ImmunoGen, Inc. (IMGN)
F1Q13 Earnings Call
October 26, 2012 08:00 am ET
Carol Hausner – Executive Director, Investor Relations and Corporate Communications
Daniel M. Junius – President and Chief Executive Officer
Gregory Perry – Executive Vice President and Chief Financial Officer
Simos Simeonidis – Cowen and Company
Cory Kasimov – JP Morgan Securities
Thomas Wei – Jefferies & Company, Inc.
Joel Sendek – Stifel, Nicolaus & Company
Adnan Butt – RBC Capital Markets
Ling Wang – Summer Street Research Partners
John S. Sonnier – William Blair & Co. LLC
Matthew Harrison – UBS Securities LLC
Jason Kantor – Credit Suisse
Mara Goldstein – Cantor Fitzgerald
Ryan Martins – Lazard Capital Markets
Boris Peaker – Oppenheimer & Co.
Yale Jen – Roth Capital Partners LLC
Previous Statements by IMGN
» ImmunoGen's CEO Presents at UBS 2012 Global Life Sciences Conference (Transcript)
» ImmunoGen's CEO Presents at Morgan Stanley Global Healthcare Conference - Transcript
» ImmunoGen's CEO Discusses F4Q12 Results - Earnings Call Transcript
Thank you, good morning. At 6.30 this morning, we issued a press release that summarizes our financial results for our first quarter ended September 30, 2012. 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 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. Dan?
Daniel M. Junius
Thanks, Carol, and good morning, everybody. I think it was another good quarter progress for ImmunoGen. We are at a stage now where T-DM1 is undergoing regulatory review both in the U.S. and Europe. Roche has indicated that they expect commercialization in the U.S. to begin in the next few months. And based on this, we thought it would be appropriate time to provide more details on the financial terms of this license.
At the same time we have three wholly owned product candidates and seven other partner compounds advancing in clinical testing. We are seeing progress here with data on most of all of these compound expected in 2013. In addition, we look to have one additional proprietary compound entering the clinic in 2013.
So let me walk through the pipeline and I will start with T-DM1. Here as I think all of you know the lead indication is for treatment of HER2+ metastatic breast cancer in patients who previously treated with Herceptin. Across a couple of medical conferences we’ve heard how T-DM1 has significantly improved, both overall survival and progression-free survival easing the co–primary endpoints of the studies.
And this is done with fewer Grade 3 or greater adverse events. Based on this, marketing applications have been submitted in U.S. and in Europe in August and Roche has indicated the U.S. approval is expected in late 2012, or early 2013, and with European approval later in 2013. Approval for this use could open T-DM1 to all of the HER2+ metastatic breast cancer patients previously treated with Herceptin.
So that means, it would be for some first-line patients in the metastatic setting, as well as all second-line and later metastatic patients. While this is moving forward, the MARIANNE is continuing, patients have been Enrolled there with enrollment completed earlier this spring. Data now is now expected as early as late 2013. Approval here would open T-DM1 to the rest of the HER2+ metastatic breast cancer market.
As we look at early-stage breast cancer registration trials in three settings are on track to start in early 2013. This will include adjuvant, neoadjuvant and patients with residual invasive disease with first data, that being for the neoadjuvant patients expected in 2015.
At the same time, enrollment is underway in a trial assessing T-DM1 relapsed advanced HER2+ semi-cancer. Roche has indicated they expect to apply for this use sometime in 2015. We are often get asked about the potential for T-DM1 to capture much of the existing Herceptin market. While that certainly part of the picture, we believe there are other dimensions to consider.
T-DM1 is being developed for all of Herceptin key usage today, plus additional uses. HER2+ breast cancer, Herceptin is approved for first-line treatment of metastatic disease and for adjuvant use in patients with high risk disease, in other words, those patients who are node positive.
T-DM1 is being developed for both of these uses and more. For example, in metastatic breast the EMILIA trial supports T-DM1 for patients who previously received Herceptin, this would be a new indication for Roche. In early-stage disease, it’s being developed for neoadjuvant use and for treatment of patients with residual invasive disease following surgery, again two new markets.
Beyond indication expansion, T-DM1 is expected to be priced at a premium to Herceptin based on comments Roche has made. While T-DM1 pricing has not been disclosed, we know that recently approved Perjeta is priced at $5900 per month, compared to $4500 per month for Herceptin. Again, we don’t know T-DM1 pricing, but we think this provides some direction and potentially magnitude of where they may choose to position T-DM1.