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Array BioPharma Inc. (ARRY)
UBS 2012 Global Life Sciences Conference
September 20, 2012 8:30 am ET
Ron Squarer – Chief Executive Officer
Andrew Peters - UBS
Previous Statements by ARRY
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Good morning everyone. It’s a pleasure to be here with you today. It’s been a very, very exciting time at Array. We’ve seen great progress with the stock up about 160% year-to-date, about 60% just in the last three months or so, really based on a number of items which are leading to the momentum with the company.
I am going to be making some forward-looking statements here that are associated with risk. For a full discussion of risk, please consult with our 10-K.
So for those of you who aren’t familiar with the company, there’s two quite remarkable things about Array. One is the quality of our pipeline. There have been INDs filed for 18 Array invented products. Fifteen of those products are still active and in development. A full 10 of them are in Phase II, and so it’s quite remarkable to see so many molecules stand the test of time and development with so many progressing to Phase II. What’s even more remarkable is as we look forward between now and the end of 2013, we see a potential of five Phase III starts as that very robust portfolio begins to emerge.
The other thing that’s quite remarkable about the company is our ability to partner with great companies and to see good value from those partnerships, so currently we have 10 partnerships with great companies like Novartis, AstraZeneca, Celgene, Amgen, Roche, just to name a few. And the value associated with those deals has been very robust. We’ve raised about $170 million in dilutive financing just in the last period, just over about two years, and just recently last year signed a deal for Genentech for a ChK-1 preclinical program. And just to give you a sense of the valuation of those types of deals, about 30 million upfront, milestones totaling as much as $700 million, and the potential for double-digit royalties.
If you add up all of our partnership, just the milestones, you get to about $3.4 billion that would emerge, assuming success, and that’s before royalties. And as you’ll hear today, we do have a number of additional great partnering opportunities but we also have the intention to take forward two products that are wholly owned by ourselves all the way to market. And in fact, what we’ve stated quite clearly as of our last quarter call is that it is our intention to progress with our two wholly-owned hem/onc programs – that’s ARRY-520 for multiple myeloma and ARRY-614 for myelodysplastic syndrome – we plan to take those to market ourselves.
Other important catalysts that have been part of the recent momentum include the results that we presented on our pain program, 797, quite remarkable results that I’m going to touch on today and we can also discuss further at the breakout session. But we did meet our primary endpoint of showing significant efficacy over the placebo arm and comparable efficacy to opioids in that study. In addition, many of you are familiar with the very impressive data that emerged at ASCO earlier this year, both with our Novartis partnered MEK162 – that would be in the NRAS mutant melanoma population – as well as the data presented on selumetinib, which is partnered with AstraZeneca that was in a KRAS mutant lung population. There was also an oral presentation on thyroid, and there is a lot of data that has been emerging around our MEKs beyond just ASCO. We also received a milestone associated with our Amgen diabetes collaboration just a few weeks ago, and we’ve seen the ChK-1 program at Genentech actually initiate a Phase I combination with gemcitabine, so a lot of very exciting progress in the portfolio.
As I mentioned, we are going to be progressing our two wholly-owned hem/onc programs and we expect to see the data emerge between now and the first half of next year to drive those decisions. We’ve announced that we will be partnering 797. We are in active discussions with a number of companies that have shown great interest in the program. We also initiated a Phase II for our asthma program, 502. We initiated that in February of this year. We expect to read that data out at ATS in May of next year, and that would provide another source of potential non-dilutive financing through partnership. We’ve also decided to partner our early stage diabetes program, the GPR119, in order to allow us to focus fully on our hem/onc portfolio.
So I’m going to touch a little bit on 614, which is one of our very exciting wholly-owned opportunities. The disease, just as a quick intro, is quite large – about 150,000 patients. We are specifically focused on the low risk Int-1 population which represents about 65% of the total. Within this population, initially we’re studying HMA failures. These are folks who have failed either Vidaza or Dacogen. For those who aren’t familiar with the disease, the burden is very heavy, leading to multiple cytopenias, and the prognosis for the HMA failure patients is quite bleak. Data will be emerging, we believe, later this year showing how short the median survival is for these patients, and that data has not been widely dispersed to date but we expect it to support our position with FDA that this is an extremely high unmet need population where patients have absolutely no alternative therapy.