’re thinking about how it might compare and contrast to SurgiBot. And how a question I often get asked is whether if their launch would be at all contemporary news with the rollout SurgiBot, do you think that slows your ramp down or hospital decision making in a process, how do we think about it?

Thank you very much.

Todd Pope

Yes, thank you Rick. Yes, coming out of stages, I think is continues to be a lot of activity around the surgical robotics space, it continues to confirm our belief that it’s at a very attractive market; it has some unmet needs both from the incumbent and others.

So we’re encouraged by the feedback that we’ve gotten when we talked to on the market about our product how relates to others that might be coming, we probably now want to get into a lot of specific comparison on products that neither are out in the market yet, but though thing we continued to hear when we talk about our product and then we talked about it juxtapose to others is surgeons are excited about the SurgiBot and being able to remain the sterile field. We’ve talked about that just a benefit to that affords them, they’re excited about remain in the sterile field as they always been with their surgeries.

They really are starting to see real comparison and differentiation with the SurgiBot, we mimic our replicate laparoscopic motions and that’s very familiar, we’re going to be going to approach laparoscopic surgeons and to be able to give them that same motion that they are used to, it’s been a big benefit and certainly lower capital investment that the SurgiBot provides. all are we think differentiators that will set us up well.

Frederick Wise

Thank you very much.

Todd Pope

Yes, thank you Rick. I appreciate the questions.

Operator

Our next question is from Larry Keusch with Raymond James.

Lawrence Keusch

Hi, Todd. Could you just review again I know you set a high level that timing for the submission and broadly what needs to get done between now and then and including the gathering of the data but could you give little more granular on what exactly needs to occurred to get this things filed.

Todd Pope

Certainly Larry. Thank you for the question.

So we’ve completed the majority of the world necessary for five 510-K filing. We’re retired a quite a bit of risk over the past couple months, our key remaining task are some verification and validation that needs to be finalized.

And then really the assembly of the submission itself, it will take a fair amount of effort in time much of the writing has been completed but we need to in certain lot of the remaining data that we’re collecting to finalize that. so we feel good about that, obviously reiterated timing this morning, in our release and in the call here this morning and confidence is high on that.

Lawrence Keusch

Okay, great and where we stand with the CE mark plans?

Todd Pope

Yes, well we are really thinking about as far as CE marker pursuing that after we get our FDA submission in, there is certainly some international markets that you can leverage within FDA clearance and we’re going to able to do that prior with our spider product that’s going to be our focus on CE mark after submission.

Lawrence Keusch

Okay, great. And last one, I guess for Joe is you had the earned here about $10 million, how do we think about that burn rate as we move through the year and could you also help us think about, I think you said $5.7 million net on the ATM.

I think you have up to $25 million again, how we might think about the potential to tap into that to raise the cash balances?

Todd Pope

Sure, Larry. With respect to burn, just think about burn rates for the rest of the year about the same kind of in the $8 million to $10 million range closer to $8 million in general but that kind of range could show up, which will give us cash gets us - our current cash gets us into the first quarter of next year and as far as ATM goes we’re just being very strategic and careful about how we balance raising capital with the impact on the stock price and I think we’ve been very successful so far.

But we may or may not be in the market with the ATM going forward.

Lawrence Keusch

Okay, terrific. Thanks very much guys.

Todd Pope

Thank you, Larry.

Operator

Our next question comes from Greg Chodaczek with CRT Capital.

Gregory Chodaczek

Thanks. Good morning, guys.

Just a couple quickies, because Rick took my other 35 questions. In terms of filing, will most of the instruments be with the filing or is that a separate filing on top of it and specifically the advanced energy instruments, how would that work?

Todd Pope

Our filing will include the majority of our instruments as it has in the past.

Gregory Chodaczek

Okay. And in terms of procedures, you have three surgeons at SAGES who are across the board with urology and general surgery, is all those type of procedures is what you are going after not for filing, this is just - if it’s done laparoscopically, it can be done by the SurgiBot, is that truly how this is going to be marketed?

Todd Pope

Well, I think it’s a differentiation of what is clinically capable and then how we go through our filing and the approval we get. So, right now, as we go out and talk to our primary focus surgeons around pediatrics, general, colon rectal and GYN and we will see as we go through the filing process and get our approval that will really sharpen our focus as far as where we go.

But those are the specialties that we’ve been interacting with the most up to this point.

Gregory Chodaczek

Okay. And then last but not least for you, Joe, I’m assuming R&D starts to tick down now once the filing has been done?

Joseph Slattery

Hi. Just because of the accounting treatment of the way without product approval, any work we put into inventory build, internal documentation and those kind of things, it all gets charged to R&D.

So the R&D - it’s not pure R&D the way you think about it, from an accounting treatment a lot of our operating costs will still be charged to R&D for the next couple of quarters. And then it will tick down in the fourth quarter as it migrates more toward commercial product.

Gregory Chodaczek

Okay, fantastic. Thanks, Joe.

Thanks, guys.

Joseph Slattery

Thanks, Greg.

Operator

Our next question comes from Jeffrey Cohen with Ladenburg Thalmann.

Jeffrey Cohen

Hi Joe and Todd, thanks for taking the questions.

Joseph Slattery

Good morning, Jeff.

Jeffrey Cohen

So just a few as most of them taken up. So firstly, thank you for organizing the surgeon panel, SAGES is actually very helpful to hear the opinion of a few of the experts.

And with that, could you talk a little bit about follow on clinical programs, I know that your focus right now is upon approval but if you could talk a little bit about interest from surgeons as far as any investigator initiative studies or any plans or requirements for follow on studies or Phase IV studies, if you could comment on that would be helpful?

Joseph Slattery

Thank you, Jeff. As in most 510(K) when we get an approval, we’ll be out in the market and then we’ll gather data post approval in our early launch, we always like to gather data, see how it’s being used and continue to update the community on that and that’s what our plans will be like most typically 510(k) post approval roll outs.

Jeffrey Cohen

Okay. And any insight into I mean, is there interest out there amongst investigators as far as wanting to do some studies post approval?

Joseph Slattery

Well, I think any time that you have a market that has the interest of robotics, you have few options for them when a new technology gets out there, there is high interest certainly and we’ve certainly feel that interest from multiple specialties about multiple procedures, but we want to go through our regulatory process first, really focus on that and then we have no lack of interest from people that are interested in getting going with it and taking a look at it in different areas.

Jeffrey Cohen

Got it. Okay.

Just too little early, that does it for me. Thanks very much.

Joseph Slattery

Yes, Jeff. Thank you.

Operator

I would like to turn the conference back to Todd Pope for any additional or closing remarks, sir.

Todd Pope

Thank you and again thank you all for joining us today to discuss our first quarter 2015 results, we look forward to updating you on our progress on the next call. Thank you.

Operator

This concludes today’s conference. Thank you for your participation.