ImmunoGen Inc (IMGN) 2011 Q4 法說會逐字稿

Good day, and welcome, everyone, to the ImmunoGen fourth quarter fiscal year 2011 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 the Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Thank you. At 4.00 this afternoon we issued a press release that summarizes our financial results for our fourth quarter and fiscal year ended June 30, 2011. I hope you've all had a chance to review 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 the projections made. A description of 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 provide guidance for our 2012 fiscal year. We'll then open the call to questions.

Dan?

Thank you, Carol, and good afternoon, everyone. I think that we came through with the end of our fiscal year in a very productive fashion. It was a strong year for ImmunoGen. Greg will take you through the financial picture, but I'd like you -- to provide you with a status of our pipeline as we come out of our fiscal 2011 into fiscal 2012.

We end the year with seven compounds in the clinic where we have an economic interest, and we remain on track for six additional compounds to enter the clinic by mid-2012 -- that would be calendar 2012. Two of these new compounds are wholly owned by us. We've designated them as IMGN529 and IMGN853.

IMGN529 targets CD37, which is found on non-Hodgkin's lymphoma in addition to CLL. It's a TAP compound with the distinguishing feature of having an active antibody, so we think this makes for a very interesting and differentiated compound going into the non-Hodgkin's lymphoma and CLL space.

IMGN853 targets the folate receptor 1. This antigen is expressed -- overexpressed on a variety of ovarian and other solid tumors, including non-small cell lung cancer. The differentiating feature here would be that it has a new linker, and this particular linker is very effective in multi-drug-resistant cancers. So, in addition to what we think is a very interesting target, we think the linker will provide us some very interesting information and hopefully will assist in the success of this compound.

These are the first new ImmunoGen compounds since we began rebuilding our product pipeline after completion of our research obligations to sanofi. Beyond these two compounds there are four other compounds coming into the clinic. The first of these, from Bayer HealthCare -- they've designated this BAY 94-9343 -- has already been submitted. The target for this, mesothelin, is found in mesotheliomas as well as many pancreatic and ovarian cancers.

So, taking the seven current compounds in the clinic and these additional compounds, that would put us with 13 clinical-stage compounds in the clinic by this time next year, and as many as four of those in Phase II or later. Those would be T-DM1, IMGN901, SAR3419 and BT-062. I'd like to focus my discussion on the three most advanced of these compounds, T-DM1, 901 and SAR3419.

For T-DM1, or trastuzumab emtansine, the registration strategy continues to be on track. From Roche we've learned that they expect to apply in 2012 for marketing approval in both the US and in Europe for second-line treatment of HER2+ metastatic breast cancer with data from their EMILIA study. They also expect to apply in 2014 for marketing approval, again in both the US and EU, for first-line treatment of HER2+ metastatic breast cancer with data from the MARIANNE study.

We should see additional data coming out on T-DM1 over the next year. Certainly we'll see very important data coming out at ESMO this fall, which is scheduled to be held in Stockholm in late September. This would be on the Phase II first-line study for HER2+ metastatic breast cancer, and the design of this study, this 137-patient study, is looking at T-DM1 alone versus Herceptin plus chemotherapy in first-line patients.

What we're looking for in terms of data -- there was data on this study that was disclosed at ESMO a year ago -- is an update on the objective response data. This data should now be mature. The data that was shown a year ago, which had a 48% response rate for the T-DM1 arm and a 41% response rate in the control arm, also had 11 patients, or just under 10% of the patient population, evaluable patient population, with unconfirmed PR. So we would expect at the -- when the data is released at ESMO next month that we'll get insight into how those unconfirmed PRs, where they fell out relative to the two arms.

We also expect to see updated data on progression-free survival. It was disclosed in April that the T-DM1 arm showed significantly better progression-free survival than the control arm, but we've not yet seen the underlying data. It's been indicated by Roche that that data would be available at ESMO.

The other data that we would expect to see would come sometime in the middle of 2012. We would expect to be -- that to be at ASCO, and it would be roughly in conjunction with the submission for marketing approval for second-line treatment. That would be the EMILIA data, and, again, the expectation is we will see that midyear at ASCO.

We also expect to learn sometime in the coming months more about what Roche's intentions are in other -- with -- for other indications. They have been looking at T-DM1 in development for adjuvant therapy. A Phase II safety study started in October last year assessing T-DM1 in the adjuvant/neoadjuvant setting. They've not yet committed to further development in that particular setting, but they have indicated that they would inform us, that they're working on their longer term development plan and have given some indication that they may be willing to discuss that in the coming months.

The other area that would be of interest is what they're planning to do in gastric cancer. There's been data recently published from preclinical studies in this indication. That is a potential significant opportunity if Roche should choose to pursue T-DM1 in gastric cancer.

Moving on from T-DM1, let me talk about our lead wholly owned product candidate of IMGN901. The findings to date were presented at ASCO in an oral presentation on our [testing] -- our trials in multiple myeloma. These include final results from assessment as monotherapy, where 41% of the patients showed benefit despite having been previously -- heavily pretreated. We've completed this monotherapy study and now have a combination study underway. The oral presentation focused on the findings of this combination study looking at 901 dosed in combination with Revlimid and dexamethasone in previously treated patients. Again, these patients have been exposed to a number of prior therapies.

The findings from the study that were disclosed were that across 13 efficacy-evaluable patients 69% of them had clinical responses, five of them VGPRs, three PRs and one minimal response. We're now enrolling into the expansion phase of this combination study. The enrollment here will be limited to about 20 patients. The registration strategy for IMGN901 is for small-cell lung cancer. We view at this point -- we view multiple myeloma at this point to be a potential secondary indication, but the limited assessment that we're taking at the maximum tolerated dose we think will add value to this compound going forward.

For small-cell lung cancer, the development plan is to assess 901 for first-line treatment in small-cell lung cancer when dosed with etoposide and carboplatin. We're establishing the dose now in a Phase I study that's underway. Once we have the Phase II dose we'll initiate a Phase II to assess 901 in the target population, again that being first-line small-cell lung cancer patients. Our expectation is to start this Phase II study late this year or early next year.

We expect to have about 20 or more sites enrolling patients across four countries. We're targeting 120 patients into this randomized study. The primary endpoint here is progression-free survival, and the expectation, assuming we get the productivity that we're looking for out of the numerous sites that will be participating, is to have some response rate data in the second half of next year. Assuming that benchmarks are met in the Phase II study, our intent is to advance then into a Phase III study, and as such we're in the process of beginning preparations to having pivotal material available for that study.

The third indication we've talked about for 901 is Merkel cell carcinoma. Here we continue to assess if benefit -- if there is benefit in pursuing Merkel cell separately from small cell. The timing benefit would be clearer if we were going to pursue it as a single agent. However, the single-agent findings, quite frankly, were inconclusive. We had two very durable complete cures -- they've been complete responses for multiyear periods -- however, no PRs across the patient population of 13 patients.

Were we to pursue Merkel cell as a separate indication it would be using the same combination that we're using in the small-cell study, that is, 901 with etoposide and carboplatin, and that's based on the biologic similarities of the two diseases. So we would need that Phase II dose from the small-cell study before we could move to the next step, which would be to meet with regulators concerning the requirements for approval in Merkel cell. And it's uncertain how those discussions would evolve, given the different requirements in the EU and for the FDA.

But the data that we get out of the small-cell Phase I will give us the information we need to understand the timeline, which would allow us -- the timeline through discussions with the regulators and give us the ability to potentially pursue Merkel cell -- a Merkel cell registration study. However, the plan today is to focus on small-cell lung cancer. We'll continue to monitor the opportunity in Merkel cell, but in the context of our small-cell lung cancer progress.

The third compound is SAR3419, which is being advanced by sanofi-aventis. This was a compound created by ImmunoGen that went to sanofi in the broader research collaboration that we had with them. It's a CD19-targeting TAP compound for non-Hodgkin's lymphoma. This is a market dominated by Rituxan today, although note Rituxan is often used in chemotherapy in dosing patients for NHL.

The first-stage data from a weekly dosing study was reported at ASCO in June, and also at the 11th International Conference on Malignant Lymphoma in Lugano, also in late June. This study was looking at heavily pretreated patients. They'd received a median of three prior treatment regimens. All but one of the patients had relapsed after prior treatment with Rituxan, and half of these patients were Rituxan refractory.

In this advanced patient population there was a 33% objective response rate at the maximum tolerated dose and a duration of responses that ranged from five weeks to at least 55 weeks. The activity that was seen was similar in both the Rituxan-refractory and responsive patients, and there was efficacy seen across histological types enrolled, including diffuse large B-cell lymphoma. And, of note, there was no significant myelosuppression.

Sanofi expects to begin Phase II testing in the coming months. They plan to initiate Phase II trials this year in both diffuse large B-cell lymphoma and also in B-cell acute lymphoblastic lymphoma. The development program -- this development program is designed to support rapid progression into pivotal testing, and I'd note that the material for these studies was made using a commercial-scale manufacturing process developed by ImmunoGen for sanofi.

So, we're seeing good progress across our programs. As you'll hear in a minute, we're on the front end of a very active period for ImmunoGen, and I'll come back to that after you hear from Greg about the financials.

Greg?

Thanks, Dan.

Our net loss for our fiscal year ended June 30, 2011, was $58.3 million, or $0.85 per share, which compares with $50.9 million, or $0.87 per share, in our 2010 fiscal year. Our revenues in fiscal 2011 were $19.3 million, as compared to $13.9 million in fiscal 2010, with increases across all categories -- research and development support, license and milestone fees, and clinical materials reimbursement.

Our operating expenses in fiscal 2011 were $79.5 million, as compared to $65.2 million in fiscal 2010, with the increase due primarily to our increased investment behind aggressively developing our own compounds. And our net loss in fiscal 2011 was slightly better than our guidance of $60 million to $64 million.

Our cash used in operations was $8 million for the year, benefiting from the $45 million upfront payment we received with the establishment of our collaboration with Novartis in October. Our cash use was slightly greater than our guidance of $0 to $4 million. One contributor to this difference was our receipt of the $2 million milestone payment from Bayer after the close of our fiscal year on June 30. We had expected to receive this prior to year end.

We ended our fiscal year with $191.2 million in cash and cash equivalents. This includes $88 million in net proceeds from the public offering we did in May. We anticipate that our current capital resources and expected future collaborator payments will enable us to meet our operational expenses and capital expenditures through our 2014 fiscal year.

Looking forward, our guidance for our 2012 fiscal year is that our net loss will be between $65 million and $70 million, our cash use in operations will be between $60 million and $65 million, and our capital expenditures will be between $4 million and $5 million, and we'll end our fiscal year on June 30, 2012, with cash and marketable securities of between $125 million and $130 million.

These projections do not include any sizable new partnerships due to the challenges around predicting magnitude and timing but reflect our expectations of our clinical stage pipeline doubling from two to four products during this fiscal year, IMGN901 advancing into Phase II testing, beginning our preparations for pivotal manufacture of IMGN901 for its first registration trial, continuing to aggressively expand and advance our preclinical pipeline, and some additional investment in our technology portfolio to maintain our leadership position.

By this time next year we expect to have four compounds of our own in clinical-stage testing, with our IMGN901 in a randomized, Phase II trial. We expect EMILIA data will have been presented and T-DM1 will be on the path for marketing approval in the US and Europe. And we expect eight other compounds will be in clinical testing through our partnerships with both SAR3419 and BT-062 in Phase II testing.

Dan?

Thanks, Greg.

So, as you heard from Greg, we've come out of 2011, fiscal 2011, into fiscal 2012 in what I would have to characterize as very strong -- a very strong financial position. We continue to see a lot of interest in this field in terms of business development, which gives us considerable flexibility in terms of doing additional business development deals as a means of funding the opportunities that we have for our proprietary pipeline.

The entire pipeline continues to be moving forward both in terms of number of compounds as well as moving deeper into studies -- 13 clinical compounds by mid next year, as I noted earlier, four of them ours, so doubling our own proprietary compounds, four out of the 13 expected to be in Phase II or later by this time next year. So, we think that as much progress as we made in 2011, we think there'll be dramatically more as we move through fiscal 2012.

Let me provide some highlights by noting some of the events that we're looking to see over the next 12 months. In walking through them in a somewhat chronological basis we look for SAR3419 to be starting their Phase II sometime in the coming months. We'll see the data that I referenced earlier at ESMO in the third quarter of 2011, in late September. IMGN529 should also be in this quarter. We expect that to be filed sometime before the end of September. And then we would look to have two new partner compounds coming into the clinic sometime before the end of this calendar year.

In terms of data, we'd look to see the additional Phase I data on SAR3419 at ASH in the fourth quarter. There's the potential for additional T-DM1 preclinical or clinical data at the San Antonio Breast Cancer Symposium in December. And then hopefully this year but possibly [it'll be] early next year we'll see the Phase II start in first-line small-cell lung cancer for IMGN901.

As we begin calendar 2012, we would look to have our IMGN853 IND presented to the FDA. We would look for another new partner compound to come into the clinic in the first calendar quarter of next year. The EMILIA data should be available or published over the -- at a medical conference, probably ASCO, in the first half of 2012, and that should be in the proximity of when the marketing application would take place in the US and EU for T-DM1. And, lastly, a little bit past the one-year time frame we would look to have the first data from the 901 small-cell lung cancer study potentially in the second half of next year.

Those are the events around individual compounds. As I noted, from a business development standpoint there's always that opportunity. That's much more difficult to predict in terms of event and timing, but we continue to have discussions in a number of areas, and we'll just have to see how those evolve, but there's the potential for announcements in that arena, as well.

So, Carol?

Great. Thanks, Dan.

We are about to open the call to questions. I'd like to ask that the questions be limited to one to two per person until everyone who wants to has had a chance to ask questions, and then we'll certainly allow you to come back on and ask additional questions if there's time.

Operator, we're now ready to open the call to questions.

Thank you.

(Operator instructions).

We'll take our first question from Jason Kantor, with RBC Capital Markets.

Thanks for taking my one question. I noticed a slight change in the way you're talking about Merkel cell. It always had seemed to be a foregone conclusion that once you had your combination dose that you would move forward in that indication, but you sounded a whole lot more hedged about it this time. I'm wondering if you've somehow reassessed that opportunity and are less confident in moving forward there.

Yes, that was the message we were intending to convey. I mean, I don't know [that it's] less confident. I think there's a confluence of elements that we've considered here, Jason, as we look at the positioning of Merkel cell, and some of them revolve around the sort of binary data that I referenced. Out of the 13 patients where we've disclosed data we've had two very strong responses, as I noted, complete responses, multiyear, no further therapy, and they've come in very early after patients have initiated treatment, but then sort of nothing in between -- some stable disease, but no other durable activity.

As we think about that and the positioning for the compound and what does that mean in terms of market size -- because, as you know, this already is something of an ultra-orphan disease -- and then think about the regulatory timeline to meet the expectations of the FDA for a randomized study and just that uncertainty while we also are pursuing small cell, the thinking is we would probably push any action we take in Merkel cell for a registration study back to when we see activity out of small cell.

So, I think the nuance there is that the likelihood of us pursuing Merkel cell as the sole indication with 901, if you will, is diminished. We're still getting data out of the CD56-positive solid tumor monotherapy study. There have been additional Merkel cell patients there. But I think the expectation that we would be pursuing that immediately once we have the dosing information out of small cell is one that we think -- that we've backed off of and want to make sure that investors understand that we think it would run in tandem with what we see coming out of small cell. It still may offer us an opportunity for registration at a faster pace than we would get out of small cell, but we would want to have the confidence that we're going to be pursuing small cell before we would make the substantial commitment that would be involved in pursuing Merkel cell.

I guess I'll ask a second question on the SAR3419. It sounded like some new information there. I'm wondering, were those -- are those trials posted on ClinicalTrials or somewhere publicly to look at? And your comment about it moving -- being designed to move quickly into registrational studies, are these themselves registrational Phase IIs, are they adaptive trial designs that allow it to move into Phase III, or what was the meaning of that statement?

I don't think that they're -- that these studies themselves would constitute studies that either could be adapted or are designed to be registration studies. The data is fairly fresh. It was disclosed this week at a conference on the West Coast by sanofi. And so we were able, then, to provide an update to our investors, so that event made it public.

So, yes, that is new information in terms of the target population, the fact that they'll be running two different Phase IIs. But it's my understanding at this time that those would not constitute registration studies, the point being that they're moving on a number of fronts at the same time in terms of indications. They have already taken the steps to have pivotal and commercial material available. So I think that they're positioning themselves that based on the data that they see out of these indication-specific Phase IIs would allow them to move quickly into later stage studies.

Thanks.

We'll take our next question from Thomas Wei, with Jefferies & Company.

Thanks. I had a question on the small-cell program and then a question on T-DM1. So, we know in small-cell lung cancer there have been some failed programs even very recently where companies have seen an increase in the response rate but no improvement in overall survival. When we look at 901 in that context for small cell, is the trigger for you to go into Phase III trials going to be based off of the look at response rates in the second half of 2012, or are you going to wait to see whether or not there's an actual PFS benefit?

I think we have to look at durability of response, as opposed to simply looking at PFS, Thomas, based on, as you note, the other data that has come out for some additional studies. We appreciate that. We would expect to see, frankly, certainly a response rate -- you should get a response rate at least equal to what you're getting for the base -- for the existing therapy of carboplatin and etoposide. Now, hopefully we can enhance that with 901, but I think the critical element is going to be some improved durability to that response rate. So we would be looking for that.

And some of the secondary endpoints are looking at PFS at 12 months and I think overall survival at 12 months, our secondary endpoints. We'd want to see those before we made any decision to move to registration studies.

And, I'm sorry, from a timing standpoint, does that mean that you would have preliminary data on the response rates in the second half of 2012 and then we'd have to wait until 2013 for you to reach that point, or just from an absolute timing standpoint that would be helpful.

Yes, obviously it's going to depend on enrollment. As I noted in my comments, we're trying to be aggressive in the number of sites and where we're opening sites. I think the best we could expect would be a response rate by the end of 2012. But, given the characteristics of this disease and the poor prognosis, I think that getting durability information shouldn't take a significant amount of additional time.

That's helpful. And then on T-DM1 for the front-line study that's going to be presented at ESMO, can you just remind me, if the unconfirmed PRs became confirmed responses, what would the overall response rate look like in each arm?

We don't know that. Because there were 11 patients with unconfirmed PRs, and that came out of the oral presentation that took place at ESMO. There wasn't any distinction as to what the distribution was of those 11 PRs across the two populations. So, we have to wait for ESMO to understand that better.

Thanks.

Yes.

We'll take our next question from Bret Holley, with Oppenheimer.

Yes, thanks for taking the questions. I'm just wondering about the nature of the overall survival data in the front-line T-DM1 trial that might be presented at ESMO. Is there any information that's going to be presented at the meeting?

There's no insight there. All that they -- that we understand thus far, Bret, is around PFS. Now, there's certainly the opportunity for them to have overall survival data. It, again, gets back to the point of is the data mature at this point. And I just -- I can't help you, because I don't have any further insight. All we've been led to expect out of this in terms of further data is the mature objective response rate and the details behind the significantly better PFS. But clearly I understand that OS would be of interest, as well.

And I guess the follow-up to that is given the experience with Avastin in breast cancer and the evolution of that whole discussion, I mean, how important at this point does Roche -- in your -- from your perspective -- think that overall survival is going to be in breast cancer?

Well, I don't have any direct insight, and when you get into the whole discussion around the recent Avastin issue, there's -- we could spend a lot of time on that and the views of many different constituents on it. I think there's -- I think with the EMILIA study next year, we clearly will have some preliminary OS data, not final OS data, because, as you recall, they expanded that study to be able to develop the mature OS data to allow for full approval at 18 months after the filing in 2012.

So, I think that they have an appreciation of the interest of the FDA. And, remember, the FDA is interested in OS, the European authorities less so. They tend to -- they will accept PFS as a surrogate. So, I know we'll see that at some point. Whether we get preliminary OS with EMILIA or not, since it won't necessarily be part of the filing in the US, I don't know. Whether we see it for the first-line Phase II at ESMO, again, I can't help you. I don't have any insight there.

Okay. Thanks a lot, Dan.

You bet.

Our next question comes from Shiv Kapoor, with Morgan Joseph.

Thanks for taking my question. I want to understand your business development strategy going forward. It seems like your financial status currently is much better, you're on much firmer ground now than you have ever been. Is there a point -- does -- is there a point where you will stop considering business development and only work on proprietary compounds? And, if not, what kind of proprietary strategy will you have going forward?

I think there is a point that we will take that position, Shiv, but we're not quite there yet. We have now four compounds in the clinic. We have thoughts around what would be following that from a proprietary standpoint. I think we have the luxury of having a technology that has significant appeal, and there is a little bit of a balancing act, but I think we come down at this point of wanting to take advantage of that to further enhance the financial position that we've been able to achieve that you've referenced.

I think you're right. We are in the strongest financial position the Company's ever been in, both in terms of current liquidity as well as the perceived quality of the assets, whether that is the opportunity to license the technology platform -- as we saw, we were able to generate significant cash with Novartis last year -- there's been interest expressed in certain of our preclinical assets.

So we have tremendous flexibility. But I think before we sort of shut off the access to our technology platform there's probably room to do a little bit more work there. But we want to be very careful in doing it that we don't disrupt the progress we've made and are continuing to make with the proprietary technology.

So, that day is out there. But even when we get to that point it will probably shift somewhat, because then we may be looking at some deals around, again, assets that we may choose not to pursue on our own, assets where it would make sense to bring a partner in. But you are -- you are seeing a shift, but we're not all the way to the back end of that.

Okay. Congratulations.

Thanks, Shiv.

We'll take our next question from Brian Klein, with Lazard Capital Markets.

Hi. Thanks for taking the questions. So, regarding the Phase I dose escalation trial of 901, when might we see that data, and what proportion of patients in that trial are going to be small-cell lung cancer? Thanks.

Brian, we've thought about that and -- in terms of presenting that data, and, first off, I don't know the percentage. It's well under half of those patients are small-cell patients. That's important. The other is that these are not first-line patients. And one of the elements of our strategy to pursue development in small cell in first line is because of the aggressiveness of this disease and the importance of getting it as early as you can to be able to have the patients in the best physical status as well as to try to arrest the disease before it's gained significant momentum.

So, the thinking at this point is that we would not have data on the Phase I simply because I think it would be too easy to misinterpret, given that it just -- it is not our target patient population. Recall, the patients that we're enrolling into this study are patients who would receive etoposide carboplatin for their diagnosis, whether it's in small cell, whether it's in Merkel cell, ovarian -- we're seeing a variety of different tumor types. So, I think the safety is important, but I do think disclosing that or having that data disclosed could be confusing, because I think it would lead to a lot of questions and confusion around what efficacy is or isn't achieved in that study.

Great. Thanks.

Yes.

(Operator instructions).

We'll take our next question from John Sonnier, with William Blair.

Hey, thanks for taking the question, and congrats on all the progress over there, Dan. My question is also a business development question, I guess, to come back there. You said at your R&D Day, and I think you said earlier on this call, that you still would consider doing deals, but that, I guess to summarize, you want to be much more selective in the way you think about that.

So there's really two questions around how you strike the balance between keeping proprietary programs and partnering. One is, can you talk about what types of collaborations you want going forward? Is it more ownership, is it more participation in clinical development, is it keeping geographies, etc.? And the second one would be what is your internal clinical development capacity? Can you give us a sense of how many programs you could actually handle internally as these programs start to move into mid-stage or even late-stage clinical development? Thanks.

There's a few different variables that will probably evolve as we look at further business development deals. And let's just stay with platform as opposed to compounds. The things that -- there are potential opportunities with meaningful players that introduce aspects that can be interesting to us. It may be targets where there's some proprietary element or an avenue that we haven't considered in the past. There may be new vehicles that could open up a wide range of potential therapeutic opportunities. It may be looking to structure a transaction that would afford us a higher level of participation. So, we look to be aggressive with how we structure this or innovative in what elements are there.

Now, that's not to say that we will -- that that's where we'll end up. But that's certainly on the list as we have discussions with parties and try to evaluate -- I don't know if we'll be in the position of actually having things evolve and being able to literally pick and choose among potential partners, but if we do, those are considerations that will come into play.

Your comment about capacity, I mean, there is some -- there's limited elasticity to our capacity, but there is some. As we're working on the front end we can move things through at a certain pace from one element of the operation, be it biochemistry, into our process development group and then manufacturing, etc. And we don't want to go crazy in terms of expanding those individual groups, not just because of the people implications, but it gets into additional space and the like. But we also have to be prudent to look at what the level of interest is, what our potential is, and whether it makes sense to enhance that.

Now, we have over the last couple of years shifted our research organization so that they really are moving, in many cases, more into development support than they are into pure research. Now, we certainly still have -- and even pure research there's a little bit of a -- I'd have to qualify, because we're not doing, for example, target discovery. I think the most that you could say that we do on the pure research side is when we do work around linkers and cytotoxins. But, so we have made that shift. That's given us more capacity to support programs coming through the research phase.

In terms of development, we have added capacity on our clinical organization, and we will probably continue to do that. We're gaining some bandwidth back as some of the earlier studies, like the single-arm solid tumor study and the single-arm multiple myeloma studies wind down, we have bandwidth to be able to support some additional studies coming forward.

But we've set a target for ourselves of being able to bring one new proprietary compound through an IND submission process per year. With IMGN529 coming into the clinic, or coming -- going to the regulatory authorities this fall, 853 coming in in the first quarter, that's probably a little bit faster pace than we had anticipated, but they're not always going to fall into a 12-month timeline. I think it speaks to the productivity of our research group. But I think future compounds will be spaced roughly in a 12-month period. And I think that we can accommodate that, and we will keep a very close eye on the organization to ensure we have the resources to support that and not overcommit ourselves on the partner side so it's disruptive to be able to move those forward.

Thank you.

Your next question comes from Karen Jay, with JPMorgan.

Good afternoon. This is Karen Jay for Cory Kasimov. Thanks for taking my question. Most of them actually have been covered; I just have one remaining on T-DM1. It has to do with the new adjuvant study that started last year. I was wondering if you could give us a sense of timing of when that study might be done. I know it's probably long. But also, seeing that it's not randomized, will there be interim updates that you're aware of?

We don't know the specific answer. Given the fact that it's a safety study and not an efficacy study that probably has a shorter window than you otherwise might anticipate. If it was efficacy, obviously that would be an extended period of time. But as they initiated that study they were very clear to say, "This is a safety study." So I would be speculating if I told you when they might have data. I don't have any particular insight there. But based on that, my expectation is it's much sooner than if this was designed as an efficacy study.

Great. Thank you.

It appears there are no further questions at this time.

I'd like to turn the conference back over to Carol Hausner for any additional or closing remarks.

Great. I'd like to thank you all for your attention, and if you do have additional questions, give me a call at 781-895-0600. And have a good evening.

That concludes today's conference. Thank you for your participation.