PETX

Aratana Therapeutics, Inc. (PETX)

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Start Time: 16:52

End Time: 17:26

Aratana Therapeutics (PETX)

Q1 2014 Earnings Conference Call

May 13, 2014 04:45 PM ET

Executives

Steven St. Peter - President and CEO

Craig Tooman - CFO

Analysts

Timothy Lugo - William Blair & Company

Jonathan Block - Stifel, Nicolaus & Company

Jose Haresco - JMP Securities

Douglas Tsao - Barclays Capital Inc.

Presentation

Operator

Good morning, and welcome to the Aratana Therapeutics’ First Quarter 2014 Earnings Conference Call. All participants will be in listen-only mode. (Operator Instructions) Please note this event is being recorded.

I’d now like to turn the conference over to Dr. Steven St. Peter. Dr. Peter, please go ahead.

Steven St. Peter

Thank you, Ed. Good afternoon. This is Steven St. Peter, President and CEO of Aratana Therapeutics. I’m here with Craig Tooman, our Chief Financial Officer.

Welcome to our first quarter 2014 earnings call. I’ll make a few opening comments, then review the continued progress and product development. Craig will then review the financial results. After the prepared comments, we’re pleased to take questions.

Before we begin, I’d like to let you know that we’ll be making some forward-looking statements today. Actual events and circumstances which maybe up 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 risk factors set forth in our filings with the SEC.

For those of you that joined our full-year 2013 earnings call in March, you will recall that we discussed at a high level the impact of the Okapi Sciences acquisition and the subsequent secondary financing. Today we’re pleased to present our first quarter 2014 results as a single integrated Company.

Some highlights. On January 29, we announced the USDA license for AT-005, our canine specific monoclonal antibody against CD-52, which is intended as an aid in the treatment of T-cell lymphoma in dogs. In March, we entered into an immuno-oncology development agreement with Advaxis. The first product in development is an immunotherapy for canine osteosarcoma.

During the quarter, Aratana had a patent issue related to targeting CD-52 in T-cell lymphoma. Two patent applications filed on AT-001 and one patent application published for AT-002. Since the beginning of the year, we’ve added three new Board members. And today we confirm that product development continues to be on track. The anticipated launch dates for each of AT-001, AT-002 and AT-003 continues to be 2016.

We expect that AT-004 and AT-005 were received four USDA licensure by 2014 and ’15 respectively. At Aratana we are singularly focused on bringing the best of science and human medicine to pets. We’ve invested aggressively, but appropriately and we continue to demonstrate our ability to execute well on this ambitious agenda. We believe Aratana is well positioned with a human capital and financial capital to realize our vision for the Company.

So now let me transition and provide some specific product development updates. First, AT-001, which is our EP4 antagonist for the treatment of pain associated with osteoarthritis. As we announced earlier this week, we’ve initiated the pivotal field effectiveness study in dogs.

If the results which we anticipate in late 2014, or shortly thereafter, are favorable, commercialization will commence upon approval, which is still anticipated to be in 2016. With respect to AT-001 in cats, we met with the FDA in March regarding the design of a pilot field study and a chronic pain indication. And we intent to initiate that pilot study this quarter.

I’ll now discuss AT-002, our ghrelin agonist for inappetence. The Company previously announced that it has initiated its pivotal field effectiveness trial in a 150 client-owned dogs and I’m pleased to report that enrollment is progressing well. We continue to expect top line results in the first half of 2015 and the Company continues to anticipate U.S. approval in 2016.

With respect to AT-002 in cats, we met with the FDA in March and presented a study protocol to treat chronically diseased client-owned cats. In this study we will measure appetite stimulation and body weight. The pilot field study design and safety protocols are now being finalized and we anticipate starting a field study in mid 2014.

Next AT-003, our liposome bupivacaine injection for post-operative pain. The pilot field studies have started and we will initiate a new field study and client-owned dogs in the second quarter of 2014. This study will evaluate AT-003 for post-operative pain management following orthopedic surgery. We expect to initiate a proof-of-concept study in laboratory cats in the coming weeks.

Let me turn now to our antibody franchise. First, AT-004 as an aid for the treatment of B-cell Lymphoma in dogs, I’m pleased to report that we now expect a full license in 2014, which is more accelerated than previously anticipated. Furthermore, Aratana will be submitting manuscripts to peer reviewed journals on two separate studies, investigating the utility of AT-004 in combination with certain chemotherapy protocols, and these studies are supportive.

However, I remind you that AT-004 is partnered with Novartis Animal Health in the U.S. and Canada. So Aratana does not control the commercialization of this product.

Next as previously mentioned in the quarter, we received a conditional license from the USDA for AT-005 is an aid in the treatment of T-cell Lymphoma in dogs. We are pleased to announce today that enrollment for the trial for full licensure has been completed and we continue to expect full USDA licensure in 2015.

We’ve initiated two additional studies to create data that will help position the product in chemotherapy-based cancer treatment protocols. Upon completion of the enrollment of these trials, which we anticipate to coincide with a Veterinary Cancer Society Annual Conference, in October 2014, we will make our product available for commercial sell to our investigators and selected other sites. Hence, starting in late 2014, we anticipate generating product revenue, but modest revenue for AT-005.

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