ImmunoGen, Inc. (IMGN)
Analyst and Investor Day
April 12, 2013 8:30 AM ET
Carol Hausner - Head of IR
Dan Junius - CEO
Charlie Morris - CDO
Jim O'Leary - CMO
John Lambert - CSO
Greg Perry - CFO
Marshall Urist - Morgan Stanley
Adnan Butt - RBC Capital Markets
Cory Kasimov - JPMorgan
Matthew Harrison - UBS
Mara Goldstein - Cantor Fitzgerald
Thomas Wei - Jefferies
Boris Peaker - Oppenheimer
Bret Holley - Guggenheim
Previous Statements by IMGN
» ImmunoGen's CEO Presents at Citi 2013 Global Healthcare Conference (Transcript)
» ImmunoGen's CEO Discusses F2Q 2013 Results - Earnings Call Transcript
» ImmunoGen's CEO Presents at the JP Morgan Healthcare Conference (Transcript)
Our meeting agenda today, we will start with introductory remarks by our CEO Dan Junius who will talk about ImmunoGen and how we are changing the paradigm of the treatment of cancer. We will then have Dr. Charlie Morris who joined us is a most recent member to join our management team, who is our Chief Development Officer and he will talk about development at ImmunoGen. And then Jim O'Leary who is our Chief Medical Officer will talk in more detail about how we are advancing our clinical stage compounds.
We will then have a break that is about 10 minutes and I know that there is a temptation to want to ask questions during this period. I would like to ask everybody just hold their questions till the official Q&A so that they can be webcast. This whole event is being webcast and we do want your very important questions to be webcast.
Dr. John Lambert, our Chief Scientific Officer will talk about IMGN289 which we just unveiled data for at ACR. And then our Chief Financial Officer, Greg Perry will talk about investing to build value. We will then open the floor to questions. We have a lot of time allowed for Q&A, we welcome your questions and then Dan will be back with closing remarks.
As I mentioned, the whole event is being webcast. In the course of this event, we will of course make forward-looking statements and of course there are risks and uncertainties around forward-looking statements so we encourage you to review our SEC filings including our risks factors in them including our latest 10-K.
And on that, I will turn it over to Dan.
Thank you Carol and let me add my welcome this morning. We appreciate everyone taking the time to join us to get an update on ImmunoGen. Well we have other members of management in addition to the speakers’ here this morning. We will introduce them as we get to the Q&A because we want them to participate in that portion of the program.
We also want to introduce, we have three of our Board members who have joined us this morning. I want to both introduce and thank them for joining us; Dr. Joe Villafranca is with us, Dr. Nicole Onetto is with us and Howard Pien is with us as well so again thank you for joining us.
Let me start in talking about maybe somewhat in a high-level fashion talk about changing the paradigm of how cancer is treated and I don’t we are understating that given that the events that have taken place and how this space is evolving. From a company standpoint, we start with a foundation of a very strong technology platform, and it’s probably worth pausing a moment just to give my view of what that technology platform represents because it’s often misconstrued and viewed to be well ImmunoGen’s technology is its linker or its cytotoxic agent. What you really have is I think is an integrated system of a number of elements that compose the platform so it certainly is the linker. We have we think very interesting linker technology that forms the basic task of keeping a cytotoxin attached to the targeting antibody. But it also conveys certain properties on the cytotoxin when it’s released within the cell; the cytotoxin itself is not simply chemotherapy as it’s often referenced but a highly potent purpose developed agent that is used in the context of this whole system. And it also is, is the antibody itself, currently our targeting vehicles is for restricted antibodies and then in the future you may see other vehicles that are used to deliver a payload.
And all of this is supported by a very deep body of knowledge around both the technology itself as well as the biology of a cancer cell that we need to interact with to have this whole system to be effective.
So from a technology platform, I do think it’s a good starting point to talk about where the company is going. We believe this technology platform is certainly best-in-class. We now can talk about demonstrated success with our first approved therapy. And it’s a platform in which we continue to invest and innovate. I referenced our linkers; we have four linkers that are in the clinic today across a number of different compounds. We have additional linkers that we have developed that we test as we are looking at new formulations. I am sure we will be coming up with additional linkers that can convey additional properties to future compounds. Cytotoxins, we are looking at other cytotoxins that may have therapeutic window in some diseases that are current tubulin -based technology can't meet.
So it is a dynamic area where we are continuing to try to evolve the technology. What it’s led to for us is a very robust and expanding platform and one that importantly is addressing or looking to address a variety of unmet medical needs for patients. Today we stand with one approved product. We will talk about that in just a moment. We have three wholly-owned clinical stage programs.
There are seven additional clinical stage programs from our partners and there is a very deep pre-clinical portfolio both for ourselves and from our partners. Out of that, pre-clinical portfolio you will see another compound coming into the clinic at the back half of this year. We will spend some time this morning talking about some of the pre-clinical data that has led to, it’s been involved in building that particular compound.
And the technology has potential, not simply in liquid tumors but in solid tumors as well. We think that is very important being able to extend this technology. All of this, being focused on the promise that it delivers, and that is being able to transform how doctors are able to treat their patients.
The first product now is approved. So, Kadcyla is going commercial. Also in a minute, I will talk about some data that came out yesterday from Roche around the success that they are having with that introduction. You are aware of the data that came out of the AMELIA study, it showed significant improvement in overall survival, better tolerability and that was in a head-to-head study against Tykerb plus Xeloda.
It’s important to appreciate that the population that it served in that particular study was Herceptin failures. These were patients who were no longer responding to a Herceptin-based therapy. And the reason that's important is I think it speaks to the fact that these patients were benefitting from the enhancement of the ADC technology as opposed to any inherent characteristics of the underlying antibody that you would otherwise anticipate.
With Kadcyla it represents the first ADC that’s been approved for a solid tumor indication; that's important because about 90% of all cancers that are diagnosed are solid tumors. In absent surgery, they then tend to be more difficult to treat particularly when they are first diagnosed often in a metastatic state.
And finally what you see is tolerability benefits of this targeted approach using our maytansinoid-based payload. Historically, the treatment for cancer, as you would push to the maximum tolerated dose and you had efficacy but a very significant issue in terms of patient tolerability. I think what we are seeing with the approval of Kadcyla is the ability to have a very effective treatment while allowing continued good quality of life for the patient.
So, we talk about changing the paradigm, how is it that we think we are changing the paradigm. You now have with the approval of Kadcyla a personalized therapy; so it’s a targeted program that provides enhanced efficacy which in the case of Kadcyla with much better tolerability than other alternatives that are available.
I think as these programs evolve what you will see is there are instances where the more effective application is going to be in combination with another therapy but again because of the nature of this targeted therapy that we have today, we can add that on to existing therapy and maintain that tolerability level while providing enhanced efficacy.
So, we look at Kadcyla has now as we no longer have to speak about the promise of our technology that technology has been delivered and that's extremely important. I think this notion of changing the paradigm really was manifest when we came out of ASCO. It’s certainly something that we have believed as we have been developing this technology over a number of years.
But what you heard from oncologists after they saw that Kadcyla data from the AMELIA study at ASCO they immediately extrapolated beyond the treatment of HER2-positive breast cancer and said this offers a new avenue, a new way to treat patients and so much of an oncologist’s time is spent dealing with side effects. The ability to have a therapy that was going to relieve them of that burden and the patient of the burden of having to deal with the side effects they saw as extremely important in how cancer therapy can evolve.
So, when we think about having this technology developing these products it raises a question. How is that ImmunoGen is going to take these forward? What is the opportunity? As we think about the compounds, the pipeline that we’re building we certainly are looking forward and looking at the potential of commercialization in the long run. But in the short run it’s our intent to maintain ownership of these compounds through proof-of-concept.
We think that, that getting to proof-of-concept de-risks the asset. It’s a very important inflection point in terms of value creation and we’ll see that as we go through our development; we’ll understand what the appropriate path is in terms of our ongoing involvement in these compounds. Each time that we’re generating clinical data, it presents our options to us for moving forward. I think those options will be enhanced based on the magnitude of the success as well as our own internal capacity to move these compounds forward, that would be on case-by-case basis.
Now as we think about a portfolio and we have to think in those terms given that we now will have four compounds in the clinic by the back half of this year. We want to be able to look the overall portfolio and be appropriately aggressive but at the same time not be overwhelmed by the scope of what’s involved. So we’ll be on an ongoing basis looking at how we balance that based on the data that’s generated from the portfolio.
An underlying tenet however is that as we look at what we do with these compounds, we want to ensure that we maintain a significant interest in U.S. rights. We think that that’s not a tremendous revelation. We think that the U.S. is a key market. We think that it offers the clearest path to commercialization for ImmunoGen.
At this stage, we have three clinical compounds that we believe are highly differentiated. We think each of them represents an opportunity to service a significant unmet medical need. In the case of the IMGN901 here is a Phase II compound currently in the study for small-cell lung cancer. This is a cancer that you’ll hear more about very aggressive with really no improvement in the treatment paradigm for at least two decades. For IMGN853 that’s in the Phase I study, we think that the principle indication that we will be pursuing here as ovarian cancer, another cancer that has a very poor prognosis on initial diagnosis.
And then finally IMGN529, this is in Phase I for non-Hodgkin’s lymphoma clearly an area where there’re varieties of therapies available for what is a broad disease that gets broken down into a number of subcategories; however, within then there’re many patients groups that today are underserved. So we think that the characteristic of 529 offers the opportunity to begin to address those unmet needs and you’ll hear more about that later.
The newest compound IMGN289 will be coming into clinic later this year. This is a compound that targets EGFR. Preclincally, it has shown very good efficacy in particularly models that are resistant to EGFR inhibition. All of these compounds are ADCs. They incorporate antibodies that we have developed, our linker technology and our payload agent.
So where are we today? Today, we’re investing to aggressively develop this pipeline. In that context however we’re looking to do that in a fashion that allows us to maintain financial discipline, I’ll come back to that in a moment. At the same time that brings the responsibility and the need to manage the organization as we advanced as we become broader as we have need for enhanced functions to address the additional sophistication and complexity that we faced as these compounds move forward.
While Kadcyla is important as a compound to provide us cash it also has now provided further validation of the technology not simply from a clinical standpoint but now also from a regulatory standpoint having passed the hurdle of receiving FDA approval. One of the dimensions that it introduces that we’re conscious and that we’ll be looking to take advantage of this increased awareness among physicians. This year for the first time we’ll have a booth at Askow to provide visibility to the physician community who is becoming actively engaged with the number of studies that we’re involved with today and that we’d anticipate starting in the future.