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Endocyte, Inc. (NASDAQ:ECYT)

Q4 2012 Earnings Conference Call

February 25, 2013, 16:30 PM ET

Executives

P. Ron Ellis - CEO and President

Mike A. Sherman - CFO

David Meek - CCO

Analysts

Chris Raymond - Robert W. Baird & Co.

Adnan Butt - RBC Capital Markets

Jason Kantor - Credit Suisse

Howard Liang - Leerink Swann

Robert (Bert) Hazlett - ROTH Capital Partners, LLC

David Nierengarten - Wedbush PacGrow Life Sciences

Operator

Good day, ladies and gentlemen. Welcome to Endocyte's Conference Call to discuss the company's Fourth Quarter 2012 Financial Results and Operations Update. At this time, all participants are in a listen-only mode.

Speaking today with be Ron Ellis, President and CEO; and Mike Sherman, Chief Financial Officer. Following their comments, we will open the lines for questions. Please be advised that today's call is been recorded and webcast.

During this conference call, the company may make predictive statements concerning future events or development such as their expectations related to the regulatory approvals, timing of clinical trial execution, clinical trial results and financial outlook.

Actual results may differ materially from those indicated by forward-looking statements due to the variety of risks and uncertainties. Please refer to Endocyte's filings with the Securities and Exchange Commission for a discussion of these risks and uncertainties.

Now, let me turn the call over to Ron Ellis.

P. Ron Ellis

Thanks everyone for joining us for our fourth quarter 2012 call. I'm just going to take a couple of minutes and highlight some of the -- update us on some of the things that occurred last year and -- occurred the first quarter of this year and then I'll it over to Mike to go through the financials.

First off, we're on target in enrollment in both the Phase 3 ovarian PROCEED study. This is a study that we're running in platinum-resistant ovarian cancer patients. We're also on target with our Phase 2 TARGET study. That's the study in second line non-small cell lung cancer. It's a three-arm study that compares vintafolide against docetaxel and vintafolide in combination with docetaxel. So both of those studies were enrolling well.

As we have announced previously, the EU application was accepted. As back in November, we'll be coming up on our 120-day question period in the end of March but we're really pleased to have those applications in and under review at the EU. This will be the first targeted drug for ovarian cancer that's ever been reviewed and we hope to see some good news out of that later this year.

We have two additional drugs that we'll be filing INDs in, in this year. We've talked about those previously. One's a -- we call it 1456, which is a folate-targeted tubulysin drug and the other one's for prostate cancer targeting PSMA. We ended the year on a nice financial position, just over $200 million in cash. Again, Mike will go through that. That's largely a result of the partnership with Merck.

Let me just make a couple of comments about how the partnership with Merck is going. First off, I'd say we can't be more pleased with how nice it's been to partner with Merck. They've been really outstanding. The teams have worked really well together as we've thought about how best to develop this really exciting new compound and the targeted and the imaging agent. And so I think I've been really very pleasantly surprised in how great it has been to work the Merck team.

In relation to that, Merck has decided to broaden the development plan and increase their commitment to the program. I think the first thing is that they've announced or we're announcing that one of the indications that we'll be moving vintafolide into triple negative breast cancer. It's based on a lot of preclinical work and discussions about the need in that area. It's a high express for folate receptors and we think it will be sensitive to the overhead. That indication will be starting out towards the end of this year. That will give us three indications where we're running randomized studies in. So I think it underscores Merck's commitment to the program.

The other thing that Merck are doing is they're going to increase the sample sizes of the PROCEED study. The way this works is we'll enroll up to the 250-patinet, which is the original study designed. At that point, the DSMB will review the data and they have the option if they would like to increase another 100 patients in this study just to support OS analysis. Merck has agreed that they'll pay almost all the cost of that additional patients, at least 75% of the additional cost. And we're working with Merck as well to add sites and countries to accelerate the development or the timelines for enrolling of the study. But as I mentioned earlier, right now we're on target with our PROCEED enrollment.

One another change that we also have made to the protocol we talked about talking to the FDA about this, the original study was going to include FR 0% patients would be enrolled in the Phase 3. But after meetings with the regulatory agencies, they've agreed to let us drop the 0% patients from the study. And so going forward, we'll only enroll patients who have at least one positive folate receptor targeted lesion. So that's another change to the Phase 3 protocol, one that we think is a positive one because we've shown in a lot of preclinical work as well as clinical data that these 0% patients don't benefit from treatment. I think the FDA agrees with that, understands that there is really no benefit in putting them in a Phase 3 study.

So it was a really very productive year last year. The partnership with Merck has gone really well. We're pleased with not only the relationship with Merck but their continued commitment to the program as evidenced by increasing the size of the PROCEED study and the study in triple negative breast cancer which will be a randomized study. We have more products moving into the clinic which we're also excited about and of course we'll all be anxiously waiting for the results of the EMA review for this first targeted drug in ovarian cancer for early condition approval.

So with that, I'll turn it over to Mike to go through the financial statements and then we'll take questions.

Mike A. Sherman

Thanks, Ron. I'll take a few minutes to cover the financials and then touch on some operational updates as well. First, we recognized 14.5 million in revenue in the quarter. That was up from 12.4 million in the third quarter and 200,000 last year.

You'll note that the $5 million milestone for EMA's acceptance of the marketing application is amortized in the same way that the reimbursable research is. So it's spread over that period beginning when the transaction was closed at the end of April through the end of 2014. But all future milestones will be recognized in the period that they're earned.

2013 revenue will have 13 million per quarter based on the events to-date than any reimbursable research conducted during the year or milestones received will add to that. R&D at 10.5 million was up from 9.9 million in the third quarter and 7.8 million last year. That was driven by increasing enrollment in the PROCEED trial, a portion of which is reimbursable by Merck and then the TARGET trial, all of which is reimbursed by Merck.

G&A at 5 million was up from 3.8 million in the third quarter and 2.9 million last year. That was driven by an increase in compensation, professional services and commercial investments which began in the fourth quarter. On that now we're establishing a headquarters office in Switzerland for a small commercial team to support the potential new launch. Along with Merck, we're expanding our relationships now with KOL globally and in support of that expect more frequent and larger presence in medical conferences and more frequent publications this year.

Total expenses and net of what's reimbursable from Merck were 11.3 million which was up from 9.1 million in the third quarter and 10.2 million last year. We ended the year with a strong cash position, 201.4 million in cash which was down from 204.7 million at the end of the third quarter. As I noted, the $5 million milestone was received this quarter which partially offset operating expense.

As Ron mentioned, our TARGET and PROCEED trials are enrolling according to plan, a higher screening for a folate receptor, 100% patients in both trials has been helpful in our regard. We also continue, as I've noted before, to monitor the availability of Caelyx in Europe. The new supply process has been approved but we knew it would take a few months for full commercial supply to ramp up, so we monitored that as we have continued to activate sites in Europe.

Looking at financial guidance for 2013, we expect net expenses to increase to approximately 65 million this year. That's up about 20 million compared to our fourth quarter 2012 annualized. As highlighted in the release, that will be driven by three categories of investments. First, the PROCEED trial which we fund more than half of (inaudible) if indeed we end up enrolling this additional 100 patients and then Merck would cover 75% of that incremental cost. So that would begin to play out though in 2014. Second, bringing forward the pipeline drugs including the Phase 1 trial tubulysin; and then third, some early commercial investments.

I also wanted to note of a release that we had made previously of our plan to host an Investor Research Day in New York on March 22nd. Our agenda that day will cover a summary of our strategic plan, a deeper outline of pipeline technology, also including the development plans for pipeline drugs and our EU launch strategy. Hopefully many of you can attend that in person, but we'll also be webcasting that event.

With that, let me turn it back to the operator to see if we have any questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Our first question comes from Chris Raymond from Robert Baird.

Chris Raymond - Robert W. Baird & Co.

Thanks, guys. Just on the addition of the 100 more patients, can you kind of walk through the decision why -- why the decision was made between the two companies? And maybe give us a little color on how it impacts the statistical plan and the timing? I know you said it was into the nine to 10 months to enroll the patients. Should we just assume that you tapped that on to the readout, which I think you guys had said was one half '14?

P. Ron Ellis

Chris, I'll just kind of try to go through those in reverse but make sure I cover everything. Yeah, you just tack it onto the back where we thought the 250 would be. And again as we mentioned before, we're working with Merck on trying to add sites in countries to accelerate the timeline for the overall study, but our best estimate right now and I'd say our conservative one is that we'd have the 250 in the first half of '14 and then we'd have another nine to 10 months to give the extra 100 on. The decision process really came out of a number of factors and heavily involved the -- clinicians involved in the study both DSMB as well as our advisory clinicians, our PIs.

As they talked about the study and the importance of trying to get to more OS data for the United States and after discussions with those advisory boards, we didn't want to really slow down this trial, at least getting PFS data. So we put into the protocol the DSMB has really three options. And so the 250 is enough to handle the PFS analysis, so the PFS ends at 250. If at that, when they look at the data, if it's futile not showing any PFS benefit, then the study stops and the additional 100 doesn't come on. If the data is really, really good meaning you've got very, very positive PFS data and the OS data looks extremely positive, DSMB has the option to say we're going to stop the study for efficacy.

We don't think it's ethical to continue to put patients into an inferior arm. So they have that option as well. And then the third option is to say, well, we see positive PFS but we need to put -- we want more patients in for the overall survival analysis. That would be an extra 100 patients. They would only be FR 100% patients in all likelihood since that's the primary end point and that data would only be used to support overall survival analysis.

Chris Raymond - Robert W. Baird & Co.

So that timing then for the futility analysis is sort of unblinding for efficacy, is that still first half '14?

P. Ron Ellis

Yeah. But it's not unblinded -- well, yeah, it could be unblinded for efficacy, you're right. Yeah, first half '14 is where we'd estimate that to occur.

Chris Raymond - Robert W. Baird & Co.

Great. And then one more question on this trial, if you don't mind. I know you've explained this to me before and I'm still kind of unclear. Can you explain how you control in PROCEED for a prior Avastin use?

P. Ron Ellis

Yeah, in the PRECEDENT study, the Phase 2 study, patients were allowed to have Avastin before coming onto the study. So we allowed for one biologic and that carried through exactly the same in the Phase 3 study. They can have Avastin and still be enrolled in this study.

Chris Raymond - Robert W. Baird & Co.

Okay. But is there a balance between arms, mechanisms for that?

P. Ron Ellis

No, there is not. There is no stratification on that.

Chris Raymond - Robert W. Baird & Co.

Thank you.

Operator

Thank you. Our next question comes from Adnan Butt from RBC Capital Markets.

Adnan Butt - RBC Capital Markets

Thanks for taking my questions. Hopefully, you can hear me. I have two questions. First is on the trial [launch], so how many FR 100% patients versus less than that? And I guess no FR 0% patients? And secondly, what's the thinking behind the additional 100 patients? Was it theoretically possible to just increase the size of the trial at this stage and sort of doing an interim, I'll start the dose 250?

P. Ron Ellis

So I think the first question was around the breakdown of the percent of patients that are FR 0 versus 100. It's roughly as we saw in the Phase 2 study, approximately 40% are FR 100%, about 40% are less than that and 20% are FR 0.

Adnan Butt - RBC Capital Markets

Okay, Ron. I guess what I'm asking is why not just make the study bigger instead of waiting another 10 months?

P. Ron Ellis

Why not just make the study at 350 and say we'll just make it that big? There was a lot of discussion around that. It's a great question. And in the end what they – the reason they did this that if there was the possibility that you don't hit your primary endpoint at 250, there's no reason to add an extra 100 for OS. It's just an extra cost that would have no value, so a lot of the stock really for futility. On the opposite end also it gives the DSMB the flexibility that at 250 it's very, very positive, they could stop right there. So it just gives them a little more flexibility to address the -- increasing this power for OS analysis with keeping the PFS analysis right where it is at 250, which is plenty of power to evaluate PFS.

Adnan Butt - RBC Capital Markets

And just one quick question on the (inaudible), I guess the (inaudible) for a decision by the end of the year. What gives the company confidence that the timelines would be a part of that? Then I'll get back in queue. Thanks.

Mike A. Sherman

Are you talking about the EU review process?

Adnan Butt - RBC Capital Markets

I am, Mike.

Mike A. Sherman

Yeah. No, as we've mapped out, there are a number of options that could play out in that in terms of the questions that EMA could ask and whether they request an oral presentation, for example, of is it during that process? And as we play those scenarios out, really the driver is going to be our ability to answer the 120 questions in a timely manner. As long as we can do that and within a few months time period, then the process should play out by year end.

Adnan Butt - RBC Capital Markets

Okay. Thanks, Mike. Thanks, Ron.

Operator

Thank you. Our next question comes from Simos Simeonidis from Cowen and Company. Your line is open. Your next question comes from Jason Kantor from Credit Suisse.

Jason Kantor - Credit Suisse

Thanks for taking my question. I'm also a little bit confused by the protocol to expand Phase 3 trial. So since this is just based on OS and you need to essentially hit your PFS endpoint with the original 250, I mean will we know at that point of time when you expand the trial that in fact you have hit your PFS endpoint, would that be part of that announcement that yes, you've hit PFS and you're continuing to enroll to get more power for OS?

P. Ron Ellis

Jason, you know that we're -- that DSMB has recommended moving forward with 100 additional patients.

Jason Kantor - Credit Suisse

But you're saying that that expansion is only to increase the power for OS. I mean if futility determines -- if you don't hit your PFS endpoint with 250, is that futility?

P. Ron Ellis

Yeah. We would not continue enroll if we have no chance of hitting PFS.

Jason Kantor - Credit Suisse

With the expanded patients though?

P. Ron Ellis

You're right. If we've not hit PFS at 250, then the study ends.

Jason Kantor - Credit Suisse

Okay. So we will know that you hit PFS with the original 250, we just won't know what the hazard ratio is and all those various things that we would want to know. It will be kind of a yes/no answer at that point.

P. Ron Ellis

Yes.

Mike A. Sherman

That's right. And when we…

Jason Kantor - Credit Suisse

Go on.

Mike A. Sherman

As I said, we need to communicate that probably so that the timelines are clear for either a filing or continued enrollment.

P. Ron Ellis

Jason, we'll be blinded to that analysis at 250. So we won't know what it is. We'll just know the DSMB's recommendation, so we won't know the…

Jason Kantor - Credit Suisse

Okay. But I just want to be clear, they have some kind of algorithm for recommendation and being short of your primary endpoint at the analysis would not get that recommendation?

P. Ron Ellis

That's correct.

Jason Kantor - Credit Suisse

Okay. So what is the statistical basis for deciding to increase the trial size because it was always going to be an interim OS analysis at that point anyway? Is there a particular hazard ratio where something that's considered close but underpowered so that you would then increase the power? Or said differently, what kind of survival difference do you have the power to detect at 250 and then at 350?

P. Ron Ellis

We're not able to release the exact powering calculations from the trial because of the blinding and Merck's asking that we don't release those. I think it's safe to say that we have a much better chance, of course, of hitting an OS endpoint at 350 than we do at 250. I've kind of characterize it as we've talked about with the 250 study it really was a pure PFS study and hoping to see a positive trend in OS to support accelerate approval. Moving up to 350 gets us in what we think maybe a window where we could also see a positive OS analysis. But that's about as much as we can disclose right now.

Jason Kantor - Credit Suisse

Okay. All right, that helps. Thank you.

Operator

Thank you. Our next question comes from Howard Liang from Leerink Swann.

Howard Liang - Leerink Swann

Thanks. So, sorry just a couple additional questions on the atypical analysis. So does this change the fiscal hurdle for the PFS analysis with 250 patients?

P. Ron Ellis

No.

Howard Liang - Leerink Swann

So why wouldn't because you would add additional patients to do the OS analysis. I guess is PFS still a primary endpoint then the…

P. Ron Ellis

The extra 100 don't go as events to the PFS, they only go to OS.

Howard Liang - Leerink Swann

Okay.

P. Ron Ellis

Howard, the PFS analysis finishes at 250.

Howard Liang - Leerink Swann

Right. But if you have only one trial and you add additional patients, why would that not change the physical or the allocation of the alpha? Or I guess maybe OS is always a secondary endpoint.

P. Ron Ellis

Yeah.

Howard Liang - Leerink Swann

Okay. Say for the (inaudible) hurdle for PFS, it's still 0.5?

P. Ron Ellis

Yes.

Howard Liang - Leerink Swann

Okay. So are there pre-specified hurdles for DSMB to make recommendations for each of the three scenarios you outlined or is it their judgment call?

P. Ron Ellis

Their guidelines, I'd call them. There's still always some judgment, but we've set out some hurdles that we would want them to see, so it's not just arbitrary. But again the DSMB does have flexibility to build up the data and recommend something else. But we've pre-specified what we would like to see.

Howard Liang - Leerink Swann

Okay. And has this been embedded with the regulatory authorities?

P. Ron Ellis

Yeah, Howard, the increase in 350 has been submitted to the agency, but we didn't anticipate any push back on that. They've always wanted as many patients as they could get for overall survival. So that's not an issue. There's a meeting in March where the full statistical analysis plan is going to be reviewed and we may get some feedback from that. But we really actually don't anticipate anything but positive from the FDA since they've always asked for as many patients as they could for overall survival.

Howard Liang - Leerink Swann

Is there another example of this similar design where there is an option to add additional patients after an interim analysis?

P. Ron Ellis

For a secondary endpoint?

Howard Liang - Leerink Swann

Yeah.

P. Ron Ellis

I don't have any off the top of my head. But I know I was on the conference call when it was discussed with the DSMB as well as with the PIs of the study. And they were strongly supportive of doing it.

Howard Liang - Leerink Swann

Okay. Can I ask you a question about the breast cancer study that you're starting, maybe you can tell us the percentage of FR 100% which I assume is the percent of that population in the triple negative breast cancer patients?

P. Ron Ellis

Howard, we don't know that right now. Like in lung and ovarian, we have not imaged enough breast cancer patients to delineate them between 100% and less than that. We do now that approximately 50% to 60% should have at least one positive lesion based on [IFC]. But as we've reported in the past, whenever we go from [IFC] analysis to imaging, we always see that percent go up. So, we don't know the answer to the question right now.

Howard Liang - Leerink Swann

Okay. Thanks very much.

P. Ron Ellis

Thanks, Howard.

Operator

Thank you. (Operator Instructions). Our next question comes from Bert Hazlett from ROTH Capital.

Robert (Bert) Hazlett - ROTH Capital Partners, LLC

Thanks. My question on the folate receptor richness was just asked, so I'll move to some of the commercialization work that you plan to do in 2013. Could you give us a little bit more detail as to what you expect to do in Europe and maybe when you start to spool that up?

Mike A. Sherman

Yeah. We actually have Dave on the line and I'll give you a high level answer and he can add to that. I'll start by saying that I would like to in March go into some more detail on the longer term plan and the specifics of what we're doing in Europe. But in the meantime, you'll recall that we're responsible for the commercialization efforts related to the imaging agent. And so we believe that that will be a relatively focus organization that we'll be able to put in place to do that to make sure that physicians are trained on how to use the imaging agent and have appropriate supply of it.

A lot of the -- the other part of the work that we need to do in the meantime is prepare for the reimbursement process. We're working closely with Merck on that since it will have to be closely tied to the therapeutic, but we'll need some capability there in Europe to help facilitate that. Also some medical capability to make sure where -- so the ongoing development of the imaging agent is -- we've got some oversight into that and also support the execution of the clinical trials in the meantime. Dave, I don't know if you can maybe also add some of the high level things that we're doing in general on the commercial side.

David Meek

Yeah, Mike. It's a couple other things that we're going to do in addition to what Mike said. You'll see significant presence with Endocyte that the advisory board, especially in the early launch countries were starting out one-to-one physician interaction with the nuclear medicine physicians. So advisory boards actually having medical science liaisons from the Endocyte team ramping up in Europe too, to prepare the market and prepare the customer for the entry of etarfolatide and vintafolide. You'll see us in all the major congresses. And as Mike said, I'm preparing our reimbursement dossiers for all the markets in Europe.

Mike A. Sherman

No, any other specific questions maybe on that?

Robert (Bert) Hazlett - ROTH Capital Partners, LLC

No, I guess we'll get a little bit more in March, but I did have a couple of other questions about some other programs. I guess just briefly if you can mention any other publications that are upcoming or at the medical meetings where you expect to present data?

David Meek

Yeah, I can answer that. You'll see a presence with publications have been submitted to pretty much every major Congress you can imagine from oncology as well as nuclear medicine. Right now, those publications, abstracts and so on have been submitted. But as you know, they're not going to accept it yet just because the timelines aren't there yet. So we expect to know more in early second quarter about the summer meetings of whether or not these presentations have been accepted as well as publications to peer-reviewed journals, more and more of that will be coming out. There will be a significant increase over the past.

Robert (Bert) Hazlett - ROTH Capital Partners, LLC

And then in terms of the folate tubulysin program, again it looks to me to be quite promising and I've heard you remark in different settings along those lines as well. Can you talk about any potential efficiencies in terms of the development of that program that you might be able to capture based on what you've done with vintafolide? Is there a more rapid route to success here with tubulysin?

P. Ron Ellis

This is Ron. I don't know if regulatory wise in development there's a more rapid, we'll still have to dose acceleration and we'll have to run the normal tox studies, et cetera, that we had to do with vintafolide. But where we do think the acceleration will come is that we're probably going to be a little smarter about where the dose would be based on what we know with folate vintafolide. So we could be a little more efficient we hope in the Phase 1 study and get into the optimal dose.

The second thing is we have a lot of experience now with dosing in patients in lung and ovarian, so we'll have some experience and know what percent of patients are positive. And we've also got a lot more data now on other cancer types that are folate positive. So I think we'll be a lot more educated about how to develop the compound now that we've at least gone through the first folate targeted compound.

Robert (Bert) Hazlett - ROTH Capital Partners, LLC

Thank you for those. And just one other quick one. The increase in the trial size is – the 100 additional patients is really driven for the U.S. application, it's really secondary to the European accelerated application at this point, correct?

P. Ron Ellis

Yeah, that's correct. Of course, it will help in both. But the primary driver is for the U.S.

Robert (Bert) Hazlett - ROTH Capital Partners, LLC

Okay. Thank you.

Operator

Thank you. Our next question comes from David Nierengarten from Wedbush Securities.

David Nierengarten - Wedbush PacGrow Life Sciences

Thanks for taking my questions. Most of them have been asked. But I was just curious if you had access to blinded data from the DSMB or from the PROCEED trial that had the entire PFS or OS survival in these patients that might have been part of the decision process for you guys and Merck? Thanks.

P. Ron Ellis

No, we had no access to the data.

David Nierengarten - Wedbush PacGrow Life Sciences

Okay, fair enough. Thanks.

Operator

Thank you. I'm showing no further questions in queue at this time.

P. Ron Ellis

Okay. Well, we appreciate everyone spend their time with us. Again, I think it still is a really good year last year. We're very excited about these new compounds going in the clinic. I think we're very happy with the Merck partnership. We're hopeful with the EMA filing. I was especially appreciative of our colleagues for their commitment to stepping up to a full randomized study in triple negative breast cancer. They could have taken a much smaller study size and start with the small Phase 1, but the data that we had generated and looked at the indications, they felt like they're willing to put a lot more money into the program to get the drug developed earlier.

So this randomized study is a big commitment by Merck. I think the other big commitment by Merck is their willingness to increase the size of the study. It's a great thing to do for the study and for the drug and for patients ultimately. And we'll work as hard as we can to get the timeline in as closely as we can, but adding the extra 100 patients showed another significant contribution by Merck. We look forward to seeing people on March 22nd for the Research Day and they go through more of the program and take more questions.

So with that, thank you very much.

Operator

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

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