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Aratana Therapeutics, Inc. (PETX)
Q2 2013 Results Earnings Call
August 13, 2013 8:00 AM ET
Dr. Steven St. Peter - President and CEO
Louise Mawhinney - Chief Financial Officer
Steve Crowley - Craig-Hallum
Jon Block - Stifel
Josh Schimmer - Lazard Capital Markets
Tim Lugo - William Blair
Jose Haresco - JMP Securities
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Please note, this event is being recorded. I would now like to turn the conference over to Dr. Steven St. Peter, CEO. Please go ahead.
Dr. Steven St. Peter
Thank you. Good morning. This is Steven St. Peter, President and CEO of Aratana Therapeutics. I’m here with Louise Mawhinney, our Chief Financial Officer.
Welcome to the second quarter 2013 earnings call. Our first earnings call as a public company. This call is significant milestone, I mean, years of hard work behind and before us, and on behalf of the entire Aratana team let me begin by thanking each of you for your interest in this unique and exciting company.
Before we begin, I’d like to let you know that we will be making some forward-looking statements today. These statements involve uncertainties and risks, and therefore, should not be relied upon as predictions of future events.
Actual events and circumstances which maybe beyond our control may differ from today’s forward looking statements, including but not limited to as a result of the risks, uncertainties and other important factors set forth in our filings with the SEC.
For those of you who are new to Aratana story, let me briefly restate our business strategy. So, Aratana is focused on the licensing, development and commercialization of innovative medications for pets -- for pet therapeutics. Our strategy is to in-license proprietary compounds from human biopharmaceutical companies and to develop these product candidates in a capital and time-efficient manner.
We believe that this pet therapeutics will permit veterinarians to manage pet’s medical need safely and effectively resulting in longer and improve quality of life for pets and strengthening the human pet bond.
Over the next 20 minutes, we will provide an update on our product development efforts, followed by a business development update and conclude with the financial results for the quarter and financial guidance. We are pleased to take questions following the prepared comments.
With respect to product development, product development continues to be on track with what we discuss at the time of our initial public offering. The anticipated first launch date for each of our products, AT-001, AT-002 and AT-003 continues to be 2016.
In a moment, I will give some topline product by product updates, but I also want to announce that Aratana will be hosting an Investor Day to comprehensively layout the pet therapeutics regulatory framework and provide additional product develop -- product updates. That event is called our Pet Therapeutics Primer and Product Update and it will be on September 11th from 6 to 7:30 Eastern in Boston. We will be able to accommodate a few dozen investors in person but the event will also be webcast live and then available on our website afterwards.
Here is what we will cover? First, a regulatory framework at the FDA Center for Veterinary Medicine or CVM will be explained by Dr. Linda Rhodes, Aratana’s Chief Scientific Officer. Dr. Rhodes will discuss the three concurrent regulatory works stream for pet therapeutics approval namely safety, efficacy and manufacturing. She will also discuss the mechanics of filing an administrative New Animal Drug Application or NADA, and a subsequent notification of approval.
Although, the focus will be on the U.S. regulatory process, Dr. Marie-Paul Lachaud, Aratana’s Head of Drug Development in Europe will also participate. Our Vice President of Chemistry, Manufacturing and Controls, Tammy Newbold; and our Vice President of Manufacturing, Don Stitzenberg will also be available.
We will then move to a product by product update by Dr. Ernst Heinen, Aratana’s Head of Drug Development and Evaluation. We will have time for Q&A after each session and more information about this event is available on our website.
So now let me transition and provide the product development updates. First, AT-001, our EP4 antagonist for the treatment of pain. With respect to dogs, we are pleased to announce that earlier this month we completed enrollment in our dose-ranging field study. We had over 400 dogs screened.
We expect the result before Thanksgiving and we will send out press release of the topline results when they are available. We will discuss these results with the CVM to reach concurrence with them on the next steps for the pivotal efficacy submissions, including additional trials if needed.
With respect to our work with AT-001 in cats, we anticipate initiating additional proof-of-concept study this month to further explore the therapeutic window. As we previously disclosed in the S-1, we saw good efficacy signal but have some unwanted liver function effects. We will explore three doses in these new cats study and obviously, we are looking for an effective dose with the widest safety margin. We anticipate the results of the cat proof-of-concept study before Thanksgiving.
Next, I will discuss AT-002, our ghrelin agonist for inappetence. With respect to our dog program, we are continuing our discussions with the CVM to gain concurrence on the pivotal trial design for efficacy. This is obvious we are taking somewhat longer than we had anticipated during our road show, but we are focused on achieving the optimal outcome. We are also waiting to formulate clinical trial material from our contract manufacturer. We anticipate commencing the pilot trial in late 2013 or shortly thereafter.