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TESARO Inc. (NASDAQ:TSRO)

Q1 2014 Earnings Conference Call

April 29, 2014 4:15 PM ET

Executives

Jennifer Davis – Senior Director of Corporate Development and IR

Lonnie Moulder – CEO and Co-Founder

Ted English – VP, Controller and Principal Accounting Officer

Mary Lynne Hedley – President and Co-Founder

Analysts

Robyn Karnauskas – Deutsche Bank

Chris Raymond – Robert W. Baird

Chris – Citigroup

David Friedman – Morgan Stanley

Howard Liang – Leerink Swann

Peter Lawson – Mizuho Securities

Operator

Good afternoon, and welcome to the TESARO First Quarter 2014 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’ll 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 afternoon and thank you for joining us today to review TESARO’s first quarter operating results. I’m joined today by our CEO, Lonnie Moulder; our President, Dr. Mary Lynne Hedley; and our Vice President of Finance, Ted English.

Earlier this afternoon, we issued a press release detailing our first quarter 2014 financial results. Please note that the slide presentation that we’ll refer to during this call is available via webcast on the Investors section of our website, www.tesarobio.com.

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 from those described in these forward-looking statements. 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, 2013.

We may refer to certain non-GAAP financial measures that involve adjustments to GAAP figures. These non-GAAP financial measures are not a substitute for GAAP financial measures, and are unlikely to be comparable to non-GAAP information provided by other companies. We believe non-GAAP measures may be useful to investors as a supplement to, but not as a substitute for, the applicable GAAP numbers.

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

Lonnie Moulder

Thank you, Jen, and thank you everyone for joining us. This afternoon, I’ll review our first quarter accomplishments, Ted will discuss our financial results for the quarter, Mary Lynne will provide an update on our rolapitant, niraparib, TSR-011 and immuno-oncology programs, and finally, I’ll briefly summarize the data presentations we have planned for the 2014 American Society of Clinical Oncology or ASCO meeting in June. We’ll then open up the call for questions.

We made significant progress with each of our development programs during the first quarter. Following the successful completion of two Phase 3 trials at the end of 2013, we announced in March that enrollment in the third and final trial of rolapitant was complete. We look forward to announcing the top line results as soon as they become available and we plan to present the full dataset from all three pivotal trials at the upcoming ASCO meeting.

We believe that the product profile we now have in hand, will enable us upon approval to bring a meaningful advance in chemotherapy-induced nausea and vomiting or CINV treatment to healthcare providers and patients with cancer.

Patients are being treated both with Phase 3 BRAVO breast cancer, and Phase 3 NOVA ovarian cancer studies of niraparib. And with regards to TSR-011, we continue to enroll additional ALK-positive and TRK-positive patients.

Finally, as you know, we expanded our pipeline via the strategic immuno-oncology transaction we announced in March. This collaboration is off to a great start, and we are quickly moving forward with our programs targeting PD-1, TIM-3 and LAG-3.

I’ll now turn the call over to Ted English to review our first quarter financial results. Ted?

Ted English

Thank you, Lonnie. For the first quarter of 2014, TESARO reported a net loss of $49.8 million, compared to a net loss of $18.9 million for the first quarter of 2013. This net loss was primarily driven by the inclusion of a one-time payment of $17 million for acquired in-process R&D expense, which was made in connection with our immuno-oncology agreement with AnaptysBio, and higher R&D expenses versus the year ago quarter.

Research and development expenses increased to $28.1 million for the first quarter of 2014, compared to $16.5 million for the comparable quarter of 2013, as a result of higher costs related to our expanded development activities.

General and administrative expenses increased to $4.7 million for the first quarter of 2014, compared to $2.4 million for the comparable period of 2013, primarily as a result of higher non-cash stock-based compensation expense.

Total non-cash stock-based compensation expense included in our operating expenses for the first quarter of 2014 was $2.5 million, compared to $0.8 million for the first quarter of 2013.

As of March 31, TESARO had approximately $180 million in cash and cash equivalents. This amount includes approximately $94 million in net proceeds that were generated from our follow-on offering of 3.2 million shares of common stock that was completed in February, and also includes $17 million upfront license payment made to AnaptysBio in March.

For the rest of 2014, we expect our operating expenses and cash utilization to increase over the course of the year, as compared to the first quarter of 2014 net of the $17 million to AnaptysBio. These increases will be driven primarily by higher overall costs related to ongoing clinical trials and development programs.

Specifically, we expect that R&D expenses will continue to increase as a result of our niraparib program, primarily driven by activities in support of the Phase 3 NOVA and BRAVO trials. Costs related to our immuno-oncology programs and to a lesser extent efforts with respect to our TSR-011 and IV rolapitant programs.

We expect that these increases will be partially offset by lower costs associated with the oral rolapitant development.

With that, I’ll turn the call over to Mary Lynne. Mary Lynne?

Mary Lynne Hedley

Thank you, Ted. We continued to make significant progress in advancing our development programs during the first quarter. I’ll now walk through each of our programs and speak to our plans for the rest of 2014.

Regarding rolapitant, we have completed a pivotal program for oral rolapitant that will form the basis of our NDA submission. The program included three Phase 3 trials that were designed to evaluate the activity of rolapitant in preventing CINV.

We announced in December that two of these Phase 3 studies, one study, which primarily enrolled the breast cancer patients receiving anthracycline/cyclophosphamide or carboplatin-based regimens, and one in patients receiving cisplatin-based highly emetogenic chemotherapy were successfully completed. Each of these two trials achieved its primary endpoint.

We completed enrollment of the third Phase 3 study in early March and we plan to announce the top line results in a press release as soon as they become available. The detailed results from the final study, in addition to the full results from each of the other two Phase 3 studies, are planned for presentation at ASCO and MASCC.

NDA preparations are well underway, and we are on track to submit the oral rolapitant NDA to the FDA mid-year.

Turning to the rolapitant IV formulation. We have completed our dose finding works and identified a dose of IV rolapitant for further evaluation. Current plans for development include completion of the ongoing multiple-ascending-dose or MAS study, which will occur during the second quarter, and initiation of a clinical trial to assess the bioequivalence of the IV and oral formulations. We continue to expect that the IV formulation of rolapitant will be launched approximately one year after the oral becomes available.

Turning now to niraparib, our PARP inhibitor. We are enrolling patients in two Phase 3 trials; the NOVA trial for patients with platinum-sensitive relapsed ovarian cancer, and the BRAVO trial which is for patients with germline BRCA positive breast cancer.

We plan to enroll 360 patients in the NOVA study and anticipate approximately 100 sites will participate. We have received Ministry of Health approval from each of 15 targeted countries, and for the first nine months that the NOVA trial has been open to patients, enrollment has been tracking in line with our internal projections.

Ministry of Health approval has been obtained in the first nine countries for the BRAVO study. A number of trial sites have been initiated and patients are actively being treated. In addition, our partners at SARC, the Sarcoma Alliance through Research and Collaboration remain on track to initiate the Phase 1 study of niraparib in combination with temozolomide in patients with Ewing’s sarcoma by mid-year.

Looking beyond breast and ovarian cancer, we see other potential opportunities that merit evaluation. We believe niraparib may have utility in a variety of tumor types, and we view it as a portfolio opportunity for TESARO. We are currently evaluating several options to expand our niraparib development program. Our thought process for selecting additional indications is driven by unmet needs, the current standard of care and the potential for use of a clinical or genetic marker to select patients for clinical trials.

We look forward to providing an update on our strategy during our investor event at ASCO.

I will now turn to TSR-011. We continue to evaluate 011 at a dose of 60 milligrams daily in an expanded Phase 1 cohort. In addition to a number of ALK-positive patients with non-small cell lung cancer who progressed on crizotinib, we have enrolled several TRK-positive patients and ALK-positive ALK-inhibitor naïve patients into this study.

The 60 milligram dose is being fractionated to provide more consistent plasma concentrations and exposure. We currently have dosed 11 patients with the fractionated dosing schedule, and formulations have been developed and are being tested in parallel to identify a controlled release formulation that will enable convenient dosing to clinical trials.

Finally, we have a number of upcoming milestones related to advancing our immuno-oncology antibody drug candidates. We anticipate selecting a clinical candidate for our anti-TIM-3 antibody in this quarter, which would be a first-in-class candidate, selecting an anti-LAG-3 antibody candidate by Q3 2014, and identifying a dual reactive antibody strategy targeting PD-1/TIM-3 and PD-1/LAG-3 by the first quarter of 2015.

We plan to begin pre-clinical investigation of TSR-042, our anti-PD-1 antibody with each of TSR-011 and niraparib later this year. And we expect to begin our first clinical trial of TSR-042 in mid-2015.

And with that, I’ll turn the call back over to Lonnie. Lonnie?

Lonnie Moulder

Thank you, Mary Lynne. It’s shaping up to be a busy ASCO meeting for TESARO. We are pleased that six abstracts have been accepted proposed to presentation, highlighting data from our development programs. We plan to present the full result of the Phase 3 trial of rolapitant in patients receiving AC or carboplatin-based regimens and from the two Phase 3 trials of patients receiving cisplatin-based regimens.

We remain on track to submit the rolapitant new drug application or NDA, mid-year to the U.S. FDA. As you know, we recently announced completion of the full database lock and analysis of the successful rolapitant Phase 3 trial in patients receiving AC or carboplatin-based chemotherapy, which included important subgroups and provides a full dataset from all six cycles of therapy.

In particular, a significant portion of the patients enrolled in this trial were from U.S. sites, including those that are part of some of the largest oncology treatment networks, very compelling data resulted from these U.S. subgroup analyses which provide us with even greater enthusiasm for the commercial potential for rolapitant. And these data are targeted for presentation at the ASCO and MASCC meetings in June.

Based upon our substantial experience in the CINV field and interactions with community oncology leaders, we believe the results from the analysis of the U.S. dataset and our market access strategy could drive significant adherence to CINV guidelines and market uptake.

We look forward to sharing these very exciting results with you, and look forward to seeing many of you at our investor event on the evening of June 1 in Chicago.

As we approach the time of NDA submission, we are also implementing our pre-launch activities for rolapitant. We plan to launch rolapitant with a full commercial organization, including a field sales force and appropriate medical affairs, marketing, reimbursement and account team support totaling 120 associates. We intend to use this team as the basis for all of our oncology product commercial launches going forward.

Our commercial organization will be an asset that can generate significant leverage for TESARO. Once rolapitant sales annualize at a run rate of approximately $50 million to $60 million, we expect that the P&L for the rolapitant brand will breakeven and this clearly represents an opportunity to quickly create value for the company and our shareholders.

In summary, with the completion of our first pivotal development programs, TESARO is transitioning to become a fully integrated development and commercial company. We have two late-stage product candidates, rolapitant and niraparib, that each address significant market opportunities, and our pipeline is characterized by differentiated molecules with potentially best-in-class profiles.

We also believe that our immuno-oncology portfolio will enable TESARO to be a part of the changing cancer treatment paradigm. And following the completion of our first quarter follow-on offering, we are in a solid cash position to continue to execute on our development and pre-launch programs.

Operator, at this point, could you please open up the call for questions.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from the line of Robyn Karnauskas of Deutsche Bank. Your line is open. Please go ahead.

Robyn Karnauskas – Deutsche Bank

Thanks for taking my question. I guess two quick questions. Number one, Mary Lynne, maybe you could help us understand what we should be looking for at ASCO, or maybe what you learned of anything from AACR in the PD-1/TIM space. Maybe there are some developments or maybe pipeline that we were looking for understanding more about the science in that area? And then second question. Just thinking about rolapitant and how – there are three million potential doses in the MEC area that really haven’t been penetrated. I know you said that Merck hasn’t really marketed that drug. But why are they penetrated HEC versus MEC, and has it anything to do with the dataset that they have? Thanks.

Mary Lynne Hedley

Yes. So starting with what to anticipate generally with immuno-oncology, given that the titles are all that we have available at this point across the field, it’s difficult to know until we see the abstracts and more information. I think clearly the big companies are going to be presenting combination data which will be interesting and we’re potentially interested in seeing the PD-1/LAG-3 data that might come out at ASCO this year.

Related to rolapitant?

Lonnie Moulder

Robyn, the history with aprepitant or Emend is really that at the time of launch in 2013, the drug was in an oral formulation that had a three-day regimen that was not ideal for patients of course that are nauseated following their chemotherapy. And the initial label indication was only for HEC, in this case as you know with the FDA, HEC is defined as cisplatin.

So the indication was just cisplatin. And there was reasonable penetration in the cisplatin arena that makes a significant difference for those patients. And it really took some time for the MEC approval to occur. By then, the drug had already established itself as having some issues with oncology clinics because of the high level prior authorization that was required and the complications that causes administratively for the office staff of oncology clinics.

And then eventually the drug penetrated the cisplatin area significantly, but then seven years later – it took seven years for an IV formulation that is just delivered once per cycle to become available. And I think by then, the drug had already established itself as well-penetrated in the cisplatin, but there just wasn’t a lot of momentum, or frankly support from either a medical spending sales force standpoint to really go much beyond that.

So we believe that substantially all the cisplatin market is penetrated by Emend, 80%, 90% but the key regimens under the FDA definition of MEC, which include anthracycline, phosphamide combos in breast cancer or the carboplatin regimens that clearly if you adhere to the NCCN guidelines, those patients should receive an NK-1 receptor antagonist but that’s not happening.

Emend probably has about 20%, 25% penetration, only in that area. And that’s a significant opportunity for us. As we said, the moderately emetogenic chemotherapy trial pivotal Phase 3 that included AC and carboplatin has very strong results and we look forward to sharing the U.S. subgroup analysis that will be really important to the oncology clinics at ASCO.

Robyn Karnauskas – Deutsche Bank

As a follow-up, can I just ask like, when you’re thinking about uptake given the lack of penetration, do you think it’ll occur first in HEC just because it’s an unmet need even though there isn’t a competitor there, or Emend is there, or do you think it’s really MEC is the initial low-hanging fruit. How you are thinking about like launch trends I guess, even though we’re a year away?

Lonnie Moulder

There is a point where I won’t go into the very specific details of our strategy that I think will serve us well, based on our conversations with people in the oncology community that we’ve had long standing relationships with. But I would believe that the penetration will occur in a similar fashion in all regimens that fall under the guidelines in how we’re going to approach this.

Robyn Karnauskas – Deutsche Bank

Thanks a lot.

Operator

Thank you. Our next question comes from the line of Chris Raymond of Robert Baird. Your line is open. Please go ahead.

Chris Raymond – Robert W. Baird

Hi. Thanks for taking the question. Just curious, I know you’ve been a little vague on this, but now that you have the third Phase 3 enrolled, the second HEC trial. Can you give us a sense of the, sort of the ballpark in terms of the patients that have been enrolled or is that something you’re going to hold for ASCO?

Mary Lynne Hedley

You mean the number?

Chris Raymond – Robert W. Baird

Yes, the enrollment.

Mary Lynne Hedley

Sure. 532.

Chris Raymond – Robert W. Baird

Okay. So I thought at some point the attempt was to get more than the first HEC Phase 3?

Mary Lynne Hedley

No, the intent was to enroll the predetermined and our pre-specified number which was 530. We ended up enrolling 532 because of course there were some patients ringing when we got to that last patient, so we had to let them in.

Chris Raymond – Robert W. Baird

Got it. Okay. And then, do you have any update on your thinking in terms of the ex U.S. strategy for rolapitant?

Lonnie Moulder

We have some time, Chris, to work that out. Obviously we will have the results of the final Phase 3 program here in the near-term. And we’re working on putting the NDA together, that work has been underway for some time. That’s our highest priority [ph]. When we have all the results in hand, we’ll go back to the authorities in Europe and we’ll walk – we will then work through the submission strategy.

And as we’re doing that, we’ll think through what is the best way to access patients in Europe for instance, and maximize the opportunity economically for TESARO and for our shareholders. And there is a variety of ways to do that from potentially commercializing rolapitant on our own with a companion product, that would then make that a compelling business, or collaborating with a party that already has resources in place, probably less likely would be an outright out-license that’s really not our strategy, and that’s Europe.

For Japan, again once we have the final Phase 3 results, we’ll then have the full package to really extend discussions that were initiated some time ago with potential Japanese partners. And in that case, it’s much more likely that we would do an outright out-license.

Chris Raymond – Robert W. Baird

Okay.

Lonnie Moulder

Does that address your question, Chris?

Chris Raymond – Robert W. Baird

Yes, absolutely. And if I could sneak one more in on niraparib. I know you’ve talked about the NOVA study enrolling, tracking as you thought. Should we still be thinking about a potential interim look in germline BRCA arm by the end of the year?

Mary Lynne Hedley

We haven’t provided any guidance as to when a potential interim would occur. We have said that, if it makes sense that we would – well, we would anticipate enrolling the non-germline BRCA cohort first, because just based on the ratio of non-germline BRCA patients to BRCA patients in the population. And if we had the data for the non-germline BRCA patient population known, we built in an optional interim analysis into the germline BRCA patient population that we might take a look at if in fact we had non-germline BRCA data in hand, and that data looked reasonable. That would be one scenario in which we might want to go ahead and do that optional interim analysis.

Chris Raymond – Robert W. Baird

Thank you.

Mary Lynne Hedley

Yes.

Operator

Thank you. Our next question comes from the line of Yaron Werber of Citi. Your line is open. Please go ahead.

Chris – Citigroup

Thanks for taking the question. This is Chris in for Yaron. You mentioned that you announced top line rolapitant data in a press release, is that something we could expect before ASCO, or you most likely going to wait till the data is presented at ASCO? Second question is what differences in the data for rolapitant that you’re going to present at MASCC and ASCO? Are we going to see the same data or will you present slightly different datasets?

Mary Lynne Hedley

So related to when we would announce the top line results. We’ll announce them as it will be appropriate when we have them and that will be before ASCO.

Lonnie Moulder

And related to the presentation of datasets on rolapitant. There will be some slight differences between what will be available at ASCO and at MASCC. There was one item that was accepted for MASCC for presentation that’s not available at ASCO. But I don’t think MASCC acceptances have been made publicly available expect to authors. So I can’t comment on that MASCC dataset yet, but there will be significant overlap.

Chris – Citigroup

Thank you.

Operator

Thank you. Our next question comes from the line of David Friedman of Morgan Stanley. Your line is open. Please go ahead.

David Friedman – Morgan Stanley

All right. Thanks for taking the question. Just on the IV formulation for rolapitant. Can you maybe just walk through the steps, I mean I know you sort of laid them out in general, but is there a certain number of patients that you need to treat before you file, is there a certain duration of dosing that you’ll need to do? What’s your understanding of sort of the regulatory hurdles in what you’ll need to accomplish between now and the time of filing? Thanks.

Mary Lynne Hedley

So just to remind you on the strategy overall. We started out with a single-ascending-dose study. And the purpose of that study was to start at a low dose and the escalating dose to achieve dose that we thought would be based on all of our modeling, look similar to the dose exposure provided by the 200 milligram oral formulation, and also to look at dose responsiveness overall, right. So we wanted to see a linear association on the exposure with the dose.

So that was achieved and we identified a dose that’s actually quite in line with what our model predicted that we would then move forward into a bioequivalent study with the oral 200 milligram formulation.

Right after the single-ascending-dose study completed, we initiated a multiple-ascending-dose study and this is to provide additional safety data, where we’re dosing cohorts of individuals. And these are all healthy volunteer studies by the way with three different dose levels of IV rolapitant, but compressed into 10 daily doses, okay. And that provides us some additional exposure data, accumulation data and safety data with repeat dosing.

And then we’ll take that package. We’ve completed some additional pre-clinical work. We’ll take that package and have a discussion with the FDA. And based on the outcomes of all of that data, we anticipate today suggesting to them the bioequivalent study that I just described to you with the oral formulation.

Well, we’ve always built into the plan is bridging safety study, and we built into the plans in the very beginning about 300 subjects in that study, not knowing exactly what the regulatory authorities would want to see. We felt that seem reasonable based on precedent. So that’s our anticipation now. We’ll have a conversation with the FDA and we’ll have more information and provide that at the time of obviously when we have it.

And all collectively together, we still believe that we’ll be able to put that kind of a package together and submit it right after we have approval of the oral formulation, which would mainly launch the IV formulation about a year later.

David Friedman – Morgan Stanley

Thank you.

Mary Lynne Hedley

Yes. You’re welcome.

Operator

Thank you. (Operator Instructions) Our next question comes from the line of Howard Liang of Leerink. Your line is open. Please go ahead.

Howard Liang – Leerink Swann

Great. Thanks very much. Can you talk about – maybe characterize the progress for the two Phase 3 trials for niraparib, whether they’re ahead of schedule or on plan?

Mary Lynne Hedley

Yes. So the NOVA study is, as I indicated, in track with our expectations in terms of enrollment. We have planned for 15 countries to be enrolling patients and all 15 have regulatory approval. And we have planned for approximately 100 sites. And the majority of those are up and running at this point.

In terms of the BRAVO study, it’s too early to predict enrollment. We’ve enrolled a handful of patients at this point and we anticipate – we’ve got approval in nine countries. We’re going for 14 countries, and we have several sites initiated. I think beyond that would be too early for me to give you any more assessments.

Howard Liang – Leerink Swann

And the BRAVO study, the patients are being treated – they’re the ones that have been enrolled?

Mary Lynne Hedley

Yes. They’re being treated. They are randomized in the BRAVO study similar to the NOVA in the sense of two to one niraparib to physicians’ choice.

Howard Liang – Leerink Swann

Okay.

Mary Lynne Hedley

Yes.

Howard Liang – Leerink Swann

On 011, can you talk about when will be the next data update? I know you have an ASCO publication. And also if you could talk about what type of patients that you’re going after at this point in terms of ALK, now that the LDK or I guess Zykadia is approved, whether it affects your strategy?

Mary Lynne Hedley

It actually doesn’t affect our overall strategy. We continue to enroll patients who have been treated previously with an ALK-inhibitor including crizotinib. And we’re actually seeing pretty impressive responses. I mean one of the – for the patients that have gone through enough cycles to actually give you information at this point, we’ve had one of the patients who had received crizotinib previously has been on our drug and responding for 10 months. Another one had been on the drug responding for 13 months, both of these significantly longer than they were on crizotinib.

Additionally, we have ALK-inhibitor naïve patients enrolled and that’s a very important part of our strategy as well. To enroll those subjects, we have a more difficult time in the U.S. for obvious reasons that we had expanded the trial to European countries and that’s where we’re seeing more enrollment of the ALK-inhibitor naïve patient. And we also are enrolling the TRK-positive patients.

Howard Liang – Leerink Swann

Thank you very much.

Operator

Thank you. And our final question today comes from the line of Peter Lawson of Mizuho Securities. Your line is open. Please go ahead.

Peter Lawson – Mizuho Securities

Mary Lynne, just going back to Howard’s question. When do you think you’ll have 011 Phase 1, 2 data?

Mary Lynne Hedley

Yes, sorry I did forget that. I anticipate that we would be providing an update from a clinical perspective at the EORTC meeting.

Peter Lawson – Mizuho Securities

Got you. Thank you. And then on niraparib. When do you think you’ll identify the targets there? And when do you think will have Phase 1 data coming up for Ewing’s?

Mary Lynne Hedley

For Ewing’s. I think and truly enroll the first subject, it’s hard for me to predict when we would actually have data for Ewing’s coming out. In terms of identifying additional indications and tumor types that we might pursue, as I said, we should – you should look forward to our ASCO investor event.

Peter Lawson – Mizuho Securities

Good. Thank you. That’s helpful. And then BRAVO versus NOVA. Which one do you think would yield top line data first?

Mary Lynne Hedley

Well, given that NOVA has been enrolling for nine months, which is obviously longer than BRAVO has been enrolling, just by that measure alone one might [Technical Difficulty] similar number of patient 360 in NOVA and 360 in BRAVO, one might anticipate that NOVA would finish first.

Peter Lawson – Mizuho Securities

Great. Thank you so much.

Mary Lynne Hedley

Yes.

Operator

Thank you. I would now turn the call back over for Lonnie Moulder.

Lonnie Moulder

Thank you. I’ll close with a brief summary of our corporate objectives for 2014.

We plan to announce the top line results from the final rolapitant Phase 3 trial as soon as they become available and present clinical data at ASCO, MASCC and ESMO for our product candidates, including a presentation of the full data for all three Phase 3 trials of the oral rolapitant at ASCO; submit the NDA for oral rolapitant to the FDA in mid-2014; advance the rolapitant IV clinical program; continue to advance the niraparib Phase 3 NOVA and BRAVO trials; initiate the trial of niraparib in Ewing’s sarcoma in partnership with SARC mid-year; define our strategy for expanded niraparib development in additional tumor types; identify an optimal dosing schedule for 011 and continue to evaluate activity of 011 in ALK-positive and TRK-positive patients; advance the development of 042, our anti-PD-1 antibody; select a potential first-in-class anti-TIM-3 antibody clinical candidate this quarter; and select an anti-LAG-3 antibody candidate by Q3 2014.

We appreciate your interest in TESARO. Thank you, and have a good evening.

Operator

Thank you. This concludes the TESARO first quarter 2014 operating results conference call. You may disconnect at this time.

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