Earnings Labs

Vyome Holdings, Inc. (HIND)

Q1 2014 Earnings Call· Wed, Apr 30, 2014

$2.13

-0.93%

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Transcript

Operator

Operator

Good morning ladies and gentlemen and welcome to the EnteroMedics’ First Quarter 2014 Financial Results Conference Call and Business Update. At this time, all participants are in a listen-only mode. Later, we will conduct the question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded. I will now turn the call over to Greg Lea, Senior Vice President, Chief Financial Officer and Chief Operating Officer to start the call. Mr. Lea?

Greg Lea

Management

Thank you for joining us this morning to discuss our first quarter financial results and business update. As a reminder, this conference call, as well as EnteroMedics’ SEC filings and Web site 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 the 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 27, 2014. With me on the call from EnteroMedics is, Dr. Mark Knudson, our President and Chief Executive Officer. We will begin with prepared remarks when these are concluded, we will open the call for questions. I will now turn the call over to Mark.

Mark Knudson

Management

Thank you, Greg. Our focus for the last several quarters has been centered on preparing for advisory committee or panel meeting with the FDA, as part of a larger goal of achieving regulatory approval in the U.S. of the Maestro System as a treatment for obesity with the June 17th date now scheduled and published in the federal register we are closer than ever to achieving this goal. The obesity epidemic is one widely described by the medical community and regulators as a serious and urgent threat to the public health. Among existing options for treating this disease, there exists a significant gap in the treatment spectrum as evidenced by the lack of progress in reducing the rates of obesity. We believe that VBLOC Therapy may fit in this gap as a unique alternative to options that are either ineffective or fail quickly, or which patients avoid for fear of adverse safety and lifestyle effects. VBLOC is a safe, effective and patient-friendly option for those seeking a long-term solution to achieve their health and weight loss goals. It works by controlling, both hunger fullness while promoting healthy weight loss without punitive dietary or other long-term side effects. EnteroMedics has built significant experience with VBLOC Therapy. More than 600 patients having done implanted with the Maestro System to-date, some received their devices over five years ago. The cornerstone of our regulatory effort is the five year ReCharge Pivotal Trial for which we have announced safety and efficacy results at 12 and 18 months. At 12 months the trial demonstrated statistically significant, durable and medically meaningful weight loss of 24.4% excess weight loss compared to a sham control group weight loss of 15.9%, a superior record of safety was also demonstrated with a 3.7% related serious adverse event rate, well below the…

Greg Lea

Management

Thank you, Mark. For the three months ended March 31, 2014, the Company reported a net loss of 6.7 million, or a $0.10 per share. Research and development expenses were 2.6 million and general and administrative expenses were 3.9 million. Operating expenses were primarily associated with the cost of supporting multiple ongoing clinical trials, including the ReCharge Study, the Company's PMA Application and continued development of VBLOC Therapy. On March 31, 2014, the Company's cash, cash equivalents and short-term investments totaled 24.4 million. As of April 29, 2014 the Company had raised a total of approximately 16.8 million under its $20 million ATM equity facility. Utilizing this facility in combination with our current capital and expense projections, we have the resources to fund operations through our upcoming pivotal regulatory milestones and to begin building our commercial infrastructure in anticipation of the positive FDA approval decision for VBLOC Therapy this year. I will now turn the call back to Dr. Knudson. Mark?

Mark Knudson

Management

Thank you, Greg. To conclude, EnteroMedics stands at the cusp of a transformative event, the potential for FDA approval of VBLOC vagal blocking therapy for the treatment of obesity. In support of this goal, we remain focused on preparing for advisory committee panel meeting and on working with the FDA toward an approval decision. As these efforts progress, we will continue to explore strategic partnering opportunities while we efficiently build an infrastructure for our U.S. commercial launch, as well as develop our global commercial strategy, all with a goal of delivering VBLOC Therapy to the millions of individuals suffering from obesity and its related comorbidities. As is customary in our industry, approaching the June 17th advisory committee meeting we expect to turn the majority of our attention to final preparation for panel. We therefore expect to enter a quiet period starting mid-May. Once we are through the panel meeting, we look forward to discussing results with you and to communicating our path forward. With that I will open the line for questions, operator?

Question

Management

and:

Operator

Operator

Thank you, Dr. Knudson. (Operator Instructions) Our first question comes from William Plovanic with Canaccord. Your line is open.

William Plovanic

Analyst

Great, thanks. Good morning. Can you hear me okay? Canaccord Genuity: Great, thanks. Good morning. Can you hear me okay?

Mark Knudson

Management

Yes, good morning Bill we can hear you fine.

William Plovanic

Analyst

Good. So you just hired Mark Bullivant and obviously within a high towards commercialization my general kind of question here is you have the panel meeting come up in June when do you start like putting resources behind like serious resources behind the commercialization and building an infrastructure is it post panel if it’s positive enough or is it post actual FDA clearance I mean given kind of the cadence of this technology to market thus far? Canaccord Genuity: Good. So you just hired Mark Bullivant and obviously within a high towards commercialization my general kind of question here is you have the panel meeting come up in June when do you start like putting resources behind like serious resources behind the commercialization and building an infrastructure is it post panel if it’s positive enough or is it post actual FDA clearance I mean given kind of the cadence of this technology to market thus far?

Greg Lea

Management

Bill, this is Greg. We are taking the -- as we have discussed in the past taking the commercialization rollout steps one step at a time when we get FDA approval we’ll expect to recruit and retain additional personnel for our commercial operations that will include sales and marketing and customer service to support the commercial launch. For now as Mark had mentioned earlier we’re focusing on a obtaining approval and beginning our commercial rollout plan which was started with announcing Mark Bullivant. And doing some of the longer lead time initiatives like reimbursement that we’ve already ramped up strategically we feel it’s important to use the most prudent use of our resources right now focusing on the FDA approval process. We also believe that the initial stage of the commercial launch a limited sales and field support staff as Mark mentioned earlier we’ll target the existing centers and that are all strategically positioned across the country. And as I will remind everybody we’ve had -- we've got experienced surgeons onboard already and healthcare teams in place so we’ll start there. And we’ll discuss our commercial plans in greater detail once we get through the PMA process.

William Plovanic

Analyst

Okay, thanks. That’s all I had. Canaccord Genuity: Okay, thanks. That’s all I had.

Operator

Operator

Thank you. And our next question is from Matt Hewitt with Craig-Hallum. Your line is open.

Matt Hewitt

Analyst

Good morning gentlemen. Craig-Hallum Capital Group: Good morning gentlemen.

Mark Knudson

Management

Good morning.

Matt Hewitt

Analyst

A couple from me, first you the 12 month data from ReCharge that was released in February of last year and I am just wondering if you have had a chance to look at 24 month data is that something that you have compiled, will we and investors get a chance to maybe see that information or obviously I would assume that you’re going to be providing it for the FDA as well? Craig-Hallum Capital Group: A couple from me, first you the 12 month data from ReCharge that was released in February of last year and I am just wondering if you have had a chance to look at 24 month data is that something that you have compiled, will we and investors get a chance to maybe see that information or obviously I would assume that you’re going to be providing it for the FDA as well?

Mark Knudson

Management

For the study plan and the clinical investigation plan and FDA requirements, we continue to provide updates to FDA during the entire five year term of the ReCharge study. At this time, we are not planning to release anything about the 24 month data before panel.

Matt Hewitt

Analyst

Okay. And then just regarding the partnership opportunities maybe walk us though kind of what you’re looking for whether it’s geographically is it potential partnerships in Europe or in Asia Pacific region, is it situation where maybe domestically there is an opportunity to partner with somebody maybe not necessarily on the sales and marketing front but maybe they’ve got some applications or some fingers into different markets just any kind of guidance there would be helpful? Craig-Hallum Capital Group: Okay. And then just regarding the partnership opportunities maybe walk us though kind of what you’re looking for whether it’s geographically is it potential partnerships in Europe or in Asia Pacific region, is it situation where maybe domestically there is an opportunity to partner with somebody maybe not necessarily on the sales and marketing front but maybe they’ve got some applications or some fingers into different markets just any kind of guidance there would be helpful?

Greg Lea

Management

Matt as we’ve talked this is Greg, as we have talked in the past we’re really open to any type of partnership first of all that may increase most important, shareholder value and support our technology. But I think you’ve mentioned some of them. We’ll look at really potential distribution agreements outside the U.S. once we get through this approval process. We certainly would be interested in partnerships that would help us explore other indications related to our technology, but as we suspect the majority of that interest or discussions I think because we’re still close to this panel date now will occur after we get through this process.

Matt Hewitt

Analyst

Okay. And then maybe one follow-up on that and then I’ll jump off. But as far as these partnerships are concerned is it safe to assume that with those contracts you would be looking for some type of upfront payment from these partners therefore reducing your need to comeback to market to raise additional equity? Craig-Hallum Capital Group: Okay. And then maybe one follow-up on that and then I’ll jump off. But as far as these partnerships are concerned is it safe to assume that with those contracts you would be looking for some type of upfront payment from these partners therefore reducing your need to comeback to market to raise additional equity?

Greg Lea

Management

Clearly we’re exploring all financial opportunities but that certainly would be one of them that we would be very focused on with the positive outcome from a panel and the FDA would be to receive some kind of capitalization as part of the partnership.

Matt Hewitt

Analyst

Okay, great. Thanks for the update. Craig-Hallum Capital Group: Okay, great. Thanks for the update.

Operator

Operator

Thank you. (Operator Instructions) Our next question is from Suraj Kalia with Northland Securities. Your line is open.

Suraj Kalia

Analyst

Good morning gentlemen. Northland Securities: Good morning gentlemen.

Mark Knudson

Management

Good morning Suraj.

Suraj Kalia

Analyst

So, Mark and Greg, if you could give us some color on the composition of your MOC panels and what areas are your MOC panels focusing on? Northland Securities: So, Mark and Greg, if you could give us some color on the composition of your MOC panels and what areas are your MOC panels focusing on?

Mark Knudson

Management

So our MOC panels have been extremely helpful in preparing us for our panel presentation. We try to match the MOC panelists with the types and expertise of panelists that have historically been on panels of the division that were in the gastrointestinal neurological devices group of FDA. And generally the panels have focused on the three areas that we expected are the critical questions that all of us are waiting for obviously FDA generally asks more than these three, but the question on safety, the question on demonstration of efficacy and the question on demonstration of a positive benefit risk. And those are the areas that we are focused on with those panels and have helped us really hone our discussion about the effect of a sham control trial and in the face of excellent and predicted weight loss in the treatment arm. And it’s been a very effective piece of preparation for us.

Suraj Kalia

Analyst

So Mark, is it fair to say that your MOC panels and again I do understand this might be an unfair question I am just trying to understand the preparation behind the scenes. Is it fair to say that the MOC panels you’ll are not really focusing per se on EWL versus TWL the sham arm between 12 to 18 months is it fair to say that is not a core area of focus? Northland Securities: So Mark, is it fair to say that your MOC panels and again I do understand this might be an unfair question I am just trying to understand the preparation behind the scenes. Is it fair to say that the MOC panels you’ll are not really focusing per se on EWL versus TWL the sham arm between 12 to 18 months is it fair to say that is not a core area of focus?

Mark Knudson

Management

I guess it’s hard to answer that question because the FDA is moving more toward using total body weight loss but that was not a TBL or TWL or IPWL whatever acronym, whatever piece of literature your reading happens to use but the real focus for us has been really to build the story around positive benefit risk which takes into account EWL or total body weight loss and a safety profile in this group of patients for which there really is right now a very large fair clinic gap between diet exercise and drugs and the currently available bariatric surgical procedures. So that’s really where we have been focused Suraj.

Suraj Kalia

Analyst

Fair enough. And Mark forgive me my memory fails me here did you release the median I know the mean is there the 12 and 18 months meaning EWLs have you released the median EWL at any time point? Northland Securities: Fair enough. And Mark forgive me my memory fails me here did you release the median I know the mean is there the 12 and 18 months meaning EWLs have you released the median EWL at any time point?

Mark Knudson

Management

No we released though the responder data and we also released both the standard deviation and the 95% confidence intervals which indicate that there is not a lot of skewness to the data so the mean and median are relatively close.

Suraj Kalia

Analyst

Fair enough. Gentlemen, thank you for taking my questions. Northland Securities: Fair enough. Gentlemen, thank you for taking my questions.

Operator

Operator

Thank you. And our next question is from Chris Lewis with ROTH Capital Partners. Your line is open.

Chris Lewis

Analyst

Hi guys thanks for taking the questions. ROTH Capital Partners: Hi guys thanks for taking the questions.

Mark Knudson

Management

No problem.

Chris Lewis

Analyst

In the prepared remarks you mentioned the study design which led to some of the maybe shortfalls on efficacy endpoints I was hoping you could just elaborate on your views there and perhaps how have you seen those these type of sham control trials evolve since the ReCharge trial design and endpoints were established? ROTH Capital Partners: In the prepared remarks you mentioned the study design which led to some of the maybe shortfalls on efficacy endpoints I was hoping you could just elaborate on your views there and perhaps how have you seen those these type of sham control trials evolve since the ReCharge trial design and endpoints were established?

Mark Knudson

Management

Sure Chris. Well as you know FDA about the time that we were designing this trial five years ago or however long ago it was seems like the answer but that’s just me, was really looking to try to do sham controls and to include very aggressive super superiority margins and what we’ve seen since then is several trials in which sham controls have responded very well and it’s not surprising when you think of the fact that if people are willing to undergo the kind of procedures that are required to actually undergo a sham control trial you add that on top of your are ending up with a sham device in our case we had a very robust response. And so while we were able to show statistically a significant effect of VBLOC Therapy over even the background therapy that the sham control had I think that right now we are moving toward a discussion revolving around the fact that the responder analysis is really the key to understanding in these kinds of instances of how a therapy truly works and whether it is effective for patients and as you saw in the initial data release that we did we had a very vigorous and robust responder analysis with all patients with all the EWL thresholds above 20% or at 20% and above showing that it has performed twice to 13 times the level of the sham control which again shows therapeutic effectiveness. The other thing that we think is quite interesting about the trial design is that by 15 to 18 months as you saw in the data we released that the EWL in the sham arm had fallen off dramatically they had regained 40% of the weight that they’d lost whereas the treated arm continued to maintain that weight loss. So for a number of reasons we think that our discussion about the efficacy of the device having met what we thought it would the excellent safety profile and the need lead to a very positive benefit risk profile.

Chris Lewis

Analyst

Great, thanks for the color there. So just to confirm the penal will have access to both that 12 and 18 month data so they can see the discrepancy in the arm, in the sham arm? ROTH Capital Partners: Great, thanks for the color there. So just to confirm the penal will have access to both that 12 and 18 month data so they can see the discrepancy in the arm, in the sham arm?

Mark Knudson

Management

Yes they will.

Chris Lewis

Analyst

Okay. And then in terms of the briefing docs usually put out earlier in the week or the week before can you walk us through the expectations you have there in terms beyond the three traditional questions any other relative discussion points that we can expect and then any new kind of takes or highlights on your data that will be highlighted in those documents? ROTH Capital Partners: Okay. And then in terms of the briefing docs usually put out earlier in the week or the week before can you walk us through the expectations you have there in terms beyond the three traditional questions any other relative discussion points that we can expect and then any new kind of takes or highlights on your data that will be highlighted in those documents?

Mark Knudson

Management

At this point we are getting so close that we do not feel that we should speculate on the tone of either our briefing book or FDA’s briefing book to-date we have enjoyed a good working relationship with FDA and that relationship has involved an open and productive dialog and that has continued. And that’s really all I feel comfortable saying right now.

Chris Lewis

Analyst

Understood. And then could you walk us through the timing expectations on the reimbursement front in the U.S. post approval, what needs to be done for Category I approval? ROTH Capital Partners: Understood. And then could you walk us through the timing expectations on the reimbursement front in the U.S. post approval, what needs to be done for Category I approval?

Greg Lea

Management

Good question Chris, this is Greg. First and foremost we need to get the product approval which is the process we’re in right now then we’ll create the RC of information that will include a complete and detailed description of the production and the procedure, a detailed description of the typical patient and the work provided by the physician or healthcare practitioner, patient diagnosis for whom the procedure would be performed, copies of peer reviewed publication from U.S. journals related to the safety and efficacy, along with an estimate of the frequency of the procedure that would be performed and as its projected performance. And any supportive information and that would all go in, the timing depends on when we receive panel approval obviously and the panel deliberation takes place three times a year for CPT I codes at the editorial panel meetings and the panel review the code changes and code applications and it begins one month prior to each panel meeting. So it is necessary to have the application in and that’s kind of the steps we’ll go through once we have the product approved.

Chris Lewis

Analyst

Understood, okay. Thanks for the time guys. ROTH Capital Partners: Understood, okay. Thanks for the time guys.

Operator

Operator

Thank you. And our last question is from Bruce Jackson with Lake Street Capital. Your line is open.

Bruce Jackson

Analyst

Good morning. Just to be clear on the commercialization time line did you say you’re going to start hiring after you have the PMA approval in hand or after you get an affirmative panel vote? Lake Street Capital Markets: Good morning. Just to be clear on the commercialization time line did you say you’re going to start hiring after you have the PMA approval in hand or after you get an affirmative panel vote?

Mark Knudson

Management

The majority of the hiring Bruce will take place after we have a positive direction from the panel. We’ll really gear up then, start looking at the resources we need, we’ve started the process of designing and determining what we will need to do once we get through that panel decision.

Bruce Jackson

Analyst

Okay. And then do you have any kind of a ballpark budget figure that you’re working with in terms of how much it’s going to cost you to build up that commercial operations group? Lake Street Capital Markets: Okay. And then do you have any kind of a ballpark budget figure that you’re working with in terms of how much it’s going to cost you to build up that commercial operations group?

Mark Knudson

Management

We haven’t announced anything publicly but back when we IPOed we did talk about building a staff and my comment on this call that we’d start small with a smaller organization and feel that even at the maximum we’re talking 75 to 100 employees about 50% of them would be technical support staff and 50% of them would be sales and marketing for the sales organization. And that would be part of the budget the majority of the budget that we would talk about going forward.

Bruce Jackson

Analyst

Okay. Then the other component of the commercial launch is the manufacturing. Can you tell us just broadly in terms of the preparations you’re making for manufacturing, are there any FDA inspections that have to be done, do you have your supply chain lined up, how quickly do you think you could start building units? Lake Street Capital Markets: Okay. Then the other component of the commercial launch is the manufacturing. Can you tell us just broadly in terms of the preparations you’re making for manufacturing, are there any FDA inspections that have to be done, do you have your supply chain lined up, how quickly do you think you could start building units?

Mark Knudson

Management

Our supply chain is all lined up as we’ve commented in the past we have FDA approved contract manufacturers supporting us at all of the components of the Maestro System they go through reviews with the FDA just like we go through reviews as part of the panel process they’re all lined up and ready to go they’re sitting there waiting to move with us and accelerate with us once we get approval.

Bruce Jackson

Analyst

And again when you say approval, is that a process that would start after the panel or after the formal PMA is received? Lake Street Capital Markets: And again when you say approval, is that a process that would start after the panel or after the formal PMA is received?

Mark Knudson

Management

Well, we’re already in the process of preparing our suppliers and going through the appropriate testing and build proxies to make sure that they can ramp with us so that’s ongoing right now. We’ve acquired what we think is the appropriate lead times and inventory pipeline and that’s starting. But Bruce the majority of that will occur once we get the positive direction from the panel in preparation and anticipation of the FDA approval.

Bruce Jackson

Analyst

Okay, thank you very much. Lake Street Capital Markets: Okay, thank you very much.

Operator

Operator

Thank you. And I am not showing any further questions, Dr. Knudson, would you mind proceeding with any further remarks?

Mark Knudson

Management

Certainly. Well thanks everyone. We look forward now to moving into the panel approval process and then from there into our continued work with FDA towards receiving a full FDA approval. Thank you very much for joining us on the call today. If you have any further questions, please do not hesitate to contact the Company. Thank you very much. Good bye.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone have a wonderful day.