ImmunoGen Inc. (IMGN)
F1Q11 (Qtr End 09/30/10) Earnings Call
October 28, 2010 4:30 pm ET
Carol Hausner - Executive Director, IR and Corporate Communication
Dan Junius - CEO
Greg Perry - CFO
George Farmer - Canaccord
Shiv Kapoor - Morgan Joseph
Adnan Butt - RBC Capital Markets
Ling Wang - Brean Murray
Bret Holley - Oppenheimer
Matthew Lowe - JP Morgan
Adnan Butt - RBC Capital Markets
Curtis Wang - Needham & Company
Previous Statements by IMGN
» ImmunoGen, Inc. F4Q10 (Qtr End 06/30/10) Earnings Call Transcript
» ImmunoGen, Inc. F3Q10 (Qtr End 03/31/10) Earnings Call Transcript
» ImmunoGen, Inc. F2Q10 (Qtr End 12/31/09) Earnings Call Transcript
» ImmunoGen, Inc. F3Q09 (Quarter End 03/31/09) Earnings Call Transcript
At 4 o’clock this afternoon, we issued a press release that summarizes our financial results for the quarter ended September 30, 2010, which is the first quarter of our 2011 fiscal year. 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 the projections made. 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. Dan?
Thank you for joining us this afternoon. I want to start just with a remainder for everybody about our business model, as the event for the last quarter provided a pretty good illustration of how this model effect and how we are trying to execute against the model.
In the quarter, it is to develop our own compounds for a proprietary pipeline. At the same time in the context of business development to use that as a means to advance our technology and have it be a source of non-diluted cash.
In this business model and give us a number of ways to generate value for our shareholders certainly through our partner product achievement and for ImmunoGen certainly over the last several years that’s been the most dominant avenue because T-DM1 has gotten as much attention it has and we will talk about that in a moment.
That increasingly we are going to see advancement of our own products we updated that and we will talk about just come out from ESMO and certainly from business development in the last couple of weeks, we have had prominent development there. You are seeing certainly in the last several months how all of this fits together for our business model.
Let me talk a little bit about T-DM1 given that seems to attract the most attention. Since we spoke at our last quarterly conference call, you are all aware that Roche received the reduced file letter from the FDA for third line HER2+ metastatic breast cancer, which is a US event. This was announced in late August. It only affected their regulatory plan in the US.
At the same time and since then, Roche has continued to talk about their commitment to T-DM1 how it is a very strategic product to them. As I said, when we talked to you at the time of that announcement, this is still view to be a technical issue, not a fundamental one, relative to T-DM1.
It did impact the regulatory plan that Roche has for T-DM1 in the US and they now have been forced to look at the first filing for approval for T-DM1, as being in mid 2012 using data from the second line Phase III EMILIA study.
They also modified that study to add overall survival as a core primary endpoint, the other primary endpoint being is PFS, which is it was at the outset. At the same time, they have substantially expanded the trial now to 980 patients, it had previously been 500 and changed just under 600, so a meaningful increase, but not one it’s going to change the availability of the data for filing in mid-2012.
Recall that EMILIA is second line, so it will be filing for second line, but the same time they will be adding third line to give them a broader label. We have indicated they are looking to file for accelerated approval with PFS and then for full approval with OS, but all that is going to be subject to discussion with the FDA.
Now, the impact on us is that, it moves the potential approval, which would have been for third line for the final I should say to 2012 and approval probably into 2013 if the FDA chooses to approve.
Second line filings unchanged. That was always going to be based on data and filed in 2012 with EMILIA study and there has been no change in the EU either in timing or strategy as the second line and beyond was always to be part of a filing to take place in 2012.
The more direct impact on us is the potential approval milestone that we are looking at to receive in fiscal FY ’11, our current fiscal year, obviously gets pushed out to whatever approval would take place post the second line filing. Recall, we had to mentioned that is being an eight figure milestone, but low eight-digits less than $15 million
The start date for any royalties on third-line sales would now come with that subsequent to the filing and again with the potential approval, so that could push out as well, but within our financial plans in the guidance we provided. Our ambitions here on royalties were conservative so, that’s not a meaningful impact on our financials.