ImmunoGen Inc (IMGN) 2013 Q2 法說會逐字稿

Good day and welcome, everyone, to the ImmunoGen Second Quarter Fiscal Year 2013 Financial Results Conference Call. Today's call is being recorded. At this time, for opening remarks and introductions, I would like to turn the call over to Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Good morning. At 6.30 this morning, we issued a press release that summarizes our financial results for the second quarter ended December 31, 2012, the second quarter of our fiscal year. I hope you've all had a chance to read it. If not, it's available on our website. During today's, call we will make forward-looking statements. Our actual results may differ materially from such statements.

Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings, which also can be accessed through our website. In our call today, our Chief Executive Officer, Dan Junius, will provide an update on ImmunoGen and our Chief Financial Officer, Greg Perry, will discuss our financial results and guidance. We'll then open the call to questions. Our Chief Development Officer, Dr. Charlie Morris, is here with us for the Q & A section of the call. Dan?

Thank you, Carol, and good morning, everyone. We look for 2013 to be a very important year for ImmunoGen. Certainly, for TDM-1, there are a number of significant events anticipated that would start with the approval and launch in the US sometime around or hopefully before the February 26 PDUFA date. We also look to see approval in Europe and launches to begin there over the course of this year, as well as the continued advancement of their clinical programs across a range of indications and expansion into some additional areas that they've announced in terms of early breast cancer.

At the same time, we're looking for marked progress across our wholly owned pipeline. Over the course of the year, we plan to have clinical findings in each of our three lead TAP compounds and we're also preparing to advance a fourth, IMGN289, to IND and then into the clinic later this year. While we expect T-DM1 to provide a significant revenue stream to ImmunoGen, we believe our own programs offer the greatest long-term value for shareholders and therefore, my comments today will focus on our wholly owned programs. Before I get to that, though, I'd like to comment on an organization event since our last call. As noted earlier, our proprietary programs are expected to generate important data over the course of this year.

With this in mind, we established a new position of Chief Development Officer to expand ImmunoGen's skill set and knowledge base and to provide leadership to our expanding development activities. We're very pleased to have Dr. Charlie Morris now with us in this role. Charlie, who, over his career, has been in senior medical research and development roles with Allos, Cephalon, and AstraZeneca, strengthens our existing capabilities through his understanding and experience in late-stage development and registration strategy. We look forward to Charlie's contributions in this new position.

Let me now turn to our wholly owned compounds and I'll start with IMGN901, which is for CD56+ cancers. This would include a number of cancers, including small cell lung cancer, the majority of multiple myeloma cases, Merkel cell carcinoma, neuroendocrine tumors, other hematologic diseases; so CD56 is broadly expressed in a wide range of indications.

Currently, it is in Phase II testing for first line treatment of small cell lung cancer in our NORTH trial and I'd like to update you on that study. Patient enrollment's underway at about 40 centers in the US, Canada, UK, and Spain. I'm pleased to report that we're very close to completing enrollment of the first 59 patients. These patients will represent the first stage in what is a Simon two-stage design and we will follow-up with this group as a cohort with the end point of PFS at six months.

We expect to have this data in the back half of 2013. This will allow us time to complete enrollment of these patients, then follow them for six months and clean up and lock the database. We'll report whether the trial met our pre-defined hurdle for the first 59 patients and that data and the endpoint will enable us to make certain development decisions, particularly in the area of CMC, but also, it will enable us to seek further KOL input and begin discussions with regulatory agencies. Our intention is to report the data at a medical conference.

While we're looking at the first 59 patients, we'll continue to enroll the full 120 patients in this study and we'd expect to complete that enrollment over the course of 2013. If we can get that accomplished, we would then look to present the results from the full trial in 2014 and we're tentatively targeting ASCO.

While we're making progress in our small cell study, we recently reported data in an oral presentation at ASH on a multiple myeloma study that we had undertaken.

This is a Phase I trial assessing IMGN901 used in combination with Revlimid and dexamethasone in patients with CD56+ disease who are relapsed or relapsed refractory to earlier therapies. We were encouraged to see activity in patients previously treated with Revlimid, including in Revlimid-refractory patients with a good tolerability profile. While we don't plan to pursue this indication at this time, the data generated will be important as we evaluate long-term development options for IMGN901.

Let me now go to IMGN853. This is a TAP compound for cancers that overexpress the folate receptor 1 and this would predominantly be ovarian and non-small cell lung cancers. Here, we're making good progress as well. We have a protocol that allows us to have single patient cohorts at lower dose levels. This has enabled us to move through these lower dose levels quickly and we're now in a position to be assessing the compound at higher dose levels. We're planning to submit an abstract to ASCO, where we would report our first clinical data on this compound.

Our last clinical compound is IMGN529. This targets CD37, which is found on B-cell malignancies, so at this point in time, it's in Phase I testing for non-Hodgkin's lymphoma. With CD37 as the target, chronic lymphoblastic leukemia is also a potential opportunity. We believe there's a strong rationale for 529 in that it's highly differentiated from other agents in the clinic for NHL, including other ADCs. This is because we have an antibody here that's been selected for its pronounced anti-cancer activity in pre-clinical tests, and to that we've added our ADC technology using DM1 as a cytotoxin for IMGN529. Enrollment and progress in this trial has been a little bit slower, in part due to the need to start at lower dose levels; however, we still plan to report our first data in 2013, most likely at ASH.

Lastly, let me mention IMGN529. This is a TAP compound we've developed for cancers that overexpress EGFR; that would include squamous head and neck cancer, and non-small cell lung cancer. For IMGN529, an antibody that we developed ourselves and we've added to that again the DM1 as the cytotoxin. Within the construct, the antibody itself has anti-cancer activity that provides the capability for EGFR inhibition, but by bringing DM1 into the picture, we've now provided a second mechanism for cell killing. This contrasts with current compounds that target EGFR, whose sole mechanism of action is EGFR inhibition, and therefore, they don't address the issue of potential resistance.

The conjugate that we're taking into pre-clinical testing, the IMGN289, has greater potency than naked EGFR-binding antibodies and it has activity against tumors that are resistant to EGFR inhibition. At the same time, we've been able to select an antibody that has shown, pre-clinically, to have tolerability similar to T-DM1, in that we found an antibody that doesn't manifest the skin toxicity seen with an agent such as Erbitux. Our plan is to report clinical data at AACR in April on 289 and then we have a development plan to submit the IND in mid-year that would allow us to begin patient dosing later in 2013. With that, let me turn it over to Greg to walk you through the financials for the quarter.

Thanks, Dan. Let me walk you through the press release. Our net loss for the second quarter of fiscal year 2013 was $24.4 million or $0.29 per share and that compares to a net loss of $12.8 million or $0.17 per share for the same quarter last year. Revenues for our second quarter were $2.6 million as compared to $7.6 million for the same quarter last year. License and milestone fees overall were $400,000 in the current quarter compared to $6 million last year. The previous period includes $5 million in milestone payments earned with three product achievements by our partners that were not repeated in the current quarter.

Revenues for the second quarter of fiscal '13 also include $2 million from Research and Development support fees compared to $900,000 last year and $100,000 of clinical material reimbursement compared to $600,000 in the same quarter last year. Revenue can vary significantly by quarter depending on the work we're doing to support our partner programs, as well as the timing and progress partners are making with their programs.

Our operating expenses for the second quarter of this fiscal year were $27.1 million compared to $20.4 million for the same quarter last year. In the current quarter, expenses include $21.7 million of R&D expense compared to $15.6 million last year. The increase is primarily due to greater investment to advance our wholly owned product candidates and that includes increased third party costs to produce antibody fees and clinical materials, increased clinical trial costs, and increased personnel expenses. Our second quarter expenses also include general and administrative expenses totaling $5.5 million and that compares to $4.8 million in the same quarter last year. This increase primarily reflects increased patent costs and recruitment costs. Cash used in operations for the first half of our 2013 year was $42.7 million compared to $24 million for the same period last year, reflecting increased cash used to fund our net loss. Our capital expenditures were $2 million.

Our guidance for our full 2013 fiscal year is unchanged from our last quarterly call and we project that our net loss for our fiscal year ending June 30, 2013 will be between $70 million and $74 million and net cash used in operations will be between $78 million and $82 million. In capital expenditures, we expect to be between $4 million and $5 million.

As you'll note, we're guiding to a full year net loss that is below what you would estimate by just extrapolating our first half net loss. That's primarily because we're expecting significantly higher revenues in the second half of fiscal '13 primarily from an expected $10.5 million milestone due with a T-DM1 approval in the US, as well as other partner-related events that trigger either recognition of deferred revenue or a milestone. While there's always a risk with predicting the timing of partner-related events, at this time, we feel comfortable leaving our guidance as is.

As a reminder, these projections don't include the $5 million milestone we earn with T-DM1 approval in Europe, as we're projecting this to occur after the end of our fiscal year in June. We also haven't included T-DM1 royalties in these projections, as we expect these will be reported one quarter in arrears and to be at earlier stage when our fiscal year ends in June. Of note, we believe our current cash position combined with the expected revenues from T-DM1 will be sufficient to advance our three compounds, 901, 853, and 529 to proof of concept. We believe demonstration of proof of concept with a wholly-owned ImmunoGen product candidate will be an important value inflection point for the Company. Dan?

Thank you, Greg. Let me then just summarize what we expect to see taking place for the various compounds over the course of 2013. We would expect with IMGN853 to have the first clinical data reported in the second quarter of this year; with IMGN901, we would expect the first Phase II readout to occur sometime in the second half; and for IMGN529, we look to have the first clinical data in the fourth quarter of this year. For 289, the pre-clinical data should be available at AACR, which would be in April, and then the IND would become active sometime just after the middle of this year.

Looking at partner compounds and starting with T-DM1 for metastatic HER2+ breast cancer patients who had previously been treated with Herceptin, we would look for US approval early this year and then EU approval sometime in the back half of 2013. For early HER2+ breast cancer, there are three registration trials that are scheduled to start over the course of 2013, some of them in the earlier part of 2013, and we would expect to see enrollment continue in second line HER2+ gastric cancer, a study that was initiated last year.

I should also remind you that we have seven other partner compounds in the clinic; two of those have reported data thus far. We would look to see further information on those two compounds, as well as see the first data on the other five compounds that our partners are advancing in the clinic. We would look to see one partner compound moving to pivotal testing over the course of 2013.

That's our picture as we come out of our December quarter. Let me turn it over to Carol and we'd be happy to respond to your questions.

Great. Thanks, Dan. We're about to open the call to questions. We ask that these be limited to one to two questions per person until each analyst has had a chance to ask questions. Operator, we're now ready to open the lines.

(Operator Instructions) Simos Simeonidis, Cowen and Company.

The first question has to do with the proposed label in the US. Can you give us any color based on your discussions with Roche and their discussions with FDA? What's your expectation for label? Will you be able to treat patients that are essentially first line in addition to second line?

Simos, our read is really based on the design of the study and the request, the submission by Roche as opposed to any further discussions with them. Given that this study included patients who had received -- whose disease had advanced on Herceptin in the adjuvant setting, and therefore were first line metastatic patients -- and there were, I think, about 15% of the patients in the study that represented that particular profile -- it would seem logical that that would be in the label. But I think we have to see how the process goes between Roche and the FDA and ultimately what they determine.

Okay. My second question is on the commercial front, do you have an idea how quickly post-approval they can launch, meaning the next day, a few weeks after? In terms of the sales force they'll be using, I assume it's going to be the same sales force that's detailing the other products, including Herceptin, Xeloda, Perjeta. Do you have any color on that?

No color from a commercial standpoint. My assumption would be the same as yours. We do have some insight into their preparedness on the CMC side and I can't imagine that there would be any obstacles there.

So you would assume that they would be able to go right away?

That would certainly be my expectation, absolutely.

Okay, great. Thank you for taking the questions.

Ryan Martins, Lazard Capital Markets.

Firstly, on 901, Dan, can you remind us again the rationale for looking at the PFS at six months and make CMC decisions off that? What kind of (inaudible) we may have for the final data from the Stage II of that trial?

This is Charlie. Yes, the study's been designed based on historical data which, in some of the largest studies, shows a medium PFS around 5.5 months. We've got a pretty good handle on what we think the PFS should be in this type of population. I think as a result of that, that gives us the ability to really be able to put the data in light of what is known from the historic data, plus also having the control arm in there to make sure that we are consistent with those data.

I think any study which comes in the Phase III setting is almost never to be -- going to have overall survival and time to event endpoint, so I think basing this off of the time to event endpoint makes a lot of sense at this particular stage. I'm sorry, could you remind me what the second part of the question was?

It was just what kind of implications the data would have for your final readout from Stage II?

Yes, I think depending on what the data looked like at the first point, obviously that may be an inflection point upon which to base some important decisions in terms of CMC and regulatory consultation, as well as (inaudible) feedback. But then, obviously, by the time we'd be in a position to finalize the design and start a Phase III, we would have the final data from a larger group of patients to further inform the study design and really to check that certainty of the assumptions that we've put together made sense.

Okay. Maybe on 289, I think Dan mentioned that you have some activity against the EGFR-resistant tumors. Have you seen specific activity against the T7090M mutation? Should we see some of this data at the AACR?

First off, we don't want to get ahead of data that we would have at AACR, Ryan, so why don't we hold off on that? We'll have several posters dealing with safety, dealing with activity, and so I think we would want to wait until we have that data at AACR.

Okay, thanks.

Ling Wang, Summer Street Research Partners.

So for IMGN853, can you give us more details about how many patients have been dosed and what are the doses has been up to?

It's Charlie again. I don't think it's necessarily going to be helpful to get into the precise details of number of patients at this point, but I think it's enough to say that we are pleased with the progress of the trial. We've been recruiting to the type of schedule that we were hopeful for from the beginning, and therefore, we remain highly optimistic that we will be able to provide some updated clinical information at conferences during this year.

I see. By ASCO, should we see the therapeutic dose? Do you expect we could see that from the therapeutic dose of this compound?

I would be hopeful that is the case, but obviously, as the conference comes around we shall know more. But we'd be optimistic that that would be the case.

Okay, thank you.

Joel Sendek, Stifel Nicolaus.

On 901, first, you mentioned the 5.5 months. I'm wondering what kind of a delta over that you would need to see in order to be encouraged by that. Then on 289, I'm wondering if you can give more background as to why you're not -- or maybe if you might consider moving the naked antibody forward?

What was the rest of that on 289, Joel?

Yes, I'm just wondering, it seems like you've seen activity as a naked antibody; maybe that might be worthwhile looking into as well as the conjugated version. I'm wondering what the thought process was.

In terms of 901, we haven't disclosed thresholds there. We did -- as we developed the study design, there was a dialogue with KOLs to determine what would be an appropriate hurdle to be interesting. You heard Charlie go through some of the discussion around what we were looking at for endpoints. That first endpoint, or the interim, I should say, with PFS at six months will allow us to make some incremental financial decisions on top of what we've already been doing to have material available for later stage studies. But the actual -- we haven't disclosed the detail of what the specific threshold is, but we're looking for a meaningful increment for durability, not for response rates. Because as -- I think as you know, patients do respond well to existing first line therapy.

As it relates to 289, maybe there's a little bit of an open question. We may consider that. I think that we're most interested, at this point, in taking the conjugate forward, and there may be avenues to pursue it beyond some of the indications that we're already looking at, given the activity of the antibody as a naked agent. But right now, our focus is on advancing the ADC.

Okay, thank you.

Marshall Urist, Morgan Stanley.

Two from me. First, just on 901, can you just give a little bit more detail on the disclosure plans for that interim analysis? Are you going to tell us what the six-month PFS rate was or just kind of talk about it met our hurdle and we're going on to the whole study? Just a little bit more detail there would be helpful. If you could remind us in small cell historically, what's your view of the correlation between PFS and OS benefits from historical trials, particularly for targeted agents versus chemo?

Just to follow-up on the one question on the folate program, would you expect to have a significant number of lung and ovarian patients in the early dose escalation to give us a sense of activity in those key two indications? Thanks.

Okay, it's Charlie again. From 901 perspective, at the interim point, I think the disclosure will simply be whether or not we made our pre-defined hurdle. Obviously, our level of optimism based on the exact numbers will depend on the data as we see them, but the intended disclosure will just be whether we crossed that hurdle.

In terms of PFS versus OS, it's always a difficult conversation. I think, though, that we do know that there are very few drugs which have been shown to significantly impact overall survival in the second and subsequent lines in small cell lung cancer.

I think if a drug can have a significant impact on progression-free survival, particularly given that we have something very specifically targeted, CD56, as you know, extensively expressed in small cell lung cancer, and we're following on from what the pre-clinical data has shown us, I think that combined with a positive outcome from this Phase II study would greatly encourage us to be going forward.

I think the final thing is, in terms of the folate study, the 853 study, we are certainly hopeful to include a number of patients with lung and ovarian, both through the Phase I dose escalation and then also into the dose expansion, where there'll be cohorts of patients with non-small cell lung cancer and two cohorts of ovarian cancers. Obviously, those clinical data -- and we'll be able to see that mix of patients when we provide those data at a conference during this year.

Marshall, the one comment I'd add beyond the disclosure that Charlie referenced, we would expect that we would have the data itself for the interim patient population at a medical conference following our -- once the data is available. It's just not clear what that timetable would be; so the disclosure would sort of come in two steps.

Great, thank you.

Matthew Harrison, UBS.

Two questions. First just on guidance, just so I understand, because we've seen -- or we have a better idea of the run rates now on expenses. Do those run rates make sense and so we should imply the kind of revenue that you're thinking about to get to your net loss guidance? Or should we expect to see R&D go up or go down for the rest of your fiscal year?

The second is on 901. I guess the question is why won't you disclose what the hurdle is that you're looking for? Maybe as a follow-up to that, can you talk about what -- if you hit that hurdle, you said there will be some open questions that you'll be able to better think about in terms of how to design a larger study, so maybe if you could just let us know sort of what those open questions are. Thanks.

Thanks, Matthew. First, on the guidance, yes, I think on the expense side, we're continuing to invest in preparedness for pivotal materials in 901 and 853. So I'd expect back half expenses to be higher as those plans continue to progress, as well as clinical trial-associated costs. We are adding personnel to support partners, which are then built out in terms of revenue, as well as to support our advancing programs in clinical pipelines. So I'd expect back half expenses to be somewhat higher than front half, and then I think the revenue then solves the equation for you.

Thanks.

It's Dan, Matthew, on the hurdle question. The hurdle, the way the study is designed, the study, because as it's Simon 2 stage, it's really set up as a futility study. So really the interim is intended to directly tell us whether we should continue this study or not. We're going to continue to enroll patients, so we're not going to utilize that particular dimension. And the hurdle is really set up for the data from the full study, so we would be looking off of the full 120 to have the threshold that's there.

It would be -- obviously, we'll be looking at what we see off of the 59 patients and extrapolating into what that would project for the full 120. We just think that because once we have the full data set, obviously there will be a hurdle -- we'll be looking at not just PFS, but at OS and a number of other dimensions that it does get to be -- that's somewhat judgmental in looking at the data in aggregate as opposed to telling you there is this single data point off of the full data set. But with the interim, we'll have a decision to make, as I said, that will involve incremental spending, and we will make that decision one way or another and then have the data to disclose, as I said, at a subsequent medical conference.

Okay, thanks.

Adnan Butt, RBC Capital Markets.

First, a bigger picture question -- what's the difference between DM4 and DM1 and how do you select which one to prepare the antibody with? Secondly, for 853 specifically, do you expect to show activity maybe middle of the year at ASCO or something? How long will patients be dosed for and what would next steps be for 853?

Let me maybe deal with the first one, and then Charlie may want to comment on, again, on 853, although I may have to ask you to repeat the question. It didn't come through that well. In DM1 and DM4, I think, as you know, both tubulin inhibitors, the cytotoxin itself is -- they both are comparable in terms of potency.

They can be used with different linkers and in some ways, the combination of cytotoxin and linkers is somewhat more defining than differences in the inherent molecule DM1 versus DM4 itself. In certain configurations, we can make DM1 into a cleavable cytotoxin in terms of how it's released within the cell and then the attributes that it would have subsequently. In other cases, we can have it be non-cleavable.

We find in looking at them pre-clinically and even in the clinic, there are somewhat different profiles that we see. DM4 is in the clinic with Sanofi with SAR3419, so they do manifest in somewhat different ways. But inherently, they both convey the same property as an antimitotic and have comparable potencies. It's, again, which can be used with which linker and what you end up with the end result there. Maybe you can repeat the 853 question, Adnan.

Sure. Firstly, what's the toxin for 853? Secondly, do you think there might be activity data at ASCO, perhaps? How long will patients have had the treatment in -- well, the different patient sub-types, ovarian or non-small cell lung cancer?

With 853 -- this is Dan -- again, getting back to your question that actually is DM4, but maybe it links into the response I had. Here, we have a new linker. This is the first time we've taken this linker into the clinic. We refer to it as sulfo-SPDB-DM4, with sulfo-SPDB as the linker. As we've talked in other forums, that particular linker has properties that allows the metabolite, the cytotoxin with elements of the linker that remain attached, to counter multi-drug resistance; the efflux mechanism, specifically. Here, you do have an example, we've used a different cytotoxin; DM4 happens to marry well with the sulfo-SPDB-DM4 -- sulfo-SPD configuration. Charlie, you may want to comment then on --.

Right, for the second part of the question, I apologize. It didn't come through terribly clearly again.

No, not at all. Do you think 853, we might be able to see some signs of activity at ASCO?

Certainly, our hope would be that would be a possibility, yes. As I've said to the previous question, we are encouraged by the rate of recruitment into the study. We believe that we're getting close to what should be the therapeutic range and we are obviously trying to encourage the patients most likely to have an opportunity to respond to the treatment to enter onto the study. Obviously, the duration of exposure will be dependent upon activity and the patient and the disease characteristics themselves, but clearly, the intention is to provide clinical data, meaningful clinical data, when we first disclose that information.

Okay, thanks. I'll get back in line.

(Operator Instructions) Karen Jay, JPMorgan.

Good morning, this is KJ in for Cory Kasimov. I just have a couple on the NORTH trial. First, could you remind us when enrollment began, maybe specifically first patient in? Also are you assessing CD56 expression in the patients as they're coming in? If so, maybe any comments you could make on how the expression profile compares to what you've seen historically or published.

The study began just under a year ago, so first patient in was March of last year. Expression, we're not screening patients for CD56 expression because it's relatively homogenous in small cell lung cancer patients and virtually all patients express, KJ. So we are capturing the data but we're not screening for it to see if there's anything that's useful as we look at the data against the clinical results that we get from the study.

Great, thank you.

David Miller, Biotech Stock Research.

First question is on 289. Is the lack of skin response that you're seeing, do you think that's due to the binding site, binding strength perhaps, or maybe something else?

At the risk of repeating previous answers, I think we'd like to really get into the detail of that with the disclosures at the time of the AACR. Obviously, there's going to be a lot of information, a number of posters on this particular molecule, which we're very excited about, including some of the discussion about why we believe there are differences in the keratinocyte responses in these models.

Okay, fair enough. I want to try to understand the NORTH data process, so let me see if I have this right. In the second half of this year, you're going to tell us whether you met the hurdle for the interim analysis, but we won't get any data. Then at a medical conference, we will see is -- is it going to be -- are we going to wait for the medical conference to see data from the interim or are we going to wait all the way until you have data from the full trial before we actually see data on what happened in NORTH?

The essence of the first analysis, as Dan said, is futility -- you're quite correct -- where if we do not cross a predefined threshold consistent with the Simon 2-stage design, the study will close. Assuming that we continue, yes, we would intend to bring to a medical conference those interim data, assuming that by that point we would also expect that the full study would have recruited by that time, as well. So there should be two pieces of data following on relatively quickly -- the presentation of those data could follow on from each other relatively quickly, but we will hold back the full detail of that interim analysis for a subsequent medical conference.

I think we become subject to what the schedule of medical conferences would be relative to when the data would be available, David. If we had the data -- there was an appropriate medical conference to report the interim data, we would look to do that. But we just don't know exactly when it's going to be available, what the schedule of medical conferences is, what the cutoffs would be for submissions, et cetera. So it's difficult to give you much more clarity.

Okay, I think I understand. Thank you.

Jason Kantor, Credit Suisse.

Most of my questions have been asked, but just given the focus here on this interim Stage 1 of the NORTH trial, I'm just curious, what is the financial commitment that you're holding off triggering until this event? How much money are we talking about in terms of investment in the program that you're holding off?

Jason, it's Greg. It's primarily related to scale-up on the antibody side, as well as some of the other pivotal aspects of the program. So I think we're in that kind of $5 million to $10 million range, in that ballpark.

Just to be clear, we haven't -- there was the opportunity for a smaller investment to begin some of the development work, so we haven't been entirely waiting until we see that. We were able to make some investments to lay the groundwork, but the next increment is what we're holding off on until we have some additional data.

Thank you.

Thomas Wei, Jefferies.

I wanted to ask on 901, just a reminder of what the median overall survival is for small cell lung cancer patient population? At the time of that interim, do you think that there's going to be interpretable data on overall survival?

I think median survival is generally reported as being in the 9- to 11-month range. At the point where we'll be looking, we'll be looking at the six-month PFS rate, and so I don't think there will be interpretable overall survival events at that particular point. By the end of the study, yes, it may be somewhat indicative, but I think the number of events overall is likely to be low prior to going into Phase III.

I'm sorry, prior to going into Phase III, the number of overall survival events would be low? Wouldn't you have mature overall survival data from the whole study?

Yes, what I mean is, in terms of being able to make any sort of definitive statements about whether we have seen a prolongation of overall survival. But yes, I think the PFS data are the ones on which we are going to basing our next investment decisions.

But before you go into an actual pivotal trial, if you had a prolongation of PFS in this study but there was no overall survival benefit on the 120 patients, would you move this forward into pivotal trial?

I'm reluctant to give you an absolute answer without seeing the full data set, but I think it would be a much more difficult decision if we see PFS improvement but no overall survival benefit.

One last question. For this study, are there really only two time points where you're looking at the data? Or is this something where you have the ability to look at it at really any point in time that you choose, so that at ASCO of 2014, you would actually do a more mature cut of the data again maybe on all 120 patients?

I think the initial design of the study is for those two time points. Obviously, with further follow-up, yes, there may be the ability to provide further follow-on data at the later time. Obviously, what we would do would be to continue to observe and make those decisions as we go. But certainly we're not intending any additional looks at the data within the initial point up to the PFS data from the first 120 patients.

Okay, great. Thanks.

Yale Jen, Roth Capital.

Thanks for taking the questions. I have two. The first one is for SAR3419, I'd just like to get some update or anything you can talk about. I know it's a partnered program.

SAR3419, just for everyone's benefit, is under development by Sanofi and is currently in three Phase II studies; one of them being a combination study with Rituxan. Two of those are in diffuse large B-cell and one is in ALL.

We should be seeing data on that. I don't have any definitive information. I know that ASCO would be an opportunity. Sanofi, in the past, has used ASCO as an opportunity to disclose data around 3419, so I think that's the best picture I can give you at the moment. I know it's continuing to advance. They remain encouraged by the program, but we'll just have to see what they decide to do from a data disclosure standpoint.

Great, thanks. The follow-up question, again, on 901, which is that the median progression free survival is about 5.5 months, I guess, from the current treatment, whereas you're looking at, roughly, progression free survival at six months. These numbers seem to be very close, so how do you reconcile -- is there anything to read into that?

No, I think what we've chosen is an appropriate point in time. Remember the math is relatively simple; if the median is about 5.5 months, we would expect, historically, the data for PFS at six months would be around about 40% to 50% -- 40% to 45% of patients being progression free at that point. And so that becomes the assumption based off of the PFS6. But what we were trying to do was try and find a binary endpoint rather than a continuous endpoint for the design of the study, so we used a PFS at six months.

Okay, great. Thanks a lot.

Ryan Martins, Lazard Capital Markets.

I just wanted to clarify, did you say you are not expecting to recognize any T-DM1 royalties in this fiscal year? I just want to clarify that.

This is Greg. That's correct. So with a PDUFA of February 26 and our expectation that this reporting cycle would be a quarter in arrears, we haven't included any T-DM1 royalties in this fiscal year guidance.

Okay, thank you.

There are no further questions in the queue. At this time, I will turn the conference back over to Carol Hausner for closing remarks.

Great. I'd like to thank everyone for your interest in ImmunoGen and if you have any additional questions, please don't hesitate to call. Have a good day.

This concludes today's conference. Thank you for your participation. You may now disconnect.