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TESARO, Inc. (NASDAQ:TSRO)

Deutsche Bank 39th Annual Health Care Conference

May 7, 2014 1:30 pm ET

Executives

Lonnie Moulder - CEO

Mary Lynne Hedley - President

Analysts

Robyn Karnauskas - Deutsche Bank Securities

Question-and-Answer Session

Robyn Karnauskas

All right. Good afternoon. Thank you all for joining us. Don't be afraid to sit closer than the back row. I'll call on you directly if you sit in the back row.

All right. So next we have one of the more exciting small cap biotech companies currently out there. We cover it, TESARO, Incorporated. Speaking on their behalf we have the CEO Lonnie Moulder.

My name is Robyn Karnauskas, I work at Deutsche Bank. I'm one of the Biotechnology analysts. If you have any questions, there is this little app here that you can email me questions anonymously, but I encourage you to be brave and raise your hand. I keep offering prizes for people that raise their hand and offer a question. And then rescind them afterward, because no one really -- I can't legally do that.

So anyway, thank you Lonnie for joining us. I appreciate it.

Lonnie Moulder

Great to be here. We appreciate DB inviting us.

Robyn Karnauskas

Okay. Well, just big picture. You got many different parts of the business now, all of which we could argue are undervalued. What are the main questions that you are getting in the -- getting from investors right now? Where do you think investors minds are?

Lonnie Moulder

Other than I think some of the paying people are feeling based on how the sectors perform more recently, as it relates to TESARO, the questions are across the entire gamut because we filled the pipeline up with a variety of product to assets that are balanced from a stage of development and a risk and rewards standpoint. People have various levels of interests in those different assets.

Of course, Rolapitant, which will be the subject of an NDA submission mid this year, we're in the pre-commercialization mode. We do receive a lot of questions about how we are going to approach the market, what kind of data will be available at the upcoming American Society of Clinical Oncology Meeting?

As it relates to Niraparib, of course, we are currently executing on two global Phase 3 trials, so there will not be data coming from those trials until conclusion. But people are trying to better understand where it fits in from a commercial standpoint, from a competitive standpoint.

TSR-011, our earlier clinical stage asset, just how we are thinking about the ALK inhibitor opportunity as it relates to the potential to pursue a path not in the refractory setting, patients that are refractory to Crizotinib but perhaps, in frontline. And then, where the track inhibition potential may play out, which is quite early even from a science standpoint today.

And then, finally, the immuno-oncology portfolio that we brought in under our license agreement with AnaptysBio, what the strategy is there, how we are thinking about that since obviously the lead molecule is an anti-PD-1? How do we see that fitting into in overall strategy?

And then, of course, enthusiasm being generated about the earlier molecules. We have a anti-TIM-3, which could be the first anti-TIM-3 in the clinic and then anti-LAG-3 that is near the front of the pack also. So the questions vary across all of that for good reason.

Robyn Karnauskas

Okay. Maybe we can start first with the last one, the immuno-oncology portfolio. I'll play the question I get the most. Its how did you get the m so cheap? Because people think that may be there is something wrong with the asset. Like, do you -- well, how did you get such a good deal on this? Because many other companies have them in-house and they are looking for assets like this all the time. So why would not they gobble that first?

Lonnie Moulder

Well, I would say, first of all, our upfront for this was more than double what we paid for any of our other assets. So I don't consider it cheap. Maybe a better question for AnaptysBio because it was a competitive situation and the price upfront did run up over time, because of how excited people are about this entire field. I think one thing that we offer that is compelling for a small company such as AnaptysBio is that this clearly will be a priority. We don't go through twice a year portfolio review and kick things out of the pipeline; if we do it we are committed to it. It's critical to our success as a company. And I think, in general, our collaborative nature; this is a company of really strong science. They have some aspirations to move towards clinical. And the way we worked together to this point, we are actually assisting them with that a bit. And they are conducting the science part of this, the early part, because we don't have a team to do what they do.

So I -- and I think if you look overall, the way they deal with structure, there is a rather significant win for them over time. And they have done multiple deals. They have done work with -- and these are all publicly announced. They have variety of transactions, more around immune disorders, not we had the immuno-oncology piece but various immune targets where they have a collaboration with Novartis, another one is Roche, I think Gilead, Celgene, but actually this was the biggest deal they have done so far. So I think for them it was quite compelling than a lot of non-dilutive capital to them and to their venture investors. So it worked out well for everybody.

Robyn Karnauskas

Okay. And so how do you like envision -- so help me understand the strategy for developing the assets as a whole? Because everyone else is doing combinations too and how do you make sure that you are in a competitive position with them?

Lonnie Moulder

Yeah, I think this is pivotal, the fact that we have a lead molecule that is an anti-PD-1. If you think about where oncology is going and you may come down on a different side on this, but we believe that immuno-oncology approaches will be foundational to treating many tumors. And we already have seen how anti-PD-1, monoclonal antibodies can shift the survival curve. So if the future is combination and that's a backbone and you are an oncology company, small mid-cap oncology company that has multiple drugs in the pipeline and looks to bring in more drugs over time, in this case, it also includes our anti-TIM-3 and anti-LAG-3 that should be combined with anti-PD-1, where do you obtain an anti-PD-1?

Well, you can collaborate one of the big companies to have those. And at least one of those companies has shown some interesting collaborating, they picked three big partners to collaborate with. Or you can wait until those products are available in the market and buy them unless it's you're developing the same exact indication where it's approved, so the payor will pay for it. But if you want to go anywhere else, you will have to buy it in the open market. You can more than double your cost per patient to do a cancer trial.

Well, we want to advance our TIM-3, our LAG-3. We want a PD-1 to do that with. We want our own. There are many small and mid-cap companies out there that have interest in immuno-oncology approaches, that need to be added to an anti-PD-1. We have one. And we have an open collaborative approach to how might want to work with a variety of people. So we see the anti-PD-1 as really enabling our own pipeline and perhaps, enabling others and our business development strategy over time and, of course, with our anti-TIM-3 which could be first in class. We already will have an anti-PD-1 in place to combine with. So that is how we think of the strategy.

Robyn Karnauskas

And why would they open -- why would they partner with you over, say, a more advanced PD-1?

Lonnie Moulder

They may. If they can get to that other one either buy it in the open market for whatever it's going to cost or if they can convince one of the large players to collaborate with them. And so far, I have only seen I think Merck is collaborating with Amgen, Pfizer and Incyte. And I think there are lot of other people that with would like to access to that that are not getting it.

Robyn Karnauskas

Let me ask you about too so what I found grate was that you have now lot of products in-house. And I had mentioned on the call that Roche was talking about how you want to have all these things in-house so that you can price the drug affordably; you don't want to have to partner three different PD-1s or different types of drugs because that could be $300,000 for the patient. So how do you think in your partnering these assets with other like, for example, like Amgen's TVEC with PD-1, when you are looking other assets how do you think about making sure the cost benefit make sense for to put the money into developing the drug that ultimately that you are going to be able to afford to charge? And if it's the price in --

Lonnie Moulder

Yeah. And that is an excellent question. And it depends on the circumstances related to that specific other approach whether it is another immuno-oncology approach, whether it's a small molecule, who owned it, what the business arrangement is. Obviously, if its just a collaboration from a development standpoint and both parties retain their assets fully and set price, that's different than is we are doing a collaboration that ultimately allows us to have an option to that product to make it part of our commercial portfolio, which I think over time could be the case with a variety of small mid-cap companies where we are an in-licensing model. We will have a fully integrated commercial and medical affairs organization in place. Our intent is to continue to build that. So if we end up in a collaboration that results in us having a commercial rights then, we control price and we can handle what you just brought up.

For our own portfolio, combining an anti-TIM-3 or an anti-LAG-3 with and anti-PD-1, you are right, we can control what the pricing will be around that. We spent time historically working through pricing and contracting with oncology in the U.S., and the oncology community clinics primarily. So it's something we are quite familiar with.

If you look at the other molecules we're developing under the AnaptysBio arrangement, the dual reactors that's an opportunity as it plays out to actually combine anti-PD-1 and anti-TIM-3 in a molecule and anti-PD-1 and anti-LAG-3 in a molecule. And that's another way to potentially answer the question about combining very expensive therapies, it's the same molecule if you have an opportunity to establish an appropriate price around that, yet you are hitting two targets.

Robyn Karnauskas

So just to be clear, so say, if you were to do a partnership with someone that has another drug that would be synergistic and you say you could enable their drug and they can enable your drug. Would you make sure that either you have the option to bring it in the control price or that whatever that drug combination would be that it would be affordable?

Lonnie Moulder

I think…

Robyn Karnauskas

(inaudible).

Lonnie Moulder

I think you will find a variety of different collaborations over time. Some of them will lead to a business arrangement, right upfront, some may have an option arrangement and some may be purely clinical collaboration to determine whether there is something there that can make a real difference in a patient and the business piece will have to be worked at some future date. So I don't have a recipe, its more of a menu.

Robyn Karnauskas

Okay. Any questions on immuno? Okay. So then, turning to you the part -- actually turning to first ALK. All right. The top question that I get is how can they afford? So say you go forward, you have a higher response rate and that your patients have been the current ALK inhibitor and that you want to pursue a first line strategy, how do you prioritize that program with all these other programs ongoing? Can you afford it?

Lonnie Moulder

Yeah. That's exactly right. You have to prioritize it, right. So when the time comes that we have the data and, let's say, the data is compelling, where in the ALK positive non-small cell lung patients that are ALK inhibitor naïve, that cohort patients that will be building over time, we look at the response rate, we look at the duration of response. We know our tolerability, which is substantial. And this is -- as far as the agents in the class, we really like our tolerability profile. When you look at that and you need to make the decision, is there a path here to pursue a first line indication. And doing that means a head-to-head first trial versus Crizotinib, I think that's what you are speaking too because, obviously, Crizotinib is marketed and we now what it cost. That's a setting over. Crizotinib is now approved, the payers pay for it. So the expense isn't associated with buying Crizotinib. The expense is just executing on normal pivotal trail, obviously, with the typical $70,000, $80,000 per patient in a cancer trail cost. So we are not paying for Crizotinib in that setting because it's approved now first line.

Robyn Karnauskas

And then how big the trial has to be to look head?

Lonnie Moulder

That's premature. Let's see how our data plays out and what we think how we would perform in a pivotal trial versus how we believe they will perform based on the data that exist. And the design and the powering will be worked out at some future date. So it's premature then.

Robyn Karnauskas

Financing that, you would just have to prioritize that program over other programs or do you think that you would be in a position? I mean, I don't know what the timing of that decision would be, that can be next year I think, correct? Or there would be fees?

Lonnie Moulder

Yes, it could be next year. And it will be a priority decision based on where we are with the other opportunities we have because the ovarian program or Niraparib, the NOVA program, we know we are well along in that from enrollment standpoint. The BRAVO program in metastatic breast is up and running. So internally, when are those costs coming down and what else is then going to come up from there, because Rolapitant costs are substantially less going forward other than commercialization.

And from a commercialization standpoint, if you think about how we're building out that organization to bring the drug to market once Rolapitant hits a run rate of approximately $50 million to $60 million, an annual run rate, the Rolapitant business, the Rolapitant P&L goes positive. So it starts spinning off cash. So Rolapitant is now in that place. The ovarian and breast cancer programs for Niraparib are coming down, what else is there? Well, we are now more in the Phase 1 stage with immuno-oncology, that's not overly expensive. And potentially, other Niraparib programs in addition to 011. So I would not project our R&D spend to go down but if -- with those other things that dynamic happening is not that it is going to substantially increase.

Robyn Karnauskas

Got it. One last question on the out, for those who don't know the space very well, maybe can you remind your view of the safety profile of your drug or the tolerability of your drug versus Crizotinib?

Lonnie Moulder

The drug, obviously, as any new anti-cancer drug is developed, was in a dose escalation and then sort of a dose expansion phase. Dose escalation, we started at 30 milligrams. And one patient cohorts, if we didn't see a grade 2 or greater, you go to the next cohort. We went all the way to 480 milligrams, so that's just grade 1s along the way. And then, we hit a DLT. The DLT was prolongation of the QT interval, no clinical sequelae but at 480. But at 60 milligrams from a (inaudible) standpoint, we are above the EC 50. We like our fractionated 60 milligram dose. How much is a time from a plasma standpoint, this is of course correlated to the pre-clinical activity. are we at the EC90? So we set out on the 60 milligram dose, is a dose that should demonstrate the activity that we want to see and it's substantially below the DLT. And at that dose we have not seen a grade 2 or greater event. So having just grade 1 events clearly has a best in class tolerance profile --

Robyn Karnauskas

Best in class.

Lonnie Moulder

Versus Crizotinib or any of the ALK inhibitors.

Robyn Karnauskas

Great. Any question on ALK? Okay. Moving to PARPs. Okay. Here are the two top questions I get on part. Well, here is one. So I was trying to figure out a potential timing in -- of an interim, if an interim has decided to happen. So maybe its just be helpful to just solely go through remind us when the trial begin enrolling, how many people were shooting for, what's the median time in which people progress on this drug, so we can just sort of think about it and then guess?

Lonnie Moulder

And I guess, you already have probably.

Robyn Karnauskas

Right.

Lonnie Moulder

But we're speaking of the ovarian maintenance trail. This it the NOVA trail. This is a trial in 360 women who have high grade serous ovarian cancer and are the -- are in their second response to platinum. Those patients are brought into the trail and they are tested for their BRCA status germline BRCA. If their germline BRCA mutated they go in one cohort and then non-germline go in a second cohort. Those two cohorts are completely independent; they're analyzed independently. And that's all in concurrence with the regulatory authorities in the U.S. and in Europe.

And within each of those cohorts, its 2:1 randomization; Niraparib, which is standard of care in the maintenance study which is placebo. And we're measuring PFS. And the study is really sized based on the Olaparib Ledermann work, where the control arm is expected to perform at in the range of about four and a half months of PFS and the outcome that we're looking for is really a doubling of that about nine months. And the powering of all that is really around the non-germline cohort, which tells you that the germline cohort is well overpowered. The non-germline cohort should logically enroll faster because there are more non-germline BRCA patients. The Ledermann paper showed that approximately 60% of the patients were non-germline, 40% were germline. So in the germline cohort we have an optional interim analysis. Why is that?

Well, the non-germline enrolls faster and we have the outcome there and we like that outcome, would it not make sense to look across at the germline cohort with the optional analysis since that cohort is still overpowered anyway and see what we have in hand. And if we like both then go submit. So it's really dependent on the non-germline enrolling and the output of those results to then determine that we jump over to the germline cohort and take a look.

Robyn Karnauskas

Okay.

Lonnie Moulder

Did that make sense, Robyn?

Robyn Karnauskas

Yeah. So then let's go from there. So say 60% of patients, the 350 was still out there, can do the math and tell me how many patients that is. Help we think about when did you start the trial? And remember, what you said, I don't think you said much about where you are in enrolment? And then, may be we can take about -- the third point would be Niraparib, how long did it take for them to enroll their Phase 2 trial?

Lonnie Moulder

Yeah. So a few data points. I'll start with the last one. The Ledermann paper on Niraparib. We're enrolling 360 or 180 each cohort. That trail was about 260. And then, was it somewhere around the 80 sites and it took 15 months, we're 360 and we're at 100 plus sites and we're not guiding but enrolments right on where our internal projections are. And we started the enrolment last July.

Robyn Karnauskas

Okay. So it's been a year. Okay. So then, presumably, by my back-of-the-envelope analysis, we could have data in the next year, some people say later this year. So in --

Lonnie Moulder

Clearly within a year there will be data.

Robyn Karnauskas

Right.

Lonnie Moulder

But we're not guiding on that. In fact, there will be a point this year when we will get much more specific about that.

Robyn Karnauskas

Okay. So you (inaudible) --

Lonnie Moulder

So then, people won't have to guess any more.

Robyn Karnauskas

So we won't have to guess any more?

Lonnie Moulder

That's right.

Robyn Karnauskas

About whether or not you will take that interim and all the stuff?

Lonnie Moulder

Right.

Robyn Karnauskas

So I think the point we're tying to make is, people were asking -- like there is a big perception that a lot of this data, if you are newer to the story, is far away. And I think just by doing this exercise people are -- I think will hopefully understand that data is really shortly coming and may provide insight to other PARP indications too. All right. Then the second question I get on PARPs a lot is Olaparib, really go to back. And what do you think about Olaparib? And do you know if the burden of pills, if that has changed from the original formulation?

Lonnie Moulder

Yeah. I believe it has. There was a time when it was 16 capsules per day and then new formulation was put together and they are using that new formulation in their current trials. Its still b.i.d drug; it's still multiple tablets b.i.d.

Robyn Karnauskas

Okay. Any questions on PARP?

Unidentified Analyst

(Questions Inaudible).

Robyn Karnauskas

What?

Unidentified Analyst

(inaudible).

Lonnie Moulder

The --

Robyn Karnauskas

(inaudible).

Lonnie Moulder

The BRAVO trial that's a trail in metastatic breast cancer patients that do have the BRCA germline mutation using the Myriad test, it's a trial of the numbers 306 patients and it's randomized 2:1 Niraparib versus dealers choice of a number of chemotherapies. And the primary endpoint also in this trail is progression-free survival. And that trial, as we said on our first quarter call recently, we started enrolling patients, so we have patients enrolling. And we're doing that trial in collaboration with the Breast International Group or BIG along with the EORTC realizing that the vast majority of patients in the trial like that are going to come from outside of the U.S. And we're quite enthusiastic about all of their assistance in having the top sites in other parts of the world participate in this trail to help us with our crew.

Robyn Karnauskas

Okay. Then, moving on to Rolapitant, your lead asset. I guess I don't want to start with the specifics, for people are not familiar we're listening to Rolapitant. Okay, so you have a history of developing drug in the CIND space, were very successful with that. We have good data; we're going to have more data in ASCO. And the data shows very strong effect in preventing chemo-induced nausea and vomiting. And the key controversy people ask all the time is whether or not you can launch in a generic environment. Can you just first address the launch? Like, when does (inaudible) generic for the pill and when does it go generic for the IV and how are you in your experience thinking about remind people what they are doing in advance as a launch and so forth?

Lonnie Moulder

Sure. We'll wrap out with that. We only have few more minutes.

Robyn Karnauskas

No, no, no. Did I give you a really tough question?

Lonnie Moulder

So -- and you had made reference to a prior CIND drug. Actually, there are two prior CIND drug experiences I have had. But the last one was a drug called Aloxi that we launched in MGI Pharma. Aloxi is a 5-HT3 receptory antagonist that blocks Serotonin, is the baseline therapy for preventing CIND. Aloxi, we launched to a market where Glaxo was selling Zofran, Roche was selling Kytril and Sanofi-Aventis was selling Anzemet. And these drugs mattered to the oncology portfolio and we attained about a 50 share. Since that time those three drugs have gone generic. So all the 5-HT3s are generic expect for Aloxi, it still maintains a 50 share that explains the dynamic in this marketplace.

We're launching a drug Rolapitant and there's only one competitor out there now. It's Merck who does not put a lot of support behind their drug necessarily compared to what Glaxo did for Zofran. An additional drug will be launched by Helsinn and Eisai, so that's two competitors.

The interesting thing here is that we have a situation where the marketplace is such that the IV formulation of the Merck drug is not generic until 2019. Remember, what I just said about Aloxi in a generic marketplace? They have an oral formulation though that will go generic sometime late 2015, which is about 20% of their brand's sales. And then, the Helsinn drug of course will be a new launch. So that's the generic situation.

This is a opportunity where a significant number of patients still go home and they're nauseated and they vomit. So an NK1 receptor antagonist, which blocks substance P, which could then, therefore, help reduce vomiting and nausea is added to a 5-HT3. And P guidelines, the NCCN guidelines, the ASCO guidelines actually lay out triple therapy. A 5-HT3 and NK1 in dexamethasone should be administered to every patient prior to their first administration of chemo in their very first cycle so that they will have a good chemo experience as it relates to nausea and vomiting. If they are receiving cisplatin intercycle and cyclophosphamide combinations for breast cancer or select patients receiving carboplatin and we point to women receiving carboplatin. When you look at that that should equate to a market of about 5 million cycles. Merck's current pricing is about $300 per cycle, so that's a $1.5 billion opportunity in the U.S. and right now there is only one agent. It's only penetrated 20% of that.

So our job is to work with the larger oncology networks, the key decision makers, who many of them produced the clinical data you will see from the U.S. analysis at ASCO to put Rolapitant in their pathways. And in most cases it will be for regiment where those patients right now are not receiving the benefit of an NK1 receptor antagonist. So they will have pathways that adhere to the quality guidelines that already exist and we will do that obviously in -- by supporting them with education and a business relationship that involves volume based contracting. That's our approach.

Robyn Karnauskas

So when you launched the Aloxi, when I look back you would be through to executions immediately within the first year. Now, that you are launching with the drug going generic, like kind of in the same year, how does that change the dynamics of launching Rolapitant?

Lonnie Moulder

So you have a drug that's penetrated 20% of the opportunity and of that drug only 20% of it is in the formulation going generic. The opportunity we're talking about in A/C with breast cancer, carboplatin those patients are not getting that drug to begin with. We're going after really an open part of the market to work with the oncology providers to just that hear to the NCCN guidelines. Whether -- there is three-day oral regimen, our drug is a one-day regimen, long half-life, given just prior to chemotherapy, protect the patient for five days. The potential generic is a three-day oral regimen with a substantial number of drug interactions. I think we're positioned well based on our strategy and based on our profile compared to that drug's profile.

Robyn Karnauskas

How do you target MEC versus HEC? Is there a difference?

Lonnie Moulder

No.

Robyn Karnauskas

Same patients, just same…

Lonnie Moulder

No. It's really just how the pathways are written. The -- in fact, we're not even using HEC or MEC. Let's just call -- talk cisplatin, A/C and breast cancer, carboplatin women, that's the market.

Robyn Karnauskas

Okay. So one other top questions I get on this side too is about Helsinn and whether or not they are a real competitor, and I mean they did show an (inaudible) benefit in their Phase 2 trial. How do we think about them? Where they are set --

Lonnie Moulder

I think what one used to do is when they look at the data is look at the analyses and the totality of the analyses and the P values as have been displayed in some of the Helsinn data sets that are unadjusted P values. And clearly, when we have posters and manuscripts you will see the unadjusted P values associated with Rolapitant and then draw your conclusions.

Robyn Karnauskas

So that goes to like ASCO and how we're thinking about ASCO. And in your slides which you released in a 8-K, was it like in the December? I think you put some of -- like some descriptions around how to think about different data sets. Can you -- they can be complicated if you don't know vital stats. I mean, how clear do you think you could be at ASCO about the profile of the drug, just from big picture standpoint? And help us -- because you're going to see the full data set? I guess the simple was of answering that question is, how can you help us clearly understand the impact of your data set on picking in the market?

Lonnie Moulder

Yeah. When we announced the Phase 3 results or top-line results we're just talking about what was the met, what wasn't met from a statistical standpoint. Clearly, the primary endpoint was met. We have a drug to submit, we have a drug that we're confident in. And at ASCO though, you have the full data set. So having all of that in front of you, I think it will become really clear. And we thought about how we will communicate this, so people understand the profile, the profile of that drug, plus its inherent profile the long half-life that really played out well for the Aloxi commercialization. And then, our strategy with the key customers that have produced this clinical -- these clinical data with their internal investigators. So all of that together I think people will understand why we find such a commercially compelling opportunity.

Robyn Karnauskas

Okay. Are there any other questions in Rolapitant?

[Call ends abruptly]

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