VIVUS, Inc. Q1 2010 Earnings Call Transcript

Executives

Tim Morris – CFO

Leland Wilson – CEO

Peter Tam – President

Analysts

Cory Kasimov – JPMorgan

Alan Carr – Needham and Company

Mike King – Wedbush

Terence Flynn – Lazard Capital Markets

Thomas Wei – Jefferies

Ian Sanderson – Cowen

James Armstrong – Wells Fargo Securities

Len Yaffe – Sock Stock Partners

Boris Peaker – Rodman & Renshaw

VIVUS, Inc. (VVUS) Q1 2010 Earnings Call May 3, 2010 5:30 PM ET

Operator

Good day, ladies and gentlemen, and thank you for your patience. You have joined the VIVUS first quarter 2010 results call. All this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions). As a reminder, this conference may be recorded.

I would now like to turn the call over to your host, Mr. Tim Morris. Sir, you may begin.

Tim Morris

Thank you, operator. Before we get started, I would like to remind you that during the course of this conference call, VIVUS may make projections or other forward-looking statements regarding the future events or future financial performance of the company. We wish to caution you that such statements are just predictions and actual events or results may differ materially.

Investors should read the risk factors set forth in the VIVUS Form 10-K for the year ended December 31, 2009 and the periodic reports filed with the Securities and Exchange Commission. These documents contain and identify important factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements.

I will now like to turn the call over to Mr. Leland Wilson, CEO of VIVUS.

Leland Wilson

Thank you, Tim. Good afternoon and thank you for joining us today. Joining me on the call today along with Tim is VIVUS’s President Peter Tam.

Since we last spoke to you in March, a couple of significant dates have been established. First, we previously announced that the Endocrinologic and Metabolic Drug Advisory Committee has tentatively scheduled to review the company’s new drug application for Qnexa on July 15^th.

VIVUS submitted its NDA on December 28^th, 2009 and seeking approval to market Qnexa in the United States. On March 1^st, 2010 the FDA accepted the NDA filing for review. The target date for the FDA to complete its review is October 28^th, 2010. I think it goes without saying a positive review by the Advisory Committee represents a critical milestone for VIVUS. Peter Tam will have additional thoughts on the panel in a moment.

Second, we announced this morning an important addition to our senior management team. Mike Miller joins VIVUS as Chief Commercial Officer and will be responsible for leading the Qnexa commercial efforts.

Mr. Miller brings 30 years of commercial experience from executive positions in marketing, sales and business development in the pharmaceutical and biotechnology industry.

Mike has played a central role in the launch, growth and success of multiple brands spanning specialty and primary care markets, and has managed business development activities and partnerships with several leading pharmaceutical companies.

Most recently, Mike served as Vice President of BioOncology Business Unit at Genentech, where he presided over three marketing teams and three sales forces and drove top-line growth for Herceptin, Tarceva, and Xeloda to $2.5 billion in combined revenue in 2009.

He was also responsible for the pre-launch activities for multiple pipeline products and the US commercial collaboration with OSI Pharmaceuticals. Previously, Mike was Senior Vice President and Chief Commercial Officer of Connectics Corporation.

He also served as Vice President at ALZA Corporation, a Johnson & Johnson Company, where he launched Ditropan XL and negotiated partnerships with companies including UCB Pharma, Abbott Laboratories, and Bayer Corporation.

Mike brings significant specialty and primary care experience to our management team and has the strategic vision, leadership skills, and track record for success as we evaluate potential partners and to finalize commercial plans for Qnexa.

Finally, we filed notice last Friday that two of our Directors, Graham Strachan and Founder Virgil Place would not stand for re-election at the Annual Shareholders Meeting and would consequently step down from the Board. The reasons are purely personal and the timing was unexpected. We wish to thank Gram for his years of outstanding service as a Director.

We would specially wish to thank Virgil as our Founder of the Company. Virgil started VIVUS 19 years ago and it is his vision and leadership that has brought us to this point. The Nominating Committee has been formed and will begin to process the selecting one new outside Board member as soon as possible.

Additionally, I would like to point out that in the next several months we will have a significant presence through abstract presentations at seven major medical meetings in the US and in Europe. Peter will share with you the details of those presentations.

Our primary focus in the second quarter will obviously be in preparation with the FDA Advisory Committee. Our internal team and consultants are working diligently to prepare the briefing documents and the multitudes of slides that are necessary to answer all the possible questions the panel may have.

Further analysis have been completed as we go through the preparation of these slides and briefing document. And this further analysis confirms the top-line result of the risk benefit profile of Qnexa for overweight and obese patients remains very strong. We remain confident in our ability to gain approval of Qnexa.

With that, I will now turn the call over to Peter for further comments.

Peter Tam

Thanks, Le. With the notification of the Advisory Committee meeting scheduled for July 15^th, we have accelerated our preparation. We have assembled the team of external experts to assist us in the preparation and presentation of the Qnexa clinical results. We are preparing the briefing package for the Advisory Committee and look forward to discussing our results with the panel.

As Le mentioned, the results of Qnexa as a potential treatment for obesity is beginning to be recognized by the medical community. Several of the Qnexa abstracts have been accepted for presentation at the upcoming medical meeting.

Tomorrow, May 4^th, Dr. Susan Oparil, the Cardiologist from the University of Alabama at Birmingham and past President of the American Society of Hypertension will make an oral presentation during the late-breaking clinical trial session entitled Once-Daily, Low-Dose, Controlled-Release Phentermine/Topiramate Improves Blood Pressure and Results in Weight Loss in Overweight/Obese Patients Through 28 Weeks.

The presentation will be made at the American Society of Hypertension 25^th Annual Scientific Meeting and Exposition in New York. This presentation will feature whole data from all of the Phase III Qnexa clinical study showing the effects of Qnexa on systolic and diastolic blood pressure at 28 weeks. This presentation through the cardiovascular community is important as we believe this is the first time we have observed significant and meaningful effects on blood pressure with a weight loss agent alone.

On Thursday to Friday, May 6^th and 7^th, Dr. Kishore Gadde, a Principal Investigator in the Phase III trials will present two posters during the Euro Prevent 2010 Meeting in Prague. Euro Prevent is an Annual Meeting of the European Society of Cardiology and it’s the main scientific meeting place for all who are engaged in the prevention of cardiovascular diseases in Europe. Dr. Gadde’s poster will include data on weight loss, the anti-hypertensive effect and changes in triglycerides after 12 months of Qnexa therapy.

Dr. Tim Garvey will make an oral presentation highlighting the effect of Qnexa on weight related co-morbidity in over weight and obese patients following Qnexa treatment during the Third World Congress on controversies to consensus in diabetes, obesity and hypertension or CODI meeting in Prague May 15^th. CODI is a comprehensive congress fully devoted to clinical debates and controversial issues on a wide spectrum of topics such as diabetes, obesity and hypertension.

Dr. Charles Bowden will present additional details from the Phase II study of Qnexa and obstructive sleep apnea in a poster session during Sleep 2010, the 24^th Annual Meeting of the Associate of Professional Sleep Society. The sleep meeting will be held in San Antonia, June 7^th to 9^th. Dr. Timothy Garvey will make an oral presentation of the Qnexa trial results to the endocrine community on June 19^th, during the 92^nd Annual Meeting of the Endocrine Society or Endo.

During the American Diabetes Association or ADA, Annual Scientific Meeting this year in Orlando, June 25^th to 29^th, VIVUS and Qnexa will have a major presence. All six of our Qnexa abstracts have been accepted. Doctors Garvey, Gadde, and Donna Ryan, the President of the Obesity Society will each present posters, including posters during the moderated tour portion of the program. The highlight of the ADA will be a podium presentation on Monday, June 28^th by Dr. Gadde, featuring the significant weight loss of Qnexa and patients with type 2 diabetes and the related effects of weight loss on diabetes.

Lastly, the International Congress on Obesity or ICO in Stockholm, July 11^th to 15^th will include two Qnexa presentations. Dr. David Allison will make a poster presentation on July 14^th on the results of the EQUIP trial and Dr. Kishore Gadde will make an oral presentation on July 12^th on the results of the CONQUER study.

We have additional abstracts submitted and we will continue to share the data from the studies with those in the medical and scientific community.

For Avanafil, Dr. Irwin Goldstein, a key opinion leader in the field of urology will present the TH301 study results, the first Phase III trial of Avanafil in an oral presentation during the American Urology Association Annual Meeting in San Francisco on June 1^st. We anticipate the second phase III Avanafil trial in diabetics to report before the end of the second quarter.

I will now turn the call over to Tim to discuss our financial results and our IR activities.

Tim Morris

Thank you, Peter. At the end of March, VIVUS had cash, cash equivalents and available-for-sale securities of approximately $195 million. This compares to the $207 million we had at the end of last year. As it relates to the rest of the financial results, I would refer you to the press release for more information on the first quarter.

On the Investor Relations front, conference season is beginning to heat up. We have six conference presentations over the next six weeks. Upcoming presentations include: the Deutsche Bank Securities Conference in Boston on May the 5^th; the JMP Securities Research Conference in San Francisco on May the 11^th; the Bank of America Merrill Lynch Health Care Conference in New York City on May the 13^th; the Rodman & Renshaw Global Health Care Conference in London, May the 18^th; the Citigroup Annual Global Health Care Conference in New York City, May the 26^th; the Needham Health Care Conference in New York City, June the 9^th; the Jefferies Health Care Conference in New York City, June the 10^th; and lastly, the Wells Fargo Securities Health Care Conference in Boston on June the 23^rd.

With that, I would like to turn the call back over to Leland for some closing comments and Q&A.

Leland Wilson

I personally just returned from the East Coast where I spent a considerable amount of time with several of our major shareholders and institutional investors as well. The feedback from this group was very positive and they are very supportive of Qnexa and VIVUS. They are encouraged by our progress to date and anxiously await the panel meeting in July. Obviously we are preparing for that advisory panel meeting with great efforts and the confidence continues to build around VIVUS for a successful outcome of that meeting.

With that, I will open the call back open for questions.

Question-and-Answer Session

Operator

Thank you, sir. (Operator Instructions). And our first question comes from Cory Kasimov of JPMorgan.

Cory Kasimov – JPMorgan

Hi, good afternoon guys. Thanks for taking the questions. I have two for you relating to your panel preparations. So the first one – obviously it goes (inaudible) going to be a very interesting panel and one that is probably very different from most other advisory committees, given that each of the drugs in Qnexa are so well characterized, so one would think it makes it relatively easier to predict exactly what the FDA may focus on. So to that end, how much real-world feedback are you seeking from physicians who use these drugs, especially those who – I guess probably the focus for many investors and the ones I am talking to is topiramate and using that in a chronic type setting for migraine therapy. Are you bringing a lot of these types of physicians in and getting their advice and trying to anticipate what types of questions you may get from the panelists in July?

Peter Tam

Cory, it’s Peter. Yes, we are talking to a lot of outside experts, retain their services to help us with, speaking about the risk benefit of the product. So the – as you said, these are two drugs that are well characterized when using low doses. But this is really the first time that these – that this combination has been tested in obese patients with weight related co-morbidity. We are getting a lot of positive feedback from these people during our discussions with them. So they are there to help us go through these risk benefits with the panel and so far things are looking very positive.

Cory Kasimov – JPMorgan

Okay. And then, the second question is also related to the panel. And Peter you had mentioned that you guys are already working with outside consultants in your preparation work. Are the – in addition to clinicians and investigators, are you also dealing with ex-FDA staffers? And if so, can you kind of talk about where their focus has been on this preparation?

Peter Tam

Yes. Our outside consultants range from thought leaders in various fields as well as former FDA reviewers. So they range from CMC to clin pharm to clinical, so we are just getting the advice from all these experience people that are available to us.

Cory Kasimov – JPMorgan

Okay. And then, my last question would be on the Board resignations announced late last week. I understand they are purely for personal reasons, but some may look at this just given the company’s current inflection point with some skepticism. Any reason to fear the timing of this whatsoever?

Leland Wilson

None whatsoever. These are for purely personal reasons that over time will become obvious to everyone. But there are – if you stop and think about the individuals, you will probably have some basic understanding of the situation. So they are purely personal and have nothing to do with them being going on within the company, so everybody should feel very confident in that.

Cory Kasimov – JPMorgan

Alright, great. Thanks and good luck.

Leland Wilson

Thank you.

Operator

Thank you. Our next question comes from Alan Carr of Needham and Company.

Alan Carr – Needham and Company

Good afternoon. Thanks for taking my question. Congratulations for bringing Mike Miller on board. I think a good place to start here then would be in the commercialization area. What sort of efforts do you have ongoing there? And I am also wondering what your assessment of the market is telling you these days. How concentrated are the prescribers in weight loss?

Leland Wilson

Okay, well, yes we are real excited to have Mike on board. I have followed Mike’s career for a long time. We worked together at Syntex. It seems like a century ago, but Mike’s been a shooting star in this pharmaceutical industry for a long, long time. We are very grateful to have him on board.

Mike, as I mentioned has extensive experience both in business development and in launching major products. And so with that, we are pursuing as we have said publicly before, we are doing everything inside the company necessary for a successfully launch of this product. And the reason for that is if a partner comes on and we are well prepared for them to take it over and go from there, so it’s necessary for us to do all that.

The second part of it is it really strengthens our negotiating positions. And while we are talking about this effort, we can talk about partners too. And what we have said is that the partners that we have that are interested, which are a substantial number are obviously anticipating the outcome of the advisory panel. So this has been an area of great concern for our products in the obesity market segment, so risk reduction around the advisory panel. So Mike can help us both on the corporate partnering level as well as preparing for the launch.

And now talking about the concentration of prescribers for obesity and I take your question is relative to how many could a small company reach with a relatively small sales organization. Well, the market for obesity is only partially developed. It is certainly my expectation that the market will develop to a much greater extent with a product that can get double-digit weight loss.

And so – and my belief is is that you will see some concentration in high prescribers and it will be high prescribers which are not the high prescribers of phentermine and Meridia, et cetera today. There will be obesity clinics to establish and people will take this up as a specialty, because it is I think a huge potential patient pool that physicians can tap into. So we will see how that develops over time. But right now, it’s fairly diverse prescriber population and not really highly concentrated at the present time.

Alan Carr – Needham and Company

Great. Thanks for that. And Tim, any change to burn guidance for the year?

Tim Morris

No, we haven’t changed our guidance since the last call, Alan. Still approximately 95 for the year.

Alan Carr – Needham and Company

Great. Thanks very much.

Operator

Thank you. Our next question comes from Mike King, Wedbush. Mr. King, your line is open.

Mike King – Wedbush

I beg your pardon. Thank you for taking my question and congrats on your progress guys. Just a couple of random questions. I just wanted to follow up on the previous question about commercialization and I wonder if you guys could talk about – I think prior to the announcement of the panel date, it was expected that panel would happen later in the year. So I am just wondering how has the July panel played with your schedule? Has it thrown it off at all? Are you prepared to launch if, let’s say, things go smoothly and there is a positive panel and they – a first-cycle approval on the 28th of October. Will you be able to meet all the milestones you would have been able to meet had it happened later in 2010?

Leland Wilson

Well, actually it’s an advantage in my view having the earlier panel, because it will give you additional time after the panel where your risks of hiring, for example, are reduced. And so we look at it as good – a very good risk reduction step. And to that point, I would comment that that we have been actively engaged since January with the FDA and a review of this NDA. So it has progressed in my personal view a very satisfactorily, aggressively. And so I think the panel is just – the date of the panel is just kind of a statement of the FDA’s readiness to have a panel for this product. And so I think everybody, both the FDA and VIVUS will going to be at a high state of readiness on that date. So we are as I said very confident and really can’t wait to get there.

Mike King – Wedbush

Will you say anything about your ability to supply the market, Le, sometime around or after the PDUFA date? And will we see evidence later in the year of you building clinical supply?

Leland Wilson

Yes, if your question regards to the manufacturing activity, yes, we have complete capability of having a launched quantities available on October 28^th.

Mike King – Wedbush

And have you been inspected? Can you say if the plant has been inspected at your manufacturers?

Leland Wilson

We use the contract manufacturer. The contract manufacturer has been inspected many times. We have not had an inspection on Qnexa at this time at their plant.

Mike King – Wedbush

Okay. And can you say anything about your sites are being audited or is that an ongoing – clinical sites.

Leland Wilson

We don’t comment on that, but you might know that in every NDA that I have been associated with at least, sites are audited, it’s just standard activities.

Mike King – Wedbush

Yes, no, I know that. I am just saying are we there? Is the process active on the part of the agency now and will that or that does that need to happen? I am just trying to figure out what gating items might –

Leland Wilson

The agency is extremely active on all aspects of the review.

Mike King – Wedbush

Okay. And I don’t mean to parse your words too finely, but you did say and maybe it’s just my senility setting in again. But the wording in the press release said it is a tentative panel date and I don’t know that you have used that term before, but perhaps I have mistaken.

Leland Wilson

That’s – my guess is kind of standard lingo from the FDA. They have reserved the rights to change it, so – but I haven’t seen one change, but that doesn’t mean they haven’t changed.

Mike King – Wedbush

But it’s not official till it’s in the federal register.

Leland Wilson

That’s exactly right.

Mike King – Wedbush

And then, one final question, I will jump back in the queue. Any thoughts – I mean, the data that I have been reading lately suggest that the obesity is starting to level off in adults, but still climbing at an alarming rate in adolescents and peds. So I am just wondering what VIVUS can say at the moment about a commitment to studying Qnexa in a pediatric population?

Leland Wilson

Yes, okay, couple of things. I haven’t noticed any decline in the people around the neighborhood.

Mike King – Wedbush

I am just telling you what the –

Leland Wilson

Not to be flip with two-thirds of the population overweight obese, the market hasn’t gone away for sure. And what was the second part of your question again, Mike?

Mike King – Wedbush

All I am saying is that –

Leland Wilson

The pediatric plan, so Peter you might comment on our pediatric plan.

Peter Tam

Yes, it’ part of the NDA submission. We are – we have submitted the pediatric plan in place. So there is a plan I can’t really comment in great detail on it other than the fact that we thought that through very, very carefully that once Qnexa is approved, we are ready to get that plan kick started.

Leland Wilson

And I think the important part here it has to follow post approval and then we will also during the pediatric plans in the European theater as well.

Mike King – Wedbush

Alright, terrific guys. Thanks so much.

Operator

Thank you. Our next question comes from Terence Flynn of Lazard Capital Markets.

Terence Flynn – Lazard Capital Markets

Alright, thanks for taking the question. Just wondering on the – you didn’t give us an update on the sleep apnea trial and I think you guys said in the past you were going to meet with FDA over the near term and to determine next steps, so I am just wondering if you could give us a quick update there? Thanks.

Leland Wilson

Yes, Terence, we did meet with the FDA, and right now we are working out a late-stage Phase III type of development plan with the FDA. So we will provide more color, more detail in the next quarterly conference call.

Terence Flynn – Lazard Capital Markets

Okay. And so you can’t give us any more insights in terms of thinking about endpoints and size of trials.

Leland Wilson

I think I will just lead (ph) Terence, what I would say is that clearly this is the first application that the FDA has dealt with for the syndication. So there is a lot of negotiation let’s say that goes on in establishing all the different parameters as to how trials should be designed to kind of patients we have, how long they have to be treated, et cetera.

So this was our first meeting with them, extremely receptive. They came well prepared as you might expect. And so we are going through those discussions as Peter said and I expect to have them worked out relatively quickly, but we will wait and see until we all have the end points, the trial design, the patient populations and all those things in hand, and we will let you know when we are ready to start Phase III.

Terence Flynn – Lazard Capital Markets

Okay. And will you guys seek an SPA?

Leland Wilson

Yes, we will.

Terence Flynn – Lazard Capital Markets

Okay, thanks a lot.

Operator

Thank you. Our next question comes from Thomas Wei of Jefferies.

Thomas Wei – Jefferies

Yes, I wanted to ask about Qnexa and whether you could share any of the insights that the FDA gave to you in their 74-day letter when you were notified about acceptance of – with the filing.

Leland Wilson

You might take it, Peter –

Peter Tam

Well, yes, we – it’s not a whole lot of insight. Certainly the FDA is very quick with their review. All the questions so far have been expected and really nothing out of the ordinary, various aspects of the NDA review from clinical, pre-clinical, which is very comprehensive. It goes to show that the FDA is looking very diligently on this NDA.

Thomas Wei – Jefferies

And I wanted to just check on that presentation title for the hypertension meeting. When it refers to low-dose that that doesn’t mean just the lowest dose of Qnexa, right? It was affecting (ph) across the entire dose range in the studies.

Peter Tam

Yes, we will be presenting the different doses at this meeting.

Leland Wilson

We typically characterize our product as a low-dose combination of phentermine and topiramate, so that’s what that’s referring to.

Thomas Wei – Jefferies

Okay, perfect. And I did also want to just ask given the fact that the same FDA panel meeting will have just spent the last day prior to yours debating cardiovascular risk with one of the diabetes drugs. I just wanted to get your sense of – or a reminder on a pooled basis, how many major cardiovascular adverse events did you have in those studies versus placebo? Do you know what the raw numbers are off the top of your head?

Leland Wilson

Yes, no. We have not. Those are something that’s being adjudicated and we do not have the final data on those at this point. We are hopeful to have them by the advisory panel. But that’s something that’s outside of our hands right now, because that’s an independent adjudication committee. We feel very strongly as you know that the cardiovascular benefits of this drug are really outstanding. And so we are anxious to present our cardiovascular data. It is outstanding.

Thomas Wei – Jefferies

But it’s not part of the initial filing and it probably won’t be something that is going to be presented at the panel meeting.

Leland Wilson

Well, my personal preference is I would like to present it, but we will have to wait for the adjudication to occur.

Thomas Wei – Jefferies

Okay. Do you have a sense just even generally from the investigator coded number of cardiovascular events if you applied the same cardiovascular guidance criteria that exists for the diabetes drugs and did a meta-analysis of the Phase II and III trials, are you – how many patients are you shy of being able to fulfill the criteria for the upper bound of the 95% confidence interval for once again separately for as it has been applied to the diabetes drug?

Leland Wilson

We are as anxious as you are to get this data and get us out there to you guys. But let’s wait until we have the final data before we comment on that. But what I have said in the past is that the number of the events that we have had in this trial are not all that high. I think that’s characteristics of obesity trials. They are not quite yet as sick as diabetic patient population, so the number of events are fairly low. But let’s wait till we have that data to present it and we are as anxious as you are to get it out there.

Thomas Wei – Jefferies

And then one last question just on psychiatric adverse events. I am sure that you – the FDA has probably asked you for a similar meta analysis like the one that we have done for Acomplia. Can you share with us any findings from that analysis on how Qnexa looks versus placebo?

Leland Wilson

Well, I am not quite sure exactly what you asked about, but let me just speak a few words, maybe Peter can chime in as well. We have presented all the data that we have on our psychiatric AEs to this point.

I mean clearly we have probably most through and complete look at both depression and suicidality of any product that’s ever been through the FDA and through the Phase III program. And clearly, we really have a zero indication of any suicidality. When you look at the PHQ-9 test scores, we actually have a slight improvement on treatment. If you look at quality of life, we have an improvement of every major – of every domain that is tested.

Now the one area that we have focused on is the drop out rate for patients on depression. And as we have previously presented to you that the drop out rate is higher on the high dose. But that drop out rate, the depression that was there was primarily mild and manageable and resolved on more – on the majority of cases while still on the drug and still on the study. So we think we have a very thorough and very convincing review of the psychiatric adverse events and we are really very confident that we are in very good shape here.

Remember as I always liked to say, the – when you talk about the psychiatric adverse events, you are talking about topiramate in general. And so the doses that we use are very low compared to the approved doses of the topiramate and the experience in the marketplace now. And I think – and then we have the counterbalance act, balancing activity. The complementary pharmacology of phentermine which is really I think helps to ameliorate some of those side effects.

Importantly, I think in our study as well that we study patients, up to 30% of the patients came in with some kind of psychiatric history. High teens of patients were on an anti-depressants is my recollection Peter. And so we have just done an A to Z look at this and really in my view there is really nothing here to report.

Thomas Wei – Jefferies

Thanks very much. That’s very helpful.

Operator

Thank you. Our next question comes from Ian Sanderson of Cowen.

Ian Sanderson – Cowen

Good afternoon, thanks for taking the question. Have you had any discussions with the FDA at this early stage regarding a REMS plan and would that be something that might be presented at the Advisory Committee.

Peter Tam

Yes, it’s – we will be presenting that at the Advisory Committee. There is really nothing up unusual or different than what is currently available for topiramate. So I expect something similar to medication guide, the communications plan to professionals as well as patients.

Ian Sanderson – Cowen

Okay. And I guess that will be the expectation, but you know or do you know that the FDA will include cardiologists on the Advisory Committee panel.

Leland Wilson

At this point, we don’t know the makeup of the panel, but we are certainly preparing for that. So yes, this is something we are preparing for.

Ian Sanderson – Cowen

Okay. And then quickly on Avanafil, any update on filing plans there?

Leland Wilson

With the guidance that we have provided is that we plan to file an NDA about approximately the first half of next year.

Ian Sanderson – Cowen

Okay, thank you.

Leland Wilson

Okay.

Operator

Thank you. Our next question comes from James Armstrong of Wells Fargo Securities.

James Armstrong – Wells Fargo Securities

Hi, guys. Actually all of my questions have been answered. Thank you.

Leland Wilson

Thank you.

Operator

Thank you. Our next question comes from Len Yaffe of Sock Stock Partners.

Len Yaffe – Sock Stock Partners

I had two questions. The first one was as you talk to your physician clinician consultants, and of those who have participated in trials with other anti-obesity drugs that have completed advanced stage clinical studies, what are the differences between Qnexa and other products that they highlight to you that they find to be either especially beneficial or potentially an adverse issue?

Leland Wilson

Len, that’s a great question. But as you know, I really don’t comment on other people’s products and – but we are very confident in both the efficacy from a weight loss standpoint and its effect on co-morbidities particularly cardiovascular co-morbidities of our product. So I think we have the best in the class, but you will have to check with the other guys to see what they think about their prospects as well.

Len Yaffe – Sock Stock Partners

Okay. Then the second question is I have always been impressed with the FDA statisticians who have been able to call out from their analysis findings that the presenting companies often don’t give voluntarily when they present their data before the FDA and their analysis of the drug either as it relates to efficacy or safety. Is there anything in the either efficacy or safety that you find of concern to yourselves that you feel may be most focused on by the FDA and their statisticians that may be of concern?

Leland Wilson

I will say this upfront, we may be different than the other companies, but we spend 90% of our time trying to find any kind of little hook or issue that could become an issue at the FDA. And I can promise you that each of those issues that may or may not be an issue will be dealt with fully in the briefing document and in our presentation.

We believe that it’s just smart to address the tough issues right upfront. And so we are doing that and you will be able to read about everything that we have found that as any possible issues and that includes former FDA reviewers, that includes statisticians that are of note in our industry. And so we have tried to route every possible question and we will deal with them openly and straight upfront in our briefing document and presentation.

Len Yaffe – Sock Stock Partners

Great. Thank you so much.

Operator

Thank you. Our next question comes from Boris Peaker of Rodman & Renshaw.