Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)  

TESARO, Inc. (NASDAQ:TSRO)

Q4 2013 Earnings Conference Call

February 19, 2014 4:15 PM ET

Executives

Jennifer Davis - Senior Director, Corporate Development and IR

Lonnie Moulder - CEO and Co-Founder

Ted English - SVP, Finance and Administration

Mary Lynne Hedley - President and Co-Founder

Analyst

Robyn Karnauskas - Deutsche Bank

Yaron Werber - Citigroup

Rich Goss - Leerink Partners

Laura Chico - Robert W. Baird

David Friedman - Morgan Stanley

Operator

Good afternoon and welcome to the TESARO Fourth Quarter 2013 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 fourth 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 fourth quarter and year-end 2013 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, 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 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 today. This afternoon, I’ll provide a brief overview of the progress we made during 2013 and our goals for 2014. Ted will discuss our financial results for the quarter and full year. Mary Lynne will provide an update on our rolapitant, niraparib and TSR-011 programs and finally I’ll spend some time discussing the commercial opportunities we see for rolapitant and niraparib. We’ll then open up the call for questions.

2013 was a pivotal year for TESARO marked by advancements in each of our three clinical programs. As you know, we reported successful top-line data for rolapitant from two completed Phase 3 trials. The product profile we now have in hand positions us well upon approval to penetrate the CINV market with a meaningful product for cancer patients and healthcare providers.

We initiated two Phase 3 trials for niraparib our PARP inhibitor just over 12 months after acquiring the program from Merck and we’re working alongside two leading organizations, ENGOT and BIG to advance those programs. We also partnered with SARC, the Sarcoma Alliance for Research through Collaboration to evaluate niraparib in patients with Ewing’s sarcoma in combination with temozolomide. Finally, we identified the dose that we believe is optimal for TSR-011 and are expanding our Phase 1 trial to further evaluate its activity in ALK-positive and TRK-positive patients.

As we look ahead to the rest of this year, we believe we’re well positioned to continue to advance and expand our pipeline. With the successful completion of a follow-on offering of common stock earlier this month that raised net proceeds of approximately $94 million and cash and cash equivalents totaling $130 million as of December 31, we’re well positioned to fund the rolapitant launch activities, support our development programs and execute in the business development arena.

Our key priorities for the rest of this year include, the NDA submission for oral rolapitant to the FDA, advancing IV rolapitant following dose selection, continued execution of the Phase 3 NOVA and BRAVO trials for niraparib, strategic evaluation of additional potential tumor targets for niraparib, presentations of new clinical data for rolapitant, niraparib and TSR-011, including the full pivotal dataset for rolapitant and further characterization of TSR-011 in ALK and TRK-positive patients. We will also continue to be active in evaluating additional in-licensing opportunities to expand our pipeline.

I’ll now turn the call over to Ted English to discuss our fourth quarter and 2013 financial results. Ted?

Ted English

Thank you, Lonnie. For the fourth quarter of 2013, TESARO reported a net loss of 23.3 million compared to a net loss of 18.7 million for the fourth quarter of 2012. This net loss was primarily driven by R&D expenses, which increased to 18.9 million for the fourth quarter of 2013 compared to 15.6 million for the comparable quarter of 2012. As a result of higher costs related to our expanded development activities.

General and administrative expenses increased 4.5 million for the fourth quarter 2013, compared to 2.1 million for the comparable period of 2012, 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 fourth quarter of 2013 was 2.7 million compared to 0.8 million for the fourth quarter of 2012.

Turning now to our full year results, TESARO reported a net loss of 92.4 million for 2013, compared to a net loss of 61.8 million for 2012. R&D expenses for 2013 increased to 75.7 million compared to 47.2 million in 2012, primarily as a result of higher cost related to our expanded development activities in niraparib and rolapitant.

General and administrative expenses increased to 14.8 million for 2013, compared to 6.7 million for 2012, primarily related to higher non-cash stock-based compensation expense, increased headcount and higher fees for professional services. Total non-cash stock-based compensation expense for 2013 increased to 7.8 million compared to 1.8 million for 2012. This increase was the result of overall growth in our organization and incremental expense associated with awards to our former CFO.

As Lonnie previously mentioned, TESARO had approximately 130 million in cash and cash equivalents as of December 31, 2013. This amount does not include approximately 94 million in net proceeds that we generated from a follow-on offering of 3.2 million shares of our common stock, we’ve completed earlier this month.

We anticipate that our current cash balance will be sufficient to fund our development programs and commercial operations through the rolapitant launch. For 2014, we expect our operating expenses and cash utilization to increase modestly over the course of the year as compared to average expense and cash utilization levels for the second half of 2013. These increases will be driven primarily by higher overall costs related to our ongoing clinical trials and development programs.

Specifically, we expect that R&D expenses will continue to increase as a result of our niraparib and TSR-011 programs, primarily driven by activities in support of the Phase 3 NOVA and BRAVO trials and our Phase 1/2 trial of TSR-011. And to a lesser extent advance with respect to our IV rolapitant program, we expect that these increases will be partially offset by lower costs associated with the oral rolapitant pivotal program.

And with that, I’ll turn the call over to Mary Lynn.

Mary Lynne Hedley

Thank you, Ted. We continued to make significant progress with each of our clinical candidates in the fourth quarter. I’ll now review the status of each of our programs and speak to our plans for 2014. Starting with rolapitant, as you know we’re currently conducting a pivotal program for oral rolapitant that will form the basis of our NDA submission. The program consists of three Phase 3 trials designed to evaluate the activity of rolapitant in preventing chemotherapy induced nausea and vomiting or CINV.

We announced in December that two of these Phase 3 studies, the Moderately Emetogenic Chemotherapy or MEC study, which primarily enrolled breast cancer patients receiving anthracycline/cyclophosphamide. And one cisplatin-based Highly Emetogenic Chemotherapy or HEC study was successfully completed. Each of these two trials achieved its primary endpoint.

The third Phase 3 study which is being conducted in patients who are receiving cisplatin is now more than 95% enrolled. We expect enrollment to complete shortly and as a result we plan to present the detailed results from each of these three rolapitant Phase 3 studies at ASCO. NDA preparations are underway and we remain o-track to submit the oral rolapitant NDA to the U.S. FDA in mid-2014.

The rolapitant IV formulation is being evaluated into dose finding and escalation study with the goal of identifying a dose that provides comparable exposure to the oral dose. Rolapitant is highly bio-available and as a result we believe the selected IV dose will be within 10% of the 200 milligram oral dose. We continue to expect that the IV formulation of rolapitant will be launched approximately one year after the oral becomes available.

Following completion of this ongoing study, we plan to compare the safety and exposure of IV rolapitant with the oral formulation in a subsequent bioequivalence clinical trial, with a goal of supporting the future submissions or registration following regulatory approval of the oral formulation of rolapitant.

I’ll now turn to our PARP inhibitor, niraparib. We’re pleased with the profile that we had seen for this candidate and believe the Phase 1 data described a potentially best-in-class product with durable responses and a favorable benefit risk profile. With a 75% research response rate at the Phase 3 dose among patients with platinum sensitive high grade serious ovarian cancer, a 46% research response rate across all dose levels and a 50% research response rate across all dose levels in patients with platinum sensitive ovarian cancer and germline BRCA mutations, we believe the data clearly supports our Phase 3 program design.

These responses were durable with a median duration of 431 days for platinum sensitive germline BRCA patients and 444 days for platinum sensitive patients who are not germline BRCA mutation carriers. Importantly, these results were achieved in a heavily pre-treated patient population. As expected for this class of molecule, Thrombocytopenia was identified as the dose limiting toxicity. As you know, we’re conducting two Phase 3 trials, the NOVA trial in patients with platinum sensitive relapsed ovarian cancer and the BRAVO trial, in patients with germline BRCA-positive breast cancer.

Both trials are evaluating continuous dosing of a daily 300 milligram oral dose of niraparib. We will enroll 350 patients at more than 100 centers in the NOVA study and we’re very pleased with the level of interest we are receiving in this trial from investigators and patients and with the pace of patients’ enrollment.

We have received Ministry of Health approval from 12 countries and continue to expand the trial geographically. Since the NOVA trial has been open to patients, enrollment has been tracking in line with our internal expectations. Ministry of Health approval has been obtained in the first seven countries for the BRAVO study. Several trial sites have been initiated and patients are actively being screened. We expect to initiate patient treatment shortly. In addition, our partners at SARC, the Sarcoma Alliance through Research and Collaboration are on-track to initiate the Phase 1 study of niraparib in combination with temozolomide in patients with Ewing's sarcoma by midyear.

Looking beyond breast and ovarian cancer, we see other potential opportunities that marry the valuation and we believe niraparib may have utility in a variety of tumor types. We are currently evaluating several options to expand our niraparib development program. There are a number of tumor types against which PARP inhibitors may have activity and we view niraparib as a portfolio opportunity for TESARO. Our strategy for niraparib will be driven by assessments of unmet need, the current standard of care and the potential use of a clinical or genetic marker to select patients for clinical trials.

For example, sensitivity the platinum can be a predictor of PARP inhibitor sensitivity. We have the opportunity to explore a maintenance setting in certain tumor types through which platinum is used to derive an initial response, because the number of courses of platinum that a patient can receive is limited by cumulative toxicity.

Small cell and non-small cell lung cancers maybe indications for which we could evaluate niraparib as a maintenance therapy. In addition, the ERCC-1 and other mutations found in certain non-small cell lung cancer tumors may inhibit DNA repair pathways and enable synthetic lethality or synergy with a PARP inhibitor. Gastric and prostate cancers also exhibit mutations that inhibit DNA repair pathways and could represent potential tumor targets for niraparib. We are also looking at ways to potentially combine a full dose of niraparib with lower doses of chemotherapy for certain tumor types and are evaluating the strategy for patients with Ewing's sarcoma in partnership with SARC.

I will now turn to TSR-011.

We presented the first clinical data from our ongoing Phase 1 study of TSR-011 at the European Cancer Congress or ECC in September and at the 15th World Conference on lung cancer in October. We have expanded our ongoing Phase 1 study to evaluate the clinical activity of TSR-011 in patients with ALK and TRK-positive tumors. We continue to evaluate 011 at 60 milligrams daily in an expanded Phase 1 cohort and have enrolled additional ALK-positive and TRK-positive patients. The 60 milligram dose is fractionated to provide more consistent plasma concentrations and exposure, which at steady state will be within the range that resulted in tumor growth inhibition in mouth ALK driven tumor models.

Importantly, the ALK-positive lung cancer patient who experienced RECIST partial response as a part of this trial maintained plasma concentrations of 011 within this range. We currently have dosed six patients with a fractionated dosing schedule and we are also developing a controlled release formulation of 011 in order to enable convenient dosing in future clinical trials.

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

Lonnie Moulder

Thank you, Mary Lynne. I’d like to spend a few minutes discussing the commercial opportunities for rolapitant and niraparib and our strategy for building the commercial infrastructure to support the rolapitant launch.

Rolapitant and niraparib will each address large market opportunities, have compelling revenue potential in gross margins and may be very meaningful for patients, healthcare providers and TESARO. We’re quite enthusiastic about the opportunities for both of these products, specifically regarding rolapitant we believe that the potential NK-1 receptor antagonist market equates to approximately $1.5 billion in the U.S. annually. By totaling all AC-based breast cancer regimen cycle initiation, a portion of the carboplatin-based treatment initiations and all cisplatin-based regimen initiations, we estimate that there are 5 million chemotherapy initiations annually that are appropriate for NK-1 utilization.

Our goal is to further penetrate this existing underserved market with a product that can make a meaningful difference for patients and providers. Importantly, the oncology practice guidelines established by NCCN and ASCO support significantly expanded use of NK-1 receptor antagonist for the prevention of CINV compared to current practice. Data indicates that less than 25% of this market is currently being penetrated.

With a profile characterized by a long half life and duration of action, a lack of CYP3A4 mediate drug interactions and the availability of a single oral and IV formulation that both potentially provide protection from CINV for full day after administration, we believe we’re well positioned to significantly expand this market, capture [indiscernible] there and provide value to patients and providers. We intend to leverage our knowledge, relationships and decades of experience in oncology and specifically the CINV category to make rolapitant a success and we look forward to sharing data from the rolapitant pivotal program at ASCO.

With Niraparib, we have the opportunity to introduce a new class of anticancer agents to the market. We believe that niraparib maybe a best-in-class PARP inhibitor. As Mary Lynne described, we’re taking a portfolio approach toward niraparib development and we’ll make strategic development decisions based upon genetic and clinical markers which can help to identify patients who maybe more likely to respond to therapy, we estimate that the market opportunity for niraparib for its first two potential indications will be approximately 10,000 ovarian patients and 10,000 BRCA-positive metastatic breast cancer patients in the United States at the time of launch with similar market sizes available in Europe.

We plan to launch rolapitant with a full commercial organization, including a full field sales force and appropriate medical science liaison, marketing, reimbursement and account team support. Based upon our past experience in launching oncology products in multiple markets, we intend to build and deploy a U.S. commercial organization of approximately 120 associates to support the rolapitant launch. We plan to hire the majority of this team as we get closer to the time of product launch.

Our commercial organization will be an asset that can generate significant leverage for TESARO. We intend to use this field team at the basis for all of our oncology product commercial launches going forward. 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. This factors in, the cost of product supply, our milestone of royalty obligations, expenses related to the commercial team and necessary marketing and promotional support spend and clearly represents an opportunity to drive value for the Company.

In summary, as we look out over the next 12 to 18 months, TESARO is well positioned to make the transition from the development stage to become a Company with wholly-integrated development and commercial capabilities. We have two Phase 3 product candidates that each address sizable market opportunity and our pipeline is characterized by differentiated candidates with potentially best-in-class profiles. Following the completion of our recent follow-on offering, we’re in a solid cash position. We intend to leverage our team’s experience by in-licensing, developing, and commercializing oncology products to create value for patients, healthcare providers and our shareholders.

Operator, at this point could we please pull for questions.

Question-and-Answer Session

Operator

Certainly. (Operator Instructions) Our first question comes from the line of Robyn Karnauskas from Deutsche Bank. Your question please.

Robyn Karnauskas - Deutsche Bank

Yes. Thanks for taking my question and for all the details in the slides. I guess first just one question on PARP, one on rolapitant. So for the PARP program you talked about maybe PARP -- peak opportunity in general for PARP which is 3 billion and then you outlined here the initial market, can you help us think about what are the things you’re looking for, for a go decision in the next tumor types. And how do we think about the big picture market opportunity for PARPs and how long it will take potentially to get there?

And then the question on rolapitant, when you’re thinking about hiring people, where do you initially put expertise as far as for the launch and where will your initial focus be for those reps and how much experience will you have had potentially with those reps in the past. I may assume that a lot of people maybe people you worked with before? Thanks.

Lonnie Moulder

Thanks, Robyn. I’ll start with the last part of your question or your second question. The first part of the launch really is more of a medical [indiscernible] support strategy. So the initial hires will be those people that are obviously involved with publication planning, continuing to interact with the key opinion leaders to KOLs in the field. And now that we have data generated from Phase 3 trials, taking that data out to our investigators and then the deployment of course of medical science liaisons in support of the rolapitant launch, but also in support of the overall pipe, so that comes first.

Although in parallel the senior leadership here continues to interact with the practice leaders of the largest networks, community oncology networks. So the dialogue continues so as we lead up the launch, we have an idea of what our business relationship will look like in a variety of areas, how we partner with all the services they provide, and then ultimately how we contract with them to drive volume of our product. So those are the initial activities and then as we get into next year, right, as the NDA is under review and things are progressing we start populating the organization with some key hires in sales and marketing and then, last quarter before launch is typically when we roll out the full sales force.

We’re able to hold off on some of that because we’ve done this several times before and as you mentioned there are a lot of relationships out there and people that we think would really enjoy the opportunity to build a company together with us and those people have experience in this field.

To your question about niraparib, Mary Lynne touched on that, I’ll turn it over to her in a minute, obviously some of the other tumor types we’re looking at are at least equal to or greater in potential patient size to the first two indications but the criteria as was mentioned to determine their type really is, are there tumors where there’s either clinical criteria or a marker based on science that could allow for selection of patients.

Robyn Karnauskas - Deutsche Bank

That’s helpful, thanks, and one quick follow-up, the data in ASCO and MASCC could there be any differences in the data that’s presented do you anticipate at this time, or could we learn more at the MASCC meeting versus ASCO?

Lonnie Moulder

I think that the pivotal data that you’ll see at ASCO forms a basis for what was submitted at MASCC so you would expect to see similar data sets.

Robyn Karnauskas - Deutsche Bank

Great, thank you.

Operator

Thank you. Our next question comes from the line of Yaron Werber from Citi. Your question please.

Yaron Werber - Citigroup

Hi. Thanks for taking my questions, so I think it’s for Mary Lynne, it’s -- the ongoing Phase 3 that’s 95% enrolled we’re going to get the data in Q2. Help us understand a little bit what do you know about the patient composition, I’m trying to get a sense of any salient differences between that study and the previous study. And sort of to try to calibrate what our expectations should be in terms of the placebo group and the control, and the active arm? And then I have a follow-up as well.

Mary Lynne Hedley

Yes, so as you know Yaron the trial design is similar, so where -- how could this study be different in terms of the overall populations, I think generally speaking you could expect similar tumor types as the majority of tumor types usually in Highly Emetogenic Chemotherapy or cisplatin-based trials are lung cancer patients and also urogenital tumors, head and neck tumors, those are, those usually form the bulk, so I think that will be similar. There might be variations in the number of males versus females in the trials, there might be variations, clearly there will be variations, from the graphical perspective but I think other than that, those are really the primary places where we might see a difference in terms of the demographics of the population.

Yaron Werber - Citigroup

Great. And then niraparib for the NOVA study and the breast cancer study, any sort of, I don’t know if you can share with us a little bit, when do you think you’d be able to finish enrollment in ovarian, is it sort of late next year and then what are you thinking on breast, is that early ’16? Does it sound reasonable?

Mary Lynne Hedley

We haven’t as you know we haven’t provided any guidance specifically about when we might complete enrollment and what we have directed people to do is look at the Letterman Study, Study 19, which was published in the New England journal, there they had 82 sites I believe and enrolled the study at 265 subjects in 16 months time. So what we’ve indicated is that we have 360 patients in over 100 centers that are enrolling in the NOVA study, the fundamental difference of course is that when they enroll the 265 subjects they didn’t select for germline BRCA, or non-germline BRCA alright, so we’re requiring 180 non-germline BRCA patients and similar population of germline BRCA, so you have to factor that in.

At ASCO, they reported that they just looked at that population of 265 because they had retrospectively analyzed the germline BRCA status of the patients at that point, it was about 60% of the patients that ended up being non-germline BRCA and 40% of the patients that ended up being -- 60% non-germline and 40% germline BRCA, so with all of those numbers you can kind of triangulate into what might seem reasonable and of course factoring in startup time in getting all the different countries up and running. But I think that will give you a reasonable way to estimate what enrollment could like.

Lonnie Moulder

Yaron, I think I heard you mention the end of next year and that’s clearly not the case.

Yaron Werber - Citigroup

Yes, probably mid next year is much more reasonable maybe data early ’16?

Lonnie Moulder

We’re not commenting.

Yaron Werber - Citigroup

Okay, thank you, I appreciate it.

Lonnie Moulder

Sure.

Operator

Thank you. Our next question comes from the line of Howard Liang from Leerink Partners. Your question please.

Rich Goss - Leerink Partners

Hi, this is Rich Goss calling in for Howard, thanks for taking my question. I was just wondering if you’d go into a bit more detail on potential in-licensing opportunities, specifically are you -- what are you focused on in terms of the stage of the asset and is it too soon to expect a transaction in 2014?

Mary Lynne Hedley

Our comment has always been that every 12 to 18 months we would intend to bring something in and that how we intend to grow the business at TESARO so our last product was brought in, in May 2012, so I think it would be reasonable to expect something this year. I think in terms of what we’re looking for specifically we don’t set a criteria for a stage of development. I mean the earliest we’ve tended to go is 18 months, 20 months from an IND and of course we’re open to commercial opportunities if those are reasonably priced to leverage what we believe will be a very efficient sales force. But floating in the middle is fair game at this point.

Rich Goss - Leerink Partners

Thank you.

Mary Lynne Hedley

Yes.

Operator

Thank you. Our next question comes from the line of Jim Birchenough from BMO. Your question please.

Unidentified Analyst

Hi. This is Nick standing in for Jim today. Couple of questions on the TSR compound, I think your call at ESMO there was a QT signal for the 6 patients you dosed with a fractionated 60 milligrams, is that now avoided this QT signal?

Mary Lynne Hedley

Yes, in fact just to remind you that QT signal was seen at 480 milligrams so that was the DLT. We also did see a slight signal at 320. So the fractionated dosing is designed to minimize the Cmax which is typically associated with QT prolongation, bearing in mind any potential for drug interactions or variability, again thinking towards ultimately a registration type study we want to position the drug as best we can right now. So we would want to minimize Cmax and maximize Cmin, right and by doing that we can keep the exposure of the drug in the range that has led to significant tumor reduction in animals and also produce recessed clinical response.

So that’s the goal. We have now dosed patients three at each of the two fractionations that we were looking at and we should have PK data from those patients in the spring time so that will give us a sense of if we are achieving the plasma concentrations we set out to achieve but we are not seeing QT signals at those doses.

Unidentified Analyst

And as you think about further development of this compound do you see yourself moving ahead in ALK as well as TRK or focusing on one of those targets first?

Mary Lynne Hedley

We are rolling ALK and TRK patients in the clinical study currently, and you know our intent is to be able to demonstrate or show or determine if one could demonstrate that having a very potent TRK inhibitor can result in tumor shrinkage and patients who have TRK fusions and or TRK mutations and over expression, so as soon as we have that clinical signal we would of course be interested in following it further and initiation of clinical studies that are specifically focused on patients who have TRK.

Unidentified Analyst

Okay. And just very quickly in terms of the flow release formulation, do you have a candidate ready for the clinic, what’s the timing for that?

Mary Lynne Hedley

We actually have three prototypes already created and the intent would be to initiate at least one of those -- we want to narrow them down in terms of what we stick into the clinic just to maximize efficiency but we would anticipate introducing at least one of those into the clinic this year.

Unidentified Analyst

Okay, thank you very much.

Mary Lynne Hedley

You’re welcome.

Operator

Thank you. Our next question comes from the line of Laura Chico from Robert W. Baird. Your question please.

Laura Chico - Robert W. Baird

Everyone, thank you for taking my call, just two quick questions, Mary, when you gave some great color in terms of the ovarian cancer trial for niraparib using the Letterman Study as a proxy, I was just wondering is there a suitable proxy we can use for the BRAVO trials?

Mary Lynne Hedley

There is not as -- well the Letterman Study is perfect, right, because it’s the exact patient population et cetera so no there isn't one that is as quite as perfect. But we think of them in terms of similar patient size so we use this internally we are using the same per patient, per site, per month estimate for the germline BRCA ovarian and germline BRCA breast.

Laura Chico - Robert W. Baird

Okay, that’s helpful. And I guess one other question I am not sure if this is already asked, but in terms of what to anticipate for ASCO outside of rolapitant I know you mentioned niraparib and TSR-011 should we be expecting incremental data on either of those programs there?

Mary Lynne Hedley

I think from a clinical perspective you should look more for lung and [indiscernible] for 011 and any potential update from PARP would be coming from our Phase 3 studies this year, but -- so I think clinically we might be able to get something then related to the sarcoma study, but it’s still early days.

Laura Chico - Robert W. Baird

Okay, thank you very much.

Mary Lynne Hedley

You’re welcome.

Operator

Thank you. (Operator Instructions) Our next question comes from the line of David Friedman from Morgan Stanley. Your question please.

David Friedman - Morgan Stanley

Thanks for taking the question. It's just on the 011 compound, in terms of TRK, can you just describe sort of the current state of diagnostics and is this something that is broadly tested for or something more, in an academic setting, and is this something that you also require a piece of tissue for? Can it be done with something like a brushing or a fine needle aspirate? Thanks.

Mary Lynne Hedley

Okay. So that's a lot of questions. Tell me if I get them all. Al right, so the TRK is not generally being screened for, for example in the community. Universities or academic institutions that have arrangements or are just by default and even some community oncology organizations are starting to sequence tumors and for those organizations they would be aware, obviously of patients who present with TRK fusion so -- or TRK point mutation and so you can get if you're running clinical trials referrals from those types of institutions.

We actually have developed our own TRK diagnostic with a partner and we are using that to help us in our screening effort, so in terms of the ways that one could go about doing this with tissue or aspirates would be immunohistochemistry, FISH analysis and then of course I mentioned sequencing, so those would be three pretty standard ways to screen for TRK patients at this point in time.

David Friedman - Morgan Stanley

And just quickly the diagnostic that you guys have developed, is that something that would be patented and used exclusively during your development or is this something where it would be used more broadly for anyone else developing in the space? Thanks.

Mary Lynne Hedley

Currently it is exclusive to us.

David Friedman - Morgan Stanley

Alright, thank you.

Mary Lynne Hedley

Yes.

Lonnie Moulder

Thanks David.

Operator

Thank you. We’ll take one final question. And our final question comes from the line of Eric Criscuolo from Mizuho. Your question please.

Eric Criscuolo - Mizuho Securities

Thank you for taking my question, just filling in for Peter Lawson tonight. I guess on the rolapitant IV bioequivalent study, approximately how long would that be expected to take?

Mary Lynne Hedley

So these are typically done in healthy volunteers at Phase 1 units and traditionally with the number of subjects that we’re thinking these are studies that take some start to finish, finish meaning clinical study report six to nine months.

Eric Criscuolo - Mizuho Securities

Okay. And would it begin right after that dose is identified?

Mary Lynne Hedley

Yes. So the plan is to do the single ascending dose which is done now at this point, identify the dose to move forward into the bioequivalent study. Also as part of that clinical study is what we call MAD study or Multiple Ascending Dose study and there what you’re doing is we’re testing 10 daily consecutive doses of rolapitant and the purpose there is to gather safety data because as you know chemotherapy patients receive multiple cycles of chemotherapy so this just compresses that safety into 10 consecutive days of dosing.

So that SAD data plus the MAD data will be obviously important in terms of determining the dose to move forward in the bioequivalence but also just providing some safety information. And once we have that MAD data would be when we would initiate the -- and have a conversation with FDA very importantly would then be to have to initiate that study the final bioequivalent study.

Eric Criscuolo - Mizuho Securities

Got you, okay. Thanks for that color, it helps. And I guess…

Mary Lynne Hedley

I’m sorry Eric…

Lonnie Moulder

Just to add a comment I think you probably recall that the plan is and we stated this earlier that with the approval of the oral that’s when the IV is submitted so you can imagine based on the timing that Mary Lynne gave you there is quite a bit of time here so we have to have that package ready especially oral to reference drug it gets approved and then sometime thereafter the IV goes in. So we anticipate the IV will be approved about one year after the oral.

Eric Criscuolo - Mizuho Securities

Got you and thanks for the clarification there, and if I can just on TSR-011, how many clinical trials are ongoing right now or are right about to be initiated in that compound?

Mary Lynne Hedley

There is just one trial ongoing, the way that we designed it allowed us the flexibility to essentially start with the dose escalation then go into the Phase 1 expansion where we’re testing this fractionated dosing and then once we have that identified and have the preliminary read on the extended release formulations then we’ll do the three parallel cohorts of the ALK inhibitor naive patients, the ALK inhibitor resistant patients and TRK patients. But today we’re still enrolling those three groups of patients or just pulling them altogether at this point. Does that make sense?

Eric Criscuolo - Mizuho Securities

Yes, it does. Thank you. And then just lastly if I can on the licensing and acquisition front would you consider acquiring a diagnostic asset or is your focus just going to be on therapeutic assets?

Lonnie Moulder

Therapeutics.

Eric Criscuolo - Mizuho Securities

Great, thank you.

Operator

Thank you. I will now turn the call back over to Lonnie Moulder.

Lonnie Moulder

Thank you everyone, I’ll close with a brief summary of our corporate objectives for 2014. We plan to complete the third and final Phase 3 trial of rolapitant, advance the rolapitant IV clinical program, present additional clinical data at ASCO, MASCC and ESMO for our product candidates including a presentation of the full data for all three trials of oral rolapitant at ASCO. Submit the NDA for oral rolapitant to the U.S. FDA in mid-2014, continue to advance the niraparib Phase 3 NOVA and BRAVO trials, initiate the trial in Ewing’s sarcoma and partnership with SARC midyear, define our strategy for niraparib development in additional tumor types identifying optimal dose schedule for TSR-011 and continue to evaluate 011 in ALK-positive and TRK-positive patients.

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

Operator

Thank you. This concludes the TESARO fourth quarter 2013 operating results conference call. You may disconnect at this time.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: TESARO's CEO Discusses Q4 2013 Results - Earnings Call Transcript
This Transcript
All Transcripts