Array BioPharma Inc. (ARRY)
F4Q10 (Qtr End 06/30/10) Earnings Call Transcript
August 10, 2010 9:00 am ET
Tricia Haugeto – IR
Bob Conway – CEO
Mike Carruthers – CFO
Kevin Koch – President and Chief Scientific Officer
Eun Yang – Jefferies
Edward Tenthoff – Piper Jaffray
Stephen Willey – Stifel Nicolaus
Previous Statements by ARRY
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Thank you, Lisa. Good morning and welcome once again to Array BioPharma's conference call to discuss our financial results for the fourth quarter and full year of fiscal 2010. You can listen to this conference call on Array's website at www.arraybiopharma.com. In addition, a replay of the conference call will be available via telephone for the next seven days and via the Internet.
I'd like to introduce Array's Chief Executive Officer, Bob Conway, and our Chief Financial Officer, Mike Carruthers, who will lead the call today. I'd also like to introduce Kevin Koch, our President and Chief Scientific Officer, and David Snitman, our Chief Operating Officer and Vice President of Business Development who will be available to answer questions as needed.
But before I hand over the call to Bob, I would like to read the following Safe Harbor statement. The matters we are discussing today include projections or other forward-looking statements about the future results, research and development goals of Array and its collaborators, and future financial performance of Array. These statements are estimates based on management's current expectations and involve risks and uncertainties that could cause them to differ materially from actual results.
We refer you to risk factors discussed in our filings with the SEC, including our annual report filed on Form 10-K for the year ended June 30, 2009 and in other filings Array makes with the SEC. These filings identify important risk factors that could cause actual results to differ materially from those in our projections or forward-looking statements.
Now I would like to turn it over to Array's CEO, Bob Conway.
Thanks, Tricia. Thanks for joining the call this morning to discuss Array's fourth quarter and full year results for fiscal year ending June 30, 2010. I hope everybody got a chance to review last night's press release. We're pleased to report on our progress this past quarter and full year in both our proprietary and partnered programs.
During fiscal 2010, we raised $110 million in non-dilutive capital from our partners, largely from our deals with Novartis and Amgen. Today we have nine partner drugs in clinical development and three significant discovery collaborations, which are beginning to add to our partner development portfolios, as drugs move from the research collaborations into clinical development.
If you add up all the economics in these partner programs, we have potential upside of $2.7 billion in milestone payments and double-digit royalties on multiple programs. As of June 30, we had $129 million in cash and marketable securities. If you add this to our projected milestones, both for the coming year and in future years, we are well positioned to advance our pipeline of 100% owned Array drugs.
Let me start today talking about our partnered programs. And the first programs I’d like to review are our two MEK partnerships. One is with Novartis and the other with AstraZeneca. As you recall, in April 2010, Array partnered with Novartis for the worldwide development of 162 – of ARRY-162, which has now been renamed MEK162. Array received an initial payment of $45 million and is eligible to receive an additional $422 million if certain clinical regulatory and commercial milestones are achieved.
Our agreement provides Array with double-digit royalties on sales of approved drugs outside the United States with a significantly higher royalty rate for US sales, provided Array meets its development for co-funding. Also, Array has a co-detailing right in the United States.
Over the past year, we’ve made tremendous progress with 162, and during fiscal 2010, we filed an IND that cleared FDA on August 15, 2009. We completed a Phase 1 trial and reached MTD in January 2010. In April 2010, we initiated a Phase 1 expansion trial in biliary tract cancer patients at 10 clinical sites in North America. And we also did the Novartis deal in last April.
Going forward, we are initiating a second Phase 1 expansion in KRAS mutant colorectal cancer patients. We are also planning to initiate a very large randomized Phase 2 trial in patients with KRAS mutant colorectal cancer later this calendar year. Novartis is in the planning phase to initiate a number of clinical trials in the coming year.
Our second MEK inhibitor that I’d like to talk about today is our one with AstraZeneca. AstraZeneca presented positive Phase 1 results at ASCO on AZD6244, also known as ARRY-886, which we think was overlooked in the flood of data presented at ASCO this past year. The study evaluated two doses of 6244 in combination with four different chemotherapies and had a 56% response rate in patients with BRAF mutations and observed progression free survival of greater than seven months, whereas no responses were observed in patients with wild-type BRAF.
This is the first disclosed efficacy data with the new formulation of AZD6244. While previously reported data were with a mix in drink formulation, the new solid dosing form provides twice the drug exposure at a preferred dose. AZD6244 is being tested today in four multi-arm randomized Phase 2 trials.