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Array BioPharma Inc. (ARRY)
The 31st Annual J.P. Morgan Healthcare Conference Call
January 8, 2013 6:00 PM ET
Ron Squarer – CEO
Matt Lowe – JP Morgan
Matt Lowe – JP Morgan
Previous Statements by ARRY
» Array Biopharma's CEO Presents at Lazard Annual Healthcare Conference (Transcript)
» Array Biopharma Management Discusses Submitted ASH Abstracts - (Transcript)
» Array BioPharma's CEO Discusses F1Q2013 Results - Earnings Call Transcript
Good afternoon everyone. I’m very excited to be here today. We have had a great year of progress towards what’s going to be a very exciting year in 2013. And so I’m happy to able to walk folks through the very consistent and steady and I like to think predictable progress that Array continues to make. I’m going to be making forward-looking statements and so we ask you to consult our 10-K, 10-Q for discussion of relevant risk factors.
So, in a nutshell, there has been a lot of very significant events for us over the last year. We describe our company really in three buckets of value, the wholly-owned hem/onc programs for myelodysplastic syndrome and MDS, that’s ARRY-520 and ARRY-614. The MEK Inhibitors partnered with AstraZeneca and with Selumetinib and MEK162 with Novartis, and then a very substantial bucket of value in a long series of partnerships. We’ve also highlighted a couple of additional partnerships we’d like to see deliver near term non-dilutive value to the portfolio.
And so, really starting at the top with 520, we had a fantastic ASH with a lot of data which I’m going to touch on today. We believe that as our data matures, we’ll be talking to FDA in the not too distant future and then we’ll be in a position to make a Phase 3 decision later on this year. But certainly things are moving in the right direction for 520.
With 614, we committed to seeing FDA in 2012 and we did so in December and we’re pleased to share with you today that we have a clear path to market that we’ve agreed with the FDA and some options to explore as well. With that data and our new formulation maturing we believe we’ll have an opportunity to make a decision on Phase 3 later this year as well.
And then, just today as if on cue, Novartis did publish on clinicaltrials.gov the MEK162 NRAS melanoma study. And so, it is official Array now has its first Phase 3 program out there and in the clinic. We do also anticipate them continuing in BRAF and with other potential indications. With AstraZeneca, recently announced additional studies in lung cancer to support their registration path I’ll touch on that today.
And then, we did have a successful Phase 2 in our pain program. We are in partnering negotiations presented some great disease modification data at ACR. And then with 502 we remain on track to find – to look at the data really around the middle of this year, it is a blinded study and so we’re unable to give any more guidance than that. But it could be a very important value generator for the company. So consistent progress and looking forward to a very exciting year.
We continue to call out five potential Phase 3 start – decisions or starts in the case of 162, we’re there and data is going to drive those decisions. But we remain positive and hopeful across the portfolio. And we have now 11 Phase 2 programs with VentiRx and Celgene beginning our 11th Phase 2 and great partners, I’ll touch on in a moment.
We have a strong history of raising non-dilutive capital, having raised about $170 million from partnerships in the last two to three years. Very substantial value associated with our partnerships in terms of milestones and royalties, raised money late last year in order to enable us moving forward with our hem/onc programs, we’re very pleased to be in that position. And we believe that we have several other opportunities for additional non-dilutive financing going forward.
So, the pipeline and you’re familiar with this. The last product I didn’t mention, potential Phase 3 start is Danoprevir currently owned by Roche and we look forward to them announcing their decision during this year.
I’m going to touch now on our hem/onc programs because we’re very excited about the Multiple Myeloma, one of the largest hematologic conditions out there. We are initially focused on the very large refractory population. We have a unique mechanism, not a proteasome inhibitor, not an IMiD, and we think this is important because it holds promise for benefit in late stage patients who have failed both of those mechanisms but also the promise of offering synergy when combined with agents of those mechanisms. And I think the ASH data is really beginning to point in that direction.
So, I’ll start now with the complete single agent data that we presented at ASH. This was, we had initially presented some of this, prior ASH. I think what’s really striking other than a response rate that’s comparable to carfilzomib and you could argue better than POM as a single agent in similar populations, we were very impressed with the 19 months of survival that we’re seeing in that single agent study. Now we believe that Dex is going to be an important part of our path forward. And as with POM, when we add Dex, we do see an improvement. So, a couple of data points to focus on here.