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VIVUS, Inc. (NASDAQ:VVUS)

Q3 2010 Earnings Call

November 8, 2010 4:30 p.m. ET

Executives

Tim Morris – SVP, Finance and CFO

Leland Wilson – CEO

Peter Tam – President and COO

Analysts

Chris James – McNicoll, Lewis & Vlak

Alan Carr – Needham & Co.

Michael Tong – Wells Fargo Securities

Steve Bial [ph] – Bank of America

Thomas Wei – Jefferies & Co.

Adam Cutler - Canaccord

Operator

Good day, ladies and gentlemen, and welcome to the VIVUS third quarter 2010 results conference call. At this time, all participants are on 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 call is being recorded.

I would now like to turn the call over to your host, Mr. Tim Morris. Please go ahead, sir.

Tim Morris

Thank you, operator. Before we get started, I’d like to remind you that during this conference call, VIVUS may make certain statements in this call that are considered forward-looking within the meeting of the Private Securities Litigation Reform Act of 1995.

These statements maybe identified by the use of forward-looking words, such as anticipate, believed, planned, estimated, and intend, and among others. These forward-looking statements are based on VIVUS current expectation and actual results could differ materially.

There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substances of VIVUS written response to the FDAs complete response letter, the FDAs interpretation of the information VIVUS submits, relating to the teratogenicity and cardiovascular safety, the FDAs interpretation of the data from our SEQUEL study, or OB-305. Their request, if any, to conduct additional clinical trials, substantial competition, uncertainties of paten production and litigation, alliance on sole-source suppliers, limited sales, and marketing resources, and dependence upon third parties, risk related to the development of innovative products, and risk related to the failure to obtain FDA clearances or approval, and non-compliance with FDA regulation

As with any pharmaceutical in development, there are significant risk in the development and regulatory approval and commercialization of new products. There are no guarantees that our response to the FDA with the CRL will be sufficient to satisfy FDAs safety concern, and that the FDA will not require us to conduct any additional studies, or that any product will receive regulatory approval, or any indication or prove to be commercially successful.

VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS Form 10-K for the year ending December 31, 2009, and periodic reports filed with the Securities and Exchange Commission.

I will now 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, along with Tim is VIVUS's President, Peter Tam.

On today's call we will first review the Qnexa CRL received on October 28, 2010, and our planned response. Then we will summarize our results for OB-305, the SEQUEL study we released in late September. We will then provide an update on EU filing for Qnexa, followed by an update on avanafil. We’ll then summarize the MUSE transaction, and finally we’ll provide an update on the cash balance and guidance for the end of the year.

As we previously discussed on October 28, 2010, we received the complete response letter, or CRL from the FDA regarding the Qnexa NDA. The FDA issued the CRL to communicated decision that the NDA cannot be approved in its present form.

We are preparing our response to the FDAs request for information, and are on schedule to submit our response by December 15.

The CRL included request for additional analyses to help the FDA further assess teratogenicity and cardiovascular safety. For teratogenicity, the FDA requested a comprehensive assessment of topiramate and Qnexa to radiogenic potential.

As part of our response, we are compiling analysis integrating existing nonclinical and clinical data, including published research on topiramate. Our response will include a detailed plan to mitigate any potential risk in women of child-bearing potential.

For cardiovascular safety, the FDA asked VIVUS to provide evidence that the elevations in heart rate associated with Qnexa do not increase the risk for major adverse cardiovascular events. In our response, we’ll provide several new analyses which would include data from our SEQUEL and sleep apnea studies. Data from SEQUEL and sleep apnea studies were not included in the original NDA. The CRL also included a request for submission of the final study report from the two-year SEQUEL study.

Peter will review the results from the SEQUEL study momentarily.

Top-line results from this study, were announced by VIVUS on September 21, 2010, and final study report is being prepared as part of our response to the FDA.

The FDA also requested a safety update of any new adverse events since the last safety update.

Finally, the FDA stated that it proved connection with the scheduled fourth drug, due to the phentermine component. FDAs comment on final labeling and REMS are expected after the written requirement is accepted.

We believe we have sufficient data from existing studies with Qnexa to satisfy the FDA’s request. In the CRL, no new clinical studies were requested. However, in the event that FDA concerns are not alleviated by the information of our response, additional clinical studies may be required. We’re working with our regulatory advisors and the FDA to optimize our response strategy. We are on schedule to submit our answers to the questions raised in the CRL by mid-December.

The FDA will tell us if our response is adequate. If it is adequate, then our formal amendment to the NDA will be submitted. To date, we have not requested a meeting with the FDA. We may in the future request a meeting with the agency to discuss our response. We are focused on the ultimate approval of Qnexa and will adjust our regulatory strategy as necessary.

And with that, I’ll turn the call over to our President Peter Tam.

Peter Tam

Thanks, Lee. In September, we announced topline results from two year study SEQUEL for OB-305, a 52-week extension study for a subset of patients who completed the previously reported 56-week CONQUER study.

The total study period was 108 weeks. SEQUEL included 675 obese or overweight patients who had two or more weight-related co morbidities and an average base line BMI of 36.1. Patients in the study taking the top dose of Qnexa achieved and maintained average weight loss of 11.4% of their initial body weight, or 26 pounds at the end of two years on an IPPLOCF basis.

Consistent with the first year experience, Qnexa therapy was well tolerated with no new or unexpected adverse events. The most common side effect seen were constipation, tingling, dry mouth, altered taste, and insomnia.

In addition to sustained weight loss greater than 10% over two years, Qnexa demonstrated other benefits. Weight loss with Qnexa in SEQUEL was associated with statistically significant improvements in weight-related comorbidities such as hypertension, dyslipidemia, and diabetes.

Importantly, among patients with diabetes at baseline, without diabetes at baseline, the incidence of new onset of Type II diabetes was reduced by 54% and 76% from mid and top dose respectfully, as compared to placebo.

The completion rate in SEQUEL was approximately 83% from both Qnexa doses, and 86% for the placebo group. The continuation, due to adverse events were 3.9 and 4.1% for the mid and top dose, respectfully, and 2.6% for the placebo group with no single adverse event leading to discontinuation in more than 1% of patients.

We are currently preparing the final study report to be submitted to the FDA as requested by the FDA in the CRL.

For our European filing, as we have stated previously, we are on track to file for approval of Qnexa in Europe by the end of this year. It is our view that the CRL received in October, would not affect the European filing, as planned. We are filing for a European approval under the centralized procedure.

For avanafil, we continue to make progress with this development program and the assembly of the NDA. We have completed the long-term safety study, TA-314. TA-314 was an open-label safety study of avanafil that evaluates the long-term safety and tolerability of avanafil. TA-314 was conducted over a one-year period in approximately 700 patients across 40 U.S. centers.

Patients completing either the 12-week REVIVE, or REVIVE diabetes studies are eligible to participate in TA-314. Result of this study are expected this month.

We continue to make progress in filing the NDA for avanafil. Our team held a pre-NDA meeting with FDA in late October. In our pre-NDA meeting, we confirmed with the FDA that the post-radical proctectomy study for avanafil, TA-303, does not need to be included in the NDA. We plan to submit the study report for TA-303 as a supplement, later on.

Based on the meeting, we confirmed we are on track for filing of the first half of 2011.

I will now turn the call over to Tim, to discuss the financial results and the IR activity, Tim.

Tim Morris

Thank you Peter. At the end of September VIVUS had cash, cash equivalence, and available for sale securities of approximately $158 million. This compares to the $175 million we had on the balance sheet at the end of June. The decrease in cash of $17 million for the quarter, is primarily due to cash used in operations.

As we stated last time, we continue to conserve cash, and have curtailed several planned expenditures. Based on the remaining planned expenditures for the year, we estimate our cash and security balance at the end of the year will be in excess of $135 million.

As we announced this morning, we have closed the sale of the MUSE to Meda, our European partner, we had a longstanding relationship with Meda. Based on their experience with MUSE, and their desire to expand in the United States, we believe Meda is an excellent fit to take over MUSE.

The purchase price was $23.5 million, with included $22 million upfront, and a potential milestone of $1.5 million. The milestone is based upon achievement of certain MUSE revenue targets.

The transaction includes all the MUSE patents and IP, the NDA, and foreign approval, existing inventory, and a manufacturing facility in New Jersey. A majority, if not most of MUSE employees have accepted positions with Meda. VIVUS retains the accounts receivable and any pre-closing liabilities.

In conjunction with the transaction, we prepaid the amount owed to Crown Bank for the mortgage on the facility, and we gained the right to use avanafil for the repayment amounts owed to Deerfield Management and their affiliates.

Deerfield has no residual rights to use avanafil. From an accounting standpoint, we have accounted for the transaction at discontinued operations. All of the historical complications relating to the MUSE business, have been reclassified in the financial and presented in the discontinued operations line.

All residual accounting for the MUSE business will run through this line item, and I would guide analyst to remove MUSE from their models.

As it relates to the rest of the financial results, I refer you to the press release for more information, on the third quarter nine-month results.

On the investor relations front, we will continue to participate in several investor commerce throughout the remainder of the year. This week, I will present at the Credit Suisse Healthcare Conference in Phoenix, and next week I will be in New York City at the Resort HealthCare Conference. In December, we will present at the Canaccord Adams Diabetic and Metabolic Conference, and lastly, we will present at the Deutsche Bank Bio FEST in Boston on December the 14.

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

Leland Wilson

Thank you Tim. For the next six weeks, we’ll remain focused on one, responding to the FDA in our CRL. Number two, filing for approval of Qnexa in the EU.

I’d like to mention that I appreciate all the excellent efforts of our clinical and regulatory groups today, in both of the – all of the regulatory activity that we’ve conducted over the years with Ed Bevis [ph], but most specifically, the excellent work that’s being conducted today on Qnexa.

The MUSE transaction marks an end of an era. Virgil and I started VIVUS based on the MUSE technology in 1991. I specifically wish to thank all of our manufacturing employees and sales reps that have contributed to the success of MUSE over the years.

I also specifically want to thank Ed Marsh, our Vice President and General Manager, who has run the MUSE operation for the last 10 years. Thank you all, it’s been great to be – to develop our relationships and friendships over the year, and I appreciate your work and contributions tremendously.

And now, I’ll open the call to questions.

Question-and-Answer Session

Operator

Thank you, sir. (Operator Instructions) Our first question comes from Christopher James with McNicoll, Lewis and Vlak

Chris James – McNicoll, Lewis & Vlak

Hi, guys. Good afternoon, and thanks for taking my question. Just a couple here; with respect to the elevation in heart rate, and the increased risk for cardiovascular problems down the line, what are you going to submit with the new analyses and sort of how is that going to look with respect to the CONQUER data and specifically outliers in that data? And can you comment on the atransientness of the tachycardia?

Peter Tam

Chris, it’s Peter. First of all, we’ve presented some of those analyses at the ATCOM. We’ve actually conducted quite a few additional analyses looking at heart rate and it’s associated, or lack thereof with regards to these cardiovascular serious adverse events.

First of all, I want to say that there are – our opinion is that, based on the data, that there is no association. We’ve looked at outliers, we’ve looked at patients with existing, pre-existing cardiovascular diseases as well as concomitant medications for their cardiovascular conditions and we see no association based on all the work that we’ve done.

You know, we also shared with the ATCOM as well as public that the rate pressure product goes down compared to baseline and that’s a favorable response overall. We looked at patients who have outlier heart rate and we also saw favorable reduction in their blood pressure. So we are confident that we will be able to demonstrate the that Qnexa does not increase the risk of these major adverse cardiovascular events..

Chris James – McNicoll, Lewis & Vlak

Thanks. That’s helpful. Just one quick follow-up housekeeping question. The drop in R&D quarter for quarter and the drop – the small drop in G&A, how should we view these lines in the near term, particularly in the fourth quarter and early 2011, although obviously it’s going to be clearly difficult to predict just given your situation with the FDA?

Leland Wilson

Yeah, Chris, we haven’t given any guidance and I don’t give any guidance on individual line items, but it’s probably safe to assume since the majority of the critical work has been completed and also with the MUSE business being sold, you would expect those trends to probably continue. In the fourth quarter you will have a gain on the sale of MUSE as well, so there will be some interesting accounting items. But other than that, I think you’re okay with your trend.

Chris James – McNicoll, Lewis & Vlak

Thanks.

Operator

Thank you. Our next question comes from Alan Carr with Needham & Company.

Alan Carr – Needham & Co.

Hi. Thanks for taking my question. When can you give us an update on partnership strategies? Have there been any evolution in your disposition since ATCOM? I wonder if you’re any more inclined to a more targeted commercial effort with your own sales force? Thanks.

Leland Wilson

Yeah, no new guidance other than what you understand about the regulatory approval process here. Clearly, I’ve stated on many occasions, Alan, that you know, for us to be able to drive the best deal, we have to eliminate the regulatory risk here. So I think the best deal will occur after the approval is given by the FDA. So we are prosecuting this.

I’d also say that, as I’ve said in the past too, that we are doing all the work necessary for us or a potential partner to launch the product in terms of all the market research and branding and those kinds of activities, they’re all underway right now.

Alan Carr – Needham & Co.

I get the since – no change, I guess in your inclination or likelihood of this one going to market on your own?

Leland Wilson

Well, we haven’t said, and that will be dependent upon obviously what kind of deal structure we can muster. Clearly, we will be prepared because as I said, all the work that we’re doing right now, we will be prepared to launch this product on our own and we’ll do the deal when we get the best deal.

Alan Carr – Needham & Co.

And then a quick one, I can’t recall if you guys have discussed this before. When might we see details on the two-year data?

Leland Wilson

The two-year data will be presented in a cardiovascular meeting or some meeting, I'm not sure, Peter, do you know exactly where it’s going to be presented? It’s going to be presented at the first meeting that we can get it to.

Alan Carr – Needham & Co.

All right. Thanks.

Operator

Thank you. Our next question comes from Michael Tong with Wells Fargo Securities.

Michael Tong – Wells Fargo Securities

Hi. Thanks for taking my question. Peter, I was wondering if you can clarify when you said submitting the response to CRL on December 15, is that the response that if the FDA accepts it would trigger either a Class I or a Class II review, or are there steps after that before you get to that point?

Peter Tam

There will probably be steps. Again, we’re working in parallel here. There’s the response and there’s the resubmission, the formal resubmission. Again, we are confident in our belief as to what FDA is looking for, so work is being prepared in parallel with the formal submission. So as we mentioned, we may talk to the division or meet with them to ensure that the content of our submission is aligned with our expectation. But nevertheless, we expect those things to happen pretty quickly, one after another.

Michael Tong – Wells Fargo Securities

Okay. So after the December 15 submission, the FDA will then let you know whether you’re on the right track and then you go for the official response, or the official resubmission at that point?

Peter Tam

Yes.

Michael Tong – Wells Fargo Securities

Great, thank you.

Operator

Thank you. Our next question comes from Steve Bial [ph] with Bank of America.

Steve Bial [ph] – Bank of America

Hi. I was just curious about the strategy here. You seem confident that you know what the agency’s looking for in terms of the evidence that there’s no increased risk for CV events, do you anticipate meeting them after you prepare your argument? And I’m curious as to why not request a meeting ahead of that response?

Peter Tam

Well one, the CRL is cleared in our view and we’re confidentially working with consultants to talk about this and it is all believed that it would serve our best interest to get the response to the FDA as quickly as possible, namely because we have conducted these analyses that will point to these two particular risk areas. And at the same time, you know, we believe that FDA is currently working on the various projects and we may again want to talk to them again to make sure that they are comfortable with our approach. And then if we need to make some adjustment, we will make adjustments accordingly.

Steve Bial [ph] – Bank of America

And Peter, I want to make sure I understood you in one of your responses earlier in the call. I thought I heard you say that patients who had a history of cardiovascular disease did not have any increased rate of cardiovascular adverse events. Is that right, and could you test patients that have a history of cardiovascular disease?

Peter Tam

No, we look at a spectrum of patients with varying degree of cardiovascular disease. For example, some have documented hypertension, some are on more than two anti-hypertensive meds, and despite being on two anti-hypertensive meds, they also have – they continue to have an elevated blood pressure. So we looked at high-rate affects, outliers in those patients and didn’t really see any increases or anything unusual about any of these subpopulations. That’s what I was referring to.

Steve Bial [ph] – Bank of America

Okay. All right, thanks. And then just lastly, you often refer to the rate pressure of product. I was wondering if you had dialog with the agency and whether they share your view that that’s a meaningful indicator of risk?

Peter Tam

Those have been shared with the division, the reviewing division. They haven’t specifically commented, and we don’t expect them to, to say whether they love it or they don’t like it, but there’s no controversy that we see as of now.

Steve Bial [ph] – Bank of America

Okay. Thank you.

Operator

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

Thomas Wei – Jefferies & Co.

Hi. This is actually Tommy for Thomas. My question was more less answered but I just wanted to confirm someone else’s question that it sounds like you are opening up to the possibility that you could take the usual FDA meeting within 30 days after receiving the letter. Am I correct in that, or if so, what has changed in your thinking? Was it feedback from your consultants, or something else? Thanks.

Peter Tam

Well, we never closed our minds to what’s the right thing to do. Tommy, the right thing to do is make sure that we get all the information available and make our decision accordingly. And ultimately, we want to minimize the – any potential delay in FDAs review of our submission. So that’s the ultimate goal. You know, right now, as we stated previously, the – our first job is to get all these analyses complied, put together in the in the right manner, send them to the FDA and if at some point – content is most important. If the FDA agrees with these arguments, they certainly will say, fine, or they need more, and then we will react accordingly.

So you know, our job is to never close any possibility of talking with the division because it doesn’t help us to be arrogant or say we don’t need the FDA here. So we will adjust mid-course if necessary.

Thomas Wei – Jefferies & Co.

Great, thanks. I’ll jump back in the queue.

Operator

Thank you. Our next question comes from Brian Jeep of Wells Fargo Securities.

Brian Jeep – Wells Fargo Securities

I apologize. I tried to cancel, but my question’s already been answered. Thank you.

Operator

Thank you. Our next question comes from Adam Cutler with Canaccord.

Adam Cutler - Canaccord

Hi. Thanks for taking my question. I’m wondering – just to make sure that I fully understand your plans –

Peter Tam

Did we lose him? Are you there?

Operator

Sir, if you could please press start one again if you have a question.

Peter Tam

Go to the next question, operator, and then we’ll come back to Adam when he gets back on.

Adam Cutler – Canaccord

Can you hear me?

Operator

Mr. Cutler, your line is open.

Adam Cutler - Canaccord

Okay, thanks. Not sure what happened the first time. But I was just wondering, just to make sure that I fully understand your intentions around resubmission. So am I right that right now what you’re doing is assembling all of the data that you feel like you need in order to satisfy or answer the FDAs questions and some of it was very specific, others were more issues that they were hoping that you could provide some more clarity around, and that you’ll resubmit those at which point you’ll get a Class I, or Class II designation and then maybe further discussion with the FDA? Or is it the idea that you’ll assemble everything that you feel like you have and that you need to answer the questions and then in one form or another have some discussion with the FDA before you get to the point of officially resubmitting and getting your Class I or Class II and your new PDUFA date?

Peter Tam

Yeah, let’s make sure we all have this real clear here. The written response that we’re providing to the FDA on December 15 will, in our opinion, answer their questions. Okay. Now, the FDA has to make a determination whether it answers their questions or not. And if they think it’s adequate, then we will make the formal resubmission or amendment to the NDA at that point.

So we believe this has a couple of advantages. One, it doesn’t hurt our timeline. Number two, it gets the benefit of having the FDA look at the answers that we have so that they have some [inaudible] for them to discuss. We’ve always found that to be better to provide the FDA information and in order to get good feedback. Over the years it’s proven to be a very time-saving activity. And if they look at it and they have smiles on their faces, I think we’ll all have smiles on our faces and the submission will be made immediately.

Adam Cutler - Canaccord

So I guess under what protocol would you provide the information to the FDA for them to look at it if it’s not yet your official resubmission?

Peter Tam

Well, you can – there’s a number of ways which that can happen. You can actually submit it in say a briefing document to a meeting, and that has, you know, you understand I know Adam, very clearly it falls into the regulatory process. So that’s just one possible way.

And the FDA, I will say, has been very responsive and so when we have questions or issues that we need to deal with, they have been very responsive to us. So we’ll cross that base when we get to our submission, our written response here in December.

Adam Cutler - Canaccord

So have you requested the meeting with the FDA?

Peter Tam

No, we haven’t.

Adam Cutler - Canaccord

So maybe I'm missing something. I don’t mean to be difficult. I’m just wondering why you wouldn’t have already requested a meeting with the FDA since we’re just a little bit more than 30 days away from when you expect to have your resubmission ready and you are hoping to share it with them and discuss it before you had officially resubmit your NDA. Is there something I’m missing in the process?

Peter Tam

No, I think Adam, there’s a couple issues. One, the FDA has to have time to take a look at it. And then we have both formal and informal communications going on. So we’re not sure exactly what the response will be from the FDA. It could be, go ahead and submit the amendment, or it could say come in and let’s talk. In any case, the ball will be at the FDAs hands at that point and we’ll follow their lead. But we’re hopeful that what we are submitting will be adequate and the FDA will, you know, it could be as simple as a phone call back to us or a brief phone meeting or something to that nature that allows us to go ahead with the submission.

Adam Cutler - Canaccord

So – and just a couple of more question on this point. So the December 15th guidance that you’re giving, that’s for when you expect to communicate with the FDA or that’s the time by which you expect to have already communicated with the FDA and made your formal resubmission?

Peter Tam

We’ll have our formal resubmission to the FDA on December 15. That’s the plan right now.

Adam Cutler - Canaccord

Okay. So between now and then you would expect to have some sort of correspondence with the FDA that gives you an indication of whether the information you’ve assembled seems adequate?

Peter Tam

Well, the FDA will determine when they response to us, but you know, we will be asking questions and hopefully we’ll get the answers that we want. So we’ll have to just wait and see.

Adam Cutler - Canaccord

Okay. Thanks.

Peter Tam

Okay, Adam.

Operator

Thank you. I’m showing no further questions in the queue. I would like to turn the call back over to Leland Wilson.

Leland Wilson

Okay. Thank you. And again, I want to sincerely thank everybody associated with MUSE. This is – I watched the truck pull out of the parking lot the other day, which had the MUSE NDA on it, which is the final documentation that’s been transferred to Meda. And I can’t help but say that I did get a little bit of a twinge in my heart. It’s been a product that has been – I think the safest drug ever launched in the pharmaceutical industry. It has provided a wonderful benefit to many men suffering from erectile dysfunction and under Meda’s guidance, it will continue to provide benefit for many years to come. It’s a wonderful product. It was great for us to start the company on and if we hadn’t had a little issues like the Viagra or PDE5 inhibitor come along, that product would have been a major pharmaceutical product.

That’s all happenstance today, but again, thanks to all the employees and to everybody associated with MUSE.

Thank you.

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the conference and you may now disconnect.

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