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VIVUS (NASDAQ:VVUS)

Q2 2012 Earnings Call

August 07, 2012 4:15 pm ET

Executives

Timothy E. Morris - Chief Financial Officer, Senior Vice President of Finance and Global Corporate Development and Secretary

Leland F. Wilson - Chief Executive Officer and Director

Barbara Troupin - Vice President of Scientific Communication & Risk Management

Michael P. Miller - Chief Commercial Officer and Senior Vice President

Wesley W. Day - Vice President of Clinical Development

Analysts

Steve Byrne - BofA Merrill Lynch, Research Division

Karen E. Jay - JP Morgan Chase & Co, Research Division

Thomas Wei - Jefferies & Company, Inc., Research Division

Marko Kuzol

Jason N. Butler - JMP Securities LLC, Research Division

Simos Simeonidis - Cowen and Company, LLC, Research Division

Joshua Schimmer - Lazard Capital Markets LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the VIVUS Second Quarter and First 6 Months 2012 Financial Results Conference Call. Slides can be found at vivus.com. I'll now turn the call over to the Chief Financial Officer, Tim Morris.

Timothy E. Morris

Thank you. Tim Morris, Chief Financial Officer. Thank you for joining us today, and thank you to everyone on the webcast. Again, we will be making some forward-looking statements, so I refer everyone on the phone and all the investors to read our SEC documents for risks that may affect your investment decision.

With that, we'll turn the call over to Leland Wilson who will go through the agenda for the day.

Leland F. Wilson

Thank you, and thank you, all, for coming here today. It's nice to see all the seats filled and people standing in the back. It's very rewarding to me. Thank you. Also, thank you for joining us on the webcast today in this, I think, a very important time in VIVUS' history.

And first, let me introduce some of the members of VIVUS management teams that are here today at the podium. Mike Miller is our Senior Vice President and Chief Commercial Officer, first guy, and you'll be hearing from him a little bit later; the now famous Dr. Barbara Troupin from the Ad Com, who is, and I'll get her title right here, MD, VP Scientific Communications & Risk Management; obviously, Tim Morris; and I think all of you know Wes Day, who is head of our Clinical Program and really the mastermind behind the clinical trials.

I feel, in many ways, just extremely privileged to have been at the helm here at VIVUS over the last 3 months, particularly because of the fact, frankly, that the 2 approvals of products which, I think, have the potential to make major contributions to medicine. It's so rare when any of us even gets to work on an NDA, particularly those of us who've come out of the research organizations, let alone to have 2 approvals of products that we think that have the potential to really make an impact in the market.

Qsymia, specifically, I think has the change to -- has the chance to change how medicine is practiced around the world and that's -- I don't come by that statement lightly. Historically, we have been treating the symptoms of weight gain, obesity for years and years; with medicines to treat diabetes, Type 2 diabetes; medicines to treat hypertension, et cetera. And we all know that those weight-related co-morbidities are caused by weight. And so I think for the first time, really, we have a drug here in Qsymia that has the potential to really make a major impact on those co-morbidities by lowering weight. And so our efforts are really now in a place now to really aggressively go after this patient population, which is in real need for weight loss. And so I'm very proud of that.

I also want to thank the investors in this room. I see so many faces that I've seen for so many years. And I can tell you without hesitation, without your support, we would have never been able to raise the money to make this important contribution that I think we are about to make.

I also recognize that we have many goals ahead of us. I've been asked often, did we really celebrate with the approval of Qsymia here, particularly most recently. And I can tell you within our company, it was not a celebratory mode because we understand that this is kind of an interim thing. For those of you who like sports, it's kind of a jinx to start celebrating when you win your first playoff game because the goal is to win the championship. We have to deliver this product to patients, and we will not be satisfied until we get the product out. And that's what we'll remember. We will not remember how much money we made. We'll remember that we were part of something that was really important.

Obesity is, as all of you know, better than I even, a major catastrophe around the world and particularly in the United States. And the pharmaceutical industry can play a unique role in helping to disseminate information, if nothing else, but you need to have the financial capability to disseminate that information. Now we see government programs, all the way from the President's wife to the Secretary of Health, et cetera. A lot of those programs have been around awhile and they don't get traction. But when you have a pharmaceutical company that has a drug that has the potential that we believe that Qsymia has, you can talk about medicine that will help patients lose weight. You can talk perhaps even more importantly about the need to lose weight, so that everybody is educated in this country about the importance of weight loss and managing their weight going forward. I think that alone will have a very major impact on a countrywide basis on how we view obesity and how patients will try their best to lose weight, whether or not they're on a drug or not. So I think we have a very important -- a cross to bear in disseminating this information out to the patients out there.

And I also believe that Qsymia has characteristics that are rare in the pharmaceutical industry. Having been doing this now for 7,500 years, it seems sometimes that -- they're rare. The drug is well-tolerated. We put into place a very important REMS program so that we can reduce the risks of patients that are not appropriate to use the product, that is women of child-bearing potential who do not -- are not on effective contraception. And so we've -- it is a very well-tolerated drug.

And as all of you know, both of these drugs are on the market with QNEXA or with phentermine being the most widely prescribed product by itself for weight loss for many, many years. Topiramate was one of the largest selling drugs in the marketplace for migraine headache. So there's a lot of safety record here, so we don't expect some surprise that sometimes happens with drugs that are approved and on the market. So there is a risk reduction associated with that.

But I think the important part here is the characteristic of the drug itself, well-tolerated; and importantly, patients that start on Qsymia lose weight very rapidly. That's an important part of the reward system to encourage patients to: a, exercise; b, watch their diet; and continue on therapy. That little magic that occurs, we get the rewards and feedback from our patients all the time that: "this is a drug that very quickly changed my life. I am exercising. I am not centered on food, and I can live my life free from the burden of craving food constantly throughout the day." So there are characteristics here that I think that you'll get a better appreciation for once this gets into the marketplace and you start hearing feedback from patients going forward.

I also believe that the marketing of this compound, Qsymia, carries a unique responsibility within the company. We're going to do everything we can to keep this from getting into the hands of patients which are not appropriate for this drug. I kind of tease, but seriously tease within the company, I have sales reduction programs like Mike has sales programs to increase sales. The sales reduction program is that we're not going to err on anybody getting this product that is not appropriate, and we're going to make sure people are educated.

We're going to have a controlled launch that Mike will talk to you a little bit about before. Because one of the things that can really hurt us, and I think you all know that in this room, is if we get inappropriate use of the product and that we actually get some pregnancies and those kinds of things. That is just something that we're not going to tolerate So we're going to work hard on a controlled launch to make sure this happens just so you know that's going forward. Obviously, we have a very large market out there to address. There are clearly plenty of patients that we -- that are appropriate for the drug, and we're going to try to reach them in a very effective way.

Some of the other -- obviously, we have some very important goals that we have not met yet. When I mentioned before, did we celebrate? No, because we have additional goals. So next day, we were clearly looking at challenges in the stock market. And clearly, we have goals of partnering both of our products, both in the European theater. Clearly, we have to get approvals for both products in European theater, and I think we've made some great progress along those ways. And classically, we need to launch this product very successfully. And so there's plenty of short-term goals that we're looking at right now that is keeping us more than busy. And I have a very strong belief that we're going to meet each and every one of these challenges just as we have met the challenges of gaining approval through the U.S. FDA for both of our products.

And so with that, I think the next one up to talk today is Tim, and we're going to talk -- Tim, I think, is going to address the patent questions that you may have. And so with that, we'll come back later in the day to answer your questions, but thank you all again for being here.

Timothy E. Morris

Thank you, Leland. Just a couple of things. Just to reset exactly where we are from a company update standpoint. Clearly, Qsymia was approved here as we've previously announced. We do have manufacturing agreements in place with Catalent, and they're currently manufacturing large quantities. We do anticipate a launch in the fourth quarter 2012. We've also executed our contract sales organization agreement with PDI. And then in Europe, something that people probably are going to focus on, we are scheduled for oral hearings with the CHMP in September of 2012.

With STENDRA, obviously, the product was approved by the FDA on April 29. Partnering discussions, I think, are well underway. We did announce, and we'll touch on this briefly in a minute, with Mitsubishi Tanabe that gives us a couple of nice things. And lastly, the product is under review in Europe as well, with an anticipation of a decision sometime in the first part of next year.

Just to touch briefly on the supply chain, we've also, as you're well aware of, have secured a supplier for API. That's ScinoPharm, the company that we've been working with ever since the beginning of development program. They're well-known. Obviously, they've got an excellent track record with the FDA, and so we have a very secure supply of topiramate API.

We've also, as I mentioned, completed a manufacturing agreement with Catalent. This is a very large, very well-known company with 75 years of pharmaceutical experience. Again, they have been manufacturing the drug for us ever since the beginning of the Phase III trial. And then lastly, we've got our distributor of 3PL, Cardinal Health. This is the same group that we worked with in the past, and I think they will be excellent in terms of helping from a distribution standpoint.

A little bit more about Catalent in the commercial manufacturing. Obviously we're very comfortable with this manufacturer. I think they've got an excellent track record. They've been with us ever since the start of the program. They clearly have sufficient capacity to meet a needed demand. And with the approval of the name and the final label and the like, they are currently manufacturing significant quantities for launch.

We also did execute the amendment to the Mitsubishi Tanabe agreements today. This gives us really 3 important things: First of all, it transfers all the manufacturing rights to VIVUS. Historically, the agreement was that Mitsubishi was to manufacture. We now have secured all the manufacturing rights, and we can begin to transfer after a minor transition period here. In addition, it gives us some additional time to secure and prepare for the launch, so we have an additional 6 months, or 12 months in total. And lastly, and this is an interesting advantage, I think, we have as well, that we now have all of the indications for avanafil, not just erectile dysfunction or penile sexual dysfunction. So it was really a nice amendment here, and we think it's a win-win for both parties. And we're excited to tell you about that.

We'll touch briefly now on the second quarter results. I think everyone has seen the press release. We don't go into that in much detail. We did end the quarter with cash investments of about $310 million. The actual GAAP net loss in the second quarter was $24 million. The cash used in operations was $37 million for the first 6 months. That will obviously go up in the second half of the year. And we've grown our headcount quite a bit. We're currently in excess of about 100 people, and Michael will touch on some of the important adds predominantly in his group there.

We are going to be back out on the road telling the story again and updating investors. This is just a sampling of the invitations that we've accepted to present, which will include conferences in San Francisco, Boston. Again, Barbara will be up in Boston at the Citibank. She'll be in New York for BioCentury. And then I'll follow-on with Morgan Stanley, Rodman. And lastly, we're pleased to have Steve Byrne host us in London for their conference as well.

IP, a topic of discussion, has been for several years, and I think our position remains. We do have issued patents that protect Qsymia into 2020 -- June 2020. There are 4 issued patents in excess of 160-some-odd claims. We do have issued patents that have been validated in Europe as well in about 19 countries. And we do have additional pending patents. We're not going to go into the detail there, but we have a pending patents in both the U.S., Europe and Asia. They should, if granted, provide some additional protection and from a timeline standpoint as well. As you all know, outside of any of the IP or the patents that we have in Europe, we do get 10 years of exclusivity. And so I think that's a huge advantage from a market standpoint. And lastly, we have begun our life-cycle management, that's in development. Clearly, the goal of this is to the extend the product life beyond 2020.

Again, I want to reiterate, we have a very strong patent position. There have been some questions lately about validity and freedom to operate and folks talking about certain references. Clearly, the Shank and McElroy patents were considered by the U.S. patent examiner. Obviously, the claims were issued. There is a very high burden for a third party to challenge any of these claims that have already been issued on the basis of validity.

Second, freedom to operate. Obviously, before we started into this development program, we sought advice and had lots of experts opined and weigh in. And clearly, we consider both the Shank and McElroy patents before moving forward. And really just in summary, we are very comfortable with our freedom to operate, and we believe we have a very clear path forward for the commercialization of Qsymia.

With that, I'm going to turn over to Barbara. She's going to talk a bit about the REMS and then some of the dosing administration.

Barbara Troupin

Good afternoon. So today, I'm going to talk a little bit about the REMS program, give you a little bit more sense for what it is, but also importantly, what it isn't. We'll walk and we'll talk through aspects of the label and where there are things that we want to point out and highlight from the label that we've for received an approval.

So the goal for our risk management program is to inform prescribers and patients about the risks and how to mitigate those risks. The risks are solely related to teratogenicity. There are no other risks included in our risk management program. That's the only thing that we are focusing on throughout that program.

The medication guide is one of the key components to the risk management program, and that will be provided every time a patient receives a prescription or refill for Qsymia. There are also 2 elements to assure safe use that are pivotal to the program. One of them is health care provider training, and we'll talk about that in a moment, as well as the certified pharmacies. The 2 go hand-in-hand and work very well together. There's a strategy behind that design to be able to make sure that we have access to informing prescribers and patients, and it's specifically focused on how to do that most effectively.

The timetable for assessments, all REMS come with a requirement to do assessments. And we'll start with an early look at 6 months, and then we'll continue at 12 months and annually thereafter.

So starting with the health care provider training. Our goal is -- our goal and our commitment is to make sure that training is offered to health care providers, broadly to all health care providers. And we will do that in a way that includes providing a health care provider letter. We've got a Qsymia REMS website that is freely accessible to everybody. But we will be doing outreach, as well as responding to inbound questions to make sure that everybody that has the potential for prescribing Qsymia has been informed of those risks and how to mitigate those risks.

Part of that -- one of the cornerstones of that program is the health care provider training program. It's available in several formats. One format is an online format. It takes about 15, 20 minutes to go through. It talks about risks. It talks about means to mitigate the risk. It talks about dosing and administration. It gives people a little understanding how to select and initiate patients on treatment. At the end of the online program, people enter some information, including a unique identifier such as a DEA number, and we'll get back to where exactly we use that. That will be -- so that unique identifier gets put into a database, and we maintain that database. The certified pharmacies will also collect information, including unique identifiers, so that we can specifically look at who's had the training and who is prescribing. And we can do a match for anybody that is prescribing that has not yet been trained. And we have an escalation program where we will reach out via email to provide links to the training program, PDFs of a print version of the training program to make sure that, that training is offered to anybody that's prescribing who has not yet completed the training program.

The home delivery pharmacy network. So Qsymia will be delivered directly to patients at home when -- so when their prescriber prescribes the prescription, that will go into one of the certified pharmacies and those will be delivered directly by mail order to patients at home. To be a certified pharmacy, the pharmacies have to agree to be able to prescribe -- to provide a medication guide and a patient fact sheet that will go with every prescription. So initially, we're doing this through the mail-order pharmacies because they're automated. They can do this in a very high-volume way with essentially 100% assurance that those materials will be distributed with every prescription and with every refill of the prescription.

Another requirement for certification is that the pharmacies have trained everybody involved in dispensing, and that they are trained on the REMS requirements. They know that they have to dispense the medication guide. They're also required to collect information on the prescribers, so we will have a database for the prescribers, including that unique identifier. Not only does that help with training, that allows us to do outbound communication to that prescriber audience and to know exquisitely with great detail who is prescribing the drug, how they're prescribing the drug. We'll understand the characteristics of use of the product in a way that is unlike a more open distribution system.

Uniquely, one of the things that happened with our approval letter, and you may have recognized this in reading the approval letter, the FDA specifically asked us for a modification to the REMS in our approval letter to help us broaden access. FDA's biggest concerns are always decreasing burden to physicians and increasing access for patients. So in our initial approval, they have asked us to propose how we would improve access and decrease burden. That REMS modification is underway, and we will provide it to the FDA prior to launch.

So we've talked a little bit about what the REMS is. Now we want to shift what the REMS isn't. We do not have a patient registry. There isn't a component of patient enrollment where only patients enrolled into a closed system are allowed to receive drugs. There's also not prescriber enrollment. We have prescriber training, but the prescriber base is not required to be enrolled into a closed group. There are not hard stops for the ability to prescribe and dispense. We will actively be educating prescribers, providing information to them, but there is not a hard stop or a pharmacy lockout to prevent prescription. The practice of medicine -- we will not be intervening on the practice of medicine. We will be providing information. We've provided a number of monitoring guidelines. Those monitoring guidelines are recommendations, and they're supported in our labeling. But there's not a hard stop on prescribing. So as we recommend following labs or following pregnancy tests, those are recommendations and we agree with the labeling on those recommendations. But if those -- the prescribers do not have to turn something in to the pharmacy to release the prescription. And to point out the obvious, topiramate, as it currently stands for its approved indications for epilepsy and migraine, does not currently have a REMS program. It does not currently have any of these restrictions, and we have no onus or responsibility to do any sort of monitoring on topiramate alone.

So let's move on to the indication. So from our labeling, this is a pretty consistent labeling for the indication for BMIs greater than 30 for obese patients or 27 or greater with at least one co-morbidity. Contraindications are pregnancy with a Category X, glaucoma, hyperthyroidism, potential drug interaction with MAOIs or hypersensitivity to the component.

When we look at tolerability and safety, warnings and precautions do provide information about the risk of orofacial clefts if exposed during first trimester pregnancy, talks about the potential for increased heart rate or mood changes, cognitive or -- cognitive impairment, glaucoma or metabolic acidosis. Those are all provided for information with guidance in the labeling. The most common side effects are what we have described in our previous presentations: paraesthesia, dizziness, insomnia, constipation and dry mouth. Tolerability concerns, not safety concerns. And then the dropout rates are listed here as 11% to 17% versus 8.5% for placebo.

So dosing and administration. So this compound, Qsymia, can be taken -- is to be taken once daily. So only once a day in the morning with or without food, so easy to administer. You start with the starting dose of 3.75/23 for 2 weeks. And after 2 weeks, you increase to the recommended dose, 7.5/46. Patient stays there for while. They go in and they see their physician. Physician asks, "How are you doing? How are you doing on your weight loss?" And you look if you've got less than 3% weight loss, there's a potential that, that person is a nonresponder, and so you choose either to discontinue or escalate the dose. Now in reality, 84% patients at the 7.5/46 dose at 12 weeks have responded in the level of 3% or greater. At that point, if the decision is to escalate, you do 2 weeks at the 11.25.69 dose and then you go on to the 15/92 dose, and you can stay at that dose. At about 12 weeks, a couple months later, normal touch points for a clinician relationship, you look again at weight loss. If you have somebody at that point that hasn't lost 5%, that they are unlikely in the long run to have a really meaningful weight loss, and so you would choose to discontinue. But again, in reality, almost 90% of patients at the 15/92 dose for 28 weeks achieve that greater than 5% weight loss. They're guidelines. They're guidelines for how often to see the patients, the kinds of things that you're looking at for success in weight loss. There isn't a lockout specifically, and our success rate at these benchmarks is really quite high.

How do you prescribe Qsymia? So we have -- there are 2 easy ways to do this. You can complete the Qsymia Rx form, which gives all the information you need to complete as the provider and for the patient. Your prescriptions go on the bottom. It gets faxed in. The fax numbers, phone number, everything is on the form. These forms are widely disseminated to clinician offices. They're available on the website. They'll be in the back-office kit. They'll be available to clinicians in any sort of face-to-face visit with VIVUS field personnel.

The other alternative is that the provider can hand the prescription to the patient with the sheet of information that says call one of the pharmacies. All the pharmacy numbers are listed. The pharmacies will talk them through exactly how to provide them the information they need. They mail in those prescription, and they'll be fulfilled and sent directly to their homes.

So with that, I'm going to pass the podium to Mike Miller who will talk about our commercial launch plans.

Michael P. Miller

Thank you, Barbara. Good afternoon. Welcome to Palo Alto. I'm going to just review the Qsymia U.S. launch plan for all of you. This should not be news to you but it was news to many. Obesity was absolutely remarkably off the charts in terms of new stories; clearly, the approval of 2 drugs in this time frame. But I would say the overall obesity has certainly caught the attention of the press, the government, private payers, patient advocacy groups, what have you. So it's very much a topic of conversation and interest.

So as a result, we had a lot of interest upon our approval. We had about 500 million impressions based on print and online and broadcast and social media since approval. Our Qsymia website went live at approval. We had 91,000 unique visitors, 13,000 registered for more information. And of those, 87% were identifying themselves as patients, 12% were health care providers and I think the 1% might be on the room and on the phone. So also available at approval was the QsymiaREMS.com, and we already have several hundred HCPs who have already completed the training program to date. So there has been a great amount of interest in the product.

When we look and distill the messages that we think will be most impactful in selling Qsymia, clearly, the first pharmacotherapy with the proven potential of allowing patients to achieve and maintain greater than 10% weight loss. For completers in our pivotal studies, categorical weight loss after 1 year of treatment was up to 64% greater than 10% and 43% at greater than 15% at the top dose. As Barbara has shown, it was shown to be well-tolerated in clinical studies; available on multiple strengths; simple, once-a-day dosing. These are messages that certainly resonate with our providers and our payers in communicating the attributes of the product.

I think you all know these results from our pivotal trials, and these are the ITT-LOCF results in our label. And again, these demonstrate that the product works extremely well. We again have shared this with many providers in our market research, with payers, with employers, and it really causes the product to stand out very much on the basis of efficacy for this market. And we think it really will meet a need that this market presents.

You also know this very well. This is our timed series on the weight loss from both pivotal trials. I think the takeaways on this is certainly the sustained weight loss that we saw in our clinical studies, but more importantly, the rate of weight loss. And I know that all of you have certainly thought about patients, if it's predominantly a cash-paid patient who is initially -- what kind of feedback are they going to get for outlaying cash and seeing the kind of results. And I think what we've seen in our clinical studies, and we certainly hope to see in the real world, is that weight loss that is detectable and recognizable early on that will support patient use and refill.

All of our pivotal studies are currently in -- are published, and you're familiar with all of those. And this is certainly making up much of our package that we'll put together for payers, and I'll get into that in a moment.

Our health care provider strategies at launch are the following: create awareness around Qsymia, convert written weight loss prescriptions in appropriate patients with specialists, educate primary care on the importance of treating obesity and provide tools to providers to help counsel them and engineer successful new starts.

I won't go through the laundry list of tactics, but suffice it to say, it will be a well-rounded launch program. I think we have provided a lot to our sales force and certainly, most importantly, to the offices of the provider. And I'll get into the patient materials in a moment. But our thrust is really around education, both in terms of the category and the product for safe and effective use. And I think everything that we have put forth certainly meets those objectives. We are looking at a considerable effort to educate primary care. We believe that, that is a critical challenge for us. And we believe that what we've put forth, we'll attain that.

Patients are very, very important. We want to create awareness around the approval of a new and effective product for obesity. We are not doing DTC at launch. We want to certainly elevate the awareness around health risks of obesity and certainly beyond cosmetic treatment, facilitate meaningful discussions with their health care provider and engineer patient success and compliance through tools and support.

And I think these tactics are provided to the health care provider, certainly for their office but more importantly on the patient support program, our online program. We certainly have an extensive digital marketing effort going on as well. And today, as I've said, we have seen considerable interest already from patients.

Tim spoke about some of the hiring that we've engaged as a company. In the last 6 months, we have hired about 50 new people into commercial and medical affairs. We had been very fortunate to attract the kind of talent that we have, and we've attracted it from a big pharma biotech. We've done it both locally and nationally so we are very, very fortunate in that regard. And I feel very blessed with the kind of team that we're putting together.

Let me talk a little bit about the identification of targets that we're looking at for launch. If just to orient you to the table, these are deciling of prescribing. So on the y-axis, we have the antiobesity prescribing in the U.S. and we've deciled those. And then on top, what we do is create an index based on hypertension, statins and Type 2 oral diabetic agents to create a co-morbidity index. And then we identify where the prescribing lies. So real easy. The corner in the right, the lower right, the 2,000 high prescribers, these are high prescribers both in terms of obesity agents and co-morbidity agents, and these are very much a key target for us. The additional 13,000 to the left of that box are high antiobesity prescribers. And then adding to the 15,000 in the upper right is the high co-morbidity index physicians. So these physicians are seeing a lot of cardiometabolic disease. And while they may not be very high in terms of prescribing obesity agents, we believe that they are very much a very good target for Qsymia.

Leading us to that belief or certainly when you look at some of the co-morbidity agents and look of the patients that are on these agents, I'll give you an example, metformin or Januvia, about 80% of those patients are within our label, meaning that they are BMI 27 or above and they have a co-morbidity or Type 2 diabetic. That's 70% in the statin area and about 60% in the hypertension area. So it's a matter of converting these physicians to thinking about treating obesity. That's certainly a challenge that we look forward to, and I think that's where -- when I look at this market, that's I think where this market takes another step up, a very considerable step up. When you break that same 25,000 or so down to specialties, about 80% of the 25,000 that we've discussed is primary care; 8% is endo; 12% is other. Other also includes cards, by the way. So that's how we look at it when we think about our personal selling efforts.

And to that end, as Tim mentioned, we did -- do contract with PDI, which is a contract selling organization. We have chosen to hire a sales management team, that is an NSD, 2 RSDs, a director of sales training, director of sales ops and 16 district managers. They are VIVUS employees, and they are currently on our payroll and have been contributing highly.

We have been very busy with the 150 territory representatives as we are looking at recruiting PCP sales reps with cardiometabolic selling experience in those specific geographies. To date, as of today, we have 134 offers extended and 114 accepted, so we're actually moving along at a very nice clip in that regard.

Let me touch on payers and coverage. Just to orient everyone in the room, just think of 3 buckets: Medicare Part D. Medicare Part D per the Medicare Part D statute specifically excludes weight loss agents. In Medicaid, states have the option of covering obesity. Currently, about 10 states do. And private payers, approximately 1/3 of prescriptions for weight management drugs are currently reimbursed.

So people often ask me, "How do you see the payers' future?" Certainly, on the commercial payer side, we see that payers are telling us the Qsymia approval will push the plan PBM to consider formulary placement, and most predict a policy decision within 6 to 12 months. We already have spoken to a number of plans in that regard. And with employers, employers are clearly the ones who get a very good sense for obesity. They know that obese employees, the health cost around that is about 4x that of a non-obese employee; higher absenteeism, functionality is a very, very important issue in the workplace; workman's comp; muscular or skeletal disorders, things of that nature. Employers are very, very aware of that.

How we see playing out is the following: We see employers looking to take the rider for obesity. We think that fully insured or self-insured employers will choose to take the rider. That means they will take -- they will opt to take the coverage. The plan will offer weight management drugs for an option for this. There will be extra costs, but we will cover these drugs. And I think that's an important first step. Slowly after that, we would look to commercial payers to look to include that in part of their normal coverage, if they will, in terms of normal benefit, the standard benefit. We do see employers shaking their head a little bit at the obesity problem, meaning that they're corporate wellness programs and things of that nature are really not making a dent in the problem, so they're looking for solutions. And these -- I think the advent of Qsymia is very much one that will turn some heads. We already have had a number of employee -- advisory boards on that very subject.

In Medicare Part D, certainly, we all know how quickly the federal government moves. But we have pursued the legislative and federal policy change strategy in attempt to remove that exclusion, and that's a longer-term play. But nevertheless, it is a very key objective of ours. And we believe that as that falls, we will absolutely -- after that, there would be -- the commercial players very much have to make it standard benefit. So Medicare Part D is a key but it's a longer term. So if you think of first riders, then moving on to getting into standard benefit, then the Medicare Part D statute removal.

So what are the activities that we're doing to embark upon this? Our Qsymia approval notifications are being sent to plan and PBM medical directors and pharmacy directors, as well as state Medicaid directors. Our AMCP dossier will be available to fulfill unsolicited payer request by mid-August. This is a dossier that's put together for P&T Committee review. I think we have a very compelling one with the kind of results and publications that we have in place. We have been fortunate enough to recruit a seasoned group of national account managers that will begin calling on target accounts, with an educational focus around the health impact and cost of obesity. And then we have pharmaco-economic research underway for publication to support the value proposition of Qsymia.

Barbara talked a little bit about the home delivery pharmacy network. We are in the final stages of contracting with large, nationally known mail order and PBM pharmacies. Those are, as we indicated actually at the Ad Com: CVS, Express Scripts, Kaiser, Walgreens and Wal-mart. And that's going in a very good direction.

I have been asked about significant barriers to off-label generic prescribing. Let me kind of walk you through this. First of all, we have done primary research with both specialists and primary care, and we know that they will be less likely to want to prescribe, particularly topiramate off-label, once Qsymia is available. And what's driving that is the fact that we have a REMS and a Category X label designation.

It's also complicated in terms of dosing. We are the only QD med out there, and the milligram strengths that Qsymia is available in are not commercially available out there. So it complicates dosing and certainly complicates trying to replicate it. Payers will only cover the Qsymia prescriptions. Certified pharmacies cannot substitute Qsymia for generic components. And I guess, I think one thought is that the out-of-pocket cost for patients, even getting it from a dispensing physician, are not insignificant. There is a market coming out of dispensing physician offices as well, and we will be very conscious of the price that we choose. And let me just say we're not going to announce the price, so just to put out there. But I think we'll be very conscious of that. We're conscious of what out-of-pay, out-of-pocket costs are, what are the walkaway points, what are payers looking for in terms of price points. And so we're very, very aware of that and we've done some great research on it.

I'll just leave you with -- we have been quite busy over a period of time, and we see it doing nothing but intensifying between now and launch. We have announced launches in Q4 of this year. And we look forward to doing a very effective, responsible and educational launch for the product.

So with that, I'll thank you for your time, and I think we'll move on to Q&A. Thanks.

Leland F. Wilson

Thanks, Mike. One of the questions that I'm asked constantly is, "Why do you think this launch will be successful when many of the other launches with other similar small size pharmaceutical companies have not been successful?" Well, I ask you to look into those launches specifically as we have. And I think it boils down to one final element here, and that is we offer a great value proposition to both patients and physicians and employers and into society itself. We obviously all know that the market is -- the market potential is very large. The cost of these drugs relatively -- relative to other maybe biotech kinds of products, et cetera, is going to be very small, competitive largely to the products that are on the market today. So the value proposition here for a patient, I think, is quite large and, of course, to the physician seeing the blood pressure drop, the diabetes reversed and those kinds of things, offers a real value proposition. So we do not think this is a -- what's happened recently in the small biotech and pharmaceutical product launches is indicative of what's going to be with this product. So we're open to challenges on that. We'd love to discuss that.

And so with that, let's open this up to questions, and we'll go from there, please.

Question-and-Answer Session

Steve Byrne - BofA Merrill Lynch, Research Division

Steve Byrne, BofA. Have you submitted your proposed protocol for the CVOT? And if so, what do you expect the duration of the study to be, and how does that coincide with your data exclusivity period?

Wesley W. Day

So the CVOT protocol was submitted to the FDA by the end of July. It is an event-driven trial so the time will be dictated by the number of events in the trial. But we estimate the average time on treatment to be approximately 3 years. Relative to exclusivity, I'll give that over to Tim or Lee.

Leland F. Wilson

Well, we have patents that go through June 2020, so that's where we're comfortable.

Next question.

Karen E. Jay - JP Morgan Chase & Co, Research Division

Karen Jay from JPMorgan. Two questions. The first one is on Qsymia, just on the expansion of the pharmacy network. Wondering how VIVUS factored that as to increasing access, maybe if you have any data in terms of what proportion of prescriptions that actually flow through that and what timing is on when that might start if you're submitting just before launch?

Michael P. Miller

Sure. With regard to the expansion, so the expansion is something that we are submitting a modification request to the FDA, and we have a proposal on that expansion. And I think at this point, what we'll say is that it would expand access in a pretty logical way. But beyond that, we're not going to say anything until the FDA would approve.(Operator instructions) I think there's not going to be an access issue. I think as we look at the modification, again, we need to meet all the requirements of our REMS and we'll do so. We look forward to -- we thank the FDA for giving us the opportunity to come forward and make that request.

Karen E. Jay - JP Morgan Chase & Co, Research Division

Okay. Maybe I know the focus is on Qsymia, but maybe I can ask a quick question on STENDRA. The change in strategy to market the drugs on your own, maybe you could tell us what's behind the change, is it partnership, discussions or...

Leland F. Wilson

Sorry for the misconception. We have not decided to market STENDRA on our own. We are in the process of partnering that product worldwide, and so that's our strategy and nothing has changed there. But thank you.

Unknown Analyst

I'm just wondering if you could talk about some of the anticipation about how Qsymia might be step edited. Wondering if you think with insurers and large employers might require documentation of the failure of diet and exercise, or have to actually go through generic phentermine first before they would actually be eligible for Qsymia?

Michael P. Miller

Yes. I mean we can talk about that. I think the -- I look forward to that moment because I think once you do that, you are entering the world of coverage, so I look forward to that. Our discussions with payers have not looked as -- at phentermine as a step edit because phentermine per label is short-term use. So with our chronic use indication, there would not be a step to it. Now certainly, failing diet and exercise, I think that's prudent. And I think that's per our label as we should be used in the same way. I actually think it's good that we have the REMS. The payers actually thought well of the REMS in that regard in terms of appropriate use and making sure that it was there. We have received positive feedback on the stopping of rules in our label, and would look forward to them engaging with us to use that as a way of making sure the drug is used in a proper way.

Unknown Analyst

I just wanted to follow-up on that large employer concept. Can you just talk about just how large -- how big is big and how many large employers are there -- sorry, how many -- how large is the large employer in your view, and how many of those large employers are out there in your market research?

Michael P. Miller

When you look at business coalition, health councils, they designate a large employer as greater than 10,000 employees.

Unknown Analyst

How many are there?

Michael P. Miller

Oh my God. I can get the information, but that's the kind of [indiscernible].

Unknown Analyst

I was hoping you might be able to follow-up on Slide 34 where you provided the 13,000, the 2,000 and the 10,000 physicians. Do you see each of these boxes as equivalent in size or some sense of whether some might be the relative size of each? And do you plan to be targeting each of these in sort of the same relative size? Anything additionally you might be able to provide about that. And I guess, where do the big weight-loss centers sort of fit into these boxes? And then I have one follow-up question.

Michael P. Miller

Okay. So I think if I'm just to clarify, when you say how big each of these boxes are in terms of the prescribing potential, or do you mean in terms of -- they're defined as size and numbers of docs to colon, but we do look at this as a different opportunity for each. So is that...

Unknown Analyst

Well, I mean, so as you launch the product, each of these will be -- is it 1/3, 1/3, 1/3 or you're seeing -- or how would you sort of define the relative proportion of each of these to the overall launch and then in terms of your time spend, how much focus you have on each of these? I'm just trying to get a sense for the overall strategy for the launch as it relates to this?

Michael P. Miller

Sure. So what we do within these boxes is we actually designate reaching frequency targets for all of these and do so in a way based on territory load and doctor count. And the high prescribers we target 18 times a year, medium targets about 12 times and lesser targets about 6. And that's how we build up our reached frequency models to look at our sizing and optimization. With regard to where the business is, clearly, the high prescribers, the 2,000 in the lower right-hand corner, are folks that are primed and treating obesity today in high numbers. But if you look at the high co-morbid prescribers, those are folks that actually see a lot of patients. And while they are not treating obesity today, their patient load is extraordinary. So in terms of potential, I would say that the 10,000 high co-morbid prescribers have a lot of potential. But we're going to look at -- we're going to personally see these 25,000, so we will cover all of those boxes in our launches.

Unknown Analyst

Okay. And then you had talked about getting a lot of information as doctors prescribed. Do you plan to sort of modify how the targets evolve based on that feedback? Can you do that in real time?

Michael P. Miller

You do. But when you're guiding a sales force, you don't want to keep switching out targets because it takes a while to develop a call plan. It takes a while to make appointments with physicians and develop the relationship with the office to get access. So if I keep switching targets on you every month, you're not going to be a very effective selling person. So you do want to hold tight to your target identification at least for 3, 4, 5, 6 months and then allow certainly the knowledge that you've gained along way. But while saying that, any new target that comes along, we would certainly target for a nonpersonal reach-out in a number of ways. So we'll -- and again, data that we get will be exclusively precise, so we'll know exactly who's prescribing.

Thomas Wei - Jefferies & Company, Inc., Research Division

Thomas Wei from Jefferies. Actually, just a follow-up question on this chart here with the prescribers. Do you know how many patients or how many obese patients actually fall into these 25,000 doctor practices? What like portion of the market...

Michael P. Miller

The number of patients that they treat?

Thomas Wei - Jefferies & Company, Inc., Research Division

Well, maybe not so much the number of patients -- yes, the number of patients that they have in their practice that's maybe not even treated with obesity, but who would fall within your label. Do you have an estimate for the number of patient rates?

Michael P. Miller

Well, I think clearly -- yes, I mean, I think under the 2,000, I would say that probably 100% of their patients are -- pretty close to 100% of their patients are likely in our label. With regard to the 13,000, these are physicians that do see obese patients to varying levels. You could see in terms of the degrees there. But the high co-morbid patients are seeing many patients who are obese, but they are not treated. So again, that's I think where the potential lies. And also the question you need to look at when you look at this is, not all these physicians have the same patient load. Some of these physicians have very, very high patient loads. So a very, very busy multi-specialty primary care practice sees a lot more patients than a specialist does. So we need to take that all into account and be certain that we are going after the absolute right doc, right patient on label.

Thomas Wei - Jefferies & Company, Inc., Research Division

And I guess I'm assuming from your answer, is it very difficult to know how many patients fall within those practices?

Michael P. Miller

I can't answer that specific question.

Thomas Wei - Jefferies & Company, Inc., Research Division

Okay. That's fair. And then I had a question just in terms of reimbursement coverage. So when you say that 1/3 of obesity prescriptions are covered, I'm having a hard time understanding how many lives out there in the U.S. do you believe actually have coverage of some form for obesity? Because the 1/3 could be a little bit self-selecting, right? So if you didn't actually get your obesity prescription covered, then you might not have gotten it anyway. And so the covered prescription may be overrepresented in that metric that you're providing. Is it about 1/3 of patients have some obesity coverage, or is it actually substantially less than that?

Michael P. Miller

I can't answer the absolute number of lives in terms of having pharmacologic obesity coverage today. We know that 1/3 of prescriptions for obesity are covered by third parties. So what you try -- you tend to look at that more than on lives. The problem is that many plans, because of the lack of obesity meds, have not developed formal positions on obesity medical coverage. So you're not -- it's kind of hard to answer that question.

Thomas Wei - Jefferies & Company, Inc., Research Division

Maybe a different way of asking it would be if you think about big payers in the U.S., you have huge chunks of patients. Do any of the large payers have formal pharmacologic drug coverage of obesity?

Michael P. Miller

So it goes back to -- many offer it, but they offer it on the riders, so it goes back to the employer. So that's really the driver. So if you're asking how many plans have it in standard benefit, few. If you ask how many plans offer it as a rider, many. But again, it goes back to the employer. Does the employer take the rider for the coverage? That's the question. Does that make sense? The difference between standard benefit and a rider.

Thomas Wei - Jefferies & Company, Inc., Research Division

And then my last question, just to -- I know you were asked this on the call about approval, but do you really go into the rationale behind not sampling the drug? It seems like something that would be very -- lend itself very well to sampling, given the titration and you could start people out on the lower dose of the titration and get them used to do doing it, and you could make sure that the doctor has the medication guide with that first sample. What was the rational behind not sampling?

Michael P. Miller

Well, so I guess there's a distinction between sampling, and then we certainly would consider providing free goods with a coupon and starter pack, that type of thing. Let me be clear about sampling. It is a controlled substance. So to do that, that would mean providing reps with a controlled substance by which they have to follow audits and maintain records and that type of thing, so that complicates their lives.

Thomas Wei - Jefferies & Company, Inc., Research Division

[indiscernible]

Michael P. Miller

[indiscernible] That's a scheduled platform. Yes, but it requires paperwork. So that's -- I mean, it doesn't block you from it, but it also creates a lot of work. So something that we would consider is free goods at the pharmacy, so you'll get coupons for redemption of free goods along with the starter kit.

Thomas Wei - Jefferies & Company, Inc., Research Division

So we should not think that, that could mean [indiscernible] probably is in card to broadly

sampling [indiscernible].

Michael P. Miller

Not at a launch, no.

Leland F. Wilson

We do have a couple of questions from the conference call.

[Technical Difficulty]

Leland F. Wilson

Okay, why don't we go back to the room until we get that technical difficulty straightened out, please. Two back there.

Unknown Analyst

What more can you tell us about your pharmaco-economic research plans? We already know about benefits of weight loss, the win over payers here.

Leland F. Wilson

So we have a number of projects underway, particularly a model that we would look to share through a number of publications, looking at the cost of obesity, the benefits of weight loss and its effect on other co-morbidities. It will come out in a publication, but we'll also share it to a number of others.

Unknown Analyst

[indiscernible]

Leland F. Wilson

Certainly within the next 6 to 12 months.

Brian, way up to the back?

Marko Kuzol

Marko Kuzol, Leerink Swann. Just wanted to maybe ask you to define a little bit more who the 10,000 high co-morbid prescribers are, if you give us a little more detail, please?

Michael P. Miller

Sure. They tend to be physicians who are treating a lot of patients with cardiometabolic disease. So they are using agents that are indicators of that disease process in their office. So this is -- what you're seeing there is the top 2 deciles of the writing of the combined index for these agents. So these are very, very busy and productive docs who see a lot of patients with cardiometabolic disease. They can be primary care, GPFP, IMDO, card, endo. But again, it's non-specialty specific. It's around their prescribing activity. Does that help?

Operator

Our next question comes from Jason Butler with JMP Securities.

Jason N. Butler - JMP Securities LLC, Research Division

I just wanted to follow up on one of Thomas' questions. Can you talk a little bit more about how you may or may not use payment assistance programs and copay assistance programs as you ramp up reimbursement coverage?

Michael P. Miller

Sure. This is Mike, and we would certainly entertain copayment assistance programs as coverage ramps. And particularly, if replaced on a Tier 3 with a copay, that would be something that we would consider.

Jason N. Butler - JMP Securities LLC, Research Division

Okay, great. And then just going back to Slide 34 again. Can you talk about what you see the hurdles for a physician writing the first prescription would be? Is it inbound patient demand, intensity of detailing, education? I assume a mixture to some degree of all of these.

Michael P. Miller

Well, I think it's very dependent on the type of physician. If the physician is already treating obesity medically, then I think there's very little hurdle in the way of beginning Qsymia. If it is one of the physicians that is -- that are not currently using anti-obesity meds and is not accustomed to treating obesity medically, then I think an education process needs to go on. And they really need to understand how to start these patients, how to manage these patients, how to monitor these patients, particularly ones with co-morbidities and polypharmacy. So I think there's a number of things. Barbara, do you have any other?

Barbara Troupin

Yes, I think many of our activities over the next 6 to 12 months will be at all of the specialty meetings related to the prescribers who have these patients in their practices. We'll be providing grants for CME activities, for educational activities. Our reach through our website and dear health care provider letters just to increase awareness, education, offer more ways for folks to be comfortable. We'll also be doing a lot of modeling for patient types cases, modeling conversations around initiating treatments for obesity, understanding conversations around the REMS, so just to increase overall comfort level with subject area for obesity and for Qsymia, specifically, to really help those that aren't yet comfortable get that last step to prescribing.

Leland F. Wilson

I think it's important for everybody to recognize that there's benefits to the REMS as far as marketing is concerned. We have the ability to find every physician immediately when they write a prescription or prescription is presented for filling. And so we immediately email to that person that they need to be trained, if they're not already trained. They need to go to our website, at which point they'll become completely educated on how to prescribe the product appropriately, assure safe use, et cetera, what their obligations are. So in all the world of selling pharmaceuticals that I've been doing for a long time, I have never had that kind of opportunity to touch a physician that writes even one script for product quickly. And so -- and if they write another, we can get them again. And as someone said earlier, there will be changes as we go forward on our call universe, and this is a great way that we can ensure that we're getting to the right physicians. So there's benefits to this system to reach physicians, a wide body of physicians very rapidly so that they're educated.

Operator

Our next question is from Simos Simeonidis with Cowen and Company.

Simos Simeonidis - Cowen and Company, LLC, Research Division

Is there a plan, or what are your thoughts on the pediatric population? Obviously, it's growing and the need's there, too. What are your thoughts on expanding there?

Wesley W. Day

This is Wes. We do have agreements with the FDA to perform first adolescent studies, followed by pediatric. These studies have to be preceded by an interim safety endpoint in the cardiovascular program, as well as a preclinical study. So the plans are in place, and it's just a matter of timing.

Simos Simeonidis - Cowen and Company, LLC, Research Division

Okay. Then the second also ask a question about Slide 34. From the docs that you characterized as anti-obesity, the 15,000 it looks like, what percent of them are obesity specialists or treat only obesity, for example, phentermine and topiramate?

Michael P. Miller

This is Mike. I just, I would say that the -- most of the obesity specialists actually reside in the box in the lower right, the 2,000 or so physicians that are really in the high decile identification are likely. Certainly, as you move down decile 6 to 7, it certainly includes some. But the real busy ones are in the lower right. Barbara, you wanted to make one other comment on that last part?

Barbara Troupin

Yes. Just for a comment on pediatrics and adolescents. We are -- there is a development plan underway, but our current labeling states adults only. So that while we'll continue to update people on the progress of those programs, our labeling currently states only adult patients.

Simos Simeonidis - Cowen and Company, LLC, Research Division

Okay, great. And then last one, on the IP. We know the U.S. IP expires in June 2020. First of all, can you tell us your thoughts on how much you could potentially get under Hatch-Waxman patent extension? And then going forward after 2020, I guess it's a combination of lifecycle management and your pending applications?

Timothy E. Morris

Simos, Tim Morris here. We will apply for additional patent term extension just based on the development time frame, and we'll let you know when and if we get it. And also in terms of we have several patent pending applications. Obviously, we hope that, that would extend the life-cycle of the product. It will be on 2020, and we'll let you know when those issue as well.

Operator

Our next question is from Josh Schimmer with Lazard Capital Markets.

Joshua Schimmer - Lazard Capital Markets LLC, Research Division

I guess I have 2 of them. First is a combination of 2 already approved drugs. Can you discuss how you see reimbursement playing out in Europe and what precedency is to inform that for you? And then second is, why is the Medicare strategy change the longer-term objective given the political support momentum you had through approval?

Leland F. Wilson

I'll take a shot at the first one, talking about reimbursement in Europe. We're working on that project as we speak. We've hired experts in the field to help prepare the dossier that Mike referred to, that he's already prepared in the United States to prevent -- present to the decision-makers for reimbursement. And again, there's a couple unique things here. It's another place where I think the risk mitigation plan, as what it's called in Europe, plays a key role on potential reimbursement in Europe. The risk mitigation plan 10 has a purpose to make sure it's only appropriate patients get the drug. And that's very important for any risk mitigation plan that's in place and payments that you're likely to receive because of that. Now it's too early to tell whether we'll get reimbursement or not and at what price, et cetera. But we are in that process right now, and we'll let you know how it comes out.

Michael P. Miller

This is Mike. On the Medicare Part D question. If I communicated that it was 1/3 in priority, that was my error. Medicare Part D has been very much in our sights for a long time, and that's why we had been so diligent on some of our activities around it. I guess what I tried to communicate in that effort is that changing statute in Washington, D.C. takes a bit of time. And I think realistically, I think we can get some base hits with commercial payers and employers, all the while we are moving the ball with Medicare Part D. So I will look at all of those as very much our priorities at launch with regard to payers.

Joshua Schimmer - Lazard Capital Markets LLC, Research Division

Can you talk a little bit more about the Part D activities that are underway, and then ultimately how you see this playing out? Do you introduce a bill? Do you lobby politicians? When do you think you can get this done and what are going to be the drivers for success?

Michael P. Miller

We do use a lobbyist, and we are active in those efforts.

Leland F. Wilson

Okay, well, thank you -- I think the questions are closed now. I want to thank everybody for coming here, for coming today and appreciate your support over the years again, and look forward to some exciting times over the next few months here as we meet our -- hopefully continue to meet our goals with the successful launch, getting approval in Europe and the partnering activities we're doing for both products. So thank you again for coming.

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