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Vyome Holdings, Inc. (HIND)

Q3 2015 Earnings Call· Thu, Dec 17, 2015

$2.13

-0.93%

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Transcript

Operator

Operator

Good morning, ladies and gentlemen. And welcome to the EnteroMedics' Year End Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the call over to Greg Lea, Chief Financial Officer. You may begin.

Greg Lea

Analyst

Thank you for joining us this morning. As previously indicated, we decided to host a year end conference call in order to give our new CEO Dan Gladney time to transition into the role. I am pleased to be joined by Dan on this call as he provides an update on our commercial progress and we discuss our recent company developments. Dan Gladney, Brad Hancock, our Chief Commercial Officer and I will be available for questions during the Q&A session that will follow our prepared remarks. As a reminder, this conference call, as well as EnteroMedics' SEC filings and website at enteromedics.com contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors. These risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, particularly those factors identified as risk factors in the company's 10-K filed March 13, 2015. I will now turn the call over to Dan. Dan?

Dan Gladney

Analyst

Thank you, Greg. And thank you everyone for joining us this morning. I apologize in advance I am losing my voice really, so please bare with me. I am looking forward to sharing my observations with you. That’s my first month of tenure with EnteroMedics'. What attracted me to this opportunity was the ability to create significant value for our patients, our company and our shareholders with the unique groundbreaking technology, vBloc, Neurometabolic Therapy. In 2015 it has been a transformational year for the company, beginning first with a FDA approval of vBloc Therapy on January 14, an accomplishment that could not have been achieved without the hard work of the dedicated and talented employees and the support from you our shareholders. This achievement marked the beginning of a change from a developed and stage organization to a commercial enterprise and I am excited to be leading the company at this crucial point in its growth. vBloc therapy is in a class all its own within the obesity treatment spectrum. One that fills a wide gap between diet an exercise, pharmaceuticals, restrictive short term options and of course traditional bariatric surgery. vBloc is designed with the patient experience in mind, something really no other bariatric procedure can offer. Unlike these other options, vBloc therapy yields weight loss without altering a restricting anatomy or the digestive tract, rather it reduces calorie consumption by controlling fullness in hunger using cutting edge neurometabolic technology. vBloc offers the safest long-term device options for people with obesity looking for both personally and medically meaningful sustained weight loss and control of their obesity related diseases, such as type II diabetes. Our system is implanted in a minimally invasive same-day procedure, allowing for a discreet and quick recovery. vBloc patients experience fewer daily side effects giving them…

Greg Lea

Analyst

Thank you, Dan. To deliver not just on our clinical but commercial promise, our vBloc therapy, the company has spent the years since approval managing its current assets, while concurrently building up its resource to take its commercial plans to the next level. Recently the company entered into an agreement to secure 25 million through an issuance of senior amortizing convertible notes. Key to these efforts is securing shareholder approval to effect a reverse stocks split increasing a number of shares of common stock authorized and approving the issuance of shares of our common stock underlying the convertible notes. With approval from you, our shareholders at the upcoming special meeting on December 21, we will have the necessary resources to support these efforts into 2017. On the product side, we are worth to ensure adequate supply of devices and have lined up our supplier to begin building inventory on demand and product sales begin to ramp. We believe that we have the capability to meet the requirements for the commercial activities anticipate in 2016. With our commercial progress in place, we plan to revisit our product development activities in an effort to reduce the size and product cost of our system and advance our technology to the next level. With that I'd like to open up the call to questions for Dan, Brad or me. Operator?

Operator

Operator

Certainly. [Operator Instructions] Our first question comes from the line of Suraj Kalia from Northland Securities. Your question please.

Suraj Kalia

Analyst

Good morning, gentlemen. Dan…

Brad Hancock

Analyst

Morning.

Suraj Kalia

Analyst

Welcome on board.

Dan Gladney

Analyst

Thank you.

Suraj Kalia

Analyst

So Dan, and the obvious question, you all mentioned about and gave some additional clarity on self paying patients. It’s an interesting strategy Dan of DTC, with a relatively higher disposable income geography focused campaign. Can you give little more clarity Dan in terms of how the nuts and bolts of this would work or is it too early in stage to be talking about this? Just trying to get a sense as we roll into, let’s say second quarter of '16, how should we rely on this approach to your ticket [ph] adoption increasing?

Dan Gladney

Analyst

Yes, well, first of all what we're doing here is we're going to start with seven markets and those will be seven high income markets and the intention would be to hit those markets with radio advertising, some short TV advertising and print advertising. And there is some indication here that that’s going to be successful, because one of our hospitals in New York recently on their own did a little tri-state area, this were I think about a month, radio advertising, and they had lot of calls and they ended up spending in the neighborhood of about three months seeing a lots of patients. Now of course some of the patients didn’t fit into our category. But the values are - it was, you know, if kind of look at our funnel right now they represented close to half of all locations in the funnel. So we know that that type of program is going to work and we think by doing that test margin it in this kind of initial seven geographies we'll get a very good read of kind of results we're going to have and how many cash paying patients we'll receive. If it ends up being close to over holding then we'll expand that in the next quarter, probably in the neighborhood to about 12 to 15 and then sometime in early in the second half we would expand it from there to more areas. But we'll have a pretty good read I think by early quarter two, early to mid quarter two on the programs.

Suraj Kalia

Analyst

So Dan, would I be fair in saying that you know, the conventional approach, if I can use that word, where you have feet on the ground, knocking on doors, saying hey, have a look at my product, this is more of a - at least in the initial stages that did drew [ph] strategy where you all are trying to go in very pinpoint marketing, hence cut down on the investments needed on the SG&A line item. Am I thinking through this correctly and then you all look at expanding the feet on the ground?

Dan Gladney

Analyst

Well, the realties are you kind of need them both. So what you want to do as you want to put money into this market – very focused marketing program to generate the leads and then those - that marketing program will handhold the patients until it gets to the surgeon. But at the same time you have to remember that the surgeons have to agree and be very loyal to the fact that they are going to work with that patient and hopefully get them implanted at vBloc. So that takes the relationship and to be established there on the ground by our local sales team. And as you know, we have small, very small sales team today, but we are going to be expanding that in 2016. I think you need both components. You need a relationship established at the center with both the surgeons, as well as his coordinator and his staff to make sure that they are handling this patient and bring him through the process, getting them implanted versus kind of losing the patient along the way, with either poor [ph] communication or in that really having a relationship with the company where the patient could slide in something else, like a gastric sleeve or something. So we think it’s important to have both components ready and on the ground force, as well a system that’s – that generate in patient leads.

Suraj Kalia

Analyst

Fair enough. One last question Dan, and then I'll hop back in queue. Obviously you have a lot on your plate Dan. From all the studies that have been done at vBloc, at least that I remember, the numbers on EWL are fairly consistent should I say, at 24, 25% EWL and the results have been consistent, at least that I remembered, up to 24 and 36 months. So - and also the adverse events what 2%, 3%, 4% give or take in that range. So this integrated delivery network, this chain of hospitals that you were talking about or for their coverage lives. I am just curious I heard you talk it on your prepared remarks about a short trial, what is that that they are looking, is it the different patient of set, is it for their demographics or any color would be great? Thank you for taking my questions.

Dan Gladney

Analyst

Sure. Well, I'll give you my initial feedback that I've learned over the last month, and I think this is a pretty good strategy. But I'll also open it up to our –as I spread the sales, if you like to add to that. What it is, its kind of two fold program. First, there is an economic part of the program that shows an IDN that because of the very low complication rates of this product, that it’s cost effective for them to incorporate this into their bariatric program versus lets say some of the already existing technologies that are out there to have much higher complication rate. So complication rates to let say a gastric sleeve take the overall procedure cost from, let’s just say $18,000 as an example, their complication in total now is up in the neighborhood of $65,000. So by just working the percentages and data that’s readily available out in the marketplace you can determine that this is a very cost effective approach because of our low complication rates, number one. Number two, we've got a technology that it really fits nicely into that what I would call the void. The void is what do you have a patient tries, a diet and exercise doesn’t work. The patient tries pills, it doesn’t work, now is a patient willing to take that big step going from pills to an anatomy altering procedure in a lot of cases they are. So this is a perfect step that kind of bridges that gap, and offering them a very minimally invasive same day go home that day procedure that has great result. So we think that the IDNs are - that we're talking to are interested primarily because of those two metrics.

Suraj Kalia

Analyst

Thank you.

Operator

Operator

Thank you. [Operator Instructions] Our next question comes from the line of Chris Lewis from Roth Capital Partners. Your question please.

Chris Lewis

Analyst

Hi. Morning, guys. Thanks for taking the questions.

Brad Hancock

Analyst

Sure.

Dan Gladney

Analyst

Thank you, Chris.

Chris Lewis

Analyst

Dan, you've been at the helm now for few months, thanks for the clarity, and kind of color on what you've seen so far. One question I guess is just what's been your biggest surprise maybe after coming through your business review relative to before you started?

Dan Gladney

Analyst

Well, I don’t know if it would so much be a surprise Chris. The realities are I knew in my diligence before taking this job and I've been at the job about two months. So my diligence I was obviously I was attracted to the technology and the overall size of this market. I mean, I was and first started getting into my diligent point, you'd be surprise that the bariatric market really only addresses like about a 2% of this obesity probably in the United States. So that was an indicator to me that there is a great opportunity to grow this market, especially with a minimally invasive product like we have. So that was of real interest. When I took the company over and had a chance to start working in the field, I worked with our regional directors, I worked with our surgeons, our initial surgeons and I've had the opportunity to talk to patients. What I found is that in a reimbursed versus a non-reimbursed situation, the good news is that I got a kind of strong percentage of the surgeons, telling you that Dan once this thing is reimbursed this is going to be very big successful company. So that suggest to me that they see the benefit and they want to work with us. It was also a little bit surprising to come up against in this non-reimburse environment, you really have to work hard to get the surgeons support who want to work with you because these guys can do a gastric sleeve and get paid the next day, right, and that’s all covered. And getting them to say okay, look, not only do I think it’s a good technology, but I am willing to work with you, I am willing to wait…

Chris Lewis

Analyst

Thanks. Very helpful. On the PA process, you mentioned about 60 patients in the - undergoing the PA process now, but not all of them convert to implants necessarily. So can you talk about what determines kind of the success of conversion if you will in that PA process for patients, walk us through the defect [ph] dynamics to think about and kind of what your - what the company is doing to support more of those patients being converted in the implants over time?

Dan Gladney

Analyst

Yes. So initially Chris, as you would expect, if you don’t have a lot patients filling up that funnel, it’s really the private payers just saying no. They are not going to pay attention to it. They are not going to focus on it. They are just going to say no. So these early patients that are coming through there is probably high probability that they are not going to get approval, right. I think we need to have a funnel that’s got at least a couple of hundred patients or more in it before a local payer is going to say, hey wait a minute [ph] to pay attention here and maybe we really need to take a hard look at this. So this funnel right now is at 60, I think there is a pretty high probability that number of those folks are going to fall out of the funnel after that three or four months with an answer of no from the insurance payer. So for those patients we just need to be or offer them our technology at a competitive price with what they would receive, lets say with either gastric sleeve or gastric bypass procedure. So we just need to be kind of in a competitive range. We don’t want to meet that pricing. We want to have a premium, but it needs to be a reasonable premium. And those prices kind of vary all over country. I don’t know if you looked at the average reimbursement as an example gastric sleeve by state. But they range as high as about $27,000 in a number of our states, dollars low as $12,000 in just a few sates. So it’s kind of all over the board. So one of the other things we need to make sure we do is that we focus our advertising and our attention hopefully in areas where there is fairly strong reimbursement.

Chris Lewis

Analyst

Appreciate it. Just one more for me. You mentioned potential IDN partnerships, can you walk us through what a trial - initial trial would look like in terms of size and length of that and when we could potentially see some of those IDNs establish a more formal network wide reimbursement in that…

Dan Gladney

Analyst

Realities are - yes, that’s a good question Chris. The realities are with most of these – they want to have a six month trial, but on small number of patients. So they are willing to do that for about 10 patients. They just want to be a follow up patients for six months if you are really losing weight and what is your – or how does it look on you blood panel, we really starting to see that you're pre-diabetic, but your blood sugars have come down. They need to do that over about a six month period.

Chris Lewis

Analyst

Okay. Thanks for the time.

Operator

Operator

Thank you. Our next question comes from the line of William Plovanic from Cannacord Genuity. Your question please.

Unidentified Analyst

Analyst

Hi, this is Ryan on for Bill. Can you hear me okay?

Dan Gladney

Analyst

Sure, can.

Brad Hancock

Analyst

We can.

Unidentified Analyst

Analyst

All right. Great. So you mentioned those patients in the funnel, just point of clarification, those patients go in the funnel, are those softer lead per se are they patients that are going through education, qualifications and screening right now. And as you think about that going forward, are there things that can be done to improve the selection process, so that those patients in the funnel increase the livelihood of getting success?

Dan Gladney

Analyst

Yes. So those patients have already been screened. Those are patients that know what they have in front of them and they are deciding between us where you have to wait, three or four or five months as far as – to try to get insurance coverage or they can choose to move forward with one of other gastric procedure. So these folks have already been screened. They are already patients that are going to fit into our category and they have chosen to wait and try to get coverage for vBloc.

Unidentified Analyst

Analyst

Okay. Great. Great. And then can you just give a little more color on maybe the society physicians and if and when you could expect something from them in regard to support of a product?

Dan Gladney

Analyst

Yes. Actually I think I mentioned it in my script, that we are presenting to the larger societies and we would hope to have their support and have that support published sometime in the first half of 2016.

Unidentified Analyst

Analyst

Okay. Great. Thank you very much. That’s all from me.

Dan Gladney

Analyst

Thank you.

Operator

Operator

Thank you. [Operator Instructions] And this does conclude the question-and-answer session of today's program. I'd like to hand the program back to management for any further remarks.

Dan Gladney

Analyst

Okay. Thank you very much folks for your time today and thank you for joining us on our call. I look forward to having an ongoing dialogue with you as we continue on this journey to make vBloc therapy the premier bariatric therapy of choice for both patients and physicians. We look forward to the quarters ahead and to reporting on our progress with this exciting new technology. In the meantime, please feel free to reach out to us today or in the future with any additional questions. Thank you. Have a good day and have a happy holidays.

Operator

Operator

Thank you, ladies and gentlemen for your participating in today’s conference. This does conclude the program. You may now disconnect. Good day.