ImmunoGen, Inc. (IMGN)
F4Q10 (Qtr End 06/30/10) Earnings Call
August 04, 2010 04:30 pm ET
Carol Hausner - IR and Corporate Communications
Dan Junius - President and CEO
Greg Perry - SVP and CFO
Shiv Kapoor - Morgan Joseph
Pamela Bassett - Cantor Fitzgerald
Adnan Butt - RBC Capital Markets
Bret Holley - Oppenheimer
David Miller - Biotech Stock Research
Previous Statements by IMGN
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» ImmunoGen, Inc. F3Q09 (Quarter End 03/31/09) Earnings Call Transcript
Good day, and welcome everyone to this ImmunoGen's fourth quarter fiscal year 2010 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, Ms. Carol Hausner. Please go ahead ma'am.
Thank you. At 4 o'clock this afternoon, we issued a press release that summarizes our financial results for the quarter end, our fiscal year ended June 30, 2010. 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 the projections made. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings, which can also 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?
Thanks Carol and good afternoon everyone. Thank you for joining us. There certainly have been a lot of progress since our last quarterly call in April. The headline item would have to be that our BLA was submitted for T-DM1 in July, and this makes that the first TAP compound to go before the FDA or for that matter from a pay regulatory authority for potential marketing approval. So, it's certainly a big invention in the life of ImmunoGen. The results have a lot of clinical progress. We saw the first clinical data reported for IMGN388 compound at ASCO in June. The first clinical data we reported for a TAP compound used in combination that would be for the T-DM1 plus pertuzumab compound or combination also reported at ASCO.
Patient enrolment got underway in July for the second T-DM1 Phase III trial that named MARIANNE assessing it for 1st-line use. And meaningful new clinical data were obtained from the rate of TAP compounds enabling presentations to be scheduled or expected at each of the major upcoming conferences that would be ESMO, EORTC, ASH and SABCS.
At the same time the number of clinical stage compounds in that ImmunoGen is involved and continue to increase, that number was at six at the time of our last call, clinical testing with SAR650984 started in June and we expect patient dosing with SAR566658 to start shortly, that would bring the total to eight. We expect up to four more compounds to end the clinic in 2011, two to three would be through our partnerships and one being our wholly-owned ImmunoGen compound.
That wholly-owned ImmunoGen compound would begin the flow of what we expect to be a sustained stream of proprietary compound entering the clinic from our R&D program. Finally in the quarter, we conducted a successful financing raising $77.5 million from new and existing shareholders in a tough market environment.
Today I'm sure all of us will remember May 6 when the market drops a 1,000 points, nonetheless we had a full book, we actually upsize the deal slightly we issue with exercise and I think that it was had a very fair price and has accomplished some very important element, first it gave us the funding to allow us to be aggressive in the advancement of our own compounds and our pipeline and also gave us the flexibility to be firm in our business development negotiations which we think, which was a very important element that we are hoping to address through the financing.
Let me go through the product pipeline or our service T-DM1. As I noticed our marketing application was submitted in early July by Roche, it applied for accelerated approval, that would mean a decision to be forthcoming within six months which will take us to early 2011, very early 2011. This is for patients with advanced HER2+ breast cancer previously treated with multiple HER2 targeted medicine and chemotherapy, in other words third line and later use. It was submitted as a DLA, DLA for its longer protection than NDA filings under the new healthcare reform bill in some of those protections and supplemented what's afforded by a patented state.
Roche continued to make solid progress and development of T-DM1 for second line use, over a 185 clinical sites across 20 countries now really participating the Phase-III trial for this indication. Roche has noted that a successful this trial to use to support regulatory filing of T-DM1 in 2012, the second line use in the US and Europe. This then would make that the expected approval pathway for T-DM1 in Europe since the third line study will not be eligible for filing in Europe.
Patient dosing started in the Phase III trial MARIANNE in early July which assesses T-DM1 our first line use head to head with Herceptin used for the Taxane. This is also intended to support regulatory filings in the US and Europe.
Prior to starting this Phase III trial, Roche conducted a randomized phase-II trial assessing T-DM1 for first line use again head to head with Herceptin use with the Taxane, specifically Taxotere.