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Elanco Animal Health Incorporated (ELAN)

Q4 2016 Earnings Call· Thu, Mar 2, 2017

$21.73

-1.92%

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Transcript

Operator

Operator

Welcome to the Fourth Quarter and Year-End 2016 Financial Results Conference Call and Webcast for Kindred Biosciences. [Operator Instructions] Please note that the remarks today will include forward-looking statements and that actual results could differ materially from those projected or implied in our forward-looking statements. For a description of important factors that could cause actual results to differ, we refer you to the forward-looking statements in today’s press release and the note on forward-looking statements in Company’s SEC filings. It is now my pleasure to turn the call over to KindredBio’s CEO and President, Richard Chin. Dr. Chin, please proceed.

Richard Chin

Analyst · Ladenburg. Your line is now open

Thank you, operator. Good afternoon and welcome to our year-end 2016 financial results call. Joining me today from the management team of KindredBio are Denise Bevers, our Chief Operating Officer and Wendy Wee, our VP of Finance. We had had a fantastic and highly productive year in 2016. The Kindred Bio team is executing flawlessly and the programs are proceeding very well. Building on the tremendous successes of 2016 we expect 2017 to be a better year as well as we transition to a commercial stage company less than five years after founding the company. On Mirataz program in the space of a single year we announced the positive pilot results started the pivotal study, announced the positive [indiscernible] results which was completed ahead of schedule and filed the NADA. Recently only about a year after announcing the pilot study results we announced the early approval of the effect of this technical section of the NADA. We expressed approval of Mirataz by the second half of this year assuming no one had unanticipated issues from the FDA. Of course I should remind you that regulatory approvals are inherently unpredictable but based on our interactions with the agency so far our expectation is approval on that timeline. We have recently been asked about our launch timelines after approval. We expect our commercial launch shortly after approval, the team at Kindred Bio are doing everything that needs to be done on the manufacturing side as well as the commercial side to ensure a timely launch. Denise will discuss the commercialization of Mirataz in detail but I'm pleased to say that we received multiple attractive offers for the U.S. rights to Mirataz. Frankly the interest was overwhelming. However, based on our more detailed market research we have conducted recently we believe that Mirataz…

Denise Bevers

Analyst · Ladenburg. Your line is now open

Thank you, Richard. To echo your comments we had an incredibly productive 2016 and are very excited about 2017 particularly about transitioning to a commercial stage company. We have recruited some top talent in both commercial and veterinarian affairs positions and also have a very sophisticated commercial operations infrastructure in place. We have built a CRM set up our third party logistics and warehousing and have established our commercial manufacturing and forecasting systems with our CMOs. Importantly and why I use the term sophisticated we have a fully integrated ERP system in place. This allows us to manage our finances in real time and will also allow us to manage inventory and sales in a single system. As you know there are many well established revenue generating companies that do not have this caliber of integration in place. We are fully prepared for a rapid and successful launch. We've also been deeply engaged in conversations with our thought leaders and what we have heard clearly from them is that there is a great need for both Zimeta for the control of fever in horses and Mirataz for the management of weight loss in cats. This is consistent with the fact that we have had phenomenal interest in our products at the American Association of Feline Practitioners and American Association of equine practitioners meetings this fall and most recently at the North American Veterinary conference in February. We are headed this weekend to the Western Veterinary Conference and look forward to our meetings with thought leaders and veterinarians. Regarding manufacturing, it is important to note that we have performed all the necessary work to ensure rapid launch after approval. We will not need to transfer the process to a different manufacturer nor introduce changes to the manufacturing process. We have also…

Wendy Wee

Analyst

Thank you, Denise. As both Richard and Denise noted that we continue to advance our pipeline in the capital efficient manner as well as preparing to transition to a commercial stage company. For the quarter ended December 31, 2016 Kindred Bio reported a net loss of 5.8 million or $0.29 per share compared to a net loss of 6.4 million or $0.32 per share for the same period in 2015. Research and development expenses for the fourth quarter of 2016 totaled 3.5 million compared to 4.6 million for the same period in 2015. General and administrative expenses for the fourth quarter of 2016 were 2.4 million compared to 1.9 million for the same period in 2015. For the year ended December 31, 2016 Kindred Bio reported a net loss of 22.5 million or a $1.13 per share versus a net loss of $27.1 million or a $1.37 per share for the same period in 2015. Research and development expenses for the year ended December 31, 2016 were 13.9 million compared to 19.4 million in 2015. Stock based compensation expense related to research and development was 1.5 million versus 1.9 million in 2015. The 5.5 million year-over-year decrease in research and development expenses was primarily due to lower payroll and related expenses following a reduction in headcount along with lower clinical trial cost and stock based compensation expense. 2015 expenses included pivotal field trial costs for [indiscernible] and Zimeta. General and administrative expenses for the year ended December 31, 2016 were 8.3 million compared to 7.9 million in 2015. General and administrative stock based compensation expense was 2.2 million in 2016 versus 2.3 million in 2015. The 0.4 million increase in general and administrators expenses was related to increased headcount including higher marketing and corporate expenses as we have initiated pre-launch…

Richard Chin

Analyst · Ladenburg. Your line is now open

. : Operator we're ready for questions.

Operator

Operator

[Operator Instructions]. And our first question comes from Kevin DeGeeter of Ladenburg. Your line is now open.

Kevin DeGeeter

Analyst · Ladenburg. Your line is now open

Really I'm going to focus primarily on Mirataz commercialization and disclosure that you do plan to bring that to market yourself in the U.S. How should we think about the level of investment in sales force buildout for Mirataz for 2017 and how does that factor into the guidance with regard to operating spend of 30 million to 32 million.

Richard Chin

Analyst · Ladenburg. Your line is now open

So we're planning on launching with about 20 to 25 sales reps and the guidance we're giving includes those costs.

Kevin DeGeeter

Analyst · Ladenburg. Your line is now open

And when should we look for those costs that primarily begin to filter in third quarter, are they potentially into the first half as well?

Denise Bevers

Analyst · Ladenburg. Your line is now open

We've built a lot of our infrastructure already as I've already discussed, the last thing we will do is bring on our sales reps. So our goal is to complete our customer relations management system, all of our sales training material and the very last thing we'll do is pull the trigger on the sales reps, get them trained and get them deployed. so I think you know second half TO third quarter Somewhere in that range and we will judge that based on our communication with the agency.

Kevin DeGeeter

Analyst · Ladenburg. Your line is now open

And as we think of building commercial infrastructure within the feline market. As you evaluate potential acquisition business development opportunities does some of those include the potential for the addition of a feline or companion animal sales force with some of those assets or should we think about business development as being really independent of the question of the build out of sales force for Mirataz.

Richard Chin

Analyst · Ladenburg. Your line is now open

So most of the opportunities we're looking at would come with a product not necessarily a commercial infrastructure with it. Having said that we're looking pretty broadly because every product that we can add to the portfolio improves our margins and improve our numbers.

Kevin DeGeeter

Analyst · Ladenburg. Your line is now open

And then just lastly for me and I'll get back into queue and let others ask some questions. In the context of a European commercial strategy for Mirataz, mentioned interest from partners should we think of the right approach in Europe is likely including a single partner or should we think of the more likely scenario being country by country or regional partnerships is the right way to build out the markets for Mirataz?

Richard Chin

Analyst · Ladenburg. Your line is now open

That would be dictated by the economics. We have been talking to quite a few partners, I would say about half the partners are large and would cover the entire continent. I would say the other half are you know regional players and what we'll do is we'll look at the terms sheet as they come in and then make the decision based on the economics.

Kevin DeGeeter

Analyst · Ladenburg. Your line is now open

And lastly just is your working assumption that there's a potential for that to be a first half of 2017 event or is it really too early to put that level of granularity around the discussions?

Richard Chin

Analyst · Ladenburg. Your line is now open

Yes, at this point we wouldn't be giving guidance on when. We do have a little bit of time because as I said European dossier will go before the end of this year. We have several months to consider it at least.

Operator

Operator

Our next question comes from [indiscernible]. Your line is now open.

Unidentified Analyst

Analyst

Just following up on Kevin's of question on Mirataz, you mentioned that you now see it based upon the survey work that you've done, that it's a larger product or likely a larger product than you had initially anticipated. I guess how big do you see that market being and if you can't answer that I guess how much bigger than your original assumption did that study comeback as showing?

Richard Chin

Analyst · Ladenburg. Your line is now open

So we would prefer not to give revenue guidance as you probably expected. Every time we do more detailed research and provide more information about our product to the veterinarians and pet owner the better the results look indicating to us that this product specifically with the administration and the safety and efficacy profile has is very attractive. What I would say is that the new numbers really speak to the untreated population. So theirs is about 9 million cats with this condition every year about 3 million are currently treated, our initial numbers were largely based on replacing the currently treated market and the untreated market that's where a lot of the potential upside is. So what I would say is that it's substantially larger -- I would hesitate to put you know precise numbers out there.

Unidentified Analyst

Analyst

And then you mentioned during the prepared remarks smaller products that you could you come out with that don't necessarily need regulatory approval, what might those look like and how big might those opportunities be?

Denise Bevers

Analyst · Ladenburg. Your line is now open

Sure. So we're keeping those a little bit close to the chest just for competitive reasons but they are relatively small products but there are certain products that we will be able to market without FDA approval, so we want to do the best we can to amortize the commercial infrastructure you know as Richard said we're working very aggressively on M&A opportunities but we always want to leverage the sales force if we can. So as we get closer to having those products planned and we commit to those we'll make announcements.

Unidentified Analyst

Analyst

Okay. And then when it comes to epoCat it sounds like you have enrolled quite a few cats there, I guess how many have been enrolled and when should we expect to see some data from the pilot study?

Richard Chin

Analyst · Ladenburg. Your line is now open

So the enrolment is ongoing, we haven't disclosed yet how many have been enrolled. We expect to have some results this year so where we are now is if you recall we did a pilot study in healthy laboratory animals and that looked good and right now we're in enrolling client owned animals or pets with anemia and we are testing out different doses. So we are -- I would say we are well on our way to having sufficient results to disclose but beyond that if I want to hold off on discussing it.

Unidentified Analyst

Analyst

Okay. And then just a couple more quick ones for me, what do you anticipate the pilot field study looking like for the equine metabolic syndrome, how horses, how long are you going to follow them etcetera?

Denise Bevers

Analyst · Ladenburg. Your line is now open

Yes. So we're working on our protocol for that and working with the FDA to finalize that protocol. So we haven't disclosed that yet and it will be a longer study given the indication you know again it's a bit similar to Type 2 diabetes in humans so it certainly won't be as shorter study as we saw with Zimeta for treating fever but when we do get closer to having a final protocol you know we can talk about it at that time.

Unidentified Analyst

Analyst

Okay. And then you mentioned the Western Vet Conference, it looks like you got a 10x20 booth there meeting with key opinion leaders and that. Any other activities you have planned or anything else that you can discuss that might come out of that maybe?

Denise Bevers

Analyst · Ladenburg. Your line is now open

Yes, you're absolutely right. We have lots of meetings scheduled with thought leaders. We have some scientific discussions set up with some of our consultants who are working with us in the thought leaders space to talk about some of our programs. We do have some discussions set up with some potential partners for as Richard mentioned you know future potential for biologics or the ex-U.S. rights to Mirataz. So we have a tremendous amount of activity for Western Veterinary conference.

Operator

Operator

And our next question comes from [indiscernible]. Your line is now open.

Unidentified Analyst

Analyst

This is RK and I'm sure you guys are excited entering into 2017 with potentially two products coming to the market. So I have a few questions, let's start out with Mirataz. It looks like the topic of the hour at this point. In terms of what is going on with the FDA in terms of them reviewing your application. In the human world there is certain "times" that the FDA takes. Is there something like that in the vet world and also in your discussions with the FDA how do you see this dialogue going?

Denise Bevers

Analyst · Ladenburg. Your line is now open

Sure. So each technical section and the main sections being effectiveness, safety and manufacturing, each one of those sections has a 180 day or six month review timeframe so that’s why we mentioned we are very pleased to get an early response on effectiveness. We are anticipating our feedback on our safety in the coming months and then we have already responded to our questions on manufacturing so as far as the communication with FDA is it's been quite good, we haven't seen any showstoppers, there were no questions that we couldn't answer. So things are really proceeding as we expected we're very pleased.

Unidentified Analyst

Analyst

Okay. And then on the commercialization front, I understand generally that vet products get off in selected geographies before progressing into a nationwide launch and with regards to the strategy for Mirataz let's say the product gets uploaded sometime in late summer or early fall 2017 so how much time would you need such that you are promoting this product nationally.

Denise Bevers

Analyst · Ladenburg. Your line is now open

Yes. So we done a lot of the groundwork already. We've already mapped out our territories where we anticipate having our very own Kindred Bio sales people, we've met with distributors so we understand very well their capabilities, their territories that they'll be supplementing and our goal is to launch as quickly as humanly possible after approval. So there are certain things that just take time, you get the final label and you've got to get that label on your packaging so there are certain things that are just things that take weeks you know following the approval but aside from that we're being as proactive as possible and we've had a tremendous amount of unsolicited interest from various sales reps and because our team is so well entrenched in the animal health industry we already have many of our eye on many of our sales reps, so we anticipate a very smooth recruitment process, again getting them very well trained and deployed quickly. But we don't want to keep a bunch of sales reps on the book if we don't need them that would be the very last thing we do is bringing the sales rep.

Unidentified Analyst

Analyst

Fantastic. Couple questions on Zimeta, I understand that the you're getting ready to start your oral trial, what needs to be done before you pull the trigger and get the trial started? Are you waiting for certain commentary to come back from the FDA before they start that study?

Denise Bevers

Analyst · Ladenburg. Your line is now open

Sure. So this program will be a very straightforward program for us given that we had such a successful program with IV [ph]. So we have our protocol ready to go we're just doing the final packaging of things if you will on our formulation and then we just have to initiate the sites and get the study started. So we're deploying our clinical operations team as we speak to get that going and so you literally within the next couple months we'll have that trial up and running.

Unidentified Analyst

Analyst

Okay. And then once you get your IV approved is there any part of that application that you can take and utilize into expanding into the oral formulation or do you need to conduct as if we are conducting for the first time the whole bit in terms of clinical development to get the oral formulation approved?

Denise Bevers

Analyst · Ladenburg. Your line is now open

Sure. That’s actually a really good question, so we spent a lot of time before starting this program you know thinking through strategically and meeting with FDA to discuss it because we were thinking you know perhaps we could do a bridging study or some sort of bio-equivalent but when we mapped it all out it actually took longer to try to tie the IV program to the oral rather than just doing an oral discreet program and again it's a short indication you know it's acute treatment and we had we had such a successful program initially, we knew we could run this very expeditiously. So it actually came out to a shorter and more expeditious timeline to run a discrete development program for oral than to try to tie it to IV but that's a really good question.

Richard Chin

Analyst · Ladenburg. Your line is now open

And I think the key is that these programs are so much less expensive compared to the human side when you do the evaluation sometimes it works out better this way.

Unidentified Analyst

Analyst

I understand the cost I was just more thinking in terms of the timing. And then you know one last question on Zimeta before we move on to another topic. In terms of preference that is preference by the vets or by the horses, is there are preference between the IV and oral and would there be any reason for the vets to wait for the oral formulation even though you have the IV on the market?

Denise Bevers

Analyst · Ladenburg. Your line is now open

So the vets are very excited and familiar with the IV formulation, so they like to have that in their trucks ready to go to again very rapidly treat you know an acute fever. However they really like to have a lead behind in their armamentarium for the owners. So we really see the oral expanding upon the IV use and I don't see any reason why the veterinarians in particular would wait for the oral formulation.

Unidentified Analyst

Analyst

And that's good to know. One last question and this is more on the manufacturing plan that you're putting together and trying to commission. Now that you're spending a lot of money and getting a facility done. So are you planning to do this so that your next expansion on the clinical programs is mainly going to be biologics and you want to control the costs of that development and that's the reason why you're putting up you know this upfront money that you may not need to be spending.

Richard Chin

Analyst · Ladenburg. Your line is now open

So we do expect that the majority of our products will eventually be biologic that’s because number one from the human side we know that the efficacy and safety profile of biologics often tend to be better than small molecules. So for example if you look at the atopic dermatitis space we see [indiscernible] we see that it is effective we see the side effects and we know that on the human side when you've had a small molecule, an kinase inhibitor competing against an antibody, antibody typically wins. So that's number one, number two we think that biologics aligned interests of veterinarian with us because it means that they will see the patients more often that day they will administer the drugs and as you know veterinarians rely on dispensing drugs for substantial part of their profits. They won't have to worry about that revenue source being taken away from them by internet stores or big box stores so for a variety of reasons we think the biologics will be a better thing for the patients, for the veterinarian and for us. In addition, we think we have a really good biologics team and we think that will be a source of competitive advantage. Now given all that we would like to be in control of the manufacturing for both cost and for quality and we did calculations on what it would cost to outsource first versus keep the manufacturing in-house and with the number of products in our pipeline it clearly came out that economically it made sense for us to build our own plant. So that's the background behind why we decided to put up a plant.

Unidentified Analyst

Analyst

Thank you and thanks for bringing up epoCat [ph] Richard. So let me ask you this last question so in your program for atopic dermatitis, would you be required or would you like to do you know compare your product against [indiscernible] just so that you get an edge at least for commercial success even if it's not for an approval requirement.

Richard Chin

Analyst · Ladenburg. Your line is now open

Right. So it is definitely not an approval requirement and most likely we won't do a comparison at the beginning because lot of the advantages I think speak for themselves for example administration, IV administration which we think is superior form of administration and oral administration for conditions like this and most products if you look on the human side once again have not needed head to head comparisons. Now I won't rule that out later down the line but I think we will need that.

Denise Bevers

Analyst · Ladenburg. Your line is now open

We will definitely don't need it for regulatory approval, as a matter of fact you know the Center for Veterinary Medicine really considers placebo control trials to be the gold standard. So we would do what is most expeditious to get to an approval from a regulatory standpoint.

Operator

Operator

Thank you. Ladies and gentlemen this does conclude our question and answer session. I would now like to turn the call back over to Dr. Chin.

Richard Chin

Analyst · Ladenburg. Your line is now open

Thank you, Operator I would like to thank the listeners for your support as we embark on the next stage of this very exciting journey Thank you.

Operator

Operator

Ladies and gentlemen thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.