TESARO's' (TSRO) CEO Lonnie Moulder on Q2 2014 Results - Earnings Call Transcript

Jul.24.14 | About: Tesaro (TSRO)

TESARO Inc (NASDAQ:TSRO)

Q2 2014 Earnings Conference Call

July 24, 2014 04:15 pm ET

Executives

Jennifer Davis - Sr. Director, Corporate Development & Investor Relations

Lonnie Moulder - Chief Executive Officer, Director

Tim Pearson - Chief Financial Officer, Executive Vice President

Mary Lynne Hedley - President, Chief Scientific Officer, Director

Analysts

Robin Karnauskas - Deutsche Bank

Jason Zhang - Edison Investment Research

Peter Lawson - Mizuho Securities

Howard Liang - Leerink

Chris Raymond - Robert Baird

Nick Abbott - Bank of Montreal

Operator

Good afternoon and welcome to the TESARO Second 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 will now turn the call over to Jennifer Davis, Senior Director and Corporate Development of Investor Relations at TESARO. Please go ahead.

Jennifer Davis

Thank you, Daniele. Good afternoon and thank you for joining us today to review TESARO's second quarter operating results. I'm joined today by our CEO, Lonnie Moulder; our President, Dr. Mary Lynne Hedley; our CFO, Tim Pearson.

Earlier this afternoon, we issued press release detailing our second quarter 2014 results. Please note that this press release and the slides presentation that we will refer to during this call are available on the Investor 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 and we undertake no obligation to update or revise any forward-looking statements for any reason. 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.

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 the 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 will 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 briefly comment on the significant pipeline progress made during the second quarter. Tim Pearson, our new CFO, will discuss our financial results for the quarter. Mary Lynne will provide an update on our Rolapitant, Niraparib, TSR-011 and immuno-oncology programs. Finally, we will open up the call for questions.

The second quarter was highlighted by very successful ASCO and MASCC meeting for TESARO. As you know, we presented the detailed data set from all three Phase 3 trials of oral Rolapitant at both medical meetings in June. We were very pleased with the enthusiasm and feedback we received from KOLs and key customers regarding the data and potential product profile for Rolapitant.

Our pre-launch commercial activities are now well underway and we are wrapping up our new drug application or NDA submission to the U.S. FDA. Patients are being treated in both, the Phase 3 BRAVO breast cancer and Phase 3 NOVA ovarian cancer studies of Niraparib. Momentum is building around BRAVO, and we are now far enough along with NOVA, where we can project completion of enrollment for one of the cohorts.

Planning continues to support initiation of new studies of Niraparib in small-cell lung cancer and first-line ovarian cancer. Finally, we are enrolling additional ALK positive and TRK-positive patients in our Phase 1 trial of TSR-011 and we are quickly moving forward with our immuno-oncology programs targeting PD-1, TIM-3 and LAG-3

I am very pleased to share with you today that Dr. Mary Lynne Hedley, President and Founder of TESARO, has been appointed to the position of Chief Operating Officer. In four years since we founded the company, Mary Lynne has been instrumental in defining our company strategy, establishing and advancing our pipeline and building the key functions required of a fully integrated biopharmaceutical company.

She is overseeing the successful global Rolapitant registration program, initiation of two global Phase 3 trials to Niraparib and our earlier stage TSR-011 and immuno-oncology programs. In addition to R&D Mary Lynne has responsibility for our medical affairs, clinical, regulatory and manufacturing functions.

Of course many of you know Mary Lynne and can attest to intellect, knowledge, experience and personal qualities for leadership. Before I turn the call over to Tim Pearson, our Executive Vice President and CFO, I want to welcome Tim to TESARO and his first quarterly call with us.

Tim's debt and breadth of experience gained in leadership roles with successful commercial stage life sciences companies will serve TESARO and our shareholders well as we prepare for the commercialization of our first product.

I will now turn the call over to Tim. Tim?

Tim Pearson

Thank you, Lonnie. For the second quarter of 2014 TESARO reported a net loss of $37.1 million compared to a net loss of $21.6 million for the second quarter 2013. This net loss was primarily driven by higher R&D, G&A expenses compared to the year ago quarter.

Research and development expenses increased to $30.6 million for the second quarter of 2014 compared to $18.2 million for the second quarter of 2013, mainly the result of higher costs related to our expanded development activities for Niraparib and our immuno-oncology programs in addition to increased headcount.

The company also recorded $900,000 of in-process R&D expense during the second quarter of 2014, as a result of making a milestone payment related to Niraparib clinical development. General and administrative expenses increased to $5.6 million for the second quarter of 2014 compared to $3.4 million for the comparable period of 2013, primarily due to increased headcount and higher non-cash stock-based compensation expense.

Totaled non-cash stock-based compensation expense include operating expenses for the second quarter of 2014, was $3.1 million compared to $1.6 million for the second quarter of 2013. As of June 30, TESARO had approximately $151 million in cash and cash equivalents.

For the second half of 2014, we expect our base operating expenses and cash utilization to increase compared to levels from the first half of the year, excluding the $17 million upfront license payment we made of AnaptysBio in March.

Specifically, we expect our cash use for each of the third and fourth quarters of this year will be in the mid-$30 million range net of the $5 million milestone that we are required to make upon acceptance of the Rolapitant NDA. This anticipated increase in cash utilization is a result of higher overall costs related to our ongoing development programs, including startup costs related to expenses related to our new oncology programs and the development of Rolapitant IV. These increases will be partially offset by lower costs associated with oral Rolapitant.

With that, I will hand the call over Mary Lynne.

Mary Lynne Hedley

Thank you, Tim. We continue to advancing our development programs during the quarter. I will now walk you through each of our programs and speak to our plans for the rest of this year. Beginning with Rolapitant.

As you know, the pivotal program that will support our NDA is now complete. Each of the Phase 3 trials of oral Rolapitant successfully met its primary end point and data from these trials along with the results from the Phase 2 study form the basis of our NDA submission.

We recently held our pre-NDA meeting with FDA to discuss our application and we are finalizing the formatting and last details now. We remain on track to submit the Rolapitant NDA in the next six weeks.

Turning to the Rolapitant IV formulation, we have selected a single intravenous does of 185 milligrams for further development. We have also completed a multiple ascending dose study of IV Rolapitant, which confirmed the safety and tolerability profiles and linear pharmacokinetics of repeat daily doses.

As part of the registration program for Rolapitant, we plan to initiate clinical studies comparing the exposure of Rolapitant IV and oral formulations and to evaluate the safety of IV Rolapitant. We continue to expect that IV Rolapitant will be launched approximately one year after the oral becomes available.

Turning now to Niraparib, our PARP enrollment is ongoing in two Phase 3 trials. Enrollment trial for patients' platinum sensitive relapsed ovarian cancer and the BRAVO trial for patients with Germline BRCA breast positive cancer.

Enrollment study continues to track in line with our expectations. As you know, there are two cohorts of patients in NOVA, those with Germline BRCA mutations and those who are platinum sensitive that do not have Germline BRCA mutations.

Based upon the pace of enrollment we have seen today, we now expect the non-Germline BRCA cohort of patients to be fully enrolled by year end. Once this cohort is fully enrolled and after we are able to analyze the required number of PSF events among these patients, we then have an option to take an interim look at data from the Germline BRCA cohort.

Regarding BRAVO, momentum is building following initiation of enrollment in April. Ministry of Health approval has been obtained and 11 countries for the BRAVO study. More than half of our trials have been initiated and patients are actively being treated in both, the U.S. and Europe. In addition, we and our partners at SARC, the Sarcoma Alliance, do research and collaboration has begun treating patients with Ewing's sarcoma and the Phase 1 study of Niraparib in combination with temozolomide.

Finally, planning continues to support initiation in new trials of Niraparib and small-cell lung cancer and first-line ovarian cancer in early 2015.

I will now turn to TSR-011. We continued to evaluate TSR-011, our ALK TRK inhibitor 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 patients who were ALK positive and ALK inhibitor naïve.

Based upon the safety profile and plasma levels achieved in crizotinib-resistant ALK positive patient who responded on our fractionated dose, we are enrolling patients at a total daily dose of 120 milligram and plan to begin assessing the controlled release formulation in the next quarter.

Finally, we continue to advance our immuno-oncology programs. We have identified a clinical candidate and several backups for our anti-TIM-3 antibody and we are on track to select an anti-LAG-3 antibody candidate during the third quarter and we expect to identify a dual reactive antibody strategy targeting PD-1 TIM-3 and PD-1 LAG-3 by the first quarter 2015.

Activities are underway to support pre-clinical combination of anti-PD-1 antibodies, with each of TSR-011 and Niraparib, and discussions are ongoing with several parties who have approached us about conducting studies that combine our immuno-oncology molecules with their pipeline candidates.

We have selected a contract manufacturer for TSR-042, our anti-PD-1 antibody candidate and we are working to develop our clinical supply, which we expect will enable us to submit an IND in late 2015.

With that, I will turn the call back over to Lonnie.

Lonnie Moulder

Thank you, Mary Lynne. Based upon our experience in the CINV field, interactions with interactions with community oncology and most recently our discussions with KOL's at ASCO and MASCC, we are very enthusiastic about the commercial potential for Rolapitant and believe it will be a meaningful product for patients and healthcare providers.

As we approach NDA submission, our prelaunch commercial activities are well underway. We added key leaders to team in medical affairs, marketing and market access. We plan to launch Rolapitant with a full-scale commercial organization totaling approximately 120 associates, including a field sales force and appropriate medical science liaison, marketing, reimbursement and account team support.

This team will serve 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 annualized rate at a run rate of approximately $50 million to $60 million, we expect that the P&L Rolapitant will breakeven. This clearly represents an opportunity to quickly create value for the company and our shareholders.

In summary, with the Rolapitant NDA submission, 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 in-class profiles.

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

Operator, can you please open up the call for questions?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Our first question comes from Robin Karnauskas from Deutsche Bank. Your line is now open. Please go ahead.

Robin Karnauskas - Deutsche Bank

Hi, guys. Thanks for taking my question. Three quick ones, so when you think about hiring people, the 120 people, can you help us understand the timelines for hiring the different buckets of people, so we can think about modeling.

The second question is what are the factors that will go in your decision as far as taking that interim look? Then the third one is, the question I get a lot from people is, how do you think about developing your PD-1 franchise in the face of other drug already being on the market. People ask me that all the time. How do you create value there coming in with an earlier program? Thanks.

Lonnie Moulder

Thanks, Robin. On the hiring, as I mentioned, we have the leadership in place now for a marketing, medical affairs and market access and we will hire just a handful more people yet this year. We will be doing a lot of recruiting in the first quarter and the bulk of the hiring will take place really in second quarter, in the summer of next year.

Based on the network of relationships we have and how we approach commercializing that had experienced in the past, the field group related to the sales force, the account management team will put contingency hires out there in the first half of the next year then we will be ready to pull the trigger at about mid-year and that's when the bulk of the spend starts.

Mary Lynne Hedley

Turning to the question related to the interim look, I think some of the things that would go into our decision related to that would be what are seeing in the non-Germline BRCA cohort in terms of the overall risk benefit profile and where are we in terms of the PFS events in the Germline BRCA cohort.

Those are really the two big drivers about going ahead and taking that interim early look. We certainly want to have PFS events in the Germline BRCA cohort to do that. Ideally, we would like to have obviously the positive data that we expect in the non-Germline BRCA.

Then related to the PD-1 formulation, I think that the first thing that we would start out doing and loss for startup, I think, we obviously don't have the whole path mapped out in great specifics, but conceptually, I think, you would think about starting the initial dosing studies, where you are doing the dose finding in subjects where you would anticipate having no response, so these are trials that you had initiated in patients what we already have learned from the other PD-1 antibody, but I think you would quickly move into what we believe is really critical identify the patient populations that you think would be most likely to respond in a smaller population from a tumor-type perspective.

We are learning a lot about how PD-1 antibodies work rather than just throwing a force approach at it like has been done of course as we expected earlier on in the development of PD-1 antibody. We are learning a lot more about which populations of patients are tending to respond and which aren't, so we are going to take advantage of all of that learning and be able to go into a defined macro-positive type of population to be able to quickly work in the PD-1 base alone, but then bring in the combination or by specific approach is right behind that.

We have a great deal of believe that ultimately patients are going to need more than a PD-1 antibody, which was the whole rationale and doing not just the PD-1 deal, but a deal which enabled us to have potentially five different antibody candidates in development.

If we see evidence that certain markers, which we believe exists, will help us identify patients in which testing a PD-1 TIM-3 and PD-1 LAG-3, make sense and we can see activity. If we have a buy-specific approach, one might quickly introduce that buy-specific or dual-specific antibody into the clinical rather than the combination, so that's sort of how we think about it from the monotherapy moving to combo therapy, which would be replaced if it's feasible with a buy-specific, dual-specific approach in targeted patients.

Robin Karnauskas - Deutsche Bank

Thanks a lot. That's helpful. Thanks.

Mary Lynne Hedley

Yes.

Operator

Thank you. Our next question comes from Jason Zhang from Edison Investment Research. Your line is now open. Please go ahead.

Jason Zhang - Edison Investment Research

Hi. Question to Mary Lynne. Again, NOVA's trial, I just wanted to be clear. The completion of the enrollment for non-Germline BRCA1 patient would be - and then you say, you are going to have an interim look in the Germline BRCA1 population. I guess, if I [design] you don't have interim look for the non-Germline BRCA1 population. Is that right?

Mary Lynne Hedley

Well, the first thing is, we would have to finish enrollment of course in the non-Germline BRCA and we would have to have the number of PFS events required to actually analyze that data, right, in the non-Germline BRCA patients, analyze that and then decide whether we will take an interim look at the Germline BRCA.

Given that non-Germline BRCA patient population is larger than the Germline BRCA, that's why we would obviously anticipate finishing that first. Currently, we don't have an interim analysis built into the non-Germline BRCA, so I wouldn't anticipate taking an early look there.

Jason Zhang - Edison Investment Research

I see. Okay. Just get back to the question in terms of timing and I guess at this point it's hard to really pinpoint whether the interim look the Germline BRCA1 population will happen. Most likely it will be in 2015, but it's hard to given more precise timeline more than that.

Mary Lynne Hedley

Yes. I think the most guidance we have given related to this previously has been related to guiding people towards enrollment using the Letterman publication that came out of New England Journal in 2012, I think, it was, which describes how long it took them to enroll the non-Germline BRCA and the Germline BRCA, and you can guesstimate what the PSF duration is in those populations from that patient population. Then I think you can kind of triangulate to one might expect if our results are similar to that trial.

Of course, we can't predict the number of events today. We certainly know what our target is, but I don't think we can give any more guidance than what we provided today, which is the completion of the non-Germline BRCA enrollment by the end of the year.

Jason Zhang - Edison Investment Research

Okay. Then a question on anti-PD-1, when the deal was announced in March, you kind of project that IND will be filed in mid-2015, now you are saying late 2015; I know it's hard to really give such a precise estimate. I wonder if because of some additional work find now you need to do or it's just because it just never can be so accurate?

Mary Lynne Hedley

Actually it was the time it took us to identify and sign up contract manufacturer, so we went through a great deal of thinking through what that choice would be to give us the most opportunity and flexibility on a global basis, so that we thought was a very important step to take and put some time and effort into that and we think we have chosen quite wisely.

Jason Zhang - Edison Investment Research

Okay. Also related to that is competitors such as CMS and Merck has done a very non-traditional Phase 1, where they actually - 400, 500 patients. Would that affect your thinking and strategy for your Phase 1 trial of this compound?

Mary Lynne Hedley

If what you are commenting on is the fact that Phase 1 trials are becoming much larger than the traditional, old approach, dose escalation, three-plus-three design, then yes, I think what people are deciding to do is to not close Phase 1 studies, but to continue them and amend them, so that you can continue to enroll patients. It's just logistically much faster to do it that way and cost less money, so that's why you end up with now what is more traditional actually, which is like the ALK TRK-011 approach we are taking, which is you start the front end with dose escalation. Then you move into cohort expansion, which allows you to test many populations within that Phase 1, and it really becomes sort of your signal seeking approach and that's why these Phase 1s start to get much larger, so we will take every measure that is appropriate to be able to develop our PD-1 antibody quickly and I anticipate that would mean a very cleverly designed Phase 1 that would include multiple expansion cohort, but that's just the guesstimate of course at this particular point in time in that particular guidance.

Operator

Thank you. Our next question comes from Peter Lawson from Mizuho Securities. Your line is now open. Please go ahead.

Peter Lawson - Mizuho Securities

Mary, congratulations on the COO role, I think getting back to Robin's question, PD-1 differentiation. Do you think 42 has to be identical or is there any forward differentiation molecule versus existing PD-1s and do you think differentiation is old rather guess. Is differentiation based around the patients selection and setting?

Mary Lynne Hedley

I think it's possible to have both. You know, I think, we have seen things in the some of the early data that led us to believe that we could potentially have differentiation. That view hasn't changed, but I think one has to be clever about how you develop and we would want to take all of the information at our disposal as we move into the Phase 1 trial to differentiate ourselves with respect to development.

Remember when our competitors started out their development program, which has been going on for several years now, they didn't have the benefit of all the knowledge they have today. Now, we have a lot of that benefit now from their work and so I think we will be able to really expedite the work in the PD-1 area.

Peter Lawson - Mizuho Securities

Then just on Niraparib. When is the next data we would see for that? Would that be Ewing's?

Mary Lynne Hedley

It's possible that Ewing's data can come out quickly. It really depends on, because it's a Phase 1 trial, right? Patients typically progress relatively quickly on Ewing's sarcoma, so it is possible that we could have data sooner than when we have it in the registration program. I guess, we could leave it at that.

Peter Lawson - Mizuho Securities

When do you think we should get Ewing's data?

Mary Lynne Hedley

Well, we have just enrolled our first patient, so I think you have to give us a little time.

Peter Lawson - Mizuho Securities

Okay. Then TIM-3, I guess the same kind of question, when do we see the first initial pre-clinical data?

Mary Lynne Hedley

At this point, pre-clinical data could be available at meetings, certainly. There has been some data already presented at the ACCR meeting, demonstrate that our TIM-3 antibodies that are being generated from this platform can in fact enhance the activity of PD-1 antibodies and to self-stimulation assays and that is in fact the assay that we utilize, we select the TIM-3 antibody, so additional supporting the selection of our particular candidate, you could expect to see in a medical meeting.

Peter Lawson - Mizuho Securities

Great. Thank you so much.

Mary Lynne Hedley

You are welcome.

Operator

Thank you. Our next question comes from Yaron Werber from Citi. Please go ahead.

Unidentified Analyst

Great. Thanks for taking the question. This is Christian for Yaron. My questions have already been answered, but just build upon some of the pervious questions. Can you speak a little bit about how your PD-1 is differentiated or how you think can maybe differentiated based on the pre-clinical data that you have seen.

Then second question is, can you speak to the rational for taking Niraparib into small-cell lung cancer? Thank you.

Mary Lynne Hedley

Sure. I would actually rather present our PD-1 data at a meeting than specifically refer to it right here. I don't want to lose that opportunity, but related to the small-cell lung cancer, the rational is that, and a lot of this data is published, but if you look at small-cell lung cancer cell lines and new inhibit PARP with siRNA. You see a significant proliferation of those cell lines.

Similarly, if we treat those cells with Niraparib, we can inhibit proliferation in those cell lines and also in tumor models, we see effects in small-cell lung cancer with Niraparib. In addition, if you look at the data from the Cancer Genome Atlas, you can see that there are a significant number of those patients.

As would be expected from the fact that about 80% are platinum-sensitive, so a significant number of those patients also have deficiencies in [combination], so all of that points to the fact that a PARP inhibitor would in fact be effective in that population, so that's some of the rationale that we are using for moving towards the indication.

Unidentified Analyst

Great. Thank you.

Mary Lynne Hedley

You are welcome.

Operator

Thank you. Our next question comes from Howard Liang from Leerink. Please go ahead.

Howard Liang - Leerink

Thanks very much. Congrats to you, Mary Lynne. Can you remind us the proportion of patients or Germline BRCA mutation versus non-mutation in the platinum-sensitive ovarian cancer patient?

Mary Lynne Hedley

Sure. I don't want to give our specific data at this point, but I will refer to the Letterman data, which suggested that the ratio between non-Germline BRCA and Germline BRCA was 60-40, and I would say that we are relatively consistent with that.

Howard Liang - Leerink

Okay. That was sort of the other group, the group with Germline mutation enrollment is relatively closed to the first group.

Mary Lynne Hedley

Well, we are not going to provide guidance related to that. I am just going to again, refer you back to the Letterman study.

Howard Liang - Leerink

Okay. For the TIM-3, I guess, my understanding is it's a difficult target to generate antibody. Again, does that mean - can you talk about for your candidate whether there is less affinity related to the other antibodies such as PD-1 body?

Mary Lynne Hedley

There is absolutely not lower affinity to our TIM-3 lead got to that matter relative to our PD-1, but you are correct. It is very difficult to generate and anit-TIM-3 antibody and that was precisely why we chose to do the deal with Anaptys.

Because of their ability to do affinity maturation in-vitro and have a selection process, which allowed for simultaneous selection of functionally active antibody as well as a very tight binder by core assays, this really speeds up the process that one have to go through to go through multiple rounds of selection to get the best antibody possible.

The other alternative you are looking at is my natural sort of approaches related to page display as an example or immunizing them out and relying on them to create an antibody. Frankly, might still create great antibody to TIM-3, so we believe that this collaboration with Anaptys has been a real very successful from our perspective. I think, from Anaptys perspective so far and all that we were hoping from them and from the collaboration has been completely realized at this point, so we are very pleased that their process and platform has been able to produce several antibodies for us.

Howard Liang - Leerink

Great. Should we assume that TIM-3 is about a quarter behind PD-1 in getting into permit?

Mary Lynne Hedley

Correct.

Howard Liang - Leerink

Okay, so early '16 I guess?

Mary Lynne Hedley

Yes. Sorry, - what year it is.

Howard Liang - Leerink

Last question on the sustained release TSR-011, what's the - advantage to be able to do QD dosing?

Mary Lynne Hedley

Yes. Actually, what we think is that, we will be - we believe going to the BID approach will allow us to achieve the plasma concentration that we achieved, about 240 milligram dose without having that Cmax, so it keeps the plasma exposure very flat, which is important, because as we pointed out that the DLT in this particular case is a key [T1], so it allows us to get to that exposure and that exposure produces very durable responses.

Just to give you an example of that does, we were able to achieve. We had two in particular actual ALK patients who were crizotinib resistant. They have been on crizotinib, one, for about two-and-a-half months. One for about seven-and-a-half months, and they are actually approaching their year anniversary on 011, so we are really pleased that the drug is doing what we thought it would do base on the pre-clinical data when we in-license since we really believe that the strong potency and selectivity of this compound will allow us to have very durable responses.

When you can take a crizotinib resistant patient, who had failed crizotinib about two-and-a-half months and have them on your drug for about a year, that's pretty profound, so that's why we are so bullish about this compound and about the potential for this compound not only in the ALK-positive patient, but in the TRK-positive patient as well, so that's why we are doing this work. I know it takes time, but we are putting this work in to identifying that optimal dosing regimen which will allow us to achieve that plasma concentration in a very tolerable way.

The adverse event profile from these patients compared to what you are seeing with other ALK inhibitors is nothing. I mean, there are very, very great one or great two events in these patients, so that's why we continue to remain very strongly positive on this compound.

Howard Liang - Leerink

If I could ask question on Rolapitant, did you had to have a pre-NDA meeting with agents. Do you assume nothing has change according to your plan?

Mary Lynne Hedley

We chose to have a pre-NDA meeting. You always want to make sure that you have that conversation in a way that you are presenting the data for the agency is the way that they anticipate seeing it. At this point, we are besides ramping up the final documents and we will be sending them to the publisher soon.

Howard Liang - Leerink

Thanks very much.

Lonnie Moulder

Thanks, Howard.

Operator

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

Chris Raymond - Robert Baird

Hi. Thanks. Just getting back to the Niraparib NOVA trial, so I understand sort of the dynamics here in terms of the interim look and you have been kind of deferring questions as to specifically what that threshold is, but for the Germline BRCA, mutated patient, but could you maybe give a little color?

When you think about once the non-Germline BRCA cohort is enrolled and you get to a -are allowed to take an interim look, is there just one threshold or there is there range? I understand you don't want to tell us what the PFS events are. What's the deciding factor here in terms of taking a look? Other than just enrolling the non-Germline BRCA patients?

Mary Lynne Hedley

Well, you obviously wouldn't want to - or maybe not obviously. I don't think, we would or we probably wouldn't want to take a look at the Germline BRCA until we have the non- Germline BRCA, right? It's not just the non- Germline BRCA enrollment, it's the data, right? We would probably want the PFS data from the non- Germline BRCA cohort as well.

If we feel, we can accelerate the program by taking a look at the Germline BRCA data, we will do that, but it really gets down to, do we think we could accelerate it without compromising it and it's always that play-off between those two things and that's why I am not maybe as specific as you would want to hear, because it's (Inaudible) of things that you look at any given time before you make that decision. Because once you make it, you obviously can't go backwards, so we will look at all kinds of factors intrinsic as well as extrinsic to make that decision.

Chris Raymond - Robert Baird

Okay. Good. Maybe more of an abstract question, but (Inaudible) sort of came in when and obviously this is a bit somewhat apples-to-oranges comparison, but are there any learnings that maybe you can walk through from that review process?

Mary Lynne Hedley

I guess, it was great to hear both, sides of the arguments, because whenever you do that, you always learn how to find a way to present any data that you have in a better way, right, because you know what the concerns of an audience will be. I think that there were certainly learings. We were pleased to hear from our perspective that the guidance of the agency provided at the meeting. He didn't specifically by posture was that our - I think, it's something I want to quote him, but he said something on the order of our guidance - the company or company is related to PFS hasn't changed.

I think, confirming what we have been saying, which this is a risk benefit argument related to PFS is an end point. I think the Adcom really confirmed that. That was an important thing from my perspective that people hear, so I wasn't surprised particularly by the outcome. We have had this conversation before. I would have probably tried it too if that was easy, but when you take the Phase 2 study and you have to do retrospective analysis, you can't predict where you lose randomization.

Even though the FDA couldn't identify, but the real specific about being able to identify a - lose randomization, the uncertainty behind whether you did was enough to want them to wait for that Phase 3 data, but there are little learnings in terms of how do you present and prepare and frame the story. I know they are always helpful, but the strongest message that came out of it is a confirmation that this is a risk benefit discussion and PFS is a viable end point.

I think that's what came out of it from my perspective at the end of the day.

Chris Raymond - Robert Baird

That's great. Thanks very much.

Mary Lynne Hedley

Welcome.

Operator

Thank you. Our next question comes from Nick Abbott from Bank of Montreal. Your line is now open. Please go ahead.

Nick Abbott - Bank of Montreal

Good afternoon and thanks for taking my question. Congrats Mary Lynne. Although given your list of responsibilities, I am not too sure I would like to be in your shoes, but never mind. I have to say, I must be having a stupid day, because now I am completely confused by precisely what's going to happen in NOVA.

I thought I heard that you, when you get to the requisite number of PFS events in the non- Germline BRCA, you can look at the Germline BRCA and the non-Germline BRCA data. Then if desired, you can look at the Germline BRCA.

Mary Lynne Hedley

That's correct.

Nick Abbott - Bank of Montreal

Maybe it's not such a stupid day. My question then is for the non- Germline BRCA, obviously you have got to look at methylation and a whole bunch of things by next-gen sequencing, are you doing that along the way or you are going to do that at the end? If you are going to do it in a batch mode at the end, how long does that take to process and analyze all that data?

Mary Lynne Hedley

Yes. I think you are referring to the fact that we have always talked about taking the non-Germline BRCA patient population and trying to understand is there a subset within that population that responds even better, right?

Nick Abbott - Bank of Montreal

Correct.

Mary Lynne Hedley

By respond, I mean, the PFS is even longer. We archive sample, so when the subjects come in, they have to sample those requisite and that's archived and we are working on collaborations with establishing collaborations with other companies that would be ready to test those samples immediately, so we wouldn't anticipate that the test that we are thinking about would take a huge amount of time, but I don't want - I mean, it's not half-a-year, let's just say.

Nick Abbott - Bank of Montreal

Right.

Mary Lynne Hedley

It's a reasonable period of time to be able to analyze all those samples, because you basically do it in batch and you could even do it at the same time as you are doing the PFS.

Nick Abbott - Bank of Montreal

I know you have already described a little bit of the ALK data. Is there anything else you can characterize in terms of 011 and ALK for example responses, patients with brain met or patients that have failed more than one ALK inhibitor?

Mary Lynne Hedley

I think at this point, we probably should just believe all the rest of that ALK TRK data to the next meeting.

Nick Abbott - Bank of Montreal

Sure. Okay.

Mary Lynne Hedley

Medical meeting.

Nick Abbott - Bank of Montreal

Yes. Just going back to PARP, one of the datasets I was particularly impressed with at ASCO was the combination with cediranib, which was a pretty horrible drug, but how do you view that data? Is that something that you would be looking to try and pursue the combination with a good VEGFR inhibitor?

Mary Lynne Hedley

I thought the data was very interesting, but I also view it with a bit of skepticism, simply because the analysis is done on less than 2,000 subjects in that at the end of the day, right? Very, very interesting and certainly something that would be of interest from my perspective anyway to continue to understand.

Nick Abbott - Bank of Montreal

Okay. Then just lastly in terms of Rolapitant, and there were a couple of sessions I attended at ASCO, where the Italians were talking about eating a boatload of dexamethasone everyday as that's all you need and a lot of concern about cost.

I know, Lonnie, you have described what your approach is going to be. Since you made those initial descriptions, I think, last year has there anything changed in that overall landscape that alters your approach?

Lonnie Moulder

No. Not at all, Nick. In fact, that same group has been talking about alternatives to

NK1 receptor antagonists for many, many years. For many years before that talked about alternatives to 5-HT3 receptor antagonist - that metoclopramide would be just as good.

Nick Abbott - Bank of Montreal

Yes.

Lonnie Moulder

Although, tolerate that and the issue with the more dexamethasone and this is the reality especially community oncology clinics. They give it on day one, but unlike the protocols that suggest multiple days the patients just have issues with it. Many patients have comorbidities, metabolic disorders diabetes et cetera and many, they can't sleep on multiple corticosteroid days of therapy. It has a stimulant effect. It's just uncomfortable, so the practices to give it on day one and mostly be done with it, so that's not at all an issue from our perspective.

Just in general if you look at the data that's been generated and published relative to Rolapitant, the data that's been generated and published on other NK1 receptor antagonists were every bit as bullish as we have ever been and as you know our strategy in many ways relates to getting the utilization of NK1 receptor antagonist up to what the guidelines suggest is appropriate to give these patients an opportunity to better tolerate their chemo.

Now have a large Phase 3 program. Our controlled arms tell you just how many patients aren't doing well when they are given even full dose dexamethasone in HT3 receptor antagonist, so it will be our job in combination with the relationships, the business relationships the contracting to really communicate the data, be part of the pathways that allow for these patients automatically receive the best possible care and to improve their overall chemotherapy experience, so we are enthusiastic get the NDA in, wrap up our pre-launch activities and get to the marketplace next year.

Nick Abbott - Bank of Montreal

Great. Thank you very much.

Operator

Thank you. This concludes the Q&A portion for today's call. I would now like to turn the call back over to Lonnie Moulder.

Lonnie Moulder

Thank you, operator, I will close the call with summary of our corporate objectives for the remainder of 2014.

As you heard, we plan to submit the NDA for Rolapitant to the U.S. FDA in approximately 6 weeks, advance the Rolapitant IV clinical program, continue to advance the Niraparib Phase 3 NOVA and BRAVO trials, continue patient enrollment in the combination trial of Niraparib and temozolomide in Ewing's sarcoma in partnership with SARC, execute on our plans for initiating new trials in Niraparib in small-cell lung cancer and first-line ovarian cancer, continue to evaluate activity of TSR-011 in ALK-positive and TRK-positive patients, advance the development of both, TSR-042, our anti-PD-1 antibody and our anti-TIM-3 antibody candidates and select an anti-LAG-3 antibody candidate by third quarter 2014.

We appreciate your interest today and thank you. Have a good evening

Operator

Thank you. This concludes the TESARO second quarter 2014 operating results conference call. Please disconnect at this time.

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