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Corcept Therapeutics Incorporated (CORT)

Q1 2016 Earnings Call· Tue, May 3, 2016

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Transcript

Operator

Operator

Welcome to the Corcept Therapeutics Conference Call. My name is Anna and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Charlie Robb. Please go ahead.

Charlie Robb

Management

Thank you. Good afternoon. My name is Charlie Robb, Corcept’s Chief Financial Officer. Joining me today is Dr. Joseph Belanoff, our Chief Executive Officer. Thank you all for participating in the call. Earlier today we issued a news release giving our first quarter 2016 financial results, a reaffirmation of our 2016 revenue guidance and the corporate update. To get a copy of this release, go to corcept.com and click on the Investors tab. Complete financial results will be available when we file our Form 10-K with the SEC. Today’s call is being recorded. A replay will be available through May 17, 2016 at 1888-843-7419 from the United States and 1630-652-3042 internationally. The passcode is 42398569. Before we begin, I want to remind you that any statements during this call other than statements of historical fact are forward-looking statements subject to known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements include statements regarding our anticipated revenues and expenses for 2016 and beyond, the pace of Korlym’s acceptance by physicians and patients, the anticipated contributions of our sales organization. The cost and timing of preclinical and clinical trials whether conducted by us or by our academic collaborators, and the results of such trials, the clinical attributes and advancement of our next-generation selective cortisol modulators, including CORT118335, 125281, 122928, and 125134 the protections afforded by Korlym’s orphan drug designation for Cushing syndrome or our other intellectual property rights including our patents concerning the use of cortisol modulators to treat triple negative breast cancer and castration-resistant prostate cancer. These and other risks are set forth in our SEC filings, which are available at our Web site, corcept.com, or from the SEC’s Web site, sec.gov. We disclaim any intention or…

Joseph Belanoff

Management

Thank you, Charlie, and thank you all for joining us. Before I talk about our recent results and key development programs I want to set our first quarter accomplishments in context by briefly discussing Concept’s business model which is different from that of most other biotech companies. First the scope of the therapeutic platform we are developing, cortisol modulation, is exceptionally broad. Our research together with the work of our academic collaborators around the world has shown that cortisol also known as the stress hormone plays a role in many serious illnesses. Pre-clinical and clinical studies using mifepristone the active ingredient in our approved product Korlym and proprietary selective cortisol modulators have generated promising data in a wide range of disorders. Most prominent of these is Cushing syndrome which Korlym treats and for which we are advancing our lead selective cortisol modulator CORT125134 to Phase 2 this quarter. Studies of Cortisol modulation as a potential therapy have also yielded positive results in oncologic diseases such as triple negative breast cancer, ovarian cancer, and castration-resistant prostate cancer, metabolic disorders, such as antipsychotic induced weight gain and non-alcohol fatty liver disease and psychiatric indications such as post-traumatic stress disorder and alcohol and cocaine dependence. The second and perhaps most uncommon feature of Concept’s business model among biotech companies at least is that our revenue pays our plan development program. To be sure our top priority right now is not increasing our cash reserves, our bottom-line will fluctuate from quarter-to-quarter as we use our increasing revenues to broad and advance our cortisol modulation platform. Nonetheless we’ve built a fundamentally sound business that has grown significantly since Korlym’s launch and will we believe grow much more. Finally, an important feature of Corcept’s business model is that we’re able to rely on the work of…

Operator

Operator

We will now begin the question-and-answer session. [Operator Instructions] And we have a question from Charles Duncan from Piper Jaffray. Please go ahead.

Charles Duncan

Analyst

So my first question really is on the ASCO Meeting coming up, it sounds like I mean you've been making progress on triple negative breast cancer with mifepristone and I'm just kind of wondering why you didn't have that data for ASCO, is it pushing out impart due to patient enrollment and then also how many patients do you anticipate being able to include in that data in midyear?

Joseph Belanoff

Management

Okay, so it's a couple of questions. Charles we actually will have a -- in fact we've already submitted our abstract for it and it will be presented at ASCO and we will present an up to the moment evaluation of where we are at that point, but the study is still ongoing. And it is not complete, we don't anticipate it'll be complete, because patients are still active in it, at the time of ASCO and of course we'll produce the results as it will finally complete. But as you know our idea really as this is an open label study and this is a major meeting so we thought that as we did with the San Antonio Breast Cancer Meeting that we would present exactly where we stood at the time of the ASCO Meeting and we will do so, although as I said I think the study will continue to go beyond that point in time.

Charles Duncan

Analyst

Okay. So, you're not really targeting, but you're targeting midyear but in addition there'll be information at ASCO?

Joseph Belanoff

Management

That’s right mid-year is our best estimate but we actually will give up to the date -- up to the moment information at ASCO as to exactly where we stand at that point.

Charles Duncan

Analyst

May be that is done to evaporate syndromes that response et cetera, right?

Joseph Belanoff

Management

That’s correct, Cushing free survival response rate so on and so forth. We will characterize the patients as broadly as we can just as we did at the San Antonio Breast Cancer Meeting to give you the most update we can at that point.

Charles Duncan

Analyst

And then moving onto 134 in terms of oncology, I'm wondering what kind of patients you'd like to have in that study, do they all need to be expressers of glucocorticoid receptor, will you be testing for that or will you just be kind of taking all comers and then testing for that?

Joseph Belanoff

Management

Well Charles I am actually going to take the opportunity to take a breath and introduce you to Bob Fishman, I think you might have met at the last call, Bob is our Chief Medical Officer and he can answer that question for us.

Bob Fishman

Analyst

As you know the study will have two parts, the first is dose finding and then we will advance to a variety of dose expansion cohorts, the dose finding phase of the study will enroll all comers with solid tumors for whom the investigator has decided that nab-paclitaxel is an appropriate treatment, we will be of course assaying for GR positivity but that will not be a requirement for their entry in beginning, in the entry -- excuse me at the time of entry into the study. Similarly for the dose expansion, cohorts we will, it's typical that the results of the GR assay become available some time after enrollment that was one of the lessons learned from the mifepristone eribulin trial so we will gather those data but again at the time of entry patients who are suitable candidates will be allowed to enroll into the selected dose expansion cohorts which are to be determined at this time.

Joseph Belanoff

Management

Hi Charles, let me just elaborate just a little bit on that and a very interesting thing that we've learnt last summer was we did a large tumor bank screening I think the first one which had ever been done certainly by far the largest for GR positivity in a variety of tumors and we actually found several interesting thing, one of which we’ve already talked about, which is that triple negative breast cancer although in a literature really talked about sort of being 25% to 50% GR positive, it is really a proven to be much closer to 100%, certainly above 75% and that’s really proven to be the case in the current study we’re running. Now what’s interesting about that is I think that there are tumors that are in fact very GR positive and some tumors which are not so GR positive, but we’re really still gathering that information and I think that really will be part of what we’re thinking about as we go to the expansion cohorts, whether or not we really do have to select along those lines or whether or not it's a particular tumor where one would expect most of the patients to be GR positive and therefore be in some sense automatically eligible for treatment with the GR antagonist.

Charles Duncan

Analyst

I was wondering if this could be potentially companion diagnostic in the future, but it seems like you’re still defining what GR positivity means and how it correlates with potential response in these patients?

Joseph Belanoff

Management

And whether or not in fact the prescreening tool is actually the most efficient way to go, but yes it is something that we think about all the time.

Charles Duncan

Analyst

And then my last question and then I’ll hop back in the queue it is more operational onto Korlym revenues had a good year-on-year growth. I am wondering about the quarterly or sequential growth? I know that this is a little bit of a mathematical issue, or denominator issue. But I am wondering about the growth rate, if you will, and if that’s a function of something that happened perhaps last year that was made it very high versus this? And what are you planning to do to continue to drive Korlym revenue and growth?

Joseph Belanoff

Management

Charles I am just going to point you to Charlie who is going to answer the question.

Charlie Robb

Management

We had a challenge in the first quarter of this year that’s the same as a challenge. We really had in all of the first quarters we’ve operated in since launch, which is that as you know insurance companies tend to put their patients, especially their patients, orphan drug patients through a reauthorization process at the start of every year. And for a lot of patients this is really bad news because they’re denied access to medicine while they straighten out their insurance, going to go through the reauthorization process. We don’t do that to patients we continue to provide them with medicine and a system as we can as they work through the reauthorization, which we do with great success typically. But what that does mean for us is that in the first quarter typically we have patients shift from commercial to free drug for a time before coming back. So, we do the right thing by the patients to make sure they get their medicine. This is a challenge that we anticipate every year and it's something that we took into account when we generated our revenue guidance, which is why we are now for the year -- which is why we’re comfortable reiterating it now. We put in place programs this year to shorten that time of the reauthorization, some of them worked, many of them didn’t and we already are working on our ideas for next year. So that’s just a headwind that we run into every first quarter.

Operator

Operator

Our next question comes from Christopher James from FBR Capital Markets. Please go ahead.

Christopher James

Analyst

I guess, yes my first question is on the existing Cushing’s business. Maybe either one of you guys can speak to the incremental effects of the salesforce expansion that you’re seeing and maybe do you see an opportunity to potentially further expand the sales team?

Joseph Belanoff

Management

And let me introduce the whole audience to Sean Maduck who is our Senior Vice President of Commercial and runs the whole Cushing syndrome franchise.

Sean Maduck

Analyst

Chris thanks for the question and maybe just stepping back just to remind everyone on sort of the growth of last year. We made a decision early in the year to increase the size of the salesforce pretty substantially by about eight clinical specialists up to 25. And a good part of the early part of last year was training up those individuals and getting them into the field and one thing we’ve touched on previously is that it takes up to five to seven touches to actually move a naïve physician to being a productive physician. And I can tell you that that expanded field force as well as our existing clinical specialists have been productive. We’ve seen an increase in productivity both in Q4 as well as in Q1 and dispersed enrollment activity from across the country. And one other thing that I think is important to remind everyone of in terms of our model is that, when patients first come on board it's a chronic condition and it takes a while for these patients to dose to their most efficacious dose. So they come in at 300 milligrams and it does take some time to get to the optimal dose which then drives from a value standpoint revenue in the organization. So there is anywhere for three to six month lag on that increased activity to actually sort of appear in terms of output from a model standpoint. So to your second part of your question is in terms of expansion, I mean we are always looking at opportunities to increase the size of the field where appropriate. We will not add bodies to just add bodies, but where we feel we can hire the right talent in a territory where you can have incremental gain on the organization we will do that. So, since we know we last talked we actually have increased the size of the field by a couple of clinical specialists and we're now at 27 plus our four regional managers and we also have eight MSLs and one MSL head, so we continue to again look for the opportunistic both territory and an individual to bring into the organization to grow when appropriate.

Joseph Belanoff

Management

Hi Chris, I'm just going to, just because I think it's important, I want to make sure the whole audience gets it, I just want to reiterate a couple of things that Sean said, one is that as we talked about before we think it takes -- we've now done it for multiple years, really about six months to train people up to the point where they are really productive and that for us was about the first of the year. The new group of reps were very productive in the first quarter but then again as Sean really points out we can see their productivity but it doesn't show up in a financial way as much as it's going to show up as the year goes along just because of this being a chronic illness in the way the medication is dosed, so again, as we expected -- that was how we hoped it would go and we hope fingers crossed that it continues in that way as the rest of the year progresses.

Christopher James

Analyst

And then on CORT125134, can you discuss maybe what you're seeing or how you are thinking about this pharmacologically -- really sort of what drives the decision to combine it with Abraxane on that nab-paclitaxel versus eribulin with mifepristone just what is the sort of rationale there?

Joseph Belanoff

Management

Yes, I think I can really answer your question more generally which is that -- at this point in time we think that GR antagonism can enhance any treatment that is -- that has a tumor that is potentially sensitive to cortisol regardless of what the background therapy is. And we're really at sort of the discovery point as to what the best companion therapy might be. As you know with mifepristone there has actually been a study which was done with nab-paclitaxel, we're now doing one with eribulin, there's another one going on with the combination of gemcitabine and carboplatin and there's no a; priority guesses to which the best of those are going to be. We think that this for GR positive tumors, there is an enhancement of chemotherapy no matter what the chemotherapy is. Now it happens that nab-paclitaxel is sort of a broadly applicable chemotherapy, so it's a good first companion agent for 125134, but I just want to make sure everyone understands that this is the first potential combination that we might use, there might be others involved and in some sense you have to start somewhere and this was really a very reasonable place to start. I mean one of the things that we put out in our press release of the last week which I just thought was intriguing it was the very first animal study that we've done but it was an interesting one to do was that we looked at a PD-1 inhibitor in an animal model of colon cancer in combination with CORT125134 and it clearly in a highly statistically significant way enhanced its effect. So, I just think for the audience generally I think you have to understand that I think this is a very interesting modality of treatment and we're really learning ourselves where it can be best be applied, there's really in some sense no more to it than that.

Christopher James

Analyst

And then finally can you maybe address some of the -- you have a lot going on with the investigator-sponsored trials, I think the post traumatic stress disorder study is pretty interesting maybe can you discuss maybe the rationale and when could we potentially see some data there?

Joseph Belanoff

Management

Yes, I'll try to do it briefly, because I don't want to take the rest of the afternoon for what's really an interesting topic for me. And maybe more interesting for me than almost anybody, but in some sense I think everyone understands that by its very nature post traumatic stress disorder is related to cortisol stress -- I mean we talk about Lehman’s term from stresses actually, the physiologic expression of too much cortisol activity and we really think that potentially by modulating that we might be able to not only treat post traumatic stress disorder but prevent post traumatic stress disorder and maybe really the primary reason is that memories which form under high stress states are very-very different in memories which form under normal stress states and there are potential treatments which can take advantage of that by reducing cortisol activity as patients are actually brought through on a psychotherapeutic level to deal with the trauma that they faced. Now the Bronx VA ran a pilot study with mifepristone I guess about four years ago, small study but with big effect size quite positive results. And VA is now paying for a much larger study which is ongoing, again arms length from core septal that we provide medication to try to utilize cortisol antagonism as a treatment in post traumatic stress disorder and as I always point out to people the timeline is not as tightly under our control as when we do our own study, but it is progressing, we know that it is, and we think that results in it -- well certainly those cards should be turned over in the next 12 to 18 months. And I think there really is a lot of good preclinical and actually human data that would point us in the direction that this might be an effective therapy. So, yes that is one of the investigator studies which has a particular interest to me it's got a relatively near term readout and good science behind it.

Operator

Operator

And our next question is from Roy Buchanan from Janney Montgomery. Please go ahead.

Roy Buchanan

Analyst

I guess just on the same lines as the last question. Can you update us on the alcohol dependence studies, what’s going on there?

Joseph Belanoff

Management

Yes, I’d be glad to Roy and thank you for asking about it. I think as many of you know, there is -- who follow the Company more closely, there really is very interesting scientific program, which is now in later years proceeded to a clinical program on the use of cortisol modulation to help with addictions, and you’ve asked specifically about the alcohol addiction, I’ll point to that. Basically, and again I’ll tell the story very briefly. You probably all heard some form of the joke, it's easy to but it's not funny. But it's easy to quit alcohol I’ve done it 100 times, that’s the problem. The problem is that it's actually very stressful for people who are -- used alcohol on a chronic basis to stop drinking. And one of the things that where an intervention really could might be most effective is actually at the beginning as people begin to come off alcohol and see if they can really get them to stay off. And I think that the issue really is that the stress that they feel when they stop drinking is actually very supportive of the cravings they feel to restart drinking. And if it can be modulated in that early period, and essentially in the first few weeks before that, you might really do a much better job of getting people who really do want to quit drinking to be able to quit drinking. And again I’d point you to the academic papers, this started as an animal based model and then ultimately was in a double blind human study which was done at Scripps and is now in a much larger study also being led by Scripps. I know it is enrolled well, it's again not a joke but there are plenty of people who want to quit drinking and we also expect that that data although again I have to always give the same caveat not under our control but that data will actually turnover results in the next 12 to 18 months too.

Roy Buchanan

Analyst

And then just circling back on the 125134, in oncology you guys had the press release with some interesting data in the mouse data graph last week what looks like there was at least a trend of efficacy superior to mifepristone and PD-1 inhibition for 125134. Do you guys have any ideas about a possible mechanism why that might be the case?

Joseph Belanoff

Management

Well you know I have to just answer that more broadly. It's a subtle and interesting question. One of the things that we -- and again I’ll take you back again for context. For those who follow the Company for a long time our initial goal was really to see if we could just create mifepristone without progesterone antagonism for all the reasons we talked about many-many times and really come up with a single follow on drug. But when we started to actually do empirical testing on it we found out that these compounds were not identical although they all shared the property of cortisol modulation with no activity at progesterone. And it really turned out I think again on empirical basis as we started testing them, some were more potent to creating insulin sensitivity, some were more potent to creating weight loss, some got into the brain some didn’t get into the brain. And then as we began to test them in our oncologic models some were more potent in mifepristone and some were less potent in mifepristone. And it turns out that 125134 for reasons we don’t entirely understand but really are exploring with our academic investigators as well as our own work, it's pretty consistent. Mifepristone is a good companion agent in the preclinical model so far 125134 has been even stronger. And we’ll just have to see whether that actually translates to the human effect in the study that Bob and his group are currently running.

Roy Buchanan

Analyst

And then I had a question to follow up also on the, from the prior study of Abraxane plus mifepristone in breast cancer. I think investigators made some comments about metabolic interactions and influencing the dosing, is that not going to be the case with 125134 is it metabolized through different pathway and are you not as worried about potential dosing interactions? Thanks.

Joseph Belanoff

Management

Well, it's actually drug-drug interaction is often something you look at in these early studies. And there is potential for drug-drug interactions with CORT125134. We don’t know exactly how it's going to interact and it's part of what we look at in this form of the study, so, to be determined.

Roy Buchanan

Analyst

And then I had one last question and then get out of the line. But just wondering about partnering interest I assume you’re probably getting inbound interest on the compound. Are you guys aggressively looking for partnering of any of the compounds? You guys have a pretty large library or are partners kind of waiting for to see you guys get through a certain phase of development? Thanks.

Joseph Belanoff

Management

Well, I think that you’re certainly right in a very important regard is that we have a very interesting portfolio of pipeline compounds and maximizing their utility to patients is really our goal. And what can get us there in the most efficient way is what we want to do. I will tell you at this point in time kind of two facts. One, we have the money to advance them in the way that we would like to at this point in time. And I think that’s a very nice position to be in. The other is that we’re really as I tried to point out through this call still really characterizing them. There is still information as to where they will work best that is unknown and I think that they increase in value as we actually do that research and that’s going to happen again as we talked about in the timeframe that I discussed the really again in the next 12 to 18 months we’ll have a lot more information about where these medications are potentially most useful and can have broader conversations on topics at that point. But we have the money to do the information gathering. We think that the information gathering adds value and that’s what we’re doing.

Joseph Belanoff

Management

Okay. All right, well thank you very much for all those who participated in this quarter's call and look forward to talking to you next quarter.

Operator

Operator

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.