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TESARO, Inc. (NASDAQ:TSRO)

Investor Conference Call

December 23, 2013 8:00 AM ET

Executives

Jennifer Davis – Senior Director, Corporate Development and Investor Relations

Lonnie Moulder – Chief Executive Officer and Co-Founder

Mary Lynne Hedley – President and Co-Founder

Analysts

Yaron Warber – Citigroup

Chris Raymond – Robert W. Baird

Robyn Karnauskas – Deutsche Bank

Howard Liang – Leerink Swann

Jim Birchenough – BMO Capital Markets

Eric John Criscuolo – Mizuho Securities

Operator

Good morning, and welcome to the TESARO Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this conference call is being recorded and webcast.

I’d now turn the call over to Jennifer Davis, Senior Director of Corporate Development and Investor Relations at TESARO. Please go ahead.

Jennifer Davis

Thank you, operator. Good morning and thank you for joining us today to discuss top line results from the first two Phase 3 trials of Rolapitant. I’m joined today by our CEO Lonnie Moulder; and our President Dr. Mary Lynne Hedley. We issued a news release earlier this morning describing the top line data we have from the first two Phase 3 Rolapitant studies and we will discuss these results on today’s call.

Before we begin, I would like to remind you that discussions during this conference call will include forward-looking statements. These statements are subject to a number of risks and uncertainties that could cause our actual results to differ materially. The factors that could cause actual results to differ are discussed in the press release issued today and in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2012.

I’ll now turn the call over to Lonnie Moulder, CEO of TESARO. Lonnie?

Lonnie Moulder

Thanks, Jen. Good morning everyone. We are very pleased to announce this morning the successful outcome of two pivotal Phase 3 trials of our lead pipeline candidate Rolapitant. As I’m sure you all can appreciate this is a significant event for a young biotech company. I want to thank all of our associates here at TESARO and the investigators and their staffs located at over 200 clinical sites in 25 countries who worked tirelessly on these two successful studies.

With these results in hand, we begin the transformation of TESARO into an integrated commercial and Development Company determined to make a difference in the lives of cancer patients. We are enthusiastic about the commercial potential for Rolapitant and believe it will be a meaningful product for cancer patients and for healthcare providers.

With that I’ll turn the call over to Mary Lynne for a review of the trial design and endpoints. Mary Lynne.

Mary Lynne Hedley

Thank you, Lonnie. As you know the Rolapitant pivotal program consist of three Phase 3 trials. A trial and patient who received moderately emetogenic chemotherapy or MEC and two trials in patients who received highly emetogenic chemotherapy or HEC. This morning, we reported top line results from the MEC trial and the first of two HEC trials and we are pleased to have successfully achieved the primary endpoint for each study.

The Phase 3 MEC trials of Rolapitant was an international multicenter randomized double-blind and active-controlled study that enrolled 1,369 patients, approximately half of the patients who enrolled in this study were receiving anthracycline-based chemotherapy for breast cancer. This is important because these breast cancer patients are considered by the guidelines to be at the highest risk for CINV and make up almost 70% of the total patient population eligible for NK-1 receptor antagonist. Patients were randomized to receive either the control therapy, which consisted of a 5-HT3 receptor antagonist plus dexamethasone or the control therapy plus 200 milligrams of oral Rolapitant.

The Phase 3 HEC trials of Rolapitant was also an international multicenter randomized double-blind active-controlled study that enrolled 555 patients. Highly emetogenic chemotherapy was specified as cisplatin at a dose equal to or greater than 60 migs per meter square. These patients are also considered by the guidelines to be at the highest risk for CINV and make up approximately 10% of the population of cancer patient eligible to receive an NK-1 receptor antagonist.

Patients were randomized to receive either control, which consisted of a 5-HT3 receptor antagonist plus dexamethasone, or 200 milligrams of oral Rolapitant plus control. The primary endpoint in each of the Phase 3 trials with complete response in the delayed phase, which was defined as no emesis and no use of rescue medication in the 24 to 120 hour period following the initiation of chemotherapy administration.

Secondary endpoints included complete response in the acute or 0 to 24 hour and overall or 0 to 120 hour timeframe and the rate of no significant nausea. As this standard industry practice, we intend to present the detail results of the full pivotal program at a medical meeting next year. In order not to jeopardize our ability to make this presentation, we will not be providing data beyond what was described in today’s press release.

Turning now to the results of the first two Phase 3 trials. The Rolapitant arm in is important to pivotal MEC study successfully achieved statistical significant over the control arm for the primary endpoint of complete response in the delayed phase. Similar to the MEC trial the Rolapitant arm in the HEC study also achieved statistical significance over the control arm for the primary endpoint of CR in the delayed phase.

In both trials a greater proportion of patients treated with Rolapitant had a complete response in the acute and overall phases and experienced no significant nausea, but these secondary endpoints did not reach statistical significance. Safety and tolerability results were comparable for patients who received Rolapitant and those who received control, and were consistent with earlier clinical studies. Adverse events were balanced across treatment arms and the most frequently observed AEs included fatigue, alopecia and loss of appetite.

Although we had originally planned to complete enrollment as a third and final Rolapitant Phase 3 study at year end, we’ve made the decision to leave that trial open to enrollment while we complete the detailed data analysis for the first two pivotal trials. Preparations are ongoing to support a mid-2014 NDA submission which will be based upon the three pivotal trials and a previously conducted Phase 2 studies. We are enthusiastic about the commercial potential for Rolapitant and believe it will be a meaningful product for patients and healthcare providers.

With that, I’ll now turn the call back over to Lonnie.

Lonnie Moulder

Thank you, Mary Lynne. We believe we have an excellent commercial opportunity with Rolapitant and we expect to meaningfully differentiate it in the marketplace. I’ll speak to some of these features in more detail, but we believe that Rolapitant may have advantages due to its extended half-life, which may contribute to the protection of patients from CINV for up to five days with a single dose. Potential availability in both oral and IV formulations to address the full market opportunity, differentiated safety profile based upon a lack of CYP3A4 drug interactions and its ability to be combined with any approved 5-HT3 receptor antagonist which enables clinicians to select a anti-emetic regimen that is most appropriate for each patient.

Rolapitant has a unique safety profile compared to the other NK-1 receptor antagonists, because it does not inhibit or induce the liver enzyme CYP3A4. This is important, because many concomitantly [ph] administered drugs are metabolized via the CYP3A4 pathway. Patients who are receiving chemotherapy frequently takes several medications in addition to their anti-cancer therapeutics and anti-emetic drugs, such as antihypertensive agent and statins and in total about 60% of pharmaceutical products are metabolized via the CYP3A4 pathway. Part of our promotional message will be to remind clinicians to consider the potential for drug interactions as they select anti-emetic therapies.

Rolapitant will also be able to address the full NK-1 market opportunity, because we are developing both oral and IV formulations as many of you know the CINV market is heavily weighted towards IV utilization. Approximately 80% of the anti-emetic market is IV and 20% is oral. Certain payers do prefer oral dosage forms yet IV administration of anti-emetics enables healthcare providers to ensure patient compliance, because we are developing two formulations, Rolapitant will be able to address this entire market opportunity with a convenient single-dose that can protect the patient from CINV for up to five days.

We also believe that the ability of an oncologist to select the 5-HT3 receptor antagonist that is best for each of their patients in combination with an NK-1 is important. Rolapitant can be administered in combination with any marketed 5-HT3 receptor antagonist and enables flexibility within the anti-emetic regimen. Importantly, ASCO and NCCN guidelines which are based on the profile and data for the only currently available NK-1 receptor antagonist indicate that patients will benefit from expanded use of this class of product, it will be our job to help the oncology community move toward improved compliance with the existing recommendations and as you know this represent a $1.5 billion market opportunity in the U.S. alone.

To do this, we intend to increase awareness of CINV by partnering with nurses who are more aware and directly involved with day-to-day clinic operations and by educating doctors about the benefits of NK-1 receptor antagonist utilization. Our confidence and our ability to be successful with Rolapitant is based impart upon our team’s decades of collective experience in oncology and oncology supportive care. We have the opportunity to partner with community based oncology networks and will work to place Rolapitant into treatment pathways.

We strategically conducted our Phase 3 trials at some of the largest oncology centers in the U.S. to enable them to get a clinical experience with Rolapitant and we have solid relationships already in place with the key opinion leaders in this field. With a potential differentiated profile, including an extended half-life, lack of CYP3A4-drug drug interactions, ability to be used with any marketed 5-HT3 receptor antagonist, plus the availability of two single-dose formulations oral and IV, Rolapitant is well positioned to expand the NK-1 market, capture share and provide value to patients and to providers.

With that, we’ll open up the call for questions. Operator.

Question-and-Answer Session

Operator

(Operator Instructions). Our first question is from Yaron Warber of Citi. You may begin.

Yaron Warber – Citigroup

Yes, hi good morning and thanks for taking my question. So Mary Lynne and Lonnie, give us a little bit of a sense first of all do you – was there anything sort of unexpected in the study itself that happened relative to the sort of the Phase 2 that can maybe part of some of the data and then I have a follow on.

Mary Lynne Hedley

So there…

Lonnie Moulder

Lynne.

Mary Lynne Hedley

Nothing – go ahead Lonnie. There is nothing that stands out at this point in time Yaron related to the data, we obviously are just looking at the top line results and haven’t completed all of the additional analysis, but today there is nothing that stands out that looks different.

Yaron Warber – Citigroup

Okay. And in the study the back when 5-HT3 did inline with historical?

Mary Lynne Hedley

5-HT3 receptor antagonist that was used in the study was granisetron and all of the data that we have in hand and is published, suggested it behaved very similarly to ondansetron.

Yaron Warber – Citigroup

Okay. And so the thought about continuing the enrollment in the third HEC study is to potentially overpower it to maybe hit some of those secondary, is that what you’re thinking?

Mary Lynne Hedley

Well given that we haven’t completed all of the detailed analysis, it just seems to make sense at this point to keep that open and since it won’t delay our overall NDA timeline, we just think that’s prudent.

Yaron Warber – Citigroup

Okay and Lonnie maybe just for you from a commercial perspective, I mean the study obviously is successful congrats on that but some of the secondary’s obviously were important to differentiate from the competition, including really hitting some of the CR in the acute and in the overall phases. The profile obviously is differentiated, but the market is getting more competitive, so help us understand maybe how do you position it an efficacy not just sort of on the overall profile? Thank you.

Lonnie Moulder

Yes, as I summarized just a few minutes ago, we have some unique features associated with our drug and Yaron you mentioned that the market is getting more competitive, but I think the reality is if you look at the current stage, there isn’t a lot of promotional activity at all in support of the currently marketed NK-1 and the NK-1 receptor antagonist that could potentially come to market the Netupitant/Palonosetron combo as you know at this point in time that’s just an oral formulation and that’s approximately 20% of the market.

So from an overall competitive standpoint, I think we’re well positioned in particular because of our differentiation on CYP3A4 drug interactions and that differentiation is against both of the other agents and then of course having the IV formulation that allows us to really differentiate ourselves from the Netupitant drug at this point in time.

So I think clearly the opportunity as we’ve discussed over and over again as you well know, is to expand the market opportunity. If all, anyone of us did was just a grab more share of the current penetration that wouldn’t be that exciting, the opportunity here is that we have guidelines in place that clearly state that certain patients receiving certain regimens should have an NK-1 receptor antagonist. And the largest population and Mary Lynne referred to this in her points, is the breast cancer patients undergoing treatment with any variation of AC or anthracycline/cyclophosphamide combination.

The guidelines point to an NK-1 needing to be used that’s not happening at this point in time and we think with our features associated with our products and our effort and what we’ve done in community oncology with placing our studies and our past partnering in that area that we can penetrate that marketplace and that is a significant opportunity and that’s – that really is the opportunity not necessarily just differentiating versus currently marketed drug that doesn’t have much penetration and a new drug coming that doesn’t have a dosage form that satisfies most of the market. So that’s why we feel so bullish about the opportunity with this product.

Yaron Warber – Citigroup

Thank you.

Operator

Thank you. Our next question is from Chris Raymond of Robert Baird. You may begin.

Chris Raymond – Robert W. Baird

Hey, thanks for taking the question. You know I’m just kind of curious looking at the Emend label, so they have a benefit in the acute and overall phase and although it’s a secondary endpoints for you guys. How important is the acute assays in terms of – is this an issue for you going forward that you have got maybe an advantage there on the Emend label?

Lonnie Moulder

The comment and Mary Lynne may want to also comment, but the – when the HEC part of this the highly emetogenic chemo part, although we have two pivotal trials in that setting, and we had previously highly successful Phase 2 trial that was conducted by Schering-Plough that’s really all about cisplatin, which is about 10% of the market as you know Chris. the MEC trial that we have where if you look at the Merck label it just refers to chemotherapy induced nausea and vomiting, not acute and delayed, so that’s a bit different in their label, because of the results of their MEC trial and we’re quite pleased with the outcome of our MEC trial and that as I said earlier is really the market opportunity, because within our MEC trial, MEC being the FDA definition 50% of the patients were breast cancer patients receiving the anthracycline based therapy and that’s the opportunity here. So I don’t see us at any differential disadvantage from an indication standpoint and then of course we’ve already mentioned what we think is our differential advantages potentially. So I’m not at all concerned about that but I do understand your question.

Chris Raymond – Robert W. Baird

Great, thank you.

Operator

Thank you. Our next question is from Robyn Karnauskas of Deutsche Bank. You may begin.

Robyn Karnauskas – Deutsche Bank

Hi guys. All right so two quick ones, so when are the possibilities that we could see the detailed datasets and then second question is just during the time you’re competing on the oral market, like how you compete with Netupitant and just within the oral market segment how will you compete, I understand that they can combine their drug with any 5-HT3 but they will have significance potentially in the detailed dataset in the label. Thanks.

Mary Lynne Hedley

In terms of the overall dataset, it’s likely that would appear at ASCO or MASC and MASC is a supportive care attention meeting that appears right after ASCO kind of thing.

Lonnie Moulder

Robyn, could you repeat the second part of your question?

Robyn Karnauskas – Deutsche Bank

Sure, so when you compete in the oral market segment so there will be a segment that is oral, how will you compete versus Netupitant? I understand you said that you can combine your drug with any 5-HT3, but maybe you can help us understand a little bit more that part of the market segment?

Lonnie Moulder

Right, right so as you described it’s 20% of the market opportunity and the currently marketed NK-1 receptor antagonist the three day regimen it has CYP3A4-drug interactions, the Netupitant product that you are asking about is just one dose covers the patient that has – it also has the same CYP3A4 issues, if you recall at last year’s ASCO and MASC meeting the data was presented regarding those drug interaction. So it has that same issue that the [indiscernible] has relative to drug interaction.

Robyn Karnauskas – Deutsche Bank

Okay. Thanks.

Operator

Thank you. Our next question is from Howard Liang of Leerink. You may begin.

Howard Liang – Leerink Swann

Hi, thanks very much. Lonnie can you just regarding the drug-drug interaction benefit can you – I know you said 60% of pharmaceutical products are metabolized through this mechanism, but can you talk about what percentage of patients receiving either HEC or MEC that have – that are on another drug that is a metabolized through CYP3A4.

Lonnie Moulder

I don’t have specific numbers for you, although we’ve taken a look at that and in general cancer patients have at least the same number of morbidities or prevalence of morbidities as the general population and in some cases have more comorbidities, so the type of poly pharmacy that cancer patients experience is similar to other people in the same age group, if you match it or even greater. So there is a very high number of patients that undergo chemotherapy that do take drugs that are metabolized by CYP3A4 Howard.

Howard Liang – Leerink Swann

Okay on the safety and tolerability side I think in the press you mentioned alopecia, fatigue and loss of appetite I believe. Can you talk about whether these are different from – these observation are different from either Phase 2 or what’s in Emend label?

Mary Lynne Hedley

Yes, we didn’t see anything that was different in the Phase 3 from the Phase 2 and those actually are most likely associated with chemotherapy, because they’re similar between the control and the Rolapitant group it’s just those are the AEs that were most commonly reported.

Howard Liang – Leerink Swann

Okay thanks and then on the – you’re enrolling the third Phase – sorry the third Phase 3 the second MEC study, can we assume that you’re relatively close in hitting some of the secondary endpoints, therefore you are maybe perhaps you can achieve statistical by enrolling a larger population in a third Phase 3?

Mary Lynne Hedley

You know it is probably not appropriate for me to comment specifically on that but I think its just anytime you’re not fully complete with the analysis of the arm of the completed HEC study, we think it makes sense to keep enrolling in the second HEC study and in particular because it’s not going to delay the NDA. So you know why not do that while we complete the analysis and see if there is any particular reason that would help us?

Howard Liang – Leerink Swann

When should we expect that there is study or data?

Mary Lynne Hedley

Until we complete the analysis of the ongoing studies and decide how much more enrollment to do, I don’t think – I don’t want to give you an estimate, I mean we had intended to stop enrollment by the end of the year, so I think that gives you an idea that we’re nearing our completion.

Howard Liang – Leerink Swann

Okay, great. Thanks very much.

Operator

Thank you. Our next question is from Jim Birchenough of BMO Capital. You may begin.

Jim Birchenough – BMO Capital Markets

Yes, hi guys, congrats on the top line results. There have been some expectation that you would hit the nausea endpoint based on the Phase 2 results, so I guess I’m wondering is there anything that happened here in terms of patient population or trial design that might explain not hitting some of these key secondary endpoints. And then the second part of it is, as you think about the strategy to expand the market and gain share with Rolapitant, do these results make it a bit more difficult and do you need to compensate with more promotional effort, how do you deal with what might not have been the target profile you are looking for in this trial. Thanks.

Lonnie Moulder

Yes Jim this…

Mary Lynne Hedley

Yes, so I…

Lonnie Moulder

Go ahead Mary Lynne and then I’ll follow-up.

Mary Lynne Hedley

Okay. So related to the first part, nothing – again its we just got the top line results, but there is nothing in the analysis at this point that would lead us to believe the Phase 2, Phase 3s were particularly different, I think completing the subgroup analysis and see if there is any imbalance which could have lead to these results is really where we need to focus our efforts and that’s what, what we will be doing. Lonnie.

Lonnie Moulder

Yes Jim from a market standpoint, the marketplace whether those would be community, oncology, practice leadership, nurses, oncologists that are involved in this, there was no real focus on nausea, they haven’t sliced and diced the Phase 2 data like the financial community has. What they’re looking for is a convenient agent that works and a company that has partnered with them as we’ve done with our Phase 3 program and intends to partner with them as we did in another company when we launched the market leading 5-HT3 receptor antagonist through a economic sharing, through contracting and allowing them in their treatment pathways to be frankly more incentivized to comply with what our guidelines already in place by the top guideline setting organizations, NCCN and ASCO.

So the whole nausea upside we’ve recognized could have been there, but we clearly have at a minimum the differentiation we have with Aloxi which ultimately had approximate 55, 60 share against the three big pharma companies that were actively promoting that’s not nearly the case here and we have at least the same differentiation. So the nausea secondary endpoint, I understand some of the focus that came from analysts such as yourself, but that’s not the focus frankly of people that will be establishing their treatment pathways and prescribing the drugs. We have a long-acting drug that has a single dose either oral or IV potentially and we don’t have the same drug interactions that exists with the other two agents.

But most importantly we have a path to partner with them, so that they will drive compliance with guidelines that already exist really for the benefit of patients and as I said it’s primarily breast cancer patients receiving AC that are being under prophylaxis [ph] these are the patients that are home after the chemo suffering from nausea, unable to eat, unable to get back to work, unable to help their families as they want to and that’s the focus and we think we’re well positioned to make that happen with the practice leaderships of the largest community networks that we know well and we’re already working with.

Jim Birchenough – BMO Capital Markets

And Lonnie I might have missed it at the beginning, but can you remind us of the timelines for getting the IV on the market?

Lonnie Moulder

Yes we’ve been talking about the actual approach, the way that we’re in the clinic now working out and finalizing the dose and then establishing based on discussions with the FDA, a path demonstrating similar exposure, the same path that was utilized with the first launch of the Emend IV and with other drugs out there in the marketplace that leads to a likely launch approximately one-year after the launch of the oral, the intent being to submit the IV package right after the oral is approved. So we estimate that to be one-year, we’re concertedly saying it would be a full year review.

Jim Birchenough – BMO Capital Markets

And everything you’re seeing in terms of the dose ranging work you’re doing is keeping you inline with those timelines?

Lonnie Moulder

Yes.

Mary Lynne Hedley

Yes, I can take that. So yes we started a dose escalation study and have escalated up to 200 milligram dose, remember that oral Rolapitant formulation is about 100% bio available, so we would anticipate the IV dose to be very similar and that’s in fact what we’re seeing at this point and we’ve dosed about 18 subjects, I think at the 200 milligram dose at this time.

Jim Birchenough – BMO Capital Markets

Great. Thanks guys.

Mary Lynne Hedley

Yes.

Operator

Thank you. Our next question is from Eric Criscuolo of Mizuho Securities. You may begin.

Eric John Criscuolo – Mizuho Securities

One question. Just filling in for Peter Lawson today. On the uptake in the breast cancer market, why hasn’t the treatment seen an uptake there, what is the barrier?

Lonnie Moulder

It’s interesting, we experienced this when we launched the 5-HT3 receptor antagonist Aloxi some years back, where patients – when they go home and although they don’t feel well, they frequently do not complain and we hear directly from patients about this, they don’t complain about how bad they feel. So you really need to inspire the clinic personnel and primarily the nurses to maintain a dialogue with their patients.

At that point in time, years ago when that drug was launched that I’m referring to, the concept of delayed nausea and vomiting was just being introduced, it wasn’t really even recognized, and now it’s fairly well established, but still there needs to be a lot of education and frankly just promotional effort and reminders so that the clinic personnel stay in dialogue with their patients in order to understand how they’re feeling, so that the patients don’t have the concern about offering up in fact they have side effects.

You know if you are a cancer patient and you believe complaining about the chemotherapy may lead your chemotherapy dosing to be reduced or perhaps even delayed that’s quite frightening, so they silently suffer through this and we know from data that’s published, the data that was utilized by the guideline setting committees that there is extremely high incidence of delayed nausea and vomiting in that population and it’s really up to us in partnership with all these large community networks to address that and we think the profile of our drug and then the approach we’re going to take as I mentioned before will be effective.

Eric John Criscuolo – Mizuho Securities

Thank you for that that clears it up, but is there a reason why it’s more profound or more pronounced in the breast cancer population versus the other cancer populations?

Lonnie Moulder

Oh, I’m sorry. Let me clarify that. It may not – it’s not necessarily more of an issue or more profound, the point I was trying to make is that that population is the largest population of the eligible patients receiving regimens that cause a significant amount of delayed nausea and vomiting. So when we look at the market opportunity for an NK-1 receptor antagonist in the U.S., we believe there are approximately 5 million annual doses and of that about 70% happens to be the breast cancer population, because of the regimens they are receiving.

Eric John Criscuolo – Mizuho Securities

Got you.

Lonnie Moulder

10% of that is really cisplatin and then the remainder consists of various moderately emetogenic regimens frequently carboplatin utilized in women. Does that clarify?

Eric John Criscuolo – Mizuho Securities

Yes, it does. Thank you very much.

Lonnie Moulder

Sure.

Operator

Thank you. We’ll take our last question from Yaron Warber of Citi. You may begin.

Yaron Warber – Citigroup

Hey thanks and just – I have a little bit of a follow-on, just it’s a slightly different topic. I mean congrats on this data and this is going to be important, but what I think far more important long-term is that Niraparib. And recently we’ve seen some positive data the neoadjuvant setting in combination with the PARP and in chemotherapy in breast cancer and there have been some obviously positive Phase 2 in gastric and signals in small-cell lung cancer. I’m trying to get a sense of what should we expect from you guys in terms of how you think about your Phase 2 program or your overall programs aside from the metastatic, ovarian, metastatic breast cancer setting. Thank you.

Mary Lynne Hedley

Yes, so I guess I’ll first comment on the neoadjuvant breast data, because that’s the most recent data that’s come out. Actually that data was demonstrating the advantage of carboplatin plus ABT’s compound Veliparib plus taxane versus carboplatin plus taxane, so I’m sorry versus taxane alone. So it’s really not clear whether or not the advantage in the neoadjuvant setting came from carboplatin or Veliparib or the combination of both and in fact in the triple negative breast cancer patient population and there are only 38 of those I believe in this neoadjuvant study, the ASPIRE-2 study that receive this combination of drug in triple negative with carboplatin a similar PCR rate has been observed in the absence of Veliparib.

So I think the data is pretty still – it’s still not clear I think what the advantage of a PARP inhibitor in the neoadjuvant setting would be or how best utilized a PARP inhibitor in that setting, you know we’re very excited about the opportunity of Niraparib in other potential indications and possibly at some point in neoadjuvant, I just want to be clear about what data it exist right now and what’s happened and in particular we’re looking at some of the settings that you mentioned as well as non-small cell lung, which you did not mentioned.

So over the next probably three to four months we’ll be working through some additional studies and we’ll then of course make all of you aware of where we intend to take Niraparib in addition to ovarian and breast where we are right now.

Yaron Warber – Citigroup

Mary it sounds like so you are already testing it in non-small cell, in small-cell and gastric?

Mary Lynne Hedley

No, no. what I meant to say is that those are indications that we are also looking at as possible ways to move forward with Niraparib. The reasons people are looking at those makes sense to us, maybe I should say that.

Yaron Warber – Citigroup

Okay, it makes sense. Great thank you.

Operator

Thank you. I would like to turn the conference back over to Lonnie Moulder for closing remarks.

Lonnie Moulder

Well thank you everyone for joining us this morning, we’re clearly bullish about the potential of Rolapitant as our first commercial product and look forward to updating you as we make progress this year and in addition as we make progress on Niraparib our PARP inhibitor and TSR-011. All of you have a great holiday and a happy New Year. Take care.

Operator

Ladies and gentlemen this concludes today’s conference. Thanks for your participation and have a wonderful day.

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