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ImmunoGen, Inc. (IMGN)
F2Q13 Earnings Call
January 25, 2013 8:00 a.m. ET
Carol Hausner – Executive Director, IR and Corporate Communications
Daniel Junius – President and CEO
Gregory Perry – EVP and CFO
Charles Morris – Chief Development Officer
Simos Simeonidis – Cowen and Company
Ryan Martins - Lazard Capital Markets
Ling Wang - Summer Street Research Partners
Joel Sendek - Stifel Nicolaus
Marshall Urist - Morgan Stanley
Matthew Harrison - UBS
Adnan Butt - RBC Capital Markets
Karen Jay - JPMorgan
David Miller - Biotech Stock Research
Jason Kantor - Credit Suisse
Thomas Wei – Jefferies & Company
Yale Jen - Roth Capital Partners
Previous Statements by IMGN
» ImmunoGen's CEO Presents at the JP Morgan Healthcare Conference (Transcript)
» ImmunoGen's Management Presents at Lazard Capital Markets 9th Annual Healthcare Conference (Transcript)
» ImmunoGen's CEO Discusses F1Q13 Results - Earnings Call Transcript
Good morning. At 6.30 this morning, we issued a press release that summarizes our financial results for the second quarter ended December 31, 2012, the second quarter of our fiscal year. I hope you’ve all had a chance to read 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 and 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 with us for the Q&A session of the call. Dan?
Thank you, Carol, and good morning everyone. We look for 2013 to be a very important year for ImmunoGen. Certainly for TDM-1 there are number of significant events anticipated that would start with the approval and the launch in the U.S. sometime around or hopefully before the February 26 PDUFA date. We also look to see approval in Europe and launches to begin there over the course of this year as well as the continued advancement of their clinical programs across a range of indications and expansion into some additional areas that they’ve announced in terms of for early breast cancer.
At the same time we are looking for Merck to progress across our wholly owned pipeline. Over the course of the year we plan to have clinical findings in each of our three lead TAP compounds and we’re also preparing to advance the fourth IMGN289 to IND and into the clinic later this year. While we expect T-DM1 to provide a significant revenue stream to ImmunoGen we believe our own programs offer the greatest long term value for shareholders and therefore my commentary will focus on our wholly owned programs.
Before I get to that, though, I would like to comment on our organization events since our last call. As noted earlier, our proprietary programs are expected to generate important data over the course of this year. With this in mind, we established a new position of chief development officer to expand ImmunoGen’s skill set and knowledge base and to provide leadership to our expanding development activities. We’re very pleased to have Dr. Charlie Morris now with us in this role.
Charlie who over his career has been in senior medical research and development roles for Allos, Cephalon, AstraZeneca strengthens our existing capabilities toward understanding and experience in late stage development and registration strategy. We look forward to Charlie’s contributions in this new position.
So let me now turn to our wholly owned compounds and I will start with IMGN901 which is for CD56+ cancers. This would include a number of cancers including small cell lung cancer and the majority of multiple myeloma cases, Merkel cell carcinoma, neuroendocrine tumors, other hematologic diseases for CD56 is broadly expressed in a wide range of indications. Currently it’s in phase 2 testing for first line treatment of small cell lung cancer in our NORTH trial and I’d like to update you on that study.
Patient enrolment is underway at about 40 centers in the U.S., Canada, UK and Spain. I am pleased to report that we are very close to completing enrolment of the first 59 patients. These patients will represent the first stage in what is (inaudible) two stage design and we will follow up with this group as a cohort with the end point of PFS of six months. We expect to have this data in the back half of 2013. This will allow us time to complete enrolment of these patients, then follow them for six months and clean up and lock the database. We will report whether the trial met our predefined hurdle for the first 59 patients and that data and the end point will enable us to make certain development decisions particularly in the area of CMC but also it will enable us to seek further KOL input and begin discussions with regulatory agencies. Our intention is to report the data at a medical conference.
While we are looking at the first 59 patients, we will continue to enroll the 420 patients in the study and we’d expect to complete that enrolment over the course of 2013. If that’s accomplished (ph) we would then look to present the results from the full trial in 2014 and we (inaudible) targeting ASCO. While we are making progress in our small cell study we recently reported data in an oral presentation at ASH on multiple myeloma studies that we have undertaken. This is a phase 1 trial assessing IMGN901 used in combination with Revlimid and dexamethasone in patients with CD56 positive disease who are relapse or relapse refractory to earlier therapies.