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Incyte Corporation (NASDAQ:INCY)

Goldman Sachs Healthcare Conference Call

June 06, 2012 06:20 pm ET

Executives

Pat Andrews - EVP & Chief Commercial Officer

Pam Murphy - VP, IR & Corporate Communications

Analysts

Sapna Srivastava - Goldman Sachs

Yogesh Ahuja - Goldman Sachs

Sapna Srivastava - Goldman Sachs

Good afternoon. Thanks for waiting up; I am Sapna Srivastava; I am Biotech Analyst at Goldman Sachs and it’s my pleasure to host Pat Andrews and Pam Murphy from Incyte. Pat is really responsible as the Chief Commercial Officer and Pam is the Investor Relations entity. So you know we really want to kick this off. I just want to remind the audience that this is meant to be interactive and we want you to ask a lot of questions and keep it as interactive as possible and I am just going to kick it off with like you know really topical and really good news that we saw this morning which is the RA data and while all of us were expecting to see tomorrow, we are really pleased that it came today and we have the opportunity to discuss that at this forum.

So I am going to just start it off with like may be recapping it for the audience who did not necessarily have a chance to see the data and also just to help us understand like how you view the profile of the drug with more visibility on it?

Pat Andrews

So many of you have seen prior data on this particular compound as well as 424 and the data across RA patients has been very consistent. It’s a very potent JAK inhibitor; has a competitive profile and obviously looks very comparable to the data that’s been presented by Pfizer for tofacitinib. Our numbers are much smaller obviously so it’s early on. But it looks very promising it’s very encouraging; the data we presented on Friday in the late breaker session at ULR and then we hope later this year to show the six months data with Lilly, hopefully at ACR. And the next step would be to initiate the Phase III program and we also expect that to happen this year.

Pam Murphy

Maybe just flashing out some of the details, I mean clearly the efficacy side it seems that it is on the higher end of the ACR presented etcetera; on the appropriate doses it may look a little better than tofa at least in these early patients effects. On the same side, on the safety side I mean it seems like we saw a couple of things that we haven’t seen before like the creatinine increase on the drug. And so just want to get your thoughts of like you know do you think it’s possible to differentiate from tofa, from this week, like where do you think the differentiations will be eventually in the marketplace as the data holds out?

Pat Andrews

So I think that there will be a number of places that the products could differentiate; it’s a little bit difficult to say what all of them would be now, because they finished the Phase III and while we’ve seen quite a bit of data, we just have the Phase II data with a smaller number of patients. But some things that come to mind are very obvious such as 050 is a once-a-day drug versus tofa is a twice-a-day drug and 050 seems to not have many drug-to-drug interactions versus tofa had some and we have benefit from seeing the questions raised during the AdCom for tofa and there are some learnings from that that we could take in the design of the Phase III that should start later this year.

So all of those things I think give us the potential to have a differentiated product and we just have to see, we have to be further along with more patients before be able confident saying what they are, that 050 is JAK1, JAK2 inhibitor and the tofa product is more of an pan-JAK inhibitor. Therefore it has JAK3 that may play into. We’re not entirely sure what the value is of the JAK3 component on that and it may have some negatives to it.

But again, all pre-mature. We are generally very pleased with the tofa AdCom. We thought it showed that the drug classes are good and viable, but at the same time left a room for some differentiation and some opportunities to maybe be stronger.

Sapna Srivastava - Goldman Sachs

I guess that ACR, this is a 24-week data. Do you have it in-house by now; I mean just for the feed two different sets of it, like, we’re seeing 12-week now at ULR or is it still….

Pat Andrews

The trial is complete now, but you’ll just see the 12-week data here and the 24-week data, the 6-month data would be at ACR.

Sapna Srivastava - Goldman Sachs

And when can we expect to hear about the safety design, they’re just like from the tofa panel like when do we see the Phase III design of the trial start by the year-end……

Pat Andrews

That’s the expectation, yes and that really would be a communication that Lilly would trigger, so until that point, we don’t have too much color we can provide on the Phase III, other than we know that Lilly is anxious to begin the Phase III trials which as we are.

Sapna Srivastava - Goldman Sachs

And just if we could, on that any questions from the audience on the RA drug?

Question-and-Answer Session

Sapna Srivastava - Goldman Sachs

So congratulations again on the data, so moving to just may be the different more, the broader side of the company. It’s really a foot here as a commercial stage company and we would love to get your perspective on how we view the challenges as a commercial stage company versus being in development, especially a profession that is much truer for you Pat like you have been getting ready for it for a while?

Pat Andrews

That’s true I do come from a commercial stage company there, I worked 15 years at Pfizer, 17 years or so the challenges are primarily is just there is a lot of infrastructure that you need to build to support your product to so it’s not just the launch of the product; it’s the infrastructure surrounding it and in this particular case I think we went through all of the steps and it was really a pleasure doing them, because you get to do them de novo therefore you can create what you think is really needed for your product versus often when you are in a larger company kind of inherit what the infrastructure is and need to push your product in through it.

So for Jakafi we have a distribution system which I think is just right for the product like this. We were able to price the product in a way that it was appropriate for what the market could bear and to meet up the unmet need. We were able to hire field force that was exactly like more than 18 years experience in sales and in industry and more than 11 on averaging the hematology and oncology space.

We were able to again do the market research and positioning needed; when you are in a large company you are competing with the other products for the dollars to do and you need too for yours; when you are in a smaller company and this product is so critical into the success of the company there wasn't really competition for the dollars because we knew that we had to form the organization early, we had to do the right levels of research.

So in those regards I would say it’s actually easier in some, in many regards to launch a product particularly a product as good as this one with a small company. And in the US with an excellent ex-US partner, Novartis it would have been I think impossible to do the whole world.

Sapna Srivastava - Goldman Sachs

And then just you know given the very early stages of the lines, I mean just help us you know how you've seen one quarter of really you know for sales for Jakafi and I am curious as to like how you feel with the maximum use of the drug is, how the launch is going and you know a few more weeks away from your quarter, just how is your confidence with the drug launch and sustainability of the launch from what you have seen in the first quarter?

Pat Andrews

We clearly had a very robust first quarter and that we reported $19.1 million in net sales in under a conservative reporting network called sell through which is products actually been dispensed to the patient. That was very robust, probably more robust than we thought it would be. But I don't think it changes the overall year and our expectations for the year maybe we just got some of the patients earlier on in the year, so it maybe a little more front loading, but a lot of the patients were possibly sick or more severely ill and the patients and the physicians were following the progress of the drug through the approval process.

So I view the remaining quarters of 2012 as being, having growth in them, having growth of significance and my strategy will pace probably not at the level of growth that we experienced in the first quarter, because that was front loaded in acceleration, but nice sustainable growth over the rest of this year and for next year and probably not reaching a peak market share until two to three years out.

Sapna Srivastava - Goldman Sachs

And then, we get a lot of questions on just the discontinuation rates that you are probably seeing, I guess its too early in the launch for you to really like talk about the continuation rates. But you know if you could help remind us what you've seen in the clinical trials and what should we really think about it, how should we think about it going forward in the launch in terms of like how long can the patient stay on drug?

Pat Andrews

Sure. That's right, its way too early to have a sense of discontinuation rate or compliance in the real world, but we do look to our clinical trial data to inform what we believe is likely to happen. In COMFORT-I which was 24 weeks, the discontinuation rate for patients on Jakafi was 14% and in COMFORT-II which was 48 weeks, discontinuation rate was 18%. And in the Phase II study, at the Anderson site about 50% of patients were still on drug at three years. So collectively those data points give up the flavor for how we think patients staying on drug will be.

It is a chronic therapy and once you go on it, you would stay on it for the rest of your life. What might occur is, because as I said earlier, there maybe more severe patients, severely ill patients going on at the beginning that might temporarily increase the discontinuation rate, but as we move toward a healthier patient population, even healthier than what was actually studied in the clinical trial were we study patients who were all intermediate too or high risk and we have a broader label on that.

As we move into that patient population actually the reverse might occur and you might see less discontinuations because it’s a healthier patient population and they are more able to manage the side effects of the drug which can be thrombocytopenia; generally dose dependent and reversible, but some patients who already are thrombocytopenic from their disease might find it more difficult to tolerate. So as longer the healthier they are the longer they are able to stay on drugs.

So I think those forces kind of balance each other out and then there is the wild card of what is the like in the in practice versus in a clinical study; usually it’s slightly worse compliant or sometimes much worse compliant and so that’s still the play-out and we don’t have anything at the moment which would lead me to think that it would be significantly different from what we saw in the studies at the site.

Sapna Srivastava - Goldman Sachs

And I guess just in terms of the patients profile, the patient types that are getting on to the drug you mentioned that the more severe side, the severe patients and that’s probably not unexpected just given that is the early stage of the launch. But just help us understand like how you see the migration for the more severe patients to the more modest and the more intermediate patients and how long do you think that can take and what kind of do we really start seeing that from big practices, community practices like what really drives that, is it physician experience, more patient awareness or a mix of all that?

Pat Andrews

Sure. So I do think we are seeing more severely old patients at the moment; we do launch trackers; initially we do them every two weeks and then we started doing them every month. So we have a number of those under our belt and we ask the physicians and we ask a group of approximately 50 [hematologist-oncologist] a different group each time; about have they seen it in that patient, how did they treat that patient; did they initiate that patient on Jakafi; who started the discussion on it the patient or you; what experiences have they had if you didn’t put the patient on Jakafi? Why not, what were the barriers etcetera and so we have a fair number of one of the patient characteristics.

We have a fair amount of information from that and we know that, as I said, most of the patients were more severely ill, intermediate to high risk. Now, what we would see happening is the scenario might be, a physician has been treating this MF patient for a number of years and they’ve seen the patient get worst overtime. It is a progressive disease and they’ve not been able to really help this patient and the patient has talked about their fatigue, or their spleen has been growing, their symptoms have been worsening and then they go on product and in a month they come back to get a blood count done and a physician asks them how they’re doing and the patient might respond.

Now, I am feeling better than I have felt in years. That’s a very, very powerful thing for that physician to hear. It’s very rewarding, it’s very gratifying and it doesn’t mean that they immediately put their next in that patient on drug, I mean they still want to follow this patient but you’re creating positive customer experience which, overtime, I feel very confident we will migrate the patients from these more severely ill to more moderate patients than in mild patients to who fall within the intermediate high risk classification.

But I do think that takes time. It’s an education process where you would be educating physicians who are very patient-centric and have the prominent, the patient population in other illnesses. They may only have a handful of MF patients. So it’s not top of mind for them and they want to really understand the disease and the drugs before they prescribe it more broadly.

Because most of the patients are in the community. Most of them are with these doctors who have less of confidence level in their understanding of the disease and the product. So I think it would take two to three years to really get everyone confident enough to make the determination that they know what the right patient and put that patient on drugs. So I think its being a two to three year cycle.

Sapna Srivastava - Goldman Sachs

And I guess in the this time like the data which has been coming out and driving physician use I mean where there something out of as (inaudible) we did see the data on the low phase accounts I mean does that help some of the physicians to drive data adoption and just do you think it is much more incremental?

Pat Andrews

So we are currently our label include patients who have low platelets but our clinical studies could have patients whose baseline platelets were greater than a 100,000. And our label will include the patients who have platelets greater than 50,000 actually [silent] on the dosage and I think having that information now out in the public domain and being able to, physicians to be able to use that should help with how they treat these patients. While I think many of them initiatively think if the label is silent on the dosing and I start out at a lower dose and work my way up until I get maximum efficacy to actually now have that data in the public domain I think it is a benefit, I don’t think it expands the market but I think it may make physicians more confident and that as I said earlier an important thing to have. So you know that studies still needs to complete and advance further but the information is now out there so I think that’s a positive.

Sapna Srivastava - Goldman Sachs

And can you just remind us like in terms of structurally I think you mentioned the 5,500 physicians that you are targeting in a way you are being able to target them, how many salespeople do you have and do you think that's a structure, optimal structure to like really be focusing on this number?

Pat Andrews

Yeah. Absolutely so we are targeting 6,500 physicians. They are (inaudible) and about 85% of them are in the community and they have maybe 75% to 80% of the patients they are with them. We have a sales force of 60 very experienced rep and so they have about a 100 doctors each because we hired them from other companies in the territory that we needed them to be and they were generally very familiar with the practice if not always a specific doctor and so that's helped too.

So they have these existing relationships and they have the exciting dynamic of the new product in first in class, first in disease, area of high unmet needs so that's been very well received and we have been able to generally get in and start the education process.

However, as you know access is increasingly restricted in all the areas including oncology and so there's not, they haven't reached all of the doctors yet and they haven't reached all of them enough times yet. But they will both directly as well as we have multi-channel and indirect ways of getting information out there and some obvious things such as print, advertising and websites but also educational forums and ways for a physician to hear through speakers or webcast or some other way which is very convenient for them to get more up to speed on both the disease and the drugs.

And so we are in part of that process now I feel like the sales force is well structured and highly capable and in its right size for what we need to have happen.

Sapna Srivastava - Goldman Sachs

And what is the biggest question from the physician’s side that you know your sales force is getting? What do they want to understand, they want to understand the data to get awareness of the drug, how to diagnose the patients, I mean what is the most commonly asked questions or?

Pat Andrews

I do get after a variety of questions, but a couple of things do you center around the mutation and the role of the JAK2V617F mutation in the disease. So that’s a scientific discussion that the rep should have on the mutation and the pathway. Jakafi targets and works on the pathway rather than the mutation. So you don’t need to have the mutations to have a level of confidence that the drug should still work.

People with or without the mutations were in both arms of the clinical trials and it’s clear that on Jakafi is what makes the difference not whether you had the mutation or not. So that comes up repeatedly and I think it’s also a part of a lot of oncology products are moving toward to being a mutation specific and so this one is an exception in that regard.

A lot of oncology products also have more standard measurement, such as response rate or progression free survival or the overall survival. This is not the data points which are reflective in this disease, so are endpoints where all primary endpoint was a reduction in spleen volume greater than 35% by imaging.

So we get a lot of questions on trying to understand how those things relate to may be the more typical treatment of other cancer patients. So there is some of that socialization that needs to occur too. But I believe that overtime in the many cases almost immediately, the correlation between having a very enlarged spleen which is normally the size of a fist and not the size of football picking up [blow] the patients rib. It’s obviously pushing in on their stomach and pushing in on their lungs and not taking deep breaths.

They are not eating right, they are not walking well, those are very serious consequences of having an enlarged spleen and so the importance of that is becoming more so over time and it's clearly a reason to believe in the efficacy of the product that the spleen goes from being very large to being much smaller. So I think all of those things are coming in to play and it’s really a question of time and education on those types of questions.

Sapna Srivastava - Goldman Sachs

Any question from the audience? I guess on the diagnosis side of these patients, I mean, how much of a challenge is that, I mean, most physicians being able to diagnose these patients easily or they has been move down the less severe patients, does that become more of an issue?

Pat Andrews

Not really. The diagnosis in MF that is actually relatively straight forward. The [infinitive] diagnosis for the bone marrow biopsy and they are done very frequently. If you ask physicians, they will say 90%, 95% of the time. It may be somewhat less than that because there is other factors which when you look them in the aggregate collectively, it seems that the patients likely to have myelofibrosis and they may not want to go through the bone marrow biopsies are painful.

They may not want to go through that. On an elderly patients got very enlarged spleen plain side of (inaudible) or maybe they previously had PV and all of a sudden polycythemia vera and all of a sudden their red blood count are significantly down. And that would be a sign that they probably progressed to MF.

So the diagnosis is relatively straight forward. That being said, it does occur that when there is a high unmet need on a life shortening disease that, it’s not always the first diagnosis that is thought of. So I do think overtime, there is ability to work on making sure that people who have MF are actually diagnosed as having MF rather than some other illness like and MDS or something. And we’ll probably start incorporating that in to our educational materials but that will be later. Right now, we’re focusing on already diagnosed patients who have symptoms and based on symptoms and enlarged, they are clearly appropriate candidates for this drug. If there are an intermediate to high risks in that patient.

Sapna Srivastava - Goldman Sachs

I mean and you know this one of the big question which has come on the drug is the benefit sources and even in modifying the disease. I mean is that something that you hear out in real factors or is it more of a female an issue which has been raised by some top leaders and I mean how that really translates into the commercial adoption of JAKAFI?

Pat Andrews

We have done some research on product that was approved showing the profile to our target audience on the drug and then the Profile 1 there was no overall survival benefits. In the Profile 2 there was and we got after each case which patients would you on drug, which patient type etcetera and you would think there might be a very large difference but the profile that had overall survival but actually there wasn’t because the disease is devastating enough that even in (inaudible) clots here a spleen reduction and a symptom improvement is sufficient to put the patient on drug.

Therefore, they didn’t need the extra encouragement of also thinking there is overall survival. That being said, we do have some data, much of it quite compelling both from the COMFORT 1 study as well as the Phase II work that MD Anderson as well as my inspectors but there is probably an overall survival benefit. It’s not something that would be in our label.

So it’s not something that commercially I am focusing on but I do think that physicians, even if they are not aware of that data, overtime, seeing patients who are clearly really suffering from their disease. They’re wasting away; they’re not sleeping through the night. They have this enlarged spleen. They’re not bending over. They have abdominal pain and all the other things that go along with this disease. I think they'll see when they put the patient on drug, and generally the patient -- most patients respond and most patients respond pretty well, fairly significantly.

They'll see these patients regaining their strength, regaining their weight, enjoying life more. And in their mind they will think this patient should live longer. And I do believe that that will happen almost organically just through the physician's experience, even independently of the data that we have that does say there has been an overall survival benefit in particular studies.

Unidentified Analyst

(Question Inaudible)

Sapna Srivastava - Goldman Sachs

I'll repeat it for the webcast. Is there any work done related to value -- to help economics, essentially propositions to help economics?

Pat Andrews

Yes, absolutely there has been. It's not as needed in the United States at this point in time in order to get your product covered by payers. So that work is more driven by Novartis for their European and other markets, and it is significantly advanced. And we will be leveraging some of that in the United States. And I'm not going to comment more on it because Novartis is still in process in their European regulatory approval.

Unidentified Analyst

Are you working -- is there a plan to work with subspecialty societies, either in the United States or abroad, to further position us in a particular guideline, existing or otherwise?

Pat Andrews

So we may, at some point in the future, work to have -- work to see what guidelines might go in place for myelofibrosis. There's not one at the moment and even like NCCN doesn't have guidelines MF. But it wouldn't surprise me if they start looking into that. And of course, we are always interested in seeing -- having guidance provided to physicians on the best practice in treatment paradigms out there. But at this stage, there's not guidelines that I am aware of from any of the key major societies in the United States.

Unidentified Analyst

The question is could you -- do you believe you could be shaping treatment guidelines in the future and are there any programs in place to do so, shaping or advocating treatment guidelines?

Pat Andrews

I'm sorry. The mike blurred your voice a bit so I'm not getting the question actually.

Unidentified Analyst

(Question Inaudible)

Pat Andrews

For us to take a shape, like proactive? So my comment earlier was that we are always interested in seeing guidelines that might help physicians in practice. But I don't want to comment on whether we are at the moment involved in any of those discussions.

Sapna Srivastava - Goldman Sachs

Just on that topic, how is the payer and the formulary acceptance for the drug and date of the launch?

Pat Andrews

It's fine. It's exactly as we thought it would be in the sense that oncology products in the United States are covered under Medicare as a protected class, and Medicare made -- cover the decisions and we're covered. And most patients, they are under a standard benefit design. And commercial payers, they follow suit. They don't want to be the company that doesn't cover the oncology product.

They control or they try to control utilization through what tier it gets on and what prior authorization. But all of those are getting in place as we speak and they are quite where we expected them to be. It's not usually product specific, it's more category specific. So you have an oral oncology product, if it's a payer plan that has a two tier plan, then oral oncology products are on the second tier.

Well, ours goes on the second tier. If they have three tiers and oral oncology is going to third tier, ours goes on to third tier. So kind of flops into what is already existing there. To my knowledge, while there are a number of prior authorizations in place, they tend to be on -- you have to have myelofibrosis, which is the indication. So that's fine.

Or maybe you can't get more than one month's supply at a time because they don't want a 90-day supply going out, and the patient only taking one month and then stopping it and they have paid out three months' worth of cost. So there might be quantity limits of that sort on there. And there are some plans that ask for more information or you have to check a box and there's a bone marrow biopsy, or you actually have to submit that data.

But in general, coverage is close to a 100% if not a 100%. And even things that have been -- on the few occasions where there has been a denial, usually that denial has been worked through. To my knowledge, for on label use of the product, the coverage has nearly always occurred.

Sapna Srivastava - Goldman Sachs

And maybe just reverting back a little bit to the (inaudible) experience, we have seen a fairly vocal criticism of the product from one single (inaudible). Has that had any -- has it put any challenges or hurdles, or had a wider spread impact on the community in terms of using the drug?

Pat Andrews

So I will just give a brief commercial answer that no. It creates a little bit of headwind because there's a little bit of noise and I'd rather not have us or the reps having to take time explaining any negative criticism from a single site on early stage data. The data itself and the FDA approval and the label really do speak to the efficacy of the drug. I'm not sure if there's anything that you wanted to add?

Pam Murphy

No. I think the data from COMFORT-I and from the MD Anderson experience, I think has been widely publicized now and most people are appreciative that his experience is smaller and earlier, and that sort of has spoken for itself, Sapna.

Yogesh Ahuja - Goldman Sachs

Yeah, hi, thanks. Yogesh Ahuja, Goldman. Just wondering what your thoughts are on how you see the MF space evolving overtime with the potential combination therapy with agents like pomalidomide or others, and what things you're doing to prepare for that? And then real quickly also, if you could just talk about the PV opportunity and what type of patients you see being potentially eligible for the drug?

Pat Andrews

Sure. So on the MF space overtime, at the moment, nearly everything is being studied as single agents, and there's a lot of JAK inhibitors being studied in particular. But there's always differences across them. Jakafi is the JAK1/2 inhibitor. There are some other JAK inhibitors that are just JAK2. There are some that are aiming to be mutation specific.

There's other classes of products like a hedgehog inhibitor looking into the MF space. There's products that treat a subset of the illness, such as anemia, looking into it. So I think now that Incyte has forged the way, that there's going to increased interest in MF. I think we have shown that this is a sizeable market opportunity.

However, I also think that being first and having a first mover advantage is very powerful in this space because the patients are dispersed in the community, and the physicians generally are not acknowledgeable about this disease as they are on so many of the other diseases that constitute cancer.

That by being first and by being a good product that works in the vast majority of all patients, and being tolerable that I think most patients will, who are going to go on an oral therapy, will go on ours over two to three years. And then, so a product that comes along after that time would only be competing for newly diagnosed patients, which is a much smaller opportunity.

So I'm glad for MF patients that there's a lot of companies and products now in this space, but I believe that we will retain still the vast majority of the business for a very long period of time. Now, combinations are interesting, and I do believe that that should continue to be explored. And I would be hopeful that maybe through a combination; we could advance even further than the significant advancement already made with Jakafi.

But that will take some period of time. I think most of the combinations would be products themselves, which are investigational. So they still have a long way to go before they would be studied only in combination with our product. The PV opportunity, so the PV study, we have Phase III study ongoing. It's under an SPA and it is enrolling.

We hope to have enrollment completed by the end of this year, data at the end of next year, and then file the sNDA and hopefully have a good review mid -- and approval mid next year.

So the timing -- the following year, which would be 2014. So the timing on that is really excellent because if I said, MF sales might reach a peak penetration, not necessarily a peak dollar amount but a peak penetration in the two to three-year timeframe, which would be about the timeframe of PV coming online as an indication.

And so, you might not see the flattening that you would normally see in the product which reaches peak in its first indication, because we would have the second indication following on. And just even though you didn't ask, I will just add. And then by the time PV is maybe starting to fully penetrate its market, we would hope to have 050 on the market for RA.

And so then, we would be receiving the royalties off that. So we can see over quite a number of years, six to ten-ish, really nice, steady revenue growth coming from at least three sources.

Pam Murphy

And then, there are all the life cycle management studies going on with ruxolitinib in other cancers, in addition to PV. So there's the pancreatic cancer study, the lymphoma study. There are now some investigator sponsored studies in breast cancer that will be interesting to see. So it's a very exciting future for Incyte and ruxolitinib, and the other pipeline products.

Sapna Srivastava - Goldman Sachs

And maybe with just a minute to go, beyond the JAK, what is interesting? What do you guys are most excited about?

Pat Andrews

Well, it will be interesting to see c-MET progress, even it is partnered with Novartis but that's a proprietary compound of ours that we licensed with Novartis. That looks very interesting. We have the IDO inhibitor that just had some data at ASCO. It's a very selective IDO inhibitor.

It is a very well tolerated compound, can be moved forward into the metastatic myeloma indication and test the hypothesis pretty robustly I think, as well as ovarian cancer. So that data will be late 2013, '14. And there are some undisclosed early pipeline programs that are also in clinical development. When there's proof of concept, we should be able to describe those either later this year, next year.

Sapna Srivastava - Goldman Sachs

Great. Well, thank you so much. Appreciate the time and thanks to all of you. And I think we have one more session to go, and hopefully we can (inaudible).

Pat Andrews

Thank you, Sapna.

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