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ImmunoGen, Inc. (IMGN)
Oppenheimer 24th Annual Healthcare Conference Call
December 11, 2013 1:00 PM ET
Daniel Junius – President and CEO
Boris Peaker – Oppenheimer & Co.
Boris Peaker – Oppenheimer & Co.
Previous Statements by IMGN
» ImmunoGen's Management Presents at Jefferies 2013 Global Healthcare Conference (Transcript)
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» Immunogen Inc's CEO Discusses Q1 2014 Results - Earnings Call Transcript
Thank you, Boris and thank you to Oppenheimer for inviting ImmunoGen to present the conference. Before we start, let me note that I will make forward-looking statements both during the presentation and during any Q&A that would follow. And I would point you to the Securities and Exchange filings that ImmunoGen has for risks associated with investments in the company. So in terms of the company today, I’m going to walk through a couple of things. I want to talk about where the company is from a stage standpoint, clearly a number of things have changed over the course of the year, the biggest being the approval of Kadcyla so we’ll talk about that a little bit. I think it does a number of things in terms of validating our technology. I want to walk through pipeline. We have a pipeline that continues to grow. We have three clinical compounds of our own, seven in the clinic, two partners and I’ll talk a bit about both our cash position as well as forthcoming in 2014. So starting with Kadcyla, so Kadcyla was approved earlier this year, just as a reminder this is a compound that utilizes the antibody from Genentech, trastuzumab to which we then applied our technology, which includes both our linker and our payload to come up with the molecule. I should also note that ImmunoGen has supplied the clinical material to support early stage studies as well as put together a process that was utilized by the selected CMO of Roche, to do a commercial scale process and get large scale manufacturing.
It’s important to note it’s the first ADC or a prevalent indication and the only ADC at this point with full regulatory approval. As I noted earlier, it provides important validation around our technology from a number of dimensions as well as the first commercial related revenue that the company has been able to generate. So commercialization has started. The compound was approved and launched in the U.S. in February of this year. Since then, it’s progressed nicely in international markets. Most recently was approved in Europe last month, in September it had approval in Japan and other international markets are coming along at the same time. I would note that while approval is taking place in many instances, reimbursement is the secondary issue that needs to be addressed. Sometimes there can be a gap between approval and commercial sales in some jurisdictions. What we’ve seen thus far, is a pretty healthy launch. U.S. sales grew for the seven or eight months that Kadcyla has been approved have been 152 million CHF, add in the international sales and it’s been about almost $170 million from approval through the end of September. And the label is for later stage metastatic HER2 positive breast cancer. So it’s for patients who have failed in earlier line of therapy that included Herceptin. With approval, what was seen with the registration study was not only improved survival quotations, but a significant increase rather in the quality of life before patients. So the tolerability benefits versus the standard of care for second line in later metastatic were pretty dramatic.
Where Roche is going with this is, is looking to commercialize on a pretty broad basis. The chart here shows that the three areas of approval today for Herceptin that being for first line metastatic breast cancer for adjuvant breast cancer as well for first line gastric cancer. Over time, there are studies in place that will take Kadcyla well beyond where Herceptin is today. So we have it approved now for late stage cancer, there is a study first line study in place that we would expect to lead to Kadcyla replacing Herceptin in first line metastatic disease. A number of studies underway in early breast cancer, it should be reading out from 2015 and beyond, the earliest reading out in 2015 as well as a study underway looking at Kadcyla in HER2 positive second line gastric cancer. And we think this could prove to be quite an interesting indication, given the prevalence of gastric cancer to some extent in the U.S. but even more predominantly outside the U.S. So as we see the geographies and the indications expand, that clearly represents an increase in commercial opportunity for Kadcyla and in turn, for ImmunoGen for the royalties that we generate. I think it’s also important to note that from the studies that we’ve seen thus far, patients stay on Kadcyla longer than they stay on Herceptin based therapy. So, again as you think in commercial terms, that expands the opportunity for revenue generation from Kadcyla and at least in the U.S. the pricing for Kadcyla is 2x what it’s been for Herceptin. So if you think about Herceptin today across whole indications, it’s been roughly $6 billion plus therapy, if you think about additional indications longer treatment, higher pricing, to the extent Kadcyla can move forward and replace Herceptin that represents a rather substantial commercial opportunity.