ImmunoGen, Inc. (IMGN)

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ImmunoGen, Inc. (IMGN)

F3Q 2013 Earnings Conference Call

April 26, 2013 08:00 ET


Carol Hausner - Executive Director, Investor Relations and Corporate Communications

Dan Junius - Chief Executive Officer

Greg Perry - Chief Financial Officer

Dr. Charlie Morris - Chief Development Officer


Adnan Butt - RBC Capital Markets

Yigal Nochomovitz - Morgan Stanley

Joel Sendek - Stifel

Mara Goldstein - Cantor Fitzgerald

Thomas Wei - Jefferies

Yale Jen - Roth Capital

Jason Kantor - Credit Suisse

Matt Lowe - JPMorgan

Boris Peaker - Oppenheimer

Bret Holley - Guggenheim Securities

John Sonnier - William Blair



Good day, and welcome to the ImmunoGen Third 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.

Carol Hausner - Executive Director, Investor Relations and Corporate Communications

Thank you. Good morning. At 6:30 this morning, we issued a press release that summarizes our financial results for our third quarter ended March 31. I hope you have 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, Greg Perry, will discuss our financial results and guidance. We will then open the call to questions. Our Chief Development Officer, Dr. Charlie Morris is here for the Q&A section of the call. Dan?

Dan Junius - Chief Executive Officer

Thank you, Carol, and good morning to everyone. Thank you for joining us. This past quarter was a very significant one for ImmunoGen. We had the approval and launch of Kadcyla, the first product with our TAP technology. We also saw meaningful progress with our own pipeline. We are seeing good enrollment in the trials that we have underway with our three proprietary compounds and we reported preclinical findings on our fourth compound, which is on track to enter the clinic later this year. We are also seeing continued progress by our partners with the first clinical data reported by Bayer and the license taken by our partner, Novartis. All of this was done in the context of us continuing to maintain the strong financial position, as I will hear later from Greg.

Let me first mention talk about Kadcyla. The Kadcyla received FDA approval on the 22nd of February and launched immediately thereafter. All the indications are that it’s off to a very good start. There are reports of physicians contacting Genentech for product once it was first approved. There is also reports of reordering taking place within the first month. Roche indicated that Kadycla was incorporated into NCC and guidelines 19 days post approval, which is an extremely fast-paced. They also indicated that the Kadcyla sales for a month period or barely a month after it was approved were CHF18 million roughly $19 million. It’s too little data to extrapolate, but certainly it’s indicative of a strong start for the compound. This is the first ADC that received full FDA approval. We have certainly had clinical validation earlier, but we now can add to that regulatory validation. And it’s also the first ADC approved for a solid tumor indication.

Roche continues to make progress with its additional markets and indications. They have an application under review in Europe for the same indication as the U.S. approval off the EMILIA data. We would be looking for approval later this year, later 2013. I have also submitted in Japan again for the same indication. That application went in, in late January. Based on the MARIANNE data, which would be for first line treatment of HER-2 positive metastatic breast cancer, they would expect to apply in 2014 for approval in both the U.S. and Europe. Beyond this, they have a trial underway the trial is named GATSBY in advanced HER-2 positive gastric cancer. It would expect to apply for this use in 2015. In Friday, they have started the first Phase III trial in early breast cancer. This study is named KATHERINE. This is one of three early breast cancer studies planned to start in the first half of this year.

Let me now turn to our wholly owned compounds, and we discussed these programs extensively at our analyst event two weeks ago. So, my remarks today will be limited to highlights and updates. First, let me start with IMGN901, recall this is in Phase II testing for first line treatment of small cell lung cancer. It’s dosed in combination with etoposide and carboplatin in a randomized study. Our starting dose is now 30 milligrams per meter squared as discussed at our analyst event. This modified dose has been well received by study investigators. One clear indication of that is that the pace of patient enrollment remains very strong.

Based on the current pace, we would expect to complete patient enrollment by the end of 2013, this would include an additional 15 patients that we are adding to this study associated with the change in the starting dose. Our first look at efficacy will come in mid-2014 from the full now 135 patient study. IMGN853 as a folate receptor alpha targeting TAP compound for ovarian, lung and other solid tumors that over express this target. This trial is also enrolling well. We will report our first clinical data at ASCO, and this will be from the dose escalation phase of the trial. Once maximum tolerated dose is defined, we will be evaluating IMGN853 in patients with ovarian cancer or adenocarcinoma, non-small cell lung cancer in the expansion cohorts. IMGN529 is in Phase I testing for non-Hodgkin lymphoma. Recall this is a TAP compound, this is an active antibody. When the dose escalation phase which is open to most prevalent subgroups within NHL, we expect to report our first data at a medical conference in late 2013. Finally IMGN289, here we reported preclinical data at AACR just a couple of weeks ago. We had multiple posters which attracted considerable attention.

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