ImmunoGen, Inc. (OKS)
Q4 2012 Earnings Call
August 3, 2012, 08:00 am ET
Carol Hausner - Executive Director, IR & Corporate Communications
Dan Junius - President & CEO
Greg Perry - EVP & CFO
Jim O'Leary - VP & CMO
Thomas Wei - Jefferies
Adnan Butt - RBC Capital Markets
Mara Goldstein - Cantor Fitzgerald
John Sonnier - William Blair
Ling Wang - Summer Street Partners
Boris Peaker - Oppenheimer
Cory Kasimov - JPMorgan
Yale Jen - Roth Capital Partners
David Miller - Biotech Stock Research
Good day and welcome everyone to this ImmunoGen, fourth quarter fiscal year 2012 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. Good morning. At 6:30 am this morning, we issued a press release that summarizes our financial results for our fourth quarter and fiscal year ended June 30, 2012. 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 for our fiscal year 2013. We will then open the call to questions. Our Chief Medical Officer Dr. Jim O'Leary will be available for the question-and-answer session. Dan?
Thank you Carol and good morning everybody thank you for joining us this morning. It’s been an eventful three months for ImmunoGen and for our technology across a number of fronts. At the ASCO session in early June, T-DM1 was featured in the plenary session with Phase III data from the EMILIA study. On a number of fronts this was impressive data that showed strong improvement in PFS versus the control ARM, very good tolerability and we also got some insight into survival.
At the same ASCO session or during that session, we also learned about Roche’s plans to expand T-DM1 into early stage breast cancer and that they will be starting three trials in 2013 demonstrating a strong commitment to all lines of HER2 positive breast cancer. At ASCO there was also encouraging data on another tap compound SAR3419 under development by Sanofi; recall this as a different design in T-DM 1 and you are looking at a different linker or different cytotoxin, obviously a different antibody. And in this case, the antibody acts solely as a targeting vehicle. There was interesting data there. Sanofi now is advancing SAF3419 in three Phase II studies.
At the same time there was visible progress on our own pipeline. Our Phase II compound IMGN901 had Phase I data accepted for presentation at a medical conference in early September and we also advanced IMGN853 into clinical testing. This is the second new compound we brought into the clinic this year.
So let me start by reviewing the T-DM1 data from ASCO. Again, this is from their lead Phase III study EMILIA which is evaluating T-DM1 in patients with HER2 positive metastatic breast cancer who previously received Herceptin antitoxin. This is often viewed second line therapy, but you should note that there are patients here who could be receiving T-DM1 as their first treatment from metastatic disease having received potentially Herceptin in adjuvant therapy.
The data here was presented at an ASCO plenary session by Dr. Kimberly Blackwell of Duke Medical Center. Note that, she also spoke separately at a Roche Investor Event later that same day and provided additional color around the data. You may want to listen to that on a webcast which remains available at Roche’s Investor website.
But turning to the data, the efficacy results continue to look very strong for T-DM1 and in particular in this study. What they confirmed was the significant improvement in PFS that they previously reported in topline data and while overall survivor data was not mature and was not expected to be mature, there was an insight into the overall survivor data.
First off, it was analyzed at this time because of the statistical plan called for interim analysis of overall survival when the PFS endpoint was reached. The study had been powered for overall survival analysis when 632 events occurred; these events being patient deaths. At the time, the PFS endpoint was reached only 223 events had occurred. Nonetheless, a hazard ratio was generated at 0.621 and that’s with the P value of 0.005. Dr. Blackwell noted that the data missed reaching statistical significance by just one event and I think that’s noteworthy when you have barely a third of the events that had been planned in the statistical design of the study.
What was learned that for evaluable patients at the time of the data cutoff, two years survival was 65.4% for patients receiving T-DM1 and that compares with 47.5% for patients receiving Tykerb plus Xeloda. And Dr. Blackwell described this difference as being huge. Obviously, a very encouraging trend for what one might expect to see as the patient population matures here.
In terms of tolerability, Dr. Blackwell also noted that the drug exposure was high with the two HER2 targeted therapies with 93.4% for Tykerb and 99.9% for T-DM1. This contrast’s with a 77.2% exposure for Xeloda which Dr. Blackwell noted was what she would expect based on prior studies. 53% of the Xeloda patients had dose reductions, again reflecting tolerability issues.
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