ImmunoGen, Inc. (IMGN)

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ImmunoGen, Inc. (IMGN)

F2Q 2014 Earnings Conference Call

January 31, 2014 08:00 AM ET


Carol Hausner - Executive Director, IR and Corporate Communications

Dan Junius - CEO

Dave Johnston - CFO

Charlie Morris - Chief Development Officer


Adnan Butt – RBC Capital Markets

Simos Simeonidis - Cowen and Company

Cory Kasimov - JPMorgan

Joel Sendek - Stifel Nicolaus

Jason Kantor - Credit Suisse

Michael Schmidt - Leerink Swann

John Sonnier - William Blair & Company

Shaunak Deepak - Jefferies & Company

Andrew Peterson - UBS

Bert Hazlett - Roth Capital Partners

Steve Byrne - Bank of America



Good day everyone and welcome to this ImmunoGen Second Quarter Fiscal Year 2014 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 ma’am.

Carol Hausner

Thank you very much. Good morning. At 6.30 this morning, we issued a press release that summarizes our financial results for our quarter ended December 31, 2013, which is the second quarter of our 2014 fiscal year. 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 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, Dave Johnston will provide our financial results and guidance. We’ll 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 session of the call. Dan?

Dan Junius

Thank you, Carol, and good morning, everybody. We come into the 2014 with quite a bit of momentum having closed out 2013 with a high level of activity. We’re making important progress in our three wholly owned compounds in clinical testing IMGN853, IMGN529 and IMGN289. We also recently made the decision to discontinue development of IMGN901, and I’ll take you through that in just a moment.

Beyond our proprietary compounds, we’ve seen a significant uptick in partner activity in 2013, particularly in the latter part of the year. Clinical data was reported on six compounds by four partners in 2013. Data on four of these was in the latter part of the year. Also, Amgen, Lilly, Novartis and Sanofi opted licenses to our ADC technology in 2013. Four of these came in the back half of the year, two from Novartis. And we also took some steps to continue to augment our technology portfolio, in particular with a cross license with CytomX.

Let me walk you through the details of these, starting with our wholly owned compounds and let me start first with IMGN901. Recall that in November we announced we were stopping our IMGN901 small-cell lung cancer study. This was due to an imbalance of deaths due to infection without sufficient proof of benefit to justify continuation. Once we took that step we wanted to assess available data before deciding on any further paths for IMGN901.

As you might expect we did quite a bit of analysis and through that there was no suggestion of an issue with the compound or with the technology. However, the analysis was challenging as we had only a handful of events to evaluate for each different dimension that we were looking at out of the study. From that we were unable to identify a clear reason for the imbalance. We do suspect the combination -- that the combination played a role in increasing the level of infection from what one would see with etoposide/carbo alone, because that is we did see a level of infection in that arm of the study that did not include 901.

But out of that we’ve decided to discontinue development of the compound. This is certainly disappointing for us, for the potential that it offered to patient suffering for small-cell lunch cancer although I expect this outcome doesn’t come as a surprise to many of you.

With this decision we’ll now focus on our newer high potential products, and let me now turn to those. I’ll start with IMGN289. This is an ADC that targets EGFR. It advanced into the clinics since our last call. We are in the dose escalation Phase I study and enrollment is proceeding well. We’re looking for patients and enrolling patients likely to have EGFR positive solid tumors. And we’ll open expansion cohorts once we’ve established the maximum tolerated dose.

There is quite a bit of interest in this compound, part of it stems from this being a target EGFR that’s well known by clinicians. It also includes an active antibody, so it has potential of dual mechanism both from the antibody itself as well as from the cytotoxin in the ADC. It also parallels with Kadcyla both concerning the target and that it’s in the HER-B family and solid tumors as is HER-2 for Kadcyla as well as the design of the product it has the same linker, the same cytotoxin as Kadcyla.

The second proprietary compound I’ll mention is IMGN529. This is an ADC that targets CD37. As just noted with 289, it has the same linker, the same payload as Kadcyla. And also similar to 289, it has an active antibody and antibody that actually was very active pre-clinically. Right now we’re in dose escalation with this compound for NHL.

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