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Executives

Robert Doody – Head-Investor Relations

Paul Firuta – Vice President of Commercial Operations-Americas

Jeffrey Dayno – Vice President-Medical Affairs

Analysts

Rachel McMinn – Bank of America/Merrill Lynch

Viropharma Inc (VPHM) Bank of America Merrill Lynch Health Care Conference Call May 14, 2013 2:20 PM ET

Rachel McMinn – Bank of America/Merrill Lynch

Before joining us, and I know that this presentation is the last presentation standing between you and food. So we’ll try and hit the highlights. I’m Rachel McMinn, one of the biotechnology analysts here at Bank of America/Merrill Lynch. Thanks very much for attending our conference this year. It seems like a very energized packed group.

It’s my pleasure to introduce the Viropharma team. We actually have two individuals here who don’t usually get to see much of investors and vice versa. So I’m very pleased to have them. I’m going to introduce Bob Doody, Head of Investor Relations and he’ll help us introduce the rest of the team and provide an overview of the company.

Robert Doody

Thank you, Rachel, and thank you all for coming today. So I’m Bob Doody, I’m the Head of Investor Relations for the company and I’m joined by my colleagues here Paul Firuta, who is our Vice President of Commercial Operations for the Americas; and Jeff Dayno, who is our Vice President of Medical Affairs and as Rachel mentioned they are not always our Wall Street team, so I think they are gaining a new perspective and I think everybody is meeting with as well.

So just for those who are not very familiar with our story, I’m going to just have a couple of opening remarks and then we can dive into the more miniature related questions that I’m sure Rachel will ask us.

Rachel McMinn – Bank of America/Merrill Lynch

Definitely, yes.

Robert Doody

So we are a Pennsylvania-based biotech company. We are now focused very much on the rare diseases and areas of significant unmet need. We currently have four commercial products which are led by Cinryze in the United States, which is a drug that is a C1 inhibitor for a disease called Hereditary Angioedema which is a swelling condition that’s driven by a deficiency of C1 inhibitor. It’s a very rare ultra-orphan type disease less than 10,000 patients in the U.S. We also are building a business in Europe with three commercial products that are in the early stages of their launches, one of them being Cinryze, the other two is Buccolam, which is a drug for treatment of acute attacks of epilepsy and pediatrics, and the other is Plenadren for adrenal insufficiency.

As I mentioned, we are in the early stages. We’re going through the pricing and reimbursement processes across Europe for these products. For Cinryze and Buccolam, we expect that in the second half of this year we’ll be fully launched across Europe, having gotten pricing reimbursement. This is a process that has taken roughly 18 plus months which is – the new challenges of working in Europe is that there is a lengthy amount of time from the day you get your approval as you move across the territories of Europe to get pricing reimbursement.

Plenadren, we have four to five countries that we have launched in now, Germany and U.K. are the big five ones so far and the rest are probably going to be worked through late this year and early next. We also, on the other side of our business have a pipeline that is as more robust and it’s frankly ever been in our company’s history.

The most relevant today is our subcutaneous formulation work for Cinryze, which we believe is the next avenue of growth for us. It’s taking the current IV formulation and now making it available to patients through subcutaneous injection. That is a trial that we just completed enrollment and we expect to have a data from that study either early, early next year or perhaps even sooner.

We also have reinvigorated our maribavir pipeline opportunity which had a bit of a jaded history. We had definitely have some failures in phase 3, percentage drug at lower doses for prevention or profile access of CMV post transparent. And for a number of reasons the study ultimately didn’t work out, but we’re now looking as a treatment of higher doses for patients that have break through from the current standards of care.

Some other stuff in our pipeline we do are looking at some though IIS type investigator initiates studies and some company sponsors studies, areas that C1 inhibitor can also play a roll. Some of those are like neuromyelitis, optica or autoimmune hemolytic anemia, refractory PNH, antibody immediate rejections transplant so this is a number of different basis where complement in addition plays a roll and we are looking at smaller waste to gain proof of concept with C1 inhibitor in these areas.

Finally moving on to the financial structure of the company, we ended the first quarter with over $350 million in working capital, $216 million cash. Over the past 18 months, we had a very aggressive share buyback program in place were we brought back over 16 million shares. We do still have $200 million in our buyback program authorized although the absence of Vancocin going generic or cash flows that are little bit less than they use to be, so we might not be quite as aggressive moving forward. And then finally, the guidance for 2013 for Cinryze in the U.S., we’re expecting sales between $390 million and $400 million, and total company guidance of $440 million to $465 million. So that's a very brief overview of our company, but I think now we’re up to dive into yours and Rachel's question.

Rachel McMinn – Bank of America/Merrill Lynch

And can you just – maybe each of you just introduce yourselves and start (inaudible) in the room and what you do.

Paul Firuta

My name is Paul Firuta, I'm the Vice President, General Manager of the Americas for Viropharma.

Jeffrey Dayno

Good day. Jeff Dayno, Vice President of Global Medical Affairs, Viropharma.

Rachel McMinn – Bank of America/Merrill Lynch

So I’m happy to take questions from the audience that may be just start with Cinryze. You guys saw some consistent trends in the first quarter with regards to androgen conversion, but you’re also encouraged to see some newer trends with regards to patients switching from acute therapies on to Cinryze. So I just wanted to get your perspective on is that a blood flu. How do you – when you look at over the next one to two years, how many more androgen patients are there going to be left to convert or how many more patients are going to be coming from these like non-allergists and how do you see the dynamic right now with acute versus prophylaxis?

Paul Firuta

Sure. The numbers that you are describing are the 40% of our patients came from the steroid market in the first quarter of this year, and 60% came from the naive or acute therapies. And we believe there is still quite a bit of work to do, we've had relatively small sales forces there’s been relatively small sales forces across the HAE space, and there seems to be still significant opportunity to educate physicians. And as we educate not only allergy, but other specialties we're identifying – our physicians are identifying more patients that require treatment. So tons of therapies been significantly reduced that we're seeing patients – 40% of patients that come into Cinryze solutions are now being diagnosed in less than three years. So the industry and ViroPharma is making good progress here on educating physicians and then the physicians and the patients are deciding which therapies are appropriate for them. So we see them coming from different parts of the spectrum of treatment out there, but we still believe that there is significant demand and we're moving forward.

Jeffrey Dayno

I would like to add the second comment. Also from a clinical perspective, it's an interesting paradigm in terms of – in this orphan disease in relatively young therapeutic areas, but some of the sort of the factors that are in play in terms of physicians understanding that an make acute approach versus a prophylactic approach is different, and there are paradigms like that that are out there.

If you look at epilepsy, you look at migraine where you can either – these are acute paroxysmal disorders, you can either treat them acutely or presentably and epilepsy is an interesting concept where we don't let patients see. We treat them preventable with any epilepsy, and if they breakthrough then we use an acute short-acting anti converter.

So similar with HAE and these attacking potentially life-threatening, I think physicians are starting to understand that the acute agents have a role, but routine prevention is a very important – clinical option that they are starting to learn more and more both in the U.S. and in Europe as well. These treatment guidelines are driving some of that and in terms of overall disease burden individualize patient care, so the field is relatively young therapeutic areas continue to evolve and the issue of androgens also in the HAE treatment guidelines benefit risk of being look that a little differently with the maximum of about 200 milligrams per day being recommended for danazol use. So benefit risk may not be as optimal as what’s been thought of in the past. So there are several factors driving as this continues to evolve from a clinical, medical perspective.

Rachel McMinn – Bank of America/Merrill Lynch

That’s very helpful and I guess just thinking about the physicians in particular who are I guess recommending patients, for what your patients coming from acute. Are these mostly allergists like more of a specialists that are starting to do this, or are you seeing it more broad based across your prescriber base.

Jeffrey Dayno

So I think the leading edge of it is in the allergist, immunologist sort of KOL leading the earlier adopters that have written the guidelines that are leading some of those efforts. But as that trickles down into the general allergy immunology community, and they were referring patients and they are coming back, as well as interesting observations Paul was alluding to that, a lot of the newer patients that we’re seeing are coming out of primary care. So they were initially diagnosed by allergists, coming back and being managed in primary care, a lot of them on danazol for many years. So I think that starting with KOL that have been advancing the guidelines effort and we’re starting to see that it’s going to trickle into the broader allergy and medical community.

Rachel McMinn – Bank of America/Merrill Lynch

And I guess what’s particularly interesting is that from an investor perspective, I think everyone is going to fade at the officer but as acute therapy comes onto the market, that patient will switch away from prophylaxis. Are you seeing switches go the other way, right from Cinryze to acute or?

Paul Firuta

I think we saw that early on because if you recall when Cinryze got approved for the first 14 months of our launch, none of the acute therapies had been approved. So there was definitely a small chunk of patients who got themselves into Cinryze therapy, but we are using at more acutely, that's what in the absence of any other therapy. But we really have not seen any impact into these products has gotten approved and then as the market I think that their successes are more indicative of the larger size of the market and may be many of us really anticipated, but we really don't see like when CSL got approved and I know everybody was wondering if that was going to affect us, but as you’ve seen now, our sales have stayed rather consistent in our demand growth as well.

Rachel McMinn – Bank of America/Merrill Lynch

So in other words, if somebody reducing Cinryze in acute therapy that's where you lost share, but you don't see genuinely true like somebody goes for prophylaxis they are sticking of…?

Jeffrey Dayno

So the most important thing is not an ideal work, so it's not an ideal work so the treatment guidelines and if patients are being to be appropriate for routine prevention. And they should also have an acute HAE specific medication. So one of the interesting, it's not a fairly in either work – so the broader opportunity is disease burden in patients and if they are appropriate for prevention, like an other HAE specific agents are also sort of the appropriate in that setting. So that's nothing other way to look at in terms of choosing between one of the other.

Rachel McMinn – Bank of America/Merrill Lynch

And then just to follow-up on the commercial side, I think you had mentioned that you want to recap in non-allergists, non-KOL to really help drive a broader base of demand, because some of these patients get lost, they are not diagnosed for so long. So is this something – it's really just feed on the street being if you get more reps out there as they can do with or there is and/or their specific program or you really can – cost efficient manner get to the right people.

Paul Firuta

So we've been working with the Hereditary Angioedema Association and our partners and we have the math quite a bit of data now over the last four years and we have been triangulating physicians that potentially could be treating patients. So we’re being very directive with our sales force as to where they need to target and because obviously with 32 sales representatives we couldn’t cover primary care. So the initiative is very targeted, it’s based on targeting data that we even mass over the period time and it seems to be working quiet well at this point.

Rachel McMinn – Bank of America/Merrill Lynch

And when, I think with other Ultra-Orphan type areas with the sales force expansion from one company that I know well, they see relatively very quick pull through right because the cost of the therapy is so expensive that if you are to have one observation like that, so it’s pretty meaningful, they pay for themselves quickly. So should we expect the same and should we actually start to see an uptick in demand generated from these drugs in 2Q.

Jeffrey Dayno

2Q is a little bit early for us. We just finished hiring the eight folks at the end of the first quarter. So they gone through training and now there are getting into their territories and they are starting with their target list. They are assuming territories that have been partially covered or may not have been covered at all of this point. So were projecting something more into the third quarter where we are going to take a look at the effects of the sales for expansion. I think we’ve a better idea in six months have opposed to three. Just on the premise of the whole expansion we’ve seen where we put through expire than the expansion in the territories that were not well covered. We’ve definitely seen an uptick which would was, the premise with the whole expansion. So we feel good about what we are doing, we just want to see about six months of data before we decide what the next step is.

Rachel McMinn – Bank of America/Merrill Lynch

I mean there is one potential outcome to further expand sales force.

Jeffrey Dayno

Potential, yeah.

Rachel McMinn – Bank of America/Merrill Lynch

Okay. May be just moving on to pipeline oriented things, any questions from the audience, just moving on to the pipeline then, how important is subcutaneous Cinryze. I think this has been a big debate among investors, you guys have been very clear about not losing exclusivity prior to 2020. So how do you think about subcu in terms of defensive program as well as an offensive program growing the market may be even about geography as well whether you think it will be a bigger game changer in the U.S. versus Europe?

Jeffrey Dayno

So I think first and foremost, I think it’s the right thing to do for the patient population. So our number one goal with our patients in terms of exclusivity we believe is loyalty to the brand and loyalty to the company that continues to deliver improved formulations or improved patient service and that’s the number one driver for us. I think we definitely done great deal of market research that has shown us that the danazol patients would require more resistant to IV therapy would definitely be much more interested in clients on a subcu. So and we see some of that already with the enrollment of the different studies we have done.

So for us, there is definitely a defensive play here because CSO is out there and that we know they are doing work as well. It’s more important to provide service to the patients. We may very well be neck and neck with CSO in terms of subcu development. I think our pathways could be a little bit different. They might be trying a different product, but ultimately where we feel we prevail is the partnership we have with Halozyme and PH20 we think provides a much more advantageous formulation of the subcu and we should know better than anyone because we’ve done a lot of work already with our own version without the PH20 benefit and we know the pitfalls of that. So…

Rachel McMinn – Bank of America/Merrill Lynch

And data from that program is expected in the back half of the year.

Jeffrey Dayno

We’re going to commit ourselves to early, early 2014 and if we’re fortunate, perhaps it may be sooner.

Rachel McMinn – Bank of America/Merrill Lynch

Okay. And then from there you’d been in a position to start Phase 3 somewhere around mid next year?

Jeffrey Dayno

I think it will all depend on the data, the subsequent conversation with the FDA and then definitely I think that as data go we’ll be starting Phase 3 next year just depending on timing and how quick you have your Phase 2 with the FDA, et cetera.

Rachel McMinn – Bank of America/Merrill Lynch

In the U.S. versus Europe what you think subcu could – I mean, is it more of a game changer in Europe how – I think you’ve said that 80% of patients commercial today are doing IV at home. So with that backdrop how do you think about dynamics in Europe and whether this has been more, or less or the same?

Jeffrey Dayno

I think for Europe, I mean, the first thing, I think it could be a substantial differentiator in that market which has been driven by C1 acute therapy for 30 years. So our early foray into Europe, we know we’re bringing something different in terms of the label and the data set they we have it support of the approval for prevention which is new to Europe. But the mindset of a lot of KLOs in Europe is that, we’ve had C1 available to us first three decades now as an IV. So I think for us to bring a subcu formulation definitely is a pretty significant advancement for them. So potentially there could be some pricing power. And it could be a big driver in creating conversions for those patients on to prophylaxis.

Jeffrey Dayno

Yeah I think the expectation would be a patient-friendly method of administration, they’re friendly in terms of subcu versus IV, I think across the board would represent opportunity whether U.S. or EU.

Rachel McMinn – Bank of America/Merrill Lynch

And I’m sorry just your comment on pricing power, do you see this not only as a market share expander, but the potentially the price at premium to what they get currently half of the U.S. pricing in Europe?

Jeffrey Dayno

Well I mean we’re limited right now to reference pricing half of that, because that’s been the existing dynamic in Europe for the last two decades, so that price was set a long time ago. I think unless you bring something that’s clearly advantageous to what existing you might get a little bit of freedom in pricing. I'm not suggesting by any means its going to be best, but it could be a little flexible. I think for us the other advantage of this subcu with PH20 is that, that has a pattern. We acquired that deal through our Belgium subsidiary, so there is some tax advantages which could have a pretty significant impact on our bottom line.

So just for example through this pattern income detection rate in Belgium roughly 75% of our global profits could be captured at a 7% to 8% tax rate compared to the statutory 39% and we will be paying now. The remaining 25% will be tax at the local jurisdiction rates. So that's a pretty significant impact on bottom line.

Rachel McMinn – Bank of America/Merrill Lynch

Questions? With the strategy just to follow-up on that, would it be to save out IV because you just stayed from a tax basis like very much incentivize for how patients be 100% on subcu?

Jeffrey Dayno

I think that there certainly will be incentive on our partner, however I think the most important thing going back to the original theory is what the best for the patients. So if those patients that are particularly comfortable with the IV, we're certainly not going to make that go away for them I think.

Rachel McMinn – Bank of America/Merrill Lynch

And then just from a science basis, I know it's early you still need to generate this data that is evolving you have some initial data with the original formulation. Other than convenience is there a reason to think that subcutaneous administration would have material efficacy and it that would be part of Phase III trial design?

Jeffrey Dayno

I think it’s probably too premature to talk about the Phase III elements base. We still need to read out of the Phase II, I mean keep in mind this is the first study we are currently doing right now is the first time that there is ever going to be any kind of correlation between PK levels of C1 inhibitor and natural efficacy, so everything that's been an order sort of this point is somewhat hypothetical. I think that there is the potential that is subcu formulation could be better than IV because of the different profile. So when you have an IV infusion you have a large PK profile, whereas what we’ve seen in the early days, although it takes a little bit longer to get to the right levels of the subcu in tends to be more study.

Rachel McMinn – Bank of America/Merrill Lynch

But how would you – I mean the way you would measure that would be through break through?

Jeffrey Dayno

Through tax. Correct.

Rachel McMinn – Bank of America/Merrill Lynch

So may be you could talk about the data and like I mean how many of attacks you typically see on prophylaxis?

Jeffrey Dayno

I mean I think its variable for the patients, but I think still hypothetically the potential benefit with subcu is the PK profile is smoother than an intervene formulation where you sort of keep some values of the Kinetic. So if you get up to a sustained level and we are able to maintain that then hypothetically that is what our subcu preparation can offer.

With PH20 in terms of tolerability of subcu administration and other things that we are actively exploring in our clinical development program. The augment parameter is patient response and with clinical response, and that will vary. Patients would likely come into the study with the defined baseline in terms of the tax frequency and then look for clinical benefit.

Rachel McMinn – Bank of America/Merrill Lynch

I just wanted to switch gears starting to get a little bit low and trying to switch gears to (inaudible) and question that I have for you just a few minutes ago that why you are seeing such very encouraging initial anti-viral responsive, but you’re having handful of breakthrough, if we don't know whether they are in the low-dose during the high-dose because the study is blinded, why not break the blind today to get more confidence in the data and then just it needs to be, you would expand dosing from there. Just how should we think about that evolving over the course of the year? What is that that would trigger you to break the blind?

Jeffrey Dayno

So may be, it’s difficult to answer that question today. I think that as this study continues to evolve and we get more patients and get a little further, our thinking can evolve as well. Right now, the study was set up the way it was set up, I mentioned in the outset, you remember ever we have a bit of a tainted history. So the company itself was cautious about this, the investment were about to make here. I mean, I think one of the reasons probably was investor base I think that you’ve seen enough times where a companies will continues to throw money at a drug that may be doesn’t work. So I think we were a little nervous without even mentioning (inaudible) ever again.

So we’ve been – it’s been a very gated approach. I think that we are absolutely encouraged by the data we’ve seen so far. I mean to have over 90% response rate in refractory study is something that none of us expected to see even this early. So in terms of un-blinding I think it’s something that we’re curious about and that could happen soon. But I just don’t, I want promise anything that I typically want to get the next 40 patients, take a look, see how the trends are going. And I think each round we will think a little further, we may increase our investment though. It’s just there’s a lot of evolving that needs to occur here. I think we’re just, where we are right now is we’re very encouraged, but what we have seen very early.

In terms of why not in blind right away, I think the one of the things that we want to try to maintain some of the integrity of this study. If you un-blind those and you’re continuing the study I think that some of the investigators could be tainted by knowing that may be dose works better than the other, it will long-term affect your ability to study and really get a true dose effect or dose range, I mean one of the things that we struggle with before as we had a Phase II study and for prevention that was misleading and then relationship with those. So we are [scared] by that a little bit too.

Paul Firuta

I think a cautious approach. I think that's a good way to summarize it. So given the history, it was a cautious approach to start, as the data rollout we are being little more aggressive and taking looks at the data remaining blinded to the dosage line, and Rachael we’ve talked about – if we see a signal through point where we think we can learn more from unwinding and then let that data set in complete data set at that point in form our clinical strategy and we have the ability to do that.

Rachel McMinn – Bank of America/Merrill Lynch

And then switching down to Cinryze and other indication, I want to say you guys talked about transplant a couple of years ago. Those teams just falling off in terms of something that you are excited about, but how to do we rank order PNH failure versus AMR versus any other potential compliment may be aided indication.

Jeffrey Dayno

I probably wouldn’t rank him so we (inaudible) them work which one they work and…

Paul Firuta

So I think the good news is, potentially C1 inhibitor of the platform development opportunities in areas I'm doing a bit of work in really interesting in terms of broad range of inflammatory disorders, ischemia reperfusion injury as a model in terms of the transplant base then other classical antibody mediated complement activation conditions.

So thinking now is that we are exploring multiple other patient population potential new indication, we'll see what the data show us, some were doing to Viropharma’s sponsor safe, otherwise doing some very high level investigated initiative studies with some very qualified well-known investigators one in Neuromyelitis Optica, and Hopkins and the autoimmune hemolytic anemia in Amsterdam so we will left the data informal and I think the one difference and I know now there are some work in other areas that we're looking at treatment of acute exacerbation, acute attack, where the disease, morbidity and mortality kind of type as opposed to preventive approach. As with many diseases and disorders you can either treat them prevent ably or acutely, but our initial look at that through the IS, is treatment of acute exacerbation.

Rachel McMinn – Bank of America/Merrill Lynch

That seems so might counter that the company's overall strategy which is to have prophylaxis for its main indication, and I guess how do you think that of and if – amount from Lexicon they removing to pivotal study this year and say if they stick to their timeline so the numbers of patients that would have acute attacks could fairly substantially decline, if things were go out and if some initial study so why kind of go down that pathway may be there’s other sort of – are there other prophylactic opportunities that could be commercially large or...

Jeffrey Dayno

So main reason for that prophylaxis they are in and I just start with the PI and Hopkins in terms of is thinking when you the protocol so with no preventive therapies of 100% efficacious, number one; number two is the attack rate, the natural history of the attack rate in animal is much less than HAE. So risk benefit of routine prevention when you are tax rate is lower as opposed to a very efficacious treatment when patients come in acutely and you can – you can treat those attack very conservatively. So that is the early thinking in terms of logic around this.

Rachel McMinn – Bank of America/Merrill Lynch

And the Viropharma sponsored studies are in AMR and...

Jeffrey Dayno

Refractory PNH.

Rachel McMinn – Bank of America/Merrill Lynch

And when can we expect to see more data?

Jeffrey Dayno

So the refractory PNH, we had really talked too much about timing. It was a (inaudible) study early on pending positive signals we could turn a little of that into a clinical study. The AMR Study did take a long time to enroll, but we are very close and we expect the data this year, second half. Then probably be towards the end of the year.

Rachel McMinn – Bank of America/Merrill Lynch

And then may be just in the last 30 seconds, Europe obviously difficult environment to launch one drug at a loan loss multiples drug. I guess when do you think it is the fourth quarter this year is it really the totality of 2014, where you guys are going to have a good confidence level on the trajectory of Europe and whether its going to be something that you would continue. So it is an important growth part of your company.

Jeffrey Dayno

I think for Buccolam and Cinryze, the second half of this year will be the first time that we will be in position that we can kind of fully assess how, what’s the traction of these products, now that they are priced and reimbursed and available across all of Europe. I think that’s going to be an important measurement for us, kind of Q3, Q4. I think it’ll be too early to judge Plenadren (inaudible) fully launch which may not occur until sometime next year early. We expect our European business to be profitable in 2014, that’s something that’s important to us. But I think the broader, the broader questions about Europe in general is that, our company made a decision years ago that Europe was a place where we wanted to do business.

And we set about building an infrastructure and we’re fortunate enough and we have three drugs that we’re commercially launching when you look at them and add them together, it makes for an interesting business. But long-term, I think Europe is also important to us as well, in terms of our pipeline with maribavir and subcu and potentially the world be estimated opportunity. So I think its challenging the European environment is definitely challenging today, but at the decision our company made one at be there, I mean we don’t want to just give about half of the value of our assets away someone else I think you have to take the hard early work now to build an important value driver for our company for the future, and that’s what we’re committed to doing.

Rachel McMinn – Bank of America/Merrill Lynch

Great. Well, I can leave with there. Thanks very much.

Paul Firuta

Thank you.

Jeffrey Dayno

Thank you.

Question-and-Answer Session

[No Q&A session for this event]

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