ImmunoGen Inc (IMGN) 2012 Q2 法說會逐字稿

Good day, and welcome everyone, to the ImmunoGen second-quarter fiscal year 2012 financial results conference call. Today's call is being recorded. At this time, for opening remarks and introductions, I'd like to turn the call over to Executive Director of Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Thank you. Good morning. Our quarterly calls are now being held on Friday mornings rather than on Thursday evenings in light of the number of evening calls now competing for analyst time. Consequently, at 6.30 this morning Eastern Time, we issued a press release that summarizes our financial results for the quarter ended December 31, 2011, which is the second quarter of our 2012 fiscal year. I hope you have all had a chance to review it. If not, it's available on our website.

During today's calls we will make forward-looking statements. Our actual results may differ materially from such statements, descriptions of the risk 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. Dan?

Thanks, Carol, and good morning, everybody. Again, thank you for joining us for our morning calls as we switch the format here. Let me just position where ImmunoGen is today, and we're in a field of ADCs that is gaining increasing interest in the space of oncology therapy. And we're proud to have been a part in developing this field, we think we have a very strong position as a leader in this field. What we've been able to do with that is to build the pipeline, and I'll take you through that. This pipeline has been increasing in depth and [width] and breadth, certainly with our partner compounds, but increasingly with compounds that ImmunoGen is developing and bringing forward.

We have a number of partners that are recognized leaders in the development of significant new therapeutics, particularly in oncology. You think about Roche, Sanofi, Amgen, Bayer, all of them are aggressively advancing one or more critical stage TAP compounds, and then we have Novartis and Lilly, our newest partners, who are very rapidly moving into their compounds, to get them prepared to take them into the clinic. So we're seeing a lot of activity across the portfolio with partners, Novartis and Lilly giving these new investments on their part quite a bit of attention. You think of the partner portfolio in total, four of the top six companies in oncology now have access to our TAP technology, which we're very proud of. Financially, we continue to be in a very strong position. You'll hear Greg cover that just a little bit later.

Let me talk about the pipeline. If you look at it a year ago, or I should say at the beginning of our fiscal year, which would be July of 2011, there was only one pipeline compound that had advanced beyond Phase I, and that would be T-DM1. As we stand here today, the T-DM1 clinical program has continued to advance and expand. They started a third Phase III trial in the second half of 2011, and they also have multiple Phase II trials underway. We expect the first Phase III data from Roche this year, along with marketing submissions for T-DM1. They also have indicated, that being Roche, that they plan to update where they're taking adjuvant over the course of the year, as it pertains to T-DM1.

For Sanofi, SAR3419 is now in Phase II. There are three Phase II trials underway; one for acute lymphoblastic leukemia, that's being studied as a single agent, they're also looking at diffuse large B-cell lymphoma, both as with 3419 as a single agent, as well as in combination with Rituxan. And they intend to submit an abstract on the selected Phase II dose to an upcoming medical conference, so we'll hear more about SAR3419 at a conference over the course of this year, assuming acceptance of the abstract. But in terms of other compounds moving beyond Phase I, IMGN901 and BT-062 will be moving into Phase II this year. We expect IMGN901 to start Phase II testing in late March or early April. Currently we're at the dose confirmation stage, in that Phase I/II study.

Going beyond depth, and compounds advancing beyond Phase I and focusing on the breadth of the pipeline, over the past quarter we've seen two Amgen TAP compounds have INDs become active. In addition, we are making progress with our two next wholly-owned compounds, IMGN529 which is for non-Hodgkin's lymphoma, we think of as something of a T-DM1 analog, in that you have an antibody, which pre-clinically has shown anti-cancer activity, and to that, we've added our TAP technology, and in this particular case using the same form format as T-DM1, the SMCCBM1 combination. Here the IND is active, the first site is open for enrollment, and we expect patient dosing to begin shortly.

For IMGN853, this is a compound that targets the folate receptor, and that incorporates a linker that counters multi-drug-resistance. This is the first time this linker will be put in human clinical studies, the pre-clinical data on this compound has been very exciting. We're doing a lot of work here to prepare to submit the IND. That we think was will be submitted sometime this spring. And that would lead to the first patient dosing sometime this summer. Beyond those two compounds, we're evaluating other earlier-stage candidates, which we think will allow us to further expand the pipeline with novel product candidates.

The implications of this is that over the next six months, there's a number of things that we will understand better. We'll know at least the top line results from EMILIA from the Phase III trial for T-DM1. We'll also know more about the specific timing from Roche on the expected BLA and MAA submissions, and we'll hear more about their plans for T-DM1 in the adjuvant setting. Roche has acknowledged that there's potential for T-DM1 in gastric cancer, there's also the potential to hear more about their plans in that particular indication. For SAR3419, we'll see new clinical data, that being the dose for the Phase II testing, and their rationale for that particular Phase II dosing. And also in the next six months, we'll have at least seven Phase I and three Phase II compounds in the clinic, plus T-DM1 in Phase III. This will mean there'll be over 20 clinical trials using our TAP compound, including seven Phase II or Phase III studies. This will include trials conducted by us as well as by Roche, Sanofi, Amgen, Bayer, and Biotest.

If we look beyond the next six months and you start think about 2013, there are a number of significant events that will be taking place. We would expect to see the start of T-DM1 commercialization. In addition, we'd also expect to hear the first findings from the Phase III first-line MARIANNE study possibly in the later part of 2013. We also will get the key data on IMGN901, and potentially IMGN529 and IMGN853. If we're able to get those latter two studies started as we expect, and move them quickly through their Phase I into the expansion phase, that should give us significant insight on those two studies, as well as the Phase II for IMGN901 that will help us understand the appropriate pathway to registration for these compounds. Phase II data for SAR3419 should be available in 2013, plus data from a large number of other partner compounds. And lastly, we'll be able to look at further expansion of this product pipeline. That would include our next compound, as well as additional partner compounds.

Finally, before I turn it over to Greg, let me acknowledge our newest partnership, that being the multi-target agreement with Eli Lilly & Company. This brings another major player in oncology and through their ImClone arm, a major player in antibodies, who has accessed our technology for multiple programs. With this agreement, they've garnered the rights to use our TAP technology for antibodies that they provide. Again we call these our target-specific contracts, so they will come to us with specific targets that they have in mind, if they've not been exclusively licensed elsewhere or are in a proprietary program, they then become available for their development.

The terms of this agreement are that they paid us $20 million up front. Each individual license, or each target, has the potential for about $200 million in milestones and then royalties on any subsequent commercial sales. I think this agreement, following on the agreement that we executed with Novartis roughly a year earlier, continues to demonstrate our ability to access non-dilutive capital and at a very strong value level for the technology. Over the last 10 years, the partners have provided us over $300 million in cash in a variety of forms; up fronts, milestones, work that we've done, research work we've done on their behalf, and manufacturing.

And as we move forward, there's also the potential for a new revenue stream in the form of royalties. Beyond the economic value, I also think that working with the broad range of partners and broad range of targets has provided us vast experience that has benefited the technology, experience that we certainly couldn't have generated by simply maintaining a proprietary position with the technology. At the same time, I want to reinforce the fact that this doesn't reduce our commitment to build a proprietary pipeline, with one compound going into Phase II, two additional compounds about to go into the clinic, and more under development, I think we make a very strong statement about our commitment to proprietary pipeline, and we're always very cognizant of the level of commitment to a new partner when we enter into an agreement. So by no means is that proprietary commitment diluted with the agreement with Lily. So with that, let me ask Greg to walk you through the financials.

Thanks, Dan. I'm just going to step you through the press release. Our net loss for the second quarter of fiscal year 2012 was $12.8 million, or $0.17 a share compared with $14.2 million or $0.21 per share for the same quarter last year. Our revenues for our second quarter this year were $7.6 million as compared to $4.2 million in the same quarter last year. Our second quarter this year contains $6 million in license and milestone fees as compared to $900,000 in the same quarter last year and includes the $3 million milestone payment from Sanofi that we earned when SAR3419 started Phase II testing and the two $1 million milestones from Amgen we earned when their two TAP compounds got active INDs.

Our second quarter this year also includes $945,000 in research and development support, and $647,000 in clinical materials reimbursement, compared with $2 million and $1.3 million respectively in the same quarter last year. These revenue items obviously vary by quarter, depending on partner events and timing, and the work we're doing supporting our partners. Our operating expenses for the second quarter of our 2012 fiscal year were $20.4 million as compared to $19.7 million in same quarter last year. We had increased personnel costs, including increased stock comp expense, and patent costs in the current period in support of our internal programs, but also had lower expenses for clinical materials for our own and partner programs compared with the same period last year.

We had approximately $168.4 million in cash and cash equivalents, as of December 31, 2011, as compared with $191.2 million last year. The December amount doesn't include the $20 million up front payment from Lilly, as this cash was received after the month-end. Our guidance for our full 2012 fiscal year remains unchanged from what we provided when we announced the collaboration with Lilly in late December. Just as a reminder, we project our net loss would be between $78 million to $82 million. Our net cash used in operations will be between $40 million and $45 million, and we will end our fiscal year on June 30, 2012, with expected cash and marketable securities of between $145 million and $150 million.

Based on these figures, we expect our current capital resources, along with expected future collaborator payments, to be sufficient to meet our operational expenses and capital expenditures through our 2014 fiscal year. As Dan noted, we're seeing momentum building with our proprietary product pipeline. We're also seeing each of our partners putting solid support behind TAP compounds. Roche's Phase III program for T-DM1, Sanofi's multi-pronged Phase II program for SAR3419, Biotest's BT-062 Phase I/II program, Bayer's advancement of BAY94-9343 to the clinic, and Amgen's advancement of two TAP compounds, and earlier-stage work by our newest partners, Novartis and Lily. This represents another strong step forward for ImmunoGen in our TAP technology. Dan?

Thanks, Greg. Let me take you through what we see as anticipated events over the coming year, starting with what we see in the early part of 2012. These will primarily be ImmunoGen-driven events. Those would include the start of the Phase I study in IMGN529, which we expect to take place in this current calendar quarter, IMGN901 would be the Phase II initiation, that will be late this quarter or early next quarter. For both IMGN529 and IMGN853, we will see the next set of pre-clinical data coming up at AACR, which runs for us late March, rather and early April of this year. And then lastly, in IMGN853, that IND will become active sometime before the middle of this year, probably in the early part of the next quarter.

Then, as we get to the middle of 2012, we'll see much more going on from a partner standpoint, that would include EMILIA Phase III study from Roche. Based on what we hear from their public communication, that sounds like that will be sometime around mid-year. Mid-year would also be when we would expect to hear more about the plans from Roche on T-DM1 in the adjuvant setting. And then also, midyear is when we would expect to see the Phase II dosing information from Sanofi on SAR3419. As we then get to marketing submissions on T-DM1 in the US, EU, and elsewhere, based on, again, what we can glean from Roche's public statements, that looks like it would be sometime in the third quarter of this year, that would be the third quarter of calendar 2012. And then probably early third quarter, at least around mid-year we would look to be starting the IMGN853 study.

In the latter half of 2012, probably more towards year-end, we would expect to have the first data from the IMGN901 Phase I/II in small cell lung cancer. For example, that would be the information around the Phase II dosing and possibly some initial response data. A little bit early to have some clarity on that one. And over the course of the year, there's the potential to also hear more from Roche about their plans with T-DM1 in gastric cancer. So that's what we're looking for within this calendar year, let me turn it over to Carol and she can coordinate the Q&A.

Great. Thanks, Dan. 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 an opportunity to ask questions. Operator, we're now ready to open the line to questions.

Thank you. (Operator Instructions) Ling Wang with Summer Street Research Partners.

So, I was wondering for Roche -- you mentioned Roche plans to give further development on the adjuvant wondering whether you can be a little bit color on what forum they might disclose this? Also, then for 3419, you mentioned -- didn't quite get clear -- what data should we expect at mid-year this year? Thank you.

Good morning. For 3419, the data that we would expect is, they went through a couple different Phase I studies, looking at different dosing regimens for 3419. I think what we would expect to see coming out for data this year is, the results of that and the rationale that got them to the final Phase II dose. I don't think that was covered. They've had a couple of posters that I recall over two of the Phase I studies but never got to a final dosing discussion. This I think would be closure to that issue.

As it relates to Roche and adjuvant, we're reading the tea leaves there a little bit, but Roche has been very clear on saying that out of the Phase II study that they conducted in adjuvant and in neo-adjuvant, that they would have data in the first quarter this year, and that they would provide an update to their adjuvant plans as it pertains to T-DM1 by mid-year. That's what we know. Trying to think of what forum they would choose -- it could be any one of a number of things. It depends -- I would expect it would be something that might be timed as they're talking about the Phase III results from the EMILIA study because that would beg the question of where does adjuvant fit? Depending on what their decision is on when they're going to get into the details of the study, might provide some insight as to when they provide further clarity around their adjuvant plans for T-DM1.

Thank you. Just wanted to clarify, should we still expect -- should we soon expect that Roche might report the adjuvant Phase II data this quarter? Or not really?

I don't know what to tell you there. We know that they said that they would have data in the first quarter. That is a teaser when they say they're going to have it. It makes you think they're going to disclose it but I haven't heard them say, we're going to have and disclose. I really can't help you much of that.

Great. Thank you.

Thomas Wei with Jefferies & Co.

I wanted to just first ask about the timing of EMILIA data. It sounded like you were implying that there was a slight shift to data released a little bit later in mid-2012. Does that mean that it's unlikely to be prepared in time, or mature in time, for its submission for an ASCO abstract?

Thomas, if that's something you interpreted, it wasn't intended. The only thing that we know is, as I've said, 2012 disclosure of data at one point, there was a reference to having data at ASCO. They haven't reinforced that. There was nothing I intended to convey that suggested there was any shift in timing. Timing's been a little bit ambiguous all the way long.

I just wanted to ask you for your own thoughts on adjuvant disease and what you think the role of T-DM1 is. A lot of us are trying to figure out how this might fit into an adjuvant regimen, when chemo is given usually for the first four cycles, and then Herceptin and chemo for an additional four, maybe up to six cycles, and then a long duration of Herceptin almost maintenance therapy afterwards? Based on the T-DM1 data so far, what parts of the regimen do you think -- or if you controlled the adjuvant trial, how would you test T-DM1? What would you replace?

Well, you're talking to a non-doctor here, so we have to be -- I have to be a little bit careful. I do think that one of the strong themes coming from Roche around T-DM1, clearly the efficacy has been very important, but tolerability and being able to get chemotherapy out of the regimen has been extremely important. I think that's the theme you hear, not only with respect to T-DM1, but across the whole range of treatment in oncology, with personalized medicine, with new therapies that take these systemic chemotherapies out. So, you would think that, you would want to find an avenue to eliminate chemotherapy within the adjuvant setting as well. If you're getting more robust responses and activity in a metastatic setting, the expectation would be that you would see similar impacts in the adjuvant and neo-adjuvant.

So, I simplify it. If you're taking T-DM1 and metastatic and using it to replace the foundation therapy of Herceptin plus chemotherapy, that should at least be the starting point as you're thinking about it, in adjuvant. The question is whether you move that ahead of chemotherapy in adjuvant, and simply replace chemotherapy in total with T-DM1 or not. Adjuvant, as you referenced, is a relatively fragmented regimen or series of regimens today. To be able to simplify it with a more effective therapy that doesn't contain chemo, would seem to be an attractive path to pursue.

Just to clarify, it sounds like both the chemo start and then the Herceptin chemo part of the regimen is up for grabs. Do you see the tolerability as being good enough to, also, replace the subsequent, more than half year of Herceptin monotherapy?

Well, just again to frame the first part of your comment correctly, this is my view. This isn't a view that we're conveying from any discussion with Roche on the topic. Is the tolerability enough to replace Herceptin? There are open questions in terms of how long adjuvant therapy should last. If you bring a more effective therapy in with T-DM1, does that change the treatment paradigm for duration as well as what's used? Or will Herceptin still have a role? Can they keep patients on T-DM1 for a time and then move to Herceptin? I'm not sure -- you probably have a modestly more benign therapy with Herceptin alone, but all that remains to be seen, Thomas.

Thanks.

Jason Kantor with RBC Capital Markets.

Congratulations on all the deal-making that you guys have been doing over the last year. My question in regard to your bandwidth to do more. I know that you stayed pretty involved with your partners in terms of the early pre-clinical work on these conjugates. So, is it something that you're reaching some capacity constraint on at this point? Or could we expect more?

Well, it's something we spent an awful lot of time looking at, Jason. It's one that we can't -- we have some ability to manage, and we do that by placing caps on the level of support that we are obliged to provide to partners. For example in multi-target deals, to make sure that we don't over-obligate the organization. We also -- our support can come in stages, so that when we provide support, it may be exclusively for some of the early research around conjugate design, some of the downstream work will come into consideration later on, and we can decide whether we want to do that or not. The bias is, to do it, not necessarily for financial reasons, although that's not insignificant.

But for the reasons I noted earlier, that I think that the more work we do in this space enhances our knowledge base. To some extent, keeps the know-how in our shop as opposed to seeing it go elsewhere. So, we think we have the bandwidth metered pretty well at this point. We may selectively -- and we have been selectively adding resources to ensure that working with partners doesn't inhibit the support of our proprietary programs, but that's been relatively limited to date. I think we're okay for now.

Then, along the same line of questions with partners, we saw yesterday two Hem-Onc companies getting acquired, one next-generation antibody technology. I'm just wondering from your perspective, have you see more interest on the M&A side from partners in your discussion?

I wouldn't comment on that, Jason.

Okay. Thank you.

(Operator Instructions) Ryan Martins with Lazard.

My first question was around 901, can you give us some color on what the challenges have been in terms of terms of getting to the final dose for Phase II? Also, being studied in combination with etoposide and carboplatin, but if you can give us some idea on that? Then also, in terms of the Phase II trial, are you going to have any interim analysis in the Phase II? Your assumptions on historical PFS and overall survival in small-cell lung cancer patients?

Yes. Thanks, Ryan. The challenges, again, to the MTD really come into play because of the particular regimen that's used as standard chemotherapy for small-cell lung cancer patients, and the nuance to that is that there isn't a single regimen. The Docs work with two different standards when they combined etoposide and carboplatin. I don't think we fully either, appreciate it or certainly anticipated that, as we entered into the study. So, when we went through it, we realized to fully explore the appropriate dose, we need to look at both regimens. As a result, that took us longer to go through that than we had planned. That said, we're very close and may well be at the MTD. We have to confirm that, but that would allow us to move into the Phase II.

Your question on interim analysis for Phase II, I think we've talked to most, if not all, of you about the design of the study. Where we'll be recruiting 120 patients, 80 into the experimental arm and 40 into the control arm. What we're going to do is break that into two cohorts, so we will have 60 patients in the initial cohort. That will allow us to look at them as a separate subpopulation as that data matures, to gain some insight that will allow us to make decisions to compress the time it would take for us to move into a pivotal study here. So, we're doing this to get the fastest read that we possibly can. We're excited about the prospects for 901. We think that, this is a disease that is looking for additional solutions and we're looking forward to getting into the Phase II.

Okay. Then historical assumptions for PFS and overall survival in these patients?

PFS of for patients with small-cell lung cancer -- you're talking about five months in terms of PFS. So, these are patients that -- they respond to the basic chemotherapy, but without any durability. Survival is less than a year.

Okay. Thank you. One final question is, on the plans for T-DM1 in gastric cancer. If you could give us some idea of what [total] expression levels are, [firstly], in gastric cancer? Secondly, is this going to be looking at just HER2 positive patients in gastric cancer, or is it going to be based on the higher hard to express? You know there was better overall survival benefit in the trial that's happened.

My understanding is the expression in gastric, the HERP2 expression, is similar to what you see in breast cancer and that it's only about 20% of the gastric cancer patients over express at -- I don't know if they use the same metric, but at a 3-plus like level. That's the subpopulation for which Herceptin is approved today. If they pursue it, I assume that they would be looking at that same subpopulation.

Okay. Thank you.

Bret Holley with Oppenheimer & Co.

I'm wondering on the 853, you have obviously referred to ovarian cancers being the initial target. I'm wondering what other tumor types you find particularly attractive for 853? I think it's the follow-up question is, are you going to, I guess, concentrate ovarian cancer patients in the Phase I program for 853?

Bret, what we're going to do with that is, as you know, there's a lot of subcategories with 853, and the plan is to pursue a couple things there. One is, you want to look at what has the potential to be the fastest pathway to registration, while also trying to understand what the breadth is of the particular compound. The way we're setting up the study is that it's going to be all comers in the Phase I, but we're setting up sites that we specifically attract ovarian patients. We have some experience from some earlier studies to know that -- for 901 for example, when we were looking to attract ovarian patients as we're doing Phase I, we really couldn't get any of those patients unless we set up sites within women's health centers. So, we will be doing that, I think in the broader studies are those that aren't specific to ovarian patients, we expect to see a lot of non-small-cell lung cancer patients.

Okay. Thanks.

Cory Kasimov with JPMorgan.

Thank you, for moving your call to Friday. Two questions for you. One is on 901, I'm wondering if the Phase I portion of that study has given you any insight into how easy or difficult it may be to enroll the Phase II part of it? Then, the second question is more of a big picture for you. Again, it's around your proprietary pipeline, as you been building out the breadth of this pipeline with several new assets, can you update us on your latest strategic thinking? Or are you at the point where you're considering taking one or more of these candidates, if successful, all the way to the finish line by yourself to become a fully-integrated Company? Or alternatively, do you expect to partner these upon the concept? Thanks.

Thanks, Cory. As your comment about moving to the morning, pretty good attendance this morning. That indicates that maybe this was successful in getting this information to all of you directly.

I don't know that -- on your 901 question, about whether the insights about how easy or difficult to enroll. I'm not sure that we have a lot, really. Because as you know, Phase I should have a limited number of sites. Here we were not targeting our specific patient population, which in some ways would have lowered the bar a little bit.

I think, the fact that we're going to a number of countries, all the sites today are US. We will have a number of sites in Spain, UK, and Canada, will probably give us a different profile around recruitment. Getting away from later-stage patients and going to first-line patients will be an impact. One of the things that we've seen is that with later-stage patients, our screening has been very active. What we find is because you're dealing with later-stage patients, we run into some obstacles relative to the protocol, patients have brain metastases that exclude them from the study. So, maybe we'll run into different issues with first-line but I wouldn't draw conclusions off of the current patient population from what we might see when we get into the Phase II.

Your second question about, strategically, how do we view the pipeline and what might we do with some of these compounds if they're successful going forward. Our thinking certainly has evolved over the last several years. At one point in time, and this goes back probably three or four years ago. If you had talked to me about it, I probably would've told you that we would get compounds to a stage and then partner. I don't know -- our thinking now is that's not necessarily the path that we'll pursue. We think that there is the potential to take these forward.

Having the three compounds were talking about today and further expanding the pipeline, gives us a lot of opportunities of things to think about. We don't view there being any obstacles that couldn't be addressed that, wouldn't allow us to take a compound and fully commercialize it. It may not be on a global basis with one of the early compounds, that's a decision we can look at later. I think as we see data across the pipeline, and potentially -- hopefully positive data, it just opens up a number of different alternatives. Fully developing one of these compounds, one or more of them on our own is one of those options.

Okay. Thank you. That's helpful. One follow-up I just thought of, do you know how much Herceptin generates in sales in gastric cancer?

I don't. I don't know that, Cory.

Okay. Thank you for taking the questions.

At this time, there are no further questions in queue. I'd like to the conference back over for any additional or closing remarks.

Great. Thank you very much. Thanks all, for your interest in ImmunoGen. If you have any additional questions, please don't hesitate to call, and have a great day.