ImmunoGen, Inc. (IMGN)
F3Q10 (Qtr End 03/31/10) Earnings Call Transcript
April 29, 2009 4:30 pm ET
Carol Hausner – Executive Director, IR & Corporate Communications
Dan Junius – President & CEO
Greg Perry – SVP & CFO
George Farmer – Canaccord Adams
Shiv Kapoor – Morgan Joseph
Joel Sendek – Lazard
Bret Holley – Oppenheimer
Pamela Bassett – Cantor Fitzgerald
Ling Wang – Brean Murray
Jason Kantor – RBC Capital Markets
Previous Statements by IMGN
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Thank you and good afternoon. At 4 o’clock this afternoon, we issued a press release that summarizes our financial results for the quarter ending March 31, 2010, which is the third quarter of our 2010 fiscal year. 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 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?
Thanks Carol and good afternoon everybody. There's certainly a lot to talk about both with respect to T-DM1, which has gotten a lot of attention of late as well as the rest of ImmunoGen's pipeline. There's certainly a lot of excitement around T-DM1. There's a growing awareness that it could be on the market in late 2010 or early 2011 and generating royalty revenue to ImmunoGen.
Roche has mentioned that this is a product that can have peak sales of anywhere from 2 billion to 5 billion Swiss Francs. And while T-DM1 is the most advanced compound in our pipeline, it is not the only one. In addition to T-DM1 and its many trials, today we have five other compounds in the clinic across eight trials.
By the end of this year, we expect to have seven compounds in the clinic in 13 trials and by the end of 2011; we will look to have another two to four compounds or 9 to 11 in total across as many as 20 trials. I think that what this reflects is a product portfolio that's becoming more advanced and broadening.
Clearly, there's the potential for the first marketed product in T-DM1 in the near term. We also expect at least one more phase III trial with T-DM1 to start this year. At the same time, sanofi-aventis expects to begin phase II testing with their first TAP compound, SAR3419, later this year.
We have three trials underway with our lorvotuzumab mertansine compound including a combination trial in multiple myeloma. This is the compound formerly known as IMGN901. We also expect to start a randomized trial later this year in small cell lung cancer and we're exploring initiating our first pivotal trial with the compound in 2011.
We have a second proprietary compound, IMGN-388 in phase I testing and we expect to advance a third proprietary compound into the clinic next year. What all this means for us is that we have a wealth of anticipated events in the coming months, that includes clinical data presentations, new product starts, regulatory events, etcetera. But we expect this activity – this level of activity to accelerate not just through the balance of this year but going forward, 2011 and beyond.
Through T-DM1, we have the potential for sustained and growing revenue from royalties starting in our 2011 fiscal year, which begins this July 1. But all this helps establish that our TAP technology can achieve new drugs for prevalent cancers that represent, to use the words of Roche's Global Head of Product Strategy and Chief Marketing Officer, a revolution in cancer care.
Let me start with T-DM1 and the most recent news around it. April 15 Roche disclosed they met with the FDA and based on these discussions that they planned to apply for U.S. marketing approval for T-DM1 in 2010. The basis of the application is the phase II trial whose preliminary findings were reported at the San Antonio Breast Cancer Symposium last December.
Roche reported that the FDA reacted to the data with great enthusiasm as the data are very strong. Further, Roche indicated that they will seek expedited review, which will enable T-DM1 to be available if approved by later this year or early 2011.
We've already started to see teaser ads sponsored by Roche/Genentech in clinical oncology journals. In their most recent communication, that would be their Analyst Day held in March and their quarterly call early this month, Roche noted that T-DM1 has shown what they call unprecedented efficacy in heavily pretreated HER2 positive metastatic breast cancer. They also noted that T-DM1 has shown better tolerability as a single agent than standard chemotherapy-containing regimens. And it's their view that the pricing of T-DM1 could be more aggressive than that of Herceptin. They indicated that they believe that Herceptin is underpriced and T-DM1 offers an opportunity to address this.