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Call Start: 08:00
Call End: 09:09
Q1 2014 Earnings Conference Call
October 25, 2013 / 8:00 a.m. E.T.
Carol Hausner – Executive. Director, IR and Corporate Communications
Dan Junius – President & CEO
Charlie Morris – Chief Development Officer
John Lambert – Chief Scientific Officer
Simos Simeonidis – Cowen and Company
Adnan Butt – RBC Capital Markets
Joel Sendek – Stifel Nicolaus & Company
Yigal Nochomovitz – Morgan Stanley
Cory Kasimov – JPMorgan Chase & Co.
Jason Kantor – Credit Suisse
Mara Goldstein – Cantor Fitzgerald
Thomas Wei – Jefferies & Company
Michael Schmidt – Leerink Swann
Bert Hazlett – Roth Capital Partners
Richard Resnick – William Blair & Company
Previous Statements by IMGN
» ImmunoGen's CEO Presents at 2013 Morgan Stanley Global Healthcare Conference (Transcript)
» ImmunoGen's CEO Discusses F4Q 2013 Results - Earnings Call Transcript
» Immunogen Inc. (IMGN) Management Discusses Q4 2013 Results (Webcast)
Thank you. Good morning. At 6.30 this morning, we issued a press release that summarizes our financial results for our quarter ended September 30, 2013, which is the first quarter of our 2014 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 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, discuss our financial results, including our updated guidance, and go through our anticipated events. Dr. Charlie Morris, our Chief Development Officer, will discuss our wholly owned product candidates. After our prepared remarks, we'll open the call for questions. Our Chief Scientific Officer, Dr. John Lambert, is here with us for the Q&A part of the call. Dan?
Thank you, Carol, and good morning, everybody. The last three months have been quite active, both with our own portfolio and our technology, as well as that of our partners, so it's exciting to be able to bring that all together and talk to you about it this morning. On the proprietary front, we're advancing four wholly owned clinical stage compounds. As Carol noted, Charlie will bring you up to speed on what's taking place there.
We also continued to augment our extensive ADC technology portfolio. Just this past week, we reported on a new family of payload agents that we called IGNs, as well as another new linker that we've added to our portfolio to use, potentially in future compounds.
At the same time, there's been extended clinical data coming out to support our flagship maytansinoid-based platform. Within the last couple of months, we've seen additional clinical data on this technology with Kadcyla, as well as with a compound from Sanofi, SAR 566658, and I'll talk more about those, later. Let me start by talking about Kadcyla, where over the last couple of months, we've heard more about sales, we've seen some additional data that's been published, there have been approvals in a number of jurisdictions, as well as more information on study plans that are coming up.
Starting with sales, they're developing nicely in the US. Recall that approval and launch took place in February of this year. As of September 30, Roche reported year-to-date sales in the US of CHF152 million or approximately $164 million. When they provided that update in their quarterly call, they noted that penetration in the second and third line metastatic patients, which represents the label for Kadcyla, is above 40% and they viewed it to be continuing to penetrate well. We found that to be quite encouraging.
This could benefit, to some extent, some data that was recently reported at the European Cancer Conference on the TH3RESA trial. This was a trial for patients with HER2-positive metastatic breast cancer who'd been previously treated with two HER2-targeted agents, Herceptin and Tykerb and with a taxane. The study was a randomized study, 2 to 1, to treatment with Kadcyla as monotherapy or physician's choice.
What the data showed is what we've seen in other studies. Kadcyla was found to significantly extend duration of progression-free survival. It roughly doubled it, taking it from 3.3 months to 6.2 months. This doesn't offer an opportunity to extend the label because as I noted, these are patients that were already covered under the existing label, but it is the third controlled clinical study in which Kadcyla has shown marked benefit over the current standard of care. It does provide additional support for that current label, as well as probably providing some talking points for the Roche sales force as they try to educate physicians on the possible benefit from use of Kadcyla.
On the approval front, approvals continue around the world with more expected. On September 20, we learned that the Japanese regulatory authorities had approved Kadcyla for use in Japan. Approvals are coming through in other jurisdictions. Also on September 20, we learned about a positive opinion from CHMP in Europe. That puts Kadcyla on track for approval in the later part of November in Europe. With the two approvals, US and Japan, and the recommendation in Europe, Kadcyla is on a very clear track for approval in the three largest pharmaceutical markets.
While all this is taking place, development continues for other indications. Roche, in an update on October 1, noted their plans for use of Kadcyla in the adjuvant setting. This came on the back of approval for Perjeta, for that same patient population for neoadjuvant use, but it was using the endpoint of pathological complete response. On the basis of that, Roche indicated that they plan to start a trial in the second quarter of 2014 assessing Kadcyla for neoadjuvant use with patients with HER2-positive breast cancer. Using that same endpoint, pathological complete response, they would expect to have that data by late 2015. They're already assessing Kadcyla for residual invasive disease in the KATHERINE study. As we know, they're looking at it for first line use in HER2-positive metastatic breast cancer in the MARIANNE study.