65MM Swiss = 69.5MM USD so slightly ahead of our guesses, with the help of IMS data. That's only about $2MM+ to IMGN. Until the get over the $700MM mark, or whatever the number that starts the 5%, the actual dollars to IMGN will be low, but still it's free and positive cash flow. When sales start to get to $2BB+ we will really have something. Of course, the market will anticipate that and the stock price will move in advance. I like the call for $20's by year end, or early 14.
Very respectable numbers so far. Taking the $9800 per month that Kadcyla sells for we can back out the number of patients treated. For Q1 that was ~1,965 scrips to make up the $19.26 million in sales. Assume those are repeat customer each month, so we added ~1,207 patients this quarter. Just using that growth and projecting out to Q3 and Q4 (and this does not include EU approval) we can estimate around $81.5 million in Q3 and $93.2 million in Q4. Royalties don't pay at the 5% level until were over $700 million in sales. For the year Immunogen can expect at least $7.3 million from the royalties, plus the $10 million milestone for US approval. I believe there is another milestone payment for EU approval, I will have to go back and look that one up.
This drug is going to be one of the biggest biologics ever sold once the additional indications are approved and the label expands. And we are off to a good start. The key to the success of these conjugated antibodies is the linker technology, and so far only IMGN and SGEN have proven their technologies are viable. This should help the analysts realize that the pipeline holds a lot more value than they giving it credit for. Hope to hear some positive developments out of the pipeline when IMGN hosts their earnings call.
slumdawg, from what I have read and think II remember, the average time for CHMP recommendation is something like 13 months. I think everyone who is hoping for EU sales this year will be disappointed. For reference, Erivedge was approved by the FDA in Jan '12 and received CHMP recommendation about 2 months ago and we are still waiting on formal EU approval. A similar timeline happened with Adcentris for SGEN. Kadcyla should be on some type of accelerated path based on its need but I don't know if the EU has such a thing, do they?
Sentiment: Strong Buy
By the way, Erivedge received conditional approval from the EU in mid-July. The condition is that Roche follow up with longer term safety data, under what time frame I do not know. Point is, that the conditional approval allows them to sell Erivedge in Europe, so it is essentially the same thing as approval. If Roche does not meet their commitments to the condition they would revoke, but that isn't going to happen. CRIS having a nice up day as well on those earnings numbers.
The EU works very much like the FDA, the accepted the filing last year. It was filed in the EU in September, a little later than the August US filing date. It was not until November that the FDA stated they had given the drug priority review, and I believe that also indicated the EU would give it a priority review as well. I see that it got approval in Switzerland in June. They have their own version of the FDA in that country, but I believe their access to the filing is via the EU submission. I am expecting to see the EU approval any time now, perhaps before Europe takes their August holiday break. If they did not grant an accelerated review as we think, then approval should come no later than September.
Those who can't wait in EU for approval and have money should just get treated in the US or Switzerland. Cancer can wait. Just sad that PFS is quite short though. We still need more drugs.