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Aratana Therapeutics (NASDAQ: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.

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.

The last antibody I will mention today is a new development project, AT-015, a Feline Anti-CD20 antibody for lymphoma. If successful, this will be the industries first monoclonal antibody approved for cats, which would be another tangible example of Aratana’s commitment to innovation.

And finally, let me conclude with a few comments on the remainder of our product pipeline. AT-006 for feline ocular herpes infection is being developed under an exclusive license agreement with Novartis Animal Heath. We continue to enroll cats in what could be the pivotal study in Europe and we anticipate an EU regulatory filing in early 2015.

While this partnered program is somewhat delayed, the product moves forward and we remain enthusiastic. With respect to AT-008 in Europe, a small molecule for canine lymphoma, we’ve decided to defer initiating a pivotal field effect in the study until we review data from a study being conducted by a third-party which has U.S. rights.

The other approximately half dozen pre-development and development programs continue to move forward. We’ve had no attrition. We remain enthusiastic about each and every program and we look forward to providing updates in the future.

We continue to expect to make a decision on each of the two remaining option programs in mid 2014. As we discussed at the Jefferies Animal Health Conference, in New York in late March, one of the therapeutic categories that we’re covering in our option program is atopic dermatitis, the CRTH2 target specifically. And this concludes the development update.

I’ll now talk about some pre-commercial activities. During the Company’s early years, we’ve focused our external communication almost exclusively on the human biopharmaceutical industry, the animal health industry and the investment community. As we look towards achieving our first product sales later this year, we begin to broaden our outreach to the practicing veterinarian community.

In order to better serve this audience, we’re redesigning our Web site, which will relaunch early this summer. In addition, next month we will make our first appearance as an exhibitor at a trade show, the American College of Veterinary Internal Medicine. We will have speakers and posters discussing many of the products in our pipeline and we will also host our first Aratana booth in the exhibit hall.

We will continue to introduce the Aratana brand at various other trade shows throughout 2014. The end of August is one of the most exciting weeks in the Animal Health industry, as the Central Veterinary Conference, the Animal Health Corridor Homecoming Dinner are all held in Kansas City from August 22nd to the 25th. I’d like you to all mark your calendars for our annual Aratana open house on Sunday August 24th in the Kansas City. Last year’s open house was a great success with over 200 attendees, and we look forward to another successful event in 2014.

Finally, allow me to make a few comments regarding business development. I will begin by restating that our goal is to leverage our unique combination of animal and human health expertise connections and our innovative biotech mindset to be the partner of choice in pet therapeutics. Business development activities will be focused on traditional in-licensing, such as the Advaxis license agreement during this quarter and our option program such as we’ve done in prior quarters.

The counterparts in these types of licensing discussions include human focused biopharmaceutical companies, small animal health companies and large animal health companies. While we’ve executed two company level acquisitions in the recent past, we do not anticipate additional company acquisitions in 2014. Rather we continue to seek additional molecules for full license and we’re evaluating several candidates.

And with that, I’d like to ask to Craig to update you on the financials, after which we will take questions.

Craig Tooman

Thank you, Steven, and good afternoon, everyone. As noted earlier, this quarter the financial statements include both Vet Therapeutics and Okapi Sciences. Per our press release, Aratana reported a consolidated net loss of $9.2 million or $0.34 per share. This compares to a net loss of $3.3 million for the first quarter of 2013, which was Aratana alone.

As a result of our acquisitions, you will notice that we reported $176,000 in license collaboration revenue. The majority of the revenue reported is R&D collaboration revenue we received from our partner for ongoing development efforts for AT-006, [ph] [ocular] for feline herpes, which was acquired as part of the Okapi transaction. There is also a portion of revenue reported this quarter related to the deferred up front payments for our products AT-004 B-cell Lymphoma which was part of the Vet Therapeutics acquisition. These revenues will be reported throughout the remaining service period for each product.

Now let me turn to our R&D expenses. During the quarter we reported R&D expense of $3.6 million compared to $2.1 million for the first quarter ended March 31, 2013. As announced this week, we’ve advanced our AT-001 program into pivotal effectiveness studies. We also continue to advance our AT-002 and AT-003 programs. The increase in R&D expense is due primarily to advancement of those development programs as well as an increase from the ongoing Vet therapeutics and Okapi programs, which are included in this quarter’s expense.

Also during the quarter, as Steven mentioned, we licensed the exclusive rights to develop and commercialize a product for the treatment of osteosarcoma in dogs known as AT-014 and three additional products for the treatment of other types of cancer from Advaxis. This resulted in an in-process R&D expense of $657,000, in addition to executing this agreement we also made a $1.8 million payment for an equity purchase in Advaxis.

Aratana currently has approximately 25 employees conducting research and development. These employees are located in Kansas City, San Diego and Leuven Belgium.

Turning to our G&A expenses, which also contain some early expenditures for our commercial organization. This quarter we reported $4.6 million compared to $1.2 million for the same period in 2013. During the quarter, the Company had certain one-time non-cash expenses associated with accelerative stock vesting of a former employee during the quarter of approximately $1 million.

We also recognized an increase in stock compensation expense for current employees due to the issuance of additional grants given during the period. Again, this is the first quarter in which we included both Vet Therapeutics and Okapi Sciences. Therefore part of the increase is related to general operating expenses for our San Diego and Belgium locations.

Also comparing the first quarter of 2014 to 2013, as part of going public in mid 2013, we’ve experienced an increase of cost for certain items required as a public company. At the end of March 31, 2014 the Company had approximately 18 G&A and commercialization employees.

Finally, again as a result of our recent acquisitions, the Company reported amortization expenses of $539,000 related to its B-cell and T-cell lymphoma intangible assets. The intangible assets associated with AT-004 are being amortized over its 20-year estimated useful life, which started as part of the Vet Therapeutics acquisition since conditional approval has been received.

Conditional approval of AT-005 was received in January 2014, you will recall, and therefore we began amortizing this intangible over its 20-year estimated useful life during the first quarter of 2014.

Regarding our cash position, on March 31, 2014 Aratana had a total of approximately $79.9 million in cash, cash equivalents and short-term marketable securities. As noted this quarter is included several very important transactions that have positioned Aratana as a leader in the pet therapeutic industry. First, we completed the acquisition of Okapi. This transaction resulted in an up front cash payment of $14.1 million paid upon closing on January 6, 2014.

Shortly thereafter, the Company raised additional net proceeds of approximately $90.5 million and a successful equity offering of common stock. The proceeds from this offering were partially used to repay approximately $33 million of purchase price obligations to the former shareholders of Okapi Sciences and Vet Therapeutics. The remaining funds will be used to fund ongoing operations.

In the first quarter we used cash of approximately $9 million to fund our operations. As stated in our year-end earnings call, in 2014 we continue to anticipate use of cash from operations of between $35 million to $40 million. This excludes the one time payments for the recent acquisitions of Vet Therapeutics and Okapi Sciences and the cost of any future business development opportunities we may pursue in 2014.

We continue to be fiscally responsible on the use of our cash like focusing our activities on those areas that we can achieve differentiation and market success. Also as we continue to advance our pipeline we still expect our spending in R&D to be approximately $25 million to $30 million in 2014. Aratana believes that its existing cash and cash equivalents are sufficient to fund its operations through 2015.

In summary we are pleased to be reporting Aratana as one consolidated company today. The company is well positioned to deliver our deep pipeline Vet Therapeutics for the treatment of pets.

With that, I will hand the call back to Stevens who will open it up for Q&A.

Steven St. Peter

Thanks, Craig. We will now take questions.

Question-and-Answer Session

Operator

Thank you. We will now begin the question-and-answer session. (Operator Instructions) Our first question comes from Tim Lugo of William Blair. Please go ahead.

Steven St. Peter

Hi, good afternoon Tim.

Timothy Lugo - William Blair & Company

Congratulations on the quarter guys and thanks for taking the question. I believe you had previously expected a full licenser or AT-004 in Q4 or maybe early 2015. Now it looks like you’re guiding to a full licenser before the end of the year. I guess can you give us an update on your discussions with the USDA, has anything changed recently? What seems to be the cause for pushing up that timeline?

Steven St. Peter

Yes, so thanks Tim. As you know the FDA when you deal with the FDA there is very specific timelines 180 day periods, 30 day periods. It's a very, very orchestrated communication process. The USDA is not like that. They really work with you as a partner. They process the information as it comes in, and basically you get a sense of where you are by the sorts of questions they’re asking and the types of inspections that they’re doing. So, there has never been really a monoclonal antibody approved for full licenser in a cat or a dog like this. So this is all new. It will be the first time, but just the sort of activity and the fact also you will remember that the AT-005 we actually got a conditional license sort of ahead of what we had communicated. So we just feel like based on what we’re seeing that full license could be soon or rather than later and so that’s what we’ve now communicated.

Timothy Lugo - William Blair & Company

That’s great to hear. Well thanks for the update. Can I -- I guess one last question, obviously there is change’s at Novartis Animal Health. You have some exposure to those three partnerships which is been executed by other companies. Can you give us an update on that relationship, and maybe if there were any change of control clause’s in your previous deals with the Novartis Animal Health?

Steven St. Peter

Yes. So, Tim for those of who that may not know in April, Elanco announced that it would be buying Novartis Animal Health to create what will become the second largest player basically after Zoetis in the animal health industry. And Aratana has two products partnered with Novartis Animal Health, AT-004 and AT-006. And so, obviously there is an impact and yes there certainly are some risks, but there is also opportunity frankly. And we are not naïve, we know how things go, delays and uncertainty are pretty normal in those types of situations, and as a partner you manage that as best you can. The communication from Novartis Animal Health has been basically business as usual which is how we are proceeding, and it will keep you up to date if anything material changes we’ll certainly let folks know. There are not change of control provisions that would change the status sort of per se. And so, the other thing I’ll just mention is this is not the last transaction. This industry is a consolidating industry and the focus will be on consolidation and market leadership and market share. But eventually that market has to turn the growth to really keep the attention of the investor community. And Aratana offers growth by collaboration and potential partnerships with those companies. So, this is just I think continued activity that we certainly have anticipated and talk about. It was a little surprising obviously, it was our partner that quickly, but we are reacting to it and we will keep everyone up to date.

Timothy Lugo - William Blair & Company

Understood. Thanks for the questions.

Operator

Our next question comes from Jon Block of Stifel. Please go ahead.

Jonathan Block - Stifel, Nicolaus & Company

Great. Thanks and good afternoon. Hope that you can hear me okay.

Steven St. Peter

Hi, Jon.

Jonathan Block - Stifel, Nicolaus & Company

The first one, Steven just on 003, I think I heard you correctly, pivotal continues to move forward as expected. And then I think you mentioned another study specific to Orthopedic that you’re going to begin shortly and why that additional trial specific to Orthopedic, is that for marketing purposes or will you need sort of additional small trials for separate indications under 003?

Steven St. Peter

Right. So, Jon thanks. You are very observant. So we did indeed launch another pilot study, a pilot field study in dogs in our orthopedic indication. And part of what Aratana does which I think is distinctly different than other companies in this space is we really use the opportunity to derisk the programs by doing pilot studies. If you’re familiar with the Pacira product, the DepoBupivacaine here, that is this product, and they have been very successful as a company in large part because technique is important and you really want to make sure that you’re defining that for the best outcome. So, we have taken some learning from that and rather than launch immediately into a pivotal field effectiveness study, we wanted to do another one of these trials to just get a better sense of how the product would work. So, it's really just a development decision and I think a positive from that perspective. We do anticipate a broad label, so and this doesn’t -- we’re not going to pursue a narrow indication per se for the product, but that doesn’t mean the settings that we use the product you pick a mix. Actually similar the way Pacira has done several different settings for their product.

Jonathan Block - Stifel, Nicolaus & Company

Got it, perfect. And maybe just wondering …

Steven St. Peter

And just the timeline -- just to confirm, the timeline doesn’t change because the timeline is gated to other things like the manufacturing submission, the safety submission. So we’re still on target for the 2016. We just have decided to do some additional work to understand better how the product is going to be maximally effective. Sorry.

Jonathan Block - Stifel, Nicolaus & Company

No, perfect. I appreciate the additional color. And then just only on the option agreements, you guys have done a really good job with timelines and just on the option agreement, initially you expected some color I think earlier maybe by the end of this quarter, now you’re talking more broadly throughout 2014. And can you just talk to us Steven is this evaluating the option itself a little bit more closely? Is it evaluating the manufacturing? Is it looking at the competitive landscape? I mean you mentioned atopic dermatitis, what is causing the slight slippage in some of the option agreements?

Steven St. Peter

So, I wouldn’t say that there is slippage. We have not amended the terms of the license of those option agreements to get more time, I mean that’s something we could do but we haven't done yet. It's more about Jon, we did do actually some work in dogs and we dose dogs with actually both products. So we’re really trying to understand and derisk it as much as we can from certainly an efficacy and safety perspective. In additional one of the products in particular, one of the big issues is going to be the cost of goods, and so we had invested to figure out how we can move forward the cost of goods situation and that I'll say on one of the two programs it is kind of the critical issue, and we’re making great progress on that. But we just have not communicated. We say mid 2014 which is still I think within the timeframe of what we discussed. I don’t know, we may have previously said in the second quarter of 2014, but it will be shortly.

Jonathan Block - Stifel, Nicolaus & Company

Okay, perfect. Thanks for your time guys.

Operator

Our next question comes from Jose Haresco of JMP Securities. Please go ahead.

Jose Haresco - JMP Securities

Hi guys, good afternoon and congratulations on the activity on the pipeline.

Steven St. Peter

Thanks, Hose.

Jose Haresco - JMP Securities

So, a couple of -- as more of the products are starting to really hit their time points and you can see the light at the end of the tunnel for 004, 005, 006 and now 001. Have you changed your thoughts or do you have any more clarity in your thoughts in terms of what the sales organization is going to look like say a year from today as we start to build our models and then look at SG&A and that sort of thing. Can you give us little bit more clarity in terms of what you’re thinking on those types of issues?

Steven St. Peter

Yes, so we continue to build out our sales organization and we have hired a medical director and other key positions to help begin to build the infrastructure. I mean since our first commercial presence will be oncology that really is even like in a human medicine much more of a peer-to-peer sell. So a lot of, we have -- if you look on our website open positions for medical science liaisons who will work with our commercial and development organization to really begin to introduce the product to the veterinarians. Now the AT-001 and 002 and 003, those are more generalist products. So really beginning in 2015 the plan will be to create a more traditional sales and marketing organization with territory managers and what not and so that ramp really comes in 2015. So we continue to build out the commercial organization. I think the total number of positions open in the company today is on the order of 6-8 and I think all of those are posted on our web-page and that’s the build out for the rest of the year, so I think you can get reasonably good visibility on that. But as we move into 2015 we will then be communicating what the sales force build-out will look like to support more of a generalist organization.

Jose Haresco - JMP Securities

Okay, thanks. Somewhat relative to the question of all the M&A activity in the space on your larger brethren. This might be too early to tell, but are you hearing any chatter yet about assets being divested that could be -- provide you an opportunity to continue to build the pipeline. And when I say assets I mean both product and people, or is it just too early to tell what's going on at this point?

Steven St. Peter

Yes, so we are watching that very closely and have been articulating that for a year that in this landscape of shifting stuff we think there is going to be some opportunities for people and products. Obviously we have not announced those yet but we are definitely sticking our nose into that tent, and where there is an opportunity trying to find it.

Jose Haresco - JMP Securities

Okay, great. Thank you very much.

Steven St. Peter

Thanks, Hose.

Operator

Our next question comes from Douglas Tsao of Barclays. Please go ahead.

Douglas Tsao - Barclays Capital Inc.

HI, Good afternoon. So, just sort of following up I mean, Steven obviously with both 004 as well as 005 the timelines for full commercialization has been accelerated, obviously with 004 it's only a partnered asset for you, so not really much for you to do. But in terms of the build out for the sales force for 005, can you just walk through I mean, how much --- how quickly that will necessarily start to shift spending forward right now?

Steven St. Peter

Yes, let me kind of try to go into that. I mean first of all the B-cell product, AT-004 is partnered and so we’re not in control of that, and I think the predecessor company to Aratana was less capitalized and partnered that and hope that I think the large company would get ahead and build that market for them. I mean since we have acquired now Vet Therapeutics we Aratana have the opportunity to get out first actually. And we will go out and create a brand and begin the dialogue with veterinarians around the monoclonal antibody for T-cell. So, I think we’re actually moving towards selling the product and being with the product and perform in the market around the T-cell which for us is very exciting actually. But what's great about the Pet Therapeutics opportunity versus the Human Health Commercialization is you don’t need to have national retail pharmacy coverage or national payer coverage, because you’re dealing with a number of clinics. So for us success looks like certainly in 2014 that the 20 sites that are running these additional studies that I mentioned, the combination studies of the AT-005 in combination with chemotherapy, success for us looks like after all of those trials are enrolled, those oncologists then want to give this product to their clients. And then from there we can go to their referral centers and we can build out and include new oncologists in the commercial effort. So, what we have been focused on frankly is return on invested capital and the quality of the conversion of the doctors that you’re getting. And so, we’re not trying necessarily to maximize revenue, we’re really trying to maximize return on invested capital and that’s kind of a unique attribute of Pet Therapeutics.

Douglas Tsao - Barclays Capital Inc.

Okay, great, thanks. And then just as a quick follow-up, sticking to the theme of oncology, obviously with -- between the sort of Vet Therapeutic acquisition as well as the access licenses you obviously have a really sort of interesting platform and then antibodies as well as immunotherapy. Have you ever thought about sort of trying to expand the portfolio more broadly especially and even using sort of like chemotherapy -- sort of somehow acquiring chemotherapy agents which are obviously sort of looking to use in combination with your sort of more innovative therapy?

Steven St. Peter

Yes, so I’ll take that. So we do have a focus in oncology as our initial commercial foyer. In addition to the therapeutics what we have done Doug is focused on support products in that episode of care. So, for instance we believe that our AT-002 our ghrelin agonist will be very appropriate because you see loss of appetite in the oncology setting. And in addition oncologists are one of the highest volume users of product like AT-003 our DepoBupivacaine product for post surgical pain. So we love building out in oncology in terms of therapeutics but also the support products that go around that. We have also begun to cluster a second therapeutic area which is pain itself. I mean we have AT-001 and AT-003, and we have also -- if you look at the IP we have IP around IL-6 and there is other areas with the monoclonal antibody platform that we can look at pain although that’s an FDA regulated area for monoclonals. So, we definitely are within oncology trying to cluster and find supportive products around that, and then opening up new fronts where we’re trying to cluster.

Douglas Tsao - Barclays Capital Inc.

Okay, great. Thank you very much.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Steven St. Peter for any closing remarks.

Steven St. Peter

Great. So, thanks to everyone for joining today. You can see that we have been busy and productive in the quarter. I think the theme is execution, execution and progress. We remain excited. We remain confident, and we remain appreciative of your interest and support. And so, thank you for joining.

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

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